ArticleBMJ open2020
Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 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
- Return of participant-level clinical trial results to participants: pilot of a simplified centralised approach.BMJ open · 2024Trial
- PROTOCOL: Comparative Effectiveness of Tools for Communicating Health Research Results to Study Participants and Others With Relevant Lived Experience: A Living Systematic Review of Randomized Controlled Trials.Campbell systematic reviews · 2026Review
- Closing the loop: Benefits and challenges of sharing clinical trial results with participants after trial close-out.BMC medical research methodology · 2026Article
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- Article
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- Adequate information about clinical trial results must be given to participants.Nature medicine · 2024Article
- Framework of the strengths and challenges of clinically integrated trials: An expert panel report.American heart journal · 2024Review
- Practices and Barriers in Developing and Disseminating Plain-Language Resources Reporting Medical Research Information: A Scoping Review.The patient · 2024Article
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- Return of aggregate results to study participants: Facilitators, barriers, and recommendations.Contemporary clinical trials communications · 2023Article
- What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project.BMJ open · 2022Article
- The relative importance of information items and preferred mode of delivery when disseminating results from trials to participants: A mixed-methods study.Health expectations : an international journal of public participation in health care and health policy · 2022Article
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- Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.Trials · 2021Article
- Making the patient voice heard in a research consortium: experiences from an EU project (IMI-APPROACH).Research involvement and engagement · 2021Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.
designAudit of records.
settingPhase III clinical trials registered on the UK's research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.
main outcome measuresProportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.
resultsOut of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.
conclusionsReported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.
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.