J O U R N A L O F G E R I A T R I C O N C O L O G Y 3 ( 2 0 1 2 ) 2 0 5 – 2 1 1

Ava i l ab l e on l i ne a t www.sc i enced i r ec t . com

Effective communication of study results to older participantswith prostate cancer: Results of a survey☆

Shabbir Hussaina, Henriette Breunisa, Narhari Timilshinaa, Shabbir M.H. Alibhaia, b,⁎aDepartment of Medicine, University Health Network, Toronto, Ontario, CanadabDepartments of Medicine and Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada

A R T I C L E I N F O

☆ Financial Support: Supported in part by a gfrom the Canadian Cancer Society.⁎ Corresponding author at: 200 Elizabeth St Ro

E-mail address: shabbir.alibhai@uhn.on.c

1879-4068/$ – see front matter © 2012 Elseviedoi:10.1016/j.jgo.2012.04.001

A B S T R A C T

Article history:Received 24 November 2011Received in revised form6 March 2012Accepted 3 April 2012Available online 3 May 2012

Objectives: We examined attitudes towards, satisfaction with, and costs associated withproviding end of study feedback in a group presentation format to older men participatingin an observational prostate cancer study. We also aimed to capture the resources requiredfor such a presentation.Methods: We invited all 186 participants of a longitudinal matched cohort study examininghealth effects of androgen deprivation therapy in men with prostate cancer who wereattending an end-of-study presentation to complete a survey exploring attitudes towardsand prior experience with end-of-study results. We also explored the burden communicat-ing end-of-study results might place on study investigators and clinicians.Results: Usable surveys were returned by 59 of 70 presentation attendees (84%). Thirty-nineof 59 respondents were study participants while the rest were spouses or guests. Eighty-fivepercent of respondents agreed/strongly agreed that they had a right to know end-of-studyresults. Forty-six percent wanted to receive results via email while 45% wanted a grouppresentation. One-third of respondents had participated in clinical research before; ofthese, 84% never received study results. Ninety percent of respondents indicated that theywere more likely to participate in a study if they knew results would be provided to them.Total resources were under 40 hours and $670 CAD.Conclusions: End-of-study results are expected by most study participants. Presentation ofaggregate results in a group format may be an effective and efficient way to communicatestudy results. Including a commitment to an end-of-study presentation may enhancerecruitment. Attitudes of non-attendees should be examined in future research.

© 2012 Elsevier Ltd. All rights reserved.

Keywords:Patient communicationKnowledge translationCancerAging

1. Introduction

For clinical studies to influence practice, their results must becommunicated to the scientific community. Numerous stud-ies have examined the diffusion of results of pivotal studiesinto clinical practice.1–5 Far less is known about whether andhow results of clinical studies should be communicated toresearch participants. While an overwhelming majority of

rant from the Canadian C

om EN14-214, Toronto, Ona (S.M.H. Alibhai).

r Ltd. All rights reserved.

Canadian Research Ethics Board chairs supported conveyingresearch results to study participants after study conclusion,6

there appears to be a lack of clear guidelines in nationalpolicies governing research addressing the return of results tostudy participants.7,8 In general, federal regulations andinstitutional review boards require disclosure only of infor-mation that may affect ongoing participation in a researchstudy.9

ancer Society and a research scientist award to Dr. Shabbir Alibhai

tario, Canada M5G 2C4. Tel.: +1 416 340 5125; fax: +1 416 595 5826.

206 J O U R N A L O F G E R I A T R I C O N C O L O G Y 3 ( 2 0 1 2 ) 2 0 5 – 2 1 1

In their seminal paper on the topic, Fernandez et al.suggest that the disclosure of research results upholds theprinciple of respect for persons and the requirement thatparticipants be treated as more than a means to an end.10

However, few investigators had outlined a formal plan for thereturn of research results.11

At a practical level, researchers may communicate studyresults to participants via print newsletters, the internet,telephone, group presentations, as well as face-to-face one-on-onemeetings. However, understanding the implications ofstudy results may be difficult for laypersons. As such,individual presentation of study results (one-on-one) may bethe best method to convey information,1 but this requiresconsiderable time and resources. A group presentation is analternative where aggregate study results can be communi-cated and investigators can answer most of the queriesarising from participants in a relatively short amount oftime. Whether participants would accept this method ofdisclosure is not known. In particular, whether older adults,who may have different learning needs and styles thanyounger adults,12,13 prefer a group presentation is notknown. Additionally, no one has explored the potentialburden such disclosure might create on clinicians who arenot part of the investigative team but might have to answerany queries from anxious study participants.

