Face to face interventions for informing or educating parents about early childhood vaccination

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Face to face interventions for informing or educating parents about early childhood vaccination (Protocol) Kaufman J, Synnot A, Hill S, Willis N, Horey D, Lin V, Ryan R, Robinson P This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2012, Issue 8 http://www.thecochranelibrary.com Face to face interventions for informing or educating parents about early childhood vaccination (Protocol) Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Transcript of Face to face interventions for informing or educating parents about early childhood vaccination

Face to face interventions for informing or educating parents

about early childhood vaccination (Protocol)

Kaufman J, Synnot A, Hill S, Willis N, Horey D, Lin V, Ryan R, Robinson P

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary 2012, Issue 8

http://www.thecochranelibrary.com

Face to face interventions for informing or educating parents about early childhood vaccination (Protocol)

Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iFace to face interventions for informing or educating parents about early childhood vaccination (Protocol)

Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

[Intervention Protocol]

Face to face interventions for informing or educating parentsabout early childhood vaccination

Jessica Kaufman1, Anneliese Synnot1, Sophie Hill1, Natalie Willis1, Dell Horey2, Vivian Lin3 , Rebecca Ryan1, Priscilla Robinson3

1Centre for Health Communication and Participation, Australian Institute for Primary Care & Ageing, La Trobe University, Bundoora,Australia. 2Research Education & Development Unit, La Trobe University, Bundoora, Australia. 3Department of Public Health, Schoolof Public Health and Human Biosciences, La Trobe University, Bundoora, Australia

Contact address: Jessica Kaufman, Centre for Health Communication and Participation, Australian Institute for Primary Care &Ageing, La Trobe University, Bundoora, VIC, 3086, Australia. [email protected].

Editorial group: Cochrane Consumers and Communication Group.Publication status and date: New, published in Issue 8, 2012.

Citation: Kaufman J, Synnot A, Hill S, Willis N, Horey D, Lin V, Ryan R, Robinson P. Face to face interventions for informingor educating parents about early childhood vaccination. Cochrane Database of Systematic Reviews 2012, Issue 8. Art. No.: CD010038.DOI: 10.1002/14651858.CD010038.

Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

A B S T R A C T

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects of face to face interventions for informing or educating parents about early childhood vaccination to increaseimmunisation uptake and parental knowledge.

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B A C K G R O U N D

This review is a part of a two-year multi-stage research projectcalled ‘Communicate to Vaccinate (COMMVAC)’ (Lewin 2011).The COMMVAC project focuses on building the evidence oncommunication interventions to improve childhood vaccinationrates. Earlier project stages included evidence mapping and taxon-omy development as inputs to an international systematic reviewpriority setting exercise. The topic for this review was identifiedas highly relevant to vaccine program managers, policy makersand other key stakeholders in low- and middle-income countries(LMICs) through a series of deliberative forums. While the COM-MVAC project has a particular emphasis on LMICs, this reviewwill be global in scope.

Description of the condition

Vaccination has been described as one of the greatest public healthachievements of the 20th century (CDC 1999). Vaccination is aworthwhile and cost-effective public health measure and has led tothe global eradication of smallpox and large reductions in measles,tetanus, rubella, diphtheria, and Haemophilus influenzae type b(CDC 1999). However, over 24 million children remain withoutaccess to this important health practice (Jheeta 2008; Wiysonge2009), contributing to millions of preventable child deaths in thedeveloping world (GAVI 2010). Efforts to improve vaccinationcoverage in LMICs are central to meeting the Millennium Devel-opment Goal (MDG) of reducing child mortality (UN 2011).Routine vaccination is not only a crucial issue in LMICs. Highincome countries (HICs) also experience equity-related challengesto achieving universally high coverage rates. Equity features whichcan affect coverage include indigenous or ethnic status, poverty,large family size, and low educational attainment. Certain portionsof a country’s population may have coverage rates below the na-tional average - in some cases as low as LMICs (Thomson 2012).For example, in some regional and remote areas of Australia withhigh indigenous populations, full immunisation coverage at age12 months in 2003 was as low as 78.5% (Brotherton 2005), com-pared to 91% national coverage (ACIR 2003). This drops to aslow as 71.4% for children aged 24 months (Brotherton 2005),compared to 88% nationally (ACIR 2003). In the US, coveragerates vary little by race or ethnicity, but there are still disparitiesbased on poverty status (Wooten 2010). A study from Austria alsoshowed that low educational attainment and high numbers of chil-dren in one family are associated with lower levels of vaccinationcoverage (Stronegger 2010).Another cause of regional vaccination coverage variation in HICsis individuals who refuse some or all vaccination for their chil-dren. Vaccination objectors are more common in HICs and alsotend to be grouped in particular regions, so while they make upa small percentage of the country’s population overall, they maysignificantly lower coverage in certain areas (Hull 2010; Diekema2012).

Barriers

Parents may face a range of barriers to getting their children vacci-nated, presenting health systems with complex challenges. The fo-cus of this review is information or education interventions, whichhave the potential to increase consumer demand for vaccinationby addressing barriers related to knowledge or beliefs (misinfor-mation; parental fear about safety; lack of awareness about vaccineschedule, doses, or vaccine-preventable diseases) (Streefland 1999;Streefland 2001; Jheeta 2008; Bondy 2009; Uddin 2009; Wong2009). These barriers exist in all countries, regardless of incomelevel. Logistical barriers (shortage of vaccines; distance from clin-ics; cost of vaccines, vaccination service or transportation; lack oftime) may be addressed through supply-side interventions suchas vaccine distribution and funding; vaccine delivery training; orincentives for physicians or consumers. These interventions willnot be examined in this review.Overcoming specific barriers to vaccination is not the only rea-son to implement information or education interventions, how-ever. The right to health, including access to health information,is a fundamental human right which has been codified in UNand regional human rights treaties recognised internationally (UNCESCR 2000; UN 2008). The implementation of interventions toinform or educate people about childhood immunisations there-fore need not be predicated on an observed or assumed barrier tovaccination. Even in locations where vaccination coverage is high,such interventions support the right for all people to be informedabout health.

