Table 3 Advantages and disadvantages of providing results

Garcia, 1987 [10]

N/A

N/A

N/A

N/A

Di Blasi, 2002 [11]

N/A

N/A

Not Specified

Avoid biassing results at study follow up

Avoid extra costs

Avoid extra administrative work

Difficulty contain people

Partridge, 2004 [12]

N/A

N/A

May ultimately improve communication between health care providers and patients, improve the quality of care delivered, and increase patient satisfaction with the care received as part of a clinical trial.

Showing appreciation to patients.

Courtesy to patients.

Improving patient satisfaction with care or quality of life.

Not want to share unfavourable results with patients to avoid that treatment on a research study is designed to help future patients and not necessarily the individual patient on the study.

Negative emotional effect on participants

Participant difficulty understanding results

Consumption of resources, including money and clinician time Respondents believed that an obligation to offer study results to patients would or might negatively effect their enrolment of patients on trials.

Dinnett, 2005 [13]

Not specified

Cost associated with unblinding—specifically staff salary time. Preparation, printing and distribution of letters, main study results and unblinding documents for primary care physicians and participants.

Dixon-Woods, 2006 [14]

Receiving a results leaflet through the mail satisfactory and preferable to personal contact to enable study at length and in private. Most of the comments on the content and format of the leaflet were positive. Half expressed feelings of pleasure on receiving the leaflet, particularly at what they saw as the success of the trial, or felt that taking part had been worthwhile.

One negative consequence of receiving the results was that for some women it revived memories of a difficult time.

Avins, 2008 [15]

Responses to provision of results largely positive and all respondents thought that future studies should include in person meetings.

Not specified

Dorsey, 2008 [16]

Media release from the investigators within a day after a sponsor-issued press release and a subsequent telephone call from the site staff to the participants; and conference call for research participants 2 weeks after the results were released.

Source and timing for learning study results and satisfaction with their communication.

Study participants reported high satisfaction with the telephone call and conference call but relatively low levels with the sponsor’s press release.

Not specified

Johnson, 2008 [17]

N/A

N/A

N/A

N/A

Darbyshire, 2009 [18]

Not specified

Concern that participants were unwilling to discuss their diabetes and treatment (allocated within a trial) with strangers from the same local area in an open meeting.

Working age participants may require additional time off work to attend meeting or travel for elderly participants.

Presenting results in English to individuals who do not have English as their first language.

Partidge, 2009 [19]

Most women felt they had been treated with dignity and respect during the trial.

Women described their overall experience with the clinical trial up until the time of the survey as positive, and indicated that they would recommend participating in a clinical trial to someone else who had been diagnosed with cancer.

Anxiety should be considered, and psychosocial support may be required by some.

Some women indicated that prior to receiving results they regretted participating in the clinical trial, and 4% of women regretted participation after receiving results.

Brealey, 2010 [20]

None

Preferences for information: content, presentation and length

Most participants preferred the four-page leaflet due to use of technical information and diagrams.

Not specified

Dalal, 2010 [21]

The majority of participants were happy with the method by which they received their results and the same proportion were pleased that they were informed.

A small proportion of patients indicated that they were upset by the results.

One participant said: ‘My only criticism is that there seems to have been a long gap between completing the research and contacting me. I had thought that I had been forgotten.’

Getz, 2010 [22]

Study volunteers reacted positively to all three communication formats as did study staff. Study volunteers appreciated receiving information about their clinical trial and felt valued as contributors to the process of medical and scientific learning.

Of the three formats, focus group participants considered the written report to be the most appealing. But noted the importance of receiving post-trial results communication in multiple formats to accommodate older people.

Study volunteers want the clinical trial results summaries to be informative, easy to read, precise, not very wordy, with just the pertinent questions (who, what, when, where, why, and how) answered.

Improvement in study volunteers’ confidence in their knowledge about the clinical trial, and understanding about their study’s objectives, side effects, and key findings.

Study staff also reacted positively to being able to provide trial results summaries and in answering their questions.

Even after independently reviewing the trial summaries, focus group discussions revealed a number of areas where confusion remains among study volunteers

Mancini, 2010 [23]

Internet group received a letter stating that the trial results were available on the password-protected website, whilst the Control group received no letters

Participants expectations about the trial results, their preferences about the mode of disclosure, their declared uptake of the results and their understanding of the outcome of this trial. Whether patients discussed the results with their next of kin was also addressed.

Informing participants about the outcome of clinical trials would be useful and should be should be routine—either by patient’s request or physician’s discretion.

Preferences about how patients should be informed

about clinical trial results and by whom were expressed.

Internet was less frequently preferred than a face-to-face consultation or a mailed letter. Oncologists, followed by trial investigators, were the participants’ preferred providers of trial result information.

Participants reported discussing results with a close relative or others: such as spouse and other relatives, the oncologist, the general practitioner, and other patients.

Talking about the results was said to be easier when they were perceived as positive. Negative results were also discussed, however, in order to obtain reassurance about their personal significance.

The trial results were better understood by the Internet group than by the control group.

Not specified

Cox, 2011 [24]

N/A

N/A

Not specified

Negative psychological impact on patients/carers

Negative results/bad news were the dominant concern

Dixon-Woods, 2011 [25]

None

Description is clear

Results are interesting

What did they feel when learned about results

 • Satisfaction

 • Concern

 • Both satisfaction and

 • concern

 • Indifference

Appropriate to receive the results of the study by letter

Recommend to other to take part

Participants found it particularly hard to understand the trial design and the methods of analysis. Many participants did not recall the aims or the findings of the original trial, and recommended that any feedback provided reminders of these. Use of language and numbers important to consider to avoid unanticipated effects of interpreting (and misinterpreting) the meaning of findings.

