VAnnuAl Meeting HtAi 2008

July 6-9, 2008Montréal Canada

HtA in context

Book of Abstracts

Search Instructions The document contains all abstracts received for the Conference as of June 12, 2008. The abstracts are listed in the order of presentation during the conference, including pre-conference workshops and industry symposia. This PDF document offers the feature of searching for any information you are looking for, either a speaker’s or author’s name, a topic or any key word leading to the subject you want to find. The search function goes as follows: 1. Click the Edit button of your tool bar; 2. Click the Search button of the menu; 3. Enter the key word or name you are looking for.

M1.14 - Low level laser therapy: A rapid technology asses sment through an overview of systematic reviews Pwee K.H.1, Subramony H.1, Chin M.C.1 1Ministry of Health, Singapore, Health Technology Assessment Branch, Singapore, Singapore Objective: A rapid review was conducted of the published evidence for the effectiveness of low level laser therapy (LLLT) for various indications, including wound healing and pain relief. The information supported policy development related to licensing of private medical clinics. Methods: A preliminary scan of the literature showed there were a number of clinical trials and systematic reviews on this technology. An overview of systematic reviews was performed to provide the required information. A search was conducted for published systematic reviews and health technology assessments in the NHS CRD databases, the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE and PEDro. Search terms used were (cold OR low OR soft OR acupuncture OR biostimulation) AND laser, and systematic review filters were applied where available. Retrieved systematic reviews were summarised in evidence tables for a qualitative overview. Results: Over 40 systematic reviews were found that covered the use of LLLT for wound healing, pain relief in a variety of musculoskeletal conditions, smoking cessation and tuberculosis. Earlier reviews showed little evidence to support the effectiveness of LLLT, citing few and small clinical trials of poor to moderate quality. It has been recognised that optimum prescribed dosages and regimens have not yet been determined in this developing field. Standards for the conduct of randomised controlled trials and systematic reviews on LLLT have been published and more recent trials have demonstrated some limited effects. Conclusion: The field of LLLT is still developing and more trials should be conducted that meet recommended standards. M1.15 - An example of a “public value” randomized control led trial: Alternative treatments for age-related macular degeneration Reeves B.1, Raftery J.2, IVAN Trialists 1University of Bristol, Clinical Trials & Evaluation Unit, Bristol, United Kingdom, 2University of Southampton, Wessex Institute for Health Research & Development, Southampton, United Kingdom Objective: Licensing trials for Lucentis® to treat wet age-related macular degeneration gave treatment (or sham) monthly for two years and only investigated visual function, providing no evidence about the most cost-effective treatment duration or frequency. The IVAN Trial addresses these evidence gaps. Methods: IVAN is a factorial randomized trial of treatments to Inhibit VEGF in Age-related choroidal Neovascularisation. Participants are randomized to one of four combinations of two treatment factors: (a) Lucentis® vs. Avastin®; (b) monthly intravitreal injection for 24 months vs. monthly intravitreal injection for 3 months with monthly review and retreatment if CNV reactivates. Outcomes are visual acuity (primary), generic and vision-specific health-related quality of life, survival free from treatment failure, and resource use. The primary endpoint is 2 years follow-up. Results: The trial design was negotiated with funders, who ‘fast-tracked’ funding because of a ‘window of opportunity’ for recruitment. The IVAN trialists have encountered significant contractual and other obstacles in establishing the trial: (a) service level agreements with health commissioners for treatment costs; (b) infrastructure to administer treatment and research costs; (c) supply of Avastin®; (d) masking of treatment allocation; (e) publication of interim guidance about introduction of Lucentis® in the NHS. Recruitment is expected to start 8 months after the trial was funded. Conclusions: Health services need mechanisms to: (a) commission trials that have clear public value; (b) fast-track funding where necessary; (c) help trialists to negotiate and administer treatment costs; (d) establish a safe and reliable drug supply in the face of commercial opposition. M1.16 - Mapping a search protocol for interventional proc edures: A case study from gamma

knife technology Wilkinson A.1, Booth A.1 1University of Sheffield, School of Health and Related Research, Sheffield, United Kingdom Objective: To map sources used by Health technology agencies (Htas) when conducting reviews of interventional procedures and investigate graphical methods for depicting a search protocol. Methods: Although agencies increasingly share expertise in bibliographic searching such opportunities could be optimised by presentation of sources as a map. Gamma knife technology was selected as an exemplar topic to investigate different forms of presentation. Systematic reviews on gamma knife undertaken by Htas were identified via the HTAi vortal and Health Technology Assessment Database on the Centre for Reviews and Dissemination website. Retrieved relevant reviews were obtained and examined to establish sources that had been searched. Frequencies were collected for each source and results plotted graphically using different formats. Results: Seven reviews were identified with full text of six available online. [Final analysis will include the seventh review but interim analysis utilises its executive summary] 19 different databases were searched. Each review searched between 2 and 14 databases (median = 8). Only MEDLINE was searched for all reviews. Six other databases were searched for five reviews. PreMedline was separately identified in four reviews. Conclusions: Variation between sources searched is partly explained by differences in access, time and money between assessments. Nevertheless a putative core of sources can be mapped together with areas of variation. Graphical presentation may depict frequency of use and relative importance for multiple sources. The resultant map becomes a generic tool for planning subsequent reviews and facilitating staff training. Further research will explore generic maps by topic or type of intervention. M1.17 - Value of Analysis Analysis in HTA Dowie J.1 1London School of Hygiene and Tropical Medicine, London, United Kingdom Impressive progress has been made in developing analytically rigorous answers to the intervention question: ‘what should we do?’ Bayesian decision analysis answers the research version of this question, as well as the adoption one, providing the basis of Value of Information Analysis. But this progress is not matched by utilisation in public health or clinical medicine. The gap can be traced largely to the failure of analysts (and those who fund and evaluate their work) to accept the need to trade-off analytical rigour and practical usefulness and to treat seriously the question of ‘how should we decide what we should do?’ Paralleling Cost-Effectiveness Analysis for the intervention question, Decision Resources-Effectiveness Analysis is proposed as the analytical route to answering the decision question, as the basis for Value of Analysis Analysis, and as the source of key insights into the gap. In DREA both (Decision) Effectiveness and Decision Resources are multi-attribute index measures reflecting the weighted criteria of the decision owners/makers. We hypothesise that the DE of predominantly analytic Decision Technologies (ADTs) is monotonically increasing relative to DR, but at a diminishing rate, while that of predominantly intuitive DTs (IDTs) peaks early relative to DR and then declines. The Willingness to Decision Resource threshold (lambda) of decision owners/makers will often identify an ADT of much less DE than the current best practice one. However, because of analysts’ failure to endorse the ‘inferior’ ADT, the behavioural consequence M1.18 - The production and utilisation of contextualised evidence to support the introduction of telehomecare Gagnon M.-P.1, Duplantie J.2, Fortin J.-P.3, Lamothe L.4, Légaré F.5, Labrecque M.5 1Université Laval, Sciences Infirmières, Québec, Canada, 2Centre Hospitalier Universitaire de Québec, Centre de Recherche Hôpital St-François d'Assise, Québec, Canada, 3Université Laval, Médecine Sociale et Préventive, Québec, Canada, 4Université de Montréal, Administration de la Santé, Montréal, Canada, 5Université Laval, Médecine Familia le, Québec, Canada Purpose: This study aimed to understand factors and conditions influencing the production and utilisation of scientific evidence regarding the introduction of telehomecare in the Quebec healthcare regional organisation.

Methods: A case study was conducted in order to explore how evidence has been integrated into the decision-making processes during the introduction of a telehomecare system in the region of Gaspésie/Îles-de-la-Madeleine in the province of Quebec. A content analysis of different documents related to the introduction of the telehomecare project was carried out in order to identify the decisions that have shaped the implementation processes. Furthermore, semi-structured 14 interviews were conducted with key decision-makers from organisation, health region, and central instances. Results: Formal and informal exchanges on past telehomecare experiences seem to be the most commonly strategy used by decision-makers to obtain information. However, the need for more scientific knowledge available to ensure better decision-making was mentioned has critical. Nonetheless, many difficulties arise when healthcare professionals have to product those data. While these problems need to be answered, decision-makers highlighted the importance of knowledge sharing between as well as within experimentation sites. Conclusion: Knowledge sharing played an important part on the success of the telehomecare project. An efficient strategy to transfer evidence to support organisational decision-makers might be a forum where end-users can share their experiences and learning and researchers bring their support in providing the ‘scientific’ foundations to this ‘contextualised’ evidence. M1.19 - Multiple roles of health technology assessors (re search team) in guideline development Harstall C.1, Moga C.1, Scott A.1, Taenzer P.2 1Institute of Health Economics, Edmonton, Canada, 2Calgary Health Region, Calgary, Canada Background: A Steering Committee (guides Research Team, provides operational oversight, acts as secretariat to the Working Committee and Advisory Committee), Advisory Committee (advises the Steering Committee on strategic matters), and Working Committee (constructs the guidelines and care pathways), were established for the development of a local guideline for the management of low back pain in primary care. The process required the Research Team to expand their role beyond the traditional one of only generating the evidence base. Methods: The Research Team(RT): identified relevant guidelines (using a modified AGREE tool) on the prevention, diagnosis, and non-surgical interventions; developed standardized definitions for pain; prepared and condensed all the materials to expedite the review by the Working Committee(WC); co-chaired subgroup discussions on selected interventions; prepared meeting documents for the Advisory Committee; and co-chaired the Steering Committee. All WC meetings were conducted via videoconferencing for maximum participation by all Health Regions. Results: The RT played multiple roles during the entire guideline development process, including methodological advancement and translation of the research evidence for the multidisciplinary clinicians on the WC. Active participation on all committees, but especially at all WC meetings was necessary. The innovative approach of presenting seed guidelines and evidence expedited the guideline development process and kept the clinicians actively engaged. Conclusions: The RT identified the following success elements: a flexible, consist, and transparent methodology; credible research; involvement of clinical and policy experts to ensure locally, clinically meaningful guidance; and an open, trusting relationship among all contributors. It was rewarding experience for all. M1.20 - Frequency and determinants of additional clinical interventions in a cohort study of patients with unsuspected findings described in ima ging tests Lumbreras B.1, Gonzalez I.2, Lorente M.F.2, Calbo J.2, Ricci A.3, Aranaz J.3, Hernandez-Aguado I.1, Parker L.-A.4 1Miguel Hernandez University, Public Health, Ciber en Epidemiologia y Salud Publica, San Juan de Alicante, Spain, 2San Juan de Alicante Hospital, Radiodiagnostic, Alicante, Spain, 3San Juan de Alicante Hospital, Preventive Medicine, Alicante, Spain, 4Miguel Hernandez University, Public Health, Ciber de Epidemiologia y Salud Publica, San Juan de Alicante, Spain Objective: The aim of this study was to analyse the frequency and determinants associated with additional clinical interventions initiated as a result of unsuspected findings in imaging tests. Methods: Study of 3,223 patients referred for imaging evaluation between February-November 2006 in San Juan Hospital, Alicante. Two expert radiologists independently classified the imaging reports according to the presence or absence of an unexpected finding (observer agreement 92%). Patients

with incidental findings and a comparable cohort of subjects without unsuspected information were followed-up for 9 months (out-patients) or until the date of discharge (in-patients). Additional clinical interventions, unrelated to the initial diagnosis of the patients, were ascertained from clinical reports. Results: 957 patients were included in the cohort study; 484 presenting unsuspected findings. Overall, 115 clinical interventions were assessed in 60 patients, all with unexpected findings. Frequency of additional clinical interventions was less likely in patients with diagnosis of musculoskeletal diseases than in those with a preoperative diagnosis (adjusted RR:0.36, CI95%0.11-0.63), and also less likely in patients from the oncology service than in those attended in other clinical services (adjusted RR:0.40, CI95%0.19-0.86). The inclusion of precise clinical information in the requesting form was significantly associated with less frequency of clinical interventions (adjusted RR:0.50, CI95%0.26-0.94), compared with minor information. Conclusions: The presence of additional clinical interventions was associated with some variables such as diagnosis, quality information in the order form and type of clinical service. According to these results, it is essential to develop clinical rules of evidence to ma Diagnostic Technologies 1 M2.1 - Film to filmless transition: Productivity tools t o assess the imaging department Lemus-Martinez C.1, Ortiz-Posadas M.R.1, Pimentel-Aguilar A.B.2 1Universidad Autonoma Metropolitana, Ingenieria Electrica, Mexico, Mexico, 2Instituto Nacional de Enfermedades Respiratorias, Ingenieria Biomedica, Mexico, Mexico Objective: To provide a set of indexes designed to assess the productivity changes of an imaging department through the film to filmless transition. Methods: This paper discusses the experience of the National Institute of Respiratory Diseases in México City assessing the transition from the analog to the digital environment of the imaging department, by a set of productivity indexes that were designed for this purpose. Workflow data was collected in situ, to validate these indexes. A format for the definition of each index is provided, where the user will find information as name, purpose and the formula to calculate the index. Another format to track and validate each index is provided, where approaches as reference of acceptance levels, tendencies, evaluation period, and frequency of data acquisition are discussed. This last format offers a dynamic feedback, so its use is suggested as an administrative tool to evaluate the performance of the imaging department in each phase of the transition. Results: A set of indexes is proposed, to lead productivity evaluations of the radiology department. It reaches human resources performance, efficiency of the raw material used, and system performance issues. Conclusion: Radiology decision makers need management evaluation strategies to support and measure productivity changes, as a feedback tool, to guide their Institutions to more prosperous and beneficial stages that ultimately will reflect in an efficiently improved service to the patient. M2.2 - Rapid HTA: Endobronchial ultrasound (EBUS) guided transbronchial lung biopsies (TBLB) for the diagnosis of peripheral lung lesions Low Y.S.1, Koh M.S.2, Phua G.C.2 1Singapore Health Services, Singapore, Singapore, 2Singapore General Hospital, Department of Respiratory & Critical Care Medicine, Singapore, Singapore Objective: Obtaining histology is important in diagnosing and planning treatment for lung cancer. Endobronchial ultrasound (EBUS) uses ultrasonograpy to guide bronchoscopic localization and biopsy and is believed to be ‘safer’ and more accurate than existing modalities of percutanoues biopsy and standard bronchoscopic biopsy. This review compares the yield and complication rates of EBUS guided transbronchial lung biopsy (TBLB) with TBLB without EBUS and CT-guided transthoracic needle aspiration (TTNA) for the diagnosis of lung cancer in patients with peripheral lung lesions. Methods: We searched the databases Centre for Reviews & Dissemination, Cochrane, Medline and National Guidelines Clearinghouse from 2000 onwards and found 3 reviews, no economic evaluations, 2 guidelines and 2 new primary studies (1 case-control, 1 RCT). Results: Studies covered by the systematic reviews were mainly large case series establishing an overall diagnostic yield of approximately 60%. EBUS-TBLB consistently had higher sensitivity and

specificity than standard bronchoscopic TBLB especially for small lesions and reported fewer complications. A newly published case-control study reported that EBUS-TBLB had significantly fewer complications than CT-guided TTNA (0.7% vs 23%). Recognizing its safety and high yield, the American College of Chest Physicians recommended EBUS-TBLB in assessing histologically small lung lesions (<2cm). Conclusions: EBUS-TBLB has higher diagnostic yield than standard bronchoscopic TBLB and lower complication rates than CT-TTNA for the diagnosis of small peripheral lung lesions. The relatively low cost of adding ultrasound visualization to enhance safety and clinical performance makes EBUS a worthy option, especially in the early diagnosis of peripheral lung cancer. M2.3 - An evaluation of diagnostic tests for acute appen dicitis in adults Ng K.P.1, Molina J.A.1, Heng B.H.1 1National Healthcare Group, Health Services and Outcomes Research, Singapore, Singapore Objective: To determine the accuracy of various diagnostic tests for acute appendicitis (AA) in adults. Methods: A literature search was performed using the PUBMED database. Search terms used were: accuracy, diagnosis, appendicitis. All prospective or review articles on diagnostic accuracy of AA using adult population were selected for review. A cost analysis of the diagnostic tests was also done for hospitals within the National Healthcare Group (NHG) in Singapore. Results: From the literature review, the computed tomography scan (CT) was the most accurate in terms of both sensitivity and specificity. Sensitivity ranged from 87-100%, while specificity ranged from 86-100%. CT with contrast reported better positive predictive values than un-enhanced CT. Ultrasonography scan (US) was reported to be less accurate than CT; sensitivity ranged from 77-98%, while specificity ranged from 81-98%. Though CT with contrast seemed to be the diagnostic test of choice, the cost incurred could be more than $200 000 if routinely used for all patients with suspected AA across NHG hospitals. Cost associated could be reduced with a more selective approach for use of CT. Conclusions: CT with contrast is the test of choice to improve diagnostic accuracy of suspected AA, but has a high associated cost. M2.4 - A comparison of CT and MRI services in Alberta wi th those in other health systems Hailey D.1 1Institute of Health Economics, Edmonton, Canada Objective: To describe the efficiency of CT and MRI services in Alberta through comparison of scanner utilization and wait times with data from other health systems. Methods: Data for CT and MRI services in Alberta were obtained from its health ministry and those for other Canadian jurisdictions mainly from the Canadian Institute for Health Information. Sources of information for other countries included the OECD and professional bodies. Results: Alberta has fewer CT scanners per population and more exams per scanner than most other provinces and OECD countries. Number of exams per population is close to the Canadian average and higher than for European countries. Wait times for CT exams meet provincial access goals, and are similar to those for Ontario and England. In contrast, MRI scanners and MRI exams per population in Alberta are higher than for any other province and above the median values for OECD countries. Number of exams per scanner is near the average for Canada and higher than for European countries. Wait times are higher than in Ontario and 12 European countries, and well above provincial access goals. Conclusions: Alberta is performing well in terms of frequency of use and access to CT services. Demand and wait times for MRI services are high compared with those in other health systems. Increasing the number of scanners, or hours of operation are options, assuming availability of staff and funding, but it first seems necessary to determine why there is a high demand for MRI exams. M2.5 - Description of incidental findings in imaging dia gnostic tests: A systematic review Lumbreras B.1, Donat L.1, Hernandez-Aguado I.1, Parker L.-A.2 1Miguel Hernandez University, Public Health, Ciber en Epidemiologia y Salud Publica, San Juan de

Alicante, Spain, 2Miguel Hernandez University, Public Health, Ciber de Epidemiologia y Salud Publica, San Juan de Alicante, Spain Objective: The aim of this systematic review was to explore the available evidence on incidental findings in imaging diagnostic tests and associated factors. Methods: Articles were identified by systematic search of MEDLINE using appropriate medical headings (December-2007). We included original papers describing incidental findings in imaging tests. Selection of papers was performed independently by two reviewers (agreement 89%). The variables extracted were: year, study design, sample size, initial diagnostic, imaging technique, frequency and localization and follow-up of the findings. Results: 251 potentially relevant abstracts were identified and 48 articles were finally retrieved. The year of publication ranged from 1986 to 2007. More than half of the studies were focused on the application of computed tomography (CT) (26, 54%) and the main initial diagnosis was neoplasm (16, 33%). The frequency of incidental findings ranged from 1 to 100% (median 12%, IQR 3-31%). Incidental findings were more frequent in CT than in other techniques (medians 17% vs 5%; p=0.09). Studies with a lower sample size described a higher frequency of unexpected results than those with higher sample size (p=0.001). 42 articles (88%) reported further evaluations of the incidental findings. All incidental findings in patients with neoplasm were further investigated; in patients with other diagnosis the median of follow-up was 56.5% (p=0.027). Any study analyzed the clinical relevance of the findings. Conclusions: Incidental findings are frequent in imaging tests, particularly in more sensitive techniques such as CT. The clinical and health impact of these unexpected findings is largely unknown and deserve further research. M2.6 - Assessing the quality of diagnostic before-after studies Meads C.1, Albon E.1, Davenport C.1 1University of Birmingham, Public Health and Epidemiology, Birmingham, United Kingdom Objective: HTAs of diagnostic yield studies are rare. One methodological challenge is how to quality-assess included studies. Currently there is no agreed or validated quality checklist for diagnostic before-after studies. Methods: An HTA was undertaken of the clinical and cost-effectiveness of structural neuroimaging (structural MRI and CT scanning) compared to selective screening only where clinically indicated, in patients with psychosis. Twenty-four included diagnostic before-after studies reported any additional diagnostic benefit of structural MRI, CT or combinations compared to normal diagnostic workup. At the start of the HTA, quality assessment methods were not clear. Several checklists were assessed for relevance. Results: A modified QUADAS checklist was found to be the most appropriate and was piloted. Two of the QUADAS checklist items were irrelevant for diagnostic before-after studies. Q3 was removed because there were multiple target conditions and Q7 because the ´index test´ (normal diagnostic workup) was part of the reference standard. 2-3 other questions did not help discriminate between good and poor quality studies but were included because they could have been relevant. Additional quality items used included consecutive recruitment, prospective data collection, whether the number of patients not scanned was explained and who did image analysis. Conclusions: The HTA found that structural neuroimaging identified litt le to influence patient management that was not suspected from medical history and/or physical examination. Quality assessment helped considerably to drive report conclusions. The modified QUADAS checklist used needs to be validated in a similar way to other frequently used quality checklists. M2.7 - Management of abdominal malignancies: Does CT sca n help in patients’ selection for surgery? Khaliq T.1, Saaiq M.1, Ahamad Z.1 1Pakistan Institute of Medical Sciences, HTA Forum/ Department of Surgery, Islamabad, Pakistan Objective: To compare the CT scan findings with per-operative findings in patients with various abdominal malignancies and determine the impact of CT scan on the management outline. Study design: Retrospective chart review. And was carried out was carried out in the Department of

Surgery, Pakistan Institute of Medical Sciences (PIMS), Islamabad and included patients managed between Jan 01, 2007 to Dec 31, 2007. Materials and methods: 100 patients of either gender who presented with various abdominal malignancies were included in the study. Children below 14 years of age and patients with non-malignant masses were excluded. Results: Out of 100 patients, 60% (n=60) were males while 40% (n=40) were females. The age range was 29-72 years with mean age 33.41 ± 15.99 years. 77 patients were subjected to laparoscopy / laparotomy while the remaining 23 patients were not considered for any surgery because of locally advanced disease, ascites and / or distant metastasis. Among the 77 patients, 68 underwent laparotomy without laparoscopy while 9 patients had an initial laparoscopic assessment and only 3 of these were further subjected to laparotomy. The CT scan and per-operative findings matched in 67 patients (87.01%) while differed in only 10 cases (12.98%). (p<0.05). Conclusion: Pre-operative CT scan assessment provides correct information in a statistically significant number of patients with various abdominal malignancies. Hence it should be performed in all such patients and assessed accurately in order to avert un-necessary laparotomy / laparoscopy. Key words: Abdominal malignancies. CT scan assessment. Laparotomy. Laparoscopy. M2.8 - When to use optical coherence tomography (OCT) in retinal disease Carbonneil C.1, David D.J.1, Lee-Robin S.H.1 1Haute Autorité de Santé, Department of Medical and Surgical Procedures Assessment, Saint Denis La Plaine, France Objective: Optical Coherence Tomography (OCT) is an innovative, easy-to-perform, non-invasive, contact-free imaging technique that has potential benefit in most of the diseases affecting the retina and leading to blindness. In France, its use increased by 50% in 2006. HAS assessed its diagnostic performance in different retinal diseases in order to establish appropriate indications. Methods: We performed a systematic review of the literature on the use of OCT (1996-2007). The review was discussed by 4 ophthalmologists and then submitted to the relevant HAS Committee for their official opinion. Results: OCT is indicated as a first-line diagnostic procedure and to monitor the effect of treatment in (i) macular (diabetic) oedemas - it can be performed in addition to colour stereophotographic retinography in diagnosis; (ii) diseases of the vitreoretinal interface; (iii) open-angle glaucoma where it is performed in addition to standard techniques (perimetry, tonometry and gonioscopy). It is not suitable for screening for glaucoma. OCT is indicated as a second-line procedure in age-related macular degeneration (ARMD), severe myopia with choroidal neovessels, and diabetic retinopathy. It is a complement to the standard procedure (angiography) when diagnosing retinal or choroidal neovessels or monitoring the effects of treatment. Conclusions: HAS recommended the use and reimbursement of OCT in the above indications only. It stressed the need for further studies comparing OCT with the use of antiangiogenic molecules for the treatment of ARMD, as well as the need for health economics studies. M2.9 - Detecting mycobacteraemia for diagnosing tubercul osis in a group of patients in Medellín-Colombia Hernandez Sarmiento J.M.1, Jaramillo A.1, Mejia G.I.1, Mary Alejandra R.2, Jaime R.2, Unidad de Bacteriologia y Micobacterias 1Universidad Pontificia Bolivariana, Corporación para Investigaciones Biológicas CIB, Medellín, Colombia, 2Corporación para Investigaciones Biologicas, Medellín, Colombia Objective: This study evaluated the prevalence of Mycobacterium tuberculosis in patient’s suspect of having pulmonary or extrapulmonary TB and HIV/AIDS. Methods: Were enrolled 47 patients. Three different samples were taken from all patients, two blood samples and a third sample from the affected organ. The first blood sample was collected in a BACTEC MYCO/F LYTIC bottle, and incubated in a BACTEC 900 MB(BD) system. The second sample was collected in a CPT BD tube, and centrifuged to obtain white blood cells that were

inoculated in 7H9 BACTEC MGIT 960 (BD) and in slim cape 7H11. The third sample came from the affected organ. (sputum, bronchial wash, or other). Results: We discovered that in 10 (21%) of patients Mycobacterium was isolated in at least one of the samples taken. In 6 (60%) was isolated Mycobacterium in blood culture. (Commercial BD and 7H11) 4 samples were identified as M. tuberculosis and 2 as M. avium. The blood culture was the first method to confirm the diagnosis in all of 6 cases, and in 4 it was the only positive specimen. Conclusions: We conclude that the detection of mycobacterium in blood is a useful diagnostic tool in patients with HIV/AIDS not only for the detection of M. tuberculosis, but other species as well. The culture method of the white blood cells can be a good alternative due to cost and time consuming for diagnosis, but is important that this method continue been evaluated to get optimal results. M2.10 - Anticipating and improving drug response by testi ng for cytochrome P450 polymorphisms Fleeman N.1, Dickson R.1, Dundar Y.1, McLeod C.1 1University of Liverpool, Liverpool Reviews & Implementation Group (LRiG), Liverpool, United Kingdom Individual patient response to drug therapy is highly unpredictable. A group of enzymes known as the cytochrome P450 (CYP450) enzymes have been identified as playing a major role in the way patients metabolise a variety of pharmacological agents (e.g. warfarin, anti-depressants, anti-psychotics, cancer treatments). However, three broad areas need to be considered: evidence for the precision of testing (analytic validity); evidence for the relationship between testing and improvements in outcomes in terms of drug metabolism, drug efficacy and adverse drug reactions (clinical validity); evidence for whether testing results are useful in medical, personal, or public health decision making (clinical utility). Current research in the area of warfarin is advanced and trials are now commencing to assess the effectiveness of CYP450 screening in clinical practice. A recent review of the use in the area of anti-depressants identified gaps in the evidence base and the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group have not recommended the use of CYP450 testing in the treatment of depression. Currently a review in the area of the use of antipsychotics is being carried out and one is planned for later this year in the area of the use of tamoxifen in breast cancer. This presentation will present the results of the currently available reviews and then will go on to outline some of the challenges to be faced by HTA policy makers as we move into this complex and controversial area. M2.11 - Dedicated and moderate field MR for osteoarticula r imaging: Weak evidence of clinical utility, some cost advantages but French regulatory constraints discourage their diffusion Dowidar S.1, Charpentier E.1, Baffert S.1, Fay A.-F.1, Galmiche H.2, Montagnier-Petrissans C.1 1Assistance Publique - Hopitaux de Paris, CEDIT, Paris, France, 2Haute Autorité de Santé, DEMESP, Saint Denis, France Objective: To assess moderate-field MR (<1T) imaging and dedicated MR imagers in osteoarticular indications. Context: University hospital setting in France. Methods: Market, technical and regulatory analysis, systematic review of the literature, cost analysis. Results: Some dedicated imagers (mostly ≤0.5 T) and open moderate-field full-body systems are currently proposed; the moderate-field systems have both theoretical advantages (lesser artefacts due to metallic bodies, feasibility of interventional procedures in open systems) and theoretical drawbacks (lower signal-to-noise ratio, longer examination times, smaller fields-of-view). Some evidence was found 1/ against their use in traumatology in substitution to high-field MR; 2/ in favor of their use as a complement to conventional RX imaging, 3/ in favor of their use in the early diagnosis of chronic rheumatoid polyarthritis (nonwhistanding a steep learning curve), 4/ in favor of interventional procedures over conventional or arthroscopic surgery; however, the evidence is weak and high-evidence-level studies are needed. Dedicated systems are cheaper (-1.2 M�) than high-fie ld system, leading to lower annual costs (-0.5

M�/y) and examination costs (/2). However, this potential interest may be ineffective due to a constrained authorization allocation system for these equipments, favoring the choice of high-field, full-body, possibly open, systems. A cooperation between radiologists and clinical experts appears currently indispensable. Conclusions: The CEDIT concluded to a temporary lack of evidence in favor of the use of those systems. A wider-range assessment of moderate-field MR systems in a larger scope of indications is currently undertaken by the French national health authority (HAS). Economic Analyses 1 M3.1 - A microsimulation economic model to evaluate the disease burden associated with smoking in Argentina Pichon-Riviere A.1, Augustovski F.1, Bardach A.1, Colantonio L.1, Rubinstein A.1 1Institute for Clinical Effectiveness and Health Policy (IECS), Capital Federal, Argentina Objective: To perform a comprehensive evaluation of tobacco-related disease burden in Argentina, including both its health effects and its economic impact. Methods: A first order Monte Carlo, or probabilistic microsimulation of individual patients was built, incorporating the natural history, costs and quality of life impact of all the tobacco-related adult diseases: coronary and non-coronary heart diseases, cerebrovascular disease, COPD, pneumonia/influenza, lung cancer as well as 9 other neoplasms. Systematic searches were performed in bibliographic database, grey literature and experts. Results: The model showed adequate internal validity, with all simulated events rates falling within ±10% of the source publications. R2 between predicted and observed values ranged from 0.758 to 0.999. Third order validation showed an excellent correlation between published data and model results. Health conditions related to smoking were responsible of 129,630 annual deaths in Argentina, 25% of them (32,167) attributable to tobacco. The annual costs for the country were of about $9.5 billion pesos (Argentinean pesos, 2006), smoking being responsible for 34%. Male smokers lost 5.5 years of life expectancy as compared to their non-smoking counterparts. A total of 721,285 total annual DALYs were attributable to tobacco use, among which the main conditions were cardiovascular disease, lung cancer and COPD. Premature deaths accounted for three quarters of DALYs. Conclusions: These results confirm the local relevance of smoking as an important health an economic burden in our country. They may be of great importance as strategic inputs for decision-makers, facing the ratification of the Framework Convention on Tobacco Control goals. M3.2 - Effectiveness and cost-effectiveness of antidepre ssants and psychological interventions Perestelo-Pérez L.1, García-Pérez L.1, Peñate-Castro W.2, Pérez-Ramos J.1 1Canary Islands Health Service, Evaluation and Planning Unit, Santa Cruz de Tenerife, Spain, 2University of La Laguna, Personality, Evaluation and Psychological Treatments, La Laguna, Spain Background: Depression is associated with considerable morbidity and mortality which contribute substantially to the indirect cost of the illness, as well as quantifiable direct costs of medical intervention and community care. Successful treatment can be expected to reduce the overall costs of depression to society. Objectives: To provide an update review of the best quality evidence for the clinical effectiveness and cost-effectiveness of combined therapy (antidepressants and psychological interventions) in depressed patients. Methods: A systematic review of the literature (published in Spanish and English) and an economic evaluation were undertaken to identify clinical utility and cost data. Electronic databases (Cochrane Library, CRD, Medline, Embase, CINAHL, PsycINFO) were reviewed until July 2007. Four independent reviewers considered studies for inclusion and extracted the data; conflicts were resolved by consensus. An analysis was then conducted to compare the benefits and costs of the combined therapy, aimed in selective serotonin reuptake inhib itors, serotonin and noradrenaline reuptake inhib itors and tricyclic antidepressants to pharmacological therapy and centred in cognitive behaviour therapy and interpersonal therapy to psychological therapy. Results: Selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors and

psychotherapy (primarily cognitive behaviour therapy and interpersonal therapy) were more effective and cost-effective at promoting remission than control conditions. Conclusions: Combination of antidepressants and psychotherapy is likely to be a cost-effective first-line secondary care treatment for severe depression. Its cost-effectiveness for patients with mild or moderate depression is more uncertain from current evidence. M3.3 - Analogue insulins - Diabetes as a priority of hea lth research in Ministry of Health of Brazil Laranjeira F.O.1, Tolentino M.1, Camargo E.B.1, Silva E.N.1, Serruya S.J.1, Elias F.T.S.1 1Ministry of Health of Brazil, Department of Science and Technology, Brasília - DF, Brazil In 2007, the Department of Science and Technology of Ministry of Health, which objectives to promote and sponsor strategic health researches, determined research priorities in Health Technology Assessment with technical areas from the Ministry. From this partnership, it was obtained as result a public call for research issues in priority areas in Brazil, as diabetes. This issue was considered relevant mainly because insulins are the technologies more frequently asked by judiciary actions referring to diabetes. On Brazilian Public Health System, the available treatment to T1DM is NPH insulin, which allowed reducing the severe complications’ prevalence. In this scenario, a project about the cost-effectiveness analysis of recombinant analogue insulins for type 1 diabetes (T1DM) was promoted. After the judgment of proposals, two projects were selected about cost-effectiveness and quality of life, based on secondary data. Quality of life is an important variable, in being the mainly treatment’s aim and in increasing patient’s adherence. Both selected projects have used short time models (decision analysis) and long-time models (Markov model). These models make the projects robust relating to outcomes and costs measurement - chronic complications and life time events. The importance of cost-effectiveness analysis in developing countries must has been shown, aiming the health system’s sustainability and the guarantee of patients’ access to the best available treatment. With the results of the sponsored researches, we wish to support the Council of Technology Incorporation’s decisions. M3.4 - Angioplasty: Cost-effectiveness of drug-eluting s tents versus bare metal stents Kruse M.1 1University of Southern Denmark, National Institute of Public Health, Copenhagen, Denmark Objective: Angioplasty (PCI) is increasingly used for treatment of coronary heart disease in Denmark as well as internationally. In 90-95 percent of angioplasties, a stent is implanted in the artery. The physician chooses between two types of stents: bare metal stents (BMS) and drug-eluting stents (DES). A preference for DES is usually related to the lower re-revascularisation rate although DES as a technology is more costly in the very short run. Within the past two years, some studies have found a higher risk of in-stent trombosis (a rare, but severe and potentially fatal complication) in DES. There is no consensus regarding difference in mortality between the two. The aim of the paper is to compare two substitutable treatments: A: (BMS) cheaper, with a high risk of a mild complication (and perhaps more costly in longer run). B: (DES) more costly, with a low risk of a severe, potentially fatal, complication. Methods: Data from a clinical database (Danish Heart Register) combined with data from a small survey (200 patients), including EQ5D and SF-36. Cost data are retrieved from hospital accounts and a time study of PCI’s. The study is register-based. Patients are selected to one of the two treatments according to current practice in the analysed hospital, which is not related to patient characteristics. QALY’s are computed on the basis of EQ5D responses and observed differences in 2 year mortality. Readmissions are included on the cost side. Results: Results await 2-year mortality figures but will be presented at the conference. Conclusions: M3.5 - An analytic model for economic evaluation of immu noprophylaxis against respiratory syncytial virus with palivizumab in children

Wang D.1, Cummins C.2, Bayliss S.1, Sandercock J.1, Burls A.1 1Birmingham University, Birmingham, United Kingdom, 2Institute of Child Health, Birmingham, United Kingdom Objective: The objective of this study is to identify the groups of high risk children in which prophylaxis with palivizumab may be good value for money. Methods: An analytic model was constructed to access the long-term impact of palivizumab on morbidity and mortality of respiratory syncytial virus. The values of the model parameters were obtained (by meta-analysis when possible) from studies identified during the search for systematic reviews of clinical effectiveness and cost-effectiveness. We undertook a further search for prognostic studies. Results: The model showed that palivizumab does not reach the UK conventional levels of cost-effectiveness in any of the licensed indications if used for all eligible children. Subgroup analyses found the following high risk children groups in which the incremental cost-effectiveness ratios (ICERs) were below the UK threshold of £30k/QALY. (1) children with chronic lung disease (CLD) who are under six months old and born under 26 weeks gestational age; (2) children with CLD who also have a sibling in day care or school and under nine months old, born under 26 weeks gestational age. No prognostic studies were found for children with congenital heart disease (CHD). Conclusions: The use of palivizumab may be cost-effective, at the UK threshold, for some children with CLD who have a combination of other risk factors (low gestational age, low birth age, siblings in day care or school). It appears reasonable to extrapolate the findings for children with CLD to those with CHD, although prematurity is much rarer in the latter group. M3.6 - Economic evaluation in context: The case of inten sive blood-glucose control with metformin versus usual care in overweight type 2 di abetes mellitus patients in Beijing, P.R. China Xie X.1, Vondeling H.2 1MSc Public Health Educational Programme, Health Sciences Faculty, University of Southern Denmark, Montreal, Canada, 2Institute of Public Health, University of Southern Denmark, Department of Health Economics, Odense C, Denmark Objective: The UKPDS 34 and 51 showed that intensive blood glucose control with metformin is cost-saving and increases life expectancy in overweight type 2 diabetic patients in the United Kingdom. Diabetes is becoming an important health problem in urban China. This study addresses the effects and costs of intensive blood glucose control in this setting, aimed at supporting decision making on the allocation of scarce resources. Methods: A decision analytic model was developed to estimate the costs and effectiveness of intensive blood glucose control in overweight type 2 diabetes patients in Beijing, compared with usual care in accordance with clinical practice. The analysis was carried out from a health care perspective. Results: After 20 years of follow-up the incremental costs per QALY gained (ICER) was 90.1 K RMB (11.7 K US$), compared to 74.3 K RMB (9.6 K US$) after 30 years (lifetime) follow-up using a 3% discount rate. The ICER is sensitive to the costs of medication alternatives for metformin in the intensive treatment group and to the discount rate. Conclusions: Interpretation of the findings depends on the maximum willingness to pay for a QALY in China, which has not been officially been defined. If this would be three times the GDP per capita, a value that has been suggested in the literature, lifetime intensive blood glucose control is likely to be cost-effective. Our findings differ from the UKPDS studies and emphasize that generalizing the results of studies across countries requires considerable adaptation to the local context. M3.7 - Estimates of the costs of NAT for screening of HI V or hepatitis C virus infection in blood donations in Brazil Araujo M.A.M.1, Gava C.M.1, Garcia G.C.1, Vieira E.2, Almeida R.T.2, d’Oliveira A.L.P.1 1ANVISA, NUREM, Brasilia, Brazil, 2ANS, GEATS, Rio De Janeiro, Brazil

Objective: The implementation of nucleic acid amplification testing (NAT) for screening of blood donations imposes multiple imperatives to the Brazilian National Health System, one of which is cost. In this study, we estimated the cost of NAT in one year of blood donations, and the cost per prevented contaminations of HIV and HCV during one year. Methods: To estimate the cost related to NAT for screening of HIV and HCV in a year of blood testing, we used the number of blood donations during 2002 in Brazil, and the price per donation of NAT. To estimate the cost per prevented contaminations of HIV and HCV during a year we calculated the cost per QALY saved for HIV plus HCV, and the costs for prevented HIV or HCV contaminations using NAT. Results: There were a total of 3,035,748 blood donations in Brazil in 2002. It was estimated an expenditure of $91 millions/year with NAT applied on individual donations (ID-NAT) or on minipools (MP-NAT). The prevented contaminations for HIV using NAT were estimated as 0 to 23/year and for HCV as 0 to 131/year. Using the best scenario, the costs per prevented contamination were estimated as $1,782,066.00 for HIV and $153,198.00 for HCV. Conclusions: Considering the high cost estimates of NAT for screening of HIV or HCV infection in blood donations, further studies are needed to evaluate the economic burden of this blood testing strategy in Brazil. M3.8 - Cost-effectiveness and cost-utility of risedronat e for osteoporosis treatment and fracture prevention in women: A Swiss perspective Wasserfallen J.-B.1, Krieg M.-A.2, Greiner R.-A.3, Lamy O.2 1Lausanne University Hospital (CHUV), Medical Direction, Lausanne, Switzerland, 2Lausanne University Hospital (CHUV), Internal Medicine, Lausanne, Switzerland, 3Health Economics Consultant, Lörrach, Germany Objective: To assess the cost-effectiveness and cost-utility of risedronate in postmenopausal osteoporotic women, along different risk profiles using computer modelling. Methods: A previously validated Markov model was used and populated with mortality, fracture incidence and cost data specific to Switzerland, published utility values, and run on a population of 1000 women of 70 years with previous vertebral fracture, treated over 5 years with risedronate 35mg weekly (base case). Another 119 scenarios were investigated in 5 cohorts (according to age at start of therapy) with 8 risk factor distributions and 3 lengths of residual effects after end of risedronate administration. Sensitivity analyses included the effect of input parameter variation on key outcomes. Outcomes were cost per hip fracture averted, cost per any fracture averted and cost per quality-adjusted life year (QALY) gained. Results: Risedronate therapy proved to be dominant strategy in base case population. In presence of a previous vertebral fracture, risedronate was dominating in all scenarios from age 65 and even at age 60 when assuming a 5-year residual effect. For all osteoporotic women >60 years of age with at least one risk factor, cost-utility ratio ranged from below �30´000 to cost-saving. Age at start of therapy and fracture risk profile had a significant impact on results. Sensitivity analysis did not markedly change results. Conclusions: Assuming a 2 year residual effect, cost-utility ratio of risedronate in women with postmenopausal osteoporosis is below accepted thresholds from age 60 and even cost saving above the age of 65 for all risk scenarios. M3.9 - Economic evaluation of safety improvements in hea lthcare - Which health and non-health attributes of safety are considered most imp ortant by healthcare decision-makers? Steuten L.1, Buxton M.1 1Health Economics Research Group (HERG) - Brunel University, Multidisciplinary Assessment of Technology Centre in Healthcare (MATCH), London, United Kingdom Introduction: There is a need for economic evaluation in assessing the value of safety, but concerns exist as to what extent standard health economic methods appropriately reflect this value, since these methods do not typically incorporate the extra-consequentialist or non-health value of avoiding healthcare incidents. Objective: Identifying health and non-health attributes of safety that are considered most important by

healthcare decision-makers and could be part of a conjoint analysis (CA) to determine the cost-benefit of safety interventions and willingness-to-pay (WTP) of decision-makers. Methods: A literature review and 25 semi-structured interviews have been conducted with healthcare decision-makers experienced in safety management, considering a general healthcare, MRSA and sharps injuries context. Results: The literature review showed that in addition to likelihood of an incident and its direct medical and cost consequences, factors as preventability, dread, controllability and trust in safety devices or systems affect the value of safety and decision-makers’ WTP. The interview results consistently indicated that ‘preventability of healthcare incidents’, ’health consequences’, ‘financial consequences’ and ‘trust in safety systems / devices’ are the most important attributes across all contexts. In addition, ‘likelihood’ ranked relatively high in a general healthcare and MRSA context; ‘controllability’ in MRSA and sharps injuries; ‘dreadfulness’ in the general healthcare context and ‘voluntariness’ in the context of sharps injuries. Conclusion: A set of four common attributes including health and non-health aspects of safety was identified. The challenge remains for attaching levels to these attributes and linking the results of a subsequent CA to the standard cost-benefit framework. M3.10 - Cost effectiveness of implantable cardioverter-de fibrillators for primary prevention in a Belgian context Neyt M.1, Thiry N.1, van den Oever R.2, Galloo P.2, Vanoverloop J.2, Ramaekers D.1, Van Brabandt H.1 1Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium, 2Intermutualistic Agency (IMA/AIM), Brussels, Belgium Objective: In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), in patients with heart failure and a poor left ventricular function, implantable cardioverter-defibrillator (ICD) therapy reduced overall mortality by 23 percent compared with conventional therapy. Based on this trial, we assessed the cost-effectiveness of primary prevention ICD therapy versus conventional therapy from a Belgian health care perspective. Methods: We developed a 1-month cycle Markov model populated with SCD-HeFT clinical and effectiveness data and with real-world national cost data. Results: ICD therapy results in respectively 1.22 life-years gained (LYG) or 1.03 quality-adjusted life years (QALY) gained. The lifetime cost-effectiveness and cost-utility ratios were �60,000 (95% CI: �35,900 - �113,500) per LYG and �71,500 (95% CI: �40,200 - �134,600) per QALY gained. A cost-effectiveness ratio <�50,000 was obtained in 15.5% of 1,000 simulations. Increasing the service life of the device from 5 to 7 years would improve the cost-effectiveness to �57,200 (95% CI: �32,600 - �106,400) per QALY gained. Conclusions: Compared to currently accepted threshold values for an incremental QALY, ICD therapy may not be judged cost-effective for the primary prevention of death in patients with a SCD-HeFT profile in the Belgian context using current technology and patient selection. M3.11 - Estimating the health benefits and costs associat ed with ezetimibe co-administered with statin therapy in patients with established ca rdiovascular disease Ara R.1, Pandor A.1, Duenas A.1, Paisley S.1, Chilcott J.1 1The University of Sheffield, Health Economics and Decision Science, Sheffield, United Kingdom Objective: To evaluate the potential long-term cost-effectiveness of the combination treatment, ezetimibe plus a statin, compared with statin monotherapy in patients with established cardiovascular disease in the UK. Methods: A Markov model was used to compare ezetimibe and statin combination therapy with statin monotherapy. A published relationship linking changes in LDL-c and cardiovascular events was used to estimate the cardiovascular events avoided through lip id lowering therapies. The model was populated using results of extensive literature searches and a meta-analysis of clinical evidence. An adjustment was applied to model second line lipid lowering benefits. Conservative assumptions were employed to extend the patient pathway beyond the clinical evidence. Results: For a cohort of 1,000 patients aged 55 years, ezetimibe co-administered with current statin therapy is estimated to prevent on average 43 non-fatal MIs, 7 non-fatal strokes and 26 cardiovascular deaths over a lifetime compared with doubling the current statin dose. The events avoided provide an

average of 134 additional quality adjusted life years (QALYs). With a mean incremental cost of £3,693k, the lifetime discounted cost per QALY is £27,475 (95% CI: £27,331 to £27,620) and rises to over £30k for cohorts aged 75 years. Conclusions: Our results suggest that ezetimibe is not a cost-effective alternative in the majority of cases. The economics need to be revisited when long term effectiveness data demonstrating the benefits of ezetimibe in terms of clinical events and the corresponding safety profile emerge. M3.12 - Estimation of the burden of disease attributable to modifiable risk factors and cost-effectiveness of preventive interventions to reduce cardiovascular disease in Argentina Rubinstein A.1, Colantonio L.L.1, Bardach A.L.1, Caporale J.L.2, Kopitowski K.3, Gibbons L.L.1, Alcaraz A.L.1, Augustovski F.L.1, Garcia Marti S.L.1, Pichon Riviere A.L.1 1Institute of Clinical Effectiveness and Health Policy, Buenos Aires, Argentina, 2CENEXA, University of La Plata, La Plata, Argentina, 3Division of Family and Community Medicine, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina Objective: To provide information on disease burden associated with modifiable risk factors (MRF) of cardiovascular disease (CVD) in Argentina, including health effects, economic impact and cost-effectiveness (CE) of different interventions. Methods: An epidemiological model was built incorporating prevalence and distribution of high blood pressure, high cholesterol, high glycemia, high body weight, smoking, sedentary lifestyle and unhealthy food habits, obtained from the Argentine Survey of Risk Factors (ASRF) to determine population attributable fraction (PAF) of MRF on ischemic heart disease (IHD) and stroke. Events incidence was calibrated against national registries. Costs were calculated from local utilization databases and unit costs. QALYs were based on EQ5D information from the ASRF and DALYs from the GBD project. Results: PAF of MRFs explained more than 80% of events. Annual costs of acute and ambulatory events were A$1,221.6 and A$ 617.3 millions for IHD and stroke. Loss productivity costs had a maximum of A$ 1,315.0 and A$ 1,376.5 millions for IHD and stroke. We analyzed CE of 9 interventions, 2 targeted to the population (reduced salt in bread and a media campaign on healthy habits), and 7 to individuals (counseling for healthy diet, smoking and exercise, pharmacological treatment of HBP, high cholesterol and tobacco cessation, and a polypill intervention targeted to subjects > 55 regardless of their CV risk). Reduced salt in bread and polypill strategy were the most cost-effective interventions. Conclusions: This model, based on local data, creates a friendly framework to make informed decisions on resource-allocation to reduce the burden of CVD in LMICs. M3.13 - Latent cost-benefit of inhaled insulin therapy fo r diabetes mellitus Hisashige A.1 1Institute of Healthcare Technology Assessment, Tokushima, Japan Objectives: Recently, instead of injection, several alternative delivery systems have been developed for insulin therapy of diabetes mellitus. Dry powder inhalation is the first application to be used in clinical practice. Latent cost-benefit of inhaled insulin was estimated in the context of the Japanese National Health Insurance, based on the results of a conjoint analysis. Methods: To estimate the latent cost-benefit of inhaled insulin therapy in Japan, firstly, costs were estimated and compared between inhaled and subcutaneously injected insulin therapies under several hypothetical pricing scenarios of inhaled insulin. Secondly, benefits were estimated by a conjoint analysis. Results: In the scenarios, 60% and 30% of a premium rate of price for new drugs, incremental costs of inhaled insulin therapy were $12.5 and - $6.8, respectively. In the case of costing approach, where a recent market price in the US was applied for a surrogate, its incremental cost was $84.7. In considering willing to pay for inhaled insulin (i.e., $25.1), the net benefits of the former two scenarios were positive, while that of the latter scenario was negative. Discussion: This study shows that the latent cost-benefit of inhaled insulin therapy highly depends on pricing decision rule for new drugs in the Japanese context, as well as the reimbursement of management of inhaled insulin. When a net benefit was positive, the price of inhaled insulin was set at an extremely low level compared with the market price.

M3.14 - Perfusion CT to identify patients eligible for in tensive rehabilitation after cerebral contusion: A cost-benefit analysis Groen H.1, Metting Z.2, Rödiger L.3, Buskens E.1, Van der Naalt J.2 1University Medical Center Groningen, Department of Epidemiology, Groningen, Netherlands, 2University Medical Center Groningen, Department of Neurology, Groningen, Netherlands, 3University Medical Center Groningen, Department of Radiology, Groningen, Netherlands Objective: To determine the value of perfusion CT for the identification of patients eligible for intensive rehabilitation after cerebral contusion. Methods: Randomized comparison of cognitive outcome (Glasgow Outcome scale) and work rehabilitation with and without intensive rehabilitation, blinded for result of perfusion CT. A Cost-benefit analysis was performed of the intervention costs and costs of lost productive working hours, both in payed employment and in unpayed work. Results: 93 Patients were included in the study. Average GCS was 14.1 (range 11-15). Perfusion CT parameters, especially frontal lobe perfusion, are related to neurological outcome. Patients who receive intensive rehabilitation showed higher work resumption at 1 month (50% versus 39% fully resumed) and 3 months (71% versus 63% fully resumed) after the head injury, but this difference had disappeared after six months. Average total costs were 5943 Euro in patients recieving intensive rehabilitation and 5473 Euro in patients recieving care as usual. About 82 to 84% of these costs were caused by productivity loss. Conclusions: Perfusion CT parameters can be used to identify patients with poor outcome at 6 months after mild to moderate cerebral contusion. However, additional costs of intensive rehabilitation are not fully compensated by cost savings due to improved work resumption. Analasis of subgroups may reveal risk factors hampering rehabilitation. M3.15 - Needs assessment (NA) for venous implants in the treatment of chronic venous insufficiency (CVI) Dintsios C.-M.1, Gerhardus A.2, Hagen A.3, Krauth C.3 1Institute for Quality and Efficiency in Health Care, Health Economics, Cologne, Germany, 2University of Bielefeld, School of Public Health, Bielefeld, Germany, 3Hanover Medical School, Institute for Epidemiology, Social Medicine & Health System Research, Hanover, Germany Objective: Venous implants are a novel intervention with a causal therapeutic approach. Before performing a HTA, their indication-specific need should be determined. Methods: NA is performed to analyse the need and demand for, and the provision of health care services for CVI. NA assesses the potential of covering the demand gaps in appropriate target groups. For this purpose, methods of epidemiology, effectiveness assessment and health economics are applied. Results: Target group definition by epidemiology: CVI III patients with a low risk of surgical complications (0.4-0.8% of population). By technology: 50% of patients with post-thrombotic syndrome with primary valve insufficiency. 10% of these are interested in surgical therapy. For anatomical reasons, 50% are not suited for venous valve transplantation. For 40% of the remaining half (50.000 patients), an alternative to autologous venous transplant is needed. By economy: from the payer perspective, a further restriction of the target group is conceivable. Providing the service for patients of an employable age limits the target group to 0.03-0.07% of the total population. The technology seems to be cost-effective for the defined target groups, with an ICER compared with compression therapy of about 12 000 €/QALY. Conclusions: NA for venous valve implants determined an objective need for the defined target groups. It is the responsibility of the health care system to regulate innovative technologies efficiently in order to prevent the over-, under-, or misdirected provision of services. In this context, NA can make an important contribution even before the development and diffusion of a technology. M3.16 - Have statins met our expectations? A method to ve rify health economic modelling results with real-life data in Austria

Zechmeister I.1, Stollenwerk B.2 1Ludwig Boltzmann Institute for HTA, Vienna, Austria, 2University for Health Sciences, Medical Informatics and Technology, Department of Public Health, Medical Decision Making and HTA, Hall i. Tirol, Austria Objective: Health economic models have predicted that statins (cholesterol lowering drugs) are (cost-)effectively preventing cardio-vascular diseases (CVD) and related hospital based interventions. Ten years after the introduction of statins the predicted effects ought to be observable in improved population health and actual reduced hospital procedures.The study aims to compare model predictions with real-life data in Austria. Methods: A Markov model from the UK is adapted in order to trace yearly cohorts of actual Austrian patients who received statins from 1996 to 2006. Total benefits and costs based on clinical trial evidence and Austrian cost data are calculated. Model results are compared with epidemiological data and administrative hospital data to test the hypothesis that the predicted effects are observable in real-life data. Results: While the model predicts that the the number of prescribed statins since 1996 would have reduced both cardiovascular mortality and morbidity considerably by 2006, real life data shows a decrease in mortality but not in cardiovascular events and related hospital interventions. Predicted cost containment in the model differs from actual costs. Conclusions: The effect size of statin therapy as well as costs differ between model predictions and results from epidemiological data. This may be due to differences between drug efficacy and effectiveness in a real-life setting, data quality or model validity. Subsequent studies are required to identify the most influental factors in the discrepancy. The evidence so far does not confirm the expected effects of statin therapy in Austria. M3.17 - Generalized cost-effectiveness of preventive inte rventions for cervical cancer in Mexico Gutiérrez-Delgado C.1, Baez-Mendoza C.1, González-Pier E.1, Prieto-De la Rosa A.2, Witlen R.3 1Mexican Ministry of Health, Economic Analysis Unit, Distrito Federal, Mexico, 2Mexican Ministry of Health, Centro Nacional de Excelencia Tecnológica en Salud, Distrito Federal, Mexico, 3Harvard University, School of Medicine, Boston, United States of America Objective: To develop a generalized cost-effectiveness analysis (GCEA) of the HPV vaccine, hybrid capture screening (HC) and Papanicolaou screening (Pap) in the Mexican context. Methods: From April to August 2007 in Mexico a GCEA of the interventions was developed for 10 possible scenarios, applying a Markov model from the public sector perspective as payer. Results: Scenarios considering 80% coverage show an ACER per DALY averted for Pap of women between ages 25 and 64 of USD$1 510, for HC of women between ages 30 and 64 of USD$1 565 and for vaccine of 12-year-old girls of USD$7 609. Annual financing of USD$56.2, USD$67.1 and USD$204.2 million, respectively, is needed for these scenarios. Conclusions: A selective combined introduction of Pap-HC screening considering comparative advantages of application in different population and geographical areas is suggested. Additionally, it is suggested to introduce the vaccine once a threshold price of USD$16.40 per dose —when the vaccine becomes equal in terms of cost-effectiveness to HC— has been achieved. M3.18 - Oesophageal Doppler monitoring in critically ill and high risk surgical patients: A first step towards efficiency Hernández R.1, de Verteuil R.2, Vale L.2, for the Aberdeen ODM TAR Group 1University of Aberdeen, Health Economics Research Unit (HERU), Aberdeen, United Kingdom, 2University of Aberdeen, Health Economics Research Unit (HERU) & Health Services Research Unit (HSRU), Aberdeen, United Kingdom Objective: Oesophageal Doppler monitoring (ODM) allows continuous monitoring of cardiac output and haemodynamic status amongst high risk surgical or critically ill patients. Systematic reviews (SR) of effectiveness exist but studies reporting costs or cost -effectiveness do not. This study attempted an initial assessment of efficiency using the available data from efficacy and safety. Methods: Partial economic modelling exercises were conducted for ODM plus central venous pressure (CVP) monitoring plus conventional clinical assessment (CCA) versus CVP monitoring plus

CCA and ODM+CCA versus CCA, for high risk surgical patients, as well as ODM+CVP+CCA versus CVP+CCA for critically ill hospitalised patients. Mortality and length of stay were considered. Probability distributions were attached to model parameters (e.g. lognormal for odds ratios and normal for length of hospital stay), and probabilistic analyses conducted. Data inputs came from an updated published SR. Results were presented as incremental cost per QALY, and average extra cost per additional survivor needed for ODM to no longer be considered cost-effective. Results: The threshold value for the extra health care cost for ODM no longer cost-effective ranged from £581 to £11,600. Results are dependent on the underlying assumptions of the analyses (e.g. pair wise comparisons, limited number of studies, lack of data on relevant outcomes, small sample sizes, and different underlying conditions). Conclusions: ODM strategies seem potentially cost-effective. An economic model considering all relevant strategies instead of pairwise comparisons is needed to ratify these results although further data on relevant model parameters would be useful. M3.19 - Health literacy - An economic perspective Brügger U.1, Eichler K.1, Wieser S.1 1Winterthur Institute of Health Economics, Zurich University of Applied Science, Winterthur, Switzerland Objective: Health literacy (HL) is a concept which was introduced by Anglo-Saxon health researchers in the mid-1980s. Initially, it was defined as the ability to read and understand health information in order to make appropriate health decisions. In the current debate, HL is understood as the general competence to retrieve and critically analyze information in order to take informed health decisions and actions. From an economic point of view there has been little research in this area. Important questions are: What are the societal costs of limited HL? What is the cost-effectiveness of interventions to improve HL? Methods: We apply a stepwise approach and focus is on a specific country (Switzerland). (1) An expert workshop will give a further clarification of the conceptual framework and measurement of HL. (2) With a systematic review we will gather existing evidence regarding societal costs of limited HL and cost-effectiveness of interventions to improve HL. (3) Based on current Swiss prevalence data of HL, we will model societal costs and prospected cost-effectiveness of interventions for Switzerland. Results: The literature review is planned for February/April 2008. Therefore, the results will be presented at the HTAi in Montreal. Conclusions: Our results can contribute to a better understanding of the economic impact of limited HL and economic aspects of interventions. This may be a relevant information for policy makers to fine tune interventions such as educational programs and information campaigns to reduce the economic, social and health burden caused by limited HL. M3.20 - Extending flu vaccination to 100% of people aged 50-64 in three EU countries. Valuing social savings and budget impact using a dynamic mo del Cicchetti A.1, Ruggeri M.1, Mennini F.S.2, Gitto L.2 1Catholic University of the Sacred Hearth, Faculty of Economics, Rome, Italy, 2University of Rome 'Tor Vergata', CEIS Sanità, Faculty of Economics, Rome, Italy Objective: To quantify the amount of social costs/savings due to the implementation of a FLU vaccination strategy for people aged 50-64 in three European countries (Italy, France and Germany) and to determine the optimal budget allocation. Methods: The Influsim 2.0 dynamic model was used to design the hypothetic course in each country of a FLU infection varying the Basic Reproduction Number from 1,68 to 3. We evaluated the social savings due to the implementation of different strategies for FLU control/prevention using Aballea et al. (2007) data on Oseltamvir, Zanamvir and Vaccine costs and effectiveness. Finally a budget impact analysis was performed following Weinstein (1980). Results: The implementation of a vaccination policy in favour of the entire 50-64 population brings a social saving of 12-14% if compared with the current vaccination policies. Italy was the country were the 100% strategy is expected to bring less social savings (nominal value between 500 and 700

millions of euros) and a lower reduction of deaths. Germany was the country that showed an higher decrement of deaths and an higher social saving (between 867 millions and 1,17 billions of euros).A probabilistic sensitivity analysis on costs was performed to tests the robustness of the findings. Conclusions: The study is a first example of how to integrate an epidemiological dynamic model with a budget impact analysis. A referee value of the social benefit consequent to the implementation of a 100% vaccination policy among people aged 50-64 in three different European countries is given. M3.21 - Efficiency of Oesophageal Doppler Monitoring syst em during hip fracture repairing surgery Callejo D.1, Maeso S.1, Gracia J.1, Escalona S.1, Blasco J.A.1, Hernández R.2 1Agencia Laín Entralgo, Health Technology Assessment Unit (UETS), Madrid, Spain, 2University of Aberdeen, Health Economics Research Unit (HERU), Aberdeen, United Kingdom Objective: Optimal management of cardiac output, fluid balance and haemodynamic status is considered key to improve outcome in high risk surgery patients. There isn’t an agreed gold standard for haemodynamic function records systems. Hip fracture patientes are elderly population who have high risk of complications. Our objective is to assess if Oesophageal Doppler Monitoring system (ODM) is cost-effectiveness in hip fracture surgery. Methods: We developed a decision analysis model which includes four monitoring strategies: conventional assessment (CA), central-venous-pressure monitoring (CVP), ODM and both ODM+CVP used together. The model considered mortality as well as complications as effectiveness measures and hospital costs. The time horizon considered is until hospital discharge. Effectiveness data were obtained from available systematic reviews of randomized clinical trials (RCTs). Cost data were obtained from Government data, manufacturers and the literature. Deterministic and probabilistic sensitivity analyses (SA) were conducted. Results: Preliminary results in terms of avoided deaths/complications, based on two identified RCTs, show that strategies using ODM are cost-effective. Particularly ODM+CVP produces a lower numbers of events with minor costs. Based on direct comparisons ODM alone alternative also produces better results than CA, with a number needed to treat to avoid one complication of five, and lower costs. SA results appear to confirm these findings. Conclusions: ODM seems to be a cost-effective monitoring strategy during hip fracture surgery. Results are driven by lower number of complications that produce cost savings in our model. Results are based on few studies available (2 RCTs) and should be taken with caution. M3.22 - Cost-utility of mini-incision THR in the manageme nt of arthritic disease of the hip: Comparison of a short and long-term analysis de Verteuil R.1, Vale L.1, Imamura M.2, Aberdeen Health Technology Assessment Group 1University of Aberdeen, Health Economics Research Unit/ Health Services Research Unit, Aberdeen, United Kingdom, 2University of Aberdeen, Health Services Research Unit, Aberdeen, United Kingdom Objective: To investigate the cost-utility of mini-incision total hip replacement (MITHR) compared to standard THR in the management of arthritic disease of the hip. Methods: A Markov model was developed to model cost-utility over a one and 40 year time horizon. Data on the clinical effectiveness of MITHR compared to standard THR were obtained from a systematic review. Costs were estimated using bottom up methods and were taken from published sources and manufacturers’ lists. Data suggest equal long-term outcomes therefore this was assumed albeit with wide confidence intervals. Outcomes were presented as incremental cost per quality adjusted life year (QALY) gained and using cost-effectiveness acceptability curves. An expected value of perfect information analysis (EVPI) was performed. Results: For the one year analysis, MITHR cost approximately £300 less and was associated with improved short-term outcomes with a 95% chance of being cost-effective at a £30,000 per QALY threshold. The considerable uncertainty around parameter estimates only became apparent when the model was run over 40 years. Here, relative differences in costs and QALYs were similar however the likelihood that MITHR would be cost-effective fell to 55%. The EVPI analysis found that the greatest benefit from future research would be around long-term outcomes. The EVPI, in relation to utilities and costs, were markedly reduced in comparison, highlighting the importance of long-term outcomes in determining the total EVPI.