Description of the intervention

Information is important across all contexts of the health system toencourage people to participate in health-related activities, as theirdecisions to do so are based on the information and knowledgethey have (Zyngier 2011). Successful vaccination programs relyon people having sufficient knowledge to make the decision toparticipate (Shahrabani 2009).Information and education may be provided in various ways. Thisreview will focus on face to face interventions to inform or educate,which may include oral presentations, one on one or group classesor seminars, information sessions, or home outreach visits. Face toface communication may be undertaken on its own or combinedwith other interventions (eg telephone contact), but unless theseother interventions are combined with or compared to face to facecommunication they will not be considered in this review.This review focuses on face to face communication with parents orguardians, either individually or in groups. Interventions directedto communities will be addressed by a separate review (Sæterdalin preparation).

Defining the intervention

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This review addresses interventions to inform or educate. We ex-amined the literature to see if information was defined differentlyfrom education as this may affect the methods of the review. To dothis, we searched the following sources: major health agency web-sites, grey literature reports describing immunisation campaignstrategies, and literature about general patient education. We con-ducted a content analysis to see how these terms were used, de-scribed and defined in practice (see Appendix 1 for further details).Our main conclusion is that there is no agreement about the dif-ference between informing and educating. From the content anal-ysis, four things became clear:

1. It is acknowledged that informing may be different fromeducating, however the ways in which they might differ are rarelyexplained;

2. both of the interventions are described and operationalisedin many different ways and with varying degrees of overlap;

3. information delivery is frequently described as a componentof education, rather than an intervention in its own right;

4. interventions are not often labelled as ’informing’ or’educating’. A plethora of terms is used to describe informing oreducating interventions. For example, ’interpersonalcommunication’, ’program communication’ and ’behaviourchange communication’ are all terms that can be applied toeducation interventions (UNICEF 2005).There are some consistencies in the ways agencies and publicationsdescribe interventions to inform and to educate, but our mainconclusion overall is that there is no sufficient agreement as to howthey differ from one another. Due to a lack of detailed description,and inconsistent language, there is no reliable way to determinewhich type of intervention a given trial describes. The implicationsfor our review are that we will include all interventions that aimto inform or educate without distinguishing between these twopurposes.Our definition of the intervention

Relevant interventions are those which make consumers awareof the practical or logistical factors associated with vaccinationor seek to enable them to understand the meaning and rele-vance of vaccination for themselves, their family or community(Willis in preparation). The goal of these interventions could beto achieve outcomes such as improved vaccination coverage; ap-propriate timeliness of vaccination; or increased knowledge of vac-cines, vaccine preventable diseases or service delivery. Interven-tions may be tailored to address low literacy levels or misinforma-tion.

Face to face delivery

It is important to determine the effects of face to face communi-cation, as research has shown that information or education de-livered through written pamphlets alone is not particularly effec-tive in achieving behaviour change (Ryan 2011). The interactivenature of face to face communication means that it is a straight-forward way to share information, preferences, and decisions be-

tween providers and consumers. Being in close proximity to oneanother with the opportunity for eye contact, if culturally appro-priate, and the ability to observe non-verbal reactions contributeto the educator’s ability to: respond to fears and questions of a per-sonal nature; correct misinformation and myths; persuade parentsand bring about behaviour change; provide support; and respondto rumours and anti-vaccination messages (UNICEF 2005). Faceto face communication can be directed at individuals as well asgroups.Vaccination can be a particularly complex issue for parents due tocomplicated delivery schedules, perceived risks and the emotivenature of the decision (Leask 2002; NACI 2006). Face to facecommunication allows for real-time, two-way dialogue betweenhealthcare providers and consumers, where consumers are able toexplain their concerns or preferences and ask personally-relevantquestions. Health organisations around the world have producedmaterials that help guide and facilitate face to face discussions forvaccine decision making (NACI 2006; Krosch 2010; CDC 2011).Face to face communication can be delivered by a range of individ-uals including primary care physicians, nurses, lay health workersand community volunteers. It can take place directly with indi-viduals in one on one interactions, or with groups of people. It isparticularly useful for people who are semi-literate or not literatein either their language or the majority language.

Challenges for this review

The complexity of communication about childhood vaccinationraises a number of challenges for this review.Internationally, routine childhood vaccination schedules vary andare complex. While most country schedules include the vaccinesrecommended by the WHO, the timing and number of doses ofeach vaccine differs (see Appendix 2), most notably in relation tothe last dose of the primary series vaccines. For example, in Nigeriathis is completed as early as 9 months (MAMA Project 2010)whereas in Norway, it can occur as late as 12 years (NIPH 2011).Countries also vary in the age of school entry (Eurydice 2010)and use of age 5 or age 6 as an immunisation status checkpoint.These issues make it difficult to define consistent child age rangesfor study inclusion.In this review we will primarily consider two age ranges: infant(up to 1 year); and preschool-aged child (1 year to 5 or 6 years).School-aged children (5 or 6 years to 14 years) may be included insome trials, but if the intervention focuses on school-aged childrenonly it will not be included in this review. We have used the pointat which school begins rather than a concrete age to distinguishbetween the older age groups, because interventions addressingvaccination at 5 years are unlikely to be significantly differentfrom those addressing vaccination at 6 years, whereas interventionsto address vaccination of school children may be quite differentfrom those for preschool-aged children (eg school-aged childrenthemselves, rather than their parents, may be actively targeted).

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Immunisation status can be measured in different ways. Somestudies measure receipt of a single vaccine, while others considerall vaccines in the recommended schedule. While the term ’up todate immunisation status’ may be used differently and incorporateelements of timeliness (all doses received and at the correct times)or age (all doses received by a certain age, regardless of timing),these differences are unlikely to affect assessment of the effects of aface to face communication intervention. For the purposes of thisreview we will accept the definitions used by study authors.

How the intervention might work

Vaccination is a preventive health measure and must be deliveredwhen a child is healthy, with no symptoms of illness or other trig-gers to spur parents to take action. This means that parents’ beliefs,attitudes, and environment may play a more significant role forvaccinations than for other health decision-making. For successfulvaccination, parents must: be aware of vaccines, including how,where and when to get them; understand why vaccines are neces-sary or desirable; and be motivated and able to take their child toreceive them. Interventions to inform or educate parents may bedesigned to influence these precursors and draw from one or morebehaviour change theories (see Appendix 3), which are individual-focused but conscious of the influences of external factors. Self-efficacy and the related concept of perceived behavioural controlappear in most behaviour change theories, as these concepts areused to integrate to varying degrees the presence of systemic bar-riers to vaccination.

