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Table 1 Included studies characteristics

From: Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Study (first author and year of publication) Study title Population (trial participants/generic/staff) Number of study participants Sex (male/female) Age Setting (secondary/ primary care/community) Country Aim (verbatim from included papers) Design Type (aggregate /individual both) Timing (when results were provided)
Garcia 1987 [10] Sharing research results with patients: the views of care-givers involved in a randomised controlled trial HCP 16 Not specified Not specified Secondary care Ireland To explore views of doctors and midwives in a large maternity hospital who were involved in a randomised controlled trial (to compare methods of monitoring the foetal heart during labour) were asked whether the trial results should be passed on to women coming to the hospital for their care. Interviews N/A N/A
Di Blasi 2002 [11] Informing participants of allocation to placebo at trial closure: postal survey Investigators 212 Not specified Not specified N/A UK To assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback. Postal survey with a semi-structured questionnaire Individual N/A
Partridge 2004 [12] Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants HCP 796 Not specified Not specified N/A USA To determine the practices attitudes of oncology physician and nurses regarding offering clinical trial results to study participants. Mailed survey N/A N/A
Dinnett 2005 [13] Unblinding of trial participants to their treatment allocation: lessons from the prospective study of pravastatin in the elderly at risk (PROSPER) Trial participants 1492 Not specified Not specified Secondary care UK The aim of the study was to determine whether the unblinding process could be conducted: (1) in an efficient manner, all study participants with their study medication status and on-trial cholesterol levels; (2) to sensitively and with the support of counselling where appropriate; (3) to respect the rights of participants not to be unblinded. Postal survey Individual Simultaneously with publication
Dixon-Woods 2006 [14] Receiving a summary of the results of a trial: qualitative study of participant’ views Trial participants 20 Female Not specified Secondary care UK To explore trial participants’ responses to receiving a summary of the results of a trial in pregnancy. Qualitative study with semi-structured interviews. Aggregate Simultaneously with publication
Avins 2008 [15] Initial experience with a group presentation of study results to research participants Trial participants 225 Male >50 Secondary care USA To document experience with a group presentation of the results of a clinical trial and ways in which this process could be adapted and improved in future studies. A survey was conducted at the second presentation that assessed the value and perceptions of the meeting, addressing knowledge learned about the study from the presentation and the published paper; no formal validation of the survey instrument was conducted. Aggregate After publication
Dorsey 2008 [16] Communicating clinical trial results to research participants Trial participants 114 Both Mean age 55.1 years Not specified USA and Canada To evaluate the effectiveness of a plan to communicate results in an industry-sponsored randomised controlled trial for Huntington disease. Postal survey N/A Simultaneously with press release
Johnson 2008 [17] How do patients want to learn of results of clinical trials? A survey of 1431 breast cancer patients Trial participants and HCP 1431 Female % 18-29, 76% 40–59, 15% 60–69; 1% 70+ Secondary care UK and Belgium To find out from trial patients whether they wanted to receive trial results written in lay terms when they are available, and how they considered they wanted to receive them.
We compare their preferences with those expressed by health care professionals (oncologists and nurses) who had participated in the TACT trial.
Questionnaire Aggregate Not specified
Darbyshire 2009 [18] Presenting the results of clinical trials to participants Trial participants 140 Not specified Not specified Secondary care UK and Ireland To generate evidence from it a review how the 1-year results from the 4-T Trial were published and subsequently discussed with participants to inform further work. Information was retrospectively collected from clinical centres who held a coffee morning to disseminate the one-year results from the three year.
Treat to Target in Type 2 Diabetes (4-T) Trial (Current Controlled Trials number, ISRCTN51125379). Following a discussion of the results, suggestions for how the information collected could be used to inform further work in this area were made.