To explore these issues, we surveyed all the participants atan end-of-study presentation of a prospective observationalprostate cancer study to solicit their perceptions and attitudesabout communicating study results. Our main objectives wereto evaluate our end-of-study presentation format and under-stand participants’ attitudes towards the value and preferredformat of end-of-study presentations as well as any burdenssuch a presentation might place on study investigators orclinicians. We also estimated costs (person-hours as well asdirect expenses) to arrange such a presentation, as suchresource data have not typically been reported previously.

2. Materials and Methods

We invited all participants of a longitudinal matched obser-vational cohort study examining the health effects (physicalfunction, quality of life, cognitive function) of androgendeprivation therapy (ADT) in older men with prostate cancerto an end-of-study presentation. We first informed all studyparticipants about our presentation through a regular studynewsletter that is sent out to participants (participants couldopt out of receiving mailings) every 4 months. Later on, aspecific invitation card was sent to all study participants. Oneweek before the presentation, which was scheduled withinwalking distance of the hospital in a nearby auditorium on aweekday in the early evening, telephone reminders weremade by study staff to all participants. They were also invitedto bring a spouse, other family member, or friend. Participantsof this study were originally recruited into three cohorts:patients with non-metastatic prostate cancer on ADT (ADTusers), prostate cancer patients without metastases who werenot taking ADT (PC controls), and healthy controls. This studywas started in 2004 and the last participant was recruited in2007. Total study recruitment was originally 260 participants.

2.1. Study Presentation

The study presentation was held in an amphitheatre with aseating capacity of 175. The presentation was divided into twoparts. In the first part, the principal investigator (SMHA) gave abrief overview of reasons why the study was conducted. Co-investigators, study staff, and research students were intro-duced. A brief presentation on cancer in Canada was made byan invited representative of one of the funding agencies, theCanadian Cancer Society, followed by a refreshment break. Inthe second part the specific study objectives, methods, andmajor results for primary outcomes as well as major sub-studies were provided to participants in a PowerPointpresentation. The duration of the formal presentation wasapproximately 90 min. After the presentation, attendees weregiven time to ask questions. At the end of the formal program,an anonymous survey form was handed out with a request tocomplete it prior to leaving.

2.2. Survey Form

We prepared a brief, 19-question survey to evaluate (a)attendees’ perceptions and attitudes about end-of-study pre-sentations in general; (b) satisfaction with our specificpresentation (survey available from the authors on request).As we were unaware of any existing validated questionnairesexploring patient attitudes about end-of-study presentations,we created our own survey. The survey was organized intotwo major sections. In the first part, we collected generalsocio-demographic information from attendees. In the secondpart, we asked participants to evaluate the end-of-studypresentation and future implications of this presentation.

Most of the survey questionswere prepared to explore issuesraised in prior studies regarding presentations of aggregatedata. We asked several questions about the main ADT study aswell as general questions about how participants would like toreceive study results. We also asked several questions aboutpotential benefits of study presentation and solicited feedbackon how to improve the presentation in the future. Finally, weexplored whether providing study results would change theattitude of participants towards clinical research. Questionswere carefully formulated at a grade 8 reading level using bothLikert-type scales and rating scales as well as dichotomousquestions. To facilitate reporting, adjoining categories on Likertscales were combined (e.g., very satisfied and satisfied).Questions were reviewed by four study team members toensure clarity, readability, and face/content validity, but pilottesting with participants was not possible due to time con-straints. Both the larger study and this surveywere approved bythe hospital's research ethics board.