Conclusions: MITHR will likely be associated with short-term quality of life benefits and similar long-term outcomes and cost. Further research into long term outcomes are warranted. Pharmaceuticals 1 M4.1 - The clinical effectiveness of deferasirox, deferi prone and deferoxamine for transfusional iron overload in patients suffering from beta-thala ssaemia major and sickle cell disease Mcleod C.1, Fleeman N.1, Kirkham J.2, Dickson R.1 1Liverpool University, LRiG, Liverpool, United Kingdom, 2Liverpool University, Medical Statistics, Liverpool, United Kingdom Objectives: To assess the clinical effectiveness of deferasirox, deferiprone and deferoxamine for the treatment of iron overload associated with regular blood transfusions in patients suffering from beta thalassaemia major (Beta-TM) and sickle cell disease (SCD). Methods: Electronic databases were searched up to March 2007. The assessment was conducted according to accepted procedures for conducting and reporting systematic reviews. Results: A total of 14 RCTs, making comparisons between deferasirox, deferoxamine (DFO), deferiprone and combination therapy (deferiprone and DFO) and involving a study population of 1480 (ranging from 13-586), met the inclusion criteria. Three RCTs comparing deferasirox with DFO were found, none of which could be included in a meta-analysis; there were no studies comparing deferasirox with deferiprone or combination therapy. There was a high degree of heterogeneity between trials in terms of trial design and outcome reporting. As such it was only possible to meta-analyse serum ferritin data from six trials, making comparisons between deferiprone and DFO, and combination therapy and DFO. Only one of the results was statistically significant, favouring combination therapy over DFO alone for serum ferritin at 12 months. How this translates into iron loading in organs such as the heart is unclear, nor was it possible to determine the long-term benefits of chelation therapy. Conclusions: This review indicates that in the short-term there is little clinical difference between any of the three chelators in terms of liver iron concentration and serum ferritin. M4.2 - Ezetimibe monotherapy for the treatment of primar y hypercholesterolaemia: Systematic review and meta-analysis Pandor A.1, Ara R.1, Tumur I.1, Paisley S.1, Duenas A.1, Wilkinson A.1, Williams R.1, Chilcott J.1 1The University of Sheffield, School of Health and Related Research, Sheffield, United Kingdom Objective: To review and analyse the evidence on the efficacy and safety of ezetimibe monotherapy for the treatment of primary hypercholesterolaemia. Methods: Several electronic bibliographic databases (including the Cochrane Library, MEDLINE, and EMBASE) were searched from inception to June 2006 (supplemented by contact with experts in the field). Two reviewers independently determined the eligibility of randomised controlled trials, with a minimum treatment duration of 12 weeks, which compared ezetimibe monotherapy (10mg/day) with placebo. Data relating to study design, baseline patient characteristics, clinical or surrogate outcomes and adverse events were extracted and methodological quality was assessed. Results: In the absence of data from clinical outcome trials, surrogate endpoints such as changes in lipid concentrations were used as indicators of clinical outcomes. A meta-analysis of eight randomised, double-blind, placebo-controlled trials (all 12 weeks) showed that ezetimibe monotherapy was associated with a statistically significant mean reduction in LDL-c (from baseline to endpoint) of -18.58%, (95% CI: -19.67, -17.48, p<0.00001) compared with placebo. Significant (p<0.00001) changes were also found in total-c (-13.46%, 95% CI: -14.22 to -12.70), HDL-c (3.00%, 95% CI: 2.06 to 3.94) and triglyceride levels (-8.06%, 95% CI: -10.92 to -5.20). Ezetimibe monotherapy appeared to be well-tolerated with a safety profile similar to placebo. Conclusions: Although the meta-analysis was restricted to analysis of short-term changes in lipid levels relative to baseline, ezetimibe monotherapy significantly improved the lipid concentrations in individuals with hypercholesterolaemia. However, further long-term studies with clinical outcome data are needed to assess the efficacy and safety of ezetimibe fully.

M4.3 - The health technology assessment (HTA) of caspofu ngin for the empiric treatment of febrile neutropenia in children - A comparison with conventional and liposomal amphotericin B Costa V.1, Ungar W.1, Allen U.1, Doyle J.1, Dupuis L.1, Parshuram C.1, Sung L.1, Trope A.1 1The Hospital for Sick Children, Toronto, Canada Conventional amphotericin B (CAMB) is often used to treat invasive fungal infections in our institution. Safety concerns with nephrotoxicity, hypokalemia and infusion-related effects limit its use. Caspofungin purportedly presents a more favourable safety profile but at a higher cost. Objective: To evaluate the efficacy, safety, and cost-effectiveness of the empiric use of caspofungin compared to CAMB and liposomal amphotericin B (LAMB) in children with febrile neutropenia (FN). Methods: Clinical outcomes were based on a systematic literature review. Costs of antifungals, healthcare personnel, materials, saline loading and pre-medications to avoid nephrotoxicity and infusion-related effects respectively were included. Treatment length was based on caspofungin pediatric FN publications. Personnel time for drug preparation and administration, materials, and unit costs were obtained from our institution. Results: Lack of caspofungin comparative publications in children precluded a cost-effectiveness evaluation. For a 7-day course (20kg/0.82m2 child), costs/antifungal treatment were US$1,295, US$724, and US$1,299 for caspofungin, CAMB and LAMB respectively. Caspofungin presented the highest acquisition cost. However, a shorter infusion-time and less requirement for preventive measures and complications’ monitoring as done in our institution compared to CAMB/LAMB renders it less resource consuming, especially of nursing time. This is associated with an opportunity cost, especially for CAMB since the nurses have less time for other activities. Conclusions: This is the first caspofungin HTA in children. Caspofungin cost was similar to LAMB but higher than CAMB which may result in a considerable budget impact. Cost differences should be interpreted in the context of clinical benefits, which should be incorporated once information becomes available. M4.4 - Peer-review of medical prescription of pramipexol e in the public health system of Rio Grande do Sul - Brazil: Evidence of irrational use of dopaminergic agonists for Parkinson´s disease Socal M.P.1, Vargas A.P.2, Rieder C.R.M.3, Picon P.D.4, Brazilian Independent Study Group 1Universidade Federal do Rio Grande do Sul and Rio Grande do Sul State Health Department, Post Graduation Program in Medicine: Medical Sciences, Porto Alegre, RS, Brazil, 2Universidade Federal do Rio Grande do Sul, Medical School, Porto Alegre, Brazil, 3Universidade Federal do Rio Grande do Sul, Post-Graduation in Medicine: Medical Sciences, Porto Alegre, Brazil, 4Universidade Federal do Rio Grande do Sul and Rio Grande do Sul State Health Department, Internal Medicine Department, Porto Alegre, RS, Brazil Objective: Parkinson´s disease has a strong economical impact for the Brazilian public health system. In Rio Grande do Sul we have noticed an increasing demand for pramipexole in the last few years. According to medical literature and Brazilian Guidelines for Parkinson´s Disease, the main indications for dopamine agonist use are the first treatment for young patients and the control of motor fluctuations and dyskynesias in patients with advanced disease. With the objective of evaluating prescription patterns of pramipexole we reviewed a sample of patients who required public funding for their treatment to our regional Public Health Department. Methods: all pramipexole requests from february to december 2007 were reviewed by an expert review group. Results: 267 requests were analysed: 53,4% were women and 60,7% were older than 65 years. In 48,7% of cases no information was sent to justify the medication request. In the remaining cases, the reasons stated for pramipexole request were: first treatment (13,5% of cases), motor fluctuations/dyskynesias (12,7%), and absence of benefit with levodopa (13,1%). All of the patients who reported levodopa failure were using low levodopa doses. Only 28% of the patients met the Brazilian inclusion criteria for public funding for this treatment. Conclusions: Here we show evidence of malprescription of dopamine agonists and irrational use of public resources. In Brazil, therapy with dopamine agonists is around 10 times more expensive than with levodopa. Educational actions on doctor’s decisions urge to protect patients and reduce costs.

M4.5 - Post-listing studies of medicinal products in Fra nce Stamenkovic S.1, Maugendre P.1, Xerri B.1, Meyer F.1 1Haute Autorité de Santé, Saint Denis, France Objective: The reimbursement of medicinal products by French National Health Insurance is reviewed every 5 years. Post-listing studies establish, under real-life conditions, which are the populations treated, what are the treatments, and what is the impact of the products on patient health, treatment strategies, and organisation of care. They are requested by the Transparency Committee of HAS and fall within the scope of an agreement signed by the pharmaceutical company and CEPS (French pricing committee). Our aim was to review the current status on post-listing studies. Methods: Since 2003, pharmaceutical companies must submit the protocols of their post-listing studies to HAS, and, since 2004, a multidisciplinary working group of 11 experts ensures that the method of the proposed study meets HAS’ requirements. Results: By December 2007, the working group had examined 228 protocols for 102 medicinal products in response to 126 requests for post-listing studies. The main reasons for the requests were conditions of drug use (97%), benefit for the patient (77%), and impact on the organisation of care (17%). The status of the studies was 25% completed, 37% ongoing, 21% undergoing protocol validation, and 17% undocumented. Conclusions: Post-listing studies on conditions of use have not posed any real problems and have led to concrete actions (e.g. sanctions, publication of good use leaflets). However, impact studies under real-life conditions are tricky. Since no consensus has been reached on their methodology, this issue has been added to HAS’ agenda, to be resolved, if possible, within the framework of an international collaboration. M4.6 - Characterization of the drug selection at the Mun icipal Secretaries of Health of the state of São Paulo Zucchi P.1, Cruz Marques D.2 1Universidade Federal de São Paulo, Grides, Sao`Paulo, Brazil, 2Prefeitura Municipal de Sao Paulo, Sao Paulo, Brazil Objectives: Identify the existence of a Pharmacy and Therapeutics Committee , verify the composition of the groups who work with drugs selection and identify the elements involved in the process, such as criteria, information sources about medicines and factors that interfere with this work. Methods: Non-experimental descriptive/exploratory survey. The sample covers the nine districts of the state of São Paulo which have more than 500.000 inhabitants. Results: The presence of a Pharmacy and Therapeutics Committee is noticed in 66.7% of the districts. In 100% of them, there are physicians and pharmacologists who formulate the selection. The sources of information about medicines are: the professionals’ experience and reference lists in 100% of the districts; treatment protocols in 77.8%; scientific literature in 55.5%; and promotional material produced by the pharmaceutical industry in 22.2%. The criteria used for drug analysis are cost-effectiveness in 100% and safety, in 77.8%. In 77.8% of them, there are external factors which interfere in the drug selection process. Conclusions: Although there are physicians and pharmacists in all groups, it is necessary the implementation of the Pharmacy and Therapeutics Committee in all districts. The search for drug analysis in scientific literature is little. The criterium for drug safety is not always used, although it should be higher in relation to the cost criterium. External factors also influence the drug selection process. The improvements in the process which are described in literature must be considered by the professionals who are performing this work. M4.7 - Legal action distortions caused to the National D rug Policy in Brazil Vieira F.S.1, Zucchi P.2 1Ministério da Saúde, Brasília, Brazil, 2Centro Paulista de Economia da Saúde, São Paulo, Brazil Objective: To describe the effect of the legal actions that require medicine supply of the Health Department of São Paulo City (SMS - SP), in relation to aspects of the National Drug policy.

Methods: The analysis unit of the study is the citizen’s legal action moved against the SMS-SP and the studied period was from January to December of 2005. A databank form was standardized. Results: In 2005, 170 legal actions against SMS-SP were petitioned, requiring medicine supply. Cancer and diabetes were the most related illnesses (59%). Sixty-two per cent of the drugs requested are part of SUS lists. The total expense with non-selected items (that are not part of the municipal list of essential medicines) in 2005 was 876 thousand reais. The availability of therapeutical alternative for these items showed that 73% of them could be substituted. From the total expense, 75% was destined to the acquisition of antineoplasic agents. Two of them are not registered in Brazil and the majority of them need more studies to measure their efficacy. Conclusions: Most petitions for drugs generated by legal actions could be prevented if SUS organization and its line of directions had been considered in terms of oncological assistance as well as in relation to the list of essential drugs. When these issues are not considered, it breaks the National Drug Policy,compromising the access and rational drug use at SUS, beyond a more equitable access. M4.8 - The effectiveness of treatments for degenerative ataxias: A systematic review Serrano-Aguilar P.1, Montón-Álvarez F.2, Trujillo-Martín M.M.3, Carrillo-Fumero R.3, González-Marrero J.3, Regalado-Barrios M.2, Rojas-Pérez E.2, González-López A.2 1Canary Islands Health Service, Evaluation Unit, Santa Cruz de Tenerife, Spain, 2University Hospital of NS de la Candelaria, Department of Neurology, Santa Cruz de Tenerife, Spain, 3Canary Islands Research & Health Foundation (FUNCIS), Santa Cruz de Tenerife, Spain Objective: This study aims to evaluated the available scientific evidence on the effectiveness and safety of treatment alternatives for degenerative ataxias (DA). Methods: A systematic review of published literature was performed. Medline, Embase, CENTRAL and CRD were explored to identify original articles that assessed the effectiveness and safety of pharmacological, rehabilitative and psychological therapy in patients with DA. Controlled studies and case series were included if they fulfilled pre-specified criteria. Main outcome measures: clinical status, patient-based factors and the economic cost. Results: The search yielded a total of 4827 references but only 26 studies were finally included. Most included studies were of small sample sizes, wide age variations and low scientific validity. Only one study informed on physical rehabilitation and none on psychological therapy. The remaining 25 studies reported on the effects of different pharmacological treatments. Outcomes such as functional capacity and psychological status were evaluated by few studies. Conclusions: High-quality studies on the safety and efficacy of treatments for many types of degenerative ataxias are scarce.<br There is sufficient evidence to support that 5-HTP is more effective than placebo to improve neurological impairment in patients with FA, OPCA and CA and that Idebenone is more effective than placebo for halting and reversing the hypertrophic cardiomyopathy associated with FA. There is not valid information available on the value of physical rehabilitation and psychological support as treatments for DA. No relevant side effects were reported for products included in this review that have shown a certain degree of effectiveness. M4.9 - Systematic review of the efficacy and safety of i nsulin aspart in type 2 diabetes mellitus Rys P.1, Pankiewicz O.1, Wladysiuk M.1, Skrzekowska-Baran I.2 1HTA Consulting, Krakow, Poland, 2NovoNordisk, Warszawa, Poland Objective: The aim of this analysis was to compare efficacy and safety of rapid-acting and biphasic insulin aspart with those of regular human insulin used in treatment of patients with type 2 diabetes mellitus. Methods: The comparison was based on the results of a systematic review performed according to guidelines published by the Cochrane Collaboration and Agency for Technology Assessment in Poland. EMBASE, MEDLINE, CENTRAL and others were searched. Two reviewers independently collected data in standardized form and assessed the methodological quality. Of 323 retrieved publications 4 articles of relatively low methodological credibility fulfilled the inclusion criteria. Outcome measures included glycated hemoglobin, postprandial glucose, treatment satisfaction, quality of life, hypoglycemic episodes (severe, nocturnal, any).

Results: Statistically significant differences in favor of insulin aspart were demonstrated with respect to reduction of glycated hemoglobin level (WMD= -0,14 [-0,27; -0,01]). No statistically significant differences were demonstrated with respect to fasting plasma glucose level or incidence of hypoglycemia. Tendency towards reduction of postprandial glycemia was observed; however, it was not possible to pool the results and therefore no conclusions concerning statistical significance of differences between the groups may be drawn. Conclusions: Use of insulin aspart instead of regular human insulin in type 2 diabetes mellitus results in decreased glycated hemoglobin level; no improvement with respect to other parameters of glycemic control was demonstrated. M4.10 - An evaluation of the free drugs programs of the M inistry of Health of Brazil Martins A.M.1, Mello D.1, Oliveira C.A.2, Silva E.N.3 1Grupo Hospitalar Conceição, Porto Alegre, Brazil, 2UNIMED, Santa Catarina, Brazil, 3Federal University of Rio Grande do Sul, Economics, Porto Alegre, Brazil Objective: Analyze whether the free drugs programs are achieving their purposes, using data form the National Household Sample Survey (PNAD) carried out in 2003. Put it in another way, we are interested in factors that influence whether or not an individual get for free a drug. Methods: We used a Probit model, which is a standard way to analyze binary data. The explanatory variables of interest are gender, age, race, marital status, chronic and endemic diseases, education status, income and regional location. Results: All the sign of the coefficients of individual features reported qualitative effect as one could expect. For example, rich white married men with health insurance and high level of education have lesser probability to get a free drug than otherwise. Also individuals with chronic (diabetes, hypertension, heart and tendonitis) and endemic (tuberculosis) diseases have bigger probability to get a free drug. However, when we analyze regional dummies, the poorest Brazilian regions (Northeast and North) have lesser probability to get a free drug compared to richest one. Conclusions: Since drugs have had large impact on household budget, particularly in low-income families, the Ministry of Health of Brazil has maintained free drugs programs to guarantee that population going on medical treatment. The main aim is distribute freely drugs for primary care, mental health, chronic and endemic diseases. At individual level, the free drugs program has achieved its goals. However, at regional level there are some problems, which must be solved to achieve the program’s goals. M4.11 - Analysis of the similitude grade in requests to i ntroduce new drugs into Spanish hospitals Flores S.1, Santos B.2, Marín R.2, Bautista J.2 1Andalusian Agency for Health Technology Assessment, Seville, Spain, 2Virgen del Rocío University Hospital, Seville, Spain Introduction: The GINF is a Guideline to request the Introduction of New Drugs in a Hospital. This guideline was intended to encourage clinicians to think carefully about their request, having compiled all the information required. Objective: To analyse the similitude grade in filling in the GINF in different Spanish hospitals. Methods: There were analysed the GINF of the following drugs: Atazanavir, Bortezomib, Cinacalcet, Ertapenem and Ezetimibe. Such medicines, marketed over 2005-2006, were selected according to high economic impact on the NHS. The GINF were requested to all Spanish hospitals which it was implemented. Two researchers reviewed all the guidelines individually and one by one to find similarities among them. The GINF were considered to be filled in by the same writer when the answers to the different sections were written in exactly the same fashion. Results: 39 public hospitals participated in the project and 64 guidelines were analysed: 17 of cinacalcet, 16 of bortezomib, 10 of atazanavir, 10 of ertapenem and 9 of ezetimibe. The analysis of the guidelines, indicates that: 100% of guidelines are completely equal to those of atazanavir and ezetimibe, 75% on ertapenem, 60% of cinacalcet and 50% bortezomib. Conclusions: There is a great, extraordinary and suspicious similitude in the compliance with GINF. This can be explained by the existence of a common writer, possibly, the manufacturing laboratory, in spite of the fact that GINF was conceived as an educational instrument to clinicians and not to

encourage pharmaceutical companies to request introduction of his new drug. HTA/Technology in hospitals 1 M5.1 - Hospital-based health technology assessment (HB-H TA): How a multidimensional set of indicators can help in defining a technology replac ement plan Dori F.1, Iadanza E.1, Miniati R.1, Scatizzi L.2, Turco L.3 1University of Florence, Electronic and Telecommunication, Florence, Italy, 2Università degli Studi di Firenze, Electronics and Telecommunications Dept., Firenze, Italy, 3Healthcare Trust, Florence, Italy Objective: To develop a set of indicators for the evaluation of the technological deployment aims at prioritizing capital investments for technologies in a hospital-based setting and at supporting decision-makers in evidence based decisions and policies. Methods: Literature and previous analyses are used to collect technical/maintenance indicators. Activity-based Costing/Management is used to devise economic and process indicators. Qualitative method and steering group meetings are used to define safety/usability/ergonomics indicators. Results: A set of 40 indicators is defined, divided into five groups: technical/maintenance indicators (e.g. obsolescence), economic indicators (e.g. maintenance onerousness), intrinsic criticality indicators (e.g. technological complexity), process indicators (e.g. productivity) and safety/usability/ergonomics indicators (e.g. training on the device). This structure meets the requirement of a multidisciplinary approach in defining needs for a specific technology. Each indicator is computed for each equipment. Indicators are organized in a grid model where columns represent groups. Indicators are weighted inside each group producing a synthetic score. Such a structure allows “first level” evaluations of the equipment, basing on the partial scores for each group; a more general “second level” evaluation is provided, basing on partial scores combination. Conclusions: The study confirms that tools encompassing multidimensional evaluation aspects are useful both for the development of structured and multidimensional processes of analysis and for providing decision models that can support compatible strategies, policies and resources allocation in technological replacement plans. M5.2 - A hospital-based HTA-centre - From a library pers pective Svanberg T.1, Alopaeus E.1 1Sahlgrenska University Hospital, Medical Library, SU/Sahlgrenska, Gothenburg, Sweden Introduction: An HTA-centre at Sahlgrenska University Hospital in Gothenburg, Sweden, was established in October 2007 in order to support health care professionals in using single technology HTA (mini-HTA) as a local decision support tool. The centre includes library & information specialists, HTA-experts and economists. One major goal is to help hospital staff improve their knowledge of critical appraisal and levels of evidence. The library took an active part in planning the centre. Methods: HTA is a library priority and includes the following: - Preliminary searching to get to know the subject; - Participating in meetings; - Active involvement in defining a PICO for the current topic (what’s possible from a library’s point of view); - Two librarians perform the search, to act as each other’s quality control; - Searching also involves reading of reference lists, etc.; - Reading of abstracts and articles, with exclusion/inclusion based on PICO; - Included articles are sent to clinicians, who decide what to include in the report. Results: - An HTA-report with high acceptance in its clinical environment due to a rapid process, clinical involvement and support from HTA-centre which saves time for clinicians; - Wider knowledge of library services and competence; - More intense, but stimulating, developing and rewarding work for librarians. Conclusions: A systematic, quality controlled literature search and selection is a prerequisite for a high-quality HTA-report. Library involvement is crucial for successful HTA work but has also meant a wider recognition and higher status of the library and its resources. Library impact on decision making becomes obvious.

M5.3 - HTA Brazilian network based in hospitals Petramale C.A.1, Torres A.2, Barbosa P.2, Chagas P.2, Pini L.2, Rabelo R.2, Soares D.2, Scholz M.R.2 1Anvisa: Brazilian Health Survaillance Agency, CVISS, Brasília, Brazil, 2Anvisa, CVISS, Brasília, Brazil Objectives: To build a hospital HTA network improving evidence based health knowledge applied to hospitals practice. Methods: E-learning - Evidence based health; Network management. Results: 119 professionals trained in five hospitals: - videoconference; 1900 professionals in 82 hospitals in training: - videoconference and videostreaming; “Sentinels in Action”: 32 weekly web programs; - 208 plans to improve health care in hospitals; - 30 researches in hospitals; - Web discussion groups for leaders; 3 HTA Electronic Bulletin: BRATS. Conclusions: SUS, the Brazilian Public Health System, was created in 1988 to provide universal health care services. In 2007, the resources available were about $15 billion to meet the needs of 180 million people. It is crucial for the system to select and use only relevant and reasonable technologies which benefits are perfectly established. So, HTA is an important tool for achieving this aim. In 2004, the Brazilian Ministry of Health and ANVISA - Brazilian Health Surveillance Agency started to bring HTA to practice focusing high complexity Health Services at the federal, states and municipalities government. Since 2001, ANVISA has been working with a 104 hospitals network to gather information on risk and performance concerning health technologies, and from 2005, has been offering evidence based health courses using information technology for those hospital’s professionals and developing supporting measures to improve local HTA nuclei. At the end of five years this project intends to consolidate a stronger and modern Brazilian HTA network. ANVISA’s partners in this project are: Cochrane Brazil, Sentinel Network, State Governments, UNDP, PAHO and Sírio-Libanês Hospital. M5.4 - Evaluation of technologies in health: The process of implantation in the Israelita Albert Einstein Hospital- Brazil Kazume Oyama C.1, Gibertoni Junior A.2, Carrijo Melo J.2, Neves H.S.3, Lottenberg C.L.4 1Hospital Israelita Albert Einstein, Diretory of Logistics, São Paulo, Brazil, 2Hospital Israelita Albert Einstein, Diretory of Logistics- Clinical Engineering, São Paulo, Brazil, 3Hospital Israelita Albert Einstein, General Directory, São Paulo, Brazil, 4Hospital Israelita Albert Einstein, President, São Paulo, Brazil The evaluation for incorporation of new technologies in health is a process of inquiry and analysis of all the possible clinical, economic consequences that eventually can impactar in the health services. In Brazil the activities in this field had been initiated in the decade of 80, assumeing increasing role in such a way in the half academic how much in the public politics. Routinely new technologies of treatment are incorporated by the diverse professionals of form many times sped up and same before enough evidences that they prove its security, effectiveness and effectiveness. The use of information on costs and benefits of the interventions in health can assist in the establishment of priorities for the allocation of resources in health. In this intention, the suppliment direction identified the necessity of a structuralized process that evaluates the incorporation of new technologies in the area of the health, aiming at to keep the Institution in the border of the technological innovation. The Comite of ATS is formed by the Executive Direction of the Hospital and its partners. As results, we have: to receive the best treatment available considering the degree from clinical evidence and cost effectiveness. To reach the standards and goals determined for the Ministry of Health recognized being for the community as pioneering in the ATS in privates of health institutions, assisting the Secretariats of Health and the Ministry of Health to promote the best available funds allocation of and to improve the welfare general of the Brazilian population.

M5.5 - Three steps to successful technology management i n hospitals Gurtner S.1, Dörner N.1, Uecke O.2 1University of Technology Dresden, Department of Entrepreneurship and Innovation, Dresden, Germany, 2University of Technology Dresden, Dresden Exists, Dresden, Germany Objective: The three steps will present a theoretical basis on how to identify relevant technologies, how to evaluate and how to implement them. These considerations are crucial for success in times of rising cost pressure and diversification. Methods: A broad analysis of conventional theories on technology management was supplemented by interviews elaborating the organizational structure and the common practice in hospitals. A technology assessment model was created following the Analytical-Hierarchy-Process approach. Furthermore a study on international horizon scanning institutes, their approaches and methods as well as structural organization was conducted. Results: For a successful management of technology in hospitals three steps are important. At first relevant new technologies have to be found through an integrated technological foresight approach which connects the needs of the clinical departments with technologies in development or already in market introduction. As a second step the available technologies have to be assessed regarding the three dimensions medical benefit, economical benefit and organizational impact. Appropriate criterias for these dimensions were found and have to be weighted individually. Therefore an integration of key persons on different levels of hospital structure is essential. To overcome the barriers innovations have to face, a structure of promotors has to be established. These promotors have to provide the necessary skills of power, knowledge and communication. Personnel dynamics as well as structural changes have to be considered. Conclusions: The presented theoretical approach leads to a practical guideline for hospitals on how to establish an integrated technology management and therefore benefit from technological innovation. M5.6 - Cone beam computed tomography (CBCT): A new dento maxillofacial imaging modality diffusing with no rational basis Charpentier E.1, Rolland-Burger L.1, Fay A.-F.1, Vongmany N.1, Cesari A.1, Montagnier-Petrissans C.1 1Assistance Publique - Hopitaux de Paris, CEDIT, Paris, France Objective: Assessment and decision making about CBCT in AP-HP hospitals. Context: CBCT, a 3D imaging technique, may be an alternative to conventional CT scan in some uses. Its first diagnostic indication is dentomaxillofacial imaging, with already large (>3000) diffusion worldwide. Methods: Technical and market analysis, systematic review , economic and regulatory analysis. Results: These devices are characterized by a good spatial resolution (≥CT), a low contrast resolution (<CT), a long acquisition time and a low equivalent dose (one magnitude/CT), potentially allowing for its use in new indications. This technology has various seemingly accepted uses in dentistry (dental pathology and surgery, implants) although very few studies give good evidence of its benefits; other dental uses (endodontics, parodontics, orthodontics) are supported by low-level evidence. Its use in maxillofacial surgery (traumatology, orthognathic surgery) is supported but by case series; other uses (ENT) should be assessed. Such examinations are cheaper than a conventional CT scan (45-80� varying with annual use) and might be cheaper than other techniques it might replace (dental status +/- teleradiography); however they are not currently reimbursed by the French national insurer. These devices are regulated as simple radiographic devices and not as CT or MR scanners. They can be used by both radiologists and clinicians, whose collaboration is highly desirable in a hospital setup. Conclusions: The CEDIT recommended to install one such device in a multidisciplinary setting for assessment purposes and to ask the national insurer for a conditional reimbursement of these examinations. M5.7 - HTA and IT: Open issues and future perspectives Gelmetti A.1, Fregonara Medici M.2

1San Matteo University Hospital, Clinical Engineering Dept., ICT Unit, Pavia, Italy, 2“A.O.U. Careggi” University Hospital, Health Technology Dept., Firenze, Italy Objective: The Information Technology is now more than ever a central and strategic key to support the enterprise government in terms of organization, optimization and innovation of the same. The IT is essential to data management from different points of view (clinical, economical, managerial, technical, epidemiological). Furthermore the IT helps to keep the costs of the health systems, at both local and national level, at bay. Methods: It is therefore of vital importance to aim for an even wider application of the HTA in the IT domain: Health Information Technology Assessment (HITA) to be developed in the near future. HITA is useful in setting up guidelines in order to better programme new purchases, the updating and the management of the increasingly complex healthcare information systems. Before IT solutions are introduced in hospitals, the CIOs perform analysis on clinical, economic, organizational impacts, since those analysis are thought of as primary tool for investment evaluations, comparison of different approaches and support to strategic decisions. The HITA process should take into account also specific issues as appropriateness, risk, continuity, integration, usability, security. Results: The IT area in healthcare should improve the assessment activities and shared procedures already used on a daily basis and emphasize them as essential tool for evaluation processes and strategic decisions at departmental, hospital, local and national level. Conclusions: We propose the creation of a working group to define shared scientific procedures and to validate standard tools and guidelines for HITA activities in healthcare information systems. Safety/Risk/Injuries 1 M6.1 - Prevention of falls and fall-related injuries in the community-dwelling elderly: A review Gomes T.1, Chandra K.2 1Ministry of Health and Long-Term Care, Medical Advisory Secretariat, Toronto, Canada, 2Programs for Assessment of Technology in Health, Hamilton, Canada Objective: To perform a literature review to assess the effectiveness of interventions designed to prevent falls and fall-related injuries in community-dwelling elderly individuals. Methods: A search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, Cochrane Library, and INAHTA/NHS EED between January 2000 and September 2007. Furthermore, all studies included in a Cochrane review published in 2003 were considered for inclusion. Studies were included if they were controlled trials in a population of community dwelling elderly and examined falls or fall-related injuries as an outcome. Results: 73 studies were identified investigating the effectiveness of 10 interventions. A meta-analysis found that exercise programs of 6 months or longer in duration, and those not targeted at a high risk group effectively reduced falls (RR=0.84 [95% CI: 0.76-0.93] and RR=0.79 [0.70-0.90], respectively). Environmental modifications were effective in individuals with a history of falls (RR=0.66 [0.54-0.81]), and a gait stabilizing device for outdoor winter use effectively reduced falls (RR=0.43 [0.29-0.64]) and injurious falls (RR=0.10 [0.01-0.74]). Although neither hormone replacement therapy or vitamin D alone reduced falls or injuries, vitamin D plus calcium supplementation resulted in a reduction in the number of falls (RR=0.83 [0.73-0.95]) and fractures (RR=0.60 [0.39, 0.94]). There was no evidence that multifactorial interventions, vision interventions or hip protectors were effective at reducing falls or injuries. Conclusion: Although several effective falls prevention interventions exist, special consideration must be given to the intervention duration and population risk profile when determining the most appropriate interventions to implement. M6.2 - Incidence and preventability of adverse events in patients hospitalised in three Colombian hospitals during 2006 Gaitán H.1, Eslava-Schmalbach J.1, Rodriguez N.1, Forero V.1, Santofimio D.2, Altahona H.3, Health Technology and Policy Evaluation Group 1National University of Colombia, Clinical Research Institute, Bogotá, Colombia, 2Health Technology and Policy Evaluation Group, Hospiptal Hernando Moncaleano, Neiva, Colombia, 3Fundacion

Universitaria Sanitas, Clinical Research Institute, Bogotá, Colombia Objective: To determine adverse event (AE) incidence, preventability, classification and impact for establishing their importance as a public health problem within the Colombian social security system. Methodology: Prospective inpatient cohort from three Colombian general-practice institutions. Inclusion criteria: at least 12 hours of length of stay in 2006. Exclusion criteria: psychiatric disorders and AE that occurred before index hospitalization. Sample: 6,688 patients. Being a three-phase design, the first consisted of translating and standardising screening and causation formats, phase II of active surveillance of screening criteria and phase III of evaluating causation regarding provided care based on specialist committee concept on a scale of 0 to 6. Variables measured were age, gender, social security affiliation, cumulative AE incidence, temporality, preventability of AE and disability resulting from them. Results: 505 fulfilled positive screening criteria (7.9% 95% CI: 7.3-8.6), 310 presented at least one AE during their hospitalisation: 4.6% accumulated incidence (95% CI: 4.1-5.1). AE were considered to have been preventable in 189 cases (61%, 95% CI: 55- 66%) and permanent disability occurred in 1.3% of them. AE-associated mortality was 6.4% (20/310). Hospitalisation became increased to 1,072 days as a direct consequence of AE. Conclusions: This study revealed an important incidence of AE in three Colombian hospitals, being mainly preventable. Their ongoing measurement as a part of risk management systems could reduce costs and AE-associated morbidity and mortality. M6.3 - Promoting evidence based policy making as an aid for improving patient safety Kahveci R.1, Bulun M.1 1Ministry of Health, General Directorate of Pharmacy and Pharmaceuticals, Ankara, Turkey Following ‘To Err is Human’, the report by The Institute of Medicine (IOM), the awareness of dramatic consequences of medical errors has been raised further among health care professionals and policy makers. The tools to improve patient safety have been tried to be determined. Evidence based medicine has been discussed as being one of the most important tools and many comments have been published. Clinical practice guidelines have been declared as serving also as a tool to reduce preventable medical errors. Potential role of Health Technology Assessment (HTA) as an aid for improving patient safety has not been widely discussed. HTA, one of the most important means for evidence based policy making, promotes more rational decisions in health care. It is well known to both health care professionals and policy makers that traditional opinion-based or experience-based decisions might be harmful at times and evidence based decisions should be in the core of health care decisionmaking. Policy makers, by their decisions, directly affect health care practice and the common practice among professionals. They must be aware that their decision could well promote patient safety, through promoting safer way of provision or vice versa. Patient Safety is improved by obeying the standards of care and it is mostly the policymakers who decide about these standards. It should also be well noticed that HTA is one of the tools for setting the standards and could be a useful tool for decisionmakers in reducing harms in health care. M6.4 - The National Prevention Action Plan to contrast h ome and road traffic injuries in Italy Salamina G.1, Farchi S.2, Giorgi Rossi P.2, Borgia P.2, D'Ambrosio R.3, Patussi V.4, Greco D.5 1Centre for Disease Control and Prevention, Ministry of Health, Rome, Italy, 2Agency for Public Health, Lazio Region, Rome, Italy, 3ASL 1 Torino, Torino, Italy, 4Azienda per i Servizi Sanitari No.1 - Triestina, Trieste, Italy, 5Centre for Disease Control and Prevention, Rome, Italy Objective: In Italy road traffic injuries (RTI) and home injuries (HI) represent a dramatic public health problem, nevertheless, the surveillance and prevention of these events are still lacking. The Ministry of Health together with Italian Regions in 2005 has approved The National Prevention Action Plan for the period 2005-2008, that addresses eleven priorities in prevention, two of these are represented by HI and RTI. According to the Plan, regions will receive the funds based on the aim reached. Methods: A working group made a systematic review of the literature to produce evidence-based National Guidelines. Guidelines addressed the main issues to develop:

1) a surveillance using health-based archives to identify high risk populations and settings; 2) evidence-based interventions to adopt at regional level. Training has been offered to six officers per region. Regional Focal Points had to present local plans to implement surveillance and preventive interventions. Results: Eighteen out of twenty Italian regions presented their plans with explicit aims according to the guidelines. The National workshop has been held in April 2007 and lasted one week. All the regions participated. Six topics have been addressed: Emergency Department-based surveillance; development of maps of the spatial density of RTIs; health-promotion; physical activity promotion for elderly; housing safety; a national survey on HIs. Working groups produced technical reports directly applicable to regional planning. Conclusions: The National Prevention Action Plan introduced in Italy a new framework of health planning based on evidence-based guidelines, project management and distribution of funds according to the aims reached. M6.5 - Improving the Brazilian notification system for a dverse events and quality deviations Torres A.S.1 1Brazilian Health Surveillance Agency - ANVISA, Center for Surveillance of Adverse Events and Quality Deviations - NUVIG, Brasilia, Brazil Objective: The Brazilian Health Surveillance Agency (Anvisa), created Sentinel Network (SN) which objective is to get information on risk and to evaluate the performance of health products after-commercialization. During the years of 2003 and 2006 the SN used a private system to notify adverse events and quality deviations (Sineps) that allowed notification in three areas: Techno, Pharmaco and Haemo - Surveillance. In 2007, another system was created (Notivisa) that allows notification of multiples notifiers and health products. This study intends to compare the effectiveness of Notivisa compared to Sineps. Methods: This study is quantitative, descriptive and transversal cut. Data bases systems search in 2006 and 2007 and analysis of notifications. Results: In 2006, Sineps received 5147 notifications, 2339 in Techno, 1341 in Pharmaco and 1467 in Haemo. In 2007, Notivisa received 8487 notifications, of these 8416 (99.16%) in the common areas, 22 in cosmetics, 48 in sanitizind products and 1 in pesticide. With the following distribution for common areas: 4101 in Techno (3743 medical devices, 312 health care equipments and 46 kit for in vitro diagnosis), 2330 in Pharmaco (2263 drugs and 67 vaccines) and 1985 in Haemo (blood or components). It had an increase of 38.85% in the total notifications and 43%, 42% and 26% in common areas, respectively. In relation to the notifier group, in Notivisa 88.46% was from the SN and 11.54% from others notifiers. Conclusions: The results demonstrate that Notivisa is an important instrument to produce information to support decisions to improve the health conditions of population. M6.6 - Adverse events in four hospitals in Colombia 2006 : Lessons learned from a qualitative exploration of prevailing attitudes in institutiona l personal and areas of institutional effort Gaitan H.G.1, Gomez P.I.1, Eslava-Schmalbach J.1, Health Technology and Policy Evaluation Group 1National University of Colombia, Clinical Research Institute, Bogotá, Colombia Objective: Detecting adverse events (AE) forms part of the risk management aimed at increasing hospitalised patients’ safety. Four Colombian hospitals were studied during 2006 for determining the prevailing incidence of AE. The current publication describes the difficulties which emerged from identifying and evaluating the events and the interventions suggested by the hospital workers. Methods: This was a qualitative investigation; a semi-structured interview was held and a focal group was run with the personnel who collected and monitored this information. A conceptual framework was constructed, based on publications regarding AE at health institutions and preparing summaries by topic regarding the content of work done during the focal group by systematising, categorising and reducing the data. The triangulation method was used for guaranteeing credibility, transferability, reliability and confirmability. Results: The quality of the information obtained was associated with the gender of the person who collect the information and the number of the hospital discharges. There was a belief that scrutinising

AE was associated with potentially negative consequences arising from work. Strategies for raising personnel’s awareness regarding reporting AE were intrapersonal work, making everyone aware that no one is exempt from being involved in an AE and administrative support for resolving deficiencies. A tendency to underestimate association with an AE was observed by the specialist committees. Conclusions: Previous organizational culture has strong influence in the attitude of workers regarding report of AE. Employees should be convinced that their recommendations will be taken into account by managers in order to prevent future AE. HTA in decision-making 1 M7.1 - Photoselective vaporization of the prostate - Kee ping up with technology: The Alberta approach to evidence informed funding decisions in a Canadian province Petzold B.T.J.1, Menon D.2, Stafinski T.2, Lopatka H.3 1Alberta Health and Wellness, Health Technologies & Services Policy Branch, Edmonton, Canada, 2University of Alberta, School of Public Health, Edmonton, Alberta, Canada, 3LopAlta Consulting Ltd., Edmonton, Alberta, Canada Objective: Results of a provincial review conducted for the purpose respecting the potential of Photoselective Vaporization of the Prostate (PVP) as a publicly funded health service in Alberta. Method: Laser treatments for symptomatic benign prostatic hyperplasia, a non-cancerous proliferation of cells causing enlargement, were first introduced in the early 1990s and have evolved significantly during the past decade. PVP is a minimally invasive surgical intervention that uses laser technology to vaporize excess prostate tissue with minimal damage to other tissue and is considered an alternative to transurethral resection of the prostate (TURP). A review of the 80 watt GreenLight® laser system under the Alberta Health Technologies Decision Process (government’s evidence-informed process for deciding on funding of health services) was completed. It considered evidence around safety, effectiveness and cost effectiveness of the GreenLight® laser. Results: The rapid health technology assessment was completed in May 2007 and consultation completed in December 2007. The review of evidence suggests that PVP is safer (less urinary retention and clot retention) and equally effective when compared to TURP. In addition, PVP can be used for high risk patients with fewer adverse events or complications. Conclusions: The review focused on the 80 watt system (PV model) which was approved in 2004. In May 2007 the 120 watt system (HPS model) was approved by Health Canada, however clinical effectiveness data was not available to inform the review. Three policy options were developed to guide the funding decision by the Ministry, which is expected in Spring 2008. M7.2 - Activity report of the French Transparency Commit tee (2005-2007) de La Volpilière A.1, Tranche C.1, Py M.-P.1, Xerri B.1 1Haute Autorité de Santé (HAS), Saint Denis La Plaine, France Objective: The Transparency Committee (TC) systematically assesses all new drugs and delivers an opinion on whether they should qualify for reimbursement by French National Health Insurance. It also reviews registered drugs on a 5-yearly basis. Our objective was to review the activity of the TC over the past 3 years. Methods: We assessed the number and type of applications received, the time taken to perform the assessment, and the results of the assessment in terms of the therapeutic value (Actual Benefit - AB) of the drug (or of a new indication for a drug) and its added value compared to available drugs (Improvement in Actual Benefit - IAB). Results: A total of 622 opinions were delivered in 2005, 1192 in 2006, and 940 in 2007. The AB of a new drug / new indication was rated significant in 83-86% of applications, moderate in 5-9%, low in 2-3%, and insufficient for listing in 4-7%. New drugs / indications were considered to provide added value (IAB levels I to III) in 28% of applications in 2005, 34% in 2006, and 38% in 2007. Mean assessment time was 150 days in 2005, 100 days in 2006, and 73 days in 2007. Conclusions: Efforts to increase the activity of the TC and reduce assessment times, in order to meet the requirements of the EC transparency directive, have met with considerable success. Assessment time has been halved in 3 years.

M7.3 - Third time lucky? An analysis of the success rate of reimbursement submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) i n Australia Macabeo B.1, Lindsay P.1 1Sanofi-Aventis, Macquarie Park, Australia Objective: In Australia, the PBAC makes recommendations to the Minister for Health on the reimbursement of pharmaceuticals. The submission is accepted if the drug is determined to be clinically effective and cost-effective. However, the chance of a positive recommendation for first-time submissions is low. We estimated the success rates of major submissions by number of times they have been considered by the PBAC (“time-round”). Methods: Since June 2003 all PBAC recommendations have been made public on the Department of Health & Ageing website. We used Microsoft Access to develop a database of all the recommendations reported during the period of June 2003 to November 2007. For each recommendation, there were 4 data points associated: the date of submission; the time-round; the type of submission (e.g. major); the recommendation (i.e. positive, rejection). We estimated the percentage of positive recommendations compared to all the recommendations for major submissions being considered for the first time by the PBAC. We compared this percentage with those of submissions that had been considered by the PBAC more than once. Results: During the year 2007 (as an example), the mean success rate for major submissions being considered by the PBAC for first time was 55%. The mean success rate was significantly higher for major submissions being considered for the third time versus the second time (65% vs. 29%; p=0.04). Conclusion: The analysis of variables associated with a PBAC recommendation showed the success rate is directly related to the number of times the PBAC had considered the submission. M7.4 - Best allocate resources in public health: The hea lth technology assessment approach de Waure C.1, La Torre G.1, Chiaradia G.1, Mannocci A.1, Specchia M.L.1, Nicolotti N.1, Ricciardi W.2 1Health Technology Assessment Public Health Unit, Institute of Hygiene, Catholic University of the Sacred Heart, Rome, Italy, 2Institute of Hygiene, Catholic University of the Sacred Heart, Rome, Italy Objective: Economic resources represent a limit in Public Health choices since the spreading of new technologies and the growing of health needs. A tool to decide how to allocate resources is thus needed. Methods: Health Technology Assessment (HTA) approach is proposed to evaluate primary, secondary and tertiary Public Health interventions to guarantee a high quality, efficient and efficacious Health National Service. Particularly, according to Italian Prevention National Plan 2005-2007 topics, vaccines, such as anti-pneumococcal and anti-meningococcal ones, and screenings, such as that of celiac disease, will be assessed with HTA. The method provides the realisation of the following parts: 1. Evaluation of disease epidemiology by a systematic review; 2. Determination of current strategies to prevent and treat disease; 3. Study of resources and costs to treat disease by the consultation of hospital databases and Discharge Cards; 4. Study of efficacy and safety of the intervention/technology by a systematic review and a meta-analysis; 5. Modellisation of clinical and economic impact of intervention/technology introduction or implementation; 6. Economic evaluation by a budget impact and a cost-effectiveness analysis; 7. Study of social, legal and ethical implications of intervention/technology introduction or implementation; 8. Estimation of organizational involvements and evaluation of the best modality to introduce or implement intervention/technology. Results: HTA report on Public Health issues will be based on multidisciplinary approach and spread to local, regional and national level. Conclusions: Intended resources to Public Health are few in Italy. Therefore evidences in order to best allocate resources are expected from HTA.

M7.5 - "Evidence, economics and ethics for tough decisio n-making": Supporting informed health technology decision-making in lower resource jurisdictions (Atlantic Canada) Smith S.1, Farrell L.2, Thompson J.3, Mosher C.4, Allen M.5, Baird K.6 1Canadian Agency for Drugs & Technologies in Health-NB Liaison Office, Fredericton, Canada, 2Canadian Agency for Drugs & Technologies in Health - NS Liaison Office, Halifax, Canada, 3Canadian Agency for Drugs & Technologies in Health - PEI Liaison Office, Charlottetown, Canada, 4Canadian Agency for Drugs & Technologies in Health - NL Liaison Office, St. John's, Canada, 5Dalhousie University Office of Continuing Medical Education, Halifax, Canada, 6Capital District Health Authority, Dartmouth, Canada Objective: A poster presentation will profile this engaging initiative aimed at supporting more informed health technology decision making among senior health executives in lower resource jurisdictions that do not have hospital or provincially-based HTA capacity. The intent is to share the Atlantic experience and stimulate discussion about effective ways to continue reaching and supporting influential decision-makers in lower resource areas. Methods: In May 2007, over 60 senior health executives from the Health Ministries, District/Regional Health Authorities and hospitals in Atlantic Canada participated in an invitational conference co-hosted by CADTH and Dalhousie University Office of Continuing Medical Education. A Planning Committee comprised of senior executives from all four provinces and CADTH´s Atlantic Liaison Officers provided significant input into planning, promoting and delivering the event. The objective of the conference was to have senior health executives understand, explore and discuss influential factors in making decisions about health technologies. Specifically, content and discussion focused on: evidence-based resources; decision-making frameworks and approaches that formally incorporate evidence, ethics and economics at the local/hospital, provincial, and/or Atlantic levels; and opportunities for implementation, improvement and collaborative action. Results: Through expert speaker presentations, small work group exercises and other networking activities, participants were able to explore, share ideas and problem-solve with their peers. Conclusions: The event was well attended and received; attendees acknowledged substantial learning. The conference - the first of its kind in Atlantic Canada - was an initial step towards considering and facilitating more deliberate, organized approaches for health technology decision-making. M7.6 - The Haute Autorité de Santé recommends delisting obsolete diagnostic tests for coeliac disease and introducing a new high-performance test Quentin F.1, David D.J.1, Lee Robin S.H.1 1Haute Autorité de Santé, Department of Medical and Surgical Procedures Assessment, Saint Denis La Plaine cedex, France Objective: Coeliac disease is caused by a reaction to gluten, a protein found in some wheats. Currently, French National Health Insurance (NHI) reimburses 3 diagnostic tests (antibodies against reticulin (ARA), gliadin (AGA), and endomysium (AEMA)). A French clinical specialty society asked HAS to compare a new non-reimbursed test (transglutaminase (ATGA)) with these 3 tests and to define a diagnostic strategy. Methods: We performed a systematic review of the literature on diagnostic tests for coeliac disease (1995-2006). Results were discussed by multidisciplinary working groups and then submitted to the relevant HAS Committee for their opinion. Results: Depending upon the study, sensitivity was 35-90% for the ARA test, 74-100% for the AEMA test, and 90-100% for the ATGA test. Specificity was 65-94% for the AGA test, 89-100% for the AEMA test, and 98-100% for the ATGA test. The tests for ATGA and AEMA are indicated in cases of suspected coeliac disease. If the test is positive, biopsy of the small bowel is usually performed to confirm the diagnosis. Conclusions: HAS concluded that the ARA test (low sensitivity) and AGA test (low specificity) should no longer be used. It defined a new diagnostic strategy based on the AEMA test and new ATGA test. This strategy has been widely diffused to health professionals and patients in order to induce changes in professional practice. HAS advised NHI to discontinue coverage of the ARA and AGA tests, to maintain coverage of the AEMA test, and to start reimbursing the ATGA test.

M7.7 - Evidence and value: Impact on DEcisionMaking (EVI DEM)—applying multicriteria decision analysis (MCDA) to support healthcare deci sionmaking Goetghebeur M.M.1, Wagner M.1, Khoury H.1, Levitt R.1, Erickson L.J.1, Rindress D.1 1BioMedCom Consultants Inc, Montreal, Canada Objective: Develop a practical and quantitative methodology to structure and facilitate healthcare decisionmaking. Methods: A conceptual framework was developed that segregated components of decisionmaking into three: 1) quality of evidence available; 2) intrinsic value of the healthcare intervention; and 3) extrinsic or system-related value. Using this framework, practical tools to assess healthcare interventions were designed drawing on current decisionmaking requirements for drug reimbursement globally and an extensive review of the literature. Results: A Quality Matrix was designed to quantify the quality of evidence available for an intervention; five elements defining quality were clustered by three criteria and 12 components covering the range of evidence required for decisionmaking. Scoring was based on international standards in each discipline. To quantify the intrinsic value of an intervention, a multi-criteria decision analysis (MCDA) matrix (Value Matrix) was designed encompassing 15 key value components. Scoring allowed inclusion of the perspectives and weighted values of representative healthcare stakeholders. An integrated process to apply matrices was established. Preliminary results of a pilot testing with Canadian stakeholders will be presented. Conclusions: The EVIDEM framework is a practical approach that can be applied retrospectively to explore the context of past coverage decisions for healthcare interventions. Prospectively, it can be adapted to existing processes and will allow sharing rationales and values behind decisions in a clear and transparent manner. It also provides a practical collaborative framework for those who generate data and those who need data to make decisions, ultimately facilitating future healthcare decisionmaking. M7.8 - Presentation of the structured HTA approach devel oped at the CHUQ for decision-making Labadie R.1, Cantin V.1, Rhainds M.1, Simard C.1 1Centre Hospitalier Universitaire de Québec, Unité d'Évaluation des Technologies et Modes d'Intervention en Santé, Québec, Canada Objective: To present the approach used at the CHUQ to facilitate decision-making for managers, clinicians and professionals about the introduction of a new technology or a new clinical practice. Methods: This approach involves stakeholders (managers, clinicians or professionals) from the start and throughout the assessment process. CHUQ managers, clinicians and professionals are invited to assess their needs for HTA and submit their questions using a standardised form. Assessment questions are transmitted to the HTA Orientation Committee which selects the questions according to their relevance and anticipated benefits as well as the possibility of significant impacts for individuals’ health or for the organization. Assessment process: 1) Stakeholders receive the support of the UETMIS team which collects available evidence from a diversity of sources (scientific publications, experts opinions, etc.) using recognized literature search methods. 2) Evidence synthesis allows to assess the effectiveness, safety and costs of a technology or clinical practice as well as its impacts for the patient and for the organization. Results: Analysis of the relevant information results in the formulation of recommendations that are specifically applicable to the CHUQ context or in a presentation of the key findings to consider in the decision-making process. Members of the UETMIS Scientific Council Committee evaluate the rigour of the assessment process and the quality of the HTA reports before recommendations are submitted to the requester and the CHUQ Management Committee. Conclusions: The structured HTA approach developed at the CHUQ helps support managers, clinicians and professionals in decision-making.

M7.9 - The Scottish Medicines Consortium - Horizon scann ing for new medicines to support financial planning in NHS Scotland Lee A.1, Donnelly S.1, McIver L.1, Carson D.2, O'Connor P.3 1Scottish Medicines Consortium, Quality Improvement Scotland, Glasgow, United Kingdom, 2NHS Tayside, Dundee, United Kingdom, 3NHS Greater Glasgow and Clyde, Glasgow, United Kingdom The Scottish Medicines Consortium (SMC) undertakes rapid appraisal of new medicines and advises NHS Scotland on their clinical and cost-effectiveness. In 2005 SMC introduced a horizon scanning (HS) initiative, aimed at improving financial planning through the provision of early intelligence on new medicines in development. The horizon scanning team of pharmacists and management accountants gathers intelligence on new medicines through a process involving engagement with clinical specialists across Scotland as well as the pharmaceutical industry. An annual horizon scanning report, entitled Forward Look, is issued to Health Boards each October. Three ‘Forward Look’ reports have been produced, featuring medicines expected to become available for use in the following 12 to 18 months. Reports are focused on medicines expected to have a moderate to high net impact on the drug budget and/or significant implications for service delivery. In addition, all medicines designated as orphan drugs are included in the reports irrespective of their anticipated budget impact. For all these medicines, the report includes an estimate of uptake in the Scottish population and the corresponding potential budget impact in years 1 and 5 after the medicine is introduced. The budget impact estimates take account of the anticipated costs and savings associated with the new medicine; for example, this might involve offsetting the costs of a displaced medicine or adding the costs of any additional treatment monitoring required. The poster will outline the SMC horizon scanning methodology and provide an overview of the outputs to date. M7.10 - The National Council for Quality Improvement and Priority Setting in Health Care-Norway Mørland B.1 1Norwegian Knowledge Centre for the Health Services, Oslo, Norway Objective: To present the Council, and its mission to guide decisions in health care concerning priority setting and quality improvement. Methods: The Council was established by the Norwegian MOH in 2007 and consists of executive members from all health care sectors, universities, user/patient organisations and general practitioners. The Council does not assume authority from these institutions, but offers an arena for actors having joint responsibility for priority setting and quality in health care. Its task is to create legitimacy around difficult issues, by basing the discussions on the best documented evidence, often in the form of HTA reports. Results: The Council is instrumental in following up the criteria for priorities set by the Norwegian Parliament: 1) the seriousness of the illness, 2) the (documented) benefit of the treatment, and 3) the cost-effectiveness ratio. As in other countries, a main challenge is the introduction of new and costly technologies. The Council has drawn up consensus-based guidance depending on knowledge and mutual understanding about both the benefits and costs of measures in the health service, e.g. on the introduction of new cancer drugs, costly equipment or screening procedures. Conclusions: The Council has based its debates on best evidence, but also asked for assessments which illustrate the dilemmas and elements of uncertainty. The Council’s discussions have resulted in agreement on principles as well as specific issues where conclusions will be instrumental for implementation in practice. The institutional members have by this been able to take necessary initiatives for the follow-up in their respective positions of responsibility. M7.11 - Universal newborn hearing screening - To fund or not: The Alberta approach to a evidence informed funding decision in a Canadian pr ovince

Petzold B.T.J.1, Corabian P.2, Harstall C.2, Schopflocher D.3 1Alberta Health and Wellness, Health Technologies & Services Policy Branch, Edmonton, Canada, 2Institute of Health Economics, Edmonton, Alberta, Canada, 3University of Alberta, Faculty of Nursing, Edmonton, Alberta, Canada Objective: Results of a review conducted to examine the potential of Universal Newborn Hearing Screening (UNHS) as a publicly funded health service(s) in Alberta. Method: Newborn hearing screening is conducted in four of nine health regions in Alberta: two report doing UNHS and two provide selective screening, funded within current global allocations to regions. Pressure to provide UNHS stems from 1)the belief that early identification of serious health problems facilitates earlier follow up and treatment resulting in optimal health and well being and 2)a desire to keep up with other provinces that provide UNHS. Following referral of UNHS by the provincial perinatal program, a review under the Alberta Health Technologies Decision Process (government’s evidence-informed process for deciding on funding of health services) was completed. It considered evidence around safety, effectiveness and cost effectiveness of UNHS. Results: In August 2007 the review was completed. Only limited evidence supports the pivotal assumption of UNHS programs that early detection of PCHI leads to more effective habilitation and improved long term outcomes. UNHS is effective in terms of increasing early detection of moderate to profound PCHI. Given limitations in the screening tests and the nature of PCHI, up to 33% of infants with PCHI will be missed with UNHS as a stand alone service and is best incorporated as part of a comprehensive early hearing detection and intervention program. Conclusion: The evidence combined with funding of UNHS in other jursidictions pose a challenge for the Ministry in decision-making (decision expected spring 2008). M7.12 - Which meshes should qualify for reimbursement in the treatment of female stress urinary incontinence (SUI) and pelvic organ prolaps e repair? Thieuzard V.1, Josseran A.1, Denis C.1 1Haute Autorité de Santé (HAS), Saint Denis La Plaine, France Objective: In addition to the assessment of tension-free vaginal and transobturator foramen tape procedures for female SUI, HAS has also assessed the value of suburethral slings in SUI and pelvic organ prolapse repair, in order to advise French National Health Insurance on their reimbursement. Methods: We performed a critical appraisal of the literature (Jan. 2000 - Nov. 2006) and consulted manufacturers and health authorities. The ensuing report was discussed by a multidisciplinary working group of 11 health professionals, then submitted to the relevant HAS Committee for their opinion. Results: The efficacy of knitted monofilament polypropylene slings in female SUI is about 90% at 1 year and 80% at >5 years. Complications include bladder perforations, pain, infections and vaginal mesh erosion. The use of knitted multif ilament polypropylene and thermally bonded polypropylene slings in SUI is associated with serious late complications (infections and vaginal mesh erosion). The efficacy of monofilament polypropylene and multifilament polyester meshes in abdominal sacrocolpopexy ranges from 71% to 100% according to prolapse stage, the definition used for success, and the length of follow-up. The most frequent complications are bladder wounds, vaginal mesh erosion, and dyspareunia. No studies comparing meshes and conventional surgery for transvaginal repair met our selection criteria. Conclusions: In HAS’ opinion, only knitted monofilament polypropylene slings should qualify for reimbursement in female SUI. It recommended reimbursement of monofilament polypropylene and multifilament polyester meshes by the abdominal route for organ prolapse. Comparative clinical data are needed to confirm their value by the vaginal route. HTA Organization 1 M8.1 - Medical device categories under review by the Hau te Autorité de Santé Josseran A.1, Denis C.1 1Haute Autorité de Santé (HAS), Saint Denis La Plaine, France Objective: To be included on the reimbursement list of French National Health Insurance, branded medical devices and categories of similar devices have to undergo assessment by HAS and be

approved by the Ministry of Health. In 2005, HAS was commissioned to reassess by 2015 all medical device categories with regard to classification within the category, indications, therapeutic use, and reimbursement conditions. Methods: Each year, the Ministry publishes the work programme for the following year. The HAS reassessment method, devised in 2005, is similar to that for a first assessment, i.e. a critical appraisal of the literature, consultation of data provided by manufacturers, advice of a working group of health professionals, requests made to manufacturers and health authorities, and official opinion of the HAS committee. Results: Eight categories of medical devices have been reviewed by HAS since 2005 (self-treatment and self-measurement devices, hip prostheses, wound dressings, meshes for urinary incontinence and organ prolapse, medical beds, hearing aids, ocular protheses, and implants for wall repair). Nine categories are currently under review (vascular compression devices, perfusion devices for home use, transcutaneous electrical neurostimulation devices to relieve pain, breast implants, external breast protheses, implants for arterial embolisation, upper limb protheses (handicap) and implantable pumps). The 2009 and 2010 work programmes have been published by the Ministry of Health. Conclusions: These assessments are useful in establishing the therapeutic value of the devices within the current patient management strategy, and also in providing guidance on their most appropriate use by health professionals within specific clinical contexts. M8.2 - The Health Technology Analysis Exchange - A new C anadian HTA network Husereau D.1, Nowlan L.1, Clifford T.1 1Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada Objective: The need to advocate for and facilitate rigorous analyses that improve decision making has led to the creation of HTA social networks. The formation of a new Canadian HTA network, the HTA ´Exchange´, is described along with some of its successes and challenges in its first year. Methods: A narrative description of the development of the HTA Exchange is provided. Results: The Exchange is a network of Health Technology Assessment Producers established in accordance with Canada´s Health Technology Strategy (HTS 1.0). On March 27, 2007, the Exchange held its inaugural meeting. The Exchange currently has 14 members, and an open call for membership continues to be posted on CADTH´s web site. In its first year, the Exchange has embarked on several initiatives, including information sharing through a secure website, and the initiation of an e-mail listserv. Plans for higher level commitment and collaboration are ongoing. Several challenges have been identified including the identification of common goals across organizations with different jurisdictional perspectives (i.e., hospital versus provincial), and different mandates (assessment versus assessment/recommendation). The additional time and resources needed for mass collaboration among HTA organizations with limited additional resources can also be challenging. Conclusions: Creating an HTA Network can lead to immediate rewards, but the pace of its progress can be easily hampered by environmental constraints. M8.3 - How to satisfy different user needs: The institut ional repository of the LBI-HTA Guba B.1 1Ludwig Boltzmann Institute of Health Technology Assessment, Vienna, Austria Background: In February 2007 the Ludwig Boltzmann Institute of Health Technology Assessment (LBI-HTA) started to work on an institutional repository in order to support the dissemination of its own publications. The distribution of the research results via the web site was considered to be insufficient. The launch of the repository is scheduled for the end of January 2008. Objective: This lecture will highlight the challenges and efforts involved in implementing the open source software e-prints and the reasons for the selection of this software product. Therefore, the focus will be on the needs of various user groups (e.g. representatives of the health administration, academia, staff of the LBI-HTA). A presentation of the functions and services of the repository will be given in order to demonstrate how these different needs can be satisfied. Method: The repository offers two search methods: the users can search the repository or browse it by the subjects of the NLM classification. This approach will be compared with the search possibilit ies of the HTA database (http://www.crd.york.ac.uk/crdweb/) and assessed by the means of a survey / usability test among the users.

