Communication about standard treatment options andclinical trials: can we teach doctors new skills to improvepatient outcomes?†

Jürg Bernhard1,2*, Phyllis Butow3,4, Julie Aldridge5, Ilona Juraskova3, Karin Ribi1 and Richard Brown61IBCSG Coordinating Center, Ef!ngerstrasse 40, 3008 Bern, Switzerland2Department of Medical Oncology, Inselspital, Bern University Hospital, 3010 Bern, Switzerland3Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, The University of Sydney, Camperdown,NSW 2006, Australia4Psycho-oncology Co-operative Research Group (PoCoG), The University of Sydney, NSW 2006, Australia5IBCSG Statistical Center, Dana-Farber Cancer Institute, Department of Biostatistics and Computational Biology, 450 Brookline Avenue, LW2,Boston, MA 02115, USA6Department of Social and Behavioral Health, Virginia Commonwealth University School of Medicine, 1112 East Clay Street, Richmond, VA 23298,USA

*Correspondence to: IBCSGCoordinating Center, Ef!nger-strasse 40, 3008 Bern, Swit-zerland. Email: juerg.bernhard@ibcsg.org

†This trial was orally presentedat the International Psycho-Oncology Society (IPOS)Conference, 21–25 June 2009,Vienna.

Received: 9 September 2010Revised: 7 June 2011Accepted: 8 June 2011

AbstractBackground: The International Breast Cancer Study Group conducted a phase III trial inAustralian/New Zealand (ANZ) and Swiss/German/Austrian (SGA) centres on training doctorsin clear and ethical information delivery about treatment options and strategies to encourageshared decision making.

Methods: Medical, surgical, gynaecological and radiation oncologists, and their patients forwhom adjuvant breast cancer therapy was indicated, were eligible. Doctors were randomisedto participate in a workshop with standardised teaching material and role playing. Patientswere recruited in the experimental and control groups before and after the workshop.

Results: In ANZ centres, 21 eligible doctors recruited a total of 304 assessable patients. InSGA centres, 41 doctors recruited 390 patients. The training was well accepted. There was nooverall effect on patient decisional con!ict (primary endpoint) 2weeks after the consultation.Overall, patients were satis"ed with their treatment decision, their consultation and their doc-tors’ consultation skills. Considerable variation was observed in patient outcomes betweenSGA and ANZ centres; the effect sizes of the intervention were marginal (<0.2).

Conclusions: Shared decision making remains a challenge. A sustained training effect mayrequire more intensive training tailored to the local setting. Cross-cultural differences needattention in conducting trials on communication interventions.Copyright © 2011 John Wiley & Sons, Ltd.

Keywords: communication skills training; shared decision making; cross-cultural differences;breast cancer; oncology

Introduction

During the past decade, there has been a growing ex-pectation that patients should participate in decisionsabout their medical care and give informed consentnot only to clinical trials but also to standard treat-ments. As communities in Western societies have be-come better informed about health care issues, patientexpectations and medical ethics have moved from apaternalistic model to one promoting partnershipand patient autonomy (e.g., Declaration of Helsinki[1]).Oncologists have advocated involving patients in

decision making, particularly when the potentialgains of treatment must be weighed up against theadverse effects [2–4]. Many patients with cancer

today want to participate in decisions about theircare [5,6]. Actively participating or knowing onehas choice in treatment decision making is bene!cialto patients [7–9].Not all patients, however, prefer decisional control,

particularly if faced with distressing and unfamiliarsituations [10]. Prescribing increased involvementfor all patients could be as paternalistic as encourag-ing none. This concern has led to the paradigmof shared decision making (SDM) in which doctorstailor involvement to a patient’s desired level of con-trol rather than aiming for overall patient participa-tion [11,12].Decision-making preferences of patients with can-

cer are not always met [13–16], and often on-cologists do not elicit these [17,18]. Oncologists’