2.3. Resource Commitment

We captured the costs of organizing this event in terms of studypersonnel hours and specific presentation-related costs.

2.4. Statistical Analysis

Responses were manually entered into an electronic spread-sheet by one investigator (SH). Analyses were primarily

207J O U R N A L O F G E R I A T R I C O N C O L O G Y 3 ( 2 0 1 2 ) 2 0 5 – 2 1 1

descriptive, and most questions featured categorical re-sponses that were tabulated. SAS version 9.1 (SAS Institute,Cary, NC) was used for all statistical analyses.

3. Results

Of the 260 participants originally enrolled in the study, anumber of participants withdrew or had early discontinuationfrom the study, several participants died, while others hadpreviously informed us that they did not want to receive anykind of written communication from us. Thus, a total of 186initial notices of the presentation (in a regular study newslet-ter) and subsequent invitations were sent out, after which 153follow-up phone calls were made to current and prior studyparticipants, of whom 54 (29%) confirmed their attendanceand 14 provided regrets (Fig. 1). A number of participantsindicated they would not be able to attend because an eveningcommute to downtown would be difficult.

3.1. Socio-Demographic Information

Altogether 70 people attended the presentation, of whom 59(84%) returned usable surveys. Of these 59, 39 (66%) were studyparticipants, while the rest were either spouses or other guests.The vast majority of respondents (71%) were 65 years or olderand 81% had completed at least some college or universityeducation. In comparison to study participants who did notattend the presentation, attendees were similar in age, educa-tional attainment, study cohort, disease stage, Gleason score,comorbidity, functional ability, and quality of life (data not

186 Invitatinewslette

mail/e-m

No reply tomessagesnot reach (

Studyparticip

(n=26

153 followcalls

29 RSVP

25 RSVP

Fig. 1 – The above figure shows the flow of study participants du

shown), butweremore likely to live alone (35%vs. 18%, p=0.014)and less likely to be married (57% vs. 77%, p=0.010).

3.2. Study-Specific Questions

The majority of attendees were either very or somewhatsatisfied (80%) with participating in this 3-year study. Also,87.5% found the study presentation to be very informative orinformative. All attendees (100%) were satisfied with the waystudy results were provided, and 91% agreed that these studyresults would be very or somewhat beneficial to others (Table 1).

3.3. Attitudes Towards End-Of-Study Presentations

Eighty-five percent of participants agreed or strongly agreedthat being part of a clinical research study gave them the rightto be informed about study results. Forty-five percent wouldprefer to receive results via a group presentation, while 46%would prefer results communicated via email. The remaining9% indicated that they would like to meet with studypersonnel individually to receive results (Fig. 2).

Seventy-four percent of participants said that the studyinvestigator is the best person to provide results while 14%and 12% felt that their cancer specialist and family physician,respectively, is the best person to provide end-of-study results(Table 2).

3.4. Prior Experiences and Benefits of Study Presentation

One-third (n=19) of respondents had participated in clinicalresearch before; of these, only three respondents (16%) reported

Attrition (n=74)20 Early Discontinuation44 Study Withdrawals (6 opted not to be contacted, 16 incorrect mailing addresses)7 Deceased3 Lost to Follow-up

ons by r & ail

voice /could n=118)

ants0)

-up

4 regrets

10 regrets

ring the advertising process of the end of study presentation.

Table 1 – Study-specific presentation questions.

How satisfied are you beingpart of this study? (n=58)

Very satisfied/Somewhat satisfied80%

Neutral13%

Somewhat dissatisfied/Very dissatisfied7%

Was the study presentationinformative? (n=56)

Very informative63%

Somewhat informative25%

Not informative0%

Don't know13%

Are you satisfied with the wayresults were provided to youtoday? (n=58)

Very satisfied76%

Somewhat satisfied24%

Not satisfied0%

How did you find the level ofdetail in today's presentation?(n=59)

Way too detailed/Too detailed19%

Just right73%

Too little detail/Way too little detail9%

Was today's presentation ofstudy results helpful to youpersonally? (n=56)

