Feasibility of reporting results of large randomised controlled trials to participants: experience from the Fluoxetine Or Control Under Supervision (FOCUS) trial. Issue 11 (30th November 2020)

• Record Type: Journal Article
• Authors: Mead, Gillian; Dennis, Martin
• Other Names: author non-byline.; Anderson R author non-byline.; Buchanan D author non-byline.; Deary A author non-byline.; Drever J author non-byline.; Fraser R author non-byline.; Graham C author non-byline.; Innes K author non-byline.; McGill C author non-byline.; Perry D author non-byline.; Walker P author non-byline.; Williams C author non-byline.; Dennis Martin author non-byline.; Barugh A author non-byline.; Blair G author non-byline.; Chun Y author non-byline.; Maschauer E author non-byline.; Mead Gillian author non-byline.; Scott M author non-byline.; Forbes J author non-byline.; Hackett M author non-byline.; Hankey G author non-byline.; House A author non-byline.; Lewis S author non-byline.; Lundström E author non-byline.; Sandercock Peter author non-byline.; Lewis Steff author non-byline.; Williamson Judith author non-byline.; Forbes John author non-byline.; Hankey Graeme author non-byline.; Hackett Maree author non-byline.; Murray Veronica author non-byline.; Innes Karen author non-byline.; 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• Is Part Of: BMJ open. Volume 10:Issue 11(2020)
• Publication Date: 2020-11-30
• Subjects: stroke medicine -- geriatric medicine -- statistics & research methods; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-040492
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objectives: Informing research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results. Design: In the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019. Setting: UK stroke services. Participants: 3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond. Results: Of those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email. Conclusion: It is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future. Trial registration number: ISRCTN83290762 ; Post-results.