ArticleBMJ open2022
What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 19 papers, 3 of them syntheses 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, 3 syntheses or guidelines pooled it.
- Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs).Trials · 2025Guideline
- Current global practice and implications for future research on disseminating health research results to study participants: A systematic review.PLoS medicine · 2025Pooled it
- The effectiveness of interventions to disseminate the results of non-commercial randomised clinical trials to healthcare professionals: a systematic review.Implementation science : IS · 2024Pooled it
- 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
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- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.BMJ (Clinical research ed.) · 2025Article
- Ethical considerations for sharing aggregate results from pragmatic clinical trials.Clinical trials (London, England) · 2025Article
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- Adequate information about clinical trial results must be given to participants.Nature medicine · 2024Article
- Public perspective on potential treatment intervention harm in clinical trials-terminology and communication.Trials · 2024Article
- Article
- Researcher and patient experiences of co-presenting research to people living with systemic sclerosis at a patient conference: content analysis of interviews.Research involvement and engagement · 2024Article
- Youth and family involvement in the development of a plain language trial results communication tool: CommuniKIDS.Research involvement and engagement · 2023Article
- Return of aggregate results to study participants: Facilitators, barriers, and recommendations.Contemporary clinical trials communications · 2023Article
- Co-production of guidance and resources to implement principled participant information leaflets (PrinciPILs).NIHR open research · 2023Article
- Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): A delphi survey.PloS one · 2023Article
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Corrections and comments
- Erratum issuedCorrection:2023
Authors and funding
8 authors.
Funding
Abstract
objectiveTo generate stakeholder informed evidence to support recommendations for trialists to implement the dissemination of results summaries to participants.
designA multiphase mixed-methods triangulation design involving Q-methodology, content analysis, focus groups and a coproduction workshop (the REporting Clinical trial results Appropriately to Participants project).
settingPhase III effectiveness trials.
participantsA range of participants were included from ongoing and recently completed trials, public contributors, trialists, sponsors, research funders, regulators, ethics committee members.
resultsFewer than half of the existing trial result summaries contained information on the clinical implications of the study results, an item deemed to be of high importance to participants in the Q-methodology study. Priority of inclusion of a thank you message varied depending on whether considering results for individuals or populations. The need for personally responsive modes of sharing trial result summaries was highlighted as important. Ideally, participants should be the first to know of the results with regard to the timing of sharing results summaries but given this can be challenging it is therefore important to manage expectations. In addition to patients, it was identified that it is important to engage with a range of stakeholders when developing trial results summaries.
conclusionsResults summaries for trial participants should cover four core questions: (1) What question the trial set out to answer?; (2) What did the trial find?; (3) What effect have the trial results had and how will they change National Health Service/treatment?; and (4) How can I find out more? Trial teams should develop appropriately resourced plans and consult patient partners and trial participants on how 'best' to share key messages with regard to content, mode, and timing. The study findings provide trial teams with clear guidance on the core considerations of the 'what, how, when and who' with regard to sharing results summaries.
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.