Very helpful34%

Somewhat helpful45%

Not at all helpful2%

Don't know19%

Do you think this study willbenefit other patients? (n=59)

Very likely/Somewhat likely91%

Neutral/Don't know7%

Somewhat unlikely/Very unlikely2%

Besides gaining knowledge,did you get any other benefitsfrom attending today'spresentation? (n=54)*

Yes30%

No70%

Number of responses to each question are shown in parentheses.* Additional benefits:Meet other study participants (n=3).Exercise (n=3).To see how the tests I did fit into the bigger research puzzle.Sense of community, of contributing.Learning about funding of cancer research.Better understanding of cancer.Refreshments.

208 J O U R N A L O F G E R I A T R I C O N C O L O G Y 3 ( 2 0 1 2 ) 2 0 5 – 2 1 1

having received study results previously. With respect to futurestudies, 90% agreed theywould bemore likely to participate in astudy where they would eventually receive study results(Table 3).

3.5. Resource Commitment

Study personnel spent a total of 36 hours organizing theevent, contacting participants, and preparing the survey.Details are provided in Table 4. The amount of time spent by

How would you prefer to receive results?

By Email46%

Group Presentation45%

Individual Meeting with study personnel

9%

By Phone0%

Fig. 2 – Responses by survey respondents to the question,‘How would you prefer to receive study results?’

the principal investigator in preparing the presentation andattending the evening was under 4 hours. Total costs for theevent were $670 CAD, detailed in Table 4. Of note, there wasno charge for hall rental as the facility was affiliated with thehospital.

4. Discussion

The concept of providing research data to participants andcommunities is not novel. There is increasing recognition inthe research community that an important expression ofrespect for persons participating in research is to offer themresults at the completion of a study.14 However, a lack of clearguidelines on this issue has resulted in variable uptake of thispractice. Additionally, researchers may perceive significantbarriers, both time and financial, in providing end-of-studyresults to participants. In contrast, a benefit of routinelysharing results in this manner is a positive impact onparticipants, their families, and other potential researchsubjects.

Our study featured several key findings. First, an over-whelming majority of survey respondents in our studyexpected end-of-study results to be communicated. Most ofthem came prepared with questions and agreed that thispresentation was not only informative to them but would alsohelp future patients. Second, most participants felt thataggregate data presented in a group setting such as ours orvia a written report was sufficient. Although many re-searchers are still not in favor of considering end-of-studypresentations as an ethical or moral obligation,15 clinical

Table 2 – Preferences about receiving study results.

As a participant of a clinical research study do youhave the right to be informed about study resultswhen they are available? (n=55)

Strongly agree/Agree86%

Neutral/Don't know2%

Disagree/Strongly disagree0%

Not applicable13%

Who is the best person to communicate studyresults? (n=57)*

Study investigator74%

Specialist/Consultant14%

Family physician12%

Nurse0%

How likely are you to discuss today's presentationwith your Prostate Cancer Specialist? (n=57)

Very likely/Somewhat likely30%

Neutral/Don't know21%

Somewhat unlikely/Very unlikely5%

Not applicable46%

How likely are you to discuss today's presentationwith your family doctor? (n=57)

Very likely/Somewhat likely40%

Neutral/Don't know21%

Somewhat unlikely/Very unlikely7%

Not applicable32%

Number of responses to each question are shown in parentheses.* 0 respondents chose ‘Other’.

209J O U R N A L O F G E R I A T R I C O N C O L O G Y 3 ( 2 0 1 2 ) 2 0 5 – 2 1 1

research is impossible without the voluntary participation ofstudy participants. Beyond the possible ethical duty toprovide end-of-study results, at a pragmatic level a commit-ment to providing results at study outset may improveparticipant recruitment. Including end-of-study presentationsmay also enhance the reputation of the investigators and/orthe research institution, which may enhance future recruit-ment and/or participant retention. Third, providing such apresentation should not prove onerous for researchers orplace an undue burden on clinicians. From a scientificperspective, the principal investigator is the best person toanswer queries generated from study results, and themajority of our respondents agreed that the best person toprovide study results was the principal investigator.