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Psycho-OncologyPsycho-Oncology (2011)Published online in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/pon.2044

perceptions may be inconsistent with patients’ statedpreferences, for example, in elderly patients [19].These dif!culties are heightened when discussing aclinical trial [20–23].These issues suggest that targeted training in SDM

is warranted. Communication training in decisionmaking regarding standard care has been shown tobe effective in a randomised controlled trial in thefamily practice setting [24]. We are not aware ofsimilar studies in the oncology setting. Studies in de-cision making regarding cancer clinical trials arelimited by pre-post designs [17,25]. Jenkins et al.showed improved con!dence and competence inclinicians and nurses after training in communicationabout randomised clinical trials of cancer therapy[25]. In a pilot study by Brown et al. oncologistsvaried considerably in their SDM behaviours [23].This group conducted a phase II trial that developedand evaluated a model to promote SDM during in-formed consent discussions. Oncologists used somebehaviours of SDM (e.g., less coercion) more fre-quently after this training. Patients in the post-training cohort showed more positive attitudes toclinical trials [17].We expanded this curriculum for SDM for both

clinical trials and standard options [17], testing thisintervention in an international randomised con-trolled trial. Doctors were trained in clear and ethicalinformation delivery of standard treatment optionsand clinical trials and of strategies to encourageSDM with patients with early breast cancer. Wehypothesised a bene!cial impact on decisional con-"ict in patients of trained doctors.The relevance of decisional con"ict to prefer-

ence-sensitive decisions in early breast cancer iswell documented [26–28]. The potential bene!ts ofadjuvant chemotherapy for postmenopausal patientsin terms of prolongation of disease-free and overallsurvival must be balanced against the toxicity oftreatment [29]. In younger premenopausal patients,age-adjusted risk pro!les are complicated, consider-ing the trade-offs between delayed endocrine symp-toms but higher risk of permanent menopause withchemotherapy and the immediate but reversible en-docrine symptoms with goserelin [30]. Such cost–bene!t ratios may be dif!cult for patients to assess,causing decisional con"ict.This report focuses on patient outcomes from our

trial and discusses methodological issues relevantto trials on SDM interventions. Doctor outcomeswill be presented elsewhere.

Doctors, patients and methods

The International Breast Cancer Study Group(IBCSG) conducted Trial 33–03 in centres inAustralia and New Zealand (referred to as ANZ)and Switzerland, Germany and Austria (referred toas SGA), with the doctor as the unit of block rando-misation after strati!cation for centre. The ethics

committees of all participating centres (Appendix)approved the protocol.Medical, surgical, radiation and gynaecological

oncologists, working in major cancer centres orclinics (including private oncologists) and involvedin the treatment of patients with early breast cancer,and their patients for whom adjuvant therapy forbreast cancer was indicated, were eligible. The fol-lowing patient criteria were additionally required:lower age limit of 18 years, adequate knowledge oflocal language (English or German) and being men-tally and physically capable of participating. Doctorparticipation was independent of previous or con-current participation in other types of communica-tion training; previous communication training wasdocumented.

Procedures and measures

Centres with high patient accrual to adjuvant breastcancer trials were invited to join this trial. Local trialcoordination was supported and monitored by a cen-tral coordinator for ANZ and SGA, respectively. Af-ter giving informed consent, doctors at participatingcentres were enrolled concurrently. Following base-line assessment and before the scheduled trainingworkshop, they were randomly assigned to the ex-perimental (training workshop) or control (no train-ing workshop) group. Doctors in the control groupwere offered the training after completing trialfollow-up.Patients of enrolled doctors were recruited before

their doctors were randomised (pre-randomisationcohort) and after the workshop, if assigned (post-randomisation cohort). Local staff identi!ed eligi-ble patients within a "exible time window of about12months in each randomisation cohort. For eachdoctor, 5–10 patients were to be enrolled in thepre-randomisation and 8 or more in the post-randomisation cohort.Trial outcomes were selected on the basis of stud-

ies that evaluated decision aids designed to facilitateSDM [31]. Within 2weeks of their initial consulta-tion discussing treatment options, patients gaveinformed consent and completed a baseline question-naire gathering demographics; preferences for infor-mation (degree of detail required on a Likert scalefrom ‘prefer few details’ to ‘prefer as many detailsas possible’ and type of information required ‘onlyinformation needed to care for myself properly’,‘only good news’ or ‘all possible news both goodand bad’ [32]) and involvement in decision making(single choice among !ve speci!c statements froma doctor-focused decision to a patient-focused deci-sion [32]); quality of life indicators [33] comprisingphysical well-being, mood, coping effort [34],thought of actually having treatment [35], treatmentburden [36] and burden of self-determined problem;and state anxiety by Spielberger [37]. Research