Why it is important to do this review

Participants in deliberative forums held from June to July 2011identified face to face information or education interventions as awidely-used strategy with high relevance, particularly in LMICs.The participants, who included vaccination program managers,policymakers, researchers and other stakeholders, pointed out thatimplementation of such interventions requires resources such asmoney, time and trained personnel. It is critical to determine theeffects of this type of intervention on vaccination status and otherimportant outcomes, so that valuable resources can be allocatedappropriately.

Relationship to other reviews

This review is closely related to one existing review, “Interventionsfor improving coverage of child immunization in low- and mid-dle-income countries” by Oyo-Ita and colleagues (Oyo-Ita 2011),and a second review that is currently in preparation: “Interven-tions directed to communities to inform or educate regarding earlychildhood vaccination” by Sæterdal and colleagues (Sæterdal inpreparation).

The Oyo-Ita review considers all interventions evaluated in LMICsto improve vaccination coverage. This includes interventions di-rected at parents, caregivers and communities, such as those fo-cused on improving various aspects of communication regardingvaccination. The review found six studies conducted in LMICs,of which four were assessed to be at high risk of bias. The majorityinvolved a communication element. There was generally low tomoderate quality evidence that health education and informationcampaigns improved vaccination coverage in LMIC settings.The Sæterdal review, currently in preparation, will include com-munity-directed interventions, which will not be included in thisreview (Sæterdal in preparation). By ‘community-directed’ wemean (1) interventions directed at a geographic area; and / or (2)interventions directed to groups of people who share at least onecommon social or cultural characteristic (Baker 2011). Our reviewwill focus on interventions directed to parents, individually or ingroups, whereas Sæterdal in preparation will include interventionsdirected to groups which may or may not include parents.Our review and Sæterdal in preparation (the COMMVAC re-views) consider specific sets of ’communicate to vaccinate’ inter-ventions, but with a global rather than a LMIC focus. We knowfrom the COMMVAC mapping process that a significant propor-tion of these communication interventions have not been evalu-ated in LMICs. The overlap between the Oyo-Ita and COMM-VAC reviews will therefore be small, and the latter global reviewswill provide a more complete picture of the effects of these com-munication interventions. Oyo-Ita 2011 is being updated and theauthors of all three reviews are in close contact. We will addressany overlap by (1) outlining clearly in each review the scope of therelated reviews; (2) discussing studies identified from LMIC andHIC settings, and any differences and similarities between these;(3) discussing the effects of communication interventions in rela-tion to other interventions to improve immunization coverage, asidentified in Oyo-Ita 2011.Interventions targeted to individuals to remind or recall them forvaccination based on their personal vaccination history will not beincluded, as these are covered by existing research on vaccinationreminders (Jacobson 2005).

O B J E C T I V E S

To assess the effects of face to face interventions for informing oreducating parents about early childhood vaccination to increaseimmunisation uptake and parental knowledge.

M E T H O D S

Criteria for considering studies for this review

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Types of studies

Randomised controlled trials (RCTs) and cluster RCTs.

Types of participants

Communication interventions about childhood vaccination arecomplex because multiple participant groups are involved in theintervention. The intervention is delivered to one group (parents)to promote vaccination, which is administered to another group(children). The planning and implementation of the interventionor the immunisation program itself is addressed by a third group(program organisers). The three participant groups are:

• Children: infants (less than 1 year) or preschool-agedchildren (1 to 5 or 6 years). RCTs including school-aged childrenwill only be included if the main focus of the intervention isthose vaccines whose primary series begins in infancy or forpreschool-aged children.

• Parents: parents, guardians or others fulfilling the parentalrole, alone or in groups, targeted to receive face to faceinformation or education, and who have at least one child due oroverdue for childhood vaccinations. Participants may also beexpectant parents, who are individuals or couples currentlypregnant, considering adoption or otherwise expecting tobecome guardians of a child. The intervention may be directedto parents individually or in groups.

• Vaccine program managers: program managers are anyoneinvolved in the planning or implementation of immunisationprograms or interventions.

Types of interventions

Face to face communication interventions directed to parents toinform or educate them about routine childhood vaccinations.Such interventions describe or impart information about some fea-ture of routine childhood vaccination with the purpose of chang-ing consumer knowledge, beliefs, attitudes, behaviour or self-ef-ficacy. The type of content that may be covered includes infor-mation about: vaccine-preventable diseases (eg symptoms, preva-lence, transmission, severity); vaccines (eg delivery method, dose,ingredients, schedule, risks or side effects, benefits); or vaccine ser-vice delivery (eg where to go to receive vaccinations, costs, clinicopening hours, services to assist with access).We will include interventions delivered by anyone including physi-cians, nurses, or other healthcare professionals; trained volunteers;lay health workers; members of the community; peers; or healthvisitors.The term ‘Routine vaccinations’ means all recommended routinechildhood vaccines outlined by the World Health Organization(WHO 2012) with the exception of human papillomavirus vac-cine (HPV), which is delivered to adolescents. This review focusesonly on interventions about early childhood vaccines because in-terventions related to vaccines for older children may be signifi-

cantly different in nature (eg they may target children directly, orhave a reduced focus on the parent’s role in decision making).We will include face to face interventions conducted in clusterRCTs in the context of a mass vaccination campaign if it is pos-sible to isolate and report the effects of the face to face commu-nication interventions delivered to parents for the vaccination ofyoung children or infants from the larger campaign. Similarly, wewill include multi-component interventions with a face to faceelement if the outcomes of the face to face intervention alone canbe determined from the reported data. For example, if a trial ofa multi-component intervention involving face to face educationplus a reminder measures both immunisation uptake and knowl-edge, we would not be able to isolate the effect of the face to faceintervention on the immunisation rate but we may be able to at-tribute any changes in knowledge to the face to face interventionalone. We may also be able to determine the effect of a face to faceintervention if a trial measures outcomes at multiple time points,including one before the addition of other intervention types. In-terventions will not be considered to be ’multi-component’ if asecondary form of information or education (eg a pamphlet) isprovided along with the face to face intervention and is specificallydescribed as supplementary or supporting.Face to face interventions to inform or educate may include oralsessions; lectures; one on one or group classes or seminars; infor-mation sessions; home visits or outreach sessions.The review will address four comparisons.