Aggregate Simultaneously with publication
Partridge 2009 [19] The impact of sharing results of a randomised breast cancer clinical trial with study participants Trial participants 167 Female Mean age 51 years Secondary care USA We sought to evaluate patient perceptions of how results had been shared from a large randomised cooperative group trial, and the impact of learning results. Mailed surveys Aggregate Not specified
Brealey 2010 [20] Participants’ preference for type of leaflet used to feed back the results of a randomised trial: a survey Trial participants 132 Both Mean age 43 years Primary care UK This study aims to determine participants’ preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants’ preferences Questionnaire Aggregate After publication
Dalal 2010 [21] Communicating the results of research: how do participants of a cardiac rehabilitation RCT prefer to be informed Trial participants 154 Both Mean age 68.5 years Primary care UK To determine the preferred means by which participants in a study of cardiac rehabilitation wish to be informed of the study’s results. Postal questionnaire survey of participants in a RCT. Aggregate After publication
Getz 2010 [22] Celebrex (NCT00139776) and Sutent (NCT00137449) Trial participants 13 Both Not specified Secondary care USA To evaluate the feasibility of integrating a post-trial communication mechanism with ongoing clinical development activities; to develop and test the comprehension and impact of various communication formats and messages; and to assess perceptions and reactions to this new post-trial communication process among clinical research professionals Pilot study-study volunteers in focus groups Aggregate After publication
Mancini 2010 [23] FNCLCC-PACS04 Trial participants 115 Female Mean age 56.7 years Not specified France The aim of this study was to assess patients’ uptake and understanding of the results of the trial in which they have participated, and the impact of a letter offering patients the possibility of consulting the trial results on a specific website Randomised trial
Ppts of a trial were asked to consent to further randomisation to receiving trial results by different methods.
Aggregate Not specified
Cox 2011 [24] Feedback of trial results to participants: a survey of clinicians’ and patients’ attitudes and experiences Trial participants and HCP 81; 145 Pt 62.5% male;
HCP 63.2 male
Pt mean 63.0 years
HCP mean 47.8 years
Cancer networks UK The aim of this research was to explore the practice of feeding back trial results to those who take part in cancer trials. Postal questionnaire survey N/A N/A
Dixon-Woods 2011 [25] Providing the results of research to participants: a mixed-method study of the benefits and challenges of a consultative approach Trial participants and stakeholders 16 Female Not specified Secondary care UK We aimed to develop, deliver, and evaluate a consultative approach to inform provision of feedback about research findings to participants in the Oracle Children Study (OCS). An iterative process, including focus groups and consultation with OCS stakeholders to inform the development of a feedback package, including a results leaflet. A questionnaire survey of participants’ reactions to receiving the results leaflet was conducted. Aggregate Not specified
Locock 2011 [26] Personal experiences of taking part in clinical trials—a qualitative study Trial participants 42 27 female; 15 male 38-84 years N/A UK To investigate people’s experiences of and attitudes to participation in clinical trials interviews N/A N/A
Williams 2011 [27] The Italian-American Clinical Trial of Nutritional supplements and Age-Related Cataract (CTNS) Trial participants 610 46.7% female; 53.3% male Mean age 80.5 Not specified Italy To determine whether participants were satisfied with the trial results. Survey Aggregate and individual After publication
Darbyshire 2012 [28] Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population Trial participants 40 Not specified Not specified Secondary care UK To identify the most appropriate format for results dissemination to maximise understanding of trial results. Qualitative, postal questionnaire Aggregate Simultaneously with publication
Ferrierre 2012 [29] Return of individual research results and incidental findings in the Clinical Trials Cooperative Group setting Directors of Clinical Trials Cooperative Groups 10 Not specified Not specified N/A USA To establish some of the similarities and dissimilarities of general conduct of research and current opinions on treatment of IRRs and IFs in the Cooperative Group setting. (individual research results and incidental finding) 29 item survey N/A N/A
Getz 2012 [30] Meeting the obligation to communicate clinical trial results to study volunteers Trial participants
364; 10 Not specified Not specified Secondary care USA To assess the feasibility of a routine mechanism to communicate trial results and to test the process of setting volunteer expectations prior to disclosing the lay summaries. Mixed methods—intervention, focus groups, phone interviews and a questionnaire
Intervention—pre and posttest of understanding