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nurses or data managers assisted patients in the com-pletion of the questionnaire if necessary.At two additional time points, 2 weeks and

4months after the initial consultation, patients weremailed a questionnaire with pre-paid, addressed re-turn envelope. In addition to the baseline measures,the 2-week questionnaire assessed satisfaction with:decision (total score, six items [38]), consultation(total score, 25 items, adapted from [39,40])and doctor communication in discussing standardtreatment options (total score, 12 items [17]) andclinical trials(total score, four items [17]); patient’sknowledge of diagnosis and treatment options(multiple choice items among speci!c statements,study-developed measure); amount of information re-ceived, involvement preference and actual involve-ment (all adapted from the corresponding baselinemeasures); and decisional con"ict by O’Connor [41]as primary endpoint (total score, 12 items). The4-month questionnaire re-assessed satisfaction withdecision, quality of life and state anxiety. If the coor-dinator did not receive a questionnaire in due time,she or he contacted the patient.Prior to randomisation and 4months after rando-

misation, doctors completed the Maslach BurnoutInventory as used by Ramirez [42] (three subscales:depersonalization (!ve items), emotional exhaustion(nine items), and personal accomplishment (eightitems)), and study developed measures of satisfac-tion with their communication and the training. Inthe study by Ramirez, burnout was more prevalentamong consultants who felt insuf!ciently trained incommunication and management skills [42]. We ex-plored the potential in"uence of doctor stress andburnout on the difference in decisional con"ict be-tween randomisation groups, because this may havebeen a potential confounder of doctors’ ability tobene!t from training.All the patient measures were in English for ANZ

and in German for SGA centres. Only the anxietyand quality of life measures were available in multi-ple languages. For the others, German versions wereadapted from the English version according to stan-dardised procedures. Reliability (internal consis-tency) was con!rmed in the German version ofthese scales (scores ranging from 0.71 to 0.95).

The training

The training consisted of a 7-h interactive face-to-face workshop with one to two follow-up tele-phone calls over 2months. The elements of thistraining were evidence-based [17], incorporatingpresentation of principles [43], a video modellingideal behaviour and role-play practice. The trainingfocused on four key concepts: ensure a shared deci-sion-making framework; structure information intoa sequence or order; ensure the inclusion of different,speci!c types of information in a clear manner; and

consider the disclosure of speci!c controversial in-formation and avoid coercive communication [43].The workshops were held at the participating cen-

tres and conducted in the local language by one totwo clinical psychologists with experience in inter-actional skills training. The teaching materials werein English (i.e., strategies document and teachingvideo). Before the workshop, participants wereexpected to have read the strategies document. Foreach participant, two audio-taped consultations weretranscribed and analysed by the research team usingthe Decision Analysis System for Oncology [44,45].Con!dential written feedback concerning these tapeswas provided at the end of the workshop. One monthlater, the trainer called the doctors to reinforce andextend learning.

Statistical analysis

The target accrual was 44 doctors (22 per rando-mised group) to detect a 0.25-point difference indecisional con"ict between the two groups with90% power, a = 0.05 and 10 patients per doctor(pre-randomisation and post-randomisation cohorts).On the basis of a prospectively de!ned interim anal-ysis (2006) of 19 ANZ doctors (average of eightpatients each), which yielded an intra-class correla-tion of 0.05 and S2 (variance within doctors plus var-iance among doctors) of 0.34, 19 SGA doctors (eightpatients each) were required to detect a 0.25-pointdifference in decisional con"ict with 90% power.Language cohorts were de!ned by location: ANZ

(English) and SGA (German). All analyses were un-dertaken, and results are presented separately by lan-guage due to potential cultural differences.The primary outcome measure was patient deci-

sional con"ict. The secondary patient outcomes de-scribed previously (e.g., satisfaction with decision)were explored.The difference in decisional con"ict between the

randomised groups (Trainingpost!Trainingpre)!(Controlpost!Controlpre) 2weeks after the consulta-tion was estimated by a mixed effects model, withdata at the patient level and doctor as a random effect.A two-sided p-value of 0.05 was considered signi!-cant. Doctor and patient characteristics between ran-domisation groups were considered in the models,but the individual factors that showed a statisticallysigni!cant treatment difference did not contributeto the decisional con"ict scores and had no substan-tial impact on the estimates of the training effect;thus, the !nal models did not adjust for these factors.Estimated mean differences, standard errors and95% CIs based on the mixed models for decisionalcon"ict were reported according to data collectionpoint (pre-randomisation or post-randomisation)and randomisation group. Effect size (ES) was calcu-lated as the estimate divided by the product of thestandard error and the square root of the degrees offreedom. In an exploratory analysis, mixed models

