Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Abstract

Background There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. Methods A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. Results Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. Conclusions This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated.

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

“…Further research to explore the most appropriate ways to consider the intersections between these characteristics is needed given most research to date has not considered a wide range of diverse experiences. 8 …”

“…Q-methodology is a formal method to facilitate the ranking of a set of predefined items. 9 It produces a combination of quantitative (using ranking and factor analysis) and qualitative data (from think aloud interviews) that highlight shared and varying opinions within the population. 9 A ‘concourse’ or ‘Q-set’ (in this case of items relevant to reporting of results) is developed and participants place these on a ‘Q-sort’ grid (see figure 1 ) to rank their importance.…”

“…An initial long list of 239 content items was condensed, through discussion in the project team to identify 28 distinct concepts that formed the Q-set. 9 These content items were presented for a range of different trial scenarios (eg, where the trial demonstrated benefit/harm of intervention, demonstrated no difference), to establish whether the type of trial results affected the perceived importance of items ( online supplemental table 3 ). Participants were asked to sort for the benefit vignette first and then asked if they would like to move any items after reading subsequent vignettes.…”

“…6 7 Little is known about what participants actually want included when results are made available to them. 8 Similarly the World Medical Association (WMA) and UK Health Research Authority (HRA) recommendations for provision of trial results do not guide researchers on content. 1 2 A recent literature review identified a dearth of evidence on how best to share results.…”

“…1 2 A recent literature review identified a dearth of evidence on how best to share results. 8 Since stakeholder groups may vary in what they think should be shared with trial participants, there is value in coproducing guidance with a diverse group.…”