ArticleHealth expectations : an international journal of public participation in health care and health policy2015
Consent revisited: the impact of return of results on participants' views and expectations about trial participation.
Article in Health expectations : an international journal of public participation in health care and health policy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- Current global practice and implications for future research on disseminating health research results to study participants: A systematic review.PLoS medicine · 2025Pooled it
- Article
- Returning aggregate research results to participants: a scoping review of current practices, preferences and challenges.BMJ open · 2025Article
- Informed consent and risk communication challenges in antimicrobial clinical trials: a scoping review.BMJ open · 2024Article
- Article
- Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.Trials · 2021Article
- Characterizing health researcher barriers to sharing results with study participants.Journal of clinical and translational science · 2019Article
- Article
- Article
- Trial participation as avoidance strategy: a qualitative study.Health expectations : an international journal of public participation in health care and health policy · 2016Article
- Participants' Role Expectations in Genetics Research and Re-consent: Revising the Theory and Methods of Mental Models Research Relating to Roles.Journal of health communication · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundIncreasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants' perceptions of their original decision to consent.
objectiveWe 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.
methodSemi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method.
resultsParticipants' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust.
conclusionsSharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.