1. Face to face interventions directed to parents (individuals orcouples) versus usual care or passive intervention (ie nointervention, pamphlet).

2. Face to face interventions directed to groups of parentsversus usual care or passive intervention (ie no intervention,pamphlet).

3. Face to face interventions directed to individuals versus faceto face interventions directed to groups.

4. Face to face intervention A versus face to face interventionB.We will not include community-directed interventions, as theseare considered in Sæterdal in preparation.

Types of outcome measures

Primary outcomes

1. Children: Immunisation status of child (ie immunisationstatus up-to-date, or receipt of one or more vaccines, as definedby study authors)

2. Parents: Knowledge or understanding of vaccination

Secondary outcomes

1. Parents: Intention to vaccinate child2. Parents: Parent experience of intervention (eg satisfaction,

assessment of communication)

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3. Vaccine program managers: Cost of implementingintervention

4. All categories: Adverse effects

Justification of outcome measures

The wording of the first primary outcome was formulated to cap-ture immunisation status, given that it is varyingly reported, fol-lowing advice from colleagues in the vaccination and lay healthworker area.The second primary outcome was selected because increasing peo-ple’s knowledge and understanding of the benefits of vaccinationis the stated purpose of many programs and interventions (seeAppendix 1). The intended purpose is a useful and important wayto describe interventions, as reflected in the taxonomy of inter-ventions organised by purpose which was developed as a prelimi-nary step for this review (Willis in preparation). Furthermore, byconsidering knowledge and immunisation status equally, we ac-knowledge the tension between the desire to increase vaccinationrates and a parent’s right to choose not to vaccinate.We will not include or exclude studies on the basis of measuredoutcomes.

Search methods for identification of studies

Electronic searches

We will search the following international and regional sources:• Cochrane Central Register of Controlled Trials

(CENTRAL, The Cochrane Library, latest issue)• MEDLINE (OvidSP)• EMBASE (OvidSP)• CINAHL (EbscoHOST)• PsycINFO (OvidSP)• Global Health (CAB)• Global Health Library (WHO) (includes WHOLIS,

LILACS, other regional WHO databases)

We present the strategy for MEDLINE OvidSP in Appendix 4.Strategies will be tailored to other databases and reported in thereview. There will be no language or date restrictions.

Searching other resources

• We will search for ongoing trials in The InternationalClinical Trials Registry Platform (ICTRP) (and contact authorsto obtain further information or eligible data if available).

• We will search for grey literature in:◦ The Grey Literature Report: http://www.nyam.org/

library/online-resources/grey-literature-report/◦ OpenGrey: http://www.opengrey.eu/

• We will search the reference lists of all included papers andany key papers in the field. We will also search the ISI Web ofScience (both the Social Science Citation Index and the ScienceCitation Index) and Google Scholar for papers that cited thestudies included in the review. We will also contact authors ofincluded studies and vaccination experts from the COMMVACproject advisory group and ask for additional references.

• We will also ask authors of included studies to identify anyeconomic evaluations conducted alongside the studies.

Data collection and analysis

Selection of studies

We will combine search results in an Endnote database and re-move duplicate records. Two review authors will independentlyscreen all titles and abstracts to assess which studies may meet theinclusion criteria. Studies that clearly do not relate to the Criteriafor considering studies for this review will be excluded.We will retrieve in full text all studies determined to be poten-tially relevant. Two review authors will independently screen thesestudies for inclusion. Any disagreement will be resolved throughdiscussion with another review author. Studies that readers mayexpect to be eligible for the review but which are excluded fromthis stage in the screening process will be reported in the ’Charac-teristics of excluded studies’ table.

Data extraction and management

Two review authors will independently extract the data from in-cluded studies. They will discuss any disagreements related to theextraction process with a third author until consensus is reached.The process will be informed by lessons learned in the earlierevidence mapping stages of the COMMVAC project (Willis inpreparation). We will use a data extraction form which com-bines features of the template developed by the Cochrane Con-sumers and Communication Review Group (CC&CRG 2011),the Cochrane equity checklist (Ueffing 2011), and the COMM-VAC extraction template. The data extraction form will includethe following components:

Details of study

We will record: aim of intervention (as stated); aim of study (asstated); study design; description of comparison group; methods ofrecruitment of participants; inclusion/exclusion criteria for partic-ipation in the study; informed consent obtained (yes/no/unclear);ethical approval (yes/no/unclear); funding (including source andamount if stated); statistical methods and their appropriateness (ifrelevant); and consumer involvement (in the design of the studyand/or intervention; in delivery of intervention; in evaluation ofintervention; in interpretation of study findings).

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Participant characteristics

Parents are the primary participants in the interventions we willbe assessing. For each study we will record, if possible: whetherparticipants are parents, expectant parents or guardians; number;age: range, mean (standard deviation); gender; ethnicity; religion;language(s) spoken; household or family size; level of education;socioeconomic status as described by the study; and employmentstatus.Children are the recipients of the vaccines in the studies. We willrecord: child age: range, mean (standard deviation); gender; birthorder; if they attend school; vaccine history of the child or family;and cut-off age stated in each study.

Country and health system features

We will include, if described in the trial: country (with notationof world region and country income level according to the WorldBank definitions (World Bank 2012)); type of healthcare system(universal access (taxation or social insurance), voluntary insur-ance; individual out-of-pocket; specified access for low income/immigrant or refugee patients); vaccine program delivery (includ-ing whether the policy is to vaccinate or to offer parents informedchoice); details of language spoken or written; descriptions of mi-nority populations.

Setting

We will record: degree of regional development (urban/rural) andwhere the intervention took place (ie parent home, hospital, com-munity health centre, emergency department, church, school,childcare or other setting).

Intervention

We will record the following features of the communication in-tervention: intervention purpose (including author’s terminologyrelating to informing or educating); direction of communication;parties involved; content of communication (including details ofvaccines described); format and delivery mode; deliverer (ie servicetype or personnel); training required; setting; frequency or timingof communication; theoretical basis for intervention if described.We will record details of control or standard care as well as anyco-interventions delivered alongside the information or educationintervention.Cost data will be extracted from included studies where possible,and from any additional economic evaluations identified when wecontact study authors. We will report this information narrativelyin the review.