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for decisional con"ict accounted for the three doctorstress and burnout subscales, respectively, as mea-sured 2weeks post-randomisation. The secondarypatient endpoints were similarly analysed by mixedeffects models, with multiple assessments over time.The mean scores by randomisation group at eachdata collection point are plotted. Adjustments werenot made for multiple testing. The analyses usedSAS 9.2 (SAS Institute, Cary, NC, USA).

Results

Sample description and patient characteristics

The Consolidated Standards of Reporting Trials dia-gram is shown in Figure 1. In the ANZ cohort, 21(100%) enrolled doctors were eligible, and 304(89%) of their patients were assessable with regardto the primary endpoint. In the SGA cohort, 41(77%) of 53 enrolled doctors were eligible, and390 (91%) patients were assessable for the primaryendpoint. The main reason for doctor ineligibilitywas failure to be randomised (N = 11); one doctor en-rolled no patients.In the ANZ cohort, 10 centres participated, with

a median number of 1.5 doctors per centre (range:1–6) and 15 patients per doctor (range: 1–28). Inthe SGA cohort, the corresponding totals were 10centres, 4 doctors per centre (range: 2–6) and 9patients per doctor (range: 1–21). For SGA andANZ, respectively, 49% and 48% of patients wereenrolled in the pre-randomisation cohort. More doc-tors in the SGA than the ANZ cohort did not meetthe target of at least eight patients in the post-cohort(66% vs 45%).Baseline characteristics of eligible doctors are

shown in Table 1. There were more female doctorsin the SGA than in the ANZ cohort (26 (63%)vs 10 (48%), respectively). Doctors working in

radiation oncology participated only in the ANZcohort and those from gynaecology only in theSGA cohort. More ANZ doctors had participated ina previous communication training (11 (52%) vs 10(24%), respectively).Baseline characteristics of eligible patients are

summarised for the pre-randomisation and post-ran-domisation cohorts in Table 2. For ANZ and SGA,the characteristics of the pre-cohorts and post-cohorts and of the control and training groups, re-spectively, were similar.The primary endpoint was assessable for 91% of

patients in both the SGA control and training groups(for control, n= 194 of 214; for training, n= 196 of215), and 91% and 88% in the respective ANZgroups (for control, n= 155 of 171; for training,n= 149 of 169). Patient questionnaires were col-lected in the post-randomisation cohort trainingand control groups over 3.8 (0.1–10.1) and 6.0(0.0–15.5)months, respectively in ANZ, and 5.9(0.0–27.0) and 5.7 (0.3–24.5)months in SGA.

Patient outcome

Decisional con"ict was assessed in both cohorts ofpatients (pre-doctor and post-doctor randomisation)2weeks after the consultations. Decisional con"ictfor both ANZ and SGA appeared to be mostly nor-mally distributed for each combination of cohorts.Figure 2 shows the mixed model estimates of deci-

sional con"ict by randomisation and language co-hort. Overall, patients in the SGA cohort reportedhigher con"ict scores than those in the ANZ cohort.In the pre-randomisation cohort, patients in the ANZcontrol group indicated lower con"ict comparedwith the ANZ training group (estimated difference =0.26; ES= 0.41; p= 0.03). Post-randomisation, al-though there was no change in con"ict in the SGAcohort, in the ANZ cohort there was an increasedlevel of con"ict in the control group (estimate = 0.28;

Figure 1. Consolidated Standards of Reporting Trials diagram. Switzerland, Germany, Austria, SGA; Australia, New Zealand, ANZ

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ES = 0.17: p = 0.003). This change exceeded the im-provement in the training group (estimate =!0.14;ES = 0.09; p= 0.13). In summary, the training appearedto have no overall effect on decisional con"ict in eitherlanguage cohort.Because the patients in the pre-randomisation con-

trol group in the ANZ cohort displayed a low deci-sional con"ict that seemed to have in"uenced the

overall outcome, we further investigated their charac-teristics and compared them with those of all otherpatients. Compared with the other pre-randomisationcohort, patients from the ANZ control group wereyounger (median age: 48 vs 57.5 years) and morelikely to be node positive (48% vs 37%).Overall, patients were satis!ed with their treat-

ment decision (Figure 3a). Although there were

Table 1. Baseline characteristics of eligible doctors by language cohort (SGA, ANZ) and randomisation group (control, training)

