The stepped wedge trial design: a systematic review
Open accessAbstract
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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Analyses of stepped-wedge trials can be complex due to time-varying effects and intra-cluster correlation, requiring appropriate analytic approaches.
“In addition, contamination between participants who have received the intervention and those awaiting roll-out may occur, and analyses can be complex due to time-varying effects and intra-cluster correlation, requiring appropriate analytic approaches (3, 8, 16, 19).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [3]
The Conclusion (page not available in our copy) identifies controlling for changes in outcomes over time as a statistical challenge and calls for a model that considers time. It also mentions repeated measures on the same individuals, but does not identify intra-cluster correlation as a source of analytic complexity. The Methods of data analysis section reports varied analytic approaches. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe primary motivations for employing the SWD in SSA research are to address ethical concerns regarding withholding potentially beneficial interventions and to manage the logistical challenges of simultaneous intervention implementation across diverse, resource-limited settings.
“The primary motivations for employing the SWD in SSA research are to address ethical concerns regarding withholding potentially beneficial interventions and to manage the logistical challenges of simultaneous intervention implementation across diverse, resource-limited settings (3, 13, 18, 20).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [3]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredThe phased approach of SWD allows for adjustments based on initial findings, enhancing the intervention's overall effectiveness.
“The phased approach allows for adjustments based on initial findings, enhancing the intervention's overall effectiveness (3, 12, 20–22).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [3]
The Background (page not specified) describes sequential rollout and data collection at each step. It does not say that initial findings are used to adjust the intervention or that such adjustments enhance its effectiveness; the Conclusion discusses measuring whether the timing of intervention affects effectiveness, not improving it during rollout. (LLM, conf=0.86)
Experimental — accuracy not yet measuredStepped-wedge trials can extend study duration compared with traditional parallel designs, particularly when outcomes are measured shortly after implementation.
“Stepped-wedge trials can also extend study duration compared with traditional parallel designs, particularly when outcomes are measured shortly after implementation (2, 3, 15).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [3]
Contamination between participants who have received the intervention and those awaiting roll-out may occur in stepped-wedge trials.
“In addition, contamination between participants who have received the intervention and those awaiting roll-out may occur, and analyses can be complex due to time-varying effects and intra-cluster correlation, requiring appropriate analytic approaches (3, 8, 16, 19).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [3]
The breadth of outcome measures reinforces SWD's versatility for evaluating both health impacts and system performance within routine care and public health programs.
“This breadth reinforces SWD's versatility for evaluating both health impacts and system performance within routine care and public health programs (2, 3, 15).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [3]
This roll-out design has been used in effectiveness trials for roughly twenty years, under names such as dynamic wait-listed design or stepped-wedge design.
“This type of roll-out design has been used for about two decades in effectiveness trials, where it is known as a dynamic wait-listed design (17) or a stepped-wedge design (10).”
From An Overview of Research and Evaluation Designs for Dissemination and Implementation (2017) · cites this paper as [10]
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- Authors
- Brown, C. A., & Lilford, R. J.
- Affiliations
- University of Birmingham (GB)
- Corresponding author
- Brown, Celia A
- Venue
- BMC Medical Research Methodology
- Published
- 2006-11-08
- Volume
- 6
- Issue
- 1
- Pages
- 54-54
- ISSN
- 1471-2288 (ISSN-L)
- 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
- 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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