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Sequential multiple assignment randomized trial studies should report all key components: a systematic review

Lookup NU author(s): Dr Theophile BigirumurameORCiD, Germain Uwimpuhwe, Professor James WasonORCiD



This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


ObjectiveSequential Multiple Assignment Randomized Trial (SMART) designs allow multiple randomizations of participants; this allows assessment of stage-specific questions (individual randomizations) and adaptive interventions (i.e. treatment strategies). We assessed the quality of reporting of the information required to design SMART studies.Study design and settingWe systematically searched four databases (PubMed, Ovid, Web of Science and Scopus) for all trial reports, protocols, reviews, and methodological papers which mentioned SMART designs up to June 15, 2020.ResultsOf the 157 selected records, 12 (7.64%) were trial reports, 24 (15.29%) were study protocols, 91 (58%) were methodological papers, and 30 (19.1%) were review papers. All these trials were powered using stage-specific aims. Only four (33.33%) of these trials reported parameters required for sample size calculations. A small number of the trials (16.67 %) were interested in determining the best embedded adaptive interventions. Most of the trials did not report information about multiple testing adjustment.Furthermore, most of records reported designs that were mainly focused on stage-specific aims.ConclusionsSome features of SMART designs are seldomly reported and/or used. Furthermore, studies using this design tend to not adequately report information about all the design parameters, limiting their transparency and interpretability.

Publication metadata

Author(s): Bigirumurame T, Uwimpuhwe G, Wason J

Publication type: Article

Publication status: Published

Journal: Journal of Clinical Epidemiology

Year: 2022

Volume: 142

Pages: 152-160

Print publication date: 01/02/2022

Online publication date: 08/11/2021

Acceptance date: 03/11/2021

Date deposited: 20/01/2022

ISSN (electronic): 0895-4356

Publisher: Elsevier


DOI: 10.1016/j.jclinepi.2021.11.007


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