Switzerland/Germany/Austria (SGA) Australia/New Zealand (ANZ)

Control Training Control Training

N % N % N % N %

n 20 100 21 100 11 100 10 100Gender

Male 7 35 8 38 6 55 5 50Female 13 65 13 62 5 45 5 50

SpecialtyMedical oncology 6 30 5 24 6 55 6 60Radiology — — — — 3 27 3 30Surgeon 2 10 2 10 2 18 1 10Gynaecologist 12 60 14 67 — — — —

InstitutionPublic 20 100 20 95 7 64 7 70Private — — 1 5 — — — —Both — — — — 4 36 3 30

Previous training in communication skills 6 30 4 19 5 45 6 60Med (Range) Med (Range) Med (Range) Med (Range)

Age in years 33 (27, 44) 34 (24, 48) 47 (33, 58) 44 (38, 62)Previous years of practice 6 (1, 18) 6 (1, 24) 16 (2, 35) 20.5 (8, 37)Average number of patients per doctor recruited to trials over 6monthsa 15 (5, 200) 15 (3, 55) 15 (5, 50) 8 (3, 20)

Med, median.aRefers to any trial.

Table 2. Baseline characteristics of eligible patients by language cohort (SGA, ANZ) and randomisation group (control, training)(includes both pre-doctor and post-doctor randomization cohorts)a

Switzerland/Germany/Austria (SGA) Australia/New Zealand (ANZ)

Control Training Control Training

N % N % N % N %

n 214 100 215 100 171 100 169 100Nodal status

Missing 3 1 8 4 2 1 7 4Negative 138 64 129 60 100 58 96 57Positive 73 34 78 36 69 40 66 39

Grade of tumour1 2 1 10 5 8 5 9 52 31 14 27 13 30 18 38 223 100 47 84 39 79 46 63 37Missing 81 38 94 44 54 32 59 35

Hormone receptor statusMissing 10 5 12 6 20 12 25 15Negative 39 18 39 18 36 21 41 24Positive 165 77 164 76 115 67 103 61Training in medical !eld 27 13 39 18 41 24 33 20

Med (Range) Med (Range) Med (Range) Med (Range)Age (years) 58 (24, 85) 58 (31, 88) 50.5 (27, 81) 53 (30, 83)Tumour size (cm) 2 (0.2, 8) 2 (0, 12) 1.9 (0.1, 25) 2 (0.3, 40)

Med, median.aTwenty-eight patients with missing data on decisional con!ict are included.

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some tendencies in the expected direction, there wasno overall effect by the training in the secondary pa-tient outcomes in either language cohort. The ESswere consistently marginal (ES< 0.2). For example,patients in both the SGA and ANZ cohorts reportedmore involvement in decision making in the traininggroup after the workshop as compared with the con-trol group (Figure 3b), but this was not statisticallysigni!cant (p = 0.08 for SGA and p = 0.24 forANZ). There was higher satisfaction with doctor’sconsultation skills for patients in ANZ than forpatients in SGA, and all cohorts showed improvedsatisfaction with doctor’s consultation skills exceptfor the ANZ control group (Figure 3c), althoughnot statistically signi!cant (p= 0.08 for SGA andp= 0.26 for ANZ). Anxiety slightly decreased overtime for all cohorts. Patients in the SGA (Figure 4a)and ANZ (Figure 4b) cohorts reported comparableanxiety levels at each time point. The quality of lifeindicators showed similar !ndings (data not shown).When doctors’ stress and burnout factors were

accounted for in the mixed effects models for deci-sional con"ict, the ESs became slightly larger inthe SGA cohort but remained low. There was no in-"uence by these factors on the ESs in the ANZ co-hort (data not shown).