Conclusions: The example of the repository of the LBI-HTA yields valuable insights on user orientation. The LBI-HTA is confident of the positive impact of open access on citation / reception and cost reduction (because of savings in document delivery) and is therefore willing to share its experiences with other divisions of HTA institutions that are concerned with information management matters. M8.4 - Perspective of a migrant: Impressions of commissi oning HTA research in Canada and the UK Seto I.1, Noorani H.2 1Wessex Institute for Health Research & Development, Southampton, United Kingdom, 2Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada Objective: To provide a conceptual map to contrast the approaches to commissioning and prioritization of HTA research in Canada and the UK. Methods: Data was obtained on the process from topic identification, prioritization to commissioning in the National Coordinating Centre for Health Technology Assessment (NCCHTA) and the Canadian Agency for Drugs and Technologies in Health (CADTH). Further information on yearly budgets, organizational objectives, and the factors that drive priorities were obtained. The process was visualized, conceptually mapped, and qualitatively compared/contrasted between the two agencies. Results: Commissioning begins with topic identification and progresses through many stages of review and prioritization. Both agencies have web forms for anyone to suggest a topic, although topics come in through many different routes. Also, both agencies rely on panels of experts to advise on best research, considering both the priority of the topic as well as the quality of the science, for commissioning. A key contrast is that HTA research is carried out primarily by the commissioning body in Canada, whereas in the UK external researchers bid for funding, resulting in a competitive "market." Conclusions: While resources differ between the countries, the push for health technology assessment (and health research in general) is equally a high priority. M8.5 - Competitive biddings for health technology assess ment projects: Brazil (2007) Elias F.T.S.1, Silva M.T.1, Laranjeira F.O.1, Camargo É.B.1, Alexandre R.F.2, de Sá M.3, Elkhoury A.N.S.M.4, de Oliveira M.R.F.4, Pacheco M.F.5, Serruya S.J.6 1Brazilian Ministry of Health, Health Tecnhology Assessment General-Coordination, Brasília, Brazil, 2Brazilian Ministry of Health, Department of Pharmaceutical Care and Strategic Inputs, Brasília, Brazil, 3Brazilian Ministry of Health, National STD and AIDS Programme, Brasília, Brazil, 4Brazilian Ministry of Health, Department of Epidemiologic Surveillance, Brasília, Brazil, 5Brazilian Ministry of Science and Technology, Research and Projects Financing, Rio de Janeiro, Brazil, 6Brazilian Ministry of Health, Department of Science and Technology, Brasília, Brazil Objective: To describe the results of two competitive biddings in Brazil in 2007 that aimed to choose priority studies in HTA, to support decision-making in Brazilian Public Health System (SUS). Methods: Presentation of a descriptive analysis of all 2007 winning projects through competitive bidding. Results: A 58% rate (15/26) of all priority themes collected in responses was observed in competitive bidding. From the 127 presented projects, 40 were selected, which correspond to a US$6,492,631.09 (Can$6,905,292.39; R$12,506,106.00) investiment. In focus, projects about surgical treatments for morbid obesity (three projects); insulin for type 1 diabetes (two projects); drugs for leishmaniasis (four projects); supervised treatments for tuberculosis (two projects); impact of judicial power in Health Policies (five projects); high-cost drugs for chronic B hepatitis and dyslipidemias (four projects); monitoring of high-complexity procedures in cardiology (four projects); and studies of guidelines´ variability for stroke, hypertension and asthma were observed. Conclusions: The overlap of infections and age-related diseases show the need of funding for health research that aims regional settings. Next steps: (i) to harmonize the selected projects´methods; (ii) to encourage SUS decision-makers to go along with HTA´projects; and (iii) review of not attended topics that were previously considered as priority during competitive bidding.

M8.6 - Reassessment of drugs for Alzheimer’s disease by the French Transparency Committee Semenzato P.1, Vetel J.-M.2, Xerri B.1 1Haute Autorité de Santé (HAS), Saint Denis La Plaine, France, 2Member of the French Society of Gerontology and Geriatrics, and of the HAS Transparency Committee, Saint Denis La Plaine, France Objective: Drugs for Alzheimer’s disease (cholinesterase inhibitors and memantine) have been available on the French market over the past decade. In the wake of several recent public reports questioning their therapeutic value, the French Transparency Committee (TC) decided to reassess these drugs. Methods: We performed a systematic review of data published before 2006 on cholinesterase inhib itors and memantine, and consulted manufacturers’ files. We assessed the conditions of use of these drugs in Alzheimer’s disease. The review was first submitted to a working group of 14 experts for comment, then to the TC for their official opinion. Results: Five major meta-analyses were the basis of this reassessment. The data confirmed a modest effect on symptoms for all disease stages but poor long-term efficacy (after 6-months). Safety seemed satisfactory even though gastro-intestinal side-effects were common and led to some treatment discontinuations. The TC listed several outstanding questions relating to drug associations, switching drugs, long-term clinical effects, and conditions of treatment cessation. The impact of the drugs on the quality of life of patients and their carers is not known. Conclusions: Although several key issues remain unsolved, the TC considered the added value of the drugs to be minor and not as great as expected. It highlighted the lack of data in real-life conditions, and stressed the need to update clinical practice guidelines. M8.7 - Establishing HTA activities at macro level in Ita ly: Stakeholders’ involvement and HTA in context Cerbo M.1, Jefferson T.1, Lo Scalzo A.1, Ancona A.1 1National Agency for Regional Health Services, Rome, Italy Objective: Italy has low institutionalisation of HTA activities, although HTA is becoming more relevant in the political decision makers’ agenda. Late in September 2007, the State Regions Conference gave to the National Agency for Regional Health Service (ASSR) the remit of appraising technologies and supporting dissemination and implementation of results at regional level. Within this framework the ASSR objective was to design and implement a process for producing HTA reports based on the principles of “sharing and finding consensus”. Methods: Analysis of other countries’ experiences; cooperation, communication and networking with international HTA organisations; creation of a national stakeholders’ network composed by representatives from national technical bodies, Regions, health trusts, health professionals, producers, patients’associations, scientific societies and universities; creation of an ASSR HTA unit and strating HTA activities. Results: Production of three HTA reports on medical devices commissioned by the Ministry of Health, based on the analysis of the available secondary and primary literature, on the collection of context specific data and information through national surveys and shared with stakeholders. This will allow the establishment of a national framework of stakeholders as basis for a national HTA program. Conclusions: HTA reports production should be based also on data and information specific to the context they are going to affect and on the active involvement of all relevant stakeholders in its production. It should also be based both on the analysis of the available literature and on health care services research which provides contextual data and information. M8.8 - Institutionalisation of HTA: Structure requiremen ts Christofides S.1, Kubesch N.2, Estrada D.2, Turk E.3, Wladysiuk M.4 1Nicosia General Hospital, Medical Physics Department, Nicosia, Cyprus, 2Catalan Agency for Health Technology Assessment and Research (CAHTAR), Barcelona, Spain, 3Institute of Public Health of the Republic of Slovenia, Ljubljana, Slovenia, 4Central and Eastern European Society for Technology Assessment in Health Care, Krakow, Poland

Objective: The task of Work Package 8 of the EUnetHTA project is to develop systems to support Health Technology Assessment (HTA) in European Union Member States with limited or no institutionalisation for HTA. All this information has been compiled in a handbook. The structure requirements for institutionalisation of HTA are considered here. Methods: Through a survey of HTA Agencies by the Catalan Agency for HTA and through an extensive literature review, data was collected in order to compile the handbook. Results: Structure requirements include the infrastructure that is relevant for the viability of an HTA organisation, the human resources including training and recruitment strategies as well as the necessary facilities. Multidisciplinary teams and adaptive human resources are required that will ensure a continuous professional development that is necessary for the evolution of the organisation. A core of permanent staff, complemented by external collaborators, can increase the capability of the organisation. Cooperation on a national and international level through networks of collaborating HTA organisations is recommended. Sufficient resources are required to allow the analysis of the impact of HTA on clinical practice and policy decisions, and also to facilitate the maintenance of external relations and communication. Conclusions: The Institutionalisation of HTA is a gradual process that builds on the experience gained along the way. The available human resources must be adaptive to ensure continuous professional development necessary for the evolution of the HTA organisation with time. The flexibility to collaborate and network with other HTA organisations is also an essential requirement. M8.9 - Some considerations for the work process in HTA A gencies in EU member states with limited institutionalization of HTA Vondeling H.1, Tufanaru C.2, Atanasijevic D.3, Meiesaar K.4 1University of Southern Denmark/ Institute for Public Health, Health Economics, Odense, Denmark, 2National School of Public Health and Health Services Management, Bucharest, Romania, 3Ministry of Health, Belgrade, Serbia, 4University of Tartu, Tartu, Estonia Objective: The goal of EUnetHTA Work Package 8 is to promote HTA in EU Member States with as yet limited institutionalisation of HTA. To do this, among other activities, a draft-handbook has been developed to assist in the process of creating HTA Agencies and to support their sustainability. The presentation provides some considerations on one of the issues covered in the handbook, development of the work process. This may include many steps, of which the first three will be discussed: 1) identification of health technologies, 2) priority setting of technologies for assessment, and 3) carrying out the assessment. Methods: Literature review and a survey of HTA Agencies by the Catalan Agency for HTA, supplemented with author’s personal experience in Agencies. Results: The work process is determined by the scope of the Agency, which needs to be defined beforehand. If identification of health technologies is included, there is much to learn from Agencies with Horizon Scanning Systems in place. Priority setting should reflect the goals of the programme and the preferred way of working of those who need to be involved. In carrying out the assessment, distinguishing between levels of evidence and grades of recommendations is recommended. The choice of ‘in-house’ versus (partly) commissioning of assessments is associated with specific (dis)advantages which will be reviewed, including implications for quality assurance mechanisms (internal/external). Conclusions: The handbook will contribute to the establishment and prosperity of HTA Agencies in complex surroundings. The discussion of the approach will focus on the role of contextual factors. M8.10 - Successful model of assessment and incorporation of health technology: The experience of a Brazilian medical cooperative Bretas C.G.1, Kelles S.1, Mendonça I.1, Carvalho L.1, Avelar S.1 1Unimed-BH, Grupo de Avaliação de Tecnologias em Saúde, Belo Horizonte, Brazil Objective: To describe the process of assessment and incorporation of health technology in a medical cooperative (Unimed-BH) and to analyze the results of this experience. Methods: Unimed-BH, a medical cooperative with 4,555 member physicians and 692,000 affiliates,

implemented in 2002 a group for Health Technology Assessment (GHTA). The objective of the group, composed of six physicians and one librarian, is to synthesize relevant information as a basis for the establishment of guidelines on the incorporation of new technologies. The reports are discussed together with health committees of the relevant specialty. A consensus document is prepared in the meeting between GHTA and the specialty committee, for technical guidance of the administrative boards of the cooperative. Furthermore, the methodology of this process is disseminated to the member physicians through continued education courses on Evidence-Based Medicine (EBM) and Health Technology Assessment (HTA). Results: In 5 years of activity, the GHTA has prepared a total of 157 synthetic reports on health technologies. Evaluation of the financial impact of this activity shows a significant reduction in expenditures, with a maintenance of the quality of health care. Conclusions: The process of assessment of the technologies provides excellent results and has approval of the members of the cooperative. M8.11 - The initial functions of HTA division in Taiwan Tarn Y.H.1, Shau W.Y.1 1Center for Drug Evaluation, HTA Division, Taipei, Taiwan, Republic of China Objective: In February 2007, the Department of Health (DOH) of Taiwan made the decision to establish a new division of Healthcare Technology Assessment (HTA) in the Center for Drug Evaluation (CDE) to provide evidences on value of new healthcare technologies for decision makers. Methods: A proposed structure and responsibilities of the HTA division in relation to the reimbursement body, Bureau of National Health Insurance (BNHI), was suggested, and communicated with the officers in DOH, scholars in related academia, and people in pharmaceutical industries. The HTA function started with the similar function as CDR in CADTH. We start with providing evidences to the Drug Benefit Committee (DBC) of the BNHI in making decision on application of new drugs reimbursement listing, and revision of reimbursement guidance for medication use. Results: Since the first person on board to serve the task force full time in Jun 2007, seven people have been recruited by end of Dec 2007. Among them 3 hold PhDs degree, 1 physician with PhD, and 3 with MS degree. Thirteen new drug applications were evaluated for reimbursement listing from October to December of 2007. Currently, reports from CADTH (Canada), PBAC (Australia), NICE (UK), and other organizations were referred and abstracted to provide information to the DBC members for making the listing recommendation to the BNHI. Process, methodology, and resource for carrying out quality scientific review are also being developed. Conclusions: Both short-term and log-term plan for the development of the HTA in Taiwan were drafted. Further communications with broader stakeholders ongoing. M8.12 - Evaluation of a referral colorectal cancer progra m for symptomatic patients Valentín B.1, Blasco J.A.1, Andradas E.1, Ruiz P.2, Morillas J.D.2, Ferrándiz J.2 1Health Technology Assessment Unit (UETS), Agencia Laín Entralgo, Madrid, Spain, 2Hospital 12 de Octubre and Health Care District, Madrid, Spain Objective: A Colorectal Cancer Program was implemented to decrease waiting-times in patients with colorectal cancer (CRC) symptoms in a Health Care District of the Community of Madrid in 2004. This study evaluates referral program over a 3-year period. Methods: Program included patients of 21 Primary Care Centers with a population of 345,859 persons. Patients with high-risk symptoms of CRC should have colonoscopy done by Gastroenterology Services within 15 days of referral. Patient characteristics, referral criteria, process delay, diagnosis and treatment of CRC cases were collected. Results of referral program are compared with previous outcomes and also with routine pathway. Results: 272 patients were referred for colonoscopy; 51% were male, mean age 68.4 years (SD:14.0). An 80% of referrals fulfilled CRC high-risk criteria. A total of 52 cancers were diagnosed, 43 underwent surgery. Rapid referral Astler-Coller stages were 26.1% stage A, 37.0% B, and 36.9% C-D versus routine pathway 12.1% stage A, 42.3% B and 45.6% C-D, (p<0.05). Program mean delay for colonoscopy was 18.2 days (SD:18.5), with no difference between phases.

Surgery mean delay in first phase for CRC patients was 38.6 days (SD:24.9) versus 19.7 days (SD:15.5) in second phase, p<0.05. Global mean delay was 52.9 days (SD:22.6) in first phase versus 31.3 days (SD:14.9) in second one, p<0.05. Conclusions: Results of rapid program are maintained over time, improving surgery and global delay. Early stages of CRC are diagnosed promptly with the program. Rapid-access programs are effective strategies for avoiding waiting-times and delays in treatment of CRC symptomatic patients. HTA uptake, knowledge translation 1 M9.1 - Health technology assessment and evidence-based c linical guidelines: A Brazilian private healthcare plan experience Oliveira I.1 1Medial Saúde, Research and Development Department, São Paulo, Brazil Introduction: This paper addresses a national wide Brazilian supplemental healthcare plan. The company receives the demands from up to 1,500 thousand consumers and has his own health assistance network formed by 07 hospitals and 43 medical centers. Since 2007, the Medical Research and Development Department is producing rapid health technology assessments (HTAs), evidence-based recommendations and clinical practice guidelines (CPG) to be implemented in the organization hospitals. Objective: This study aims to describe the adoption of evidence-based health decision making and the strategies elected by the company in this approach accomplish. Methods: Descriptive case report study. Results and discussion: Rapid HTAs are based on INAHTA’s database and are prepared by the R&D Department’s staff. Up until now there are 09 rapid HTAs being used by the medical auditors (Cochlear Implants for deafness; Botulinum toxin for spasticity; Viscosupplementation for osteoarthritis; Extracorporeal shockwave therapy for Peyronie’s disease; Zoledronic Acid for menopausal osteoporosis; Botulinum toxin for sialorrhea; Rituximab for rheumatoid arthritis; Bone morphogenetic proteins and spinal surgery for degenerative disc disease; Percutaneous radiofrequency ablation for atrial fibrilation). Three systematic reviews were produced (Type 2 Diabetes mellitus; Hypertension and Chronic Pulmonary Obstructive Disease) by an external consultant. These SR are based on Cochrane Collaboration’s methodology. The first company’s CPG addresses type 2 Diabetes mellitus and is currently being developed by a group of expert physicians that are adapting the systematic review to the organization’s context. The CPG development process is reported. Conclusion: Among other regulation strategies, as physician’s second opinion, use of preferred professionals, aiming to proper net, and direct negotiation with the provider; the company adopts HTA as a base for technology incorporation decisions and EBM as a base for clinical decisions. Evidence-based decision making improves quality for all (consumers, physicians and the company) and is a cost controlling solution because it recommends the use of cost-effective interventions. Keywords: clinical practice guidelines; health technology assessment; supplemental health. M9.2 - Health technology assessment improving the public health policy in Brazil: A partnership between Ministry of Health and the Braz ilian Cochrane Centre Riera R.1, Atallah A.N.1, Trevisani V.F.M.1, Saconato H.1, Silva E.K.1, Puga M.E.S.1, Andriolo R.B.1, Lemos Jr H.P.1, Torloni M.R.1, Silva D.L.1, El Dib R.P.1, Lacroce S.1, Peccin M.S.1, Ishioka M.1, Almeida G.1, Imoto A.M.1, Lins E.1, Matos D.1 1Brazilian Cochrane Centre - Universidade Federal de São Paulo, São Paulo, Brazil Objective: To improve the Brazilian Public Health and to insure the evidences could be partake of decision-making. Methods: Since 2005, through a partnership with Ministry of Health, the Brazilian Cochrane Centre (BCC) has developed or updated systematic reviews (SR), aiming Brazilian Public Health Policy could be based on high quality evidence. Results: 36 questions were proposed by Ministry of Health: - adalimumab for rheumatoid arthritis; - efalizumab for psoriasis;

- acupuncture for carpal syndrome; - surgeries for morbid obesity; - imatinib for gastrointestinal tumours and chronic myeloid leukaemia; - transcranial electrical stimulation and piribidil for Parkinson disease; - electrophysiological and haemodynamics catheters; - stents recovered by rapamicina/paclitaxel; <br - multi-chamber pacemakers and implanted electrical cardioversor; - teriparatide for osteoporosis; - skin replacement materials for burn; - uterine artery embolization for myomas; - nucleoplasty for disc herniation; - Ferrara’s ring for keratoconus; - surgery for epilepsy; - drotrecogin alpha activated for sepsis; - agalsidase beta for Fabry disease; - laronidase for mucopolysaccharidosis; - etanercept and infliximab for severe psoriasis; - pegvisomant for acromegaly; - nucleic acid amplification and detection tests for HIV and hepatitis C virus, traditional sub urethral sling operations for urinary incontinence; - acupuncture for headache, epicondilit is and low back pain; - cages for spine surgeries; - surgical staplers reprocessing; - photodynamic therapy for macular degeneration. These evidences were used by Health Technology Assessment Department on decision process, including economic evaluation. Conclusions: This work warrants that whole population has access to an effective and safe health system and also supports public system feasibility, allowing that the government applies the resources on conducts that definitely work and readdresses the health research vestures to no-answered questions. M9.3 - Dissemination strategies promoted by the Ministry of Health of Brazil during 2007 Pontes U.1, Osório R.2, Lobo M.C.A.2, Elias F.1, Serruya S.3 1Ministry of Health of Brazil, General Coordination of Health Technology Assessment, Brasília, Brazil, 2Ministry of Health of Brazil, General Coordination of Knowledge Management, Brasília, Brazil, 3Ministry of Health of Brazil, Department of Science and Technology, Brasília, Brazil Objectives: Analyze the dissemination strategies for HTA adopted by the General Coordination of Health Technology Assessment (CGATS) of the Department of Science and Technology (Decit) of the Ministry of Health of Brazil (MoH). Methods: Study on dissemination activities during 2007 and result analyze. Results: CGATS publishes its activities electronically in Portuguese, English and Spanish at the MoH’s website and by press. In 2007, CGATS’s webpage received over 16,000 page views. Another strategy is a virtual network, intended for MoH HTA courses alumni, which comprises 500 e-mails and provides an average stream of 3 weekly messages containing studies and news. Pressed publications: “Methodological Guidelines for Appraisals on HTA for the Ministry of Health of Brazil”, “Proposal for the National Policy for Health Technology Management” and the folder “Health Technology Assessment”. The folder presents CGATS: aims, activities, organization and partners. The Guidelines compile a set which aims at standard studies sponsored by MoH. Two volumes are under development: “Systematic Reviews” and “Economic Analysis”. CGATS is organizing a set of fascicles that summarizes Systematic Reviews elaborated by the Brazilian Cochrane Centre, using comprehensive language for health and law professionals. Beyond that, CGATS collaborates regularly with the "Informativo Decit", a bulletin that divulges fortnightly the Department’s activities. Conclusions: CGATS strategies aim at an interchange with the foreign and national public. Main challenges: break the barriers regarding the language and improve international cooperation; increase the page views and facilitate the access by means of communication languages adaptation. M9.4 - Incorporating decision-makers in the format desig n of health technology assessments

to improve usability Gartlehner G.1, Felder-Puig R.1, Guba B.1 1Ludwig Boltzmann Institute of Health Technology Assessment, Vienna, Austria Objective: To present an example of collaboration between a Ministry of Health and a Health Technology Assessment (HTA) Institute that greatly improved evidence-based decision making. Background: Until recently in Austria, expert panels evaluated the effectiveness and safety of novel devices and procedures to determine if they could be included in an official catalogue of approved medical specifications. Since placement on the list plays an important role on whether costs are reimbursed by the Austrian health insurance groups, the process has been susceptible to the influence of special interests. Our HTA Institute strove to develop an alternative approach to improve decision-making which would be objective and methodologically sound. Method: Case report. Findings: To guarantee the greatest possible internal validity, we conducted systematic reviews to determine the effectiveness and safety of interventions. We developed four explicit recommendations regarding acceptance into the official catalogue by modifying a system developed by the GRADE Working Group. We actively involved decision makers in the development and structure of the format to ensure broad acceptance of the reports. The final product consists of 10 identically structured reports with fewer than 20 pages each. All of them have successfully guided and improved the decision-making process. Conclusion: When the specific needs of decision makers are incorporated, the usability of reports can be greatly improved. M9.5 - Evidence of the positive impact of health technol ogy assessment on healthcare decision-making in Ireland Usher C.1, Tilson L.1, Barry M.1 1National Centre for Pharmacoeconomics, St James's Hospital, Dublin, Ireland Health Technology Assessment (HTA) has recently become a formal function in the healthcare decision making process in Ireland. A major role of the National Centre for Pharmacoeconomics (NCPE), which was established in 1998, is to evaluate cost-effectiveness of new and existing technologies (e.g. pharmaceuticals and vaccines). Objective: To describe the positive impact of a HTA recently conducted by the NCPE to inform public health policy. The objective of the HTA was to evaluate the cost-effectiveness of implementing a universal infant pneumococcal conjugate vaccination programme in Ireland. Methods: A model was constructed in MS Excel to follow a cohort of vaccinated and unvaccinated individuals from birth over a 5 year period. The primary outcome measure was the number of life years gained (LYG). The Health Service Executive (HSE) perspective was taken. Costs and outcomes were discounted at 3.5%. The HTA was presented to the key decision makers in Ireland. Results: Pneumococcal vaccination was found to be highly cost-effective (ICER �5,997/LYG). Following completion of the HTA and review by an expert group (6 month timeframe) an announcement was made by the HSE indicating an allocation of �18 million in the healthcare budget for the introduction of this vaccine along with a Hepatitis B vaccine to the National Childhood Immunisation Programme. Conclusions: The impact of the pneumococcal HTA in Ireland has highlighted the benefits to the HSE of investing in independent and evidence-based evaluations. The assessment process has been widely accepted in Ireland and serves to highlight the value of HTA to decision makers. M9.6 - Past international HTA conferences: Where have al l the abstracts gone? Chan L.1, Stafinski T.2, Menon D.2 1University of Alberta, John Scott Library, Edmonton, Canada, 2University of Alberta, School of Public Health, Edmonton, Canada Objectives: International HTA conferences offer a forum for communicating state-of-the-science assessments of health technologies that may be used to support policy decisions. However, like most conferences, the information presented is limited. Therefore, the purpose of this project was to

determine where assessments described in abstracts presented at the 2003 and 2004 annual international HTA conference ´end up´. Methods: Abstracts presenting assessments of specific technologies were independently selected by two reviewers. Systematic electronic literature searches for corresponding papers or reports appearing in the public domain following the HTA conference (up until December 2007) were then conducted by two information specialists. Each paper was subsequently assessed by two reviewers to ensure that it described the same work as contained in the abstract. When no papers were found, authors were contacted. Results: 41% (136/333) of abstracts from the 2003 conference and 39% (121/314) from the 2004 conference were based on technology assessments. Of these, approximately 65% appeared as a full publication, either in a peer-reviewed journal (in one of 6 languages) or as a government or agency report. The 122 peer-reviewed papers represented 78 different journals, the majority of which were disease-based (e.g., Heart). Conclusion: For a significant portion of the work presented at HTA conferences, the abstract, itself, appears to be the “terminal” step of its dissemination. Such abstracts are therefore limited in their capacity to inform policy makers. Patients & Consumers 1 M10.1 - Patient influence in HTA process: A model of stak eholders and their interactions Shah S.G.S.1, Robinson I.1 1Brunel University, Centre for the Study of Health and Illness, School of Social Sciences, Uxbridge, Middlesex, United Kingdom Objective: There are several types of users and beneficiaries of healthcare technology assessment (HTA), who may be described as medical device stakeholders, with varying needs and interests. They interact with each other in many ways to meet their particular, and sometimes conflicting, objectives. To facilitate understanding their respective roles in medical device technology (MDT) assessment, it is important to formally classify them and study their interactions. Methods: A structured literature review, and subsequent development of a conceptual model of medical device stakeholders and their interaction network. Results: Stakeholders of medical devices include, for example, producers, providers, regulators, reimbursers, and patients. They have different perspectives, different roles, different expectations and different levels of influence politically and economically. They interact with each other, directly and indirectly, through a complex network focusing on supply, purchase and use of MDT, healthcare provision, reimbursement, and regulation. However, in the HTA process certain stakeholders, for example patients, have traditionally had less direct influence, and mechanisms that ensure their active involvement are lacking. Therefore, HTA objectives that directly impact upon patients are not being fully assessed. Conclusions: Understanding the needs and roles of all medical device stakeholders is important in ensuring the safety and effectiveness of MDT. To ensure the full integration of patients’ perspectives in the HTA process, they need to be actively and centrally involved. The stakeholders’ model and their interaction network presented in this paper can assist in reassessing the position of patients in the medical device development and assessment processes. M10.2 - Patient- and citizen aspects and cancer rehabilit ation in Denmark. An ongoing HTA Hansen H.P.1 1University of Southern Denmark, Institute of Public Health, Odense C, Denmark Objective: The aim of this presentation is to discuss the implementation of data about patient- and citizen aspects in an HTA.The data on patient- and citizen aspects is part of an ongoing HTA-study in Denmark aiming at creating new knowledge about cancer rehabilitation. This HTA consists of three parts. In the first part about technology aspects (rehabilitation interventions) and patient- and citizen aspects are addressed. In the second part the results from the first part is used in an empirical study to decide the ways in which cancer rehabilitation can be organised in Denmark. The fourth part, which is the last part focus on economy aspects. Methods: Data were generated through a literature review focusing on cancer rehabilitation and

patient- and citizen aspects and synthesized with data from the literature review about the technology (rehabilitation intervention). Three cancer diseases were investigated in this HTA, namely, breast-, prostate- and colorectalcancer. Results: The results show that it is not an easy task to implement data about patient- and citizen aspects in an HTA. In this presentation two problems will be addressed. The first problem has to do with methodology and how to secure that the results are on a scientific level to make generalisations. The second problem has to do with the synthezing part between the technology aspects and the patient-and citizen aspects. Conclusions: It is important to include patient- and citizen aspects in future HTA’s, but there is a need to address some of the possibilities and limitations in doing so. M10.3 - The role of patient representatives in developing recommendations for the management of MRSA in Scotland Ritchie K.1, Reid M.2, Foster L.3, Creelman R.4 1NHS Quality Improvement Scotland, Health Services Research and Effectiveness Unit, Glasgow, United Kingdom, 2University of Glasgow, Public Health and Health Policy, Glasgow, United Kingdom, 3NHS Quality Improvement Scotland, Glasgow, United Kingdom, 4Public Partner, Colintraive, United Kingdom Objective: The Scottish Government requested an HTA was carried out to determine the most clinically and cost effective strategy for screening patients admitted to hospital for MRSA colonisation. The high level public interest in MRSA required careful consideration of the perspective of patients and the public in the management of this infection. Methods: A patient-issues sub-group of the HTA Steering Group was convened including representation from an MRSA patient support group, a Public Partner, an infection control nurse specialist and a senior academic researcher. This group worked together to identify key issues in management of MRSA for patients and the public, conducted literature reviews and commissioned focus groups to explore these issues. Results: Key issues for patients included screening of staff, being nursed in isolation and communication issues. However, patient representatives on the group also had concerns they felt were not being addressed by the HTA policy question, principally relating to the impact of environmental transmission. Interestingly, the issues of importance to the patient representatives were not reflected by findings of the literature review. Conclusions: Working with patient representatives on HTAs can be challenging particularly when the focus of the assessment does not address their key concerns. The appointment of the Public Partner as chair of the Steering Group addressed some of the unease that the assessment was being driven from a clinical perspective only and this individual played a key role in mediating between the different perspectives. However difficult issues such as screening of staff for MRSA remained unresolved. M10.4 - Stakeholder perspectives on HTA: The case of NICE Sorenson C.1, Drummond M.2 1London School of Economics, London, United Kingdom, 2Centre for Health Economics, University of York, York, United Kingdom Objective: In early 2007, the UK House of Commons, Health Select Committee initiated a public inquiry into the National Institute of Health and Clinical Excellence (NICE), calling for comments from a variety of stakeholders. This study aimed to examine stakeholder perspectives on several topics, including public confidence in NICE; appropriateness of assessment methods; and, effectiveness of guidance implementation. Methods: All stakeholder submissions (n=92) were systematically reviewed and key themes were identified across three principal categories: 1) organisation and process, 2) methods, and 3) decision-making and implementation. Results: Stakeholders identified a number of overarching issues regarding NICE and HTA, more broadly. Firstly, despite its “arms-length” organisational structure, the independence of NICE is perceived to be compromised. Secondly, stakeholders contented that its methods assume an overly

narrow perspective, especially regarding the use of RCTs, QALYs, and measures of costs. Thirdly, commentators asserted that stakeholders should play a greater role in HTA processes. Fourthly, the variable implementation of guidance was deemed a significant limitation, with existing regulatory measures and other strategies insufficient to improve local uptake. Other key concerns included the overall transparency of NICE operations and the time required to issue guidance. Conclusions: Most stakeholders support the overall role of NICE and acknowledge that the Institute generally undertakes rigorous assessments. Nevertheless, many criticisms were put forth. NICE should continue to capitalise on its strengths, while devising solutions to address existing limitations and challenges. However, it is unlikely that any national HTA system will satisfy the needs and expectations of all key parties. M10.5 - An intelligent videomonitoring system for fall de tection at home: The perception of the elderly Turgeon Londei S.1, Rousseau J.1, St-Arnaud A.2, Ducharme F.1, Meunier J.3, St-Arnaud J.1 1Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada, 2CSSS Lucille-Teasdale, Montréal, Canada, 3Université de Montréal, Département d'Informatique et de Recherche Opérationnelle, Montréal, Canada Statistics all agree: one in three elderly falls at least once a year. Literature, clinical data and the media report numerous cases of elderly discovered injured or deceased at home, hours and even days after a fall. Because fall intervention programs will never be a 100% effective, there is a need to develop fall detection systems. Our research team has developed an intelligent videomonitoring system. This new system detects falls at home more rapidly than usual systems and maintains privacy. Objective: To explore the perception and receptivity of the elderly regarding the introduction of an intelligent videomonitoring system at home. Methods: A mixed methods design was used. Thirty elderly with a fall history underwent a structured interview and answered two questionnaires (socio-demographic, questions relating to the videomonitoring system). Open-ended questions (qualitative data) were used to reinforce the quantitative data. Descriptive quantitative analyses (mean, frequency, correlations) were executed with SPSS 15.0. A content analysis of the qualitative data was performed with QSR N’Vivo 2.0. Results: 85% of the participants are in favour of this intelligent videomonitoring system. Thirteen would use it comparing it to a ‘presence’ (n=11 live alone). The other participants did not agree on using this system except if they were to live alone (n=3) and if their health condition was worsened (n=10). Conclusions: The living situation of the elderly influences their perception and receptivity regarding the use and acceptance of the intelligent videomonitoring system. The next step will be to evaluate the system under real-life conditions. Cardiac Interventions 1 M11.1 - Systematic review on medical efficacy of drug-elu ting stents (DES) vs. coronary artery bypass-graft (CABG) in coronary heart disease (CHD) Gorenoi V.1, Dintsios C.-M.2, Schönermark M.P.1, Hagen A.1 1Hannover Medical School, Department of Epidemiology, Social Medicine and Health System Research, Hannover, Germany, 2Institute for Quality and Efficiency in Health Care, Department of Health Economics, Cologne, Germany Objectives: The medical efficacy of DES vs. CABG in the treatment of CHD is unclear. Methods: A systematic literature search of published controlled clinical trials and register data was conducted. The information synthesis was performed qualitatively. Results: The literature search yielded 2312 hits. 11 publications about 5 clinical controlled trials and 5 about 2 registers were included. Register data showed low rates of death (0.2-0.7%), myocardial infarction (0.5-1.4%) and stent thromboses (0.3%) for DES during hospital stay. In patients with isolated proximal LAD stenosis one study showed a significantly higher revascularization rate (16.8% vs. 3.6%, p<0.01) and a significantly higher rate of angina pectoris for

DES at 2 years (35% vs. 8%, p<0.01). In patients with unprotected LMCA stenosis 2 studies found a significantly higher survival without myocardial infarctions or cerebrovascular events (96% vs. 79%, p<0.05; 95.3% vs. 91.5%, p<0.001), but two studies a significantly higher revascularization rate (19.6% vs. 3.6%, p<0.001; 25.5% vs. 2.6%, p<0.01) for DES at 1-year. In patients with multivessel disease one study showed significantly lower mortality and myocardial infarction rate (1.0 vs. 2.7% and 1.3 vs. 4.2%, both p<0.05), but a significantly higher rate of percutaneous revascularizations (6.4% vs. 3.5%, p<0.05) for DES at 1-year. Late thrombosis after DES was uncommon (0.3%). Another study found a significantly higher revascularization rate (14.2% vs. 5.3%, p<0.05) and a significantly higher rate of angina pectoris for DES at 1 year (28% vs. 12%, p<0.05). Conclusions: The presented efficacy results for DES vs. CABG should be proven in RCTs. M11.2 - Effectiveness of telemonitoring programmes for pa tients with chronic heart failure García-Lizana F.1, Yanes-Lopez V.2 1Instituto de Salud Carlos III, AETS, Madrid, Spain, 2Servicio Canario de Salud, Servicio de Evaluación y Planificación, Sta Cruz de Tenerife, Spain Objective: To analyze and determine effectiveness of remote monitoring programmes (RMP) for patients with chronic heart failure (CHF) in comparison with usual care (UC). Methods: Systematic review of published literature from 1996-2007. The search strategy was applied in MEDLINE, EMBASE, COCHRANE LIBRARY, NHS-CRD, combining MESH-terms and free text. Manual search was performed within the references of included studies. Selected articles were randomized controlled trials comparing RMP vs UC.RMP were classified: structured telephone-support programme (TSP) and complex remote monitoring programmes (CRMP). Information was extracted and analyzed by two independent researchrs and summarized in evidence tables. Quality evaluation was performed by Jadad Scale. Results: A total of 248 references were founf, 29 were included in the study (7072 patients). Seventeen articles evaluated TSP, nine evaluated CRMP and three directly compared effectiveness of both forms of telemonitoring with UC. The most of studies show case management programmes whit multidisciplinary teams. Quality of life is not significant differences between groups. Mortality rates, adherence to medication and readmission rates were better in RMP than UC but this effect was not clear in longer follow-up. It was not clear the benefit of CRMP vs TSP in clinical outcomes. Conclusions: The evidence in effectiveness of telemonitoring programmmes for patients with CHF were limited to short-term values. More research is needed about long-term clinical outcomes, organizational impact and cost-efectiveness of programmes. M11.3 - The effect of diabetes on 1-year outcomes in high er-risk percutaneous coronary intervention (PCI) patients Eisenstein E.1, Cowper P.1, Bae J.2, Kong D.1, Anstrom K.1 1Duke Clinical Research Institute, Durham, North Carolina, United States of America, 2Eli Lilly and Company, Indianapolis, Indiana, United States of America Objective: To determine the effect of preexisting diabetes (diabetes) on 1-year death or myocardial infarction (MI) in higher-risk percutaneous coronary intervention (PCI) patients. Methods: The TRITON clinical trial compared prasugrel vs. clopidogrel in higher-risk acute coronary syndrome (ACS) patients undergoing PCI. Prasugrel had a superior overall net benefit (cardiovascular death, MI, stroke, or non-CABG major bleed) in the overall trial population studied, and patients with diabetes appeared to have particular benefit. We analyzed 6021 higher-risk patients undergoing PCI at Duke Medical Center between 1999 and 2006 and examined 1-year outcomes using logistic regression to understand outcomes between patients with and without diabetes mellitus. Results: Compared to non-diabetics, patients with diabetes had a higher rate of comorbidities, including multi-vessel coronary artery disease and history of stroke or transient ischemic attack. Diabetic patients had an increased risk of death or MI at 1 year (hazard ratio of 1.44 unadjusted, or 1.25 adjusted). Conclusions: Diabetes was an independent predictor of long-term adverse clinical outcomes in the higher-risk PCI patients studied.

Diabetes (n= 1544) No Diabetes (n=4477)

Age in years (mean) 61.8 61.2

Female gender (%) 44.3 31.8

Congestive heart failure (%) 18.1 9.2

Hypercholesterolemia (%) 65.2 50.7

History of stroke / TIA (%) 10.0 5.2

Multi-vessel coronary artery disease (%) 50.3 42.9

Death or MI at 1-year (%) 13.3 9.7

Unadjusted Hazard Ratios for 1-Year Death or MI (HR, 95% CI)

1.44 (1.20, 1.71)

Adjusted Hazard Ratios for 1-Year Death or MI (HR, 95% CI) 1.25 (1.03, 1.52)

M11.4 - The “triangular model” applied to drug eluting st ents (DES) Sacchini D.1, Refolo P.1, Virdis A.1, Pennacchini M.1, Marchetti M.2, Oradei M.2, Cicchetti A.3, Carrasco de Paula I.1 1Istituto di Bioetica, Facoltà di Medicina e Chirurgia 'A.Gemelli', Università Cattolica del Sacro Cuore, Roma, Italy, 2Unità di Valutazione delle Tecnologie (UVT), Policlinico Universitario 'A. Gemelli', Roma, Italy, 3Dipartimento di Scienze dell'Economia e della Gestione Aziendale, Università Cattolica del Sacro Cuore, Roma, Italy Objective: The work intends to assess, within an HTA process, the ethical consequences of implementing DES by the “triangular model”. Methods: The work is conducted with reference to the National Library of Medicine data. Results: The European Network for Health Technology Assessment (EUNetHTA) has assessed, within an HTA process, the ethical consequences of implementing DES by Core model (EUNetHTA, 2007), a catalogue of questions, primarily based on Björn Hoffman’s (2005). Nevertheless, the methodological approaches for integrating ethical analysis into HTA are various. Amongst them, there is the “triangular model”, that is centred on a substantial conception of human person (Sgreccia, 2007). Its methodology comprises three steps of analysis: 1. data collection, i.e. an in-depth study of all facts/data, including qualitative and relational ones; 2. anthropological aspects, i.e. the analysis of eventual values at stake, related to human life, integrity and dignity; 3. ethical-normative evaluation, i.e. the practical choices that should be made. Moreover, this model presumes a normative framework, that consists of four operative criteria: 1. the defence of physical human life; 2. freedom-responsibility; 3. therapeutic criterion; 4. sociality-subsidiarity. Conclusions: The “triangular model” on Drug Eluting Stents (DES) could be applied as possible alternative approach for integrating ethical analysis into HTA. M11.5 - A multiprofessional attendance center for cholest erol management for patients at high risk for cardiovascular events Fiterman Costa A.1, Eizerik D.2, Chiaradia V.3, Lima P.3, Silva A.4, Picon P.1 1UFRGS / HCPA / SES / MS, Porto Alegre, Brazil, 2UFRGS / HCPA / SES, Porto Alegre, Brazil, 3UFRGS / HCPA, Porto Alegre, Brazil, 4PUC / HCPA, Porto Alegre, Brazil Introduction: The cardiovascular diseases, especially the dislipidemia, present characteristics that suggest the need of the pharmaceutical care in its treatment. Objective: To implement and evaluated the effectiveness, in Brazilian Health System, a center of

multiprofessional attendance, with a pharmaceutical care program, for patient with dislipidemia, aiming the treatment optimization. Methods: A clinical trial (RCT) is being accomplished with patients being randomized for usual medical care or to a multiprofessional approach (intervention group). The treatment is guided by the Ministry of Health Clinical Guidelines for dislipidemia. The intervention consists of medical consultations (1 to 6 months intervals) and monthly consultations with pharmacist and nutritionist. In this monthly follow up, interview composed by anamnese, monitorization of the lipid profile and patient´s orientation are performed. In the pharmacotherapeutic follow up a therapeutic plan is elaborated and drug-related problems (DRPs) are appraised. The pateints’orientation is performed in a verbal way with the delivery of written material. The monitorization of capillary cholesterol is performed in the intervention group. In the multiprofessional group, all the patients are discussed among doctors, nutritionists and pharmacists. Results: This project was endorsed by the approval of the Proclamation CNPq and is in course. Until now we have 76 patients being studied. Discussion and conclusion: We expect that the multiprofessional approach will implement active pharmacosurveillance, improve the performance of the health team, promote the rational use of drugs and doing that, patients and public health will get better. Support: Hospital de Clínicas de Porto Alegre, SES - RS, CNPq. M11.6 - Low-density lipoprotein apheresis for the treatme nt of familial hypercholesterolemia Khan T.1, Chandra K.M.2, Pham B.3 1Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat, Toronto, Canada, 2Program for Assessment of Technology in Health, Hamilton, Canada, 3University of Toronto, Toronto Health Economics and Technology Assessment Collaborative, Toronto, Canada Objective: To assess the clinical and cost-effectiveness of low-density-lipoprotein (LDL) apheresis for treatment of patients with homozygous (HMZ) and heterozygous (HTZ) familial hypercholesterolemia (FH). Methods: Seven case series and one retrospective review with heparin-induced extracorporeal LDL precipitation (HELP) for treatment of refractory HMZ and HTZ FH (January 1998-May 2007) were analyzed. Results: The mean acute decrease in LDL-C ranged 53-77% with HELP. The mean chronic LDL-C decrease ranged 9-46% and the HDL-C increase ranged 12-27%. The LDL:HDL ratio exceeded target values. There was a beneficial impact on coronary outcomes demonstrated by a decrease in Agatston scores and a regression in atherosclerotic lesions. Adverse events, ranging 2.9-5.1%, were mild and related to vascular access problems. Studies were of low quality however performing controlled studies is not feasible given that HELP represents a last therapeutic option for these patients. The annual budget impact was $1.0 and $61.0 million (CAD) for HMZ and HTZ respectively. Costs were halved with biweekly treatment. The cost/CHD death avoided comparing HELP with Plasma Exchange (PE), current treatment, and with no intervention in HTZ was estimated to be $37.5 million and $18.7 million for weekly and biweekly treatment respectively. Although HELP costs twice as much as PE, it avoided 12 deaths versus PE and 22 deaths versus no intervention over a 10-year period. Conclusions: There is evidence of overall clinical benefit of LDL apheresis for HMZ and HTZ FH. The diffusion of LDL apheresis for refractory HTZ FH should factor affordability and potential capital and human resource constraints. M11.7 - The benefits and costs of cardiac rehabilitation: What have we learned? The limitations of clinical trials and the importance of patient pr eferences Raftery J.1, Jolly K.2 1NCCHTA, Southampton University, UK, Southampton, United Kingdom, 2Birmingham University, Birmingham, United Kingdom Objective: To review the contribution of recent clinical trials to the meta analysis and cost effectiveness of home versus hospital based cardiac rehabilitation. Methods: Review of systematic reviews, meta analysis and cost effectiveness before and after two UK trials (CHARM and BRUM). Results: The Cochrane review of 2000 concluded that the evidence favouring home versus hospital

provision was equivocal and that more clinical trials were required. Partly as a result, two clinical trials were undertaken in England, CHARM and BRUM, adding 74% to the total patients in the meta analysis (from 845 to 1474 participants). The updated meta analysis showed no statistically significant differences between the two models either in relation to outcomes or costs. Both trials emphasised the importance of patient preferences (although patient satisfaction was not included as an outcomes in the meta analyses. Conclusions: The value of the two recent trials was limited by their shared superiority design, such that the equivalence of the two models has not been established. All that has been proved is that home is not inferior to hospital provision. Recruitment and compliance in each trial was limited by patient preferences. A very large trial would be required to demonstrate equivalence. M11.8 - Three-years follow-up of the InCor valve replacem ents surgeries costs and effects Trindade E.1, Pomerantzeff P.2, Grinberg M.2, Brandão C.M.2, Fujii S.3 1Heart Institute of the São Paulo University Medical School, Health Technology Assessment/ DIREX, São Paulo, Brazil, 2Heart Institute of the São Paulo University Medical School, Valve Surgical Division, São Paulo, Brazil, 3Heart Institute of the São Paulo University Medical School, Informatics, São Paulo, Brazil Objective: To estimate clinical events rates and event-free survival and to ascertain risk factors and costs of valve-related events. Methods: Prospective cohort of consecutive cases requiring valve replacement at the InCor-HC/FMUSP during 2004. Routine ambulatory visits, free call center disk line and all required services are made available. Costs are calculated by micro-costs building to estimate procedure and tests, materials and all other resources using real unit costs. Physician fees are not included. Results: Biological prostheses were implanted in 359 patients, while 87 patients underwent mechanical implants, at an average 55 and 50 years of age. Initial hospital admission all causes mortality was 11% and 14% and costs for replacements were US$ $11 708.24 (CI 95% $10 599.17 $12 817.31) and $12 126.34 (CI 95% $10 852.89 to $13 399.78) until discharge. The number of re-replacements was eleven of the bioprostheses and one mechanical, US$ $22 595.74 (CI 95% $9 250.98 to $35 940.50) and $ 10 874.48, respectively after an average of 26,5 and 13,2 months post-first replacement. Re-replacement main motive was due to late endocarditis in 5 bioprosthesis, 3 with paravalvar leaks, 1 with stenosis and 2 with insufficiency. The mechanical one was replaced due to insufficiency. Follow-up ambulatory visits and required complementary tests, added with the re-operation costs for the 11 new bioprostheses and the new mechanical one, respectively, amounted to US$ 1 480.61 and $ 1 394.66; minimally influencing the yearly follow-up costs. Conclusion: Hospital costs and effects are similar for biological and mechanical valves. Interventional Technologies 1 M12.1 - Assessment of cochlear implants and of the surgic al implant procedure Collignon C.1, Biga J.1, Gernigon G.1, Galmiche H.1, David D.-J.1, Lee Robin S.-H.1, Denis C.1 1Haute Autorité de Santé, Saint-Denis La Plaine, France Objective: To assess the expected benefit of cochlear implants and of the surgical implant procedure in order to advise French National Health Insurance (NHI) on their efficacy/risk ratio and public health benefit, with a view to taking a decision on reimbursement. Methods: We performed a critical appraisal of the clinical (2000-2006) and health economics (1990-2006) literature, and consulted manufacturers’ applications. The ensuing report was discussed by a multidisciplinary working group of 20 health professionals, then submitted to the relevant HAS Committee for their opinion. Results: We analyzed the clinical performance and risks of unilateral and bilateral implants in patients with bilateral deafness and cases of users with residual hearing. We retrieved a total of 6 HTA reports, consensus conferences, and guidelines, and analysed 44 studies published subsequently. These were prospective or retrospective observational studies of low level of evidence in favour of cochlear implants for severe to profound neurosensorial hearing loss. The benefits of unilateral implants, in terms of quality-adjusted life years, were found to warrant device reimbursement, regardless of patient age.

Conclusions: Cochlear implants (predominantly unilateral implants) are effective in severe to profound bilateral neurosensorial deafness but attention needs to be paid to several key aspects of their use: (i) patient selection criteria, (ii) patient and family motivation, (iii) post-implantation rehabilitation and follow-up. Extending use to other indications (e.g. bilateral implants, patients with residual hearing) requires further clinical studies. The social (e.g. educational setting of children), ethical, organisational and economic implications also need to be addressed. M12.2 - Early assessment of natural orifice translumenal endoscopic surgery Sánchez-Gómez L.1, Luengo S.1, Polo M.1, Asensio C.1, Sarria A.1 1Instituto de Salud Carlos III, Agencia de Evaluación de Tecnologías Sanitarias, Madrid, Spain Objective: To study the effectiveness and safety of the Natural Orifice Transluminal Endoscopic Surgery (NOTES). Methods: Early assessment of NOTES, technology identified by the early warning system “SINTESIS-new technologies” of AETS. Databases searched were Medline, CRD and the Cochrane Library. The searched terms were: NOTES, endoscopic surgery, natural orifices. We reviewed studies published before December 2007 in Spanish, English and French. Results: Clinical trials were not found. The retrieved studies were case series with less than 5 patients. The studies performed a transluminal cholecystectomy to assess postoperative pain, scars and postinterventional complications of this surgery. Data showed that patients had full activity with no complications, pain or discomfort 10 days after surgery. There were no available data about the long term results of this surgery. Technical requirements and current devices for access, retraction and tissue approximation limit the use of this technology. Conclusions: NOTES is an emerging method for surgery accessing the abdomen under direct visualization. Available evidence regarding this technology is poor. NOTES appears to be an effective, quick, and safe emerging technology but more studies are needed to have a better knowledge of the effectiveness, safety, future uses and foreseeable impacts of NOTES. M12.3 - The NICE Interventional Procedures Programme - Ho w much evidence is adequate? Craven M.P.1, Davey S.M.2, Meenan B.J.2, Crowe J.A.1 1University of Nottingham, Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH), School of Electrical & Electronic Engineering, Nottingham, United Kingdom, 2University of Ulster, Northern Ireland Bioengineering Centre (NIBEC), School of Electrical and Mechanical Engineering, Jordanstown, N. Ireland, United Kingdom Introduction: The Interventional Procedures Programme (IPP) of NICE recommends whether new invasive diagnostic or treatment procedures are safe and effective enough for wider routine use in the National Health Service. It is unclear however, how much information constitutes ´enough´ in this appraisal process. Objective: To investigate the relationship between the quantity of evidence submitted and the resulting recommendation of IPP. Methods: All orthopaedic and cardiovascular related records (n=50) of the IPP database, comprising a third of the total number of records, were analysed. Evidence was categorised to include number of references cited, size of clinical trials, complication rates, and qualitative judgements such as the need for training, and potential efficacy and safety concerns. Logistic regression on the binary variable ´guidance decision´ (i.e. adequate or inadequate evidence to support wider use) was performed to identify statistically significant factors. Results: None of the numerical variables showed a statistical significant relationship with the guidance decision. The large spread of values in some categories may explain this and indicated that, even within one disease area, measures of evidence for these procedures vary widely. Conclusions: There appears to be no significant relationship between the volume of evidence considered and the subsequent guidance decision of IPP. As such, it is unclear whether any formal decision-making criteria are applied by the IPP. With the increased use of new technologies in the health service, there is a need for intensified dialogue between NICE´s IPP and medical device

manufacturers to achieve greater clarity in the evidence requirements for decision-making. M12.4 - Provincial program based on gamma knife stereotac tic radiosurgery Bellemare C.1, Lemieux R.1 1Centre Hospitalier Universitaire de Sherbrooke, Health Technology Assessment Unit, Sherbrooke, Canada Objective: Answering Quebec Ministry of Health and Social Services on therapeutic efficacy in terms of quality of life (QOL) and associated cost to the treatment using the Quebec’s provincial Gamma Knife radiosurgery (GKRS) program. Methods: A systematic review was performed using Medline, Healthstar, Embase, Sciencedirect, Cochrane Database, and Database of abstracts of reviews of effects (Dare) using gamma knife, quality of life and long term keywords. Twelve months was considered for the minimum follow up, and for the patient cohort study a minimum of 30 patients was considered. The direct and indirect costs were assessed by using data from Québec’s GKRS department. The cost was compared to microsurgery. Results: According to the literature, 16 studies can be considered of quality on cerebral metastases, AVM, and trigeminal neuralgia. From this selection, 56 to 64 % have complete pain relief after GKRS trigeminal neuralgia treatment and QOL was directly related to pain relief. There is no evidence with clear clinical outcomes that GKRS treatment can increase QOL for AVM. Compared to microsurgery, GKRS is a non invasive efficacy treatment, and in cerebral metastasis cases it increases the QOL of patients. The cost of Gamma Knife treatment was estimated to 3 900$ CAD per patient as to 8 950$ CAD per patient for microsurgery treatment. Conclusions: GKRS is a minimally invasive treatment and provides significant pain relief keeping QOL. The associated cost was approximatively half of microsurgery, giving more time for other surgeries while resulting in less hospitalisation. M12.5 - Thoracic and lumbar vertebroplasties and kyphopla sties performed in US Medicare Part B fee-for-service enrollees, 2001-2006 Gray D.T.1, Hollingworth W.2, Onwudiwe N.3, Jarvik J.4 1Agency for Healthcare Research and Quality, Center for Quality Improvement and Patient Safety, Rockville, Maryland, United States of America, 2University of Bristol, Department of Social Medicine, Bristol, United Kingdom, 3University of Maryland School of Pharmacy, Pharmaceutical Health Services Research, Baltimore, Maryland, United States of America, 4University of Washington, Neuroradiology, Seattle, Washington, United States of America Objective: To track the growth of vertebroplasty and kyphoplasty (used to treat vertebral fractures). Methods: Using CPT-4 procedure codes, we reviewed aggregate claims data on thoracolumbar vertebroplasties from 2001-2005 in US patients (mainly 65+ years old) with Medicare Part B (physician care) fee-for-service coverage. For vertebroplasty+associated imaging, Medicare-allowed facility and physician charges (combining expected contributions from all sources) were applied to nation-wide volumes. These charges (~direct medical costs from an all-payer perspective) were expressed in 2006 dollars. Preliminary 2006 data on vertebroplasty and kyphoplasty (a more complex alternative) were reviewed. Results: See Table. Vertebroplasty rates for individual states varied (0.0-515.6/100,000 Part B fee-for-service enrollees in 2001 to 9.8-849.5 in 2005). Inpatient cases (~40%) generated >70% of charges. Charges for ambulatory surgery center and physicians’ office cases increased in 2004-05. The 29,199 vertebroplasties and 42,841 kyphoplasties from 2006 generated *Part B* charges totaling $26.4 and $31.8 million respectively. However, this excludes hospital-based *Part A* charges captured below.

2001 2002 2003 2004 2005

N Charges Charges N Charges N Charges N Charges

Median state vertebroplasty rate per 100,000

35.4 --- --- 61.9 --- 74.9 --- 75.0 ---

Medicare Part B fee-for-service enrollees

Mean allowed facility and physician charge for inpatient vertebroplasty (original $)

5,932 $8,575 $8,741 10,724 $9,049 11,508 $9,022 11,597 $9,386

Mean allowed facility and physician charge for hospital-based outpatient vertebroplasty (original $)

7,989 $1,805 $2,307 13,558 $2,232 14,979 $2,426 15,098 $2,478

Mean allowed facility and physician charge for office-based vertebroplasty (original $)

173 $585 $573 194 $577 757 $3,321 1,884 $2,531

Mean allowed facility and physician charge for ambulatory surgery center vertebroplasty (original $)

48 $645 $577 80 $559 305 $3,343 511 $2,449

Mean allowed facility and physician charge for all vertebroplasties (original $)

14,142 $4,626 $5,104 24,556 $5,190 27,549 27,549 29,090 $5,235

Mean allowed facility and physician charge for all vertebroplasties (2006 $)

14,142 $5,613 $6,027 24,556 $5,828 27,549 $5,653 29,090 $5,470

Aggregate facility and physician

charges for all vertebroplasties

(2006 $)

14,142 $79.4 million

$116.6 million

24,556 $143.1 million

27,549 $155.7 million

29,090 $159.1 million

Conclusions: Nation-wide vertebroplasty volumes and aggregate inflation-adjusted charges doubled in this population (2001-2005). Rates varied by state. Vertebroplasties performed in free-standing facilities are of growing importance. In 2006, kyphoplasty use exceeded vertebroplasty use. Practice patterns and outcomes of these evolving procedures should undergo ongoing review. M12.6 - Assessing the effectiveness and cost-effectivenes s of three dressing preparations in the management of chronic ulceration of the foot in diabetes Phillips C.1, Davies S.1, Jeffcoate W.2, Price P.3, Harding K.3

1Swansea University - Institute for Health Research, School of Health Science, Swansea, United Kingdom, 2Nottingham University Hospitals Trust, Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham, United Kingdom, 3Cardiff University, Department of Wound Healing, Cardiff, United Kingdom Objective: To test whether a modern dressing is more effective and cost-effective than traditional dressings Methods: A multi-centre, prospective, single-blinded, parallel group, RCT with three treatments - N-A, Inadine or Aquacel - was set up. Diabetic patients aged 18+ with a chronic foot ulcer were invited to participate. Patients were managed in line with current guidelines for good practice, and once randomised, were shown the dressing to be used and given the choice of changing their own dressings, getting their dressing changed by their carer or by district or practice nurse. Dressings were changed daily, on alternate days or three times a week according to need and/or availability of professional staff. Results: There were no differences between the three dressing types in ulcers healed, probability of healing, ulcer-free days and quality of life. However, there was a difference between dressing types in the number of withdrawals, and this may have implications regarding amputation risk and otential additional costs per healed ulcer. There was no difference between dressing types in number of dressings per patient, or in number of consultations with professionals for dressing changes. While there was a difference between acquisition costs of the dressings, the overall cost of managing dressings for diabetic foot ulcers was the same for all dressing types. Conclusions: The additional cost of Aquacel was not offset by reduced frequency of dressing changes or in improved effectiveness. Switching from Aquacel to N-A would result in potential savings across UK of over £1million in any 6-month period. M12.7 - Unrelated donor stem cell transplantation in acqu ired severe aplastic anaemia Peinemann F.1, Lange S.1 1IQWiG, Cologne, Germany Objective: The aim of this analysis was to compare the survival times of patients with acquired severe aplastic anaemia (SAA) who underwent haematopoietic stem cell transplantation with unrelated donors (UD HSCT) after failed immunosuppressive therapy (IST). Methods: A multi-source search was performed in December 2006. An update using PubMed was done in December 2007. Comparative as well as one-arm clinical trials on UD HSCT in patients with SAA were eligible for inclusion. Only full-text publications and studies including at least 10 patients were considered. Results: Only 1 study was identified that compared UD HSCT versus repeated IST in patients who failed at least one prior IST. The estimated failure-free survival at 5 years was significantly higher in the HSCT group (4 of 31 patients had related donors). Fourteen single-arm studies were identified that included at least 10 patients. These 8 multicentre and 6 single-centre studies enrolled 1401 patients (median age range 8 to 27 years) who underwent transplantation between 1981 and 2005. Survival rates between 28% and 100% were reported for a follow-up time between 2 and 7 years after transplantation. Conclusions: The evidence base on UD HSCT in SAA patients with failed IST is weak. Recent studies showed improved outcomes compared to earlier results. UD HSCT as a second-line treatment may have an additional benefit. Nevertheless, more data from controlled trials would be desirable. The implementation of a diagnosis related data registration could be helpful. M12.8 - Hysteroscopy with bipolar electrode (BE) (Versapo int system®) for the treatment of intrauterine pathologies Luengo-Matos S.1, Polo-De Santos M.1, Alcazar-Alcazar R.1, Saz-Parkinson Z.1, Sánchez-Gómez L.1 1Instituto de Salud Carlos III, Agencia de Evaluación de Tecnologías Sanitarias, Madrid, Spain Objective: To study possible benefits of BE, in terms of effectiveness, cost-effectiveness, safety, and women compliance for the treatment of intrauterine pathologies. Hysteroscopy with BE is a new minimally invasive procedure which enables the gynaecologist to treat patients in an office setting without general anaesthesia.

