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

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.

Return of aggregate results to study participants: Facilitators, barriers, and recommendations

“…Findings from this study provide new insights into facilitators and challenges to results return, supports needed to facilitate the process, and recommendations for successful results return from the perspectives of investigators and patient partners engaged in patient-centered research. They also extend the research on preferences and important considerations for aggregate results return [ 4 , 5 ].…”

“…Researchers largely support the practice, viewing it as an ethical responsibility and an important part of conducting research [ 2 , 3 ]. Similarly, the majority of health research participants want to receive aggregate results, regardless of whether the intervention or treatment studied was beneficial, to understand any clinical implications and inform future health decisions and behavior [ [4] , [5] , [6] , [7] , [8] , [9] ]. Despite this support, researchers often do not return aggregate results to research participants, even when they initially intend to do so [ 2 , 3 , 10 , 11 ].…”

Information about dissemination of trial results in patient information leaflets for clinicals trials in the UK and Ireland: The what and the when

“…Information on when then results of a clinical trial are ready to be published and more widely disseminated can be difficult to assess before the study has been completed. However, timing has been identified by a range stakeholders as an important factor when sharing clinical trial results with participants and so can be extended to being important to share during consent [ 13 ]. Nearly half of the PILs included in this study did not provide information on when participants could expect the results and a slightly larger portion of the PILs that did provide information did so in a way that did not provide any clear time frame.…”

“…These results do not align with the HRA guidelines and highlights room for improvement. The importance and benefits of providing trial participants with the results has been previously established, outlined by the HRA guidelines, and now has co-designed evidence based guidance to support recommendations [ 13 ]. When considered alongside the upcoming requirements for trial results to be posted on a registry (or similar), providing more directive information and specifying when and how participants will have access to the results, at the point of consent, should be more commonplace.…”

“…This study builds on previous research on results information provision to clinical trial participants by adapting an existing framework for analysing how research teams stated they will provide information to trial participants through research and ethics approval applications [ 13 ]. Doing qualitative and iterative data analysis which builds on an existing framework helps in building the same knowledge base while also having the added benefit of further development for future research in the area.…”