Discussion

We studied the effectiveness of our communicationskills training cross-culturally within an experimen-tal design. To increase homogeneity, we tailoredour intervention to consultations in which adjuvanttreatment options for early breast cancer were dis-cussed, with or without a clinical trial. There wasconsiderable variation in patient outcomes betweenthe SGA and ANZ cohorts and no substantial train-ing effect. Overall, patients were satis!ed with theirtreatment decision, their consultation and their doc-tors’ consultation skills.

Most previous communication trainings have fo-cused on general interaction skills or the deliveryof bad news [46]. Such interventions have a bene!-cial effect mainly on doctor outcomes, for example,increased empathic responses [47]. Training inSDM has been studied less frequently [17,25] andits effect on patient outcomes has been studied infew controlled designs [48,49].There is some suggestion of a dose–response ef-

fect based on trials of general communication skills[47], although the minimal training duration for asustainable effect is unclear. The only trial with anenduring effect over 12months was based on a 3-day workshop [50,51]. In our trial, doctors enrolledpatients over the course of approximately 1 year inboth the pre-randomisation and post-randomisationcohorts. Such a window was necessary to study theeffect of the training on a suf!cient number ofpatients in real consultations. Our 1-day workshopmay not have been suf!ciently intensive for such awide interval of outcome evaluation. Enrollingactors portraying a patient in a shorter time frame be-fore and after the training may be more sensitive tocommunication changes [25], at least in the shortterm. However, this approach loses the ecologicalvalidity of showing a real bene!t to real patientsfrom doctor communication skills training.Logistically, the trial was very demanding. Job ro-

tation and maternity leaves of fellows had a negativeimpact on patient accrual particularly in the SGApost-randomisation cohort, resulting in fewerpatients per doctor than projected. Whether the doc-tors selectively enrolled their patients is not known.Although the pre-randomisation and post-randomi-sation cohorts were similar, individual patient differ-ences may still have clouded the intervention effects.Although we might have reduced this effect with anadditional random assignment of the patients, thiswas not feasible. Most centres were not able to com-ply with the original requirement to enrol patients inconsecutive order and document reasons for non-

Figure 2. Decisional con!ict (primary endpoint) based on estimates from the mixed model by randomisation group and language co-hort. Treatment comparisons are made in terms of differences in the patients of each randomised doctor, pre-randomisation andpost- randomisation, adjusting for language Switzerland, Germany, Austria/Australia, New Zealand (SGA/ANZ). Overall, scores of!2 of decisional con!ict are considered as ‘no dif"culty in decision making’

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participation. Our mixed effects model accounted forpotential clustering effects to the extent possible.We chose centres that already had a high accrual

to clinical trials. These centres were experienced inclinical research, had designated staff for local coor-dination and data management and generally had ahigher accrual overall and thus may have contributedto a faster recruitment to studies such as ours. Com-munication skills of these providers may alreadyhave been at an advanced level. In particular, somedoctors had previously participated in other typesof communication training. We did not exclude thesedoctors because we explicitly focused our interven-tion on SDM. Whether this lowered the impact ofthe training on the observed outcomes is not known.

It is also possible that these more experienced doc-tors were more motivated for this training. Finally,the lower con"ict scores in the ANZ cohort may re-late to the widespread availability of nurses forbreast cancer in ANZ sites who provide signi!cantinformation to patients.It was dif!cult for doctors to organise time for

telephone coaching after the workshop. Compliancewith these calls was not satisfactory. We did not for-mally document how the doctors used their trainedskills. As an alternative, we suggest an individualfollow-up based on the facilitator’s participation ina doctor’s real consultation with feedback providedafter the consultation. This procedure would poten-tially be more meaningful to the doctor and thus a

Figure 3. Patients’ satisfaction with decision (a), patient preferences for involvement in decision making (b) and satisfaction with doc-tor consultation skills (c) based on mean scores by randomisation group and language cohort. Switzerland, Germany, Austria, SGA;Australia, New Zealand, ANZ

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promising approach to reinforce and extend learning.As a consequence, the impact of the training wouldlikely be enhanced and more likely to impact patientoutcomes. Practicing discussion of speci!c trials cur-rently recruiting at the local centre may improveskills implementation.Whether patients might be more responsive to

SDM interventions than doctors is an intriguingquestion. It is not the patient’s responsibility to ad-just his or her communication skills when confrontedwith cancer. However, to enhance their participationin decision making as they move through the cancertrajectory, short interventions incorporating decisioncoaching may be useful [52].In summary, training our doctors in SDM with a

