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Int J Epidemiol. 2017 Feb 1;46(1):96-102. doi: 10.1093/ije/dyw050.

The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials?

Author information

1
Department of Radiation Oncology.
2
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
3
School for Health and Related Research, University of Sheffield, Sheffield, UK.
4
School of Healthcare, University of Leeds, Leeds, UK.

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.

KEYWORDS:

Pragmatic randomized controlled trials; cohort multiple randomized controlled trial; efficiency; instrumental variable analysis; validity

PMID:
27118559
DOI:
10.1093/ije/dyw050
[Indexed for MEDLINE]

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