Intervention quality

We will record any information on the quality of the interven-tion as assessed by the study authors, including any information

regarding the fidelity/integrity of the intervention, such as if itwas delivered as intended or not, and rate of attrition if clearlyattributable to quality of the intervention.For risk of bias of the study we will use the seven domains ofthe risk of bias assessment tool (see Assessment of risk of bias inincluded studies below).

Outcomes

For outcomes included in our analysis we will collect: definition ofimmunisation status used by study authors; methods of assessingoutcome measures; validity and reliability of outcome measures;methods of follow-up for non-respondents; number of outcomeassessments; and timing of outcome assessment (including fre-quency and length of follow-up). Where trials measure additionaloutcomes, we will note these in the data extraction template.

Study’s conclusion

We will record the conclusions drawn by the study authors. Wheredetails are not included in the published study, or are unclear, wewill contact authors requesting further information.Data will be entered into RevMan software by one author andchecked by a second author.

Assessment of risk of bias in included studies

We will assess and report on the methodological risk of bias ofincluded studies in accordance with the Cochrane Handbook(Higgins 2011) and the guidelines of the Cochrane Consumersand Communication Review Group (Ryan 2011), which recom-mends the explicit reporting of the following individual elementsfor RCTs: random sequence generation; allocation sequence con-cealment; blinding (participants, personnel); blinding (outcomeassessment); completeness of outcome data, selective outcome re-porting; other sources of bias such as contamination. For each do-main we will describe the relevant information provided by theauthors and judge each item as being at high, low or unclear riskof bias as set out in the judging criteria provided by Higgins 2011.Studies will be deemed to be at the highest risk of bias if theyscore high or unclear in either sequence generation or allocationconcealment (based on growing empirical evidence that these fac-tors are particularly important in influencing risk of bias) (Higgins2011).For cluster RCTs we will also assess the risk of bias associated withan additional domain: selective recruitment of participants (Ryan2011).In all cases, two authors will independently assess the risk of biasof included studies, with any disagreements resolved by discus-sion and consensus. We will contact study authors for additionalinformation about the included studies, or for clarification of thestudy methods as required. We will incorporate the results of therisk of bias assessment into the review through standard tables and

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systematic narrative description and commentary about each ofthe elements, leading to an overall assessment the risk of bias ofincluded studies and a judgment about the internal validity of thereview’s results.

Measures of treatment effect

For dichotomous outcomes, we will analyse data based on thenumber of events and the number of people assessed in the inter-vention and comparison groups. We will use these to calculate therisk ratio (RR) and 95% confidence interval (CI).For continuous measures, we will analyse data based on the mean,standard deviation (SD) and number of people assessed for boththe intervention and comparison groups to calculate mean differ-ence (MD) and 95% CI. If the MD is reported without individualgroup data, we will use this to report the study results. If more thanone study measures the same outcome using different tools, wewill calculate the standardised mean difference (SMD) and 95%CI using the inverse variance method in Review Manager 5.Immunisation status may be defined slightly differently acrossstudies (eg receipt of a single or multiple vaccines; timeliness ofvaccination may or may not be incorporated). We will accept thedefinition of immunisation status used by study authors.When a single study uses two separate methods to measure thesame outcome (eg two measures of parental knowledge), or mea-sures two different outcomes that could be considered part of thesame outcome category (eg parent satisfaction and parent anxiety,which both fall under ’parent evaluation of the intervention’), wewill adopt the approach to measures of treatment effect as outlinedby Brennan and colleagues (Brennan 2009):

1. Select the primary outcome identified by the study authorsthat correlates to our stated outcomes of interest.

2. If no primary outcome is specified, select the one specifiedin the sample size calculation.

3. If there are no sample size calculations, we will rank thereported effect estimates and select the outcome with the medianeffect estimate. When there is an even number of outcomes, wewill include the outcome whose effect estimate is ranked n/2,where n is the number of outcomes.To accommodate multiple or varying outcome assessment timepoints, we will record outcomes at the first follow-up after the endof the intervention and the final follow-up, with the considerationthat final follow-up measures may capture people who were de-layed in receiving immunisation directly following the interven-tion.

Unit of analysis issues

For cluster-RCTs, unless the study authors have already taken ac-count of intra-cluster correlation (ICC) in their own analysis, wewill re-analyse by taking account of intra-cluster correlation (ICC).Estimates of ICC will be obtained from contacting authors, or

imputed using external estimates. If this is not possible we willreport effect estimates and annotate ’unit of analysis error’.

Dealing with missing data

We will contact study authors for missing outcome data, missingstudy-level participant characteristics, or missing summary data.We will impute missing summary data where possible and reportany assumptions in the results tables. We will investigate the effectof our choice of any imputed data including ICCs on the pooledeffect estimate in any meta-analysis of RCTs through sensitivityanalyses.

Assessment of heterogeneity

We will assess statistical heterogeneity through a visual inspectionof the forest plot and the Chi2 test of heterogeneity. Heterogeneitywill be quantified using the I2 statistic. The threshold for accept-able heterogeneity will be an I2 value of 60%, however, this willbe interpreted in light of the magnitude and direction of effectsand the P value from the Chi2 test (Higgins 2011).

Assessment of reporting biases

We will assess reporting bias qualitatively based on the character-istics of the included studies (eg if only small studies are identifiedthat indicate positive findings in favour of face to face inform oreducate interventions), and if information that we obtain fromcontacting experts in the area and the authors of retrieved studiessuggests that there are unpublished studies. If we find sufficientRCTs (at least 10) we will construct a funnel plot to investigatesmall study effects, which may indicate the presence of publicationbias.

