Cited by 907Statistical Methods in Clinical TrialsHealth Policy Implementation ScienceAdvanced Causal Inference Techniques

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The stepped wedge trial design: a systematic review

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Brown, Celia A, Lilford, Richard J·2006·BMC Medical Research Methodology

DOI 10.1186/1471-2288-6-54

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Abstract

BACKGROUND: Stepped wedge randomised trial designs involve sequential roll-out of an intervention to participants (individuals or clusters) over a number of time periods. By the end of the study, all participants will have received the intervention, although the order in which participants receive the intervention is determined at random. The design is particularly relevant where it is predicted that the intervention will do more good than harm (making a parallel design, in which certain participants do not receive the intervention unethical) and/or where, for logistical, practical or financial reasons, it is impossible to deliver the intervention simultaneously to all participants. Stepped wedge designs offer a number of opportunities for data analysis, particularly for modelling the effect of time on the effectiveness of an intervention. This paper presents a review of 12 studies (or protocols) that use (or plan to use) a stepped wedge design. One aim of the review is to highlight the potential for the stepped wedge design, given its infrequent use to date. METHODS: Comprehensive literature review of studies or protocols using a stepped wedge design. Data were extracted from the studies in three categories for subsequent consideration: study information (epidemiology, intervention, number of participants), reasons for using a stepped wedge design and methods of data analysis. RESULTS: The 12 studies included in this review describe evaluations of a wide range of interventions, across different diseases in different settings. However the stepped wedge design appears to have found a niche for evaluating interventions in developing countries, specifically those concerned with HIV. There were few consistent motivations for employing a stepped wedge design or methods of data analysis across studies. The methodological descriptions of stepped wedge studies, including methods of randomisation, sample size calculations and methods of analysis, are not always complete. CONCLUSION: While the stepped wedge design offers a number of opportunities for use in future evaluations, a more consistent approach to reporting and data analysis is required.

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Ambasta, A., Holroyd-Leduc, J. M., Pokharel, S., Mathura, P., Shih, A. W.-Y., Stelfox, H. T., Ma, I., Harrison, M. J., Manns, B., Faris, P., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26742128
Additional file 2 of Harnessing health information technology to promote equitable care for patients with limited English proficiency and complex care needs
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Additional file 3 of Optimising personal continuity for older patients in general practice: a study protocol for a cluster randomised stepped wedge pragmatic trial
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Additional file 1 of The Perils of a “My Work Here is Done” perspective: a mixed methods evaluation of sustainment of an evidence-based intervention for transient ischemic attack
Bravata, D. M., Miech, E. J., Myers, L. J., Perkins, A. J., Zhang, Y., Rattray, N. A., Baird, S. A., Penney, L., Austin, C., & Damush, T. M. (2022) · Figshare · doi:10.6084/m9.figshare.20226923
Additional file 1 of Harnessing health information technology to promote equitable care for patients with limited English proficiency and complex care needs
Strechen, I., Wilson, P. M., Eltalhi, T., Piche, K., Tschida-Reuter, D., Howard, D., Sutor, B., Tiong, I., Herasevich, S., Pickering, B., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26743085
Additional file 1 of Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design
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Additional file 1 of Accuracy of pre-hospital triage tools for major trauma: a systematic review with meta-analysis and net clinical benefit
Gianola, S., Castellini, G., Biffi, A., Porcu, G., Fabbri, A., Ruggieri, M. P., Stocchetti, N., Napoletano, A., Coclite, D., D'Angelo, D., et al. (2021) · Figshare · doi:10.6084/m9.figshare.14767362
Additional file 2 of Re-Purposing the Ordering of Routine Laboratory Tests in Hospitalized Medical Patients (RePORT): protocol for a multicenter stepped-wedge cluster randomised trial to evaluate the impact of a multicomponent intervention bundle to reduce laboratory test over-utilization
Ambasta, A., Holroyd-Leduc, J. M., Pokharel, S., Mathura, P., Shih, A. W.-Y., Stelfox, H. T., Ma, I., Harrison, M. J., Manns, B., Faris, P., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26742125
Additional file 2 of Quality in crisis: a systematic review of the quality of health systems in humanitarian settings
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Additional file 3 of Improving care for residents in long term care facilities experiencing an acute change in health status
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Additional file 1 of A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
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Additional file 1 of Optimising personal continuity for older patients in general practice: a study protocol for a cluster randomised stepped wedge pragmatic trial
Groot, L., Schers, H., Burgers, J. S., Schellevis, F., Smalbrugge, M., Uijen, A. A., van de Ven, P. M., van der Horst, H. E., & Maarsingh, O. R. (2021) · Figshare · doi:10.6084/m9.figshare.16835242
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Authors: Brown, C. A., & Lilford, R. J.
Affiliations: University of Birmingham (GB)
Corresponding author: Brown, Celia A
ORCID: Brown, Celia A
Lilford, Richard J
Venue: BMC Medical Research Methodology
Publisher: Springer Science and Business Media LLC
Published: 2006-11-08
Volume: 6
Issue: 1
Pages: 54-54
ISSN: 1471-2288 (ISSN-L)
DOI: 10.1186/1471-2288-6-54
OpenAlex: W2101754128
Cited by: 907
References: 30
Citations by year: 2026: 24 · 2025: 34 · 2024: 35 · 2023: 44 · 2022: 45 · 2021: 70 · 2020: 70 · 2019: 65 · 2018: 57 · 2017: 62 · 2016: 78 · 2015: 83 · 2014: 73 · 2013: 57 · 2012: 34
FWCI: 1.21
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/2.0 (tdm)
Locations: BMC Medical Research Methodology (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: stepped wedge design, HIV interventions, developing countries, randomization methods, sample size determination, data analysis methods, reporting quality
MeSH terms: Clinical Protocols, Data Interpretation, Statistical, Developing Countries, Humans, Research Design, Randomized Controlled Trials as Topic

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