The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials?. (25th April 2016)

• Record Type: Journal Article
• Authors: van der Velden, Joanne M; Verkooijen, Helena M; Young-Afat, Danny A; Burbach, Johannes PM; van Vulpen, Marco; Relton, Clare; van Gils, Carla H; May, Anne M; Groenwold, Rolf HH
• Is Part Of: International journal of epidemiology. Volume 46:Number 1(2017)
• Page Start: 96
• Page End: 102
• Publication Date: 2016-04-25
• Subjects: Pragmatic randomized controlled trials -- cohort multiple randomized controlled trial -- validity -- efficiency -- instrumental variable analysis; Epidemiology -- Periodicals; 614.4
• DOI: 10.1093/ije/dyw050
• Languages: English
• ISSNs: 0300-5771

Abstract

Abstract: Randomized controlled trials (RCTs)—the gold standard for evaluating the effects of medical interventions—are notoriously challenging in terms of logistics, planning and costs. The cohort multiple randomized controlled trial approach is designed to facilitate randomized trials for pragmatic evaluation of (new) interventions and is a promising variation from conventional pragmatic RCTs. In this paper, we evaluate methodological challenges of conducting an RCT within a cohort. We argue that equally valid results can be obtained from trials conducted within cohorts as from pragmatic RCTs. However, whether this design is more efficient compared with conducting a pragmatic RCT depends on the amount and nature of non-compliance in the intervention arm.