Data synthesis

We will present summary statistics for each of our three compar-isons in table form. These tables will include baseline and followup statistics, effect estimates, confidence intervals and informationof effect modifiers and study design.The decision to meta-analyse or not will be based on an assess-ment of whether the interventions in the included trials are similarenough (in terms of participants, setting, interventions and out-come measures) to make meaningful conclusions from a statisti-cally pooled result. It will depend on there being two or more pri-mary studies available for inclusion. Due to the anticipated vari-ability in the populations and interventions of the primary stud-ies, we will use a random-effects model. We will combine RCTswith cluster-RCTs in the same meta-analyses as long as the cluster-RCTs have adjusted for clustering in the analysis.If meta-analysis is possible (ie there are at least two studies whichare sufficiently homogenous), we will use meta-analytic methodsto pool relative risks and calculate associated 95% confidence in-tervals to measure:

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Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

1. Face to face interventions directed to parents (individuals orcouples) versus usual care or passive intervention.

2. Face to face interventions directed to groups of parentsversus usual care or passive intervention.

3. Face to face interventions directed to individuals versus faceto face interventions directed to groups.

4. Face to face intervention A versus face to face interventionB.We will describe the findings (whether meta-analysed or not) in thetext of the review with consideration of the potential impact of biason the size or direction of the effect, the degree of heterogeneity andits possible sources (for meta-analysed data) and their relevance topractice. If we are unable to conduct a meta-analysis, we will groupthe data based on the category that best explores the heterogeneityof studies and makes most sense to the reader (ie by interventions,populations or outcomes). Under each category we will presentthe data in table form and narratively describe the results.We will prepare a ’Summary of findings’ table from the results ofthe meta-analysis using the methods described at chapter 11 ofthe Cochrane Handbook for Systematic Reviews of Interventions(Schünemann 2011). If meta-analysis is not possible, we will use anarrative ‘Summary of findings’ table format such as that used byChan 2011. ‘Summary of findings’ table formats will utilise theGRADE system to rank the quality of the evidence quality usingGRADEprofiler (GRADEpro) software (Schünemann 2011).

Subgroup analysis and investigation of heterogeneity

This review is global in scope but arose from a project with anLMIC focus, so in preparing the protocol we considered whetherthe country in which the intervention was delivered would changethe effects of the intervention. Consultation with key experts in-dicated that there is insufficient empirical evidence to suggest asetting-based variation in intervention effects. Given that parentalknowledge and beliefs affect vaccination coverage around theworld, and that face to face delivery of information is easily adapted

to local settings, we believe that there are not likely to be differ-ences in effect that would justify subgroup analysis based on coun-try income level.

Sensitivity analysis

We plan to undertake sensitivity analyses based on the risk of biasassessment. If possible, studies at the greatest risk of bias will beremoved from the analysis. We will also conduct sensitivity anal-yses to check imputed data including ICC values and to comparefixed-effect and random-effects analyses in the event that smallstudy effects are identified by funnel plots.

Consumer participation

Those with an interest in this review include vaccine programmanagers, policy makers, practitioners and parent interest groups.In the peer review process for the protocol and the review we willseek external referees reflecting these interests.

A C K N O W L E D G E M E N T S

The authors thank all those who have commented on this proto-col. In particular, we would like to thank Megan Prictor (Manag-ing Editor) and the staff and editors of the Cochrane Consumersand Communication Review Group; John Eyers for developingand John Kis-Rigo for peer-reviewing the search strategy; the au-thors of the companion COMMVAC review (Ingvil Sæterdal, Si-mon Lewin, Claire Glenton, Astrid Austvoll-Dahlgren, and SusanMunabi Babigumira) for their advice and support; and the restof the COMMVAC project partners (Sara Bensaude de CastroFreire, Xavier Bosch-Capblanch, and Charles Wiysonge) for theircontributions to the project and their support during the reviewprocess.

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A P P E N D I C E S

Appendix 1. Descriptions of ’inform’ and ’educate’ from a selection of sources

Organisation ‘Inform’ definition/description ‘Educate’ definition/description

UNICEF/WHO

(UNICEF 2005)• Increasing / disseminating

information• Reaching many people• Reinforcing messages• Limited interaction• The delivery of simple and basic

messages• Awareness is increased

Examples include: mass media interventionssuch as radio, TV and newspapers, posters,advertisements, public service announce-ments, banners, promotion by radio, drama,news coverage, calendars

• Can lead to greater awareness andmotivation

• There is a partnership between theparent and provider

• An empowering process• Can incorporate community

participation• Can facilitate learning• Increases comprehension• Spreads messages to people that are

difficult to reach• Educational materials give

information on vaccinationAlso referred to as educational tools, healtheducation, educational materials and canbe delivered through meetings or individ-ual contact or by mediums such as radioor TV programs, drama, talk shows, coun-selling cards, flip charts, pictures

CDC (US)

(CDC 2012)• Parent information website covering a

very comprehensive list of vaccinationtopics such as describing vaccinepreventable diseases, the schedule, andmaking vaccination decisions

• To learn

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(Continued)

NICE (UK)

(NICE 2009)• Receipt/provision of tailored, up-to-

date and accurate information, advice andsupport

• Information is promoted anddisseminated

• Opportunities (eg home visits) todiscuss concerns or issues

Health Canada

(Health Canada 2012)• Raising awareness• Interventions include: posters,

distributing educational material,including information in church bulletins,information booths/displays in public areas

• Information can be solicited fromparents (eg have “story hours” at locallibraries with people who have sufferedfrom infectious disease to come and talkabout their experiences)

• Involves a process of learning

Cochrane Collaboration

CC&CRG

• Can be written and verbal (Johnson2003)

• Can increase knowledge andencourage positive healthcare choices(Atherton 2009)

• Interactive, structured and formal(Foster 2007)

• Verbal communication, it issometimes supplemented with writtenmaterials; increases knowledge and skilllevels; helps people to understand (Stacey2011)

IUHPE

(IUHPE 2009)• Information provision • Can improve health and wellbeing

• “Efforts that enable and supportpeople to exert control over thedeterminants of health and to createenvironments that support health”

• Empowering individuals andcommunities to improve their health

Patient education academic literature • Information provision is the mostbasic level of health education (Nutbeam1998)

• Can improve knowledge (Coulter2007)

• Written information is a usefuladjunct to encounters with the healthprofessional (Coulter 2007)

• Mass media campaigns are used toinform the public (Coulter 2007)

• Information provision interventionsadministered on their own are largelyunsuccessful (Coulter 2007)

• Promotes self care and improvespatient compliance (Ling 2012)

• Includes the provision of information,instructions or advice. Advice anddiscussion is a common component(Soderlund 2011)

• Incorporates the development of skillsand self-efficacy (Nutbeam 1998)

• Enhanced to include features beyondthe delivery of information (Nutbeam2000; Pálsdóttir 2008)

• Promotes understanding (Coulter2007)

• There is a partnership between thepatient and healthcare professional and can

14Face to face interventions for informing or educating parents about early childhood vaccination (Protocol)

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(Continued)

be called shared decision making (Coulter2007)

• Educational interventions aredesigned to increase the participation ofpatients in treatment decisions (Coulter2007)