Our study is one of the first to explore some of these issuesin older patients with cancer by directly eliciting responsesfrom study participants suffering from cancer. Many re-searchers have previously suggested that a group presenta-tion can also be an effective way of communication but timeconstraints and lack of enthusiasm towards communicatingstudy results with participants have prevented routineimplementation of such presentations.1,16–20 One previousstudy by Avins et al.21 also tried to conduct a similar kind ofpresentation among patients with a non-malignant urologicalcondition. Participants in a randomized controlled trial of aherbal product for the treatment of benign prostatic hyper-plasia were invited to an end-of-study presentation. Eventhough turnout was low among participants (10%), most of theparticipants who came for the presentation felt that this kindof presentation was very helpful and an effective way ofcommunicating study results.21 A number of other studies have

Table 3 – Prior experiences and benefits of study presentation.

Have you ever participated in clinical research? (n=58) Yes (n=19)33%

If you have participated in clinical research did you everreceive study results?

Yes1 (5%*)

Has your experience as a participant in this study affectedyour interest in participating in other studies? (n=57)

Yes37%

How likely would you be to participate in a future studywhere you would eventually receive study results? (n=57)

A lot more90%

Number of responses to each question are shown in parentheses.* Only among respondents who answered yes to prior question.

reported on communicating end-of-study results,1,16,19,22,23 butfew have involved patients with cancer, and those that havetypically involved individual genetic testing, which is not suitedto group presentations. Findings in non-cancer populations aregenerally in agreement with our findings, namely that partic-ipants expect end-of-study results,1 although few of thesestudies were conducted in older populations. Additionalfindingswere that investigators supported the idea of providinglay summaries of results but perceived lack of time in preparingand presenting results as major barriers.1,20

In our experience, the time requirement to prepare anddeliver the presentation was modest. Our presentation wasalso quite cost effective, as it did not require a lavish dinner orbig hotel to be booked for study participants. The entirepresentation and survey was kept under a budget of $700 CADand study personnel time was under 40 hours, so that thisformat of providing end-of-study results can be easilyimplemented by other clinical investigators.24

Several important limitations must be kept in mind wheninterpreting our findings. One of the foremost is the relativelylow participation rate among study participants. There werequite a few reasons that were provided by respondents for notattending, including timing and location of the presentationbeing non-ideal, cold weather, and concerns about pandemicH1N1 influenza. These barriers could be overcome by provid-ing a written summary of study results to those studyparticipants who could not or did not wish to attend, byhaving more than one presentation at different times andlocations, or by putting the presentation online. Multiple oronline presentations have significant resource implications,however, and may not be technologically easy to access by

No (n=39)67%No18 (95%*)

Not applicable40

No37%

Not applicable26%

likely/Little more likely Neutral9%

A little less likely/Lot less likely2%

Table 4 – Estimate of resources to organize end-of-studypresentation.

Study personnel hours Total RS SC OP

Survey preparation 6 h 5 h 1 h n/aInvitation 2 h 1 h 1 h n/aMailing and telephone follow-up 5 h 3 h 2 h n/aEvent planning and participation 20 h 5 h 5 h 10 hPrincipal investigator (preparing and givingpresentation)

3 h n/a

n/a

n/a

Total hours 36 hPresentation-related costsRentals and various supplies $125Catering $250Printing cost (invitation+survey) $175 ($100+$ 75)Mailing cost $120Total cost $670

* RS, Research Student; SC, Study Coordinator; OP, Office Personnel.

210 J O U R N A L O F G E R I A T R I C O N C O L O G Y 3 ( 2 0 1 2 ) 2 0 5 – 2 1 1

many seniors. A second important issue is our inability todetermine the attitudes of non-attendees towards end-of-study presentations. It is possible that the majority of non-attendees did not feel an end-of-study presentation isvaluable, and that the views expressed by attendees mayreflect the views of a vocal and interested minority. However,attendees were similar to non-attendees in most socio-demographic and clinical characteristics, the exception beingthat more attendees lived alone. Although it is reassuring thatour results are similar to those of prior studies, furtherresearch among non-attendees to gauge their attitudesabout end-of-study presentations is vital to more broadlyunderstand this issue. In particular, comparing attitudestowards a written end-of-study summary versus a grouppresentation would be important.