Methods: Rapid HTA report. Databases searched were Medline, EMBASE, the Cochrane Library, CRD, and IME. We reviewed studies published in any language until December 2007, without date restriction. Results: Retrieved studies include 8 case series, 8 prospective studies, and 3 comparative studies, two of them randomized. BE was used for myomectomy and polypectomy in lesions smaller than 6 cm, and for adhesiolysis, septoplasty, metroplasty and ovarian drilling by fertiloscopy. Success rate was 88-100%. Fibroids extending into the underlying myometrium were commonly partially excised. Operation time was usually less than 30 min. No major operative complications were reported, except for two uncomplicated uterine perforations. Pain or bleeding occurred in 0.5-4% of cases. Women satisfaction, reported in one study, was 92%. One study found the mean cost of diagnosis and treatment of submucous fibroids using BE was 40% cheaper at six months follow-up than a hysterectomy or open myomectomy. Comparative studies showed that BE treatment was successfully performed with a smaller complication rate, operative time, and time away from home than following the traditional method. Conclusions: Hysteroscopy with BE appears to be an effective, safe, and well accepted procedure for treatment of several benign intrauterine pathologies. More studies would be advisable to confirm these results. M12.9 - Surgical procedures and non-surgical devices for non-apnoeic snoring: A systematic review Main C.1, Liu Z.1, Welch K.2, Weiner G.3, Jones Q.4, Stein K.1 1Peninsula Technology Assessment Group, Peninsula College of Medicine and Dentistry, Exeter, United Kingdom, 2Wessex Institute for Health and Research Development, University of Southampton, Southampton, United Kingdom, 3Department of Ear, Nose and Throat Surgery, Royal Devon and Exeter Hospital Trust, Exeter, United Kingdom, 4Cardiff University Dental Hospital, University of Cardiff, Cardiff, United Kingdom Objective: To assess effectiveness of surgical procedures and non-surgical devices for non-apnoeic snoring. Methods: A systematic review was undertaken. Key bibliography databases were searched to identify relevant studies. Studies were screened for inclusion, data extracted, and quality assessed by two independent reviewers. Results were grouped according to the intervention and study design, and combined in a narrative synthesis. Results: Twenty-seven studies were included; 3 RCTs (11%), 2 CCTs (7.5%) and 22 pre-post studies (81.5%). Methodological quality was poor, with small sample sizes. Interventions assessed were: uvulopalatopharyngoplasty (UP3) versus laser-assisted uvulopalatoplasty (LAUP) (n=2); UP3 alone (n=7); LAUP alone (n=3); radio-frequency ablation (RFA) (n=7); palatal stiffening techniques (n=5); continuous positive airway pressure (n=1), and mandibular advancement splints (MAS) (n=2). There are no consistent significant differences in effects between UP3 compared to LAUP on snoring levels. Results suggested UP3, LAUP, RFA, and pillar implants are all associated with significant reductions in bed-partner reported snoring levels. Limited evidence on CPAP and MAS indicated both effectively reduce snoring levels. Evidence of objective reductions in snoring sounds for UP3, LAUP, RFA and pillar implants was limited and equivocal. Reported adverse events were mild to moderate. Conclusions: Technologies for snoring consume considerable healthcare resources. However, there is very limited head-to-head evidence available to compare the relative effects of different surgical procedures and non-surgical devices for the management of non-apnoeic snoring. UP3, LAUP, RFA and pillar implants all effectively reduce bed-partner reported snoring levels. However, these reductions are not corroborated by objective reductions in snoring sound. Mental Health 1 M13.1 - Psychosocial risk factors for postnatal depressio n in Chinese women: A review of the evidence McMaster F.1 1National Healthcare Group, Health Services & Outcomes Research, Singapore, Singapore Objective: To assess current evidence on psychosocial risk factors for post-natal depression in

communities of Chinese women. Methods: Medline, EMBASE, ERIC, CINAHL, Cochrane and DARE databases were searched. All published studies with ethnically Chinese women with post-natal depression were included without any restriction on language or location. These included studies of psychosocial risk factors, preventive interventions, and epidemiological studies. Eligible studies were assessed for methodological quality. Results: Seven studies were included, from nursing, psychiatry and medicine. There was disagreement to whether confinement practices increased risk of depression or acted as a protective factor. Common risk factors aligned with current thinking in Western societies including pre-existing depressive episodes, social support, marital relationship and socioeconomic position. Conclusions: There are few studies that address postnatal depression in Chinese women. Studies do not address how culture can negatively impact sources traditionally thought to give social support. Further research is needed on specific populations of Chinese women in East and SE Asia, Europe and North America. More work defining concepts and interpretations of the ‘confinement’ month is necessary for cross -geographical comparison. M13.2 - Evaluating computerised cognitive behaviour progr ams for depression and anxiety Kaltenthaler E.1, Cavanagh K.2, McCrone P.3 1University of Sheffield, ScHARR, Sheffield, United Kingdom, 2University of Newcastle, Newcastle, United Kingdom, 3Institute of Psychiatry, London, United Kingdom Objective: Computerised cognitive behaviour therapy (CCBT) programs are increasingly used to provide psychological therapies to people with mental health disorders. We aimed to explore the use of well developed HTA criteria for traditional face to face psychological therapies to CCBT and adapt these criteria to the specific features of delivering a CCBT software program. Methods: The application of HTA criteria for psychological therapies to specific features of CCBT programs to appraise their quality and suitability. Results: Issues to consider in the evaluation of CCBT packages include those related to the program itself such as: which components of CBT recognised as integral to effective treatment are included, mode of delivery (stand alone, laptop, Internet, telephone), the number of sessions and amount of therapist input necessary. Patient related considerations include: methods of recruitment and diagnosis, monitoring and safety mechanisms. Efficacy trials of CCBT packages should use appropriate comparators such as treatment as usual or therapist led CBT among others. Length of treatment and numbers and reasons for loss to follow-up must be clearly stated. Well validated outcome measures should be used to measure clinically relevant changes. Patient and provider acceptability must be considered. Costs to be considered are those for computer hardware and software, technical and administrative support and office space. Relevant services use over a defined time period may be recorded. Conclusions: In order to adequately evaluate a CCBT package and be able to compare packages, a series of predefined criteria as described above be considered. M13.3 - Role of repetitive transcranial magnetic stimulat ion (rTMS) in patients with depression in developing countries Chua D.H.L.1, Fam J.2, Ng B.Y.2, Lo Y.L.2, Lim J.F.Y.1 1SingHealth Centre for Health Services Research, Singapore Health Services, Singapore, Singapore, 2Singapore General Hospital, Department of Psychiatry, Singapore, Singapore Background and objective: Depression is one of the leading causes of disability in the developing countries. Patients with refractory depression in resource poor environment especially face grave challenges, as the typical mode of treatment in developed countries by Electro-Convulsive Therapy (ECT) may be fraught with risk if conducted by inexperienced healthcare workers working in austere conditions. Role of rTMS in developing countries: rTMS, which increases the excitability of cortical pathways through electromagnetic induction, is emerging as a possible treatment option for patients with refractory depression and it has been approved by Health Canada for drug-resistant depression since 2002. While the technology is still relatively new, many primary studies have shown rTMS to be as efficacious as ECT. In resource poor settings, there are added benefits of performance in an outpatient setting without the need for general anesthesia, obviation of the mandatory seizure induction in ECT and faster procedure time. rTMS may

also provide cost saving up to three times more compared to ECT (SGD2, 500 vs SGD7, 050). These factors are significant for patients in economically disadvantaged areas who may be financially constrained and also lack access to tertiary healthcare in the event of complications following ECT. However, rTMS is relatively untested compared to ECT and the lack of appropriately trained physicians for proper delivery of rTMS may limit utility. Conclusions: Further exploration should be encouraged to assess potential application of rTMS for patients with refractory depression in resource poor settings. M13.4 - Dementia - Experiences of patients and their care giver’s Bjerrum Mortensen B.1, Palhøj Nielsen C.1, Hansen K.1 1National Board of Health, Dacetha, Copenhagen, Denmark Objective: As part of an HTA about processes of diagnosis and treatment of dementia the aim was to investigate the patients’ and relatives’ attitudes towards diagnostics and to study which factors that contributes to postponing and/or initiating diagnosis. Consequences of receiving a diagnosis and experiences with using anti dementia medicine were examined. Methods: A systematic literature review was carried out. Results: Main factors which can postpone early diagnosis are: ability to distinguish signs of dementia from normal signs of ageing; lack of knowledge on dementia; reluctance between family members to break borders of integrity; worries about future scenarios. Main factors initiating the diagnosis process: recognition of and a wish to understand abnormal patterns of behaviour and relatives wishes to prepare for the future. In relation to diagnosing the literature points to the ethical dilemmas which comprise such concepts as integrity, autonomy, “not hurting”. Even though policy of disclosure in general is more used during the two last decades, the studies line out that disclosure does not always bring security but also new ambivalence, change and insecurity in people’s life. Studies of daily life experience with anti dementia medicine are lacking. Theoretical discussions focuses on five ethical dilemmas: it creates unrealistic hope, peoples’ loss of functions “are lived over again”; it prolongs suffering; stopping treatment has no congruence to patients’ experience. Conclusion: These findings point to the importance of a broad and facetted approach to early diagnosis and intensified pharmaceutical treatment taking patients’ and relatives’ needs into account. M13.5 - Trends in hospital utilization for depression in Spain over a 25 year period Martín-Martínez M.A.1, Medel-Herrero A.1, Sarria-Santamera A.2 1Institute of Health “Carlos III”, Agency for Health Technology Assessment, Madrid, Spain, 2Institute of Health “Carlos III”, Agency for Health Technology Assessment, Health Sciences and Social Medicine Department, University of Alcala Faculty of Medicine, Madrid, Spain Objective: This study aims to describe the hospital utilization for depression (ICD-9,Cod.311), a condition that affects 10.5% of the Spanish population, over a 25 year period determined by a process of psychiatric reform. Methods: Retrospective descriptive study (1980-2004). Assessment of national hospital utilization databases. Age and sex adjusted hospital utilization rates per 10.000: discharge, total length of stay and averages length of stay, timely assisted prevalence and readmissions. Results: In the first five years, hospital discharge rates peaked to 2.6 (1984) to decline thereafter until 0.7 (2004). Depression discharges plummeted from 8.9% (1980) to 2.4% (2004) of overall psychiatric admissions. Among women, no differences were observed in the age of admission along this period of time. In men, however, admissions for 19-20 years old were highest between 1980-1994, disappearing those differences in the following decade. Urgent admissions were more frequent in 2000-2004, 68.8% (2004). LOS declined from 46.1 days per admission in 1980 to 15.4 in 2004. Total length of stay was higher in 1985, 85 per 10.000 habitants, decreasing thereafter until 10.1 in 2004. Timely assisted prevalence fell from 0.22 in 1980 to 0.03 in 2004. The frequency of calendar year readmissions remained stable, being 14.5% in 2004. Women had significantly higher admission rates and hospital stays. Conclusions: Hospital utilization (admission rates and LOS) for patients with depression has decreased along the series, despite remaining high.

Medical Devices M14.1 - Reprocessing of single-use medical devices: HTA e vidence and knowledge transfer strategies Polisena J.1, Gartenburg K.2, Hailey D.3, Jacobs P.4, Ries N.5, Normandin S.6, Noorani H.1, Lafferty S.7, Gardam M.8 1Canadian Agency for Drugs and Technologies in Health, HTA Directorate, Ottawa, Canada, 2Canadian Agency for Drugs and Technologies in Health, Communications and Knowledge Exchange, Ottawa, Canada, 3University of Calgary, Department of Community Health Sciences, Calgary, Canada, 4University of Alberta, Department of Medicine (Gastroenterology), Edmonton, Canada, 5University of Alberta, Health Law Institute, Edmonton, Canada, 6Canadian Agency for Drugs and Technologies in Health, IM/IT, Ottawa, Canada, 7Capital Health, Regional Infection Prevention and Control Program, Edmonton, Canada, 8University Health Network, Infection Prevention and Control, Toronto, Canada Objective: Reprocessing of single-use medical devices (SUDs) has become routine in some hospitals. There are concerns that the use of reprocessed SUDs may have implications for patients’ health and for legal liability. Other issues include ethical and health care environment concerns and the cost-effectiveness of SUD reprocessing. A national organization conducted a health technology assessment (HTA) on the reprocessing and reuse of single-use medical devices. Methods: The two-part report series includes a national survey of current practices in Canadian acute-care hospitals, and a clinical review, economic analysis, and health services impact commentary. Knowledge transfer (KT) strategies were implemented during the assessment process to raise project awareness and incorporate input from stakeholders into the research. Results: Three key KT strategies with the most impact in raising project awareness and facilitating the integration of evidence into policy decisions were: 1) Preliminary notification to, and participation from, health care organizations for our survey. 2) Strategically profiling our project at conferences and meetings with health care organizations. 3) Participation in the federal/provincial/territorial (F/P/T) working group tasked with establishing a pan-Canadian framework on the reuse of single-use medical devices. Conclusions: The research project and findings will be described, along with the key KT strategies and their impact on policy. M14.2 - Introduction of emerging medical devices on the m arket: A new procedure in Belgium Vinck I.1, Neyt M.1, Thiry N.1, Louagie M.2, Ramaekers D.1 1Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium, 2National Health Insurance Institute, Brussels, Belgium Objective: When new medical technologies enter the market, there is often uncertainty about the added value for the patient and for society, hampering well-considered decision making about reimbursement. Current Belgian legislation already offered opportunities for the managed uptake of possibly innovative emerging implants. However, it has also some shortcomings such as the lack of a clear research design, rendering the scientific evaluation of clinical effectiveness, cost effectiveness, and patient or organizational issues more difficult. Against this background, a new procedure was elaborated by the Belgian health insurance institute and the Belgian Health Care Knowledge Centre. Methods: Several countries with a long HTA tradition served as a source of inspiration for the new Belgian procedure. Results: A transparent and scientifically valid framework for the early evaluation of medical devices was set up by the Belgian Health Care Knowledge Centre (KCE) and the Health Insurance institute (RIZIV/INAMI). One of the phases in this framework is the controlled diffusion of an emerging technology which is accompanied by a research design to objectively prove the hypothesized added value of the technology. Conclusions: The framework offers an innovative approach to the Belgian health insurance: the combination of a managed uptake that limits budgetary risks with the production of solid impartial evidence on the clinical effectiveness and cost effectiveness of emerging technologies. To date, the procedure is not operational yet. A legal initiative to implement the procedure is expected in the near future.

M14.3 - How can the response to requests for post-listing studies on medical devices be improved Galmiche H.1, Stamenkovic S.1, Maugendre P.1, Denis C.1, Meyer F.1 1Haute Autorité de Santé (HAS), Saint Denis, France Objective: Because the data available for the assessment of medical devices by the Committee for the Assessment of Devices and Health Technologies (CEPP) often leaves unanswered questions, CEPP requests additional data from manufacturers after reimbursement by National Health Insurance has been granted. We review the proposed measures for improving the quality of post-listing studies for medical devices in France. Methods: The CEPP met to examine the current status of post-listing studies on medical devices, identify shortcomings, and make proposals. Results: From 2001 to 2007, the CEPP requested 115 post-listing studies but only 27 studies were initiated. The two main reasons identified for this low response were the nature or form of the request and manufacturers’ poor experience in conducting good quality observational studies. Three improvement measures were proposed: (i) the request should be more precise (study objective, expected data, but no explicit requirements on study design), (ii) the request should be included in the agreement signed by the manufacturer and CEPS (French Pricing Committee); (iii) quality control should be introduced. A committee of clinicians, methodologists, and statisticians, set up by the manufacturer and approved by CEPP, should ensure that the protocol meets CEPP requirements and should monitor the study. Conclusions: This procedure was set up in January 2008. Results on responses to requests for post-listing studies will be evaluated at the end of the year. The new procedure should ensure that all the data needed to assess the value and use of medical devices under real-life conditions become available. M14.4 - Ethical analysis of ventilation tubes in otitis m edia with effusion (OME) Axelsson S.1, Eckerlund I.1, Pettersson A.1 1The Swedish Council on Technology Assessment in Health Care, Stockholm, Sweden Objective: Around 20 percent of all pre-school children suffer from extended periods of otitis media with effusion (OME). This condition may cause temporary hearing impairment and consequently contribute to speech and/or language delay or behavioural problems. The standard treatment is insertion of ventilation tubes. However, even persistent OME remits spontaneously and the treatment has no effect on long term hearing. Thus, it could be questioned if the treatment is ethically justified. In a recent Health Technology Assessment report, an ethical analysis was undertaken in order to facilitate comprehensive decisions on treatment in persistent OME. This paper presents the procedure and results regarding this ethical analysis. Methods: The various stakeholders are identified, the alternative strategies are specified, and a special model for ethical analysis is applied. Results: Treatment with ventilation tubes causes conflicts between various ethical principles. On one hand, the child experiences better hearing, and the parents´ quality of life improves, due to less anxiety. On the other hand, the child is exposed to the discomfort of a surgical procedure, with only a limited influence on the choice of treatment. Furthermore, from a societal point of view, the treatment demands resources which could be used for other ends, maybe of higher priority. Conclusions: Considering the benefits for the child as well as the parents, and the fact that the intervention shows a low rate of complications, treatment with ventilation tubes in OME is ethically justified in children with significantly impaired hearing. M14.5 - How the Haute Autorité de Santé involves manufact urers in their assessments of medical devices Josseran A.1, Depardon M.1, Denis C.1

1Haute Autorité de Santé (HAS), Saint Denis La Plaine, France Objective: French National Health Insurance reimburses medical devices only after an HAS Committee and the Ministry of Health have issued a favourable opinion on the inclusion of a device or device category on the reimbursement list. Our aim was to devise appropriate ways of involving manufacturers in the assessment process. Methods: HAS bases its opinion on studies provided by the manufacturers, a literature review, and the advice of health professionals. For a single device, the manufacturer has 8 days after receiving HAS’ opinion to make comments and request a hearing. For a device category, manufacturers are only contacted after the Ministry of Health has taken a decision. As assessing a device category takes longer and is more complex than assessing a single device, HAS opted for early involvement of manufacturers in the assessment process by proposing meetings before, during (optional), and after assessment. Results: Between 2005 and 2007, HAS issued 459 opinions on single devices. Manufacturers sent comments in reply to 55 opinions and requested 84 hearings. The HAS committee revised its opinion on 22 applications. HAS also assessed 8 device categories. Manufacturers were contacted through industrial unions. They participated in 15 pre-assessment and post-assessment meetings with HAS staff and outside experts. The only contacts during assessment were by telephone to obtain technical information. Conclusions: Although this procedure has not been formally evaluated, it has met with the satisfaction of both manufacturers - who can provide useful technical information - and of HAS - who can speed up the assessment process. M14.6 - An evaluation of non-invasive temperature measure ment for inpatients Ng K.P.1, McMaster F.R.1, Heng B.H.1 1National Healthcare Group, Health Services and Outcomes Research, Singapore, Singapore Objective: To evaluate the relative merits of four non-invasive temperature measurement methods for adult inpatient use. Methods: A Literature search was performed using the PUBMED database. Published articles that included a comparison of oral, axillary, tympanic and temporal artery temperature measurements against core/ rectal temperature were selected for review. Cost of various thermometers were synthesized and analyzed for the hospitals within the National Healthcare Group (NHG) in Singapore. Results: Of the four methods of temperature measurement reviewed, oral measurement was the most accurate and least variable, followed by tympanic measurement. Choice of tympanic measurement over oral measurement using digital thermometers across NHG hospitals could save 33,000 nursing hours annually. However, there would be additional costs for equipment and consumables amounting to S$158,000. Conclusions: Oral measurement using digital thermometers is more accurate and has a lower equipment and maintenance cost. Tympanic measurement is faster in terms of speed of temperature reading and requires fewer man-hours to operate. It is also associated with increased patient comfort. Technology adoption/use 1 M15.1 - Medical technology advance in the Brazilian suppl ementary health system Coelho K.S.C.1, Carvalho J.1, Oliveira M.R.1, Cavalcante A.P.1, Rios A.C.1, Medeiros M.d.F.C.1, Pinho J.L.1, Fonseca L.1, Rodrigues C.V.1, Silva F.1, Salvador R.1 1Agência Nacional de Saúde Suplementar, Gerência Geral Técnico-Assistencial dos Produtos, Rio de Janeiro, Brazil In 1999, a federal agency was created, National Supplementary Health Agency (“Agência Nacional de Saúde Suplementar - ANS”), with the aim of both granting adequate and integral care to beneficiaries of private health care plans. In spite of its universal public health system, Brazil also counts on a meaningful private health care system, which is submitted to State regulation by the National Supplementary Health Agency. In 2007 we revised the list with procedures that had been revised for the last time in 2004. The aim of this study is to present and demonstrate that the decision-making process in policy definition was to

improve actions on promotion, protection, recovery and rehabilitation in health, integrating multidisciplinary team. In this context, there are 26 million of beneficiaries with new health plans in Brazil and 1.422 HMOs companies. Among the attributions of ANS is the periodical revision of a list of procedures that constitute the minimum obligatory coverage for all health plans. The ANS coordinated a technical group for this revision. From July to September 2007, this work was available on our website and we received 30.000 suggestions. We have reviewed all the contributions and we have done a list with 2.973 procedures, divided in chapters, groups and sub-groups. The new process improves transparency on the classification of the procedures and their techniques. This new list of procedures will guarantee more coverage for the health plans and it will provide high-quality health care to the population. M15.2 - Surveillance of health technologies in Brazil: Co nstructing assessment with quality and safety Rabelo R.B.1, Petramale C.1, Soares D.1 1National Health Surveillance Agency - ANVISA, Brasilia, Brazil The Sentinel Network Project (SNP) has been developed since 2002 by Brazilian National Health Surveillance Agency, to provide information on the quality and performance of health technologies. It is the result of a partnership with 199 hospitals (educational and public institutions), and constitute into a health technology observatory. Objective: To describe and analyze health products post marketing surveillance, implemented by SNP in Brazil, focusing on three areas: Techno, Pharmaco and Haemo-Surveillance. Methods: This quali-quantitative study, which was a product of a mastership, was based on a model of health policies analysis, with three analytical categories: Process, Content and Actors. Results: After the SNP implementation, there was an average increase of 341% in the notifications of adverse events on those areas above. The type of implementation of SNP was rational, planed and presented potential gains for all parts involved: health surveillance services, medical industry and health institutes. Furthermore, it was based on a collaborative conception, emphasizing the network idea. In this way, the cooperation between the actors involved in the process was the most present strategy, despite of some conflict found between the states and federal health surveillance departments. Conclusions: The results showed that it is necessary a clear definition about the dynamic of monitoring and evaluating actions in the scope of SNP. In the other side, we can say that it is a viable and opportune propose to structure post marketing surveillance practices, in order to guarantee safety and quality of health technologies and better health assistance for the population. System issues/considerations M16.1 - Accreditation system for suppliers, products and services relating to medical technology in Mexico Macias I.A.1 1Instituto de Salud del Estado de Aguascalientes, Biomedical Engineering, Aguascalientes, Mexico Objective: We present a proposed system for accrediting providers, medical devices and related services, it will serve as an aid in compliance with the regulations and safety regulations and quality in the procurement of medical technology on the part of State Health Services in Mexico allow for a homogenous evaluation criterion. Methods: The system is based on the evaluation of the technical components, coverage, responsiveness and service documented by technology suppliers, as well as compliance with standards and regulations applicable to medical devices. This evaluation should be carried out by a central organization under the Ministry of Health. In Mexico this organization is called CENETEC. CENETEC will be applying for the updated documentation to identify the suppliers and products that comply with the regulation both in Mexico and in the countries of origin. Once demonstrated compliance with the requirements, CENETEC be in a position to issue a certificate upon request to participate in the processes of acquisition. The certificate will be requested by the purchasing organizations and potential suppliers will be responsible for them. In this way, organizations buyers will

be responsible for assessing the technical specifications of products and services and will not have to worry about regulatory issues. To finance the operation of the certification process the providers have to pay to get the certificates. Results: The system is on the implementation process. Conclusions: This system intends to be an answer to the lack of a standard evaluation method for providers in the aquisition process in Mexico. M16.2 - The role of health technology assessment in a new financial support system for dental care in Sweden Axelsson S.1, Tranaeus S.1 1The Swedish Council on Technology Assessment in Health Care, Stockholm, Sweden Objective: A new state dental care financial support system for people aged 20 and over, will be launched in Sweden by the 1st of July 2008. A regulatory framework states that reimbursable dental care measures should be in accordance with scientific evidence, as well as being cost-effective. The aim is to use results from systematic literature reviews in this process. Methods: During the past year, reports from the Swedish Council of Technology Assessment in Health Care (SBU) have been used by the Swedish National Board of Health and Welfare in developing national guidelines for preventive dental care as well as management of caries and periodontitis. SBU has also set up two new projects to cover other areas in dentistry, the replacement of missing teeth and root-fillings. These projects are carried out in collaboration with the National Board of Health and Welfare, for simultaneous preparation of guidelines. Until the guidelines are implemented, a preliminary list of preventive measures and disease treatment form the basis for the reimbursable dental care. Results: As the national guidelines will be completed, the special state dental care support committee will take them into consideration and continuously adjust the list of reimbursable treatment measures. As evidence change - so will the reimbursable methods. Conclusions: The expected result is the establishment of a systematically structured evidence based dental care in Sweden, maintained by the means of state financial support. The health related, socio-economic and economic outcomes of this new support system will be closely monitored. M16.3 - MedNytt - An open-access database for Norwegian h ealth care workers Graff B.A.1, Ormstad S.S.1, Norderhaug I.N.1 1The Norwegian Knowledge Centre for the Health Services, Oslo, Norway Objective: To support the Norwegian health care services with identifying and appraising new technology. Methods: Every month, the databases of the Norwegian Knowledge Centre’s collaborators are scanned for early warnings. Links to the disseminations are published in MedNytt, an open-access database for Norwegian health care workers and decision makers. Norwegian abstracts are published for approximately 10 disseminations each month. The database also has a feature where healthcare workers can order disseminations for technologies not already in the database, or in cases where the published dissemination needs an update. These services are delivered free of charge. Results: We have established an open, internet-based database (http://www.mednytt.no), providing health care workers and decision-makers with disseminations of emerging technologies. The database covers methods for diagnostics, new drugs, procedures and medical equipment for a broad range of categories. January 2008, the database contained more than 450 disseminations of new technologies, and about 50 Norwegian abstracts. The database has been accessible from the 20th of September 2007. From this date and to the end of 2007, we had 5300 absolutely unique visitors from 32 countries. More than 38,000 pages were displayed in this time period. Conclusions: MedNytt is providing decision-makers in the Norwegian health care services easy access to disseminations of new technology. MedNytt has the potential of improving the processes when new technology is introduced in the health care system, and making the decisions more evidence-based. M16.4 - Effective academic leadership: Lives and wishes i n Iran

Bikmoradi A.1, Brommels M.1, Shoghli A.2, Sohrabi Z.3 1Karolinska Institutet, LIME Department, Stockholm, Sweden, 2Zanjan University of Medical Sciences, Social Medicine, Stockholm, Sweden, 3Iran University of Medical Sciences, Medical Management, Tehran, Iran, Islamic Republic of Background: During the last two decades, medical education was moved from elite to mass education, with a considerable increase in number of schools, faculties, and programs specific to new scientific fields. Because of the unique experiences and growing tendency to improvement, it is a good case now to explore academic leadership in a non-western country. Objective: The objective of study was to explore views on effective academic leadership requirements held by key informants in Iran’s medical education system. Methods: An expert panel study was conducted by strategic sampling in which participants were requested to discuss and report on requirements for academic leadership, suggestions and barriers. Results: Written notes from the discussions were transcribed and subjected to content analysis. Six themes of effective academic leadership emerged: by analysis: aspiring toward 1) a shared vision, goal, and strategy, 2) teaching and research leadership, 3) fair and efficient management, 4) mutual trust and respect, 5) development and recognition, and 6) transformational leadership. Current Iranian academic leadership suffers from lack of meritocracy, from conservative leaders, politicization, bureaucracy, and myth beliefs. Conclusions: The structure of the Iranian medical university system is not supportive of effective academic leadership. However, participants’ views on effective academic leadership are in line with what is also found in the western literature, that is, if the managers could create the premises for a supportive and transformational leadership, they could generate mutual trust and respect in the academia for increasing scientific production. Key words: Academic leadership, medical education, higher education. M16.5 - Developing guidance on the management of long ter m sickness absence and incapacity: Challenges and opportunities for good g overnance in the UK Taylor L.1, Taske N.1, Sheppard L.1, Huntley J.1, Fischer A.1, Peploe K.1 1National Institute Health and Clincial Excelelence (NICE), Centre for Public Health Excellence, London, United Kingdom The UK’s National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. Within NICE, the Centre for Public Health Excellence (CPHE) produces guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public, private and voluntary sector. CPHE has adopted a number of systems and processes to help ensure the guidance development process adheres to principles of good governance (ie is transparent, systematic and inclusive) and that final guidance is cost-effective and equitable. The purpose of this paper is to describe the challenges and opportunities in applying these processes within health policy environment - to guidance development on the management of long term sickness absence and incapacity. The guidance targets professionals and managers working within the UK National Health Service (NHS), and wider public, private, voluntary and community sectors. This paper will highlight challenges and opportunities in adhering to the principles of good governance during the following stages of guidance development: - Recruitment to the guidance development committee; - Development of a scoping document which outlines inclusion and exclusion criteria; - Production of evidence reviews; - Stakeholder consultation; - Field testing draft guidance; - Consultation with experts and co-optees; - Equity proofing. Future developments to ensure good governance in the development of CPHE public health guidance

will also be discussed. M16.6 - Barriers and opportunities in environmental healt h international development projects Sarria-Santamera A.1, Sandin-Vazquez M.1, Orosa V.1 1Universidad de Alcala, Alcala de Henares, Spain Objectives: International development is a process that encompasses governance, healthcare, education, gender equality, disaster preparedness, infrastructure, economics, human rights, environment and issues associated with these, in order to improve quality of life. Spanish City Governments finance in a decentralized way a significant number of international development projects. The objective of this work is to identify the perceptions of local government officers and NGOs personnel with experience in environmental health international development on what are the conditions that facilitate or limit successful projects in this area. Methods: 21 semi-structured interviews were conducted: 11 with NGOs personnel and 10 with City Government staff and elected officials. City Governments were located within the Region of Madrid and have an annual budget over 200.000� allocated to international development; NGOs should be located within the Region of Madrid, include health and environment projects as strategic lines, and receive funding from public organizations to develop their activities. Interviews were taped and transcribed. The ideas presented in this abstract have been selected as typical of the perceptions and experiences recorded. Results: Some of the issues identified as opportunities for improving the process of conducting international development in environmental health were: increasing funding, reducing bureaucratic constraints, and improving technical resources of NGOs. One of the key issues for success was the relationship with local organizations. Some aspects not yet resolved are related with guaranteeing long-term sustainability and evaluating the impact of those projects, and increasing the coordination between funding organizations and NGOs. M16.7 - The health technology assessment as an auxiliar t o minimize or solve judicial complaints Osanai M.H.1, Sander G.2 1Unimed Porto Alegre, NTA, Porto Alegre, Brazil, 2Universidade Federal do Rio Grande do Sul, Pós Graduação em Economia - Avaliação de Tecnologias em Saúde, Porto Alegre, Brazil Objective: To identify potential applications of health technology assessment - HTA - in judicial demands related to private health plans in Brazil. Methods: The judicial demands involving one private plan operator were searched and analyzed about their main complaint, the HTA applicability to the situation, the use of a HTA report to justify or propose the conflict and the judge final decision, if available. Results: HTA have many uses in prevention and answering judicial complaints. However, this approach is still underused and must be stimulated and need more dissemination over all segments of society including the judges and decision makers. Conclusions: There are important conflicts in the brazilian health system concerning funding, accessibility and quality. The both systems, public and private (suplementar health system), are under attack by judicial decisions that determine the government or the private health plan must pay for new procedures, new medicines or other technologic innovations, even without scientific evidence of safety or effectiveness. There are new health technologies that are much more expensive and they have minimal or absent improvement over the gold standard therapy. HTA reports and sessions are excellent options to improve the quality of health assistance and minimize the judicial complaints and conflicts. M16.8 - Assessment of a systematic method to prioritise h ealth research needs in Catalonia Berra S.1, Sánchez E.1, Pons J.2, Tebé C.1, Alonso J.3, Aymerich M.1 1Catalan Agency for Health Technology Assessment and Research (CAHTA), Barcelona, Spain, 2CIBER en Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain, 3Institut Municipal d’Investigació Médica, IMIM-Hospital del Mar, Barcelona, Spain

Objective: The IOM proposed 7 weighted criteria for priority-setting: disease frequency, cost, variability, burden, change in health outcomes, change in costs, and ethical, legal or social aspects. The CAHTA uses them for prioritising health services research topics. Each topic proposed is peer-reviewed and the 7 IOM criteria evaluated with Likert-scale responses. A final priority score is computed, as the sum of the 7 scores. Our objective here was to assess the consensus level on the IOM’s criteria, and reliability and validity of our prioritisation method. Methods: A modified Delphi technique was used to identify additional relevant criterion and to provide, for each criterion, a weight according to its relevance for priority-making. A group of 48 (first round) - 33 (third round) experts participated. Method reliability was examined analysing the scale’s homogeneity, item’s test-retest stability (correlation coefficient, CC), and inter-observer concordance (intra-class correlation coefficient, ICC). Validity was examined by comparing the priority-scores with the experts overall (categorical) assessment of priority. Results: Two new criteria were included (“translation to practice”, and “need of knowledge”). The relative weight of each criterion was modified. The most important (4.23) was “research impact on health outcomes”, instead of “burden of disease” (3.92). Scale homogeneity (CC=0.75), and test-retest stability (ICC range=0.39-0.72) were acceptable. Scale correlation with the experts overall assessment of priority was moderate (r=0.37). Conclusions: The criteria proposed by the IOM had to be extended and their relative weights modified for prioritising health services research in Catalonia. The new method is reliable and seems reasonably valid. M16.9 - Measuring physician performance: A review of the evidence McMaster F.1, Heng B.H.1 1National Healthcare Group, Health Services & Outcomes Research, Singapore, Singapore Objective: To determine key factors in measuring physician performance. Methods: A systematic review of literature was performed with a specified search strategy. Journal articles and reviews were included if they had been published within the last ten years, were in English and included information on health systems in urban settings. Articles were critically appraised, and thematically summarised with a view to the Singapore context. Results: Thirty-six articles fulfilled our search criteria with seven articles rejected on quality concerns. The twenty-nine remaining articles covered health systems in Europe (UK, Italy) and North America (USA, Canada). Fifteen articles mainly covered experiences of a particular country or system in developing performance measures, and four articles focussed on a speciality (primary care, general surgery or orthopaedic surgery). Pay for performance was the focus of 8 articles, and patient satisfaction the core of a further two articles. Conclusions: Despite the experiential nature of many of the articles, many themes emerged from the literature. Developing performance measures for physicians is a complex and costly process, requiring accurate data systems, buy-in from physicians and multiple sources of information (including other healthcare professionals and patient satisfaction surveys). Measures should be representative of the activities of the specialty, attributable to an individual rather than the whole care team and be adjusted for confounders but should also be feasible to collect. Process issues which cannot be changed should not be included in performance measures. Development of trusted performance measures is critical in the consideration of pay-for performance schemes. M16.10 - Follow-up visits from nurses after discharge from a multidisciplinary pain centre - A health technology assessment Palmhøj Nielsen C.1, Frich L.2, Sørensen J.3, Højsted J.2 1Danish Centre for HTA, Copenhagen S, Denmark, 2Rigshospitalet, The Multidisciplinary Pain Centre, Copenhagen, Denmark, 3University of Southern Denmark, Centre for Applied Health Services and Technology Assessment, Odense, Denmark Objective: The aim was to assess prerequisites for and consequences of introducing follow-up visits from nurses after discharge from a multidisciplinary pain centre in order to prevent deterioration of the patients’ health related quality of life. Methods: Evidence on effects of follow-up visits was reviewed and the results of a randomised trail

were presented. Furthermore, the HTA included an economic analysis and evaluation of the intervention from selected key partners. Results: The review showed that the best outcome was achieved if the intervention included several visits and was individualised. The trial showed an improvement of health related quality of life, prevented an increase in opioid consumption, and reduced the patients’ use of catastrophsing as a coping strategy in the intervention group. Subgroup analysis indicated that patients with low physical health related quality of life had the largest effect of the intervention. The economic analysis estimated the cost of the intervention to 670� and assessed that the intervention led to a reduction in health related cost with 2800� on average pr. patient. The savings are due to fewer outpatient clinic visits and hospital admissions. In general nurses and GPs assessed the intervention positively and patient satisfaction was high. Conclusions: The follow-up visits showed promising results in relation to preventing reductions in health related quality of life for non-malignant pain patients. Further studies can help define subgroups that profit the most from the intervention. M16.11 - Legal actions demanding drugs for the treatment o f Fabry disease in the Southern Brazilian state of Rio Grande do Sul (RS) Vinhas de Souza M.1, Balbinotto Neto G.2, Arenhart F.2, Neubarth Trindade M.2, Huber C.2, Dorneles Picon P.3, Cogo Leivas P.4, Doederlein Schwartz I.V.5 1Hospital de Clínicas de Porto Alegre, Comissão de Medicamentos, Porto Alegre, Brazil, 2Faculdade de Economia-UFRGS, Porto Alegre, Brazil, 3SES-RS e Centro de Pesquisas Clínicas/ HCPA, Porto Alegre, Brazil, 4Procuradoria Geral do Estado RS, Porto Alegre, Brazil, 5Departamento de Genética/ UFRGS e Serviço de Genética/ HCPA, Porto Alegre, Brazil According to the Brazilian Federal Constitution of 1988, "health is an universal right, and should be provided by the state". A growing phenomenon in Brazil are the lawsuits demanding the supply of drugs, especially high-cost drugs. Orphan drugs treat rare diseases and are, in general, high-cost drugs. Fabry disease is a rare disease that has 2 drugs for its treatment, both very costly. In Brazil, only 1 of them is authorized but not state supplied. Objective: Describe the characteristics of lawsuits demanding drugs for Fabry disease in the Southern Brazilian state of RS. Methods: Transversal, retrospective and observational study. The data was obtained using an standardized form. Results: 8 lawsuits were found between 01/01/2004-01/01/2007. There were a number of 15 patients demanding the drugs for Fabry disease. The mean age of the patients were 31y and 66.7% of the prescriptions were originated in the university hospital. according to all the prescribing doctors a better quality of life was the reason for the treatment; the unavailability of treatment options was also mentioned by 66.7% of them. The demand of the drug was accepted temporarily by the law-cort IN 85.7% of the cases, in a mean time of 13.8 days, based in a legal instrument so-called ‘antecipação de tutela’ (‘anticipation of the custody’) but no definitive sentence was given until the end of the study. Conclusions: The lawsuits can have a direct and potentially dangerous effect on the public health system because they can compromise the budget for medicines. Alternatives and regulations should be considered to solve this problem. M16.12 - Coverage of promising but unproven medical techno logies by basic health insurance: Experiences from Switzerland Blozik E.1, Peter K.2, Zuellig M.1, Gurtner F.1 1Swiss Federal Office of Public Health, Medical Technologies Unit, Liebefeld, Switzerland, 2Kathrin Peter Evaluationen, Bern, Switzerland Introduction: In Switzerland, there is the possibility to cover promising but unproven medical technologies by basic health insurance if health care providers participate in evaluation activities (e.g. registries). Methods: Descriptive analysis of all technologies covered under evaluation constraints between 2001 and 2007. Results: Between 2001 and 2007, a total of 33 technologies were reimbursed under evaluation constraints: 25 therapeutic, 4 diagnostic, 3 screening, and 1 vaccination procedure. The underlying

condition was chronic/ disabling (18/33) or life threatening (12/33), or the procedure was part of pregnancy care (1/33) (N/A: 2/33). Evaluation was mainly done based on national (20/33) or European (5/33) registries. Evaluation by RCT (1/33), semiqualitative studies (2/33), national surveillance data (1/33), analysis of cantonal screening programs (1/33) or test performance in unselected population subsamples (1/33) were rarely used. By 2008, 10 technologies remained under evaluation. There was a decision for definite reimbursement for most of the technologies evaluated (20/33) and against reimbursement of 3 technologies. For technologies with a definite “yes” decision, conditions for reimbursement (e.g. qualification of providers, indication lists or requirements of centers) could be refined. No evaluation was stopped due to safety reasons. Discussion: Paying for promising technologies under evaluation is a helpful way for Switzerland to provide technologies when evidence is not strong enough to allow a “yes” decision. Evaluation led to restriction rather than extension of coverage modalities. Triage of potential candidates for this reimbursement model seems to be appropriate as only a small amount of technologies has finally been shown to be ineffective. Screening/Prevention 1 M17.1 - Ethical and social implications on human papillom a virus vaccine introduction in Mexico: Reflections on a vaccination proposal Prieto-de la Rosa A.1, Gutiérrez-Delgado C.2, Witlen R.3 1Health Ministry, National Center for Health Technology Excellence, Distrito Federal, Mexico, 2Health Ministry, Economic Analysis Unit, Distrito Federal, Mexico, 3Harvard University, Medical School, Massachusetts, United States of America Objective: To analyze and discuss on ethical and social aspects for HPV vaccine´s introduction in the Mexican public health sector looking for qualitative evidence of non-financial aspects that allows an informed and fair decision making. Methods: From June to October, 2007 in México a literature analysis and discussions on key ethical and social issues concerning preventive interventions against cervical cancer, included the HPV vaccine, was developed. Results: Based on current HPV vaccine´s efficiency evidence, its introduction as an universal immunization program in México, might have negative unforeseen consequences for participant women and the entire society. While HPV vaccine´s introduction is discussed, research must be developed making clear the existing conflict of interests to gather lacking information on efficiency, cost and operative impact in short and long term to define a policy based on solid evidence for the Mexican public health sector. Conclusions: Preventive cervical cancer technologies, -included the HPV vaccine- must be examined in Mexican context; recognizing its risks and the global burden of disease without overestimating tangible or potential vaccine´s results. The National Cervical Cancer program should introduce new strategies based on solid evidence and articulated on clear reasons. Allowing stakeholders to expose openly their worries on cervical cancer prevention benefit programs in supporting, increasing or adressing resources. It is essential to expose scientific evidence, but it is also imperative to make a reasoned political decision in a responsible way on vaccination, screening and treatment programs developing a caring and respectful attitude towards rights, opinions and worries of women. M17.2 - “Penalty point legislation”. HTA evaluation of a preventive intervention in three countries Farchi S.1, Camilloni L.1, Chini F.1, Giorgi Rossi P.1, Borgia P.1 1Agency for Public Health, Lazio Region, Rome, Italy Objective: The penalty point legislations have been introduced in several countries, to promote the use of safety devices and reduce driver risky behaviours. This legislation can be considered as a preventive intervention and must be assessed as other health intervention. Aim of this study is to evaluate the effect of penalty point systems on the road traffic accidents (RTA) health consequences.

Methods: We searched in PubMed all the studies evaluating penalty points systems. The interventions have been categorised, as well as the outcomes measured. A qualitative synthesis of the results is here proposed, since the outcome measured differs from study to study. Results: We found three similar experiences published: in Italy, Brazil and Ireland. Only observational pre/post studies have been identified. The three Italian studies found: a smaller number of RTA (-24%), a higher rate of safety devices use (52% 95%CI: 49-55), a lower rate of emergency visits (-15% 95%CI: 15-16), lower rate of injuries (-19%) and deaths (-18%) after the law introduction comparing to the same season in the previous years. However, the effect was lower than expected, and it decreased over time. Irish and Brazilian study found a decrease in RTA-related emergency visits (36.7% and 33.2% respectively); in Brazil there was an overall reduction in the number of accidents (21.3%) and immediate deaths (24.7%). Conclusions: The penalty point legislation is effective in reducing RTA health consequences on the short period. In Italy the effectiveness decreased few months after implementation, suggesting that the impact depends on the law enforcement. M17.3 - Towards a national immunisation program for HPV v accines in Sweden - Or not? Allander S.V.1 1SBU - The Swedish Council on Technology Assessment in Health Care, Stockholm, Sweden Objective: EMEA has authorized two human papilloma virus (HPV) vaccines. This has prompted national health authorities and governments all over Europe, and elsewhere, to make national evaluations and decisions on whether or not to include the new vaccines in national immunisation programs. Sweden is no exception. This study will describe the roles of the different local authorities, their independent decisions, the results of the HTA report carried out by The Swedish Council on Technology Assessment in Heath Care (SBU), and the current status on a national immunisation program. Methods: SBU carried out a systematic review focused on randomised controlled trials of studies of vaccination against HPV 16 and 18 and its effect to prevent cervical intraepithelial neoplasias grade 2 or worse (CIN 2+). A review of the health economic literature was also performed. The Swedish National Board of Health and Welfare has in parallel put together a background document on vaccination against HPV. Results: Vaccination against HPV is aiming at preventing cervical cancer. Clinical studies have so far showed that vaccination of young women can prevent CIN 2+ positive for HPV 16 and 18 in individuals not already infected by these HPV-types. The long term effects of vaccination and the cost effectiveness of the method are however not known. Conclusions: The Pharmaceutical Benefits Board has reimbursed one of the vaccines for young girls, 13 to 17 years, only. The Swedish National Board of Health and Welfare will make its decision on a national immunisation program, or not, this spring. M17.4 - The clinical effectiveness of oseltamivir, amanta dine and zanamivir for the prophylaxis of influenza: A systematic review Jackson R.1, Tappenden P.1, Cooper K.1, Rees A.2, Simpson E.1, Read R.3, Nicholson K.4 1Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom, 2School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom, 3University of Sheffield, Sheffield, United Kingdom, 4University of Leicester, Leicester, United Kingdom Objective: To undertake a review of evidence for the clinical effectiveness of amantadine, oseltamivir and zanamivir in prophylaxis against influenza. Methods: A systematic review of evidence for the use of amantadine, oseltamivir and zanamivir in seasonal and post-exposure prophylaxis against influenza was performed. Results: Twenty six published and one unpublished citations relating to 23 randomised controlled trials (RCTs) were included. A total of 8, 6 and 9 RCTs were included for amantadine, oseltamivir and zanamivir respectively. The quality of the studies identified was highly variable. Amantadine prevented symptomatic, laboratory-confirmed influenza (SLCI) in seasonal prophylaxis in healthy adults (relative risk (RR) = 0.40, 95% confidence interval (95%C.I.) 0.08 to 2.03) and in post-exposure prophylaxis in adolescents (RR = 0.10, 95% C.I. 0.03 to 0.34). Oseltamivir was effective in preventing SLCI,

particularly in seasonal prophylaxis in at-risk elderly subjects (RR = 0.08, 95%C.I. 0.01 to 0.63) and in post-exposure prophylaxis within households (RR = 0.19, 95%C.I. 0.08 to 0.45). Zanamivir was effective for seasonal prophylaxis in at-risk adults and adolescents (RR = 0.17, 95%C.I. 0.07 to 0.44), healthy and at-risk elderly subjects (RR = 0.20, 95%C.I. 0.02 to 1.72) and in post-exposure prophylaxis in households (RR = 0.21, 95%C.I. 0.13 to 0.33). All interventions were reasonably well tolerated. Conclusions: Evidence for the clinical effectiveness of oseltamivir, amantadine and zanamivir in prophylaxis against influenza was highly variable. Issues relating to the issues of amantadine-associated adverse events and resistance to antivirals should be taken into consideration during interpretation of the review findings. M17.5 - Vaccination against HPV in Brazilian Public Healt h System Silva E.N.1, Laranjeira F.O.1, Conti M.A.1, Elias F.T.S.1, Serruya S.J.1 1Ministry of Health of Brazil, Department of Science and Technology, Brasilia, Brazil Objective: Investigate the efficacy, safety and cost-effectiveness of HPV vaccine to help the decision making of implementing the vaccination in Brazil, and to estimate the potential expenditure associated to vaccination strategy for 12-years old girls. Methods: It was carried out a review for the best evidence about HPV vaccination. Results: Two systematic reviews were found about efficacy and safety. There is a systematic review related to economic evaluation. From the six studies analyzed in that, the ICER varied between US$4,666/QALY and US$ 44,889/QALY. Other recent study took the Brazilian societal perspective, reporting an ICER of US$ 9,600 per life-year gained. The price stated by the Council of Drug Market Regulation to four-valent vaccine against HPV is between US$202 and US$276 per dose. There are about 1.7 million 12-years old girls. Applying the lower price of vaccine, the expenditure associated to three doses (US$607/girl) plus the logistic to implement the vaccination (US$10/girl) would be US$1.047 billion. If the upper price be used instead, the expenditure would increase 36%. Conclusions: Until now the HPV vaccine is efficacious and safe for preventing precursor cervical cancer lesions. However, there is no definitive evidence about efficacy and safety of HPV vaccine for preventing cervical cancer, due to short follow-up of studies (5.5 years). Only one cost-effective analysis about HPV vaccine applied to Brazilian case was found and it approached a social perspective. So, more evidence is needed to support Brazilian Public Health System managers’ decision. Musculoskeletal/Orthopedics M18.1 - Metal-on-metal total hip resurfacing arthroplasty Sehatzadeh S.1, Rebeira M.1 1Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care, Toronto, Canada Objective: To assess the safety, effectiveness, and the cost of metal-on-metal (MOM) total hip resurfacing arthroplasty in young patients. Methods: Studies using new generation of MOM hip resurfacing implants and published between Jan 1997 to October 2005 were included in the analysis. Results: Seven case-series studies with a mean follow-up ranging from 2.8 to 3.5 years reported on the effectiveness of MOM hip resurfacing arthroplasty. All the studies reported reduction in pain measured by Harris Hip Score which was significant in one study. Studies demonstrated improvement in function through SF-12, UCLA, and Oxford Hip Scores. The mean revision rate was 1.5% and the incidence of femoral neck fracture was 0.67%. Two studies reported on the safety of the implant materials; both reported elevated serum levels of metal ions. In one study, the median serum levels of cobalt and chromium were 7.6 and 10.6 times higher than normal at 16-month follow-up. In the second study, the mean serum levels of cobalt and chromium were 6 and 21 times higher than normal at 12 months follow-up. Using Ontario Case Costing Initiative data, the total estimated costs for hip resurfacing arthroplasty was calculated as $15,256 (Cdn). Conclusion: Based on the results of medium-term follow-up studies, MOM hip resurfacing arthroplasty is an effective procedure in reducing pain and improving function in younger patients. Patients with MOM hip implants are shown to be exposed to high blood concentration of metallic ions,

the long-term significance of which is unknown at this time. M18.2 - Compliance with biphosphonates therapy for osteop orosis Imaz I.1, Amate J.M.1, González-Enríquez J.1, Zegarra P.2 1Instituto de Salud Carlos III, Agencia de Evaluación de Tecnologías Sanitarias, Madrid, Spain, 2Instituto de Salud Carlos III, National School of Health, Madrid, Spain Objective: Study the compliance of biphosphonates in the treatment of osteoporosis and associated factors. Estimate the impact of compliance on treatment effectiveness. Methods: We performed a systematic review to update previous reviews (last one covered up to May 2006). We performed a new search using Medline between May 2006 and December 2007, in order to add new evidence. We selected studies related to the following: - Measuring compliance with these outcomes: length of persistence, percentage of persistent patients and Medication Possession Ratio. - Studying the following drugs: etidronate, alendronate, risedronate, ibandronate. - Studying factors associated with biphosphonates compliance. - Studying the impact of compliance on fracture risk. Results: We identified 29 studies that met these inclusion criteria. Most of these studies analysed claims or pharmaceutical data sets. The average follow-up time was one year. Factors associated with low compliance to biphosphonate therapy were: age, previous fracture, number of concurrent medications, satisfaction with medication, concerns about biphosphonate therapy, side effects, practical difficulties taking medication, co-morbid conditions, dosing regimens and length of drug treatment. The data retrieved show that compliance and persistence are sub-optimal. Low compliant cohorts present higher fracture risk (vertebral and hip fractures). Conclusions: Compliance level is associated with fracture risk, therefore programs oriented to increase adherence to biphosphonate therapy should be implemented. These programs should target patients with high risk factors for non-adherence. The studies should include follow up periods longer than one year, because the effect of osteoporosis therapy appears after a long period of time. M18.3 - Improving care: A random based study of an orthop aedic clinic with a pivot nurse in the province of Quebec Poder T.1, Bellemare C.1, Bédard S.K.1, Lemieux R.1 1CHU de Sherbrooke, Évaluation des Technologies et Modes d'Intervention en Santé, Sherbrooke, Canada Objective: To assess the effectiveness of an orthopaedic clinic with a pivot nurse in the province of Quebec as regard to accessibility, continuity and quality of care, efficacy and efficiency of the clinic, and patient’s quality of life. Methods: A randomly selected cohort of new patients attending an orthopaedic service in the time period February to March 2008 were entered into a database recording patient details, source of referral, diagnosis and quality of life (SF-36). In this setting, two sets of questionnaires were administered to the patients: the first one during the first visit and the second one two months later. 300 patients from the CHU of Sherbrooke (case control) are compared to 75 patients of the Hôtel-Dieu of Arthabaska (case study) where an orthopaedic clinic with a pivot nurse has been developed. Patients’ outcomes are compared according to their diagnosis, age, sex and body mass index. Results: Preliminary results showed a significant reduction in the waiting list duration (accessibility) in the Hôtel-Dieu of Arthabaska as a result of a decrease in inappropriate consultations with the orthopaedic consultant. Other results will be known and analysed by the end of the first semester of 2008. Conclusion: Orthopaedic clinic with a pivot nurse is a new concept in the province of Quebec and great expectations are based upon it. M18.4 - Guidelines for selecting prostheses for hip repla cements

Pibouleau L.1, Josseran A.1, Denis C.1 1Haute Autorité de Santé, Saint Denis la Plaine, France Objective: About 140 000 hip replacements are performed each year in France. A wide variety of prostheses are available but there are no guidelines on their selection. HAS was commissioned by French National Health Insurance to compare their clinical benefits in order to advise on reimbursement. Methods: A questionnaire was drafted on the basis of a systematic literature review and manufacturers’ applications, and mailed to 15 orthopaedic surgeons who rated their agreement with each statement in two rounds separated by a meeting. HAS used the review and expert panel conclusions to issue an official opinion on the relative clinical benefits of the prostheses. Results: (i) Total hip arthroplasty: The gold standard is the metal-on-polyethylene bearing. Ceramic-on-ceramic bearings and metal-on-metal bearings are for use in patients under 50 years of age, or between 50 and 70 years of age if they are very active and have a long life expectancy. All femoral stems - regardless of design, fixation method, or surface treatment - are considered to provide an equivalent clinical benefit. There is no difference in clinical benefit between all-polyethylene cemented cups and uncemented acatebular shells associated to polyethylene inserts. (ii) Femoral neck fractures: Total hip prostheses can be implanted in active patients under 85 years of age. Unipolar and bipolar hemiarthroplasties are indicated in patients over 85 or in low-activity patients under 85; there is no difference in their clinical benefit. Conclusions: The above guidelines on the choice of hip prosthesis need to be confirmed in high-evidence clinical studies. M18.5 - Assessment of viscosupplementation for osteoarthr itis (OA) of the knee: Bringing nuances to decision making Dagenais P.1, Framarin A.1 1Agence d'Évaluation des Technologies et Modes d'Intervention en Santé du Québec (AETMIS), Montréal, Canada Background: Viscosupplementation of the knee consists in drainage followed by intra-articular injection of hyaluronic acid (HA) in OA-affected joint. It aims at reducing joint pain and stiffness and possibly delaying surgical replacement. Objective: To assess effectiveness and cost-effectiveness of this therapy and analyse the possible impact of its coverage on Quebec´s health care system. Methods: Literature search in usual medical databases covered until December 2006. Meta-analysis and cost-effectiveness studies were examined. Coverage rules from private and public health insurance plans were also studied. Results: Six of 14 meta-analysis (MA) using randomized controlled trials comparing intra-articular HA to placebo met inclusion criteria. Included primary studies of poor methodological quality, were using heterogeneous interventions and outcomes measures, complicating assessment. Significant pain at rest improvement was found in all MA at 5 to 13 weeks following treatment. Modest pain improvements on weight bearing and for longer duration were seen with Hylane 20. Functional and global improvements reported were inconclusive. Five economic studies showed HA cost effectiveness against comparators based on methodologically-weak trials. Budget and medical resources impacts on health care system were analysed. Conclusions: Despite favourable high-ranking evidences, AETMIS had to mitigate recommendations according to study quality and contextual considerations. It suggested rejecting universal coverage, restricting indications as last resort therapy. M18.6 - Scientific evidence on the efficacy and safety of calcium phosphate bone grafts Rodrigues C.1, Fernandes L.1, Soares G.1 1Federal University of Rio de Janeiro, Department of Metallurgical and Materials Engineering, Rio de Janeiro, Brazil Objective: A lot of different types of bone grafts are available worldwide due to the increase of the use of biomaterials for hard tissue replacement. This study was designed to evaluate the scientific

evidence on the efficacy and safety of the calcium phosphate bone grafts of commercial use in Brazil. Methods: A systematic search on the efficacy and safety of the 12 bone grafts registered at the Brazilian Health Regulatory Agency (ANVISA) was performed in August 2007. The studies published from 2000 to 2006 were selected according to inclusion and exclusion criteria defined previously. Two reviewers independently extracted and assessed data. Differences were solved by discussion. Results: By applying a specific search strategy composed by the commercial names of the 12 registered products at ANVISA, 86 studies were obtained and 12 of them were selected according to the inclusion and exclusion criteria: HAP91 (2 studies); Biosorb (2 studies); Osteosynt (1 study); ProOsteon (2 studies); Gen-Ox (2 studies); Gen-Phos (1 study); Gen-Tech (1 study); MasterGraft (1 study). The selected studies were case reports based on orthopedic experiments performed in animals (75%) or human (25%). Most part of them (5 studies) was related to synthetic hydroxyapatite. Conclusions: In general, these experiments showed that the bone grafts analyzed increased the bone formation and did not have side effects. The scientific evidence on the efficacy and safety of the bone grafts available in Brazil is still scant. Additional studies are necessary in order to evaluate the clinical performance of these health technologies. M18.7 - Balloon kyphoplasty for the treatment of compress ion vertebral tumour fractures López T.1, Cediel P.1, Bouza C.1, Alcázar R.1, Amate J.M.1 1Instituto de Salud Carlos III, Agencia Evaluación Tecnologías Sanitarias, Madrid, Spain Objective: Vertebral compression fractures constitute a major public health issue in westernised countries due to its high prevalence and associated morbidity and mortality. Balloon kyphoplasty is a minimally invasive procedure intended to relieve pain but also to avoid the functional sequels of vertebral compression fractures. This technique has mainly been evaluated in the past in osteoporotic fractures. However, as it has also been used on patients with tumoural fractures, it is paramount that the efficacy and safety of the balloon kyphoplasty is assessed on this patient group. Methods: Databases searched were Medline (PubMed), EMBASE, BIOSIS, EMCare, PASCAL, PsycINFO, IME, The Cochrane Library, CRD, ISI Web of Knowlegde. There were not any language or date restrictions. Systematic review of selected papers after applying an inclusion & exclusion criteria based on their population, intervention and outcomes measured. Studies were critically appraised and when possible standard meta-analytic methods were used to pool data. Results: A total of 9 scientific papers that provided details on tumoural fractures were selected and analysed in terms of the following efficacy and safety variables: pain, vertebral height, kyphotic deformity, functional capacity, quality of life, cement material leakage, new vertebral fractures and complications. Conclusions: Balloon kyphoplasty appears to be an effective and safe technique for the treatment of tumoural compression vertebral fractures that can improve clinical outcomes in patients with these fractures. Nevertheless, the evidence is weak due to the limited amount of scientific papers presenting relevant data on this population. M18.8 - Decision support technologies on the health of th e patients with osteoarthritis knee or hip Perestelo-Pérez L.1, González-León L.1, País-Brito J.-L.2, Brito-Santiago A.3 1Canary Islands Health Service, Evaluation and Planning Unit, Santa Cruz de Tenerife, Spain, 2University Hospital of the Canary Islands, Traumatology Service, Santa Cruz de Tenerife, Spain, 3University Hospital Nuestra Señora de la Candelaria, Traumatology Service, Santa Cruz de Tenerife, Spain Objectives: Decision support technologies (DSTs) provide evidence-based information about treatment options and likely outcomes of each. The aim of the review was to identify DSTs for patients with hip or knee osteoarthritis (OA) and evaluate their efficacy. Methods: Systematic review on DSTs for patients with hip or knee OA. Published reports of randomized controlled trials and other designs identified from searches of different electronic databases and from hand searches and consultation with key informants. Studies were including if patients were the decision-makers, decisions were real, the intervention met a strict definition of a DSTs and decisions involved treatment. Two reviewers evaluated the validity of each report. To evaluate if DSTs achieved their objectives and are effective, a series of positive or negative effects on

decision-making process and decisions results are considered. Results: A total of 144 studies were considered and screened. Twenty-nine studies were eventually included. Clinical trials showed differences between DSTs groups, an increase patients’ knowledge, an improvement in the general health status and in the physical function of individuals in the intervention group. The observational studies included show similar results to the clinical trials. Conclusions: DSTs increase patients’ knowledge about hip or knee OA, and in some individuals demonstrate improved perceptions about their health status. Patients place a high value on DSTs because they find them useful when they face decision options. Nevertheless, the influence of the DSTs on decisions made by patients and on the therapeutic option eventually followed is not clear cut. M18.9 - Balloon kyphoplasty vs conservative medical manag ement in osteoporotic vertebral compression fracturs - Health care and social cost analysis Lippi G.1, Amedei A.2, Marcucci G.2, Guizzardi G.3, Pandolfo C.3, Brandi M.L.2, Scarpa F.4 1Azienda Sanitaria di Firenze, Firenze, Italy, 2Dip. Medicina AUO Careggi, Firenze, Italy, 3Neuroradiologia AUO Careggi, Firenze, Italy, 4Kyphon Italy, Reimbursement-Health Economics, Saronno, Italy Objective: Balloon Kyphoplasty (BKP) is an innovative minimally invasive procedure effectively used for the treatment of osteoporotic vertebral compression fractures (VCF).Although the clinical efficacy of BKP is clearly demonstrated in the literature, a full comparison of the costs related with this procedure vs Conventional Medical Management (CMM) has not been conducted yet. With this project we want to evaluate the overall one year costs of the VCF treatment pathway for two different patient groups: BKP and CMM. Methods: BKP: the sample included all the relevant cases (n=29) treated from April 2005 to March 2006 in the neurosurgery department of AUO Careggi (Florence); CMM: all the patients treated for osteoporosis ambulatory of the same hospital during the same period (n=30 relevant cases). Activity Based Costing Analysis was performed to assess in-hospital costs. Questionnaires and interviews were used to assess outpatient health care and social costs, sustained during the first year after VCF. Results: Average costs for the two treatment pathways: One year: CMM 7.051� (455 hospital phase and 6.596 out of hospital phase), BKP 6.878� (5.396 + 1.482). In the subgroup of hospitalized CMM patients the in-hospital costs increase with 1.945�. Conclusions: Balloon kyphoplasty is confirmed as effective treatment in reducing pain and Loss of Disability in patients with osteoporotic VCF. Although hospital related costs are higher for BKP, the overall one year costs are similar for both treatments. Better patients’ outcomes and lower costs show balloon kyphoplasty as the best choice for the treatment of osteoporotic vertebral compression fractures. M18.10 - SWISSspine - The first governmentally mandated HT A registry in Swiss orthopaedic history Diel P.1, Moulin P.2, Aebi M.1, Roeder C.1 1MEM Research Center, University of Bern, Institute for Evaluative Research in Orthopaedic Surgery, Bern, Switzerland, 2Schweizer Paraplegiker Zentrum, Nottwil, Switzerland Objective: SWISSspine is a nationwide registry for total disc arthroplasty (TDA) and balloon kyphoplasty (BKP). It was implemented to assess the safety, efficiency, and cost-effectiveness of these technologies. Based on the resuls the Swiss federal office of health (SFOH) will decide about future reimbursement of the treatments. Methods: A working group of stakeholders from industry, the Swiss Spine Society (SSS) the University of Bern and the SFOH was formed. Industry took on financing and delivery of sales figures, the SSS worked up the questionnaires and the university implemented and hosted the registry on its documentation portal www.memdoc.org. SSS members had to apply for certification in order to conduct the respective interventions; along with it came a written consent to participate in the registry. Results: From March 2005 until June 2007 there were 440 surgery forms for cervical TDA 782 followup forms, 1178 COSS questionnaires, 289 surgery forms for lumbar TDA, 531 lumbar TDA

followup forms, 1265 NASS questionnaires, 2485 EQ-5D questionnaires and 881 comorbidity questionnaires recorded. Comparison of sales versus documentation figures revealed a coverage rate of 70-80%.The results generated evidence for the decision by the SFOH to reimburse TDA and BKP by the basic health insurance under the condition of a continuation of the register. Conclusions: SWISSspine was a cultural shock and surgeons initially had problems reorganizing their workflows. The registry can meanwhile be considered a success and as foundation for other future HTA projects. It can also act as a feasibility model for comparable studies in other countries. Public Health 1 M19.1 - Electronic knowledge transfer: Public health stan dards and health inequalities Sheppard L.M.1, Morgan A.M.1 1National Institute for Health and Clinical Excellence, Centre for Public Health Excellence, Manchester, United Kingdom The UK’s National Institute for Health and Clinical Excellence (NICE) provides independent national guidance to promote good health and prevent and treat ill health. To ensure public health guidance development adheres to the principles of good governance, the Centre for Public Health Excellence(CPHE)within NICE has adopted a number of systems and processes. This paper discusses the challenges and opportunities in developing guidance which will be made available through electronic sources. Such technology aims to provide rapid access to guidance and increase the relevance and accuracy of the latest information for commissioners, service providers and practitioners. It’s unclear how such electronic knowledge transfer (EKT) technology will encompass a wider public health (PH) perspective or how it will impact on the taxonomies of PH language and supporting information technology (IT) infrastructures. Electronic dissemination of PH Guidance could become a tool for: discouraging or encouraging the implementation of evidence driven health and wellbeing practices, development of locally driven research based on gaps in the evidence base and improve accessibility to health information by minority groups. This paper will highlight challenges and opportunities in adhering to the principles of good governance during development of EKT technologies by discussing: · Issues involved in providing PH information electronically; · Questions practitioners need to ask to develop PH programmes; · How we ensure that EKT does not contribute to a widening of health inequalit ies; · How EKT can support the practice of putting evidence into PH practice. Future developments to ensure good governance in development of PH guidance will be discussed. M19.2 - Using HTA methods to support evidence based medic al standards for motor vehicle driver licensing in the UK Moore D.1, Fry-Smith A.1, Bayliss S.1, Hyde C.1, Lee B.1, Major H.2 1West Midlands Health Technology Assessment Collaboration, Dept of Public Health & Epidemiology, University of Birmingham, United Kingdom, 2Drivers Medical Group, Driver and Vehicle Licensing Agency, Swansea, United Kingdom Objective: The implementation of evidence-based driving licence legislation is important in protecting public health. Since 2005, the West Midlands Health Technology Assessment Collaboration (WMHTAC) has worked with the Drivers Medical Group and Medical Advisory Panels (MAPs) within the UK Driver and Vehicle Licensing Agency. The specialty specific MAPS advise the Secretary of State for Transport on the medical standards required for safe driving, including recommendations to withdraw licences on grounds of health-related impairment. Methods: WMHTAC: (i) assists MAPs in defining research questions in areas where medical standards need defining or revising, (ii) undertakes systematic literature searches, (iii) screens citations for relevance using defined inclusion criteria, (iv) pragmatically identifies and critically appraises the key relevant literature, (v) extracts/analyses data,