1-day workshop and support materials did not ap-pear to bene!t their patients in a measurable way.Elwyn et al. have summarised the main conditionsfor SDM to become part of mainstream clinical prac-tice: ready access to evidence-based informationabout treatment options; guidance on how to weighup the pros and cons of different options; and a sup-portive clinical culture that facilitates patient engage-ment [53]. Our intervention targeted the secondcondition. We propose the development of a moreintensive module, more speci!cally adapted to localneeds and with individual follow-up based on real-time supervision of the doctors’ communication withtheir patients. Both between and within the ANZ andSGA cohorts, we were faced with different clinical

cultures regarding the facilitation of patient engage-ment. Cross-cultural differences and local settingsneed more systematic attention in conducting trialson communication interventions.

AcknowledgmentsThis trial was a collaborative effort between the Centre for Med-ical Psychology and Evidence-based Decision-making, Schoolof Psychology, University of Sydney, and the InternationalBreast Cancer Study Group (IBCSG). It needed considerablelogistic efforts.

We would like to thank the doctors who participated in thetrial, the patients who took the time to complete the question-naires, the data managers and local coordinators in the participat-ing centres and Peter Zoller, Cornelia Zuberbühler, MonikaDzidowska, Gwynneth Wong, Gina Bark and Anna-Lena Lopezfor central trial coordination.

We would like to thank the National Breast Cancer Foundationof Australia, Oncosuisse/Swiss Cancer League (OCS–01165-09-2001/KLS–01648-02-2005), Deutsche Krebshilfe (106668), andIBCSG for funding this trial. The IBCSG Statistical Center (J.A.)is partially funded through a grant from the US National CancerInstitute (CA-75362).Con!ict of interest: There are no !nancial disclosures from anyauthors.

Appendix of participating centres, doctorsand local coordinators

AustraliaSt Vincent’s Hospital, Melbourne: R. Snyder, W.Burns, A. Dowling and Nadia Ranieri

Figure 4. Patient state anxiety in the Switzerland, Germany, Austria (a) and the Australia, New Zealand (b) cohort over time based onmean scores by randomisation group

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Maroondah Hospital, Maroondah: J. Chirgwin andSuzanne GiddingsRoyal Prince Alfred Hospital, Sydney: S. Pendlebury, J.Beith, A. Hamilton and Gina BarkSir Charles Gairdner Hospital, Perth: C. Saunders, L.Jackson, N. Spry, F. Cameron, M. Taylor, R. Chee,Anna Davies and Philippa KellyFlinders Medical Center, Adelaide: B. Koczwara andAlison RichardsWestmead Hospital, Sydney: V. Ahern, P. Harnettand Mary CooperNepean Cancer Care Center, Penrith: N. Wilckenand Penny Murie

New ZealandAuckland Hospital, Auckland: P. Thompson, V.Harvey and Joline OngWaikato Hospital, Hamilton: I. Campbell and JenniScarletDunedin Hospital, Dunedin: D. Perez and AlisonWylie

SwitzerlandKantonsspital St. Gallen: B. Thürlimann, A. Casty,M. Hoe"iger and A. MüllerInselspital Bern: S. Aebi,M. Rabaglio and C. Baumann

GermanyUniversitätsklinik Frankfurt: M. Liszka, S. Loibl, K.Schmidt, V. Gies and H. TrümperFrauenklinik Technische Universität München:K. Miska, U. Euler, D. Paepke, K. Gauger and A.BaumgärtnerUniversitätsfrauenklinik Kiel: C. Crohns, I. Mein-hold-Heerlein, A. Ulrich, S. Grebe, J. Haller, A.Lüesse and J. DürkopKrankenhaus München Schwabing: Andrea Schulte,Alexandra von Holle and Sabine SchmidUniversitätsklinikum Jena: O. Camara, J. Hermann, A.Egbe, A. Kavallaris, H. Winzer, B. Härtwig andS. Krauspe

AustriaWilhelminenspital Wien: H. Lass, T. Scholl, M.Brunbauer and M. Riegler-KeilAllgemeines Krankenhaus Wien: C. Singer, Y.Yücel, D. Gschwantler-Kaulich, A. Fink-Retter, D.Bikas and M. TeaLandeskrankenhaus Feldkirch: M. Knauer, R.Köberle-Wührer and P. Elke

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