Whether our results can be generalized to youngerparticipants with different types of cancers in differentsettings needs to be explored further. Another importantlimitation common to all surveys is that they only gauge whatrespondents state they would do in a hypothetical circum-stance; actual practice may be different. Our main study fromwhich attendees came was an observational study; whetherclinical trial study participants have different expectationsneeds to be explored. The main results from our study,published elsewhere,25,26 featured both positive (no deleteri-ous effect of ADT on objective cognitive function and self-reported mental health) and negative (declines in objectivephysical performance and self-reported physical functionwithin 3–6 months of ADT initiation with no improvementby 12 months) results. Whether more uniformly positive ornegative study results might have affected attitudes towardsend-of-study presentations is not known. We did not elicitattitudes towards or barriers associated with providing end-of-study results among investigators or clinicians. This wouldbe an obvious next step in trying to determine how to improvethe current situation in which only a minority of investigatorsappear to be communicating end-of-study results to partici-pants. Finally, we did not formally measure any distress oranxiety that might have been caused to participants bylearning of our results, although feedback on surveys and

informally among participants did not suggest this was asignificant issue.

Our findings, limitations notwithstanding, have practicalimplications for both clinicians and researchers. Cliniciansshould be reassured that there should be limited additionalburden on them as a result of end-of-study presentations bytheir patients who are study participants. Investigatorsshould realize that many study participants expect a presen-tation of end-of-study results. However, such a presentationdoes not have to be elaborate, time-intensive, or cost-prohibitive. Preparing a written summary of study resultsmay also address the needs of a significant proportion ofstudy participants. Beyond meeting ethical requirements tostudy participants, an additional benefit of committing tosuch presentations is the possibility of enhancing recruitmentinto studies.

Disclosures and Conflict of Interest Statements

The authors have no conflicts of interest to disclose.

Author contributions

Concept and design: Shabbir Hussain, Henriette Breunis, NarhariTimilshina, Shabbir Alibhai.

Data collection: Shabbir Hussain, Henriette Breunis, NarhariTimilshina Analysis and interpretation of data: Shabbir Hussain,Narhari Timilshina, Shabbir Alibhai.

Manuscript writing: Shabbir Hussain, Henriette Breunis,Narhari Timilshina, Shabbir Alibhai.

Manuscript approval: Shabbir Hussain, Henriette Breunis,Narhari Timilshina, Shabbir Alibhai.

Acknowledgements

The authors would like to thank the study participants for theirenthusiastic support. Dr. Alibhai is a Research Scientist of theCanadian Cancer Society, which also funded the larger study.

R E F E R E N C E S

1. Shalowitz DI, Miller FG. Communicating the results of clinicalresearch to participants: attitudes, practices, and futuredirections. PLoS Med May 13 2008;5(5):e91.

2. Tu K, Mamdani MM, Jacka RM, Forde NJ, Rothwell DM, Tu JV.The striking effect of the Heart Outcomes PreventionEvaluation (HOPE) on ramipril prescribing in Ontario.CMAJ Mar 4 2003;168(5):553–557.

3. Scheuner MT, Sieverding P, Shekelle PG. Delivery of genomicmedicine for common chronic adult diseases: a systematicreview. JAMA Mar 19 2008;299(11):1320–1334.

4. Ketley D, Woods KL. Impact of clinical trials on clinicalpractice: example of thrombolysis for acute myocardialinfarction. Lancet Oct 9 1993;342(8876):891–894.

5. Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, KrumholzHM. Use of fibrates in the United States and Canada. JAMAMar 23 2011;305(12):1217–1224.

211J O U R N A L O F G E R I A T R I C O N C O L O G Y 3 ( 2 0 1 2 ) 2 0 5 – 2 1 1

6. MacNeil SD, Fernandez CV. Attitudes of research ethics boardchairs towards disclosure of research results to participants:results of a national survey. J Med Ethics Sep 2007;33(9):549–553.