(vi) writes reports that include assessment of the quality of the evidence (vii) supplements reports by presentations to MAPS and aids subsequent discussion. Evidence from a wide range of study designs is used (e.g. cohort and cross-sectional studies) where methods are not as well developed as those for systematic reviews and RCTs. Results: Twenty-two reports have been completed on a wide range of topics including dementia, visual deficits, cardiac disorders, seizure, drink driving and diabetes. The types of research questions answered include (commonest first) prognosis, diagnosis, prevalence, aetiology and effectiveness. Conclusions: The application of the principles of HTA are important in helping to ensure that driving policy relating to medical disorders is based on the best available evidence so that drivers are given sound advice and the general public receive appropriate protection. M19.3 - Sources and solutions to patient anxieties around MRSA Reid M.1, Ritchie K.2 1University of Glasgow, Public Health and Health Policy, Glasgow, United Kingdom, 2NHS Quality Improvement Scotland, Health Services Research, Glasgow, United Kingdom Objectives: Within a health technology assessment requested by the Scottish Government to determine the most clinically and cost effective strategy for screening patients admitted to hospital for MRSA colonisation, a review was carried out on patient concerns of patients/ex-patients in relation to MRSA. Methods: Two approaches were adopted; an extensive systematic review of patient literature was carried out in December 2005, updated October 2007 using leading bibliographic databases (including MEDLINE, EMBASE, CINALH, PSYCHINFO); retrieved results were sifted and 38 papers reviewed in depth. Two focus groups with former patients (one group 50>, one group <50 years old), and analysed using thematic analysis. Results: Main concerns were of fear about catching the condition, and ignorance of MRSA. Patients reported concerns about entering hospital with unrealistic anxieties about catching the disease and confusion and ignorance about the nature of the condition, lacking an understanding of the nature of colonisation. The literature additionally emphasised anger at becoming an MRSA patient, and the unpleasant experience of being nursed in isolation. The focus groups (none had MRSA) reported bewilderment at the behaviour of staff some of whom did not comply with the same hand washing requirements as visitors. The focus groups emphasised the lack of sound information to guide them. Conclusion: Care of patients nursed in isolation should not result in them being disadvantaged. For these patients and others, better communication between health professionals and patients, and across the media would serve to diminish the anxieties and concerns of patients and individuals entering hospital. M19.4 - Adverse events during interferon and peginterfero n treatment in hepatitis C patients followed in an outpatient public health service Gonçalves C.1, Amaral K.1, Artico S.1, Caon S.1, Martins N.1, Sander G.1, Picon P.1 1State Health Department of Rio Grande do Sul, The Center for Application and Monitoring of Injectable Medicines - Hospital Partenon, Porto Alegre, Brazil Objective: The Chronic Hepatitis C (HCV) treatment is related to several adverse events (AE), causing a decrease in the patient´s quality of life. In Brazil, patients infected by HCV genotype 1 are assigned to treatment with PEGIFN and patients with HCV genotype 2 and 3 to treatment with IFN. The purpose of this work is to compare AE rates during Peginterferon (PEGIFN) and Interferon (IFN) treatment on the first six months. Methods: We conducted a prospective cohort of hepatitis C patients during interferon based therapy. AE were collected by pharmacist´s monthly interview and the rates were compared. Results: 307 patients were followed during PEGIFN and IFN treatment. Mean age at study entry and male proportion was similar between the groups (50.6+12y vs 52.9+11y, p=0.109; 55.8% vs 50.0% males; p=0.200). The global AE rate were different between the groups (28.3 vs 20.1 AE/patient; p<0.001). We also observed a decrease in AE monthly rate during the treatment period of six months. Anemia was present in 12.4% in PEGIFN vs 3.1% in IFN group (p=0.006), leucopenia (<1,500/mm3) in 7.6% vs 2.3% (p=0.056), neutropenia (<750/mm3) in 26.2% vs 5.4% (p<0.001) and thrombocytopenia (<50,000/mm3) in 13.8% vs 5.4% (p=0.025). Treatment interruptions were by AE in

4.6% in PEGIFN vs 4.1% in IFN group (p=1.000). Conclusions: The PEGIFN utilization seems to be associated with a greater clinical AE rate as well as laboratorial AE, however this finding is not associated to a higher rate of treatment interruptions. Conflicts of interests: declared none! M19.5 - Type of occupational health services for 21st cen tury hazards in industrial productions system Lu Y.C.1, Lu J.L.2 1Sophia Mineral Services, Quality Control, Quezon City, Philippines, 2National Institutes of Health, Univeristy of the Philippines Manila, Occupational Health Study Group, Manila, Philippines The 21st century has witnessed the rise of new type of industries that consequently present new hazard exposures. The type of occupational health (OH) services to deal with these issues should match the challenges of a global production system. The study focused on electronics industry in the Philippines where the back-end processing of microchips is concentrated. It targeted 10 industries with 500 respondents. The study looked into the prevalence of occupational illnesses and hazards, and the availability of health services. The most prevalent skin problem was allergy (98.4% of all reported skin illnesses). Among the headaches, tension headache (86.8%) were most prevalent. For the respiratory system, cough and colds (60.4%) was the highest. The most common eye problem was conjunctivitis (71.4%). Hypertension (79.1%),and gastroenteritis(50.4%), were also very common. The blood lead result of the 285 subjects revealed that 40.7 percent of the total number of subjects had blood lead result within the 21-30 ug/dL considered inimical to health of workers. For OH Services, only 60% of small scale industries and 50% of medium-scale had health and safety programs, and no nurses and first-aiders in medium-scale industries. Helath services should not only be routine, but specific to industry exposure such as lung function test for those exposed to hazardous gases. The study came up with a feasibility of management putting up its own health services that cater to the unique hazard exposures and consequent occupation-related illnesses, as cost effective as it will boost productivity. Methods 2 T1.1 - Case studies of complex HTA clinical trials: Tele medicine Scott M.A.1 1NCCHTA, Wessex Insitute for Health Research & Development, Southampton, United Kingdom Objective: This project uses a case study from the portfolio of work of the UK National Coordinating Centre for Health Technology Assessment (NCCHTA) to examine the complex of telemedicine clinical trials. Methods: Whilst reviewing our diagnostics trial portfolio, telemedicine trials were reviewed and analysed, along with the wider literature, to establish what makes performing trials in this area particularly difficult. Results: In 2006, the UK NIHR HTA Programme completed a RCT in teledermatology that compared the clinical equivalence of teledermatology intervention with conventional face-to-face consultation with diagnostic concordance as the primary outcome measure. The study showed that no valid conclusions on the clinical performance of the intervention could be drawn and the case study elucidates some important general issues on telemedicine primary research that prompted us to develop a methodological checklist for such trials. These include:

1. Failure to show non-inferiority is generally due to under-powering caused by inadequate patient recruitment in equivalence designs;

2. The choice of equivalence margin and outcome measure is crucial in the design; 3. The majority of published studies focus on early stage feasibility studies.

We define telemedicine as an inherently complex intervention in the sense that it is often difficult to specify the active ingredient of the intervention and there is often organisational change involved. Conclusions: Conducting and designing clinical trials in telemedicine presents significant challenges. Indeed, we have shown that RCTs are uncommon, and are difficult in terms of the design and

outcome due to telemedicine being an excellent example of complex intervention. T1.2 - Human factors: What we cannot afford to ignore in HTA Pinkney S.1, Trbovich P.1, Chagpar A.1, Easty A.2 1University Health Network, Healthcare Human Factors Group, Centre for Global eHealth Innovation, Toronto, Canada, 2University Health Network, Medical Engineering, Toronto, Canada Objective: In an attempt to reduce medication errors, hospitals are moving away from traditional intravenous infusion pumps towards smart pump technology that incorporates safeguards to alert users to programming errors. Despite the intended benefits of smart pumps, they introduce new tasks that may lead to new errors. Human Factors (HF) analysis can help identify the potential for theses errors. The objective of this study was to incorporate HF analysis into the assessment of infusion pump technologies to better understand the safety and efficiency issues with their use. Methods: HF analysis was applied to the evaluation of traditional and smart pump technologies. Specifically, nurses participated in usability testing to evaluate the ease of use and safety of these pumps. A laboratory simulation of a clinical environment was set-up in which nurses administered medications in a realistic environment to evaluate the effects of these technologies on nurses’ workflow and ability to detect and correct medication administration errors. Results: Although smart pump technology provided extra functionality and safeguards, nurses were more confused and had more difficulty completing tasks when using a smart pump compared to a traditional pump. The change in tasks necessary to program a smart pump led to human error and inefficiency, compromising the effectiveness of this technology. Conclusions: HF analysis can proactively identify and mitigate usability, safety and efficiency issues with a new technology prior to its introduction into clinical environments. This evidence can compliment the more traditional economic, human resource, regulatory and ethical considerations in health technology assessments. T1.3 - Examining the use of reports published in languag es other than English in systematic reviews Clark M.1, Moulton K.1 1CADTH, Ottawa, Canada Objective: As a part of a project investigating the contributions of reports in languages other than English (LOE) to systematic reviews and meta-analyses, we surveyed the Cochrane library and CADTH reports to determine the current use of reports published in languages other than English. Methods: We collected information regarding the inclusion of LOE reports in the literature search, the inclusion of LOE reports in the clinical analysis, and the language in which these reports were published. Results: A total of 50 CADTH reports and 102 Cochrane reviews were surveyed. 4% of CADTH and less than 1% of Cochrane literature searches excluded LOE. 38% of CADTH reports included citations written in LOE in the analysis. Cochrane review analyses involved LOE citations in 17% of those surveyed. Approximately 2.5% of the total citations used in the analyses by both CADTH and Cochrane were written in LOE. The most common language other than English included in CADTH reports is French (33% of LOE citations) and in Cochrane reviews is German (57%). Conclusions: Despite performing literature searches without language restrictions, LOE reports still make up a very small percentage of reports that are included in the clinical analyses of systematic reviews and meta-analyses. A CADTH systematic review examining how the inclusion/exclusion of primary research published in LOE influences estimates of effectiveness that are derived from syntheses of the evidence is now underway. T1.4 - Can all health technology assessment (HTA) studie s use the standardized approaches? Bergerman L.1, Corabian P.2, Harstall C.2 1Alberta Mental Health Board, Research, Edmonton, Canada, 2Institute of Health Economics, Edmonton, Canada

Objective: To describe the methodological issues associated with conducting an HTA study on a mental health topic. Methods: A review of the methodological approach used to conduct an HTA study on the effectiveness of organizational interventions for the prevention of stress in the workplace. The HTA study used a standardized approach following “best practice”: comprehensive literature search, a priori developed selection criteria; critical appraisal using standardized quality assessment tools; and qualitative synthesis. Results: This was not a conventional HTA study as it was focused on the use of various programs and strategies for preventing stress in the workplace. Following the preliminary assessment, there was a need to expand searches beyond conventional databases. A priori developed selection criteria needed to be modified later as there was a need to review studies to develop definitions and an appropriate framework for selecting, presenting, and evaluating the interventions. The use of 2 quality assessment tools for critical appraisal of the selected systematic reviews (SR) sometimes resulted in different quality “scores” for the same SR. Inter-rater agreement was low on quality subsections of one tool. Conclusions: A standardized methodological approach does not transfer well for assessing studies on mental health interventions. For some topics, the existing conflict of using a strict scientific approach versus being committed to provide useful information to decision makers for planning and implementation, requires open negotiation on both sides throughout the project. Hence flexibility is key to ensure that the information provided is of value to the decision makers. T1.5 - Exploring the need to update systematic reviews McNeil A.1, Thomas A.1 1BMJ Publishing Group, BMJ Knowledge, London, United Kingdom Objective: To explore the issues around the frequency of updating systematic reviews building on the BMJ Clinical Evidence experience. Methods: An oral presentation outlining some of the issues around updating systematic reviews will be given. The presenters will describe recent research on how regular updating of the evidence in the publication BMJ Clinical Evidence has changed the categorisations relating to the relative benefits and harms of interventions, discussing how this is relevant to the question of how frequently systematic reviews should be updated. Comparative research will also be presented. There will be opportunity for the audience to input on their experiences. Results: We will provide numerical and narrative data. Conclusions: Systematic reviews should be updated regularly to maintain clinical relevance and safety. Those involved in writing reviews should be aware of the need for updating in order to draw valid conclusions about the effects of interventions. T1.6 - Identifying the evidence for a health technology assessment methodological review Papaioannou D.1, Rawdin A.1, Gillett M.1, Chilcott J.1, Paisley S.1 1University of Sheffield, School of Health and Related Research, Sheffield, United Kingdom Background: Methods for identifying studies to inform systematic reviews of clinical effectiveness are well developed. However, these methods are less useful in identifying evidence to support other areas within health technology assessment such as decision-analytic modelling, methodological or qualitative reviews. Methods: An HTA methodological review investigating avoidance and identification of errors in decision-analytic models aimed to develop ways of improving modelling practice. Systematic review searching produced unmanageable results of limited relevance. A group of alternative search methods were employed starting with a brief scoping search and selection of key papers to guide search term development. A berrypicking approach to searching was employed whereby several small specific searches were carried out, followed by reference selection by the information specialist. Each reference selected generated new ideas and directions for the search. Supplementary citation and author searches were used. Strict documentation of the search process demonstrated the investigation of the literature was comprehensive. Results: A series of small results sets of high specificity were identified. In contrast, systematic review

searching typically produces a single retrieved set of large number and high sensitivity. By using search approaches based on the berrypicking model such as citation and author searching, the references identified were manageable in number. Difficulties in using this approach included problems in planning and managing the search. Conclusions: Using a berrypicking approach to guide the search process for a methodological review was successful; thus demonstrating outside the focus of systematic reviews of clinical effectiveness, alternative methods of identifying evidence need to be considered. T1.7 - Italian experience in information systems for HTA Dori F.1, Martini R.2, Sladojevich E.2, Calani G.2, Iadanza E.1, Miniati R.1 1University of Florence, Electronic and Telecommunication, Florence, Italy, 2HC Hospital Consulting S.p.A., Florence, Italy Objective: Nowadays Italian scientific healthcare community emphasizes sharing HTA methods and procedures. In fact to this day we can only evaluate local applications and methods for specific issues. Italian Healthcare Program identifies, as an important and desirable target, realizing software and operative tools in order to assist every process related to renewal and monitoring of technology. After a general survey we haven’t found an integrated software able to meet requirements of HTA and to support a multidisciplinary approach to technology management, where medical staff, significantly involved in technology assessment and evaluation, needs HTA “automated” tools allowing wider methodological approaches to meet growing health’s expectations and budget management. Methods: HTA analysis needs multidisciplinary and heterogeneous data; correlation among them for an useful result isn’t simple to achieve. Effective software and informative system have to translate “data” into “information”, to obtain results from different kinds of data elaboration. They are often founded on Bayesian approach, data mining, key performance indicators, and others. Results: The challenge consists in planning and making operative tools able to manage different kind of information; this will permit to intervene in every intermediate phase of the elaboration process. Conclusions: Software can simplify process management and support HTA activities, where “human factor” has the most significant role in decision and in estimation of relative weight of different information. In synthesis seems more useful to improve collection of informative flows, in order to influence choices about technologies and clinical government, rather than setting up wholly automated system. T1.8 - Clinical effectiveness and cost settlements of ap plication of protocols on diagnostic and treatment Birtanov Y.1, Akshalova D.1, Sadykova Z.1, Shinbolatova A.1 1Institute for Healthcare Development, Almaty, Kazakhstan Background: During the period of healthcare system reforming the most important question is to conduct researches on clinical and economic efficiency. Objective: Development of methods on clinical efficiency evaluation and cost settlements of application of Protocols on diagnostic and treatment (PDT). Methods: Research and information, sociological, expert evaluation, comparative analysis. Results: At the present time in the Republic of Kazakhstan it is developed and implemented more than 300 PDT. With object to develop methods on clinical efficiency evaluation and cost settlements of PDT application it was selected 10 monitored diseases than we studied and analyzed PDT on socially significant diseases and also indicators were selected. Clinical efficiency evaluation of PDT application in polyclinics was conducted on the case study of “arterial hypertension” in view of case rate increasing with usage of appropriate indicators. Researches results show positive influence on clinical efficiency of PDT application. In hospitals for clinical efficiency evaluation of PDT application we selected “acute appendicitis” as case study. Comparative analysis of clinico-economic profiles before 2004 y. and after 2007 y. (PDT application in medical organizations) was taken as a basis. 2007 profile shows up: - Reduction of hospitalization duration (4 bed-days); - List of diagnostic procedures became more rational; - Increasing of unit weight of surgical interventions with local anesthesia (21.5%); - Decreasing of pharmacotherapy on patient.

Conclusions: Results of research confirms that PDT application increases clinical effectiveness and decreasing expenses. T1.9 - A review of volume and outcomes: The Scottish per spective Chauhan R.1, Winning A.1 1NHS Quality Improvement Scotland, Glasgow, United Kingdom Objective: Delivering for Health committed the Scottish Government to developing an evidence base for the relationship between the volume of complex health care interventions and the quality of patient outcomes. An expert group was formed in the short term to: · Assist NHS Scotland in making better use of existing knowledge about the volume/outcome relationship. · Develop clear guidance on use of volume information in relation to other factors in service provision. · Facilitate informed debate about future information gathering. Methods: · International literature review of the volume/outcome relationship. · Involvement of healthcare professionals at hospital and Board level in understanding the volume/outcome issue. · Combination of national audit data and other clinical data collected by NHS. Updating a previous Scottish review a systematic search for papers published between 2005-2007 was performed. A sensitive search strategy was developed and applied to Medline, Embase, HMIC, Web of Science, Cochrane databases and various grey literature resources. Results: · There is a fundamental link between volume and outcome most readily seen at extreme ranges with many services lying between these. · Context specific clinical/audit data to inform service planning in terms of patient safety and service restructuring is essential. · Relevant evidence is limited causing difficulty in predicting the effects of any imposed change. Conclusions: The work of the expert group remains in progress however it is clear that methodologically sound and robust research is required in the Scottish context. T1.10 - Where and how to find information on ethical issu es for health technology assessments Droste S.1, Dintsios C.-M.1 1Institute for Quality and Efficiency in Health Care (IQWiG), Köln, Germany Objective: Frequently neglected ethical issues and values in HTAs is also caused by insufficient knowledge about sources of information and specific retrieval methods. Our aim was to develop and apply methods to identify publications on ethical issues and values in evaluating health technologies. Methods: We developed methods for the systematic information retrieval, which include a list of information sources (bibliographic databases, journals, institutions) as well as listings of subject headings and free-text terms for each information source. We applied this methods for the examples prenatal ultrasound, stem cell therapy in breast cancer, and stent implantation. Results: 24 bibliographic databases (biomedicine, economics, ethics, HTA, psychology, social science), 8 non-indexed ethics journals, 27 international and national ethics institutions and some HTA-institutions of relevance were identified. 1324 documents were retrieved for prenatal ultrasound (58% in MEDLINE/EMBASE), 887 documents for stem cell therapy (27% in MEDLINE/EMBASE), and 772 documents for stents (77% in MEDLINE/EMBASE). Publications on therapy-induced harms were mostly found in biomedical databases, whereas publications on informed consent and patient autonomy were retrieved either from biomedical or ethics databases. Publications on the controversial issue of selective abortion as a consequence of prenatal ultrasound were frequently identified in ethics databases. Conclusions: Information retrieval on ethical issues is time-consuming, as it is insufficient to search only conventional biomedical databases. The impact of each information source depends highly on the topic and on the currently discussed respective ethical issues. It is therefore helpful to select topic-related the most relevant databases before starting the systematic information retrieval.

T1.11 - What is meant by modified intention to treat: Inv estigating randomised controlled trials Abraha I.1, Montedori A.1 1Regional Health Authority of Umbria, Epidemiology Department, Perugia, Italy Objective: To explore when and why is modified intention to treat (mITT) principle used in randomised controlled trials (RCTS). Methods: Terms like ‘modified intention to treat’, ‘modified intent to treat’, and ‘modified ITT’ were employed in Highwire and ScienceDirect databases which provide full-text search option. RCTs published between 1960 and December 2007 were included in the analysis. The description of mITT were investigated and classified appropriately. Results: Of 737 records 472 RCTs that cited the mITT approach were retrieved. More than 60% of the trials were published between 2005-2007. The most frequent interventions investigated in the trials were antibiotics (20%), followed by coxibs (7.2%), antifungal drugs (6.6%), and monoclonal antibodies (3.5%). A number of conditions were used to define mITT on which to base the post-randomisation exclusion of the patients. Authors fixed one condition in 175 reports, two conditions in 194 and three conditions in 62. Receiving at least one dose of drug was the most required condition to be considered in mITT analysis: it represented 42% in trials with only one condition and 66% in trials with two conditions. In many trials microbiological, radiological or laboratory data had to be positive for inclusion in the mITT analysis. More than 80% of the trials explicitly excluded a mean of 12% of subjects after randomisation. Conclusions: Modified intention to treat is becoming popular in today’s RCTs. Its use is based on arbitrary criteria. Avoiding analysis by true intention to treat principle is highly hazardous to manipulation and consequently to bias. T1.12 - Systematic review: The usage of probabilistic lin kage epidemiological studies in the Brazilian health area Martins A.C.1, Machado J.1, Silveira D.1 1Federal Regulatory Agency for Health Plans and Insurance, GEPIN, Rio de Janeiro, Brazil In Brazil there are diverse systems of health information that are heterogeneous in terms of quality and coverage, which have been accumulated for decades without a set of common variables. Probabilistic linkage represents an adequate and viable alternative for the integration of these databases. Objective: To review the literature addressing methods, databases and software related to probabilistic record linkage usage in Brazil, synthesized current information and identified existing gaps in knowledge. Methods: The research strategy included: electronic database searches including Lilacs Medline; government web sites; examination of the bibliographies. The review included epidemiological studies that used the automated probabilistic linkage in brazilian systems of health information, bringing together information two or more files from the same person (administrative, economic or demographic files). A data extraction table was developed, incorporating aspects of the aims, designs, information systems, software, utility, feasibility and adequacy. Results: The research strategy yielded 253 records and one systematic review. The 14 studies met the inclusion criteria, covering a range of research topics, 1 case-control and 7 cohorts studies, among others. The free software Reclinkâ, that implements the Fellegi-Sunter model, was used in XX studies. Clerical review was used in most of the studies, but sometimes the size of the files makes such a task expensive or high time-consuming. Conclusions: The heterogeneity in reporting was important limitation, furthermore descriptions of methods and privacy safeguards were often limited. The following matters were identified in these studies: duplicates within a single file; errors and missing data; inconsistency of values in fields. T1.13 - Registries - What for? Evidence from registries i n cardiovascular, spine related and neurological fields Mathis S.1, Falkner E.1 1Ludwig Boltzmann Institute, Health Technology Assessment, Vienna, Austria

Objective: An important complementary approach to experimental studies is using registries. They can give a more population based view to a health problem and allow certain analyses that cannot be addressed in clinical studies, such as the identification of rare side-effects. Here we present a project that aims to evaluate the benefit of registries for health decisions. In the first step an exhaustive number of active registries in three clinical fields are identified to gain an overview of the types of questions and results that are addressed by registries. Methods: A systematic search was performed in Medline and Scopus to identify publications that present results from registry projects. In the next step a web search for the identified registries and a collection of basic data from the registries was carried out. Additionally an email-request was sent to experts to help identify registries. Results: 365 cardiovascular, 366 neurological and 64 spine specific articles were identified in the search. 159 of the cardiovascular, 108 of the neurological and 64 of the spine specific articles mention registries. These registries were located and relevant ones selected according to inclusion criteria (only registries that have been active during the past 3 years with periodic reports, certain countries). Overall, about 80 cardiovascular, 20 spine and 30 neurological registries were identified. Additionally, 8 registries were identified by experts. Conclusions: The search to identify registries helped T1.14 - Methodological guidelines for appraisals on healt h technology assessment for the Ministry of Health of Brazil Louly P.G.1, Laranjeira F.O.1, Conti M.A.1, Serruya S.J.1, Elias F.T.S.1 1Ministry of Health of Brazil, Department of Science and Technology, Brasília - DF, Brazil Objective: To assess the applicability and completeness of the Methodological Guidelines for Appraisals on Health Technology Assessment for the Ministry of Health of Brazil. Methodology: The Guidelines are a useful tool from the Ministry of Health of Brazil based on international literature of Evidence Based Medicine and Health Technology Assessment (HTA). They were elaborated by experts and discussed in three consensus meetings. Their aim is to guide and contribute the standardization of HTA Appraisals, which are the first step in the process of evaluating demands for new technologies incorporation in Brazilian Public Health System. To assess the Guidelines, 11 technicians used this document and analyzed the following issues: a) usefulness to elaborate an appraisal, b) easy and adjusted concepts’ presentation, c) adjustment of the proposed methods, and d) clarity of writing. These issues should be classified as “inadequate”, “partially adjusted” (if it was necessary any modification) or “adjusted”. Results: None of the issues was classified as “inadequate”. The issues a and c were classified as “adjusted” by 82% and 73% of the participants, respectively, while the issues b and d were considered “adjusted” by 100% of the participants. Conclusion: The tool has been considered valid to utilization, after few modifications. The Guideline has been used and tested by the decision makers from the Brazilian states. It is intended that the Guidelines will come to add to the several efforts that are being undertaken for the structuring and dissemination of Health Technology Assessment in Brazil. T1.15 - Using web-based systematic reviews for more effec tive clinical research O'Blenis P.1 1TrialStat Corporation, Ottawa, Canada Systematic reviews represent an important tool in the development and refinement of clinical evidence. Traditionally completed on paper, the process of conducting systematic reviews is rapidly falling behind the clinical research industry’s broader use of new information technologies. Moreover, research suggests 4% of systematic reviews require updating within a year and 11% after 2 years. For rapidly changing fields, such as cardiovascular medicine, 7% of systematic reviews need updating at the time of publication. Web-based systematic reviews offer one way to bridge the need for better, faster and more accurate

analysis of medical evidence. Organizations deploying IT-enabled systematic review tools are not only completing their research faster and more collaboratively but the quality and auditability of their results are also significantly improved. The presentation examines: - New developments in systematic review technologies that automate and manage systematic reviews; - How new technologies can enhance and improve upon current systematic review standards advocated by some organizations; - How organizations are using the Web to improve and speed the completion of systematic review; and - How coded data collected during the conduct of systematic reviews is now being published to facilitate and accelerate future research. T1.16 - KBV-innovation service: Quality of life (Qol) as outcome - A proposal for structured handling Schiffner R.1 1National Association of Statutory Health Insurance Physicians, Statutory Body under Public Law, Department of Health Technology Assessment, Berlin, Germany Objective: There is a consensus that Qol is an important outcome. Both the German Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) agree to that. Nevertheless, there is a lack in their methodology how that topic should be handled in detail and would influence their decisions. Methods: The proposed structure for the handling of the evaluation of Qol was be geared on our experience in preparation of HTAs. Furthermore, opinions of experts of Qol and the perspective of representatives of patients were integrated. Results: The structure is similar to the preparation of a systematic review. As a result a Qol-dossier will be generated: 1)Definition of the aim population/disease including opinions of representatives of patients as coworker. 2)Identification of Qol criteria which are relevant for the disease. 3)Literature research for useful general and specific Qol-measurements. 4)Check of validity and availability of detected Qol-measurements (e.g. languages). 5)Literature research for treatment studies of innovations which use validated Qol-measurements. 6)optional: delphi panel evaluating Qol criteria at representatives of patients if no Qol-measurements are available. 7) Short summary. The application will be demonstrated using some examples. Conclusions: As result of that structured process it is possible to get a quick overview about the state of things concerning the evaluation of Qol for a disease/medical innovation. That is important to recognize e.g. scientific lacks. Furthermore, new studies evaluating innovations could be optimized in terms of applying useful Qol-measurements. T1.17 - Multi-criteria decision analysis is the future of HTA Dowie J.1 1London School of Hygiene and Tropical Medicine, London, United Kingdom Much of the talent and resources involved in decision analysis-based Health Technology Assessment is focused on advancing ‘best practice’ as assessed by normative standards. While entirely rational from the point of view of publications, grants and careers this often has the effect of deterring the adoption, in decision practice, of less complex and rigorous analytical methods that would represent an improvement on the predominantly intuitive status quo. (See Value of Analysis Analysis abstract.) A second problem arising from the current prioritising of analytical rigour over practical usefulness arises from the fact that decision owners/makers (such as National Institute for Clinical Excellence, UK) clearly desire to take into account considerations which are not, and cannot, be incorporated in the conventional decision analytic maximand (e.g. QALYs). In order to address these two barriers to the practical adoption of more analytical methods we conclude that it is necessary (i) to move from conventional to Multi-Criteria Decision Analysis and (ii) employ an interface tool that is compatible with the key criteria for practical use (including speed, workflow fit, and cognitive demands). In this paper

we introduce a software tool, Annalisa, that addresses the weakness of existing MCDA implementations and demonstrate how it can be used in NICE-type public health HTA and decision making. We also show how it can be used to address the meta-decision of deciding how to decide. T1.18 - An evaluation system for healthcare buildings for use in Brazil - AEDET- Achieving excellence design evaluation toolkit Guelli A.1, Zucchi P.2 1Universidade Federal de São Paulo, Centro Paulista de Economia da Saúde - CPES, São Paulo, Brazil, 2Universidade Federal de São Paulo, Grides, São Paulo, Brazil This abstract places healthcare buildings within the discussion of Health Economics which highlights the need for efficiency regarding healthcare and the optimization of the resources involved. An important variable which influences the efficiency of a patient’s recovery is their perception, and that of the staff, regarding the built space where the care process takes place. The AEDET evaluation system, developed in England, is a tool which proposes to verify and evaluate the quality of healthcare build ing spaces in relation to their perception, function and technical aspects. The objective of this study was to translate the AEDET into Portuguese and adapt it for use in Brazil. This study was carried out based on the simplified method proposed in ‘Translation and Cultural Adaptation of Quality of Life Questionnaire: An Evaluation of Methodology’. Firstly, a health professional translated the tool into Brazilian Portuguese. A professional translator from England, then carried out the translation of the Brazilian Portuguese version into English. This back translation was then compared with the original English version of the tool. The discrepancies were resolved. This version was then adapted to the Brazilian reality and standards by a group of six health professionals and the final Brazilian version was established. The AEDET-Brazil was then applied in the Hospital Geral Pirajussara. We concluded that the AEDET-Brazil had been successfully translated and adapted for the evaluation and verification of the quality of healthcare buildings considering the perception of space, the function and the technical aspects. Diagnostic Technologies 2 T2.1 - The diffusion and utilization of combined positro n emission tomography/computerised tomography in China Tang Z.1, Chen Y.1, Chen J.1 1Fudan University, Key Lab of HTA, Ministry of Health, Shanghai, China Objective: Since 2000, combined positron emission tomography/computerised tomography (PET/CT) scanner has been in use,which holds much promise in the advancement of tumour localisation and management. Our intent here is to evaluate the diffusion rate and the status of utilization of PET/CT including the clinical application, economic and policy in China. Methods: A literature review of peer-reviewed, gray and web-based literature to was undertaken. The statistic data and policy from the government was also collected. Results: There are 58 located PET/CT scanners in the affiliated hospitals of Ministry of Health (MOH) until the end of 2006 since the first PET/CT was introduced to China in 2002. The average growth rate per year during 2002-2006 was 104% despite policies on the allocation has issued by MOH. There are 0.05 PET/CT scanner per million persons in china and the distribution of PET/CT has varied dramatically between regions (0-0.31 per million persons).The main purpose of scan was oncology (61%), health examination (35%) and Epilepsy. The health insurance system has not covered the PET/CT scan until now and the price of one scan using PET/CT is very expensive (average 9246 RMB).Hence, most of the operating PET/CT sites had idle capacity and less cost-effectiveness. Conclusions: PET/CT scanner was adoption rapidly in China despite policies on the allocation issued by MOH. However most of the operating PET/CT sites had idle capacity and less cost-effectiveness. The government should improve the equity of distribution of PET/CT and efficacy of the operating PET/CT scanners. T2.2 - The diagnostic role of FDG-PET in the clinical ma nagement of breast cancer

Asensio-del-Barrio C.1, Rodríguez-Garrido M.1, Alcázar-Alcázar R.1, Sánchez-Gómez L.1 1Agency for Health Technology Assessment, ISCIII, Madrid, Spain Objective: To study the diagnostic effectiveness of Positron Emission Tomography (PET) as an imaging test in patients with breast cancer. Methods: Systematic review of the literature from November-2001 to February-2007. Electronic search in Medline (PubMed), Embase, CRD and Cochrane Library, and manual searching of reference lists were made. The methodological quality of the retrieved studies was assessed according to the Evidence Based Medicine criteria. Articles selected were publications on the accuracy of PET or PET-CT with 18FDG as radiotracer, in the diagnosis of breast cancer. Qualitative analysis and meta-analysis of data from those with enough primary data to construct a 2x2 diagnostic cross table were made. Heterogeneity between studies and threshold effect were assessed. Diagnostic parameters, summary receiver operating characteristic (SROC) curves and pooled indexes using a random effects model were calculated. A subgroup analyses were made according to the PET indications. Results: From 205 articles, 35 were finally selected. Subgroups were axillary lymph node infiltration, tumor recurrence, bone metastases and detection of tumor if elevated tumor markers with equivocal conventional imaging. The pooled diagnostic odds ratio (DOR) for recurrence was 13,39; for bone lesions, 80,26; for increased tumor markers, DOR was 17,81 and the area under SROC curve (AUC). was 0,867; and for axillary node infiltration, DOR was 25,17 and AUC 0,942. Conclusions: PET is an effective technology for the detection of distant metastases, highly useful when tumor markers levels are the only suspicion of tumor recurrence and it seems relatively especific for axillary node metastases in brea T2.3 - Over-interpretation of molecular diagnostic based research Lumbreras B.1, Parker L.A.1, Porta M.2, Ioannidis J.3, Pollán M.4, Hernandez-Aguado I.1 1Miguel Hernandez University, Public Health, Ciber en Epidemiologia y Salud Publica, San Juan de Alicante, Spain, 2Universitat Autonoma de Barcelona, Institut Municipal d'Investigacio Medica, Ciber de Epidemiologia y Salud Publica, Barcelona, Spain, 3University of Ioannina School of Medicine, and Biomedical Research Institute, Department of Hygiene and Epidemiology, Ioannina, Greece, 4Instituto de Salud Carlos III, Cancer and Environmental Epidemiology Area, National Centre for Epidemiology, Ciber en Epidemiologia y Salud Publica, Madrid, Spain Objective: By examining original articles on molecular diagnostic tests, we sought to investigate whether the conclusions regarding clinical application were consistent with the design or the results obtained. Methods: Articles were identified by systematic search of MEDLINE using appropriate medical subject headings. We selected original research articles during 2006 addressing the diagnostic value of a molecular test. We classified studies as overinterpretation when the authors claimed clinical application of their results in: 1) studies on non clinically-relevant populations; 2) studies on relevant populations but with low sample size or insufficient diagnostic accuracy. Assessments were made independently by two reviewers (agreement 92%). Results: Of the 113 articles included in the study, most were case-control studies (89, 79%) and only 16 (14%) were studies on clinically relevant populations. More than half of the articles (67, 59%) were classified as overinterpretation, of which 56 articles (84%) made conclusions which did not agree with their studied population. This tendency to over-interpret findings was more likely to occur in studies from journals with impact factors in the upper quartile than in those from the lower quartile (adjusted OR: 3.58, IC95% 1.05-12.58, p=0.039) (p tendency=0.033), and in those studies reporting diagnostic accuracy in the upper quartile than in those from the lower quartile (adjusted OR: 4.37, IC95% 2.76-5.97, p=0.0709). Conclusions: Expectations of new tests based in molecular techniques are high, yet most of research carried out in this area is preliminary. Over-interpretation of the results in this diagnostic field is common, particularly in high profile journals. T2.4 - HTA report on the microbiological risk associated with contrast medium administration in computerized axial tomography at the CHUQ

Cantin V.1, Labadie R.1, Rhainds M.1, Simard C.1 1Centre Hospitalier Universitaire de Québec, Unité d'Évaluation des Technologies et Modes d'Intervention en Santé, Québec, Canada Objectives: 1) Assess the risk of contamination and infection associated with intravenous contrast medium (CM) administration, 2) suggest alternatives to decrease the risk and assess financial impacts. Methods: A literature search was performed in multiple databases to identify original articles associated with intravenous contrast medium (CM) administration. Article selection, quality evaluation and data extraction were performed by two reviewers. A multidisciplinary work group including experts was also established. Other information was harvested from direct observation and questionnaires sent to seven university hospitals. Cost-analysis of different options was performed. Results: Studies showed that CM contamination and proliferation of bacteria are possible if breaches in asepsis occur. Under normal conditions of use, valves were effective in preventing contamination from reverse blood flow. Using single-dose containers and material for every patient increased costs from 108,000$ to 286,000$ per year. Using multidose containers for multiple patients as well as adding precaution measures could increase costs from 35,000$ to 54,000$ per year. Conclusions: Considering 1) the presumption that the risk of patient-to-patient infection transmission is practically nonexistent at the time of intravenous CM administration based on the analysis of scientific evidence available to date and 2) the additional costs associated with the different options for intravenous CM administration using single-dose containers, it was recommended to carry on with the administration of CM using multidose containers for multiple patients as well as a partly shared injection system but under specific conditions including reinforcing the rules of asepsis, single punctures and establishing ongoing surveillance procedures. T2.5 - Point-of-care testing to aid in diagnosing preter m labour(PTL) in symptomatic women Corabian P.1, Harstall C.1 1Institute of Health Economics, Edmonton, Canada Background: Two point-of-care tests, Actim Partus test and TLiIQ® System, are currently marketed in Canada to aid in diagnosing PTL in symptomatic women. Both tests are relatively safe, simple to perform, and have potential to reduce unnecessary interventions by identifying symptomatic women who are not in �true� PTL. Potential advantages of Actim Partus test over TLiIQ® System include quicker results, lower cost, and independence from reader device. Objective: To inform the policy decision process on how these two tests compare in terms of diagnostic accuracy, clinical utility, and costs when added to PTL management. Methods: A rapid review of studies that directly compared Actim™ Partus test to TLiIQ® System. Studies were identified by a systematic search of literature published in English (January 2002-November 2007). Results: Three Canadian comparative studies, none published in peer-reviewed journals, were identified. Evidence from two abstracts and expert opinion indicated differences in tests’ diagnostic accuracy, with more positive results obtained with Actim Partus test than with TLiIQ® System for symptomatic women (between 24 and 35 weeks of gestation) who did not deliver within two weeks. No study compared tests� clinical utility and/or economic impact. Conclusions: The available evidence is insufficient to determine which test is superior in terms of diagnostic performance, and clinical and economic impact. Bringing together the investigators who conducted the Canadian studies and the HTA assessors to discuss their findings with local policy decision makers, laboratory leaders, and clinicians, would be an appropriate strategy for policy decisions in the absence of definitive evidence. T2.6 - Systematic review on efficacy and safety of 64-sl ice CT and mean indications Escalona S.1, Blasco J.A.1, Gracia J.1, Fernández de Larrea N.1, Ariza G.1, Gómez-León N.2 1Agencia Lain Entralgo, Unidad de Evaluación de Tecnologías Sanitarias, Madrid, Spain, 2Hospital Universitario La Paz, Madrid, Spain Objective: To assess the efficacy and safety of 64-slice CT in comparison with other diagnostic

techniques and to identify the main indications. Methods: A systematic review of the literature was performed. The Cochrane Database of Systematic Reviews, HTA, NHS EED, DARE database and the Cinahl, Medline, Embase, Pascal Biomed and ISI Web of Knowledge databases were explored. The quality of the studies was assessed. Results: Three systematic reviews, one report about radiation safety, four meta-analysis and three randomized controlled trials were included. Main studies assessed the 64-slice CT vs. Coronary Angiography (CA) to detect Coronary Artery Disease (CAD). The pooled values of sensitivity, specificity, PPV and NPV were obtained. In the study of coronary arteries these values were 97.5, 91, 93 and 96.5%, respectively. In the assessement of coronary arteries by-pass grafts were 98.5, 96, 92 and 99%, respectively. For stent restenosis were 80, 95, 80 and 95%, respectively, comparing 64-slice CT vs. CA. Diagnostic value is limited to patients with slow or irregular heart rhythms, asymptomatic patients and when there are important calcium deposits in narrow arteries. Conclusions: 64-slice CT is effective to detect CAD to compared with CA. Related to the safety it would be recommended standardized guidelines for patient shielding to reduce patient radiation dose. It is necessary more studies to assess the role of the technology in new indications as coronary diseases, hepatic diseases and biliary and pancreatic ducts images, detection of osteolysis in patients with multiple myeloma. T2.7 - Does surveillance by dermoscopy improve early dia gnosis of melanoma? Banaei L.1, David D.J.1, Lee Robin S.H.1 1Haute Autorité de Santé, Evaluation des Actes Professionnels, Saint-Denis La Plaine Cedex, France Objective: The incidence of melanoma is increasing. Mortality can be avoided by early diagnosis and surgical treatment. Early melanoma screening is based on cutaneous surveillance performed by naked-eye examination with or without dermoscopy. We assessed the added-value of dermoscopic surveillance and defined its indications and conditions of use. Methods: We performed a systematic review of the literature on dermoscopic surveillance (2000-2007). The conclusions were discussed by 12 professionals, then submitted to the relevant HAS Committee for their official opinion. Results: Surveillance by dermoscopy is indicated in patients presenting atypical naevi but with no clinical nor dermoscopic features of malignancy and/or in patients at very high risk of melanoma. No standard surveillance protocol is available. Surveillance by dermoscopy with storage of images could prevent unnecessary removal of benign lesions and improve early diagnosis of melanoma. The dermatologist should (i) undergo initial and continuous training in dermoscopic image reading, (ii) use a dermoscope fitted with a camera or digital videomicroscopy system, (iii) complete a patient record. Conclusions: Even though the evidence for dermoscopic surveillance improving early diagnosis of melanoma is low, HAS nevertheless recommended such surveillance in view of the high mortality associated with invasive melanoma. Surveillance should be carried out by trained dermatologists only. HAS advised reimbursement of dermoscopic surveillance by French National Health Insurance in the indications and under the conditions defined above but stressed the need for guidelines, specific training, and further studies, in particular on the impact of dermoscopic surveillance on mortality from melanoma. T2.8 - Systematic review of the efficacy and safety of c ontrast enhanced ultrasonography in patients with focal hepatic lesions Rys P.1, Mrozek M.1, Wladysiuk M.1, Plisko R.1 1HTA Consulting, Krakow, Poland Objective: The aim of this analysis was to evaluate diagnostic efficacy and safety of ultrasonography with the SonoVue contrast agent in patients with focal hepatic lesions. Methods: The comparison was based on the results of primary prospective and retrospective clinical trials identified in a systematic review performed according to the MSAC (Medical Services Advisory Committee) guidelines and the HTA Guidelines of the AHTAPol. Two reviewers independently collected date in standardized form and assessed the methodological quality. Sensitivity, specificity, accuracy, positive and negative predictive value and diagnostic odds ratio were calculated.

Results: Major medical databases (EMBASE, MEDLINE, CENTRAL and others) were searched. Studies, in which the comparators were: histopathological examination of a sample obtained during operation or by means of percutaneous biopsy, observation for at least 3 months or consistent results of at least 3 different diagnostic tests, were included. Of 3,449 identified publications 12 articles of medium methodological credibility fulfilled the inclusion criteria (the trials enrolled 1,973 patients). Safety analysis was based on the results of 17 trials (including 24,638 patients). In the whole efficacy population (all 12 trials) sensitivity of the test was 89.0% (from 79.6% to 100% in specific trials), specificity - 92.4% (from 66.7% to 98.1%), diagnostic odds ratio - 123,19 and accuracy - 97%. Adverse effects were observed in 0.13% of patients, severe AE - in 0.012%; no fatalities were reported. Conclusions: Ultrasonography with the SonoVue contrast agent is an efficacious test of favorable safety profile in diagnostics of hepatic lesions. T2.9 - Assessment of a new imaging modality (EOS, a low- dose 2D/3D system): A pragmatic approach when evidence is lacking Fay A.-F.1, Edlinger C.1, Vongmany N.1, Cesari A.1, Montagnier-Petrissans C.1 1Assistance Publique - Hopitaux de Paris, CEDIT, Paris Cedex, France Objective: To present a pragmatic approach of HTA when evidence is lacking. Context: Based upon a patented particle detector technology (Charpak’s Nobel Prize), EOS was initially validated clinically in AP-HP hospitals and assessed by CEDIT in 1993; at this time, dose reduction was already important but image quality was considered insufficient for diagnosis purposes. Since then, many technical improvements were brought to the system and regulatory approvals were obtained in 2007. Methods: A systematic review was performed and the potential advantages of the technology were analyzed in the context of three different hospital settings (pediatric; rehabilitation and orthopedic department with high prosthesis activity). Results: Little evidence was found in the literature, mainly technical papers submitted by co-developers of the technology; we retrieved only one unpublished clinical study; however, the technology is promising in two ways: 1/ consequent dose reduction for 2D imaging with a quality at least equivalent to existing techniques (screen-film and digital) and a possibility of imaging whole body standing patients, with simultaneous bi-plane image acquisition; 2/ new virtual 3D applications without additional dose allowing new ways for orthopedists to evaluate global balance and posture. The high investment costs could be compensated by an increase in productivity. Conclusions: Despite a lack of clinical evidence, the CEDIT considered the dose reduction was an argument in favor of the technology, especially in the pediatric hospital with high scoliosis activity; collaboration with the company should be sought to further assess the virtual 3D applications. T2.10 - Application of health technology assessment (HTA) methodology for a lab automation project: A customized solution in a critical contex t Franchin T.1, De Vivo L.1, Derrico P.1, Capussotto C.1, Ritrovato M.2, Nocchi F.3 1Bambino Gesù Children's Hospital, Clinical Engineering, Roma, Italy, 2Bambino Gesù Children's Hospital, Risk Management, Roma, Italy, 3Children's Hospital Bambino Gesù, Rome, Italy Objective: The concept of automating laboratory processes first became a topic of general discussion in the early ‘90s under the increasing pressure to reduce costs while maintaining or improving quality. The necessity to consolidate the efficiency of the organization and to best employ human resources drove the Top Management of Bambino Gesù Children’s Hospital to evaluate the reorganization and the automation of the Laboratory Analysis Unit. HTA methodology was applied to carry on this project in order to warrant the best decision-making tool for optimizing technology acquisition and best-practice in the critical context of this operative unit. Methods: A company organizational model has been implemented by the Clinical Engineering Department (CED) team to carry out a hospital-based HTA project. The model is composed by ten steps which account for the main assessment standards (safety, performance, appropriateness, efficacy, efficiency, cost-effectiveness, social, ethical and economic consequences). The CED promoted the constitution of a multidisciplinary team composed by clinical engineers, laboratory medicine physicians and technicians, health and administrative management staff. Results: A more flexible automation plan, closer to Modular Laboratory Automation (MLA), has been

identified as the most feasible to the specific and critical peculiarities of the Laboratory Analysis Unit. A “specific single-area automation” project has been proposed to reach a right compromise among automation processes, in-use devices integration and traditional job organization. Conclusions: The evaluation of the particular context in which this lab automation project should be implemented has identified a suitable customized solution to solve the peculiar clinical and facility requests. T2.11 - How is magnetic resonance imaging utilized in Ira n? Palesh M.1, Fredrikson S.2, Jamshidi H.3, Jonsson P.M.4, Tomson G.1, Petzold M.5 1Karolinska Institutet, Public Health Sciences, Stockholm, Sweden, 2Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden, 3Shaheed Beheshti University of Medical Sciences, Department of Pharmacology, Tehran, Iran, Islamic Republic of, 4Karolinska Institutet, Department of Learning, Informatics, Management and Ethics, Stockholm, Sweden, 5Nordic Scool of Public Health, Goteborg, Sweden Objective: Analysis and understanding the utilization patterns of diagnostic imaging technologies is important for planning health systems especially in middle- and low-income countries. Almost all published studies focused on utilization trends or utilization rates of magnetic resonance imaging (MRI) over time and little has been published about utilization pattern of MRI. This study aims to identify and describe the utilization pattern of MRI in Iran. Methods: Data were collected from referrals and MRI reports of the population covered by one of the largest insurance organizations (Social Security Organization (SSO)) with 28 million beneficiaries in the country. Because of practical limitations, we focused on patients who had undergone an MRI examination during one month. To analyse variations in utilization across provinces we performed linear regression analyses. Results: No strong correlation was found between the number of referrals per 100 000 population as the dependent variable with total covered population and number of MRI machines per 100 000 population as the dependent variables. Four groups of specialists including neurosurgeons, orthopedists, neurologists and internists were the most users of MRI technology. Spinal column (55%), brain (25.5%) and knee (11.0%) were the most common parts of the body scanned by MRI. Conclusions: Neurosurgeons, orthopedists and neurologists contributed with more than 88% to MRI utilization, indicating that any plan for modifying or improving MRI use should focus mainly on these specialists. Patterns of scans indicates that this technology has greatest impact on diagnosis of the central nervous system (CNS) diseases or diseases affecting CNS. T2.12 - APOB, CETP, LPL and LIPC gene polymorphisms in So uthern Brazilian dyslip idemic population Chula F.1, Fiterman Costa A.2, Dornelles Picon P.2, Almeida S.3, Borges de Lima P.2, Martins N.2, Fiegenbaum M.4, Dornelles Silva C.5, Giugliani R.2 1Universidade Federal do Rio Grande do Sul, Post-Graduation, Porto Alegre, Brazil, 2Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, 3Fundação Estadual de Produção e Pesquisa em Saúde (FEPPS), Centro de Desenvolvimento Científico e Tecnológico (CDCT), Porto Alegre, Brazil, 4Centro Universitário Metodista IPA, Porto Alegre, Brazil, 5Universidade Luterana do Brasil, Curso de Pós Graduação em Diagnóstico Genético e Molecular, Canoas, Brazil Objective: investigate the interaction between polymorphisms in the APOB, CETP, LPL and LIPC genes with lipid parameters and with response to statin treatment in dyslipidemic patients. Methods: 119 patients with dyslipidemia participated in the study. Plasma lipoproteins were measured before and throughout the study. Baseline lipoprotein parameters were compared among APOB EcoRI, CETP TaqIB, LPL S447X (G>C) and LIPC -250G>A genotypes after genotyping by PCR and restriction mapping. Data from forty-eight patients with statin treatment were used to pharmacogenetic analyses. Results: The LIPC-250G>A polymorphism was associated with HDL-C with carriers of the G allele having higher HDL-C levels (P=0.004) than AA homozygotes, although these were not confirmed after adjusted analysis. Differences among genotypes in the variation in lipoprotein concentrations for LIPC and LPL polymorphism were observed. After adjustment for covariates, GA and AA carriers genotypes showed a greater reduction in total cholesterol compared than G allele carriers (-26.4±15.5% vs. -

18.2±11.8%, P=0.034). For unadjusted data, G allele carriers for LPL S447X gene polymorphism showed a greater HDL-C increase compared to CC subjects (13.8% vs. 3.3%, P=0.047). The mean percent reduction in TC was greater in CC homozygotes than in G carriers (-26.6±13.6% vs. -20.5±13.6%, P=0.046, adjusted analysis). Conclusion: Our data didn’t find, in the adjusted analysis, association of LIPC-250G>A gene polymorphism with HDL-C. We found a significant effect of LIPC and LPL polymorphisms on statin treatment response. These results can be explained by the fact that several factors can modulate the effect of gene polymorphisms on lipoprotein concentration and treatment response. Economic Analyses 2 T3.1 - The cost effectiveness of deferasirox, deferipron e and deferoxamine for transfusional iron overload in patients suffering from beta-thala ssaemia major and sickle cell disease Mcleod C.1, Boland A.1, Dickson R.1, Bagust A.1 1Liverpool University, LRiG, Liverpool, United Kingdom Objectives: To assess the cost effectiveness of deferasirox, deferiprone and deferoxamine (DFO) for the treatment of iron overload associated with regular blood transfusions in patients suffering from beta thalassaemia major (Beta-TM) and sickle cell disease (SCD). Methods: Due to the paucity of long-term data, we developed a simple short-term (one year) model which assessed the costs and benefits of deferasirox, deferiprone and DFO in Beta-TM and SCD patients. The model used an NHS perspective and expressed outcomes in terms of cost per QALY. The only difference between chelators in the short-term was assumed to be limited to quality of life. The effects of adverse events and adherence were not considered in the analysis. Results: The results of our economic model suggest that deferasirox may be a cost-effective strategy (cost per QALY below £30,000 per year) for Beta-TM and SCD patients compared with DFO. However, the cost-effectiveness is highly dependent upon the age of the patient and the use and benefits of balloon infusers to administer DFO. If deferasirox is compared with deferiprone it is likely that it will only be cost-effective for young children. Furthermore, if deferiprone is proven to offer the same health benefits as deferasirox, deferasirox will not be cost-effective for any patient compared with deferiprone. Conclusions: This review indicates that in the short-term deferasirox may be cost-effective compared with DFO in Beta-TM and SCD patients, but it is unlikely to be cost-effective compared with deferiprone. T3.2 - Transition from in-hospital to outpatient prophyl axis for venous thromboembolism (VTE): Economic impact of rivaroxaban in the UK and Canada Lees M.1, Gilmour L.2, Mcdonald H.3 1Bayer HealthCare, Uxbridge, United Kingdom, 2Bayer plc, Newbury, United Kingdom, 3Bayer Inc, Toronto, Canada Objective: Assess the impact on healthcare costs and health outcomes of rivaroxaban prophylaxis against VTE following total hip replacement (THR) or total knee replacement (TKR). Methods: The incidence of symptomatic VTE in three large randomized controlled trials (RECORD1-3) was used to assess the impact of guideline duration prophylaxis with rivaroxaban on non-drug costs and outcomes. Periodic blood counts are recommended with standard subcutaneous enoxaparin prophylaxis, whereas oral rivaroxaban may not require monitoring and may eliminate the need for hospital nurses to administer subcutaneous enoxaparin and train patients to self-inject. Results: Rivaroxaban reduced symptomatic VTE vs enoxaparin by up to 80% following THR, and 66% following TKR. In the UK, improved efficacy yielded resource savings per patient of £12.85 (THR) or £18.20 (TKR). The reduced burden for monitoring and administration produced further possible savings of up to £27 per patient. In Canada, fewer symptomatic events produced resource savings per patient of C$25.69 (THR) or C$36.40 (TKR); oral administration and reduced monitoring increased possible savings up to a further C$71 per patient while facilitating the achievement of guideline durations of prophylaxis. Importantly, there were no increases in major bleeding, so safety endpoints are unlikely to influence cost-effectiveness. Conclusions: Rivaroxaban reduces non-drug costs and improves health outcomes when used as

VTE prophylaxis following THR or TKR. Cost reduction results from oral administration with potentially no monitoring; improved efficacy and convenience generate further possible cost reductions.Rivaroxaban may also facilitate compliance with guideline recommendations for 28-35 days extended prophylaxis in patients undergoing THR. T3.3 - The use of relative versus absolute cost-effectiv eness - What difference does it make? Grocott R.1, Schoeler R.1, Brougham M.1 1PHARMAC, Wellington, New Zealand PHARMAC (the Pharmaceutical Management Agency) in New Zealand has undertaken cost-utility analysis (CUA) to inform pharmaceutical funding decisions since 1996. Unlike many organisations that undertake CUA, PHARMAC is not concerned about what the actual ‘cost per QALY’ result is. PHARMAC must operate within a fixed budget, hence what is important to PHARMAC is how the cost per QALY of a pharmaceutical compares with other pharmaceuticals that could be funded with the money available (i.e. the relative cost-effectiveness). However the cost-effectiveness of a pharmaceutical is never considered in isolation as it is not the only criteria used when making funding decisions. Due to the focus on relative cost-effectiveness, it is not unusual for a CUA to be needed within a week in order to progress with price negotiations or prioritise a pharmaceutical. Therefore PHARMAC often is unable to undertake ‘detailed’ CUAs. Instead PHARMAC has learnt that what is most important is that the CUA is “good enough” to inform PHARMAC of where the pharmaceutical is likely to be placed on the priority lists for funding. In order to achieve this, PHARMAC undertakes four levels of analysis - rapid, preliminary, indicative, and detailed. The time required to undertake these analyses ranges from 2 days to 6 months. The level of analysis largely depends on the ability to prioritise the pharmaceutical with sufficient certainty. This presentation will outline how PHARMAC does CUA, how the results of these analyses are used, and the implications of focusing on relative (versus absolute) cost-effectiveness. T3.4 - Cost-effectiveness of smoking cessation intervent ions in seven Latin American countries Pichon-Riviere A.1, Augustovski F.1, Bardach A.1, Colantonio L.1, Rubinstein A.1, LatinCLEN Tobacco Research Group 1Institute for Clinical Effectiveness and Health Policy (IECS), Capital Federal, Argentina Objective: To evaluate the cost-effectiveness of smoking cessation interventions (SCI) in seven Latin American countries Methods: The health economic model structure was defined after analyzing regional decision maker’s information needs and the availability and quality of the required epidemiological data in the participating countries: Argentina, Bolivia, Brazil, Chile, Colombia, Mexico and Peru. A common methodology to retrieve local relevant information was convened and a first order Monte Carlo, or probabilistic microsimulation of individual patients was built, incorporating the natural history, costs and quality of life impact of all the tobacco-related diseases: coronary and non-coronary heart diseases, cerebrovascular disease, COPD, pneumonia/influenza, lung cancer as well as 9 other neoplasms. The public health perspective and standard discount rate were used. Interventions ranged from brief behavioural counselling to intensive pharmacological and cognitive behavioural therapy. Results: An initial validation against the Argentinean population showed adequate internal validity, with all simulated events rates falling within ±10% of the source publications. R2 between predicted and observed values ranged from 0.758 to 0.999. Third order validation showed an excellent correlation between published data and model results. Incremental Cost per QALY were calculated for different sets of interventions and target populations in each of the participant countries. Results in the cost effectiveness plane and acceptability curves were plotted. Cost per QALY showed great variability among treatments and countries. Conclusions: The results of the HEM will allow decision makers in the participating countries to tailor coverage policies for tobacco cessation interventions based on the cost-effectiveness evaluated for each setting.