• There is communication betweenhealth providers and patients (Hoving2010)

• To enable decision making (Hoving2010)

• Actively involves people “in theprocess of setting their own goals andpriorities for behavior related to health”(Green 1990)

Grey literature • Information giving can occur during aclinician-patient encounter using toolssuch as posters (Williams 2002)

• Increasing awareness, reinforcing amessage (Sheedy 2011)

• An acronym is used incorporatingboth terms; Information, Education andCommunication (IEC). Activities that IECare described as one on one and massmedia (CHANGE 1999)

• Education materials can supplementconversations clinicians have with parents

• Addresses misinformation (Sheedy2011)

Appendix 2. Sampling of country immunisation schedules - recommended age for seconda dose ofMMR / measles vaccineb

Country Recommended age

Australia 4 years

Brazil > 4 years

Canada 4 to 6 years

Denmark 4 years

India 16 to 24 months

Nigeria 9 monthsa

Norway 12 years

15Face to face interventions for informing or educating parents about early childhood vaccination (Protocol)

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(Continued)

Pakistan 15 months

South Africa 18 months

Turkey First grade of primary schoolc

UK 3 to 5 years

US 4 to 6 years

Footnotes

aThe ages reported for all countries except Nigeria refer to the delivery of a second dose of MMR. Nigeria’s country schedule includesonly one dose of MMR.b (WHO 2011)cTurkey’s recommendation is made according to school grade level rather than age (Ministry of Health 2010).

Appendix 3. Behaviour change theories and their application to vaccination

Theory Main points Application to vaccination

Social Cognitive Theory (Bandura 1986) • Behaviour, environment, andknowledge are intertwined and act uponone another.

• People acquire knowledge andchange their behaviour based onobserving their environment and thebehaviour of others in their social context.

• Self-efficacy, a person’s belief in theirability to perform a task, also affects theirbehaviour.

• The vaccination behaviour of parentsis influenced by their knowledge (whichthey have developed based on availableand understandable information) as wellas their social environment (the attitudesand behaviour of their peers orcommunity).

• Vaccination messages delivered faceto face allow for interaction andinformation can be tailored to addressspecific social, and environmental, orpersonal self-efficacy concerns.

Theory of Reasoned Action (TRA)(Ajzen 1985)

• The likelihood of behaviour changeor uptake can be predicted based on threecomponents:

◦ Behavioural intention (BI).◦ Attitude (AB): personal beliefs

about the behaviour.◦ Subjective norms (SN): the

influence of others in a person’senvironment.

• A person is likely to change their

• A face to face intervention to informor educate parents about vaccination islikely to target the parent’s attitude towardvaccination in order to influence theirintention to vaccinate. However, if theirsubjective norm is highly contradictory totheir personal attitudes (eg they live in acommunity where vaccination is notapproved of ) then positively influencingtheir attitude may not result in a change

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(Continued)

behaviour if they have the intention tochange.

in vaccination behaviour. Receivinginformation from a trusted and respectedsource may help overcome negativesubjective norms.

Theory of Planned Behaviour (TPB)(Ajzen 1991)

• An extension of the TRA.• Addresses behaviours which are

influenced by factors beyond a person’scontrol.

• The TPB adds the element of’perceived behavioural control’ (PBC),which is an individual’s confidence intheir ability to perform the behaviour.

• Information intended to influenceparental attitudes towards vaccinationmight differ from information toinfluence perceived behavioural control.PBC might be improved throughprovision of logistical information such aswhere, how, or when to vaccinate.Attitudes might be more affected byinformation about risks or benefits, orinformation delivered in an emotivemanner.

Transtheoretical Model (TTM)(Prochaska 1997)

• A model incorporating the conceptof self-efficacy to predict an individual’sreadiness or likelihood of acting on abehaviour.

• The TTM is a stage model with fivestages:

◦ Precontemplation (the person isnot intending to take action);

◦ Contemplation (the personintends to change within the next 6months);

◦ Preparation (the person intendsto act within the immediate future);

◦ Action (the person has madesome specific changes within the past 6months); and

◦ Maintenance (the person isworking to avoid relapse).

• Depending on which stage a personfalls into, different interventions may bemore or less effective at moving themcloser to behaviour change.

• Interventions may be tailored to thestage of readiness of the proposedaudience. Inform or educate interventionsexplaining where to receive vaccines maybe appropriate for people who are in thepreparation stage, but people who arecompletely unaware of or uninterested invaccination (precontemplation) may beinfluenced more by information aboutvaccine-preventable diseases and the risksand benefits of vaccines. Reinforcement orreminders may be a feature of anintervention targeting people in themaintenance stage.

Health Belief Model (HBM)(Janz 1984)

• Predicts how likely a person is toadopt or change a health behaviour inorder to ameliorate a particular risk.

• Developed to address preventivehealthcare behaviour.

• The HBM involves four constructs:◦ Perceived susceptibility (an

individual’s sense of vulnerability to aspecific risk);

• Interventions can be targeted to actat any of the four levels of the model inorder to influence behaviour. For example:providing images and stories of childrenexperiencing serious effects from vaccine-preventable diseases increases perceivedseverity, while education describing theeffectiveness of vaccines influences theperceived benefits of vaccination.

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(Continued)

◦ Perceived severity (how seriousthe person believes that risk to be);

◦ Perceived benefits (theeffectiveness and achievability of theproposed behaviour); and

◦ Perceived barriers (negativeeffects of changing or adopting proposedbehaviour).

