Table 1 Included studies characteristics

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

And HCP

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