T3.5 - An economic evaluation of ezetimibe monotherapy f or individuals with established cardiovascular disease in the UK Ara R.1, Pandor A.1, Duenas A.1, Paisley S.1, Chilcott J.1 1The University of Sheffield, ScHARR, Health Economics and Decision Science, Sheffield, United Kingdom Objective: To explore the cost effectiveness of ezetimibe monotherapy in the UK for individuals with hypercholesterolaemia and established cardiovascular disease who are intolerant or contra-indicated to statin therapies. Methods: A systematic review and meta-analyses of RCT evidence was used to model the clinical benefits (changes in LDL-c) associated with ezetimibe compared with no treatment. A Markov model involving angina, non-fatal myocardial infarction, fatal coronary event, transient ischaemic attack, non-fatal stroke and fatal stroke health states was used to capture long term benefits and costs. Relative risks were estimated using a relationship linking changes in LDL-c and vascular events. Age related transition rates were used to model annual probabilities of events. Results: Ezetimibe was associated with a statistically significant reduction in mean LDL-c of 18.56% (95% CI -19.68%, -17.44%, p<0.00001) compared with placebo. Using 10,000 Monte Carlo simulations, we estimated an average of 49 non-fatal myocardial infarctions, 11 non-fatal strokes and 37 cardiovascular deaths would be avoided in a cohort of 1,000 patients aged 55 years with a baseline LDL-c of 4.0 mmol/L. The mean cost per QALY was estimated to be £23,026 (CI: £22,979; £23,074). For cohorts with baseline LDL-c values greater than 4.5 mmol/L, incremental cost effectiveness ratios were estimated to fall below £20k per QALY. Conclusions: Ezetimibe monotherapy compared to no treatment is a cost-effective alternative for individuals with a history of CVD and high LDL-c levels who do not tolerate statins. T3.6 - Cost-effectiveness of drug eluting stent in high risk patients of ischaemic heart desease Martin C.1, Blasco J.A.1, Callejo D.1, López-Pedraza M.J.1, Maeso S.1, Andradas E.1 1Agencia Lain Entralgo, Health Technology Assessment Unit (UETS), Madrid, Spain Objective: Literature review of economic evaluations comparing drug eluting stent (DES) with conventional stent (BMS). Cost-effectiveness economic evaluation with the Community of Madrid perspective. Methods: Cochrane, DARE, HTA, EED and MEDLINE databases have been explored until May of 2007. Key words were used to identify randomized clinical trials and economic evaluations comparing BMS and DES. An analytical decision Markov model was designed with a 5 years time horizon for patients with BMS or DES implanted following indications of restenosis´ high risk: saphenous vein graft lesions, left main coronary artery disease, chronic total occlusions, and coronary in-stent restenosis. The transition probabilities for DES have been obtained from the DES patient’s registry of the Madrid Community and for BMS from literature review. Results: 82 potential articles were reviewed and examined looking for the available evidence on the efficiency of DES and BMS. 8 studies were selected. Our analysis shows the DES option in the studied indications as dominant over the alternative of conventional stent, because of DES option is less expensive (1,468,8� incremental cost) and more effective (0.0479 QALYs) for the base case. Conclusions: The use of DES in the patients with high risk indications: saphenous vein graft lesions, left main coronary artery disease, chronic total occlusions, and coronary in-stent restenosis is cost-effective for 6 months of long antiplatelet treatment. The DES option could not be cost-effective varying some of the basal conditions. It would be necessary to make long term studies on the effectiveness of eluting stent in high risk indications. T3.7 - Cost-effectiveness analysis of endovascular aneur ysm repair (EVAR) for abdominal aortic aneurysm (AAA) in Spain Cairols M.A.1, Crespo C.2, Brosa M.2, Rodríguez J.M.3, Brasseur P.4 1Hospital de Bellvitge, Angiology and Vascular Surgery, Hospitalet de Llobregat, Barcelona, Spain, 2Oblikue Consulting, Barcelona, Spain, 3Medtronic, Health Economic & Reimbursement, Madrid, Spain, 4Medtronic EEMC, Health Economic & Reimbursement Cardiovascular Business Unit, Tolochenaz, Switzerland

Objective: Treatment of abdominal aorta aneurism (AAA) has, until recently, been performed using open surgery (OS). The introduction of EVAR can improve the short and long-term prognosis of these patients. The objective of the study was to determine whether EVAR is cost-effective in the treatment of AAA. Methods: We constructed a Markov model based on the literature (essentially on the EVAR-1 study) plus local expert opinion for costs. The model calculated life years gained (LYG), quality adjusted life years (QALY) and mean cost (C) per patient at 1, 2, 3 and 4 years for each option. The analysis was performed from the perspective of the Spanish National Health Service. Results: The preliminary results showed that EVAR was associated with a higher effectiveness, with 0.09 and 0.24 LYG at 1 and 4 years vs. OS (with similar results using QALYs).The mean cost per patient was higher in EVAR vs. OS, with an incremental cost between 3,281� and 3,706� depending on the different scenarios, essentially because of the higher costs for purchasing the prosthesis in the EVAR option. The C/LYG of EVAR was 36,645� to 15,138� and the C/QALY gained was 29,506� to 22,450� (1 and 4 years, respectively). Conclusions: EVAR is an efficient alternative to conventional interventional surgery. From 1 year of follow-up onwards, the cost-effectiveness figures are below the threshold of efficiency, as defined in Spain. T3.8 - Cost-effectiveness of screening for colorectal ca ncer in the general population Lopez-Bastida J.1, Sassi F.2, Serrano-Aguilar P.1 1Canary Islands Health Care Services, Planning and Evaluation Unit, Santa Cruz de Tenerife, Spain, 2London School of Economics, Social Policy, London, United Kingdom Objective: To assess the relative cost-effectiveness of alternative screening strategies for colorectal cancer, including fecal occult blood testing (FOBT), flexible sigmoidoscopy and colonoscopy in the general population in Spain. Methods: The cost-effectiveness of the three screening strategies was assessed from a health service perspective using a Markov model applied to a hypothetical cohort of 50 year old individuals undergoing annual FOBT, sigmoidoscopy every 5 years, or colonoscopy every 10 years. Transition probabilities, test sensitivity and specificity, effectiveness, cost and utility data were derived from publicly available data sources. Results: FOBT and colonoscopy display similarly favourable cost-effectiveness ratios relative to a scenario in which no organised screening is available, in the region of 10,000 Euros per QALY. FOBT has an apparent marginal advantage over colonoscopy under baseline assumptions. A screening strategy bases on flexible sigmoidoscopy every 5 years appears to be less efficient and is either dominated. A sensitivity analysis shows that changes in several important parameters could alter the cost-effectiveness of the FOBT and colonoscopy options, including compliance, test performance, screening interval, and whether terminal care costs are brought into the cost-effectiveness equation Conclusions: Screening for CRC, even with imperfect compliance (around 60%), significantly reduces CRC mortality at a cost per QALY gained that compares favourably with those of other cancer screening procedures. On the basis of currently available cost and outcome data, our model suggests that FOBT represents a cost-effective option for CRC screening in Spain. T3.9 - Cost impact of early pharmaceutical intervention on primary open angle glaucoma in Alberta, Canada Yim R.1 1Institute of Health Economics, Edmonton, Alberta, Canada Objective: Primary open angle glaucoma affects 46,000 Albertans. It is a chronic ocular disease in which the internal pressure in the eyes increases enough to damage the nerve fibers in the optic nerve and cause vision loss. Optic nerve damage cannot be reversed; patients have to rely on medical treatments to control disease progress the rest of their life. If untreated, glaucoma can ultimately lead to blindness. Drug intervention, especially at the early disease is able to lower and stabilize ocular pressure, thus stops or slows down disease progress. This will reduce further medical and surgical treatments and health care cost. Currently Alberta does not practice early drug treatment on glaucoma. The objective of this study is to estimate the cost impact of early drug intervention on

glaucoma in Alberta in 2006-2007. Methods: The measure of the cost impact is the cost difference on drug use, physician and emergency room visits and eye surgery in treating early and late stage glaucoma. Utilization rates and cost of medical treatments on early stage are obtained from the literature. Actual cost of treating glaucoma in Alberta is obtained from Alberta Health and Wellness. Results: Early drug treatment cost $740, 000 more on Alberta health care expenses. Conclusions: Early drug treatment on glaucoma and other chronic diseases does not always reduce health care cost. Without such, 2,000 more glaucoma patients are likely to progress to the end stage glaucoma in 3 to 15 years, which will yield other expenses on rehabilitation. T3.10 - Assessing quality of economic evaluation of vacci nes La Torre G.1, de Waure C.1, Nicolotti N.1, Mannocci A.1, Specchia M.L.1, Chiaradia G.1, Ricciardi W.2 1Health Technology Assessment Public Health Unit, Institute of Hygiene, Catholic University of the Sacred Heart, Rome, Italy, 2Institute of Hygiene, Catholic University of the Sacred Heart, Rome, Italy Objective: HPV vaccine economic analyses were reviewed to evaluate quality. Methods: Search on PubMed was performed using keywords "Papillomavirus or HPV vaccines" and "Costs and Cost Analysis". BMJ referees’ checklist, addressing study design, data collection, analysis and interpretation of results, was applied to identify studies strengths/limits; each item was weighted. Results: 13 cost-effectiveness/utility analyses were selected. Most items of first group were satisfied except “viewpoint of analysis”, “economic evaluation form” and “justification of form choice” that were not or not clearly defined in 38.5%, 30.8% and 92.3% studies. For second group of items, 92.3% studies reported details of model but 7.7% explained the choice of model and parameters. 53.8% stated sources of effectiveness and methods to evaluate health state and benefits but no one reported details of effectiveness study or used meta-analysis. No studies stated details of subjects from whom health state evaluation was obtained; 15.4% reported methods to estimate quantities and costs of employed resources. For the last part, 92.3% studies stated discount rate but 16.7% justified its choice. 92.3% studies performed sensitivity analysis: 33.3% justified variables choice and 66.7% stated variability ranges. 92.3% studies computed incremental analysis. A score from 1 to 3 was assigned to each point; major importance was given to essential details of economic analysis such as viewpoint and form of analysis, description of sources and methods to evaluate effectiveness, outcomes and benefits. The highest possible score was 65. Conclusions: Median score was 35 (range: 27) thus meaning that vaccine economic evaluations should be improved. T3.11 - Cost-effectiveness of balloon kyphoplasty in a Sw edish setting based on the 1-year FREE-trial results Strom O.1, Borgstrom F.1, Taylor R.2, Boonen S.3 1i3 Innovus, Stockholm, Sweden, 2University of Exeter, Health Services Research Peninsula Medical School, Exeter, United Kingdom, 3Katholieke Universiteit Leuven, Metabolic Bone Diseases and Division of Geriatric Medicine, Leuven, Belgium Objective: Balloon kyphoplasty (BKP) is a surgery that is associated with increased quality of life in patients with symptomatic vertebral fracture. The aim was to estimate the cost-effectiveness of balloon kyphoplasty in an osteoporotic Swedish population with a recent vertebral compression fracture. Methods: The cost-effectiveness, from a societal perspective, of balloon kyphoplasty compared to conventional medical management (CMM) was assessed in a Markov-model. Data for efficacy, hospitalizations and surgery time were based on FREE (RCT with 300 patients, BKP vs. CMM). The procedure cost for the BKP was �4,734. The cost-effectiveness was estimated for a 70 year old population with an average T-score of -3 SD. EQ-5D and fracture rate differences between treatment alternatives were assumed during 2 years followed by a 2-year offset-time when differences linearly approached zero. 5-year mortality rates after 1st and 2nd fracture were calculated using Poisson and Weibull survival modelling of the cause-of-death register. Fracture related mortality and costs were conservatively assumed to be equal after both treatment alternatives. Results: The cost per QALY gained (CPQ) of BKP vs. CMM for 70 year old patients was estimated at �16,988. 0.268 QALYs were gained in the base-case. When all benefits from BKP were assumed to persist for 1+1 year, or 3+3 years, the CPQ was �34,847 and �11,662, respectively. Cost-

effectiveness was better in younger populations since longer life expectancy increases the accumulated benefits of BKP. Conclusion: BKP was considered cost-effective in a Swedish setting compared to CMM under assumptions of equal fracture related mortality and cost. T3.12 - Cost of care of the patients with rheumatoid arth ritis (RA) in Estonia Meiesaar K.1, Põlluste K.2, Kallikorm R.2, Lember M.2 1University of Tartu, Department of Public Health, Tartu, Estonia, 2University of Tartu, Department of Internal Medicine, Tartu, Puusepa, Estonia Objective: To investigate the annual cost of care of adult RA patients in Estonia. Methods: In 2007, we conducted a postal survey of a random sample of the RA patients (n=2000, response rate 64%). The sample was chosen based on the Health Insurance Fund treatment bills database 2006. Results: According to selfreported data, patients` direct costs associated with RA in the last 12 months were 355.6 EUR per patient (14.6% of the average annual net income). The retired or unemployed patients spent 18.2% and the employed patients 10.3% of their annual net income (p <0.05). The costs correlated positively with the disease duration (r = 0.18, p<0.0001). The following cost structure appeared (in %): cost-sharing for medicines 47.1; home remodeling cost 16.2; alternative treatment methods 13.1; transportation 6.9; rehabilitation 5.3; caregiver payments 4.4; visit fee 3.4; medical aids 3.0 and in-patient fees 0.6. Conclusions: The first empirical study of annual direct costs of care of RA for patients in Estonia shows that the longer the duration of the disease the higher the costs. About a half of the patients’ costs is related to cost-sharing of medicines. Unlike the patients employed, the retired and unemployed persons spend significantly higher percentage of their income on copying with RA. T3.13 - Economic analysis of the use of a digital non-myd riatic retinal camera Gutierrez A.1, Lapuente J.L.1, Orruño E.1, Asua J.1 1Basque Office for Health Technology Assessment (OSTEBA), Department of Health from the Basque Government, Vitoria-Gasteiz, Spain Objective: To carry out an economic assessment of two of the diagnostic tools used for the detection of diabetic retinopathy: the digital non-mydriatic retinal camera vs the conventional indirect ophthalmoscopy. Methods: We conducted a systematic review of the literature searching the following databases: MEDLINE, EMBASE, CINAHL, PASCAL BIOMED, Cochrane Library and CRD (NHSEED). Direct costs which differ for both techniques were calculated, including time spent by medical personnel, equipment, consumables, maintenance of equipment and internet connexion. We carried out a sensitivity analysis in two different scenarios: an optimistic and a pessimistic one. Results: A total of 8 articles out of the 75 retrieved met the inclusion criteria and were included in the present review. The reviewed literature indicates that the use of the digital fundus camera is more cost-effective than the conventional alternative, i.e. ophthalmoscopy. The results of the cost assessment show average total costs per patient of 8.33� and 7.67� for ophthalmoscopy and the digital camera, respectively. For the optimistic scenario, the study showed a saving of 1.57� per patient for the digital non-mydriatic camera compared to the ophthalmoscope. However, for the pessimistic scenario, the ophthalmoscope is 0.70� cheaper than the digital camera. Conclusions: For the current scenario, in which 19,076 patients are examined each year, the digital camera is 0.66� cheaper per patient and has shorter waiting lists than the traditional eye examination using ophthalmoscopy. The payback period of the cost of acquiring a digital fundus camera is 2.92 years and 3.35 years, for the two scenarios analysed. T3.14 - Health economical modeling on the use of drug elu ting stents (DES) in comparison with coronary artery bypass-graft (CABG) in coronary hea rt disease (CHD) Gorenoi V.1, Dintsios C.-M.2, Schönermark M.P.1, Hagen A.1 1Hannover Medical School, Department of Epidemiology, Social Medicine and Health System

Research, Hannover, Germany, 2Institute for Quality and Efficiency in Health Care, Department of Health Economics, Cologne, Germany Objectives: Both, DES and CABG are used in the treatment of CHD. The middle-term cost difference of DES vs. CABG is unclear. Methods: A health economical model considering linear resource use was performed from a societal perspective for time horizons of one and three years. The clinical assumptions for one and three years were derived for CABG from the ARTS-I study, for DES from the ARTS-II study and the TAXUS-VI study (all non-randomized studies). The German 2007 Diagnosis-related Group system was implemented to determine the costs of interventions. The used base-case value was 2800�, DES price 1200�, per patient stent use 3.7 and per patient daily clopidogrel costs 2.57�. Results: The average cost of angioplasty without DES were found to be 4420�, of CABG 12840�, of DES intervention 8860�. A half-year clopidogrel intake yielded 468�, the treatment of myocardial infarction during follow-up 7977�. The 1-year total costs per patient were calculated to be 13648� after CABG and 10064� after DES, showing a difference of 3584� in favor of DES. The 3-year total costs per patient were estimated to be 14085� after CABG and 10628� after DES, showing a difference of 3457� in favor of DES. Changes in cost assumptions for CABG or angioplasties, DES prices as well as per patient stent use influenced the cost differences considerably; however they did not reach a break even point. Conclusions: The presented data indicating a possible economical middle-term advantage of DES vs. CABG should be proven based on clinical assumptions derived from RCTs. T3.15 - Hospital costs and effects of congenital heart su rgery stratified with Aristotle score Trindade E.1, Tanamati C.2, Barbero Marcial M.2, Jatene M.2, Riso A.2, Lopes A.A.3, Yukiko Osato C.4, Fujii S.5 1Heart Institute of the São Paulo University Medical School, Health Technology Assessment/ DIREX, São Paulo, Brazil, 2Heart Institute of the São Paulo University Medical School, Congenital Heart Surgery, São Paulo, Brazil, 3Heart Institute of the São Paulo University Medical School, Pediatric Clinical Cardiology, São Paulo, Brazil, 4Heart Institute of the São Paulo University Medical School, Nursing Coordination, Pediatric Clinical Cardiology, São Paulo, Brazil, 5Heart Institute of the São Paulo University Medical School, Informatics, São Paulo, Brazil Objective: In developing countries risk stratification is important to assess significant investments for the congenital heart surgery complex programs. This report aims to present preliminary results and to discuss the cost-effectiveness methods applied. Methods: Procedures were harmonized with the STS Nomenclature, related and integrated to the administrative and reimbursement tables in the information system, SI3, of the Heart Institute of the São Paulo University Medical School- InCor. Micro-costs building method were applied to estimate costs related to each particular event of care. Morbidity events and mortality were documented prospectively. After hospital discharge, a clinical team ensures life long post-operative follow-up, with periodic visits and facilitated access for all required care. Results: The first 419 consecutive cases underwent congenital heart surgery in 2005. Patients´ average age and its variation were not different between Aristotle strata for analysis. Kaplan Meyer actuarial survival does not show significant differences between the lowest risk strata: 3/57 and 3/131 died amid patients in levels 1 and 2, respectively. There were, however, 14/86 and 15/145 deaths in the 3rd and 4th levels, respectively. Patients with the highest scores, 4th stratum required the double of the length of stay and ICU use than the 2nd stratum, as well as more than double the number of diagnostic tests and therapeutic procedures. The hospital costs have increased three fold from the 2nd to the 4th level of scores. Conclusions: Refinements of the complexity score may help to further discriminate diagnostic co-morbid categories and associated factors predicting use of resources. T3.16 - New answers to the 50,000 $ question: Defining co untry specific cost-effectiveness thresholds based on the gross domestic product Weber C.1 1Institute for Medical Informatics and Biostatistics, Health Economics, Basel, Switzerland

Objective: Economic utility is usually expressed as incremental cost effectiveness ratio (ICER) and a 50,000 US$ threshold is predominantly used. However it seems us not very reasonable to use this threshold value ubiquitary in all countries, because considerable differences in the structure of the health care systems and the economic power of the respective countries may exist. Methods: We defined the following criteria, which a country specific cost-effectiveness threshold should fulfill: (I) the threshold must reflect a country’s overall economic performance and take into account dynamic factors like economic growth and inflation. (II) It should not be based on a pure human capital approach. (III) It should be a uniform monetary value in international comparable terms and (IV) reflect the fact that health care spending has a return of investment. Results: We defined the gross domestic product per capita as the most suitable indicator for the first two criteria. To ensure comparability we’ve chosen to correct the values with economy-wide Purchasing Power Parity (PPP) rates. The consideration of the return of investment of health care spending is based on a recent analysis, that every dollar spend on overall health care in the United States results in a health gain worth 1.55 to 1.94 US$. Conclusions: The use of this new method may reflect better the country specific affordability than the existing thresholds. The approach offers the decision maker freedom to make allocation decisions individually for a specific health care system on the basis of the more general Bergson-Samuelson welfare function. T3.17 - Spinal cord stimulation for pain of chronic neuro pathic origin: A model-based cost effectiveness analysis Taylor R.S.1, O'Donnell R.2, Ryan J.2 1Peninsula Medical School, Exeter, United Kingdom, 2Abacus International, Bicester nr. Oxford, United Kingdom Background: The burden of neuropathic pain is substantial and associated with a marked reduction in health-related quality of life and high healthcare costs. Randomised controlled trials have shown spinal cord stimulation (SCS) to be a clinically effective therapy for the neuropathic pain indications of failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS). Objective: To assess the cost-effectiveness of SCS in patients with CRPS and FBSS paatients as part of an ongoing technology appraisal by the National Institute for Health & Clinical Excellence (NICE). Methods: A previously developed Markov model was adapted to synthesise data on health outcomes and costs over a 15 year time horizon. Health-related quality of life (EQ-5D), clinical outcome and health care resource data were sourced from randomised controlled trials and systematic reviews. Resource consumption was costed using UK national figures. Results are expressed as an incremental cost per quality adjusted life year (QALY) in 2007 GBP. Results: For both FBSS and CRPS, the addition of SCS provided superior health-related quality of life (+1.25 QALYs & +0.64 QALYs) at an increased cost compared to conventional medical management (+£11,439 & £+12,041) and an incremental cost effectiveness ratio of £9,155/QALY and £18,881/QALY. At a £30,000 per QALY threshold, SCS was cost-effective for both indications at a probability of 60% or higher. Conclusions: The addition of SCS to conventional medical management is a cost-effective therapy option for selected patients with pain of chronic neuropathic origin. T3.18 - Estimate of direct cost for preterm newborn admis sions at a public maternity hospital in the city of São Paulo Desgualdo C.M.1, Zucchi P.1 1UNIFESP - Universidade Federal de São Paulo-Brazil, GRIDES- Grupo Interdepartamental de Economia da Saúde, São Paulo, Brazil Objective: To estimate the direct costs of hospital stays of premature newborns admitted in the Neonatal Unit of Hospital e Maternidade Interlagos between January to December 2004, to assess the existence of differences in costs according to birth weight and co-morbidities and to assess the

capacity of coverage by SUS, by comparing the costs to SUS billing for these children. Methods: A retrospective study was carried, through the analysis of medical records, about the use and evaluation of the resources used in the treatment of premature newborns admitted in the Neonatal Unit during the year of 2004. Results & conclusions: The mean cost for all the premature newborns assisted in the Neonatal Unit at HMI was R$ 6.984,05 in the year of 2004, varying from R$ 11.473,49 for the very immature and low birthweight (less than 1.000g) to R$ 2.970,08 (more than 2.500g), according to birthweightand thus, to severity. The average value for premature admissions payed by SUS was R$ 1.738,87 (by adding the two possible procedures), one fourth of the mean value found. T3.19 - Moral hazard and reform in private health insuran ce market in Brazil Godoy M.R.1, Balbinotto Neto G.N.1, Silva E.N.1, Barros P.2 1Federal University of Rio Grande do Sul, Economics, Porto Alegre, Brazil, 2Universidade Nova de Lisboa, Economics, Lisboa, Portugal Objective: The aim of this paper is to measure the effects of reform on private health insurance market occurred in 1998. The reform improved the health insurance coverage level, stating no limit to physician visits. Methods: Three econometric methods were used: Poisson Regression, Negative Binomial Regression and Count Data Quantile Regression (CDQR). The CDQR joins two different econometric methods: count data and quantile regression. It makes possible to study the impact of covariates on the distribution of response variable. Data come from the National Household Survey Sample (Pesquisa Nacional de Amostra de Domicilios-PNAD) for 1998 (before reform) and 2003 (after reform). Results: The results showed that individuals with health insurance have greater number of physician visits, suggesting presence of moral hazard, even controlling for sociodemographic characteristics and health conditions. Other interesting result, obtained from count data quantile regression, is that coefficients are bigger at the right tail of distribution of response variable, particularly in chronic diseases and health insurance variables. Conclusions: The reform has been criticized by health insurance companies, because moral hazard would tend to increase. However, it was not verified in our results, once the number of physician visits did not increase after the reform. T3.20 - Public expenditures on HIV prevention, treatment, care and support services in Iran, 2004 Shariati B.1, Beck E.J.2, Pourmalek F.3, Kazemian M.4, Ghaderi H.3, Akhlaghi H.3 1Tehran University of Medical Sciences, Medical Faculty,Community Medicine Department, Tehran, Iran, Islamic Republic of, 2McGill University, Joint Departments of Epidemiology, Biostatistics and Occupational Health, Montreal, Canada, 3Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of, 4Shahed University, Medical Faculty, Health Economics Department, Tehran, Iran, Islamic Republic of Objective: To determine public expenditures on HIV prevention, treatment, care, and support services in Iran in 2004. Methods: The total country expenditure areas on HIV comprise seven main programs including inpatient care, outpatient care, provision of antiretroviral drugs (ART), blood testing and screening, public information and school students´ education, harm reduction, and armed forces’ HIV control. Using a bottom-up approach we estimated inpatient and outpatient costs and used them as a proxy for estimating national expenditure on treatment and care. The 5 other areas of expenditure were estimated using a top-down approach. Results: Total expenditures for the 7 programs were estimated to be 12 841 974 US$. Based on the sensitivity analyses, the lower and upper limit of direct public medical expenditures on HIV ranged between 11 058 967 US$ and 20 381 000 US$, respectively in Iran in 2004. One of the 15 recommendations presented in this report is that Iran needs to improve medical record systems in health facilit ies. This might be aided by setting up a multi-center prospective monitoring and evaluation system with data gathered systematically in health facilities collecting information to improve patient management and health service monitoring and evaluation.

Conclusions: Despite all efforts by the Iran government in response to HIV epidemic, the incidence and prevalence of infection is increasing dramatically. More effective, efficient, equitable, and acceptable services should be implemented. More intersectoral collaborations, community involvements and research in the pertinent area are needed. We should improve the national multisectoral monitoring and evaluation system to track the response. T3.21 - Elements for the economic analysis of a hereditar y hemochromatosis genetic screening programme in South-West Madrid Saz-Parkinson Z.1, Ayuso C.2, Amate J.M.1 1Instituto de Salud Carlos III, Agencia de Evaluación de Tecnologías Sanitarias, Madrid, Spain, 2CIBERER - Fundación Jiménez Díaz, Servicio de Genética, Madrid, Spain Objective: Study costs of carrying out a genetic screening programme for a population of 50.000, belonging to the South-West Healthcare Area 11 of Madrid, for Hereditary Hemochromatosis (HH), based on the calculated penetrance of HH in this area. Methods: Retrospective cross-sectional study of HFE genotyping requests from a subpopulation in South West Madrid, between January 2000 and June 2006. Based on our population’s genotype and phenotype, clinical penetrance was calculated. Costs, extracted from a Spanish Medical Cost database (SOYKOS), involved in treatment of HH-associated diseases, biochemical testing, genetic testing, treatment of phenotypical HH patients and follow up were analysed. Results: From our data, for the main HH-associated diseases, we have calculated a clinical penetrance, for HH genotype, in the population studied, of 1,11%, compared to 0,08% for those with wild-type HFE genotype. The main HH-associated pathologies considered are hepatopathy, diabetes and arthropathy. Cost for genetic testing of 50.000 individuals, biochemical follow up of those with HH genotype, and treatment of those with HH genotype and phenotype amounts to 848.992,95�, equivalent to 121.284,71�/phenotypical case detected. Treatment of HH-associated pathologies, if no other preventive intervention is undertaken (biochemical monitoring, preventive phlebotomy treatment), would cost 191.100,51�. Conclusions: The extremely low penetrance of HH-associated pathologies related to the HH genotype, suggests that a genetic screening programme for the entire population studied is not economically justified for the Spanish National Healthcare System, which does not exclude genetic screening of first degree relatives of HH patients and their subsequent biochemical follow-up could prove to be appropriate. T3.22 - Take the money and run: Valuing the benefits of p hysical activity Naidoo B.1, Bending M.2, Beale S.2, Crombie H.1 1National Institute for Health and Clinical Excellence, Centre for Public Health Excellence, London, United Kingdom, 2York Health Economics Consortium Ltd, York, United Kingdom Objective: NICE recently developed public health guidance on physical activity and the environment. Unlike other NICE guidance, its public health guidance considers the whole of the public sector, and not just the NHS and personal and social services. This paper considers the difficulties arising from different sectors of the economy using different approaches to valuing the benefits arising from physical activity. Methods: The cost-effectiveness of environmental interventions that increased physical activity were assessed using cost benefit analysis, as favoured by the transport sector, and cost utility analysis, as traditionally undertaken by NICE. Results: Environmental interventions such as cycling infrastructure where found to have very favourable cost benefit ratios (1:11) and incremental cost effective ratios below the upper bound of the threshold used by NICE (£30,000 per QALY). However, it is debatable about how much of the cost should be attributable to the health benefits accrued from increased physical activity, as often the main aim of the interventions considered was not to increase physical activity, but rather to, for example, reduce accidents or congestions. In addition, the NICE reference case requires that benefits are measured using a cost-utility analysis whereas other sectors of the economy tend to use cost-benefit analysis. This makes it difficult to compare, say, the valuation of a road death avoided with a QALY. Conclusions: When estimating public health benefits all sectors of the economy should use common

methods for attributing costs and valuing benefits. This will allow decision makers to prioritise interventions that cut across multiple sectors. T3.23 - How does PHARMAC prioritise pharmaceuticals to ma ximise "bang for buck"? Grocott R.S.1, Brougham M.1 1PHARMAC, Wellington, New Zealand The Pharmaceutical Management Agency (PHARMAC) is responsible for determining which medicines will be subsidised by the New Zealand Government. PHARMAC’s key legislative objective is “to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the funding provided”. As PHARMAC must work within a fixed budget, it is impossible to fund every new pharmaceutical that may potentially benefit someone. In short, choices are inevitable. PHARMAC has an established prioritisation process for the funding of pharmaceuticals. Following receipt of a funding proposal, it is reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC). This committee provides advice to PHARMAC and consists of medical practitioners with broad clinical experience and a particular interest in pharmaceuticals. PTAC makes recommendations to PHARMAC for the assignment of high, medium, or low priorities for proposal, or that a proposal be declined or referred back to the supplier for further information. Assessment of cost-effectiveness is undertaken either prior to the PTAC meeting (and revised following PTAC consideration), or following PTAC review of the evidence. Economic analyses are undertaken by PHARMAC staff, and are based on the methods and guidelines outlined in the Prescription for Pharmacoeconomic Analysis (PFPA). All pharmaceuticals awaiting funding are prioritised against other expenditure options. This is based on PHARMAC’s decision criteria, including affordability, health need and cost-effectiveness. This presentation will outline how PHARMAC prioritises pharmaceuticals for funding in order to achieve the maximum health gains for the funding available. Pharmaceuticals 2 T4.1 - The clinical and cost-effectiveness of pegvisoman t (Somavert ®) for the treatment of acromegaly Moore D.1, Adi Y.2, Bayliss S.1, Connock M.1 1West Midlands Health Technology Assessment Collaboration, Dept of Public Health & Epidemiology, Birmingham, United Kingdom, 2University of Warwick, Warwick, United Kingdom Objective: To determine the clinical and cost-effectiveness of pegvisomant for treating acromegaly patients whose IGF-1 levels fail to normalise with other treatments. Acromegaly is a rare disease associated with reduced life expectancy and is usually caused by a pituitary tumour. It is defined by over-secretion of growth hormone (GH) which induces over-secretion of insulin-like growth factor-1 (IGF-1). Methods: Systematic review of clinical effectiveness and cost-effectiveness. Modification of identified decision analytical model to assess cost-effectiveness from the UK-NHS perspective. Results: One RCT and 17 non-randomised studies were included. Little evidence extends beyond one year follow-up and most concentrates on biomarkers. Pegvisomant rapidly reduced/normalised IGF-1 in most patients but doubled GH levels though this did not affect tumour size in the short term. The drug had a generally safe adverse event profile but in a few patients treatment withdrawal, occasionally permanent, was required. Treatment was associated with improvement in several signs and symptoms of the disease. The ICER over a 20- year time horizon was estimated at £199,000/QALY and £578,000/LYG. Sensitivity analyses using plausible variations in model inputs failed to reduce the ICER below £119,000/QALY (£85,000/QALY using a “perfect” drug scenario). To achieve an ICER of £30,000/QALY a substantial reduction in the price of pegvisomant would be required. Conclusions: Pegvisomant is effective for improving patients’ IGF-1 level. Evidence is lacking about long term effects on signs/symptoms of disease, QoL, compliance and safety. In the absence of special consideration for orphan drugs, pegvisomant is not a cost-effective intervention by current standards.

T4.2 - Systematic review of the efficacy and safety of i nsulin aspart in type 1 diabetes melitus Pankiewicz O.1, Rys P.1, Wladysiuk M.1, Skrzekowska-Baran I.2 1HTA Consulting, Krakow, Poland, 2NovoNordisk, Warszawa, Poland Objective: The aim of this analysis was to compare efficacy and safety of rapid-acting and biphasic insulin aspart with those of regular human insulin used in treatment of patients with type 1 diabetes mellitus. Methods: The comparison was based on the results of a systematic review performed according to guidelines published by the Cochrane Collaboration and Agency for Technology Assessment in Poland. EMBASE, MEDLINE, CENTRAL and others were searched. Two reviewers independently collected data in standardized form and assessed the methodological quality. Of 323 retrieved publications 12 articles of relatively low methodological credibility fulfilled the inclusion criteria. Outcome measures included glycated hemoglobin, postprandial glucose, treatment satisfaction, quality of life, hypoglycemic episodes (severe, nocturnal, any). Results: Statistically significant differences in favor of insulin aspart were demonstrated with respect to: reduction of glycated hemoglobin level (WMD= 0,14; CI95% [0,20; 0,07]), reduction of postprandial glucose level (WMD= -1,13 CI95% [-1,88; -0,38]) and reduction of the risk of nocturnal hypoglycemia (RR= 0,67 CI95% [0,54; 0,83]); treatment satisfaction was also increased and quality of life related to dietary restrictions (DSQOLS scale) improved. No statistically significant differences were demonstrated with respect to fasting plasma glucose level, the number of patients, in whom an episode of hypoglycemia (any or severe) occurred, or quality of life as evaluated with the DHP questionnaire. Conclusions: Use of insulin aspart instead of regular human insulin in type 1 diabetes mellitus results in decreased glycated hemoglobin level, decreased postprandial glycemia and improved treatment satisfaction. T4.3 - Salmeterol and fluticasone (seretide) for chronic pulmonary disease: Systematic review Wrzosek A.1, Skora T.1, Plisko R.1, Rys P.1 1HTA Consulting, Krakow, Poland Objective: The aim of this analysis was to compare the efficacy and safety of the salmeterol/fluticasone propionate combination (SFC) with that of placebo, salmeterol alone (S) and salbutamol with ipratropium (SBI) in the treatment of moderate to severe COPD. Methods: The comparison was based on the results of randomized clinical trials identified in a systematic review performed according to the Cochrane guidelines. Characteristics of the studies: Medical databases (EMBASE, MEDLINE, CENTRAL and others) were searched. Of 109 retrieved publications, 10 articles of high or medium methodological credibility fulfilled the inclusion criteria; investigated combinations were: SFC vs. placebo (7 trials), SFC vs. S in monotherapy (7 trials) and SFC vs. SBI (2 trials). Results: In patients with moderate to severe COPD SFC was more efficacious than placebo (with respect to mortality, frequency of exacerbations and other parameters) but was associated with greater risk of oral candidiasis (no effect on other adverse reactions was observed). Similar results were found for SFC vs. S in monotherapy; however, no difference in mortality was observed between the compared groups. SFC was more efficacious than SBI in terms of symptoms, dyspnoea, days free from rescue medication, FEV1, morning PEF. However, no significant difference was found between treatments in mortality or frequency of exacerbations. Oral candidiasis was more frequent in the SFC group. No difference in other adverse events was observed between treatments. Conclusions: The combination of SFC in one inhaler seems to be effective and well tolerated. T4.4 - Are disease management programs effective and eff icient? Hisashige A.1 1Institute of Healthcare Technology Assessment, Tokushima, Japan

Objective: Chronic diseases account for most of the burden of diseases. The disease management (DM) approach is characterized as an organized care with multidisciplinary, incorporating the whole course of a chronic disease and using evidence-based healthcare. To evaluate and synthesize the evidence on effectiveness and efficiency of DM, as well as its applicability is extremely valuable to healthcare decision making. Methods: Eligible studies were located through systematic and comprehensive literature search. Only meta-analyses and systematic reviews were included. We searched Medline, EMBASE, the Cochrane Library, SCI-EXPANDED, SSCI, A&HCI, DARE, HTA and NHS EED from 1995 to May 2006. A study quality assessment was performed. Results: Nineteen meta-analyses and systematic reviews were included for synthesizing evidence for effectiveness and efficiency of DM programs. The synthesis of these analyses and reviews showed fair evidence of the effectiveness of DM programs on outcomes from healthcare process, health outcomes and health services, to knowledge, satisfaction, QOL and costs. Even more, the statistical analysis by meta-analysis indicated significant improvement in healthcare process, health outcomes, satisfaction, knowledge, health services, QOL, and costs. However, as to mortality, evidence is very limited and inconclusive. Conclusion: The evidence synthesized shows that there would be no controversy on the effectiveness of DM programs. Although more precise analysis and synthesis of evidence is required for mortality and cost-effectiveness, the question is no longer whether DM programs work, but rather which type or component of DM programs works best and efficiently in the context of each healthcare system or country. T4.5 - Pharmacogenomics and warfarin therapy: An emergin g technology in the field of "personalized medicine" Ndegwa S.1, Banks R.2 1CADTH, Edmonton, Canada, 2CADTH, Ottawa, Canada Objective: Pharmacogenomics is the use of genetic testing to identify patients who are predisposed to respond differently to particular drug treatments. These tests offer potential advantages, such as individualized drug dosing, fewer adverse effects, and more appropriate use of drugs in patients most likely to benefit. Warfarin (Coumadin) is a widely used anticoagulant that is commonly associated with adverse effects due to inappropriate dosing. Methods: The topic of pharmacogenomics for warfarin therapy was selected as part of our horizon scanning program due to its potential patient benefit, cost savings, and timeliness. A systematic literature search was conducted using PubMed, EMBASE, CRD, Cochrane Library, BIOSIS, and Internet sources. Two clinical experts reviewed the bulletin. Results: During our review there were several new developments. The US FDA revised warfarin labelling to include genetic variations in CYP2C9 and VKORC1 as one of the factors to consider for more precise initial dosing and approved the first pharmacogenomic test for warfarin although several other tests are commercially available. None of these tests are currently licensed in Canada. A US expert committee is drafting guidance for the use of pharmacogenomics in warfarin prescribing and several trials are evaluating the impact of pharmacogenomics on clinical outcomes. Conclusions: Commercial pharmacogenomic tests for warfarin have entered the marketplace in advance of conclusive evidence of their clinical- and cost-effectiveness or guidance for appropriate use. Postmarketing studies will be important to delineate the role of genetic testing in warfarin prescribing. Pharmacogenomics is an exciting new field for health technology assessment. T4.6 - Enzyme replacement therapy for treatment of glyco gen storage disease type II (Pompe disease) Sehatzadeh S.1, Sharieff W.1, Bhatti T.2 1Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care, Toronto, Canada, 2McMaster University, Programs for Assessment of Technology in Health (PATH), Hamilton, Canada Objective: To assess the clinical effectiveness and cost-effectiveness of Enzyme Replacement Therapy (ERT) in the treatment of patients with infantile-onset Pompe disease. Methods: Four published clinical trials were identified and included in the analysis. Kaplan Meier survival analysis was conducted to calculate survival time since birth for treated patients.

Results: All 17 patients who received ERT passed their first birthday. Seven patients died during study period or follow-up. Treated patients had a 12, 18, and 24 months ventilator-free survival rate of 70%, 60%, and 50% compared to 16.9%, 8.5%, and 4.9% for untreated patients reported in the literature. Based on 3-year follow-up data, we developed a Markov model with three scenarios: Pessimistic (no survival advantage beyond three years), Moderate (the same exponential rate as was seen in the first 3 years), Optimistic (normal life expectancy after three years). The model shows that average life expectancy with ERT may be up to 2.5, 6, and 36 years in the Pessimistic, Moderate, and Optimistic scenarios compared to approximately one year in untreated patients. The life time cost/patient may vary from $180 K to $7.9 M, cost/life-year gained may vary from $120 K to $173 K, and cost/quality adjusted life-year (QALY) gained may vary from $203 K to $322 K, depending on the assumed scenarios. The total budget impact ranged from $249,413 to $582,769 (Cdn) over a 10-year period. Conclusion: ERT is the only approved treatment available for this orphan disease. The total budgetary impact is small as the disease is very rare. T4.7 - Subcutaneous versus intravenous immunoglobulin fo r primary immunodeficiencies Cimon K.1, Ho C.1, Membe S.1, Morrison A.1 1Canadian Agency for Drugs and Technologies in Health (CADTH), Ottawa, Ontario, Canada Objective: The established treatment in Canada for primary immunodeficiencies is intravenous immunoglobulin (IVIg). Subcutaneous immunoglobulin (SCIg) is now available. We aimed to review the clinical and cost-effectiveness of SCIg compared with IVIg. Methods: A systematic review of the evidence was conducted using peer-reviewed search strategies developed by an information specialist. Primary outcomes included number and severity of infections. Secondary outcomes included serum Ig levels, adverse reactions, and health-related quality of life (QoL). Economic analysis from the Canadian public healthcare payer’s perspective was performed. Results: Limited evidence and reporting variation of outcomes from eight included observational studies and one randomized controlled trial supported a qualitative systematic review. Clinical data indicated only minimal differences between SCIg and IVIg for primary and secondary outcomes. Patients using SCIg indicated better QoL, attributed to the ability to infuse SCIg at home. The economic analysis showed that SCIg dominates (greater benefits at less cost) hospital-infused IVIg, and produces an incremental cost-effectiveness ratio (ICER) of $39,500 per quality-adjusted life year when compared with home-infused IVIg. ICER is sensitive to change in utility of infection and per gram price of SCIg. Conclusions: Based on limited clinical evidence comparing SCIg with IVIg, SCIg could be considered as an alternative to IVIg in patients with contra-indications to IVIg or poor venous access. With some degree of uncertainty, SCIg appears to be cost effective and could gradually be established as an alternative to IVIg for patients who are willing or clinically suitable to switch to SCIg. HTA/technology in hospitals 2 T5.1 - Strategies to improve the medical equipment purch ase at public hospitals Lemus-Martinez C.1, Ortiz-Posadas M.R.1 1Universidad Autonoma Metropolitana, Ingenieria Electrica, Mexico, Mexico Objective: To provide strategies to improve the medical equipment purchase, in public hospitals, as a duty of the technology assessment department. Methods: Long and tedious administrative processes must be followed for medical equipment acquisition in Mexican public hospitals. Opposed it, the decision making period is extremely short and several aspects have to be taken into consideration such as evaluating several providers, many hospital areas involved and a long number of medical equipment, all at the same time. The Mexican technology assessment agency (CENETEC) offers advice and rules for pursuing the accomplishment of some regulations; however, there are some aspects not included. That is why this document provides innovated strategies for the medical equipment purchase, focusing on the public sector, since its administrative procedures less easy to follow. Results: A series of strategies are offered to improve the purchase for medical equipment. It reaches all the process, since the clinical needs assessment to the technology evaluation, to key phase of the

bidding process, where the information will bring the best decisions for the institution. Also feedback and track strategies are suggested to evaluate the impact of the medical equipment purchase that will work as guidelines for future medical devices acquisition. Conclusion: Medical decision makers need clear management evaluation strategies implemented, to support the direction they are bringing to their institutions, in order to give a better use to the available resources and provide benefit to a greater number of patients. T5.2 - In-house technology assessment at a major academi c medical center: The first two years Mitchell M.D.1, Agarwal R.1, Williams K.1, Umscheid C.A.1 1University of Pennsylvania Health System, Center for Evidence-based Practice, Philadelphia, United States of America Objective: Develop an in-house resource to support evidence-based care at the University of Pennsylvania Health System (UPHS). Methods: UPHS created a Center for Evidence-based Practice (CEP) to summarize scientific evidence for UPHS decision making about clinical policy, and to build evidence-based collaborative enterprises with biomedical industries and payors. Results: CEP opened in July 2006, is funded by the UPHS Chief Medical Officer, and is staffed by two physician co-directors trained in epidemiology, two doctoral-level analysts, a librarian, and an administrator. More than 30 reports have been completed, including guideline development projects, standalone evidence reports, and short-form advisories. Assessments have been completed for medical and nursing leaders and standing committees (e.g. Supply Purchasing Committee). Topics have included low-cost procedures that affect patient safety and quality of care as well as high-cost and emerging technologies. Reports review existing guidelines and systematic reviews first, and review primary literature only when previous reports are not sufficient to answer the clinical question. Local utilization and cost data are incorporated so reports can be tailored to the specific circumstances of care at our institution. After reports are completed, hospital administrative data is used to measure practice changes CEP also offers educational and publishing opportunities thru faculty CME, resident electives, and an academic detailing initiative. In addition, CEP has developed relationships with industry, payors, and government organizations. Conclusions: A small TA center within an academic health system can offer systematic evaluations of high impact clinical issues. These evaluations can promote evidence-based decision-making throughout the system. T5.3 - Follow-up analysis of a health technology assessm ent (HTA) project for the reorganization of an Imaging Department Genovese E.1, Franchin T.2, Nocchi F.2, Galo J.2, Ritrovato M.3, Capussotto C.2, Cannatà V.1, Derrico P.2 1Bambino Gesù Children's Hospital, Medical Physics, Roma, Italy, 2Bambino Gesù Children's Hospital, Clinical Engineering, Roma, Italy, 3Bambino Gesù Children's Hospital, Risk Management, Roma, Italy Objective: The follow-up analysis of a project is a fundamental and critical aspect of the technology assessment because it provides monitoring expected objectives. A year after the implementation, the follow-up of the HTA project of the reorganization of the Imaging Department of Bambino Gesù Children’s Hospital is being carried out to assess critical situations and to evaluate expected targets. Methods: Data collection was implemented by a multidisciplinary team to monitor: number and typology of the performances; workflow organization and service quality, regarding cost reduction too; risk assessment and prevention activities. Results: Annual productivity showed a positive trend, increasing of 5% the number of exams despite the restructuring work in progress and the clinical staff adaptation to new technologies. The enhanced quality of exam outcomes and the increased medical application range lead to a better clinical confidence of the results and to an improved data certainty for pre-surgical and diagnostic practices. New technologies introduction in clinical routines was planned according to the clinical/technical training to raise staff education and job satisfaction. To prevent risks to workers and patients, safety courses were organized for maintenance technicians too. The RIS/PACS system upgrade was necessary to resolve transferred data rise. Conclusions: The follow-up analysis enabled identifying possible technological update/upgrade and

hypothesizing a human resource re-organization to improve scientific research and clinical practice. These results were employed for developing the Health Risk Management plan for the Imaging Department. T5.4 - Impacts of an aging population: Elderly patients in the emergency department McMaster F.1, Foo C.L.2, Ng C.2, Seow E.2, Heng B.H.1 1National Healthcare Group, Health Services & Outcomes Research, Singapore, Singapore, 2Tan Tock Seng Hospital, Emergency Department, Singapore, Singapore Objective: To provide a profile of elderly patients attending the emergency department and outline the challenges facing emergency clinicians and policy-makers to aide future decision-making. Methods: This single-centre prospective observational study in Tan Tock Seng Hospital s Emergency Department. Electronically-captured demographic, diagnosis, disposition and test utilisation data were supplemented by case-notes review of all presenting symptoms. To further investigate challenges facing clinicians, clinicians from the ED were invited to participate in focus groups. This qualitative information was transcribed and analysed thematically using NVivo 7 (QSR international). Results: 11,533 patients attended the ED during a two-month period in 2006. Of these, 24.7% were over 65 years old, and 14.1% over 75 years old. 72% of patients over 85 years are admitted to hospital. 75% have at least one chronic disease, and over 25% have two or more co-morbid conditions. Ten diagnoses account for 42% of elderly patients, with 10.2% of diagnosed with pneumonia. Staff indicated that they had not received much formal geriatric-specific training prior to working in the ED. Of the 60 clinicians interviewed, all mentioned communication, co-morbidities and lack of sub-acute care as challenges. Conclusions: The high proportion of elderly patients, with co-morbidities and atypical presentations attending the Emergency Department is further complicated by language barriers in taking good histories, a lack of pre-clinical geriatric emergency training and a shortage of subsidised sub-acute facilities. These factors must be considered in manpower, recruitment, training provision and the down-stream effects on inpatient numbers in existing and future Emergency Departments in Singapore. T5.5 - Implementation of the Brazilian National Clinic R esearch Net in University Hospitals Veloso S.C.S.1, Elias F.T.S.1, Camargo E.B.1, Silva M.T.1, Serruya S.J.1, Guimarães R.F.N.2 1Ministry of Health of Brazil, Department of Science and Technology, Brasília - DF, Brazil, 2Ministry of Health of Brazil, Secretariat Science, Technology and Strategic Inputs, Brasília - DF, Brazil Objective: To describe the implementation process of the Brazilian National Clinic Research Network in University Hospitals (RNPC). Methods: (1) Synthesize a Brazilian National public Call for projects that aim to structure the Net. (2) Analyze projects and reports send by the proponent to the Brazilian Ministry of Heath. Results: The RNPC aims to strength clinical research in the Brazilian University hospitals and to set priorities for the commitment between the units with the needs in health together with the National Health Policy. In 2005, the structural process started by publishing a public call for institutions interested. After hiring the selected institutions, the budget was given during the years of 2006 and 2007 (about $ 20 million dollars - US$ 1,74). The physical structure step occurred as established by the chronogram of each project for the construction or renovation and the acquisition of materials and equipments. At the same time a training process started with courses and seminars related to clinical research, good practice and ethics in research. The Net now has 19 research institutions. Some of the institutions are developing researches for the Ministry of Heath interests considering strategic themes in clinical research and heath technology Assessment. Conclusions: The implementation and consolidation of this Net will contribute to adjust the importance of clinical research to its strategic rote of scientific development, following the technological advances obtained in the productive complex in health. T5.6 - Degree of GINF implementation in Andalusian hospi tals

Flores S.1, Marin R.2, Santos B.2, Bautista J.2 1Andalusian Agency For Health Technology Assessment, Seville, Spain, 2Virgen del Rocio University Hospital, Seville, Spain Introduction: In 1999, the Andalusian Agency for Health Technology Assessment published a guideline for the Introduction of New drugs (GINF) in Hospitals, to facilitate to clinicians the request of introduction of a drug at a hospital. Objective: Assess the degree of GINF implementation in Spanish hospitals. Methods: All Andalusia public hospitals were identified systematically and through telephone surveys, a number of issues were assessed, namely the degree of GINF implementation, the year in which it was first incorporated, the version in use at the time of the interview, sections which had been modified at local level, and the impact of GINF on decisions taken by the Pharmacy and Therapeutics Committee (PTC). Results: The survey was carried out at 31 hospitals; the degree of implementation was 96.5%. The implementation had taken place in most cases in 2003-2004. Twenty-three out of the 28 hospitals used GINF for 100% of drugs 23, without exception; the other five only use the GINF partially, depending on the therapy group. The version most used was the first to be published. 26% of hospitals had introduced local modifications to GINF, primarily in the section on “efficacy”. 95% considered it a useful tool in the work of their PTC. Conclusions: The GINF guide is currently in place in the vast majority of public hospitals in Andalusia. However, lack of knowledge regarding the existence of subsequent versions of the guide is notorious, and this has led to scarce implementation of the most recent versions. Safety/Risk/Injuries 2 T6.1 - The effectiveness of bedrails in preventing falls Ng K.P.1, McMaster F.R.1, Heng B.H.1 1National Healthcare Group, Health Services and Outcomes Research, Singapore, Singapore Objective: To evaluate the role of bedrails in preventing falls in the acute hospital setting. Methods: A literature search was performed using the PUBMED database. Published articles on bedrail use and its effects on falls were selected for review. Local bed-related falls data was analyzed, and a cost analysis of alternatives to bedrails was done for hospitals within the National Healthcare Group (NHG) in Singapore. Results: Bedrails can be classified as restrictive or non-restrictive. Restrictive bedrail use is defined as use of two full-length or four half rails, whereas non-restrictive bedrail use is defined as use of two upper half rails, or one half or full-length rail. Literature review did not support use of restrictive bedrails for falls prevention. Most articles reviewed showed that use of restrictive bedrails had no effects on rate of falls. Other less desirable effects of restrictive bedrails reported were risk of entrapment and injuries from climbing over bedrails. Local data showed that bed-related falls accounted for a third of all inpatient falls. Of these, 78% had restrictive bedrail use. There was no significant difference in the injury rate between the group with restrictive bedrail use and the group without, though serious injury only occurred in the former group. Implementation of alternatives to restrictive bedrail use may require an initial cost of between $400 000 to $2 000 000 per NHG hospital. Conclusions: There is no evidence to support restrictive bedrail use for falls prevention in the acute hospital setting. T6.2 - Risk factors regarding adverse events in four Col ombian hospitals - 2006 Gaitan H.G.1, Eslava-Schmalbach J.1, Rodriguez N.1, Arevalo I.1, Guevara O.A.1, Health Technology and Policy Evaluation Group 1National University of Colombia, Clinical Research Institute, Bogotá, Colombia Objective: Identifying risk factors associated with the occurrence of adverse events (EA) in four Colombian hospitals. Methods: This was a prospective cohort study of 9,086 consecutive hospitalisations, involving 8,413

patients between May and October 2006 in 4 Colombian hospitals. Sample size: 7563 patients. 2% estimated at high complexity centre AE frequency and 1% for medium complexity institutions. 0.05% significance level, power 90% and ratio 2:1 An active AE surveillance programme was implemented; this was prolonged up to 30 days following being discharged from hospital. An evaluation committee decided upon whether an event should be classified as being an AE. The patients were grouped according to type of IR-DRG; 15 variables were evaluated as risk factors. Univariate analysis was carried out, followed by multivariate analysis with logistical regression. Results: The obstetric, medical and surgical IR-DRG was 36%, 33% and 30%, respectively. Multivariate analysis revealed AE to be associated with being admitted to the emergency service (OR: 1.58; 95% CI 1.18 - 2.11), prior comorbidity (OR: 1.47; 95% CI 1.09 - 1.98 ), age (OR: 1.02; 95% CI 1.01- 1.03) and surgical services (OR: 2.7 95% CI 1.93 - 3.80). An institution’s level of complexity was not seen to be significantly associated with AE. Conclusions: Adverse events being presented during hospitalisation in these institutions was associated with a patient’s being older, being admitted to the emergency service, having had prior comorbidity and being hospitalised in surgical services. It is recommended that efforts be concentrated on preventing AE in these types of patients. T6.3 - Meta-analysis of cannabis treatment for chronic p ain: More risk than benefit Martin J.L.R.1, Martin-Sanchez E.1 1Castile-La Mancha Health Research Foundation (FISCAM), Department of Clinical Research, Toledo, Spain Objective: To determine the efficacy and safety of cannabis for treating chronic pain. Methods: Review of the literature and location of randomised, double-blind clinical trials on subjects with chronic pain in which the experimental intervention was with natural or synthetic cannabinoids, on their own or in combination, applied using any pharmaceutical form and method of administration, in comparison with placebo groups. Efficacy was evaluated according to intensity of pain. Safety was evaluated by the adverse events experienced in each group. Results: 229 studies which could potentially form part of the review were located, of which only 13 were finally included. The analysis of efficacy - short term - showed a standardised mean difference of -0.62 (-0.87 to -0.37); P <0,00001 in favour of cannabinoids, and showed statistical homogeneity (I2 = 3.0 %; P = 0.40). The analysis of safety showed OR against cannabinoids for all the groups of events studied: 4.84 (3.19-7.36); P < 0.00001, for alterations in perception; 4.41 (3.01-6.45); P < 0.00001, for alterations in the motor function; 4.17 (2.12-8.21); P<0.0001, for alterations in the cognitive function. These data showed that, for events such as alterations in visual perception, NNH could be very close to 2. Conclusions: In view of the severity and frequency of the adverse events found, as well as the lack of data on the effectiveness and safety of cannabinoid compounds in the medium and long term, more clinical evidence is needed to support the use of these substances for treating chronic pathologies such as pain. T6.4 - The use of NICE´s health technology assessment me thodology to produce clinical and cost-effective patient safety solutions Garner S.1, Campbell B.1, Marlow M.1, Littlejohns P.1 1National Institute for Health and Clinical Excellence, London, United Kingdom Objective: Patient Safety Solutions (PSS) are a core programme of the WHO World Alliance for Patient Safety. NICE and the UK’s National Patient Safety Agency (NPSA) were asked to develop and evaluate a pilot project using NICE’s Health Technology Assessment (HTA) processes and methodology to produce guidance on patient safety to the NHS. Methods: Two patient safety issues were selected; prevention of ventilator-associated pneumonia and medicines reconciliation at the point admission. Systematic reviews and economic modeling were undertaken and the evidence was presented to an independent Patient Safety Advisory Committee (PSAC) who produced guidance. The pilot project was then evaluated. Stakeholder engagement occurred throughout including with patient organizations. The impact on patient safety is being monitored through audit and reporting to the National Reporting and Learning System. Results: Using HTA it was possible to identify PSS that were both clinical and cost-effective.