7. http://ohsr.od.nih.gov/guidelines/45cfr46.html [cited];Available from.

8. http://www.pre.ethics.gc.ca/eng/policy-politique/tcps-eptc/[cited]; Available from.

9. Shalowitz DI, Miller FG. Disclosing individual results of clinicalresearch: implications of respect for participants. JAMA Aug10 2005;294(6):737–740.

10. Fernandez CV, Kodish E, Weijer C. Informing study participantsof research results: an ethical imperative. IRBMay-Jun2003;25(3):12–19.

11. Rigby H, Fernandez CV. Providing research results to studyparticipants: support versus practice of researchers presentingat the American Society of Hematology annual meeting. BloodAug 15 2005;106(4):1199–1202.

12. Sommers MS. Speech perception in older adults: the importanceof speech-specific cognitive abilities. J Am Geriatr SocMay1997;45(5):633–637.

13. Reuter-Lorenz PA, Park DC. Human neuroscience and theaging mind: a new look at old problems. J Gerontol B Psychol SciSoc Sci Jul 2010;65(4):405–415.

14. Partridge AH, Burstein HJ, Gelman RS, Marcom PK, Winer EP.Do patients participating in clinical trials want to know studyresults? J Natl Cancer Inst Mar 19 2003;95(6):491–492.

15. Miller FA, Christensen R, Giacomini M, Robert JS. Duty to disclosewhat? Querying the putative obligation to return research resultsto participants. J Med EthicsMar 2008;34(3):210–213.

16. Partridge AH, Wong JS, Knudsen K, Gelman R, Sampson E,Gadd M, et al. Offering participants results of a clinical trial:sharing results of a negative study. Lancet Mar 12–182005;365(9463):963–964.

17. Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C.Disclosure of the right of research participants to receive

research results: an analysis of consent forms in theChildren's Oncology Group. Cancer Jun 1 2003;97(11):2904–2909.

18. Di Blasi Z, Kaptchuk TJ, Weinman J, Kleijnen J. Informingparticipants of allocation to placebo at trial closure: postalsurvey. BMJ Dec 7 2002;325(7376):1329.

19. Dixon-Woods M, Jackson C, Windridge KC, Kenyon S.Receiving a summary of the results of a trial: qualitativestudy of participants' views. BMJ Jan 28 2006;332(7535):206–210.

20. Fernandez CV, Kodish E, Shurin S, Weijer C. Offering to returnresults to research participants: attitudes and needs ofprincipal investigators in the Children's Oncology Group.J Pediatr Hematol Oncol Sep 2003;25(9):704–708.

21. Avins AL, Bent S, Padula A, Staccone S, Badua E, Goldberg H.Initial experience with a group presentation of study results toresearch participants. Trials 2008;9:16.

22. Buchwald H, Fitch LL, Matts JP, Johnson JW, Hansen BJ,Stuenkel MR, et al. Perception of quality of life before and afterdisclosure of trial results: a report from the Program on theSurgical Control of the Hyperlipidemias (POSCH). Control ClinTrials Dec 1993;14(6):500–510.

23. Snowdon C, Garcia J, Elbourne D. Reactions of participants tothe results of a randomised controlled trial: exploratory study.BMJ Jul 4 1998;317(7150):21–26.

24. Fernandez CV, Skedgel C, Weijer C. Considerations and costsof disclosing study findings to research participants. CMAJ Apr27 2004;170(9):1417–1419.

25. Alibhai SMH, Breunis H, Timilshina N, Johnston C, TomlinsonG, Tannock I, et al. Impact of androgen-deprivation therapyon physical function and quality of life in men withnon-metastatic prostate cancer. J Clin Oncol 2010;28(34):5038–5045.

26. Alibhai SMH, Breunis H, Timilshina N, Marzouk S, Stewart D,Tannock I, et al. Impact of androgen-deprivation therapy oncognitive function in men with nonmetastatic prostatecancer. J Clin Oncol Dec 1 2010;38(34):5030–5037.