Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial

Abstract

Background Sharing trial results with participants is an ethical imperative but often does not happen. We tested an Enhanced Webpage versus a Basic Webpage, Mailed Printed Summary versus no Mailed Printed Summary, and Email List Invitation versus no Email List Invitation to see which approach resulted in the highest patient satisfaction with how the results were communicated. Methods and findings We carried out a cluster randomised, 2 by 2 by 2 factorial, nonblinded study within a trial, with semistructured qualitative interviews with some patients (ISRCTN96189403). Each cluster was a UK hospital participating in the ICON8 ovarian cancer trial. Interventions were shared with 384 ICON8 participants who were alive and considered well enough to be contacted, at 43 hospitals. Hospitals were allocated to share results with participants through one of the 8 intervention combinations based on random permutation within blocks of 8, stratified by number of participants. All interventions contained a written plain English summary of the results. The Enhanced Webpage also contained a short video. Both the Enhanced Webpage and Email contained links to further information and support. The Mailed Printed Summary was opt-out. Follow-up questionnaires were sent 1 month after patients had been offered the interventions. Patients’ reported satisfaction was measured using a 5-point scale, analysed by ordinal logistic regression estimating main effects for all 3 interventions, with random effects for site, restricted to those who reported receiving the results and assuming no interaction. Data collection took place in 2018 to 2019. Questionnaires were sent to 275/384 randomly selected participants and returned by 180: 90/142 allocated Basic Webpage, 90/133 Enhanced Webpage; 91/141 no Mailed Printed Summary, 89/134 Mailed Printed Summary; 82/129 no Email List Invitation, 98/146 Email List Invitation. About 3 patients opted out of receiving the Mailed Printed Summary; no patients signed up to the email list. Patients’ satisfaction was greater at sites allocated the Mailed Printed Summary, where 65/81 (80%) were quite or very satisfied compared to sites with no Mailed Printed Summary 39/64(61%), ordinal odds ratio (OR) = 3.15 (1.66 to 5.98, p < 0.001). We found no effect on patient satisfaction from the Enhanced Webpage, OR = 1.47 (0.78 to 2.76, p = 0.235) or Email List Invitation, OR = 1.38 (0.72 to 2.63, p = 0.327). Interviewees described the results as interesting, important, and disappointing (the ICON8 trial found no benefit). Finding out the results made some feel their trial participation had been more worthwhile. Regardless of allocated group, patients who received results generally reported that the information was easy to understand and find, were glad and did not regret finding out the results. The main limitation of our study is the 65% response rate. Conclusions Nearly all respondents wanted to know the results and were glad to receive them. Adding an opt-out Mailed Printed Summary alongside a webpage yielded the highest reported satisfaction. This study provides evidence on how to share results with other similar trial populations. Further research is needed to look at different results scenarios and patient populations. Trial registration ISRCTN: ISRCTN96189403.

Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units

“…Although the emphasis for reporting to participants should be on information pertinent to their comparison, many participants will wish to hear about all aspects of the protocol; participants may talk together and it is fairer to transparently offer results from across the protocol’s activities to all participants should they want it [ 27 ]. Communicating efficacy results and emerging safety data requires careful tailoring to participants who were in the comparison, participants whose future management in the trial may be impacted by the findings, and participants elsewhere in the platform.…”

Engaging participants with research findings: A rights‐informed approach

“…Most discussions about sharing research findings state that participants would like to know about the findings. 12,15,41 However, it is also acknowledged that in practice research findings are not shared as often as they should be. 15,22,41 Indeed, whilst health researchers agree on the importance of making research publicly accessible, it is often admitted that it is 'easy to become untethered from these foundational principles'.…”

“…12,15,41 However, it is also acknowledged that in practice research findings are not shared as often as they should be. 15,22,41 Indeed, whilst health researchers agree on the importance of making research publicly accessible, it is often admitted that it is 'easy to become untethered from these foundational principles'. 42 The failure to share research findings with participants has been shown to impact researcher credibility and an individual's future participation in research.…”

“…The last three decades have seen a growing interest in engaging research participants and ensuring that the findings of health research are freely available to those beyond the traditional consumers of research outputs. Most discussions about sharing research findings state that participants would like to know about the findings 12,15,41 . However, it is also acknowledged that in practice research findings are not shared as often as they should be 15,22,41 .…”

Practical Guidance for Running Late-Phase Platform Protocols for Clinical Trials: Lessons From Experienced UK Clinical Trials Units

“…Although the emphasis for reporting to participants should be on information pertinent to their comparison, many participants will wish to hear about all aspects of the protocol; participants may talk together and it is fairer to transparently offer results from across the protocol's activities to all participants should they want it. 20 Communicating e cacy results and emerging safety data requires careful tailoring to participants who were in the comparison, participants whose future management in the trial may be impacted by the ndings and participants elsewhere in the platform. Ideally, participants would ag whether they wanted ndings from only "their" comparisons, results from other comparisons, or no results.…”