However, the process was hampered by the lack of reliable evidence. The Committee considered there was insufficient evidence to make recommendations on four of the potential PSS evaluated. Conclusions: Evaluating the clinical and cost-effectiveness of potential PSS is a novel application of the methods of HTA and it presents a number of challenges. The pilot project however indicated that the methodology could be used successfully to prioritise strategies for implementation. Further methodological development and research is required. It is also anticipated that in the longer-term such evaluations will promote the development of the evidence base for potential PSS. T6.5 - Assessment of mechanical circulatory support devi ces Grenouilleau A.-S.1, Schapiro E.1, Poullié A.-I.1, Quentin F.1, Despeyroux S.1, Galmiche H.1, David D.-J.1, Rumeau-Pichon C.1, Lee Robin S.H.1, Denis C.1 1Haute Autorité de Santé (HAS), Saint-Denis la Plaine, France Objective: Mechanical circulatory support devices are ventricular assist pumps for use in patients with heart failure. Our aim was to assess these devices (including artificial hearts but excluding extracorporeal membrane oxygenators) and their associated procedures with a view to their reimbursement by French National Health Insurance. Methods: We performed a critical appraisal of the clinical and health economics literature (1997 - 2007) which was then submitted to a multidisciplinary working group of 15 health professionals for discussion. Manufacturers’ application files were also consulted. Results: We retrieved 4 health technology assessments, 1 guideline, data from 2 registries and 16 clinical studies providing data on 6000 patients. Although most studies were of low methodological quality, the data from the most reliable studies was consistent. Survival at 1 year was 50%. The main complications were infections (30% of patients), bleeding (26%), and cerebral embolism (15%). The devices have a favourable efficacy/risk ratio but unfavourable cost/efficacy ratio. Conclusions: HAS recommended that, owing to the current shortage of transplants, these devices and their associated procedures should be reimbursed in two indications: (i) acute ventricular heart failure refractory to the best available treatment and with no possible alternative treatment, (ii) progressive chronic heart failure in patients refractory to the best available, the decision being taken after a multidisciplinary discussion. It estimated the number of centres required to cover the need and the conditions of patient management (follow-up after device implantation, human and material resources ...). T6.6 - Risk adjustment systems in health services assess ment Sendra-Gutiérrez J.M.1, Sarría-Santamera A.1, Palma M.1 1Agencia de Evaluación de Tecnologías Sanitarias. Instituto de Salud Carlos III, Madrid, Spain Objective: To identify original risk adjustment models generated to describe, assess and compare the effectiveness of health care services. Methods: A systematic review of the literature (1990-May 2007) and a manual search were conducted to identify studies that met the inclusion criteria. Studies had to measure as dependent variables health-related outcomes: clinical or patient perceived outcomes. The information collected included dependent variable, setting (hospital, ambulatory care, other), sources of information (administrative, clinical or specific data), independent variables, statistical techniques, goodness of fit and discrimination. Model’s were classified as: generic, procedure-specific and process or unit-specific. Results: 103 publications were identified. The most frecuent models were procedure-specific. Mortality was the most frequent outcome. 83.5% of models have been developed in hospital, being administrative and clinical data bases the most common source of information. Logistic regression was the analytic method used in 78.6%. More than 60% of the models have been developed after 2001. The country with the largest proportion of models is the United States. Cardiac surgery, cardiovascular disease and Intensive Care Unit are the procedure, the condition and the health care setting with the highest number of models developed, respectively. Conclusions: There is a current significant increase in the development of risk adjustment models. Some issues for the future development are: identify alternative outcome indicators outside mortality, in ambulatory care settings and built with a systemic view of health care services. Risk adjustment models have to be applied in the context of comprehensive programs of health care quality

assessment and improvement. T6.7 - Progressive multifocal leuko-enchephalopathy indu ced by monoclonal antibodies - A systematic review of literature: Preliminary data Socal M.P.1, Vargas A.P.2, Laporte E.A.3, Costa A.F.4, Picon P.D.5, BRAzilian INdependent Study Group 1Universidade Federal do Rio Grande do Sul and Rio Grande do Sul State Health Department, Post-Graduation in Medicine: Medical Sciences, Porto Alegre, Brazil, 2Universidade Federal do Rio Grande do Sul, Medical School, Porto Alegre, Brazil, 3Rio Grande do Sul State Health Department, Porto Alegre, Brazil, 4Universidade Federal do Rio Grande do Sul and Rio Grande do Sul State Health Department, Post-Graduation in Medicine, Porto Alegre, Brazil, 5Universidade Federal do Rio Grande do Sul and Rio Grande do Sul State Health Department, Internal Medicine Department, Porto Alegre, Brazil Objectives: Monoclonal antibodies (MABs) are recommended for several inflammatory diseases. As high cost drugs, they are frequently associated with a strong marketing and thereby potential irrational use. In Rio Grande do Sul, Brazil, more than US$ 600,000.00 was spent in 2007 with rituximab. The reports of progressive multiple leukoencephalopathy (PML) associated with MABs indicate that patient selection for this treatment should be done with caution. The purpose of this study was to perform a systematic review of all published data on the association between MABs and PML. Methods: We searched PubMed using a strategy that comprised all MABs plus the term multifocal progressive leukoencephalopathy. Results: 103 papers on the subject were identified: 4 randomized clinical trials, 7 transversal studies, 2 prospective and 2 retrospective cohort studies, 17 letters to the editor, 7 case-reports, 40 reviews, 1 metanalysis, 3 brief communications, 5 editorials, 7 experimental studies and 8 news/ alerts. We found 20 cases of PML associated with rituximab, 3 with natalizumab, 1 with etanercept and also a report with alentuzumab. 62,5% of the affected patients died in weeks to a few months after diagnosis, and the survivors had severe neurological sequelae. Conclusions: Occurrence of PML in patients who otherwise had any chronic diseases causes a dramatic increase in morbidity and mortality that should be taken into consideration when prescribing MABs. The social and economical impacts of PML contribute to increase the already high costs of this treatment. The authors declare no conflict of interests. HTA in decision-making 2 T7.1 - Definition of coverage policies in the context of health care reform in Uruguay: Description of the process and first results Rubinstein A.1, Fernandez J.2, Gianneo O.3, Mollins S.2, Buglioli M.2, Jorcin G.L.2, Rodriguez A.3, Haretche A.3, Pichon Riviere A.L.1 1Institute of Clinical Effectiveness and Health Policy, Buenos Aires, Argentina, 2Ministerio de Salud Pública, Montevideo, Uruguay, 3Fondo Nacional de Recursos, Montevideo, Uruguay Background: Uruguay is undertaking a major health care reform in the financing, organization and delivery of healthcare. One of its components focuses on defining new coverage policies for health technologies. Methods: A consortium composed of the key healthcare regulatory institutions in Uruguay, with the assistance of IECS, was created to define the package of health benefits to the population guaranteed by the new integrated healthcare system. After reviewing the list of services, the consortium decided to consider only those technologies that were controversial. A web-based questionnaire was administered to a group of national healthcare experts using delphi methods to inquiry about the criteria for adoption or not-adoption of a defined list of technologies based on level of evidence, disease burden, cost-effectiveness, budget impact and feasibility considering the local context. Results: 165 diagnostic/therapeutic technologies were randomly assigned to 36 experts. Each technology had a mean of 5 opinions. Expert agreement were observed in 108 (75% recommended for adoption) and disagreement in 48. Based on expert opinion and current coverage status for each technology, 147 (89%) were categorized according to whether a technology should be included for

reimbursement: adopted, adopted but subjected to formal HTA, not adopted but subjected to a deferred formal HTA,and not adopted. Forty-five out of 147(30,6%) were recommended for inclusion in the preliminary list. Conclusions: HTA offers an explicit and transparent approach to set priorities in healthcare. To our knowledge, Uruguay has started the first formal process for definition of a national package of health services in Latin America. T7.2 - Early temporary inclusion of innovative technolog ies on the reimbursement list Collignon C.1, Miquel B.1, Blanchard S.1, Fouteau E.1, Piotto E.1, Galmiche H.1, Josseran A.1, Denis C.1, Meyer F.1 1Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France Objective: Marketing of health technologies relies heavily on their reimbursement by National Health Insurance. In France, it is the remit of the HAS Committee for the Assessment of Devices and Health Technologies (CEPP) to assess medical devices in order to advise on their reimbursement. The CEPP set itself the objective of promoting the early availability of those innovative technologies that show clear signs of potential benefit. Methods: An experimental procedure for identifying and assessing innovative technologies was set up in 2006. It aims to speed up the processing of the manufacturer’s application and/or to incite early data collection for an optimal assessment. Results: The CEPP selected 3 innovative technologies to test the procedure: bioprostheses for transcutaneous aortic valve implantation, devices for the self-measurement of International Normalized Ratio values, and a wheelchair for the handicapped that can climb stairs. It was in favour of the reimbursement of all 3 technologies for an initial limited period on condition that their use or prescription was restricted to certain teams and that studies were immediately initiated to establish their true clinical benefit. Conclusions: Innovative technologies should be assessed using the same criteria as for other technologies. However, as they are expected to represent a significant advance, it is reasonable to take a higher risk on condition that available data, even if sparse, are of high quality. This assessment procedure should be used in exceptional cases only, once the innovative nature of the technology has been validated using established criteria. T7.3 - Application of evidence-based decision-making to purchasing of an imaging system Mitchell M.D.1, Umscheid C.A.1 1University of Pennsylvania Health System, Center for Evidence-based Practice, Philadelphia, United States of America Objective: Assist medical center executives with selection of a replacement fluoroscopy system for interventional cardiology. Methods: Traditional EBM methods like systematic review of the research literature rarely address distinctions between different devices like imaging systems. Therefore novel sources of evidence such as physician preferences, service records and technical specifications of the devices had to be considered. We consulted physicians to identify a set of system attributes. Each attribute was assigned a priority level by physician vote. Tables were then prepared comparing systems on each attribute. Data for the tables came from observation of physicians performing procedures using different devices, interviews with hospital technical staff, manufacturer’s specifications, and published device evaluations. Results: Physician and staff interviews and procedure observations helped us understand users’ concerns about system performance and device interface. System attributes included those related to user controls, patient handling, image quality and analysis, x-ray specifications, interoperability, familiarity, and patient and operator safety. The most important differences were those related to range of view, image quality, and poor compatibility with the existing picture archiving and communications system (PACS). Our analyses suggested that these differences could be minimized by selecting a system with certain configuration options and replacement of the existing PACS (which was no longer supported by the manufacturer). Conclusions: Evidence-based practice centers can contribute to better decision-making in purchasing decisions. Evaluating devices in light of user preference and under the specific conditions where they

will be used facilitates discovery of important differences that may impact decision-making. T7.4 - Assisted reproductive technologies: An evidence-i nformed approach to a funding decision in Alberta, Canada Petzold B.T.J.1, Cepoiu M.2, Chuck A.3, Borowski H.4 1Alberta Health and Wellness, Health Technologies & Services Policy Branch, Edmonton, Canada, 2University of Calgary, Centre for Health Policy Studies, Calgary, Alberta, Canada, 3Institute of Health Economics, Edmonton, Alberta, Canada, 4Alberta Health and Wellness, Edmonton, Alberta, Canada Objective: To present results of a provincial review conducted for the purpose respecting the potential of assisted reproductive technologies (ARTs) as a publicly funded health service(s) in Alberta. Method: At present, ARTs for infertile individuals or couples is available in Alberta, however, these procedures are not regulated, funded or reimbursed. The Schedule of Medical Benefits explicitly identifies: ovarian stimulation and monitoring in association with assisted reproductive technologies; artificial or intrauterine insemination (IUI); and in-vitro fertilization (IVF) as examples of un-insured services. Pressure to fund these services stems from the perceived success IVF in treating infertility and the desire to reduce the incidence and associated cost of multiple births / low-birth-weight babies (that result from pressure on physicians by infertile couples to transfer multiple embryos). Following referral of ARTs by the provincial perinatal program, a review under the Decision Process (government’s evidence-informed process for deciding on funding of health services) was completed. The review considered evidence around safety, effectiveness with the policy analysis considering the impact and role of regulation of ARTs. Results: In December 2007, the STEP analysis was completed, and the stakeholder consultation initiated in February 2008. Policy options were tied to specific goals in the Ministry Business Plan. Conclusion: The issues related to funding of /regulation of ARTs are as much about the social considerations as the evidence regarding effectiveness or safety. The review will enable government to make decisions whether ARTs should be a publicly funded in Alberta in Spring 2008. T7.5 - Supporting and collaborating with clinicians in u sing HTA for making recommendations Frønsdal K.B.1, Graff B.A.1, Kvernmo H.D.2, Hove L.M.3, Husby T.2, Williksen J.H.2, Krukhaug Y.3, Odinsson A.4, Melhuus K.2, Røkkum M.5, Skoglund K.6, Finsen V.7, Norderhaug I.N.1 1Norwegian Knowledge Centre for the Health Services, Oslo, Norway, 2Ullevål University Hospital, Oslo, Norway, 3Haukeland University Hospital, Bergen, Norway, 4St Olavs University Hospital, Trondheim, Norway, 5Rikshospitalet-Radiumhospitalet University Hospital, Oslo, Norway, 6Innlandet HF Hospital, Brumunddal, Norway, 7Norwegian University of Science and Technology, Trondheim, Norway Objective: To support a consensus group of clinicians from the Norwegian Orthopaedic Association in the critical appraisal and summary of evidence that will constitute the basis for making recommendations for the treatment of distal radius fractures in adults in Norway. Methods: Clinicians were taught concepts and methods of HTA and work was carried out principally by themselves under guidance of an HTA methodologist. Methodologist and librarian performed the systematic literature search, whereas clinicians were responsible for the selection of reviews and exclusion/inclusion stages. Clinicians assessed the quality of the studies and were also introduced to the GRADE method of grading evidence. Finally, under supervision they extracted data, summarized the evidence and worked out the conclusions. Results: This method of close follow-up and collaboration allowed clinicians to be introduced and gain experience in methods of critical appraisal and how to make and use HTA for making recommendations in hospitals. Conclusions: Clinicians have been directly involved in the HTA process for making recommendations. In this setting, clinic ians themselves were responsible for working out a systematic review. It may therefore be expected that implementation of the recommendations will be facilitated by the strong clinical involvement. It remains however, to be seen whether this process facilitates adherence to the evidence-based recommendations that were produced. This way of collaborating between HTA methodologists and clinical guideline developing groups may be useful in order to bring the best out of the various disciplinary qualifications necessary to make evidence-based recommendations.

T7.6 - Location, location, location - The impact of heal th care setting of technology use on both HTA results and funding policy Merlin T.L.1, Moss J.2, Hiller J.E.1 1University of Adelaide, AHTA, Discipline of Public Health, School of Population Health and Clinical Practice, Adelaide, Australia, 2University of Adelaide, Discipline of Public Health, School of Population Health and Clinical Practice, Adelaide, Australia Objective: To identify those factors associated with health care setting that were critical in informing the public funding decision when a triage diagnostic test was assessed for use in both hospital emergency department and primary care settings. Methods: The medical literature was searched systematically for relevant studies concerning the use of B-type natriuretic peptide testing in the diagnosis of heart failure. Studies that met the inclusion criteria were stratified by setting of use of the test - primary care (k=8) or hospital emergency department (k=19). Data were extracted on pre-specified safety and effectiveness outcomes, quality appraisal of the literature was undertaken, and a diagnostic meta-analysis was conducted. A trial-based economic analysis and a scenario analysis were undertaken for the emergency department and primary care settings, respectively. Results: Trial evidence in the emergency setting demonstrated that the test was both safe and effective at ‘ruling out’ heart failure and was cost-saving compared to the standard diagnostic strategy. Subsequently, the test was publicly funded for use in this setting. Several factors contributed to the decision NOT to fund the test in the primary care setting: 1) spectrum of disease in this patient population; 2) likely clinical use of the test; and 3) current use of the ‘gold standard’ comparator diagnostic strategy, and thus resource usage. Conclusions: This HTA stratified its assessment, a priori, according to usage of the test in different health care settings, with consequent policy impact. This approach should be considered when assessing triage diagnostic tests. T7.7 - Assessing cost-effectiveness of telehomecare: A s ystematic review of indicators Vergara Roja S.1, Gagnon M.-P.2 1ICESI University, Economic and Administrative Sciences, Cali, Colombia, 2Laval University, Nursing Sciences, Quebec, Canada Objective: Telehomecare is the application of information and communication technologies to provide healthcare to patients in their living environment. Despite increasing evidence of telehomecare benefits, the diffusion of these services is still limited. Decision-makers need strong evidence in order to expand the development of telehomecare to various populations, regions, and health conditions. This study aimed to provide a basis for decision-making by identifying reliable indicators from the international literature on telehomecare. Methods: A systematic review was conducted in healthcare and economic sciences databases to identify, classify, and assess the indicators that better address the cost-effectiveness impacts of telehomecare projects. Results: A total of 23 articles met the inclusion criteria. Indicators were assessed according to their usefulness in assessing the impact of telehomecare in terms of costs, quality and accessibility to health services. A synthesis of cost-effectiveness outcomes was also performed. There is fair evidence of cost-effectiveness for many telehomecare applications. However, the heterogeneity among cost-effectiveness indicators in the applications reviewed and the methodological limitations of the studies impede the possibility to generalize the findings. This suggests the need for developing reliable indicators that could be applied in telehomecare projects. Conclusions: This review has allowed highlighting the importance of the specific context in which telehomecare projects take place, meaning the different patients, environments, and health systems, as well as the characteristics of the technology. These findings will be of great relevance for decision-makers involved in analyzing and implementing telehomecare projects. T7.8 - HTA: Critical points for “medical” software

Fregonara Medici M.1, Miniati R.2, Dori F.2, Iadanza E.2 1Azienda Ospedaliero-Universitaria 'Careggi', Clinical Engineering Dept., Firenze, Italy, 2Università degli Studi di Firenze, Electronics and Telecommunications Dept., Firenze, Italy Objective: Recent European Directive 2007/47/EC turns clinical software into Medical Device (MD). This study aims to explore and to evaluate the HTA process for clinical software. The goal is locating Key Performance Indicators ‘KPI’ that could be included from traditional MD HTA and from software engineering. Methods: Systematic review of HTA processes was performed to better understand the typical multidisciplinary approach. Particular attention is due to new general prescriptions about a risk management process for clinical software as a medical device. Indicators from traditional HTA were evaluated according to the following criteria: “which ones are suitable for both HTAs?”, and if applicable, “how can I adapt their meaning to the software (what is its usability for sw?)”, “is the insertion of different indicators necessary (systems integration)?” or “can the priority scale be modified (maintenance, formation, quality documentation)?”. Results: Three groups of KPIs are provided classifying traditional HTA indicators. The first one includes indicators suitable both for software and Medical Device processes, the second one including parameters typical of medical devices, needing conceptual adaptations from software engineering (e.g. usability is replaced by interface complexity). The last group includes KPI specifically coming from software engineering replacing traditional not applicable indicators. Conclusions: The proposed methodology allows indicators for “medical” software HTA to be evaluated by taking into consideration the typical medical device evaluation methods and the measuring parameters related to informatics. The new European Directive approach to software led this study to be inserted in a process of guideline proposition. T7.9 - Impact of exercise training on morbidity and mort ality due to pulmonary disease Blanchard S.1, David D.J.1, Lee Robin S.H.1 1Haute Autorité de Santé, Service Evaluation des Actes Professionnels, Saint Denis La Plaine, France Objective: Impaired respiratory function due to common and severe diseases such as chronic obstructive pulmonary disease (COPD) and asthma impacts on morbidity and mortality and on the patient’s ability to perform daily tasks. We assessed the clinical benefit of exercise training using ergometric equipment in order to advise French National Health Insurance (NHI) on reimbursement. Methods: We performed a systematic review of the literature on exercise training in COPD (2002-2007). Results were discussed by multidisciplinary working groups of 13 professionals and then submitted to the relevant HAS Committee for their opinion. Results: An improvement in dyspnea was reported (7 trials, n=2299 patients). The mean gain in the 6-minute walk test ranged from 60 to104 metres according to disease stage (3 meta-analyses, 5 trials, n=3180). An improvement in quality of life was recorded (5 trials, n=2300). There was a reduction in the number of exacerbations (of 50%), in the number and length of hospital stays, and in the relative mortality risk (0.46 [95% CI 0.22-0.91]) (7 controlled trials, n=412). Conclusions: The efficacy of exercise training in COPD is proven (improved dyspnea status, exercise tolerance, and quality of life, and a reduction in mortality). Endurance training using ergometric equipment should be tailored to the patient and, together with therapeutic education, should be a key component of pulmonary rehabilitation. HAS recommended reimbursement of the procedure by French NHI. T7.10 - What factors impact public policy and coverage de cisions beyond the evidence? Alberta s experience with islet cell transplantatio n (ICT) Harstall C.1, Guo B.1, Stang D.2, Borowski H.2 1Institute of Health Economics, Edmonton, Canada, 2Alberta Health and Wellness, Edmonton, Canada Issues: After the landmark study on ICT- Edmonton Protocol published in 2000 by the University of Alberta Hospital transplantation team, ICT hospital costs were covered through the Province Wide Services (PWS) Program starting 2001. Consequently, the Health Ministry was faced with policy challenges including clarifying whether ICT was an insured service or being provided under a research

protocol. Out-of-province residents accessing this service had an impact on the inter-provincial billing agreements and received national media attention. Methods: (Involvement of HTA in decision-making process). The provincial HTA agency was approached to analyze the scientific evidence on the safety and efficacy of ICT for patients with type 1 diabetes and to assist the Ministry in clarifying the status of ICT, provide information to resolve reciprocal billing concerns, and inform a decision on whether to reimburse physicians. The resulting HTA report, published in 2003, concluded that ICT is an evolving procedure with promising results but not yet to be considered as standard of care. Results: ICT would not be an insured service in Alberta, but the PWS would continue to cover ICT hospital costs. There would be no reimbursement for physicians for performing ICT. The health region was directed to recover the full costs of providing ICT to out-of-province residents. Conclusions: ICT illustrates that important factors beyond the scientific evidence played a significant role in the decision-making process as ICT - Edmonton Protocol was an Alberta innovation. Various models have been proposed for enhancing decision-making by incorporating both scientific and contextual evidence. T7.11 - What can the Health Technology Assessment Communi ty do to support the United Nations’ Millennium Development Goals for Health? Vondeling H.1 1University of Southern Denmark / Institute for Public Health, Health Economics, Odense, Denmark Objective: In 2000, the United Nations formulated the Millennium Development Goals, which should be met by 2015 by all 191 Member States. Health is directly represented in three of the MDGs; goal 4): to reduce child mortality, goal 5): to improve maternal health, and goal 6): to combat HIV/Aids, malaria and other diseases. Searching the HTAi- and INAHTA- website and the International Journal of Technology Assessment in Health Care using MDGs as search term does not result in any relelevant hits, perhaps indicating limited awareness of the MDGs for health in the HTA Community. The objective of this presentation is to put the MDGs for health (higher) on the agenda of the international HTA community and to stimulate discussion on its potential contribution. Methods: A brainstorm with colleagues. Results: A special interest group could be established focusing on the MDGs for health or, alternatively, this could be facilitated by a special interest group on developing countries, which could be revived. The goal could be to list and assess interventions relevant to the MDGs for health and to stimulate research on implementing the findings in policy and practice. Monitoring of progress towards meeting the promised contribution to the MDGs for health by developed countries could be organized by e.g. INAHTA or general HTAi members on a per country basis. Conclusions: There are many possibilities for the HTA community to support the MDGs for health. Finally, the pros and cons of the current MDGs for health will be briefly discussed. T7.12 - Indicators for the assessment of healthcare innov ations Buehrlen B.1, The Inno-HTA Consortium 1Fraunhofer Institute for Systems and Innovation Research, Emerging Technologies, Karlsruhe, Germany Objective: Innovations in healthcare are discussed controversially, with high uncertainty about costs and outcomes. In part because of methodological constraints, HTA mainly restricts itself to treatments that are already marketed. Regarding emerging health technologies, the assessment criteria commonly used do not support the many decisions that need to be made in earlier phases of the development process. Therefore, advances in technologies and treatments are not sufficiently utilized. Methods: In the EU-funded project "Inno-HTA" indicators for early evaluation of health innovations are developed (http://www.inno-hta.eu). Based on an elaboration of the "innovation system" of all relevant actors with their informational needs and an overview of HTA methods for emerging technologies, a draft set of indicators was developed. Results: The draft set includes indicators to cover the following dimensions:

- ethical issues - knowledge base and knowledge transfer - R&D costs - availability and access - clinical utility - practicability - costs of treatment and health expenditures - health needs and health outcomes - efficiency - safety - profitability and competition - production location and employment effects - information and education - ecology. The draft list is tested in case studies and undergoes a consensus process with producers and users of HTA reports, the results of which are presented and discussed. Conclusions: To support the interest groups’ decisions around emerging healthcare technologies, a broad set of indicators is necessary. Despite difficulties in data availability, HTA can make valuable contributions to the assessment of healthcare innovations. HTA Organization 2 T8.1 - Implementation of a training programme on evidenc e-based medicine (EBM) and health technology assessment (HTA) in the framework of a t winning project between France and Poland Laborde C.1, Xerri B.1, Lipska I.2, Pajor A.2, Sauvage P.3 1Haute Autorité de Santé (HAS), Saint Denis La Plaine, France, 2Agency for Health Technology Assessment (AHTAPol), Warsaw, Poland, 3Ministry of Health, Youth and Sports, Paris, France Objective: In October 2006, Poland and France signed a twinning contract co-financed by the European Union. Its aim was to reinforce compliance with the provisions of Council Directive 89/105/EEC on the transparency of reimbursement decisions relating to pharmaceuticals in European National Health Systems. Within the global project, our objective was to set up a training programme in EBM and HTA for about 250 state employees (producers or users of HTA reports) in order to improve the decision-making process in Poland. Methods: The project had 4 steps: (i) diagnosis (review of Polish training programmes and analysis of professional needs); (ii) establishing a training programme agreed by both parties; (iii) implementation of the programme; (iv) assessment by trainees. Results: Over 40 experts from public institutions or universities in France, the UK, Germany, Spain, and Denmark acted as trainers or tutors. The needs of 30 producers of HTA reports (“doers”) were met by about 10 training sessions. Specific sessions were designed for nearly 200 “users” of HTA reports. Nine members of staff from the Polish HTA agency underwent internships in European HTA agencies. Feedback from trainees has been very good. Conclusions: The project has given rise to an informal network of HTA experts in Europe and could benefit public institutions elsewhere. However, it is still too early to assess the impact of the training sessions on the Polish decision-making process. T8.2 - International cooperation in HTA: The participati on of the Ministry of Health of Brazil as a member of INAHTA Serruya S.1, Pontes U.2, Camargo E.2, Albuquerque I.2, Elias F.2, Guimarães R.3 1Ministry of Health of Brazil, Department of Science and Technology, Brasília, Brazil, 2Ministry of Health of Brazil, General Coordination of Health Technology Assessment, Brasília, Brazil, 3Ministry of Health of Brazil, Secretariat of Science, Technology and Strategic Inputs, Brasília, Brazil Objective: Since June 2006, the General Coordination of Health Technology Assessment (CGATS) of

the Department of Science and Technology of the Ministry of Health of Brazil (MoH) is a member of INAHTA. We aim to analyze the cooperation supported by MoH in this network. Methods: Investigation of activities related to participation at INAHTA: its obstacles, advances and challenges, from June 2006 to December 2007. Results: CGATS’ team participated in two international HTAi’s meetings and presented 7 scientific papers; attended 13 surveys; and takes part in two INAHTA’s work groups: “External Partnerships” and “Impact of HTAs”. CGATS disseminated the use of the Centre for Reviews and Dissemination Databases (CRD) to provide information to the Brazilian HTA courses alumni through an electronic network; and organized an international seminar with speakers from four INAHTA’s agencies. This seminar received almost 200 Brazilian professionals who deal with HTA and Science and Technology from the entire country. Conclusions: These activities improved the Brazilian actions on HTA dissemination, collaborated to CGATS’ enhancement and permanent upgrade of MoH’s Webpage in three languages; stimulated the interest in HTA among professionals and researchers of Brazilian Public Health System and increased the interchange of experience among Brazil and other members, expanding the frontiers of knowledge. Main obstacles: access to information in other language and yet the restrict number of Brazilian HTA teams. Main challenges: to establish specific collaborations for Brazilian professionals training and to improve dissemination mechanisms intended for the international community of HTA activities from the Ministry of Health. T8.3 - Assessment of orphan drugs by the Haute Autorité de Santé Delval C.1, Meyer F.1 1Haute Autorité de Santé (HAS), Saint Denis La Plaine, France Objective: To review the opinions of the French Transparency Committee (TC) with regard to the Actual Benefit (AB) and added value (Improvement in Actual benefit (IAB)) of orphan drugs and to compare the results with those obtained for other new drugs. Methods: The TC assesses AB using a 4-point rating (significant, moderate, low, insufficient) and IAB using a 5-point scale from level I (major improvement) to level V (no improvement). We compared the results obtained for all orphan drugs that have been assessed by the TC with the results for new drugs assessed over the period January to December 2007. Results: Overall, 50 orphan drugs have received a European centralized marketing authorisation since the Committee for Orphan Medicinal Products (COMP) was established. Of these, 37 were submitted to the HAS for inclusion on the list of reimbursable drugs. They were all considered to provide significant AB (100%) and all received a positive opinion for listing. The added value of 31 orphan drugs was assessed. Of these 25/31 (81%) provided major, significant, or moderate added value (IAB levels I to III). The corresponding percentages for all new drugs were 85% (AB) and 11% (IAB). Conclusions: Orphan drugs generally receive a positive opinion from the TC despite the fact that scientific evidence available is very much weaker than for other new drugs. A higher percentage of orphan drugs than other new drugs provide major, significant or moderate added value, probably because they are considered to meet a strong need. T8.4 - An international comparison of health technology assessment organisations Moharra M.1, Kubesch N.1, Estrada M.D.1, Cortés M.1, Parada A.1, Espallargues M.1 1Catalan Agency for Health Technology Assessment and Research, Barcelona, Spain Objective: International comparison of characteristics and processes of HTA organisations to show their similarities and differences. Methods: Cross-sectional survey by means of a semi-structured questionnaire sent via email to 149 directors of HTA organizations identified worldwide. The inclusion criteria were any institution performing HTA whenever the contact details were available. Results: The overall response rate was 35% (N=52). The main barriers that HTA governmental (42.5%) and non governmental organisations (57.5%) experienced during the establishment period were Gathering trained staff (29.4% and 38.1% respectively) and Funding (26.3% and 23.8% respectively). However, governmental HTA organisations reported Reaching political interest (23.5%) as a barrier whereas non governmental organisations ranked not only Reaching political interest (19%)

but also Impact on target groups (19%). When comparing barriers with the year of establishment, the organisations established from 2000 to 2007 ranked all the categories higher than the other groups, especially Funding (50%) was the highest ranked. HTA was the main line of activity reported by governmental HTA organisations (94.1%) followed by funding research (41.2%) whereas non governmental HTA organisations reported not only HTA activity (74.0%) but also Performing (or doing) some kind of research (74.0%). Conclusions: There are common aspects and barriers experienced by the organisations regardless of their profile or years of experience conducting HTA activities. Collaboration among HTA organisations either at national or international level could lead to overcome resistance to barriers such as training staff and funding in particular at international level through attracting research grants. T8.5 - Early release of evidence to inform policy decisi ons Husereau D.1, Larsen C.1 1Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada Objective: Policy decisions cannot always wait until health technology assessment (HTA) reports are publicly released. This session will outline how the Canadian Agency for Drugs and Technologies in Health (CADTH) is facilitating access to information from HTA reports prior to their finalization. Methods: A description of the identified benefits and harms of a formalized approach for evidence producers, policy makers and knowledge brokers is presented. Additionally , real-life examples of the early release of evidence and their impact on policy decisions is provided. Results: More than 24 requests for early release of information have been completed since April 1, 2007, shortly after the establishment of a formalized process. Challenges with this process relate to understanding the potential benefit to individual decision-makers and subsequent decisions regarding the appropriate level of shared information. Particularly, early release decisions often involve weighing the potential harm of disseminating information that may lack validity and the perception of inequity from other decision makers against the benefit to the individual requester. Customizing to individual needs has led to a wide variation of response, including sharing of report summaries, portions of reports, and full reports; face-to-face presentations; and verbal consultation. Conclusions: Having a formalized process for early release may lead to more evidence-informed recommendation- and decision-making, by providing needed information in a consistent and rapid manner. T8.6 - Health technology assessment research groups in B razil Godoy M.R.1, Silva E.N.1 1Federal University of Rio Grande do Sul, Economics, Porto Alegre, Brazil Objective: Analyze the supply of human capital in health technology assessment in Brazil. Methods: Source for health technology assessment research groups on The National Council for Scientific and Technological Development (CNPq), which is an agency linked to the Ministry of Science and Technology, dedicated to the promotion of scientific and technological research and to the formation of human resources for research in the country Results: Nowadays there are 16 research groups that carry out health technology assessment (HTA) research. Of these, 9 groups focus on collective health, 4 on medicine and 1 on economy, pharmacy and biomedicine engineering. Most of the groups are stated at the South and Southeast of Brazil. There is no HTA research group in the North. On average, the research groups’ lifetime is 6 years. Six of them were established until 2000; three during 2001 and 2005; and seven after 2005. Information from CNPq’s census in 2006 reported that 71 researchers were carrying out studies on HTA, and 10 on health economic evaluation. Conclusions: Despite significant increase in number of research groups, the human capital shortage, particularly in economic evaluation, is still a problem to be solved in Brazil, even considering the recent investment of Ministry of Health of Brazil that has financially supported seven graduate courses in HTA. T8.7 - Improving HTA within Turkish Minstry of Health

Tokac M.1, Kahveci R.1, Bulun M.1 1Ministry of Health, General Directorate of Pharmaceuticals and Pharmacy, Ankara, Turkey HTA -being a very important tool for evidence based policy making- should be promoted and supported in decisionmaking bodies of each and every country. It could either be a governmental body or an arms-length body. In Turkey most important decisionmaking bodies in health care are the Ministry of Health and Social Security Institution. These two bodies sometimes involve other stakeholders in these processes as well. General Directorate of Pharmaceuticals and Pharmacy in Ministry of Health basically has the responsibility of licencing and pricing of the pharmaceuticals-as well as pharmacovigilance and medication safety. The Directorate has also a major role in reimbursement decisions in collaboration with Social Security Institution, Ministry of Finance, academics and industry representatives. HTA awareness has recently been raised within the Directorate and the need for training has been declared. Current pharmacoeconomics department was improved and an HTA expert has started to work in the department. Trainings on basic concepts have been arranged and human resources is still trying to be improved. Recently it has also been decided to use a translated version of EUnetHTA adaptation toolkit and also further trainings and international study tours have been arranged. A Project for establishment of an HTA unit within the Directorate has been proposed to WHO. Recent attempts for promoting HTA in the Turkish Ministry of Health is encouraging and emphasizes strength of the idea of transferring the decisionmaking culture from a traditional expert opinion based to evidence based policymaking. T8.8 - HTA - Crawling to first steps. Raising awareness in Turkey Kahveci R.1, Bulun M.1, Baydar A.1 1Turkish Evidence Based Medicine Association, Ankara, Turkey The Turkish Health care system is currently undergoing reform and efficient use of resources has become a key factor in determining the allocation of resources and HTA has been reported as one of the major health care challenges in Turkey. Following a SWOT analysis in development of an HTA program in Turkey- which was presented in HTAi 2006 in Adelaide and later published- an action plan to overcome potential barriers for implementation of HTA was made and major issue declared then was ‘raising awareness’. Any further steps could not be expected if HTA awareness is not gained. This major weakness is the basic barrier for a future establishment of HTA, as policymakers need to know what changes HTA could bring to health policy field. Since then an intensive effort has been spent in order to raise awareness among policymakers as well as the industry representatives and academics. Several seminars have been run, presentations in conferences given, articles published and currently a webpage is being developed. An HTA working group has been promoted within Evidence Based Medicine Association which has made an action plan for the following year including a flexible training program for HTA targeting busy professionals. The group also pays special attention to relations with interested international parties. HTA can be a great tool in restructuring health care by facilitating the allocation of resources in relation to the goals of the healthcare policy makers and now seems the best timing to introduce HTA to Turkish health care system. At this time needed is to let related parties discover their need for such a tool. T8.9 - Preliminary evaluation of heath technology manage ment post graduate course Camargo E.B.1, Elias F.T.S.1, Silva M.T.1, Veloso S.C.S.1, Laranjeira F.O.1, Serruya S.J.1 1Ministry of Health of Brazil, Department of Science and Technology, Brasília - DF, Brazil Background: In the year of 2006, the Ministry of Health of Brazil, in partnership with academic institutions started the implementation of a post-graduation program in Health Technology Management (HTM), because there are few formal programs in this field. The training action in HTM aims to promote competences, abilities and attitudes in different modalities and knowledge areas involved in health technologies assessment. Objectives: to present the results of the first partial evaluation of 4 Master’s program and 1 Specialization program.

Methods: The evaluation was done by sending a questionnaire (n=120) using the e-mail tool. Results: In relation to the responses (n=20), 75% agree the aims of the course are clear; 62% agree that the course attends with success to the initial objectives presented; 25% agree that the instructors inform about the of the students performance; 75% agree that the exercises are useful and contribute to the learning process; 25% agree that the course workload is reasonable; 75% agree that is understanding the concepts in this field and 75% agree that the materials and handouts are useful in contributing to the learning process. At the end of the questionnaire, 95% recommends the course for future students. Conclusion: The response of the questionnaire was low (16.66%), even though there was a month deadline. This program intends to create a link between the trained students, academic institutions (teaching and research), the decision makers and users to prepare and develop the Brazilian Network of Health Technology Assessment (REBRATS). T8.10 - Trans Tasman harmonisation difficulties in inter- country regulatory developments Kearney B.1 1Institute of Medical & Veterinary Science, ADELAIDE, Australia Objective: This paper explores the history of development of a Trans Tasman regulatory authority for health care. Such a body would replace MedSafe New Zealand and TGA Australia, both regulatory bodies that cover drugs, devices, prosthesis and other medicines. Both Australia and New Zealand through their Trans Tasman mutual recognition wish to develop in the interests of trade, harmonised regulatory arrangements and had determined that there were compelling issues for Australia and New Zealand to form a health technology regulatory authority spanning both Nations. Methods: A review of the literature over nearly a decade relating to the development of a Trans Tasman authority has occurred. This literature involves papers from the Australian and New Zealand Governments, industry, the community and patient groups. Results: A description of a decade long attempt to establish a Trans Tasman regulatory authority. The details behind such an authority which could act as a template for the development of other regional or continental harmonisation efforts of regulatory bodies. Conclusions: Despite enormous effort and support for a Trans Tasman regulatory authority from the Australian and New Zealand Governments, from industry, a number of issues arose and an analysis of such issues that may impair the establishment of a harmonised regulatory authority will be discussed. T8.11 - What does monitoring of new health technologies i mply - The EUnetHTA perspective Carbonneil C.1, Quentin F.1, Moty-Monnereau C.1, Lee-Robin S.H.1, European Network for Health Technology Assessment (EUNetHTA), Work Package 7 1Haute Autorité de Santé, Department of Medical and Surgical Procedures Assessment, Saint Denis La Plaine, France Objective: Clinical data on the efficacy or effectiveness of new technologies are often sparse. Data collection is thus a requirement for the conditional use and introduction of a new technology (marketing authorisation, reimbursement...). A European network for Health Technology Assessment (EUnetHTA) is being set up to coordinate health technology assessment in Europe. It is financed by the European Commission (2006-2008). Currently, 27 European countries are taking part in the project. One of the aims of Work Package 7 (WP7) is to review the different types of monitoring systems used by WP7 partners. Methods: Data were collected by a systematic review of the literature, e-meetings, a workshop, and 2 surveys of European experience. Results: WP7 arrived at the following definition of a monitoring system: “an organised system to systematically generate and collect additional data on new health technologies from the moment they are introduced into the healthcare system”. Monitoring follows an initial assessment leading to an interim conditional decision suited to the technology (temporary authorizations of use, conditional marketing authorisation, conditional coverage...). It helps trace how widely the technology has been diffused (e.g. interim coding...). Once the monitoring is over, a reassessment provides a revised decision based on the evidence that has been collected. Conclusions: Since monitoring systems are expensive and time-consuming, monitoring should be restricted to promising new technologies only, and should be performed under appropriate conditions.

Criteria for selecting technologies to be monitored should be developed. HTA uptake, knowledge translation 2 T9.1 - Complexity and economic evaluation: A decision-ma ker’s perspective Husereau D.1, Clifford T.1 1Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada Objective: To describe attitudes toward the use of economic evaluation by drug review and recommendation committees as well as perceptions by committee members of the incremental value of complexity in economic evaluation. Methods: A structured interview of representatives from 2 national (Canadian) drug listing recommendation committees, 5 provincial committees representing 8 Canadian provinces, and 1 hospital committee. Results: The average committee size was 13 persons, with an average of 1 health economist per committee. All but 1 committee had a formal requirement for economic evaluation in their deliberative processes. Committee members consistently identified barriers to use of economic evaluation for decision making, including difficulties understanding economic evaluation and general skepticism toward results of economic evaluations. Attitudes towards the need for additional complexity in economic evaluation varied, including the perceived value of probabilistic sensitivity analysis, Bayesian meta-analysis, and mixed-treatment comparison meta-analysis. Some types of additional analysis, including threshold and sensitivity analysis regarding surrogate marker validity were consistently viewed as important. Conclusions: The results of this study highlight the need for further understanding of economic evaluation in those involved with pharmaceutical listing decisions. There may be a disconnect in the perceived importance of certain types of analysis between those conducting economic evaluation and those using them. T9.2 - Strategies to bridge the gap between HTA and deci sion-making in Brazil Rodrigues C.1 1Health Regulatory Agency (ANS), DIPRO, GGTAP, Rio de Janeiro, Brazil Brazil faces two different social realities: for the rich (40 million people) are provided high quality services and good technological infrastructure, while the poor (146 million people) have public hospitals and services lacking basic supplies and updated health technologies. HTA has been developed in Brazil as an additional tool to reduce this social dichotomy by distributing the limited health public and private resources in a more rational way. In this context, some public policies and programs on HTA were developed by the Brazilian Ministry of Health and Health Regulatory Agencies (ANS and ANVISA). Despite these efforts and initiatives, the programs and actions on HTA applied by the Brazilian Government are composed by isolated initiatives. Besides, they are not completely linked to the decision-making process. Strategies proposed to strength the HTA program and to bridge the gap between HTA and the decision-making process in Brazil include: assess all HTA dimensions, specially the social aspect; develop HTA methodologies and update guidelines on the Brazilian sociocultural context; elaborate HTA reports and guidelines adapted to the decision makers; develop strategies to guarantee the continuity of HTA programs, despite the political changes; develop political policies that balance the strengths and limitations of all research evidence with the practical realities of the healthcare and clinical settings; create programs for collection, analysis and dissemination of information on HTA and guidelines; strength the multidisciplinary research on HTA; and create a research net on HTA in Brazil composed by different actors, including the decision makers and patients. T9.3 - Influence of HTA on the decision making process i n Brazilian Public Health System Laranjeira F.O.1, Louly P.G.1, Conti M.A.1, Silva M.T.1, Albuquerque I.1, Silva E.N.1, Godoy M.1, Serruya S.J.1, Elias F.T.S.1

1Ministry of Health of Brazil, Department of Science and Technology, Brasília - DF, Brazil Nowadays, it has been discussed in many countries the impact of HTA in the practice of health decision making. In Brazil, the tool to assess this contribution is counting how many appraisals produced by HTA-General Coordination (HTA-GC) were used on Council of Technology Incorporation’s (CITEC) decisions, relating to new technologies incorporation on Brazilian Public Health System. In this context, the aim of this work was to analyze how the HTA appraisals were used on helping CITEC’s decisions from 2006 to 2007, by the analysis of the meetings’ background. CITEC is a permanent institution coordinated by the Secretariat of Health Attention at Ministry of Health, of which aim is to analyze solicitations of health technology incorporation, according to health and social needs and Brazilian Public Health System’s interests. On the 21 CITEC’s meetings that happened from March/2006 to February/2008, seven HTA appraisals had been used as reference material to support the decision making process. From the whole of assessed technologies, one was incorporated, four was not incorporated and for two of them it was asked budget impact studies. It is recommended that the quality of HTA appraisals should be assessed by CITEC’s members by using an adjusted tool to estimate the applicability of their results in the decision making practice by Brazilian Public Health System’s decision makers. T9.4 - Bringing context into the health technology asses sment process Larsen C.1, Gartenburg K.1, Noorani H.1, Robertson N.1 1Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada Objective: A good understanding of context is key to ensuring research evidence appropriately informs policy and practice decisions. This poster will outline the key ways the Canadian Agency for Drugs and Technologies in Health (CADTH) is bringing context into its health technology assessment (HTA) topic prioritization, research process and knowledge transfer. Methods: Context on a potential HTA topic is gathered from decision makers across Canada prior to topic prioritization. Contextual information collected includes: expected level of interest in the topic; potential impact on policy and practice decisions; opinion leaders/collaborators; controversy related to the technology; availability and public-system coverage status; jurisdictional research initiatives; and, variations in rates of use. This information complements the core systematic HTA topic prioritization process by providing additional information for consideration. Results: Context information gathered is used by an advisory committee to help prioritize potential HTA topics. It is also used to determine the level of effort of knowledge transfer, as well as specific knowledge transfer planning, tactics, and outreach. Conclusions: Gathering and using appropriate context around an HTA topic can help improve relevance of HTA topics to better meet decision maker needs, as well as support knowledge transfer plans, tactics and outreach. T9.5 - National collaboration in action: COMPUS and the CADC Allen M.1, Rees S.2, Nguyen A.3, Bunka D.4, Regier L.5, Bugden S.6, Morrow R.7, Bean T.8 1Dalhousie University, Continuing Medical Education, Halifax, Canada, 2Canadian Optimal Prescribing and Utilization Service, Edmonton, Canada, 3British Columbia Department of Health, Vancouver, Canada, 4Academic Detailing Calgary Health Region, Calgary, Canada, 5Rx Files Academic Detailing, Saskatoon, Canada, 6Prescription Information Service of Manitoba, Winnipeg, Canada, 7Therapeutics Initiative, Vancouver, Canada, 8Centre for Effective Practice, Toronto, Canada Objective: Academic detailing is a form of continuing medical education in which a trained health care professional visits physicians in their offices to proved one-on-one evidence-based educational information. The Canadian Academic Detailing Collaboration (CADC) is a group with representation from academic detailing programs across Canada (BC, AB, SK, MB, ON, NS). For several years, the Collaboration has worked with the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) to promote academic detailing and to facilitate the dissemination of evidence-based messages. The purpose of this project was for the CADC and COMPUS to jointly develop and disseminate evidence-based recommendations about optimal prescribing of proton pump inhibitors. Methods: COMPUS developed evidence-based information about the proton-pump inhibitors through an extensive review of guidelines, systematic reviews, and primary publications. Members of the

CADC worked with COMPUS to create key educational messages and knowledge transfer tools including: interactive case studies, a newsletter, an alternate prescription pad to promote lifestyle changes, a cost-comparison chart, an upskilling document, a GI evidence overview, an evaluation framework, and a current-practice analysis. Results: Member programs of the CADC are delivering consistent, evidence-based messages about prescribing proton pump inhibitors to community-based clinicians across Canada. Conclusions: COMPUS and the CADC are an example of national and provincial evidence-based groups working together to promote optimal prescribing. T9.6 - Knowledge management in the Center of Documentati on of PAHO Nahuz F.1 1Pan American Health Organization, Documentation Center, Brasília/DF, Brazil Objective: Share in the process of parenting, capture, assimilation, and dissemination of tacit knowledge of every area/individual of PAHO, integrating it in the organizational knowledge, to be used as useful subsidy to the various activities in the area of the organization. Methods: Case study. Results: Organizational Memory, Maps of Knowledge Bank of knowledge lessons learned, better practices, alerts, Tests of individual formal Knowledge Communities of Practice, eye and virtual Forums, Communities of problem solving, Education Continuous and Mapping of Competences. Conclusions: Capture of the tacit and explicit knowledge of PAHO, Acquisition of information of a source, and promotion of its recycling in other situations, knowledge Collaboration, and sharing. Patients & Consumers 2 T10.1 - A framework for users’ involvement in the develop ment and evaluation of innovative medical devices: A case study Shah S.G.S.1, Meier P.A.2, Robinson I.1 1Brunel University, Centre for the Study of Health and Illness, School of Social Sciences, Uxbridge, Middlesex, United Kingdom, 2ETHICON GmbH, Research & Development, Norderstedt, Germany Objective: The involvement of medical device users, both clinicians and patients, is crucial to ensure success in the medical device development and evaluation process. This paper presents an exploratory framework to characterise such involvement focusing on particular types of users, their respective roles at each stage of the device development cycle, and the methods used for that involvement in the development and evaluation of an innovative device for stress urinary incontinence (SUI). Methods: Application of the theoretical framework using qualitative evaluation of users’ involvement in the development and evaluation of a SUI device. The participants in the study were female SUI patients (n=200) and surgeons (n=20). Results: Both clinicians and patients were involved in the development and evaluation of the SUI device. Clinicians were involved throughout the device development cycle from conceptualisation to market deployment. The end users of the device (patients) were involved in the final stages of testing, formal trials and then market deployment. Techniques utilised to determine users’ perspectives included the ‘voice of the customer’, expert meetings, formal interviews, ‘brainstorming’ sessions, and in vitro and in vivo testing, as well as conventional market research. Conclusions: The involvement of users, both clinicians and patients, from the conceptualisation of the device to market launch is a key to effectively meeting hitherto unmet needs of those users. An iterative users’ involvement process such as that used here helps mitigate device design technical problems. Users, especially clinic ians, feel positive as part of this innovative device development process. T10.2 - A model for investigations of patient- and citize n aspects in HTA Hansen H.P.1

1Southern University of Denmark, Institute of Public Health, Odense C, Denmark Objective: The aim of this presentation is to present and discuss a model for the investigations of patient- and citizen aspects in health technology assessments. Methods: The Danish Handbook for Health technology assessments has just been published. One of the chapters is devoted to patient- and citizen aspects presenting a new model for investigations of patient- and citizen aspects in HTA’s. This model is the focal point of the presentation looking at its components and the relationship between the components. The model is based on theories from anthropology and sociology. The model is complex and comprises; communicative-, individual-, ethical-, economical and socio-cultural relations and conditions. The different components are interrelated and must be seen in relation to at least two themes; 1) the meanings of the technology in the everyday lives’ of patients and 2) the patients’ experiences with the technology. Results: This model opens up for articulating some of the context-dependent, ethical and psycho-social objectives. The investigation of patient- and citizen aspects is needed in order to increasing HTA’s impact on decision-making and to strengthen its ability to become a multidisciplinary science. Patient- and citizen aspects are relevant in order to appraise the value of for instance screening-, treatment-, and/or rehabilitative interventions. But it is necessary to see patients and citizens in relation to socially and culturally enacted practices for instance clinical encounters between a nurse/doctor and a patient. Conclusions: In future HTA’s it is important to develop scientific ways of including and working with patient- and citizen aspects. T10.3 - Patient involvement in HTA: Experiences in the co mmunity of Madrid agency (UETS) Díaz del Campo P.1, Gracia J.1, Hoffmann O.1, Blasco J.A.1, Fernández de Larrea N.1, Izquierdo F.1 1Agencia Laín Entralgo, Unidad de Evaluación de Tecnologías Sanitarias, Madrid, Spain Objective: To describe experiences of patient involvement in the HTA development process and to set up a patients´ network to promote patient participation for guiding future projects. Methods: We have involved patients from the beginning of the developing process of a clinical practice guideline (CPG) for anxiety disorders. Techniques used include participant observation, focus groups and in-depth interviews. Moreover, patients have been an important part of the guideline development group. To produce the information for patients in the mentioned guideline as well as in other CPG (osteoarthritis of the knee), subgroups with patients were created to assess comprehensibility and applicability of the information. Selection of people for the patients’ network is being initiated through qualitative techniques. Results: Patient participation gave us the possibility to develop a CPG for mental health in primary care including patients´ interests. Also, in terms of patient information, patients’ involvement led us to develop useful advice for knee osteoarthritis and anxiety disorder patients. A patients network is being developed to get to patient participation from the preliminary phases in the projects of the Madrid HTA Unit: systematic reviews, rapid reviews, health technology reports, economic evaluations, health services research, clinical practice guidelines and patient decision aids. Conclusions: Patient involvement in some projects of our HTA Unit has contributed to a greater value of final HTA products. The creation of a patients´ network in the Community of Madrid will be useful as groundwork for patients’ participation in future HTA researches. T10.4 - Public involvement in health technology assessmen t: The views of patient and consumer organizations Fattal J.1, Lehoux P.2 1University of Montreal, Dept. of Health Admin., Montreal, Canada, 2University of Montreal, Dept. of Health Admin., Groupe de Recherche Interdisciplinaire en Santé, Montreal, Canada Objective: While several scholars suggested that patient and consumer’ organizations should be involved in Health Technology Assessment (HTA) and be part of the debate concerning health technology-related policies, very little is known about their organizational capacity to do so. While looking at the organizational capacity of patient and consumer organizations, we aim at defining what

cultural and organizational aspects are required to get involved in HTA and how these organizations could adapt to this task. Methods: Relying on an organizational capacity development conceptual framework (OCD), we interviewed 16 patients and consumers organizations from Ontario and Quebec, which were stakeholders of four controversial HTA reports. Results: We report the operational and adaptive capacities of our respondents according to four issues: Mission and Interpretive Scheme; Structures and Processes; Resources; and Networking. Cultural aspects are primary elements when deciding to be involved. Respondents identified various ways in adapting structures and resources. Four primary reasons for collaboration were identified: usefulness, resources, shared values and a satisfying level of involvement. Conclusions: An empirically-derived framework that expands on the OCD framework is proposed to summarise our findings and explain how a greater involvement of patient/ consumer organizations could be developed in the field of HTA. This framework seeks to provide guidance to researchers when targeting such organizations to be involved in the process and when planning structures and services to support these organizations’ needs. T10.5 - Why are decision technology promoters interested in patient and public involvement? A discourse analysis of clinical practice guideline d eveloppers Boivin A.1 1Agence de Santé et Services Sociaux de l'Abitibi-Témiscamingue, Département de Santé Publique, Rouyn-Noranda, Canada Objective: To describe guideline developers’ discourses on the goal of considering patients’ preferences in guideline development. Methods: Qualitative study using discourse analysis. The study population included developpers of clinical practice guideline for chronic conditions in the United Kingdom, purposively sampled (n=18) to include representatives of 1) patients and carers, 2) health professionals, and 3) public health experts. Semi-structured individual interviews were recorded and transcribed verbatim. Template analysis was performed using the software Nvivo. Results: All respondents supported the idea that preferences be taken into account in guideline development. Three main discourses emerged: 1) The Governance discourse assumes that the integration of data on public and patients’ values with other types of research evidence would increase compliance with effective and cost-effective interventions; 2) The Individual Paternalism discourse insisted on the need to protect professional judgment and individual patients’ interests against governments’ perceived attempts at rationing and standardizing care; 3) The Active Involvement discourse interprets the idea of respecting preferences as giving patients greater political power and influence in guideline development and clinical decision making. It highlights concerns of power imbalance and tokenism. Conclusions: Apparent consensus on the need to involve patients in guideline development hides deeper divergences regarding the goal of such policies. At a time when the notions of preferences and consumerism are rising values in the health policy arena, being recognized as the entity that best respects patients’ preferences have become fundamental in deciding whom—among the promoters or critics of guideline—is symbolically serving patients’ best interests. T10.6 - Patient participation in a systematic review on t he effectiveness of treatments for degenerative ataxias Serrano-Aguilar P.1, Carrillo-Fumero R.2, Trujillo-Martín M.M.2, Mahtani-Chugani V.1, Perestelo-Pérez L.2, Montón-Álvarez F.3, Ramos-Goñi J.M.2, Posada-de la Paz M.4 1Canary Islands Health Service, Evaluation Unit, Santa Cruz de Tenerife, Spain, 2Canary Islands Research & Health Foundation (FUNCIS), Santa Cruz de Tenerife, Spain, 3University Hospital of NS de la Candelaria, Department of Neurology, Santa Cruz de Tenerife, Spain, 4Rare Disease Research Institute of Carlos III Institute of Health, Madrid, Spain

Objective: This study aims to incorporate patients´ perspective in the design of a systematic review of scientific literature on the effectiveness of available treatments for degenerative ataxias (DA). Methods: 53 patients with DA were surveyed using the Delphi method, with three consultation rounds via e-mail. In the first round, obtained information was on treatments used and relevant self-perceived health problems related to DA. The following two rounds were used to prioritize according to the median value and 10th-90th percentile range and achieve a consensus on the answers. Results: Participation rate was 100% (53/53) for all rounds. Overall, 83.0% of participants underwent some pharmacological treatment, 58.5% received physical rehabilitation and 15.1% psychological support. The most relevant self-perceived health problems were limitations in activities of daily living (ADL), visual and auditory problems and diminished self-esteem. The bibliographic search was enriched by these patient contributions. Only one of the studies included provided information on physical rehabilitation and none on psychological treatment. No study informed on treatment effectiveness for the following self-perceived problems: ADL, social relationships, disease acceptance and quality of life. Conclusions: Some of the self-perceived health problems related to DA identified by the patients have never been investigated and should be considered to improve future research and adapt it to the patients’ needs. The efficient participation of patients improved the literature search and the selection of relevant outcomes measures, extending the value of systematic review to ensure that it responds to both the clinicians’ information needs and the patients’ expectations. Cardiac Interventions 2 T11.1 - The clinical and cost-effectiveness of early inte nsive versus standard lipid-lowering with statins in the prevention of cardiovascular ev ents amongst patients with acute coronary syndromes: A systematic review Greenheld W.J.1, Hyde C.1, Wilson J.1, Bayliss S.1 1University of Birmingham, Dept of Public Health & Epidemiology, Birmingham, United Kingdom Objective: To review the clinical and cost-effectiveness of the early administration (within 14 days) of high-dose statins compared with standard-dose statins in the treatment of patients following an acute coronary syndrome (ACS). Methods: The Cochrane Library (CENTRAL), MEDLINE, EMBASE, NHSEED and OHE HEED were searched to July 2007, without language restriction, supplemented by searches of the ongoing trials’ research registers, hand-searching, and enquiries to pharmaceutical companies and clinical experts. The effectiveness review included randomised controlled trials (RCTs) comparing the effectiveness of high-dose/potency statins, aimed at reducing low-density lipoprotein cholesterol (LDL-C) to <70mg/dl with standard-statin therapy aimed at reducing LDL-C to <100mg/dl. For the economic analysis a review of existing economic evaluations was undertaken. Results: The effectiveness review included two RCTs: Colivicchi (n=81), and PROVE IT-TIMI 22 (n=4162). The main weight of evidence was provided by the larger PROVE IT trial: at two-year follow-up median LDL-C levels were 62mg/dl in the high-dose (atorvastatin 80mg/day) group and 95mg/dl in standard-dose (pravastatin 40mg/day) group; Kaplan-Meier event rates for the trial’s primary endpoint (death or a major cardiovascular event) were 22.4% (atorvastatin) vs. 26.3% (pravastatin) representing a 16% (95%CI: 5-26%, p=0.005) reduction in the hazard ratio; a non-significant trend favouring atorvastatin emerged at 30 days. The review of economic evaluations included one cost-effectiveness study of intensive vs. moderate lipid-lowering for ACS patients: using data from US sources (2005 prices) the Markov model suggested an ICER of 21300 USD/QALY (approximately 10,650 GBP/QALY). Conclusions: For ACS patients the early use of high-dose/potency statins appears clinically and cost-effective. T11.2 - Clopidogrel and aspirin: How long is long enough in medical management of non-ST elevation acute coronary syndromes? Allen M.1, Kelly K.2, Bata I.3, Love M.3, Flowerdew G.4, Fleming I.1 1Dalhousie University, Continuing Medical Education, Halifax, Canada, 2Capital Health, Drug Evaluation Unit, Halifax, Canada, 3Capital Health, Division of Cardiology, Halifax, Canada, 4Dalhousie

University, Department of Community Health and Epidemiology, Halifax, Canada Objective: The optimal duration of dual antiplatelet therapy (clopidogrel plus aspirin) in non-ST elevation acute coronary syndromes (NSTEACS) is uncertain. Current guidelines are based on the CURE trial which showed benefit with dual therapy compared to aspirin alone when administered for up to 12 months. However, the CURE data also indicates that most of the benefit from dual antiplatelet therapy occurred in the first 3 months. Our purpose was to estimate the benefit of dual antiplatelet therapy during the first 3 months compared to months 3 to 12. Methods: From Figure 1 in the primary CURE publication we measured the cumulative hazard for the primary outcome (cardiovascular related death, nonfatal myocardial infarction, or stroke) on each treatment arm at t=3 and 12 months. Results: For the time period 0 to 3 months the cumulative incidence was: aspirin alone 7.9%, aspirin + clopidogrel 6.0%; absolute risk reduction 1.9%; relative risk reduction 24% (95% CI: 13% to 33%; P<0.001). From 3 to 12 months the cumulative incidence was: aspirin alone 4.9%, ASA + clopidogrel 4.5%; absolute risk reduction 0.4%; relative risk reduction 8% (95% CI: -11% to 25%; P=0.38). Conclusions: Most of the benefit from dual antiplatelet therapy in NSTEACS appears to occur within the first 3 months. This is important from an HTA perspective because there is increased expense and risk of bleeding with dual antiplatelet therapy. Therefore it is prudent to use it for as short a time as clinically necessary. A prospective randomized trial is needed to confirm these findings. T11.3 - Implementation of a province-wide field evaluatio n of the management of acute myocardial infarction with ST-segment elevation in Quebec hospitals Carroll-Bilodeau C.1, Giguère M.1, Lambert L.1, Bogaty P.1 1AETMIS, Unité de Cardiologie, Montréal, Canada Background: Acute myocardial infarction with ST-segment elevation (STEMI) is a serious medical emergency in which treatment must be as prompt as possible to improve prognosis. The Ministry of Health requested information about modes of practice and delays to treatment for STEMI in Quebec hospitals. In response, we implemented a centralised performance monitoring system in 80 Quebec hospitals that captured over 90% of all STEMIs occurring in Quebec during the study period. Objective: To describe the implementation of a data collection process to measure performance of STEMI treatment. The major challenges and conditions associated with the successful implementation of the data collection process will be described and discussed. Methods: Once pertinent process performance measures were identified and a pilot project completed, a secure web site was developed and installed in 80 Quebec hospitals. Local experienced medical archivists were designated and individually trained to collect the necessary data. A continuous central support service was assured. Results: The data necessary to measure performance of management of STEMI was successfully collected. Archivists found the data collection process to be feasible and interesting and appreciated the opportunity of learning new skills. The factors essential for success of this approach as well as obstacles to overcome and pitfalls to avoid will be presented. Conclusions: This novel archivist-based field evaluation successfully collected data necessary to measure performance in STEMI care in Quebec’s hospitals and suggests a promising model to evaluate other aspects of healthcare. T11.4 - The performance of percutaneous coronary interven tions in hospitals without on-site cardiac surgery: Review of guidelines and analysis of Quebec data from 1999 to 2004 Lambert L.1, Bogaty P.1, Brophy J.1, Boothroyd L.1 1AETMIS, Unité de Cardiologie, Montréal, Canada Background: The performance of percutaneous coronary interventions (PCI) in hospitals without on-site cardiac surgery remains controversial. The Ministry of Health solicited information about the use and associated outcomes of PCI in Quebec’s PCI centres without on-site surgery. Objective: To provide contextual information to aid Quebec decision-makers in the creation and operation of PCI centres without on-site surgery. Methods: Quebec medico-administrative data bases were used to identify all first PCIs performed in

hospitals with and without on-site surgery and to determine patient comorbidities and outcomes. Patient transfer times from PCI centres to surgical centres were also examined. Results: The incidence of coronary artery bypass surgery was lower in patients who had their first PCI in a centre without on-site surgery. Mortality at 30 days and one year increased in PCI centres without on-site surgery from 1999-2001 to 2002-2004 and in 2002-2004 was significantly higher than in centres with on-site surgery. Conclusions: The advantages of performing PCI in centres without on-site surgery are uncertain. In centres without on-site surgery, PCI should be performed under well-defined conditions and there should be close collaboration with a cardiac surgery centre. These results underscore the need for collection and analysis of medico-administrative data, ideally on a continuous basis, to provide valuable contextual information necessary to guide healthcare policy. T11.5 - Is the full potential of point-of-care testing fo r heart disease diagnosis realised? A comparison of an existing with an alternative model of diagnosis Fitzgibbon F.1, Robinson S.C.1, McCulloch D.2, Meenan B.3, Dixon D.3, MATCH 1University of Ulster, MATCH, Belfast, United Kingdom, 2University of Ulster, School of Economics & Politics, Belfast, United Kingdom, 3University of Ulster, School of Electrical and Mechanical Engineering, Belfast, United Kingdom Objectives: To establish how Point-of-Care (POC) testing for cardiac markers has been adopted, to examine whether its full potential is being realised, and to suggest a procedure which might be more effective. The advantages of POC testing for cardiac markers in the diagnosis of heart disease are established, but adoption has been uneven. Statistics from a number of hospitals suggest that almost 40% of patients presenting with chest pain are not cardiac related. Data from the Royal Victoria Hospital Belfast (RVH) show that there is a significant number of patients who could have been sent home earlier, with consequent resource savings. Methods: The RVH routinely deploys POC testing during assessment for Acute Myocardial Infarction (AMI). The procedures in place are described and compared to an alternative incorporating the ninety-minute rule-out proposed by McCord et.al. (2001), which appears to reduce admissions to the ward by 40%. Results: The analysis shows that the adoption of the proposed protocol reduces costs and patient waiting times. Conclusions: On the basis of the economics of POC testing, as reported in the literature, and on the evidence gathered from the RVH, the procedures proposed appear to be more cost-effective than those currently in place. T11.6 - Early assessment of innovative minimally invasive replacement aortic valves with transfemoral or transapical delivery systems Miquel B.1, Blanchard S.1, Collignon C.1, Galmiche H.1, David D.-J.1, Denis C.1, Meyer F.1 1Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France Objective: Severe symptomatic aortic stenosis is a life-threatening disease. Currently, the only curative treatment is surgical aortic valve replacement with sternotomy which is, however, precluded in patients considered high risk or inoperable for conventional open-heart valve surgery. Applications have been lodged in France for two innovative aortic heart valves requiring less invasive implantation procedures : the CoreValve ReValving System with a retrograde transfemoral delivery system and the Edwards-Sapien heart valve with either a transapical or retrograde transfemoral implantation. HAS performed an early assessment of the devices and procedures in order to promote rapid availability. Methods: We retrieved all published papers and clinical reports on the devices. These were discussed by a multidisciplinary working group of 10 health professionals, then submitted to the relevant HAS Committee for their opinion. Results: We identified 6 implantation studies (470 patients). An intermediate analysis of the first results has revealed improvements in the New York Heart Association (NYHA) Functional Classification, effective orifice area, and aortic transvalvular gradient. The 6-month survival rate (226 patients) was 71-84% for transfemoral and 68% for transapical implantation.

