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Lookup NU author(s): Dr Theophile Bigirumurame, 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.
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
URL: https://doi.org/10.1016/j.jclinepi.2021.11.007
DOI: 10.1016/j.jclinepi.2021.11.007
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