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Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression

Overview of attention for article published in Trials, July 2017
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Title
Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression
Published in
Trials, July 2017
DOI 10.1186/s13063-017-2059-4
Pubmed ID
Authors

Petter Viksveen, Clare Relton, Jon Nicholl

Abstract

Trials 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. In 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. This 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. ISRCTN registry: ISRCTN02484593 . Registered on 7 Jan 2013.

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The data shown below were compiled from readership statistics for 65 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 65 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 10 15%
Student > Master 8 12%
Student > Ph. D. Student 8 12%
Student > Bachelor 6 9%
Lecturer 2 3%
Other 7 11%
Unknown 24 37%
Readers by discipline Count As %
Medicine and Dentistry 17 26%
Pharmacology, Toxicology and Pharmaceutical Science 4 6%
Nursing and Health Professions 4 6%
Social Sciences 3 5%
Biochemistry, Genetics and Molecular Biology 2 3%
Other 8 12%
Unknown 27 42%