Abstract
BackgroundTrials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges.Main textIn this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design. This trial—the Depression in South Yorkshire (DEPSY) trial—involved comparison of treatment as usual (TAU) with TAU plus the offer of an intervention for people with self-reported long-term moderate to severe depression. In the trial, we used an existing large population-based cohort: the Yorkshire Health Study. We discuss our experiences with recruitment, attrition, crossover, data analysis, generalisability of results, and cost. The main challenges in using the cmRCT design were the high crossover to the control group and the lower questionnaire response rate among patients who refused the offer of treatment. However, the design did help facilitate efficient and complete recruitment of the trial population as well as analysable data that were generalisable to the population of interest. Attrition rates were also smaller than those reported in other depression trials.ConclusionThis first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits. Further research is required to compare the acceptability and cost effectiveness of standard pragmatic RCT design with the cmRCT design.Trial registrationISRCTN registry: ISRCTN02484593. Registered on 7 Jan 2013.
Highlights
In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cohort multiple randomised controlled trial (cmRCT) design
This first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits
We report on our experiences of using the cmRCT design in relation to recruitment, attrition, crossover, data analysis, cost and generalisability of Viksveen et al Trials (2017) 18:308 results for the first completed full-scale RCT of the cmRCT design: the Depression in South Yorkshire (DEPSY) trial
Summary
Recruitment Trials often struggle to reach recruitment goals on time, and many trials fail entirely to recruit a sufficient number of participants [7], especially trials in depression [8]. Attrition Patients who agree to participate in trials may be disappointed if they are not allocated to receive their preferred intervention [17] As a consequence, they may become uncooperative, report poorer outcomes than experienced and even leave the trial, which may in turn significantly affect analyses and the interpretation of results [18]. The rate at which people completed follow-up questionnaires was lower (68%) in the group randomly selected to receive the offer of the intervention (Offer group), compared with the control group (87%), where patients were not offered the intervention (No offer group). Patients in the No offer group are not informed about interventions they cannot receive This is more comparable to real-world practice and contributes to increasing the generalisability of results. This meant that (compared with 1:1 randomisation) 25% fewer patients were offered the intervention, reducing the trial intervention costs by £10,000
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