Appendix 4. MEDLINE (OvidSP) search strategy

1. Immunization/2. Immunization Schedule/3. Immunization, Secondary/4. Immunotherapy/5. exp Immunotherapy, Active/6. Immunization Programs/7. exp Vaccines/8. (vaccin$ or revaccinat$ or immuniz$ or immunis$ or immunother$ or inoculat$ or innoculat* or prophyla*).tw.9. or/1-8

10. exp Child/11. exp Infant/12. Child Care/13. Infant Care/14. exp Perinatal Care/15. exp Parents/16. (child$ or infant$ or newborn? or neonat$ or preschool* or primary school* or baby or babies or toddler$ or parent$ or mother$or father$).tw.17. or/10-1618. exp Communication/19. ((health or patient* or mediated or facilitated or augmentative or alternative or total or simultaneous or manual or mass or face-to-face or one-to-one or one-on-one or oral or cultural or risk or intervention* or interaction* or program* or skill* or aid* or tool* orboard* or device* or system* or barrier*) adj1 communication).mp.20. (communicat* or messag* or verbal* or nonverbal* or written or writing or reading or language or speech or speak* or spoken ortalk* or conversation* or voice or visual-perception or feedback or listen* or negotiat* or notify* or notification or remind* or narrat*or music* or humor or humour or humorous or adverti* or persua* or interpreting or interpreters or interpret*-service or translat*service* or translating).hw,ti.21. (readability or intelligibility or credibility).mp.22. (disclos* or trust* or truth* or deceiv* or deception or misinform*).hw,ti.23. exp Interpersonal Relations/24. hospital patient relations/25. community institutional relations/26. ((professional or physician or doctor or clinician or nurse or provider) adj1 (patient or client or family)).tw.27. ((health or patient or client) adj (education or knowledge or promotion)).mp.28. exp health promotion/29. ((education* or teaching or learning or instruction* or training or skills or online or web* or internet or video* or multimedia ormulti-media) adj1 (intervention* or session* or course* or program* or material* or package* or module* or demonstration ormethod* or process*)).mp.30. (self adj (teaching or education or instruction)).mp.

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31. ((media adj3 campaign*) or (promotion adj1 program*) or (community based adj3 intervention*) or (awareness adj3 (rais* orincreas*))).tw.32. marketing.mp.33. ((family or office or work* or school or faith or church) adj based).tw.34. (educational status or literacy).mp.35. ((improv* or increas* or enhanc* or patient) adj3 (understanding or comprehension)).tw.36. (information* adj (service* or center* or centre* or system* or dissemination or seeking or retrieval or transfer* or campaign* orprovision or aid or material* or sheet* or pack*)).mp.37. ((patient or client or health or medical or drug or written or print* or visual* or provid* or present*) adj2 inform*).mp.38. (((inform* or message* or communicat* or effect* or gain or positive or negative) adj2 fram*) or ((verbal or oral or written ortext or data or numerical or statistical or visual or graphic* or pictorial or audio* or video* or multimedia or multi-media or narrative)adj (format* or presentation* or display*))).mp.39. (counsel* or ((social or carer* or caregiver* or care giver* or patient*) adj1 support*) or psychosocial or ((social or pastoral orspiritual) adj care) or religio* or chaplaincy or behavior modification or behaviour modification).mp.40. (counsel*ing session* or ((support or peer or self-help or self-care) adj2 (intervention* or group* or program*))).mp.41. ((social or community) adj2 network*).mp.42. (self-care or self-management).mp.43. (motivat* or incentive* or goal*).mp.44. exp Communications Media/45. ((mass or communication* or electronic or digital or multi or print* or social or new) adj media).tw.46. ((print* adj (material* or based)) or paper-based or written material* or (paper adj1 pen*) or publication* or newsletter* orbrochure* or booklet* or pamphlet* or leaflet* or flyer* or handout* or poster* or illustrat* or picture* or pictogram*).mp.47. (radio or television or audiovisual or video* or tape recording* or cassette* or cd-rom* or dvd* or motion picture* or movie* orcinema* or multimedia or hypermedia or telephon* or phone or phones or sms or short message* or text message* or i-pod* or ipod*or i-pad* or ipad* or mp3 player* or hotline* or answering service* or internet or web* or online or on-line or blog* or telemedicineor telehealth or telecare or (virtual adj (reality or world or environment*))).mp.48. ((electronic or e-) adj (mail or prescri* or health or game*)).mp.49. exp computer systems/50. software/51. (computer* adj1 (system* or network* or program* or terminal* or interfac* or interact* or handheld or intervention* or therapyor graphic* or simulation* or searching or mediated or based or tailored or communication or assisted instruction)).mp.52. (touch screen or digital assistant* or pda or blackberry or mobile-device* or laptop* or notebook computer* or computer* ornetbook*).mp.53. (((automat* or interactive*) adj3 (telephon* or phone or phones or voice or hotline* or hot line*)) or ((voice or speech) adj(response or recognition or messag* or system* or technolog*))).mp.54. (cultural* adj (competen* or sensitiv* or appropriate)).mp.55. ((cultural* or linguistic* or language) adj3 (service* or care or intervention* or message*)).mp.56. (participation or advocacy or consumer* or empower*).mp.57. exp decision making/58. (decision adj (making or support or aid*)).mp.59. exp informed consent/60. (informed adj (consent or choice* or decision*)).tw.61. ((patient or person or family or client) adj (cent*red or focus*ed or oriented)).mp.62. (therapeutic adj (relation* or alliance*)).mp.63. or/18-6264. randomized controlled trial.pt.65. controlled clinical trial.pt.66. randomized.ab.67. placebo.ab.68. drug therapy.fs.69. randomly.ab.70. trial.ab.71. groups.ab.

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72. or/64-7173. exp Animals/74. Humans/75. 73 not (73 and 74)76. 9 and 17 and 63 and 7277. 76 not 75

H I S T O R Y

Protocol first published: Issue 8, 2012

C O N T R I B U T I O N S O F A U T H O R S

Writing the protocol: All

Searching for trials: JK, NW, AS

Selecting trials: JK, NW, AS

Data entry: JK, NW, AS

Analysis: All

Interpreting analysis: All

Drafting final review: All

Updating the review: JK

D E C L A R A T I O N S O F I N T E R E S T

Funding for this review and the associated COMMVAC research project was provided by the programme for Global Health andVaccination Research (GLOBVAC) of the Research Council of Norway (project number 196322/S50).

The following authors received funding support from the GLOBVAC programme: JK, SH, NW, DH, PR, VL.

The following authors received support from infrastructure funding provided by the National Health and Medical Research Council(NHMRC) for Australian-based Cochrane Collaboration activities: AS, RR.

Several of the authors are editors of the Cochrane Consumers and Communication Review Group (SH, DH, RR). They were notinvolved in the editorial and peer review process for this protocol.

S O U R C E S O F S U P P O R T

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Internal sources

• NHMRC, Australia.Infrastructure funding for Cochrane Collaboration activities (AS and RR)

External sources

• Research Council of Norway, program for Global Health and Vaccination Research (GLOBVAC), Norway.Funding support for JK, SH, NW, DH, PR, VL.

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