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

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 t

SUBMITTER: Bruhn H 

PROVIDER: S-EPMC8961145 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature