What, how, when and who of trial results summaries for trial participants: Stakeholder informed guidance from the RECAP project.

Hanne Bruhn, Marion Campbell, Vikki Entwistle, Rosemary Humphreys, Sandra Jayacodi, Peter Knapp, Juliet Tizzard, Katie Gillies* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

OBJECTIVE: To generate stakeholder informed evidence to support recommendations for trialists to implement the dissemination of results summaries to participants. DESIGN: A 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). SETTING: Phase III effectiveness trials. PARTICIPANTS: A range of participants were included from ongoing and recently completed trials, public contributors, trialists, sponsors, research funders, regulators, ethics committee members. RESULTS: Fewer 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. CONCLUSIONS: Results 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.

Original languageEnglish
Article numbere057019
Number of pages13
JournalBMJ Open
Volume12
Issue number3
Early online date25 Mar 2022
DOIs
Publication statusPublished - 25 Mar 2022

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