The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials?
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.
['van der Velden|Joanne M|JM|', 'Verkooijen|Helena M|HM|', 'Young-Afat|Danny A|DA|', 'Burbach|Johannes Pm|JP|', 'van Vulpen|Marco|M|', 'Relton|Clare|C|', 'van Gils|Carla H|CH|', 'May|Anne M|AM|', 'Groenwold|Rolf Hh|RH|']
D015331:Cohort Studies D006801:Humans D010349:Patient Compliance D064792:Pragmatic Clinical Trials as Topic D016032:Randomized Controlled Trials as Topic D012107:Research Design
cohort multiple randomized controlled trial validity efficiency Pragmatic randomized controlled trials instrumental variable analysis