Feedback development process was costly, staff salaries, consumables, the mail-out of the leaflets, recruiting and training staff for the helpline, etc.

Locock, 2011 [26]

N/A

N/A

May encourage retention

Matter of interest, personal satisfaction, respect for contribution,

Not specified

Williams, 2011 [27]

Being informed of treatment assignment did not seem to discourage participants in the placebo arm, most of whom indicated that they would have certainly recommended participation in a similar trial to other people.

Delay between trial close out and study results being published. Ensuring trial participants were still alive and contact details were current were correct.

Darbyshire, 2012 [28]

Not specified

Not specified

Ferrierre, 2012 [29]

N/A

N/A

N/A

N/A

Getz, 2012 [30]

Thank you card and two reminder cards and trial results

Understanding of study (baseline) and comprehension of trial results

Overall, study volunteers agreed that it was ‘very’ or ‘somewhat’ important that they be thanked for their participation in a clinical trial; and indicated that they appreciated receiving a thank-you message following completion of the clinical trial.

Long delay between completing participation and receiving results

Mancini, 2012 [31]

Received letter informing them of the possibility of consulting a specific website to view the RCT final results.

Trust in medical researchers

No difference between the groups

Sarradon-Eck, 2012 [32]

Not Specified

Not Specified

Armstrong, 2013 [33]

Findings suggest a potential sense of frustration for participants at knowing the trial outcomes in aggregate, but not knowing their own treatment allocation

Study also suggests caution to consider desire for unblinding is universal among trial participants. Some participants recognised that revelation of their treatment group could potentially bring risks as well as benefits, and that one of those risks was disruption of their existing narrative.

Chen, 2015 [34]

N/A

N/A

N/A

N/A

Tarrant, 2015 [35]

Women were able to reconcile their original decision to participate in the trial but there were several concerns.

Return of results led participants to question the basis of their decision to consent to the trial. Some were shocked at the outcomes of the research. They were distressed by the discovery that by taking part in the trial they had exposed their child to a possible risk of harm. This was associated with guilt, anger and a sense of betrayal by the maternity staff and researchers involved in the trial.

Others experienced a profound breach of trust. They questioned the motives and actions of those involved in the research, feeling that they had been let down, misled or exploited when they were in a distressed and vulnerable position, by the very nursing and medical staff they trusted to care for them. They interpreted the negative outcomes as indicating that the doctors, nurses or researchers had not fulfilled their side of the co-operative bargain and experienced this as a sense of betrayal.

One key implication of our study is the need for researchers to recognise that there will always be the potential for the return of results to cause distress or doubt.

Elzinga, 2016 [36]

N/A

N/A

May provide information to inform participant QoL

Raise public awareness of importance of research

Provide information to prevent future harm to participant

Emphasise importance of participant to the research project

Emphasise importance of participant to research in general

Reduce secrecy surrounding research studies

Decrease chance participant feels used by researcher

Distress caused by discovering participant was harmed by the research

Distress for family/caregiver where the participant is deceased

Distress caused by discovering participant was not helped by the research

Distress caused by worries surrounding employability/insurability

Distress caused by bringing up old memories and emotions

Distress caused by guilt surrounding selection to better arm of the study

Dietrich, 2017 [37]

N/A

N/A

Not specified

A general lack of awareness of the true patient preferences in this area and their corresponding value was evident.

Racine, 2018

Patient preferred results letter or TRUST results press release

Patient understanding

No difference between the groups

Participants wanted to receive results that are accessible and easy to understand. Preferred format is a letter.

No negative reactions

Scott, 2018 [39]

Participants’ caregivers were contacted and provided with a summary of results based on guidelines and survey.

Understanding

Whether the summary was surprising or applicable to their child.

Anxiety

Satisfaction

Guilt

Anger

Relief

Whether they have others they can talk to about the results

Overall, most caregivers’ reactions to the summary were positive describing satisfaction with the results or importance of cognitive research.

Results perceived as generally important, helpful and appropriately detailed.

Several demonstrated an understanding of the summary

New concerns or questions following summary included: lack of improvement in math skills and whether results would be long-term.

Caregivers explained feeling guilty ‘because [they would] like to do more for [their] child’ or ‘did not complete the last few sessions’ of the cognitive training.

Aldinger, 2018 [40]

Three-page, plain-language summary of results of study and a three half-page summary of the intervention study.

Whether summary was helpful

Reasons reported for sharing results: interest in research results—they wanted to learn what the study found; belief that it was an ethical expectation to share results with those who participated.

Participants were interested if results had relevance to their own health.

Participants felt research teams should spend their time doing other activities rather than disseminating result. This is balanced/contingent on their contribution having helped someone else.

Lindquist, 2019 [41]

N/A

N/A

Important factors for dissemination:

 1. Reaching out to those most affected by the results and their shared experiences with the results

 2. Leveraging connections to the study population (e.g. parents, children, caregivers)

 3. Determining the practical application of results

Patients/community

Not specified

Schroter, 2019 [2]

N/A

N/A

Benefits of disseminating results to patients included supporting the spread of knowledge in the patient community, increased accountability for researchers, and an opportunity to empower patients.

The potential to motivate people to participate in future research studies was noted by many and some suggested dissemination might encourage patients to consider interventions which could lead to better outcomes for them. It was also suggested that it might improve the doctor–patient relationship through building confidence and trust. Respondents further suggested that the impact of dissemination could be extended by giving patients the opportunity to share results within their own communities; there were mixed views on whether dissemination should be mandatory.

Some researchers said they do not think patients would be interested in receiving study results; others assumed not asking for them represented a lack of interest in getting them. Many were concerned that patients would lack the ability to understand the results and their implications.