Aggregate Not specified
Mancini 2012 [31] Transparency in the presentation of trial results may not increase patients’ trust in medical researchers Trial participants 107 Female Mean age 56.7 years Secondary care France To investigate the effect on the participants’ TMRs of providing final trial results to participants via the Internet. (TRM – trust in medical researchers) Mailed self-administered questionnaires Aggregate 8 months after the first public disclosure of the conclusions
Sarradon-Eck 2012 [32] “They should take time”: disclosure of clinical trial results as part of a social relationship Trial participants 29 Female Median 53 years Secondary care France The aim of this qualitative study (Study 1) was to explain some of the findings obtained in the previous large psychosocial survey (Study 2) in which it was nested by examining them more closely from a different angle Survey Aggregate Not specified
Armstrong 2013 [33] Unblinding following trial participation: qualitative study of participants’ perspectives Trial participants 38 Female Mean age 39 years Secondary care UK To explore trial participants’ perspectives on whether they would like to be unblinded as to the treatment arm to which they were allocated following involvement in a large randomised controlled trial (RCT). Semi-structured interviews Aggregate Not specified
Chen 2015 [34] Evaluating medical information’s potential advancement of clinical trial data sharing through lay summaries of results HCP 31 Not specified Not specified N/A Not specified To assess appropriateness of, and make recommendations on Medical Information involvement in the creation and dissemination of lay summaries of clinical trial results. Online survey N/A N/A
Tarrant 2015 [35] Consent revisited: the impact of return of results on participant’ views and expectations about trial participation Trial participants 38 Female Mean age 39 years Secondary care UK We explored participants’ views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial. Semi-structured interviews Aggregate Not specified
Elzinga 2016 [36] Adult patient perspectives on clinical trial result reporting: a survey of cancer patients Current or previous trial participants 189 37% male Median age 60 years Secondary care Canada To assess adult cancer patient preferences surrounding aggregate result disclosure to study participants. 46-item questionnaire N/A N/A
Dietrich 2017 [37] Improving information exchange with clinical trial participants: a proposal for industry Patients, and health care professionals 3045; 462 Not specified Not specified Not specified Various To capture the current status of information exchange and identify possible future practices between the major stakeholders within the clinical research ecosystem. Patients, sponsors, sites, and HCPs were engaged through surveys, interviews, and/or advisory boards N/A N/A
Racine 2017 [38 Participants’ perspectives and preferences on clinical trial results dissemination: the TRUST Thyroid Trial experience Trial participants 123 48 female; 75 male 65–74 years 69; 75+ years 54 Secondary care Ireland The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Mixed methods study with three consecutive phases.
Development Of a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment.
Evaluated using an RCT.
Aggregate Not specified
Scott 2018 [39] Returning research results: caregivers’ reactions following computerised cognitive training among childhood cancer survivors Caregivers 43 Not reported Not reported Secondary Care USA The current study explores the practice of returning research results to families of childhood cancer survivors that previously participated in the COGTRN study. Survey Aggregate 2 years after completion of study
Aldinger 2018 [40] Returning aggregate results of clinical trials: empirical data of patient preferences Trial participants and patients 211 survey 1
male 9
female 66
survey 2:
male 48
female 77
survey 1:
18–30 n=1
31–50 n=15
51–70 n=51
>71 n=9
Survey 2:
18–30 N=16
31–50 N=32
51–70 n=65
>71 n=11
Secondary Care USA To investigate the expectations and preferences for sharing of aggregate clinical trial results. Two surveys Aggregate  
Lindquist 2019 [41] Leveraging patient/community partnerships to disseminate patient centred outcomes research in geriatrics Community partners and patients 10 All females Ages ranging from 55 to 87 (with a mean age of 71.6 years, sd 8.2) N/A USA To provide written guidance or ‘how to’ for future patient/community partners and researchers to disseminate patient-centred research. Semi-structured interviews N/A N/A
Schroter 2019 [2] Frequency and format of clinical trial results disseminated to participants: a survey of trialists First authors of clinical trial papers 1818 (out of 3127 contacted) Not specified Not specified N/A 71 different countries To determine the frequency and format of dissemination to trial participants and wider patient communities, and to explore barriers to doing so. Online survey N/A N/A
  1. N/A Not applicable as included study did not disseminate results to participants as part of study design, N/S No information specified, HCP Health care professional