Conclusions: Because these innovative minimally invasive devices display high potential in patients with a poor prognosis and inoperable by conventional surgery, HAS recommended that they should be reimbursed by French National Health Insurance in these patients. However, it specified that device use should comply with well-defined protocols, be restricted to selected centres, be granted for a limited time before device reassessment, and be the object of post-listing studies as soon as possible. T11.7 - Research of cardiovascular preventive services qu ality in Russia Kontsevaya A.1, Kalinina A.2, Romanenko T.3, Omeljanenko M.3 1National Research Center of Preventive Medicine, Development of Preventive Programs, Moscow, Russian Federation, 2National Research Center of Preventive Medicine, Depelompent Preventive Programs, Moscow, Russian Federation, 3Ivanovo State Medical Academy, Therapy, Ivanovo, Russian Federation Objective: To study cardiovascular preventive services quality in Russian primary care. Methods: The study involved 843 persons, aged from 20 to 60, in four Russian regions, who visited their doctor in policlinic. Survey with standard questionnaires, anthropometry, tonometry, were performed. Risk factor prevalence was estimated by standard criteria. Preventive care quality parameters included the difference between patients’ needs in preventive services and real size of preventive counseling, and patients’ knowledge about their biological parameters (cholesterol, glucose, weight). Results: The prevalence of lifetime smoking was 36,7%, 59,4% in male and 23,3% in female. The need in specialist help was in 25,2% smoking patient. Only 26,5% of them received special doctors’ consultation on smoking. Prevalence of overweight was 36,3%. The need in specialist help was in 48,5% obese patient. Only 26,5% of them received special doctors’ consultation on body mass reduction. Prevalence of stress was 43,4%, 39,3% in male and 45,8% in female. The need in specialist help was in 55,1% patients with high stress. Only 18,9% of them received special doctors’ consultation on stress correction. Only 17,6% persons checked their cholesterol and knew its value, for serum glucose this parameter was 23,5%. Conclusions: Cardiovascular diseases remain significant epidemics in Russia as long as the risk factors are widely prevalent. Interventions are clearly needed to reduce the prevalence of tobacco smoking, obesity, and stress. Now preventive care quality is low, there is need in special forms of preventive care. Interventional Technologies 2 T12.1 - Psychosocial impact of early vs late closure temp orary faecal diversions Khaliq T.1, Hassan R.1 1Pakistan Institute of Medical Sciences, HTA Forum/ Department of Surgery, Islamabad, Pakistan Background: Temporary faecal diversions are often required after emergency/elective colonic surgery. Objective: To evaluate the practical, psychological and monetary consequence of early (two month) versus late (six month) closure of temporary faecal diversions at a tertiary care hospital in the developing world. Materials & methods: 30 patients aged between 18-80yrs of both sexes purposively sampled. Group I: 15 patients with early ostomy closure at two months. Group II: 15 patients with late closure at six months. Temporary faecal diversions only included. Both groups admitted twice, (once for colonic surgery requiring ostomy formation and then for reversal), put on the same antibiotics, and charged same hospital/surgeon fee. Comparison of psychological impact, direct/indirect costs, and practical effects made. Impact of findings on patients and healthcare with relation to the developing world emphasized. Psychosocial Adjustment to Illness Scale, a self-report questionnaire (PAIS-SR) used to aid data collection. Results: Group I found to have a better overall PAIS-SR score than Group II. Feelings of depression, low self esteem and despondency much greater in patients having late closure surgery. Average cost of work time losses in Group I $300 and Group II $900. Other cost drivers in Group II - increased cost of accessories and added doctor’s consultations (for complications such as stoma leakage, pain and skin irritation.)

Conclusion: Closure of ostomy at two months is comparative yet more cost effective in the management of temporary faecal diversions. Key words: Early closure; ostomy; cost effectiveness. T12.2 - Effectiveness and safety of simultaneous bilatera l cataract surgery (SBCS) compared to sequential bilateral cataract surgery (UCS) Ramallo Fariña Y.1, Cabrera Hernández J.M.2, García Pavillard A.1, Goás Iglesias de Ussel J.3, Pérez Silguero M.A.4, Pérez Silguero D.5, Henríquez de la Fe F.6, Serrano Aguilar P.G.7 1Foundation for Health and Research FUNCIS, Santa Cruz de Tenerife, Spain, 2Canarian Health Service, Las Palmas de Gran Canaria, Spain, 3Clinic Perpetuo Socorro, Las Palmas de Gran Canaria, Spain, 4Hospital La Paloma, Las Palmas de Gran Canaria, Spain, 5Cajal Institute, Las Palmas de Gran Canaria, Spain, 6Clinic Santa Catalina, Las Palmas de Gran Canaria, Spain, 7Canarian Health Service, Evaluation Unit, Santa Cruz de Tenerife, Spain The use of SBCS is controversial given the concerns about sight-threatening bilateral complications such as endopthalmitis. Its use, regardless of the potential efficiency of the procedure, hasn’t been accepted for routine application. Objective: - To assess the safety associated with SBCS or UCS, comparing the incidence of intra (IC) and post-operatory complications (PC). - To evaluate clinical and self-perceived effectiveness of SBCS versus UCS. Methods: Pragmatic randomized comparative trial performed in Canary Islands (Spain), with 417 patients for SBCS and 390 for UCS. Evaluation of IC and PC was performed taking every eye as unit of analysis. Three types of outcome measurements were used: The VF-14 (specific self-completed questionnaire for visual function); visual acuity for every eye by means of Snellen´s optotypes; and the EQ-5D (generic self-completed quality of life scale). Measurements were applied to all patients, before and after the surgery in order to study patient’s evolution. Ethical approval was obtained and informed consent was systematically applied. Results: No differences were found between the incidence of intra or post-operatory surgical complications comparing SBCS and UCS. Improvements for corrected and non-corrected visual acuity were equal for SBCS and UCS. There weren’t differences in the improvement of HRQL when it was evaluated with the VF-14 questionnaire. When a EQ-5D was used, EVA index showed a less favourable initial value for CCBS patients. This small but significant difference remained after surgery. Treatment impact on EVA index didn´t show statistical differences between CCDT y CCBS. Conclusions: CCBS is a surgical option as safe and effective as conventional UCS. T12.3 - Surgery for obesity - A health technology assessm ent Bonnevie B.M.1, Hansen K.1, Børlum Kristensen F.1 1Danish Centre for Health Technology Assessment, Copenhagen, Denmark Objective: The increasing problem of severe obesity makes it important to discuss the consequences of surgical interventions offered to obese individuals. Updating the evidence of the surgical interventions for severe obesity, their implications for the patients as well as examine the organisational and economic consequences. Methods: Systematic literature review supplementing with group interviews and questionnaires of involved staff. DRG/DAGS rates and databases extracts were used for the economic analysis. Results: The evidence shows that both laparoscopic banding and bypass result in considerable weight loss. Both show a significant effect in recovery or improvement of comorbidities. There are significant differences in effect and risk with advantages and disadvantages of each procedure. Patients’ quality of life increases after the operation and often reaches the level of the general population. The weight loss, quality of life, mental state, self-respect, and social relations seem to interact improving the patients’ physical, mental and social wellbeing. All hospitals but one performing bariatric surgery perform both procedures. A protocol ensures that the care pathway and requirements in general is the same. Pre- and post-operational course plays an important part for the result. Calculations of the overall hospital costs indicate that banding is a little cheaper than bypass. Other cost components; the time consumption of the patients, and increased operating room capacity, has

not been measured. Conclusions: From an overall perspective, there seems to be no significant differences between the two methods, neither technologically, patient-wise, organisationally or economically. The decision should be made in the patient-doctor dialogue. T12.4 - Obesity and bariatric surgery procedures: An econ ometric evaluation from 342 surgeries undertook during 6 years in Brazil Saccilotto I.1, Pegoraro L.M.1, Silva R.S.2, Silva E.N.3 1Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil, 2Hospital Divina Providência, CITOM/HDP, Porto Alegre, Brazil, 3Federal University of Rio Grande do Sul, Economics, Porto Alegre, Brazil Objective: Estimate econometrically which surgical procedures is more effective in losing over-weight, malabsorptive (Scopinaro) or gastric Bypass (Bypass, Capella and Fobi) techniques. Methods: We applied quantile regression approach, which means that more information can be obtained, particularly when there are asymmetric effects throughout the conditional distribution of response variable. Results: The data come from 342 bariatric surgeries undertook by the same physician, during six years (2001-2006). Approximately 70% of patients had kept visiting periodically the physician. After one year, the mean over-weight loss was 71%. The estimates are statistically significant at conventional levels and they suggest that all surgery proceedings have a positive effect on weight loss compared to Scopinaro. At the left tail of distribution (patients that lost less over-weight), the FOBI has the bigger effect (13%). However, at the median and right tail of distribution (patients that lost more over-weight), CAPELLA had the bigger effect (16-18%), but very close to FOBI effect (14-16%). Conclusions: Obesity is one of the most serious public health problems around the world. For individuals whom have been unable to lose weight through conventional methods (diet and exercises) bariatric surgery could be an effective way to achieve substantial weight loss. Based on our estimates, FOBI and CAPELLA had shown better results than Scopinaro and Bypass. We also controlled for other variables that could have some influence on over-weight loss, such as gender, eventual complication due to surgery and age. However, only gender presented coefficients statistically significant, showing a negative effect (-10%) on weight loss. T12.5 - Incidence of adverse events in surgical services in four Colombian hospitals. A high complexity matter? Gaitán H.1, Guevara-Cruz O.A.1, Castillo J.S.1, Health Technology and Policy Evaluation Group 1National University of Colombia, Clinical Research Institute, Bogotá, Colombia Objective: To determine adverse events (EA) incidence for surgery services according to complexity level in four Colombian hospitals. Methods: A prospective cohort study of consecutive surgical hospitalizations was performed between May and October 2006 in 4 hospitals, 2 intermediate complexity levels (IL) and 2 high complexity level (HL). An active AE surveillance programme was implemented. Initial screening for AE was assessed by an expert committee. Risk factors and comorbidities were assessed. Univariate analysis and multivariate analysis was carried out. Results: 2874 surgical hospital admissions were followed, 2412 had surgical procedures. At screening phase 8,96% of patients were positive for AE. After expert committee assessment AE incidence was 5,39%. A meaningful difference in AE incidence between IL and HL was found (2.65% vs. 6.55%, P<0.001). Length of hospital stay (LOS) for surgical patients was 4,7 days (SD 6,2), median LOS was 3 and 7 days for non AE and AE patients respectively (P <0,0001). Multivariate analysis shows OR for HL was 1.85 (95%CI, 1.11-3.07) adjusted by age and comorbidities. No meaningful differences were found in mortality rate by complexity level, IL 0,97% vs. HL 1,77%. Conclusions: An important AE incidence was found in four Colombian hospitals. AE risk was almost twice in high complexity level institutions, even after adjusting by age and comorbidities. LOS was significative extended in AE patients. Surveillance and preventive measures should be reinforced in HL complexity hospitals, specially in surgical wards. T12.6 - A systematic review of the effects of biofeedback for the treatment of essential

hypertension in adults Greenhalgh J.1, Dundar Y.1, Dickson R.1 1University of Liverpool, Liverpool Reviews and Implementation Group, Liverpool, United Kingdom Objective: To assess the evidence for the effectiveness of biofeedback treatment for treating essential hypertension in adults. Methods: A systematic review following accepted guidelines was conducted. Bibliographic databases were searched for randomised controlled trials that compared biofeedback procedures to anti-hypertensive medication, placebo, no intervention or other behavioural treatments. The outcome measure was change in blood pressure. Results: Thirty-six trials were included in the review, 21 employed biofeedback treatment with no adjunctive therapy and 15 others used biofeedback treatment with another therapy. A number of different biofeedback modalities were employed. The majority of trials were small with no post-treatment follow-up, or follow-up of less than six months. No statistical meta analysis was carried out due to the poor quality of trial reports and large degree of heterogeneity in terms of treatments and comparators. Outcome measures were inconsistently reported. A narrative summary of the data based on trial author conclusions was produced. Data were grouped firstly by treatment type and then by comparator. Trial results were variable and conflicting, demonstrating no clear benefits of biofeedback for the moderation of hypertension. Any benefits shown were within the standard error of reproducibility of blood pressure measurement. Conclusions: In contrast to two previous meta analyses, no consistent evidence was found demonstrating the effectiveness of any particular biofeedback treatment in controlling essential hypertension. The literature is beset by trials that are inadequately reported, of poor quality, under-powered and with differing protocols. The results of this review suggest that funding for future trials is unlikely. T12.7 - Appropriateness use of phacoemulsification Fernández de Larrea N.1, Grande M.1, Blasco J.A.1, Andradas E.1, Ariza G.1, Quintana J.M.2, Alonso N.3, IRYSS Cataract Group 1Laín Entralgo Agency, Health Technology Assessment Unit (UETS), Madrid, Spain, 2Galdakao Hospital, Unidad de Investigación, Galdakao, Spain, 3Melilla Regional Hospital, Department of Ophthalmology, Melilla, Spain Objective: To describe the appropriateness of use of phacoemulsification. Methods: Observational prospective study. Population: Patients 18-90 years old, candidate for cataract extraction by phacoemulsification in four public hospitals of Madrid (Spain). Exclusion criteria: Combined ocular surgery or inability to respond to the questionnaires. Data were collected using a questionnaire designed for this purpose. Sociodemographical and clinical variables were registered. Appropriateness criteria used were those derived from a recent study carried out in Spain following the RAND methodology. Statistical analysis: Descriptive analysis and 95% confidence intervals estimation. χ2 test was used to compare appropriateness between hospitals. Results: 1335 interventions were assessed. 38.9% were necessary, 33.3% appropriate, 20.4% uncertain and 7.3% inappropriate. Range of inappropriateness between hospitals was 1.3%-11.5%. The most frequent inappropriate scenario in two of the hospitals was characterized by unilateral simple cataract with visual acuity ≥0.5 in both eyes, low surgical complexity and no impairment in functional capacity. In the other two hospitals it was characterized by unilateral cataract associated with other ocular comorbidity, contralateral visual acuity ≥0.5 and glare as the only functional capacity limitation, and in one of them by ipsilateral visual acuity ≤0.1, expected postsurgical visual acuity ≤0.1 and high surgical complexity and in the other by ipsilateral visual acuity 0.2-0.4, expected postsurgical visual acuity 0.2-0.4 and low surgical complexity. Conclusions: Global rate of inappropriateness is comparable with that reported in other settings. However, there is considerable variability between studied hospitals. Clinical decision making tools could be useful to improve the appropriate use of phacoemulsification.

Mental Health 2 T13.1 - A systematic review of the clinical and cost-effe ctiveness of psychological therapy involving family and friends in alcohol misuse or d ependence Meads C.1, Ting S.2, Dretzke J.2, Bayliss S.2 1University of Birmingham, Public Health and Epidemiology, Birmingham, United Kingdom, 2University of Birmingham, Birmingham, United Kingdom Objective: Alcoholism is associated with considerable morbidity, mortality and healthcare expenditure. This systematic review evaluated the clinical and cost-effectiveness of any psychological therapies involving one or more family members or concerned significant others compared to treatment focused on the alcoholic alone to reduce alcohol-related outcomes. Methods: Cochrane Library (CDSR, DARE, HTA, CENTRAL, NHSEED), MEDLINE, MEDLINE-in-Process, EMBASE, CINAHL, PsycINFO, Campbell Collaboration (C2-SPECTR), ASSIA, IBSS, SCI-Expanded, SSCI, OHE HEED and NRR databases were searched from inception to July 2006 (no language restrictions). Study identification, data-extraction and quality-assessment were done in duplicate, discrepancies were resolved through discussion. Results: 34 RCTs of variable quality were included, with sample sizes ranging from 12 to 742 and follow-up of four weeks to four years. Therapy involving family or friends demonstrated better outcomes - meta-analysis results for abstinence rates were OR 2.01, 95%CI 0.89-4.55, for mean abstinent or mean percentage days abstinent were SMD 0.40, 95%CI 0.24-0.55 and for drinker treatment entry rates were OR 5.65, 95%CI 2.79-11.44 in favour of the interventions. Of two UK cost-effectiveness studies, one (RCT based) suggested little difference in clinical-effectiveness and costs between social behaviour and network therapy and individual motivational enhancement therapy. The other, (decision-analytic model based), found that family therapy was cost saving to the NHS over 20 years compared to (undefined) standard care. Conclusions: Therapy involving family and friends can reduce alcohol-related outcomes and may be cost-saving to the NHS. More specialist alcohol treatment provision and more targeted health-promotion to encourage problem drinkers to seek help is needed. T13.2 - A review of therapeutic interventions among juven ile offenders with mental health disorders Perestelo-Pérez L.1, González-Lorenzo M.1, Pérez-Ramos J.1 1Canary Islands Health Service, Evaluation and Planning Unit, Santa Cruz de Tenerife, Spain Background: Juvenile offenders usually suffer mental health disorders: conduct disorders, substance abuse, personality disorders, anxiety and depression. It is necessary to have knowledge about the real value of the different intervention options in order to treat this sector of the population. The objectives of this review were to find effective psychological treatments aimed at preventing and treating psychopathologic problems in juvenile offenders. Methods: The following electronic databases were searched (from 1996 until 2006): MEDLINE, CINAHL, PsycInfo, EMBASE, The Campbell Library (C2 - SPECTR) and The Cochrane Library. Were included studies which recruited juvenile offenders aged 12 to 21, who had received psychological intervention and were under the control of the penal justice system. The quality of the studies was assessed using the Oxman Scale for the Systematic Reviews, the Jadad Scale for the Randomized Controlled Trials and the Estabrooks Scale for the other Comparative Studies. Results: A total of 3671 references in the electronic databases were found; 172 studies reports were eligible and screened for inclusion. A total of 51 studies met the inclusion criteria. Some interventions found were cognitive-behavioural therapy, therapeutic communities and family intervention. The following outcomes measures were found: family, psychosocial and psychological-emotional functioning, social skills, conversational skills, anxiety disorders, substance abuse and conduct disorders. Conclusions: The most frequently assessed mental health measure was substance abuse, and the most effective interventions for reducing they were therapeutic communities, cognitive-behavioural interventions and family interventions. In the other measures cognitive-behavioural therapy and family therapy were also the most effective interventions.

T13.3 - Decision support technologies for depression: A s ystematic review Perestelo-Pérez L.1, González-Lorenzo M.1, Pérez-Ramos J.1, Serrano-Aguilar P.1 1Canary Islands Health Service, Evaluation and Planning Unit, Santa Cruz de Tenerife, Spain Background: Decision support technologies (DSTs) provide evidence-based information about treatment options and likely outcomes of each. However the impact of shared decision making / DSTs in primary care of depression has not been evaluated in detail. The aim of the review was to identify DSTs for depression and evaluate their efficacy. Methods: Systematic review on DSTs for depression patients. Published reports of randomized controlled trials and other designs identified from searches of different electronic databases and from hand searches and consultation with key informants. Studies were including if patients were the decision-makers, decisions were real, the intervention met a strict definition of a DSTs and decisions involved treatment. Two reviewers evaluated the validity of each report. Quality assessment follows ICES evaluation format (Estabrooks 2000) To evaluate if DSTs achieved their objectives and are effective, a series of positive or negative effects on decision-making process and decisions results were considered. Results: Over 3904 titles were initially assessed; 362 studies reports were obtained and screened for inclusion. Thirteen studies met the inclusion criteria. Video, pamphlet and guides for depression patients were identified. Patient suffering from depression involved in decision making process show higher acceptance of diagnosis and therapy. Conclusions: DSTs helpful in supporting the decision-making process. DSTs could contribute to improve level of depression knowledge, autoperceived general health status and satisfaction with decision-making process. T13.4 - Deinstitutionalization and hospital care model in mental health. Spain, 1980-2004. Hospital morbidity indicators analysis of psychiatr ic pathologies (ICD-9, Cod. 290-319) Medel-Herrero A.1, Martín-Martínez M.A.1, Sarria-Santamera A.2 1Institute of Health “Carlos III”, Agency for Health Technology Assessment, Madrid, Spain, 2Institute of Health “Carlos III”, Agency for Health Technology Assessment, Health Sciences and Social Medicine Department, University of Alcalá Faculty of Medicine, Madrid, Spain Objective: The deinstitutionalization of psychiatry care involves the dismantling of the former asylum network and the development of ambulatory and community care. It involves a significant reduction in hospital stays and the creation of new residential and therapeutic resources. It is a common process to all the countries around us that in Spain started late(mid-80s). The current study provides indicators useful in the evaluation for psychiatric care model adopted in Spain and the current trends in the hospital use as a mental health assistance resort. Methods: Descriptive study of psychiatric(ICD-9,Cod.290-319) morbidity over a 25-year period(1980-2004) using Spanish National hospital utilization databases. Studied variables include admissions, readmission, total stays and average stay. Psychiatric pathology-disaggregated data. Rates were expressed per 10.000 inhabitants. Results: For all psychiatric disorders are observed a important increase of admission rate (19,41 in 1980; 27,27 in 2004) mayor decrease of totals stays (2489,3 in 1980; 676,2 in 2004) and averages stays (128,2 in 1980; 24,8 in 2004). High levels of readmissions (20,2% in 2004). The morbidity indicators have been affected differential according to the psychiatric pathology. Same of them shows extraordinary high rates. For example, the evolution and current trend in the admission rate for schizophrenia, affective psychosis or personality disorder are particularly worried. Readmissions in the case of personality disorders is indeed especially worrying (37.2% of readmissions in 2004). Conclusions: Mayor change in hospital morbidity indicators, a reflection of changed model care. Increasing of admission rates and decreasing of average stays. Indicators and trends for same of these pathologies are particular worried. T13.5 - Trends in hospitalisation of patients with schizo phrenia in Spain over a 25 year period Medel Á.1, Cediel-García P.1, Saz-Parkinson Z.1, Amate J.M.1 1Instituto de Salud Carlos III, Agencia de Evaluación de Tecnologías Sanitarias, Madrid, Spain

Objective: Study impact of psychiatric reform on progression of hospital resource use. Changes in hospitalisation for patients with schizophrenia in Spain over a 25-year period (1980-2004) are analysed. Methods: Descriptive study of schizophrenia over a 25-year period using Spanish National hospital utilization databases: Minimum Basic Data Set and Survey of Hospital Morbidity. Studied variables include sex, admissions, and average length of stay (LOS). Rates were calculated using the Spanish population for each given year, using data published by the National Statistics Institute of Spain and expressed per 10.000 inhabitants. Results: Our data shows trends in hospitalisation rates for schizophrenics have increased over the entire period (3.70 in 1980 to 5.89 in 2004). This increase is observed in both sexes, although the rate of increase seems greater for men. LOS has substantially decreased during the study period from 510 days in 1980 to 35 days in 2004. However, this decrease has not been constant over the entire period. Within the first four years, LOS plummeted from 726 to 292 days in the case of women whilst for men, the decrease was less pronounced (387 to 290 days). Until 1994, the decrease was erratic, while in the last ten years, the reduction in LOS appears steadier. Conclusions: Following the desinstitutionalisation process of psychiatric patients that has occurred in most Western countries, in Spain, we observe an increase in admissions rates linked to a decrease in LOS for schizophrenic patients. These trends could have important implications for policy makers and healthcare providers. T13.6 - Use of the internet in management of mental healt h conditions Hailey D.1, Roine R.2, Ohinmaa A.1 1Institute of Health Economics, Edmonton, Canada, 2Helsinki and Uusimaa Hospital Group, Helsinki, Finland Objective: To evaluate the evidence of benefit from Internet - based interventions for mental health conditions. Methods: We used electronic data bases to identify studies that reported outcomes of Internet approaches to management of mental health. Study quality was assessed using an approach that considers study design and performance. Judgements were made on whether additional work was needed to establish the use of each intervention in routine health care. Results: Eleven studies were identified from 161 abstracts in the literature search. There were 5 on management of panic disorder, 3 on depression, and 1 each on schizophrenia, post-traumatic stress and alcohol abuse. Nine studies were of high or good quality, 1 fair to good and 1 poor to fair. Internet interventions were successful in 8, potentially so in 2, and unsuccessful in 1. Nine of the studies indicated that further work was needed on use of the Internet in routine care. In 1 study the intervention was compared with the same method delivered by a non - telehealth approach, in 4 the control group received no intervention, in another 4 additional services were offered to the Internet group and in 2 there was comparison with another telehealth method. Conclusions: Use of the Internet for mental health services is still in its early stages. A few good quality studies have shown the promise of this technology but there is little information on how Internet methods compare with alternative approaches. Longer term investigations are needed. Cancer T14.1 - Determining the clinical and cost-effectiveness o f digital mammography services for breast screening - HTA Mandava L.1, Brown H.1, Craig J.1, MacIntosh H.2, Foster L.1 1NHS Quality Improvement Scotland, Glasgow, United Kingdom, 2Independent Consultant, Glasgow, United Kingdom Objective: The Breast and Cervical Screening National Advisory Group requested a Health Technology Assessment be carried out to determine the clinical and cost-effectiveness of digital technology for breast screening in Scotland. Methods: Scientific literature was systematically searched to identify evidence on the clinical and cost effectiveness of digital mammography. Experts, professional groups and other interested parties were also invited to submit evidence. All evidence was critically appraised and analysed.

Results: Evidence shows that digital mammography technology meets national performance, dose and image quality standards and suggests that the clinical effectiveness of digital mammography is comparable with that of FSM. The outcomes explored included diagnostic accuracy, recall for further assessment and for technical reasons, cancer detection and adverse events. However, there was insufficient evidence to compare the performance of the two main digital mammography technologies (computed radiography (CR) and direct digital radiography (DDR)). Evidence on cost effectiveness indicates that DDR is more expensive than FSM both in terms of initial capital costs and annual operating costs. However, no evidence pertaining to the cost effectiveness of CR was found. Limited and observational evidence suggests that DDR and FSM may have similar costs per woman screened if the service adopts a substantial increase in the working hours of the screening programme. Conclusions: The robust secondary review of the literature comparing the clinical and cost effectiveness of digital mammography with FSM suggests that there is no difference in diagnostic accuracy however DDR is more expensive in terms of capital costs and annual operating costs. T14.2 - Age distribution of participants in colorectal ca ncer screening programs in Japan Hamashima C.1, Saito H.1 1National Cancer Center, Research Center for Cancer Prevention and Screening, Tokyo, Japan Background: In the National Cancer Control plan of Japan, to reduce mortality from cancer, a screening rate of more than 50% is required within 5 years. Since the introduction of cancer screening programs in 1983, screening rates have been below 20% and have flattened except those of colorectal cancer screening. Objective: We investigated the age distribution of participants in colorectal cancer screening compared with gastric cancer screening. Methods: Based on annual reports for national cancer screening programs, between 1992 and 2005 we compared the age distribution of participants in colorectal and gastric cancer screening. Results: Participants in colorectal cancer screening have increase from 2,539,492 in 1992 to 6,630,503 in 2005. However, the age distribution was significantly different between the 1992 and 2005 groups (P<0.01). In 1992, those in their 40’s, 50’s, 60’s and 70’s and over accounted for 22.7%, 27.9%, 34.1%, and 15.3%, respectively, whereas in 2005 the same age groups accounted for 10.1%, 20.1%, 34.4%, and 35.5%, respectively, with a 1.9-folds increase in those in their 50’s but a 6-fold increase in those in their 70’s. When comparing in gastric cancer screening programs over the same periods, a 20% decrease was seen in their 50’s age group whereas a 3.5 folds increase was in those in their 70’s. Conclusion: In Japan, anyone aged 40 years or over can participate in cancer screening programs and there is no upper age limit. However, to reduce premature death from cancers, we have to reconsider the preferable target group for cancer screening. T14.3 - HER-2 testing in breast cancer: From scientific e vidence to practical recommendations for Quebec’s physicians Gosselin C.1, Dagenais P.2 1AETMIS, Oncology Unit, Montreal, Canada, 2AETMIS, Montreal, Canada Objective: To present how contextual information has modulated our HTA on diagnostic performance of HER-2 testing. Methods: Contextualisation was made using: - Phone and e-mail discussions with pathologists and medical biochemists from university and community hospitals, and with public health laboratory. - Site visits to hospital laboratories where HER-2 testing is done. - Medico-administrative databases from local and governmental sources. Results: Collected information gave us a better understanding of how the various HER-2 tests, including in situ hybridization (FISH, CISH, SISH) and immunohistochemical tests (IHC), were actually used in the province. We found differences in technical methods (“homebrew assays” vs. commercial kit assays), decision algorithms for testing, and quality control practices. Differences in referral patterns to central or local laboratories were also observed. Conclusions: The observed variations in actual pathological practices had a direct impact on our report conclusions and recommendations, stressing among others, the need for standardized practice

for HER-2 testing in Quebec. T14.4 - The comparative analysis of efficacy and safety o f bevacizumab plus paclitaxel and doxorubicin plus docetaxel in metastatic breast can cer Rys P.1, Krzakowski M.2, Pienkowski T.2, Pankiewicz O.1, Szkultecka-Debek M.3, Zablotna R.3, Plisko R.1, Wladysiuk M.1 1HTA Consulting, Krakow, Poland, 2Centrum Onkologii, Warszawa, Poland, 3Roche Poland, Warszawa, Poland Objective: The aim of this analysis was to compare efficacy and safety of bevacizumab plus paclitaxel (BP) versus docetaxel plus doxorubicin (AT) in patients with metastatic breast cancer. The AT regimen was chosen as the most common treatment for MBC in Poland. Methods: The comparison was based on the results of a systematic review performed according to guidelines of the Cochrane Collaboration and the AHTAPol. Results: Five randomized clinical trials were identified - two concerning bevacizumab and three for the AT regimen. In safety analysis for bevacizumab 11 non-randomized studies and a few case reports. Median survival was 26.5 months in the BP group and 21.4-22.6 months in the AT group; median progression-free survival was 11.3 and 8.7 months, respectively. After one year statistically significant differences in favor of BP in overall survival rate (81.5% vs. 75.1%) and in progression-free survival rate (47.8% vs. 31.8%) were observed. Response rate was higher in the AT group (32.3% vs. 54.0%). Neutropenia (50.5-94.8%), neutropenic fever (33-48.6%) and decrease of LVEF by at least 20% (6-22%) were the most frequent adverse effects in the AT group, while neurological problems were encountered more often in the BP group (30.3%). Conclusions: Use of the BP regimen resulted in longer total and progression-free survival, while total response rate was higher in the AT group. The BP regimen has more favorable hematological but worse neurological safety profile. Different distribution of prognostic factors in both groups and impossibility of direct comparison are the most serious limitations of this analysis. T14.5 - Comparison of efficacy and safety of capecitabine and lapatinib in combination vs capecitabine in advanced breast cancer therapy Skora T.1, Plisko R.1, Rys P.1, Wladysiuk M.1 1HTA Consulting, Krakow, Poland Objective: The aim of this analysis was to compare efficacy and safety of capecitabine (CAP) + lapatinib (LAP) in combination therapy with those of capecitabine alone in patients with advanced, HER2-positive breast cancer and a history of unsuccessful chemotherapy. Methods: The comparison was based on the results of a systematic review performed according to the Cochrane guidelines and the HTA Guidelines of the AHTAPol. Characteristics of the studies: Major medical databases (EMBASE, MEDLINE, CENTRAL and others) were searched. Of 78 retrieved publications 1 article of medium methodological credibility fulfilled the inclusion criteria. Numerous ongoing trials were identified; however, their results were not available. Results: The investigated combination therapy was statistically significantly more efficacious (in terms of progression-free survival) as compared to CAP monotherapy in the considered population. The study was therefore terminated sooner than planned making comparison of overall survival impossible. Safety profile of both compared treatments seemed to be similar. A statistically significant trend towards lower risk of metastases to the CNS was observed for the CAP + LAP regimen. Conclusions: Lapatinib in combination with capacitabine is a efficacious option in advanced breast cancer. T14.6 - A systematic review of novel biomarkers as progno stic risk factors in early, localised prostate cancer Hummel S.R.1, Sutcliffe P.1, Simpson E.L.1, Young T.1 1University of Sheffield, ScHARR, Sheffield, United Kingdom

Objective: Better prognostic information is needed to distinguish aggressive from indolent early localised prostate cancers, to prevent unnecessary, and potentially harmful, treatment. The purpose of this review was to identify promising novel markers available prior to, or at the time of primary treatment, that are prognostic of disease outcomes. Methods: A systematic review was undertaken of novel, disease-specific prognostic markers. Eight electronic databases were searched for publications between 1970 and April 2007. Patients had early localised or locally advanced prostate cancer (clinical or pathological stage TI/T2/T3N0M0). Study outcomes included overall and disease-specific survival; biochemical (prostate-specific antigen (PSA)) and clinical recurrence. Results: Twenty-eight studies evaluated 21 novel prognostic markers in patients with early localised prostate cancer. Evidence for all markers was limited. Considerable variability in outcomes reported, poor study quality and the small number of studies for some markers meant it was not possible to quantitatively synthesise the results, and made it difficult to determine which markers are promising. Nevertheless three categories were developed and markers assigned to them based on the relative volume and strength of evidence, with 5 judged “promising”, 5 “unpromising”, and 11 “inconclusive”. PSA kinetics emerged as the strongest contender for further research, with potentially large hazard ratios. Conclusions: There is currently insufficient evidence to assess the clinical value of most prognostic markers. The quality and reporting of prognostic studies must be improved for progress in this field. Recommendations are made for future studies investigating the prognostic value of markers for patients with localised prostate cancer. T14.7 - Laparoscopic hysterectomy in the treatment of end ometrial cancer: A systematic review Reza M.1, Granado de la Orden S.1, Blasco J.A.1, Callejo D.1, Calcerrada N.1, Andradas E.1 1Agencia Laín Entralgo, Unidad de Evaluación de Tecnologías Sanitarias, Madrid, Spain Objective: To compare the safety and efficacy of laparoscopic hysterectomy vs open surgery in women with endometrial cancer. Methods: A systematic review of the literature was performed. HTA, NHS EED and DARE databases, the Cochrane Database of Systematic Reviews, and the Medline, Embase, Pascal Biomed and Cinahl databases were explored. This study sought to include systematic reviews, health technology assessment reports and randomised clinical trials (RCTs) comparing laparoscopic surgery with open surgery for the treatment of endometrial cancer. The quality of the included studies was assessed. Results: Four RCTs were included in the review. The short-term results described show that laparoscopic surgery (LS) offers advantages with respect to post-operative recovery, including reduced bleeding, a need for fewer days of intravenous fluid therapy, and a reduced need for analgesics. In addition, intra-operative and post-operative complications were fewer among those who underwent LS in all the studies reviewed. The mean hospital stay of those who underwent LS was 3-4 days shorter, and they returned to normal activity sooner. The number of lymph glands resected was the same with both techniques. LS was associated with a better quality of life after surgery. With respect to long-term results, only one study reported data. No significant differences were found in relation to overall, disease-free or cause-specific survival. Conclusions: The short-term results of LS are equivalent or better than those achieved with OS, while no significant differences were found in relation to long-term results. More long-term studies are requiered. T14.8 - A tool for patient decision aids in breast cancer in Spanish context Izquierdo F.1, Blasco J.A.1, Andradas E.1, Reza M.1, Díaz del Campo P.1, Escalona S.1 1Agencia Laín Entralgo, Unidad de Evaluación de Tecnologías Sanitarias (UETS), Madrid, Spain Objective: To develop a tool for Aid Decision making in breast cancer; to improve the quality of decisions for diagnostic and therapeutic options in the disease; to promote active participation and shared decision-making patient - health care professionals team, where decisions have an impact on health outcomes. Methods: A systematic review of tools for Aid Decision making was performed. Medline, Embase, the Cochrane database, and the HTA database were explored and additional information has been collected from websites of institutions working with Patient Decision Aids. Semi-structured interviews

of stakeholders involved in the process, patients and health professionals, and Focus Group with patients have been undertaken. Results: Previous international experiences showed evidence about the effectiveness of the application of tools for Aids Decision Making in oncology when there is uncertainty about the outcome for diagnostic and therapeutic options. We found that the use of these tools is increasing the patient knowledge about illness, generating greater realism on the expectations of patients about possible effects of an intervention and reducing passivity in the decision making process to find the option that best suits their medical and personal preferences. Conclusions: This tool is a new initiative in Spain context. It collects views and experiences, from other Patient Decision Aids tools, with significant benefits in breast cancer for patients and the health care professionals team. Implementation and dissemination of this Patient Decision Aids tool is very supportive in oncology setting. T14.9 - Quality control in intensity modulated radiation therapy (IMRT) Gutiérrez-Ibarluzea I.1, Cantero D.2, Arcelay-Salazar A.2, Boveda E.3, Celeiro J.3, López-Torrecilla J.4, Roselló J.5, Bilbao P.3 1Osteba, Basque Office for HTA, Department of Health, Basque Government, Vitoria-Gasteiz, Spain, 2Osakidetza, Basque Health Service, Vitoria-Gasteiz, Spain, 3Osakidetza, Basque Health Service, Cruces Hospital, Barakaldo, Spain, 4Eresa, Valencia University Hospital, Valencia, Spain, 5Eresa, Valencia University Hospital, Vitoria-Gasteiz, Spain Objectives: To know and assess the existence, the degree of development, the quality and the implementation difficulties of quality assurance guidelines and protocols for IMRT. Methods: We developed an overview about the existence of protocols and guidelines including the following sources of information: Medline, EMBASE, CRD-databases, Lilacs and ISI wok. We also consulted the following societies: ESTRO, SEOR, ESTRO, NQMC and ASTRO. We performed a survey about the implementation of recommendations and standards of quality in the hospitals of the Spanish NHS. Finally, we have elaborated a checklist for the quality control of the processes of treatment with IMRT. Results: The degree of development and implementation of guidelines and protocols for IMRT is uneven. In most of the hospitals and centres consulted, the technique is in the standardization process; in any case, there wasn’t any established common protocol or guideline. The current European or Spanish laws didn’t fulfil the complexity of the current technique and the existing public guidelines and regulations are insufficient to ensure the quality control. The implementation of the guidelines and standards should be assumed by all the parties involved. Conclusions: The regulatory frameworks for the radiotherapy in Europe should be modified in order to fulfil all the requirements of the new technical developments, to document the full process and to establish common standards. The implementation of the IMRT in the different systems should be in accordance to those standards. T14.10 - Collaborative effort to facilitate the use of HTA in cancer guideline development Juvet L.K.1, Norderhaug I.N.2 1Norwegian Knowledge Centre for Health Sevices, Oslo, Norway, 2Norwegian Knowledge Centre for Health Services, Oslo, Norway Objective: Cancer guidelines in Norway has up to 2006 been developed by oncologists, without recources and support to engage in evidence based processes. In 2006 NOKC was given funds to support these groups, and the guidelines given national authority through the Directorate for Health and Social affairs. We have developed a program with the following key function: - support guideline developing with HTA reports, systematic reviews and evidence based guidelines; - provide support on the evidence based processes including grading the level of evidence; - identify new and costly cancer interventions for rapid HTA reviews and cost effectiveness modelling. Methods: We search for systematic reviews in CRD and Cochrane databases. For international guidelines we search in NICE, SIGN, AHRQ, cancer care Ontario etc. to update cancer clinical teams on international guidelines. Results: Collaboration has been established that facilitate the adaption of technology assessment and

systematic reviews conducted internationally. We have also established a rapid HTA process when there is a need for updating guidelines on new and costly interventions. In December 2007 we finish updating evidence based guidelines for 6 different cancer types, this included breast cancer, kidney cancer, palliative cancer, stomach cancer, oesophagus cancer and small intestine cancer. Conclusions: We have established a collaborative network between guideline developing groups, NOKC and the Directorate for health and social affairs that facilitate the use of HTA when making recommendation on cancer interventions. This also involves a process for early and rapid assessment of new and costly cancer treatment. T14.11 - Assessing models of health care services for canc er genetics Robb L.J.1, Blancquaert I.2 1Montreal Heart Institute, Genetic Unit, Montreal, Canada, 2Université de Montréal, Genetic Unit, Montreal, Canada Objective: As new genetic tests are introduced into clinical practice, HTA needs to consider test performance, effectiveness of follow-up interventions, and modalities of service delivery and organisation. Cancer genetics raises specific organisational challenges since it is developing at the interface of genetics and oncology. This presentation aims to determine which cancer genetics service models are associated with favourable outcomes for the clientele, health care professionals and system, and which factors are applicable to the regional context. Methods: A broad literature review regarding cancer genetic service delivery was performed. No limits were set a priori with respect to study design, selection of study population or outcomes of interest, but this presentation focuses on studies proposing and/or comparing models of service delivery. Results: The research revealed major heterogeneity in organisational factors considered. Detailed analysis of the cancer risk assessment and communication process showed that it comprises four distinct steps that differ according to the patient’s actual risk estimate. A classification scheme was therefore developed based on the professionals involved in each service step for high, moderate and low risk families. Studies corresponding to each of the four major models thus derived were examined for methodological quality and outcomes, which showed considerable variability. Conclusions: Although overarching organisational trends can be identified, the limitations of the evidence-base restrict the scope of recommendations. Dissecting service delivery into key components is a useful way to facilitate the analysis of complex multifaceted organisational interventions. It allows comparisons of distinct components and analysis of applicability to regional context. Technology adoption/use 2 T15.1 - Availability and endowment assessment of telether apy equipment Gómez-Fraga S.1, Gallegos-Rivero V.1, Velázquez-Berumen A.1 1National Center of Health Technology Excellence, Ministry of Health., Distrito Federal, Mexico Objective: To analyze the effective availability of teletherapy equipment by federal state, in order to create a proposal for planning and endowment of this technology to promotes a more equitable access by Mexican population. Methods: Distribution by million inhabitants of teletherapy units (/Mhab) and functional condition and were analyzed at state and national level based upon the national registry of medical equipment in medical units of the Ministry of Health. Similar endowment criteria of the WHO and other studies on the ideal distribution of this technology were reviewed, as well as the availability in OECD countries. Results: A Total of 41 Teletherapy equipments, 19 cobalt pumps, 14 linear accelerators and 8 orthovoltage surface therapy units were registered. These equipments are distributed in 16 states and the Federal District (DF), where 34% of the equipment is concentrated. Average availability of teletherapy equipment for population attended by the Ministry of Health was 0.69 equipment/Mhab, at national level. The 15 states that do not have this technology hold 44% of the population without insurance coverage. According to PAHO, one teletherapy unit/Mhab is required (considering cancer incidence at 75-150/100,000 hab. and 1MV equipment), whereas OECD countries average availability is 6.33 equipments/Mhab. Conclusions: Current teletherapy equipment availability is completely heterogeneous in the national

territory. Almost half the population has no access to this technology in their place of residence. Therefore, there is an evident need to establish endowment criteria that promote a more equitable access by the population to cancer treatment by radiotherapy. T15.2 - Current status: Detection of established health t echnologies of limited benefit Ibargoyen-Roteta N.1, Gutierrez-Ibarluzea I.1, Ruano-Ravina A.2, Velasco-Gonzalez M.2 1Basque Office for Health Technologies Assessment (Osteba), Vitoria-Gasteiz, Spain, 2Galician Agency for Health Technologies Assessment (avalia-t), Santiago de Compostela, Spain Objective: To describe the worldwide status of standardized methods to detect obsolete, ineffective or harmful technologies with limited clinical effectiveness or cost-effectiveness. Methods: An information search was made in selected databases and the webs of different Health organisms to find if there was any project regarding the detection of ineffective, obsolete, harmful or cost-ineffective health technologies. Direct contact with identified involved researchers or organizations was also carried out. Results: In contrast to what happens with new and emergent technologies, we did not find even a standardized definition for these technologies. In fact, there were different words that should be taken into account: disinvestment, obsolete, ineffective, old-fashioned, outmoded and delisted among others. The literature related to these interventions is not very extensive and there is no guidance. There are at least three countries that intend to work in these areas: Australia, United Kingdom and Canada. Similar projects have started in Israel and Spain. We have also found some private projects related to disinvestment and private coverage promoted by insurance companies, but there is lack of guidance. Conclusions: Even when many organizations include in their aims the evaluation of obsolete technologies, they have not developed guidance to do so. The establishment of systematic identification and evaluation criteria, and even disinvestment criteria, could provide an opportunity to invest in alternative proven and cost effective health interventions, taking always into account the impact that these initiatives would have in a social, political and clinical context. T15.3 - Qualitative evaluation of telemedicine programs i n Spain based on the experience of the main actors involved in the decision making process Mahtani Chugani V.1, Martín Fernández R.1, Soto Pedre E.2, Yanes López V.2, Serrano Aguilar P.1 1Canary Islands Health Care Services, Planning and Evaluation Unit, Santa Cruz de Tenerife, Spain, 2Canary Islands Health Care Services, Health Research Fundation of the Canary Islands. FUNCIS, Santa Cruz de Tenerife, Spain Objective: To identify the main benefits and risks related to the implementation process of telemedicine programs (TP) in Spain. Methods: A qualitative study based on audio-taped telephonic semi-structured interviews was performed. Eleven interviews were carried out, and the perspective of 4 physicians, 3 administrators, 2 researchers and 2 telecommunication industry workers were included. Theoretical sampling to achieve maximum variation was used and data were analyzed by thematic inductive method. Results: In order to achieve a successful TP a number of factors were identified. The capacity to solve health care problems related to accessibility to health care services, organizational issues and special situations as psychiatric consultancy or health care for prisoners were considered as the main benefits. The main risks were related to the following topics: the commitment of the people involved, technological aspects, economic and institutional support, health care professionals and service users acceptance, flexible protocols, the need of information and training previous to the development of the TP, forward-looking approach, normalization of the TP in the organization and the need to defend equity for professionals and users Conclusions: In order to develop a successful TP it is necessary to have a propitious omens or at least a situation where risk can be foreseen. The human factor seems to be the main key. The factors identified in this study should be considered when developing strategies to increase the chances for successful TP in our context.

T15.4 - Organisational aspects in HTA reports: Applicatio n to the German situation Perleth M.1 1Federal Joint Committee (G-BA), Siegburg, Germany Objective: The organisational impact of medical technologies, as compared to the assessment of efficacy, effectiveness, safety and costs, is often not evaluated in a systematic way. In addition, there is so far no international consensus regarding the definition of what is meant by organisational impact of a medical technology. In German health care the introduction of a new technology is often linked to requirements regarding structural and process quality which in turn impact the organisation of health care. Methods: Description of the main regulations and legal aspects which are pertinent to coverage of new technologies and discussion of an analytical framework for the analysis of the organisational impact of these aspects. Results: In Germany, provision of new technologies requires legally binding agreements and guidance for the infrastructure (e.g. safety measures), professional qualification, minimum thresholds and technical standards regarding equipment. A framework of key questions and illustrative examples will be presented which may lead to a more systematic approach to analyse the organisational impact of health technologies. Conclusions: In the context of the German legal regulatory framework, quality assurance measures are important instruments with considerable impact on the health care system and thus a given element of the analysis of the organisational impact of technologies. Screening/Prevention 2 T16.1 - Screening for phenylketonuria in newborns in Finl and Leipälä J.1, Saalasti-Koskinen U.1, Blom M.1, Gissler M.2, Autti-Rämö I.1, Mäkelä M.1, Specialist group 1National Research and Development Center for Wellfare and Health (STAKES), Finnish Office for Health Care Technology Assessment (FinOHTA), Helsinki, Finland, 2National Research and Development Center for Wellfare and Health (STAKES), STAKES Information Division, Helsinki, Finland Objective: To evaluate the costs-effectiveness of phenylketonuria (PKU) screening in newborns in Finland, based on a previous report (1). Early treatment prohibits irreversible brain damage caused by PKU. PKU incidence being only 1:100000−1:200000 in Finland, there is no national programme for screening. Methods: Medline, Premedline, Cochrane, DARE, HTA and EED databases were sought for literature. The number of infants with immigrant parents in 2000─2006 was retrieved from The National Medical Birth Register combined with The Finnish Population Information System. Current practice was assessed by a survey of maternity hospitals (n= 35). Results: PKU is screened for by the Guthrie method, fluorometry or tandem mass spectrometry (MS/MS). The Guthrie method and fluorometry were found cost-effective in many countries; MS/MS was cost-effective only when combined with screening of at least one other metabolic disease. In 2000─2006, 11328 infants were born to immigrant parents in Finland. The annual costs of screening these infants would be 76 000 euro, those of screening all infants 2.7 million euro. PKU was screened for in 20 hospitals (representing 80% of all births) in newborns with immigrant parents. A single case of PKU was found by screening and no other cases were identified in 7 years. Conclusions: The cost-effectiveness of both universal and selective PKU screening in Finland is dubious. Targeted screening evokes ethical questions such as definition and identification of ethnic origin and acceptability as a public health strategy. Reference: 1. Autti-Rämö et al.: Screening for rare metabolic disease in newborn infants. Finohta report 22/2004. Helsinki 2004 T16.2 - Mammography screening: The Swiss puzzle Blozik E.1, Zuellig M.1, Gurtner F.1 1Swiss Federal Office of Public Health, Medical Technologies Unit, Liebefeld, Switzerland

From 1999 to 2007, mammography screening in the context of quality-assured programs was reimbursed in Switzerland. Reimbursement conditions are set by federal bodies; however, the 26 Swiss cantons are responsible whether or not they implement such programs. This led to considerable inequity with respect to access to mammography screening across the country. In 1999, screening programs were established in three French speaking cantons (Vaud, Geneva and Valais). In the meantime, all other French speaking cantons joined, whereas no program was established in the German speaking and in the Italian speaking part of the country. In 2007, health insurance cover was re-evaluated by the Federal authorities based on a review of the international evidence and an evaluation of the existing screening programs. There was consensus that mammography screening lead to decreased breast cancer mortality which in turn comes along with a considerable amount of “side effects” (further evaluation when cancer is suspected etc.). Key issues in the discussion were related to screening in the Swiss context: inequity across the cantons, high prevalence of opportunistic screening, responsibility for adequacy of information about benefits and harms, heterogeneity of tariffs and false incentives. In particular, the performance of the existing screening programs was heterogeneous leaving questions on how quality assurance should be adapted and controlled. Finally, the health minister decided to continue reimbursement; however, the federal authorities are in charge to develop new guidance for quality assurance within the next two years. T16.3 - Ultrasound screening for abdominal aortic aneurys m in Quebec LeBrun M.1, Côté B.1, Lance J.-M.1, Dagenais P.1 1Agence d'Évaluation des Technologies et des Modes d'Intervention en Santé, Montréal, Canada Objectives: Abdominal aortic aneurysm (AAA) is found in 5% to 10% of men over the age of 65 years. Aneurysm rupture is the major complication needing urgent surgery and causing 80% mortality in admitted patients. Currently elective surgical repair is recommended for AAA to prevent rupture. There is growing interest in population screening to detect, monitor and repair AAA before rupture. AETMIS assessed the feasibility of a Québec’s vascular ultrasound screening program for AAA in asymptomatic populations. Methods: We used standard search strategy to retrieve HTA reports and journal articles from selected database, to analyse AAA screening program impacts on health care systems. We assessed efficacy and harms, economic, financial, ethical and social implications of ultrasound screening programs and AAA treatment. It was completed with clinicians and patients interviews and analysis of medico-administrative data from the Régie de l’Assurance-maladie du Québec (RAMQ). Results: Administrative data informed us on socio-demographic characteristics of patients and AAA treatment (types of interventions, surgery sites etc.). Interviews with stakeholder emphasized their perspectives about the implementation of AAA screening in Québec. Interviews contents were analysed to complete the global picture of opportunities and challenges for initiating such a screening program in the province. Conclusion: This report illustrates the numerous key factors that might modulate the implementation of a ultrasound screening program for AAA in Québec. T16.4 - Cancer screening guidelines: Locating clinical pr actice guidelines for guideline development workgroups Chin M.C.1, Hariharan S.1, Pwee K.H.1 1Ministry of Health, Singapore, Singapore Objective: The Singapore Ministry of Health’s national clinical practice guidelines (CPGs), published since 1998, are developed through evidence-based methods by multidisciplinary workgroups. This paper describes the preliminary search for overseas guidelines that is performed for each workgroup, using the topic of cancer screening guidelines as an example. Methods: Search strategies were constructed using Boolean logic to connect the keywords identified. Where available, search filters for clinical practice guidelines were applied. Databases searched included the US National Guideline Clearinghouse (NGC), the UK National Library for Health (NLH), MEDLINE, and other guidelines agencies� websites. The search was limited to guidelines published in English within the past 5 years. A second researcher reviewed all search results and only relevant guidelines were retrieved as soft-copies. Guidelines were included if they made recommendations on screening for a preliminary list of 9 cancers (8 cancers

already covered in a previous edition of the guidelines plus a new topic: nasopharyngeal cancer screening). Results: Fifty guidelines from ten countries were identified. Few guidelines were found for nasopharyngeal cancer screening. In that case, systematic reviews, health technology assessments and other relevant articles were retrieved. The retrieved material was compiled into a CD for reference by workgroup members and distributed at their first meeting. Conclusions: Making existing overseas guidelines available to the workgroup provides a framework from which they can formulate relevant questions for developing local guidance. The search is a rapid, preliminary process, which supplements the specific searching that is performed later on for guideline development. T16.5 - Polymorphismen-screening for predisposition: Guid ance for technology assessment Wild C.1 1Ludwig Boltzmann Institute of Health Technology Assessment, Vienna, Austria Objective: Tests on polymorphism/ SNP, inherited susceptibility to disease, are already offered in private institutions. The increasing pressure on public health services to offer SNP testing leads to first methodological approaches for a generally valid regulatory framework applicable for inclusion or refusal of genetic tests into public health services. Method: Review on issues to consider in the assessment of polymorphism-screening. Results: Since genetic testing has not only clinical and economic effects on health care, but ethical consequences with profiling our understanding of “health” and “disease”, an overview of relevant aspects and background information on polymorphism testing is given. Although 2 to 3 million SNPs are identified and the journals are full of reported “significant” associations between disease and mutation, only a few can be replicated unequivocally. The ACCE (Analytic & Clinical Validity, Clinical utility; Ethical, legal and social implications)-framework was developed by the CDC: This standardized appraisal approach proposes collecting and evaluating: A. Prevalence, genotype-/phenotype relation. B. Clinical presentation: natural history; the different expressions of disease. C. Performance of the test. D. Implications for therapy and prevention. E. Conclusion for clinical applications of risk-profiling of healthy on their susceptibility to disease or for clarification of disease for therapy planning. Conclusion: Since genetic testing is urging its way into the health care system, the actual danger is, that population screening starts before valid evidence from big prospective studies have been carried out and delivered proofs of direct causal associations. A standardized approach is suggested. Public Health 2 T17.1 - Use of blood cultures in treating community-acqui red pneumonia; The evidence McMaster F.1 1National Healthcare Group, Health Services & Outcomes Research, Singapore, Singapore Objective: To determine whether blood cultures should be performed in the Emergency Department for community-acquired pneumonia. Methods: A search strategy was developed in consultation with Emergency Department Physicians, respiratory physicians and researchers. This was then applied to a review of literature. Studies were included if they mentioned CAP and blood cultures, described costs associated with treating pneumonia in hospital settings, and were published within the last ten years. We eliminated studies which only described microbiological differences in treatments. Results: Eight articles and one editorial were examined. Studies varied in design and in scope, looking at either utilisation or clinical practice. The locations of studies were either in North America (USA, Canada) or Spain. Four articles gave figures for the number of altered therapies. Three of the four studies with treatment changes showed that rates of change in treatment after a positive blood culture are extremely low (under 5%). Only one study, from Spain, showed that 49% of positive cultures resulted in a change. Conclusions: There is considerable doubt over the impact of physician behaviour on treatment and patient outcomes following blood cultures. Research consistently states that more discrimination on blood culture use is needed. Studies were all small-scale, so it is difficult to extrapolate these research situations into clinical practice here in Singapore. Further primary analysis is necessary before a final

recommendation can be made to physicians. T17.2 - Alpha interferon 2b pharmacovigilance in hepatiti s C patients - Brazilian national health care experience Gonçalves C.1, Amaral K.1, Sander G.1, Martins N.L.1, Mattos G.2, Maia M.L.2, Picon P.1 1State Health Department of Rio Grande do Sul, Medicines’ Policy Division, Porto Alegre, Brazil, 2Bio-Manguinhos/ Fiocruz, Rio de Janeiro, Brazil Objective: Pharmacovigilance studies are designed to detection, evaluation, understanding and prevention of the risks of the adverse event (AE) of medicines. The Center for Aplication and Monitoring of Injectable Medicines (CAMMI) is carrying through the Pharmacovigilance of the Alpha Interferon 2b in hepatitis C. This medicine is being produced on your country by Bio-Manguinhos/Fiocruz. Methods: The pharmacovigilance is being carried out through structuralized monthly interviews with the patient by a pharmacist. Results: One hundred and ten patients have been followed from their treatment beginning. Females account for 51.8%. The mean age at study entry was 51.7+10.1 years old. The genotype 3 is present in 84.6% of the patients. We had a 9.2% treatment interruption rate (6.1% on AE, 3.1% on patient decision). AEs occurred in 83% of the patients. The most common events were tiredness (48%), headache (44%), fever (44%) and shivering (29%). Serious AEs occurred in 6 patients (0.7%). Application site reactions were present in 34% of the applications and the most common were erythema (13%). Anemia was present in 5 patients, leucopenia in 2, neutropenia in 2 and thrombocytopenia in 1 patient. Conclusions: The experience and the structure developed in the CAMMI provided a vast field for the execution of research activities and development of efficient instruments in Pharmacovigilance studies. Through this research it is being possible to know the adverse reactions profile of medicine produced in Brazilian territory and promoting the technological and social development of the public health in the country. Conflicts of interests: declared none! T17.3 - The potential health impacts of increased mobile phone use for contacting emergency services in life threatening situations Briggs A.1, Gray A.2, Kemp T.3, MacIntyre K.1, Rowley J.4, Willet K.3, Wu O.1 1University of Glasgow, Public Health & Health Policy, Glasgow, United Kingdom, 2University of Oxford, Oxford, United Kingdom, 3Oxford Radcliffe Hospitals Trust, Oxford, United Kingdom, 4GMSA, Dublin, United Kingdom Objective: To determine whether initia l contact with emergency services via a mobile telephone is associated with increased survival in life threatening situations when compared to contact via a landline. Methods: A retrospective cohort was constructed by linking all emergency dispatches from the Oxfordshire Ambulance Service to the Patient Admission System at the John Radcliffe Hospitals Trust between 1 January 1995 and 31 June 2006. Mortality - at scene, at emergency department, and during hospitalisation, were analysed by initial exposure (mobile telephone versus landline) controlling for available potential confounding variables. Results: Overall, 354,199 ambulances were dispatched from OAS between 1 January 1995 and 30 June 2006 to attend emergency incidents. Of these, 66% ambulances subsequently carried one or more patients to hospital with 2% of ambulances being stood down due to death at the scene. Record linkage was attempted for all dispatches from 1999 to June 2006 (215,078) and resulted in a positive probability match in 164,386 cases (76%). Reporting emergencies by mobile telephone resulted in a significant reduction in the risk of death at scene compared to reporting incidents using a landline (Odds Ratio 0.596: 95% CI: 0.519 - 0.685). No significant association was found between mobile telephones and death at the emergency department or in hospital. Conclusions: In this retrospective analysis, some weak evidence of association was shown between the use of mobile telephones to alert emergency services and improved mortality rates at the scene. However these results must be interpreted with caution due to the potential for unobserved confounding.

T17.4 - Pilot study for quality of care and adherence eva luation among users of the primary health care in the Brazilian primary health care sy stem with hypertension and diabetes Milward de Azevedo Meiners M.M.1, Sampaio Vila-Nova de Carvalho R.2, de Moura L.3, Dantas S.1, Hauser A.1 1Pan American Health Organization (PAHO/WHO) Brazil Country Office, Brasília, Brazil, 2Brazilian Ministry of Health, National Hypertension and Diabetes Coordination, Primary Health Care Department, Brasília, Brazil, 3Brazilian Ministry of Health, Non Communicable Diseases General Coordination, Health Vig ilance and Control Secretary, Brasília, Brazil Quality of care and adherence evaluation for public primary health care system users in Brazil should be ensured applying standardized indicators that reflect the degree of morbidity and mortality reduction (blood pressure, blood glucose, A1c, BMI and cholesterol) and users’ care perception. Objective: Validate a model for quality of care and adherence evaluation for first level care within Brazilian public health system, to analyze work routines and processes and to indicate improvements required for effective care. Methods: Patient file review and interviews with health unit users were carried out in 11 selected cities, representative of Brazilian 5 macro-regions. For patient file data collection a modified form of Health Information System for Hypertension and Diabetes (SIS/Hiperdia) was used. For the interviews a standardized structured questionnaire was applied. Results: 547 patients’ files were reviewed and users’ interviewed, of these 63% were female, 46% were 61 to 75 years old, 76% were low educational background (25% illiterate). Self-reported prevalence of diabetes and hypertension was 38% and 93% respectively. The majority of the users preferred to follow pharmacological treatment to the non-pharmacological, but, didn’t know their therapeutic goals. Conclusions: Although the sample isn’t representative of national primary care services, some trends were observed, such as poor quality and absence of data in patient files, which hinder the evaluation process. This study demonstrated that health service professionals need to be convinced of the need to institute evaluation processes for the continuous quality improvement to enhance effective clinical outcomes and maximize the available financial resources.