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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The long-term effects of conductive education courses in young children with cerebral palsy: a randomized controlled trial
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Adapting Boot Camp Translation Methods to Engage Clinician/Patient Research Teams Within Practice-Based Research Networks
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Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application
Helou, R. I., Catho, G., Latif, A. P., Mouton, J. W., Hulscher, M., Teerenstra, S., Conly, J. M., Huttner, B. D., Tängdén, T., & Verbon, A. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-033640 · Cited by 8
Scale‐up of the Stepping On fall prevention program amongst older adults in NSW: Program reach and fall‐related health service use
Paul, S. S., Li, Q., Harvey, L. A., Carroll, T., Priddis, A., Tiedemann, A., Clemson, L. M., Lord, S. R., Close, J., & Sherrington, C. (2020) · Health Promotion Journal of Australia · doi:10.1002/hpja.413 · Cited by 8
Transdiagnostic therapeutic approaches: A global perspective
Murray, L. K., Metz, K. L., & Callaway, K. L. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-814932-4.00002-1 · Cited by 15
Evaluating spillover of HIV knowledge from study participants to their network members in a stepped-wedge behavioural intervention in Tanzania
Rewley, J., Fawzi, M. C. S., McAdam, K., Kaaya, S., Liu, Y., Todd, J., Andrew, I., & Onnela, J. P. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-033759 · Cited by 7
Efficacy of midwife-led role orientation of birth companions on maternal satisfaction and birth outcomes: a randomized control trial in Uganda
Wanyenze, E. W., Nalwadda, G. K., Tumwesigye, N. M., & Byamugisha, J. K. (2023) · BMC Pregnancy and Childbirth · doi:10.1186/s12884-023-05978-8 · Cited by 7
Implementation of a stepped-wedge cluster randomized design in routine public health practice: design and application for a tuberculosis (TB) household contact study in a high burden area of Lima, Peru
Shah, L., Rojas, M., Mori, O., Zamudio, C., Kaufman, J. S., Otero, L., Gotuzzo, E., Seas, C., & Brewer, T. F. (2015) · BMC Public Health · doi:10.1186/s12889-015-1883-2 · Cited by 9
Antimicrobial Stewardship Programs: A Review of Recent Evaluation Methods and Metrics
Palmay, L., Walker, S. A. N., Leis, J. A., Taggart, L. R., Lee, C., & Daneman, N. (2014) · Current treatment options in infectious diseases/Current treatment options in infectious disease · doi:10.1007/s40506-013-0008-7 · Cited by 7
Implementing an outreaching, preference-led stepped care intervention programme to reduce late life depressive symptoms: results of a mixed-methods study
van Beljouw, I. M. J., Laurant, M. G. H., Heerings, M., Stek, M. L., van Marwijk, H., & van Exel, E. R. (2014) · Implementation Science · doi:10.1186/s13012-014-0107-y · Cited by 7
Evaluation of an interactive program for preventing adverse drug events in primary care: study protocol of the InPAct cluster randomised stepped wedge trial
Keriel-Gascou, M., Buchet-Poyau, K., Duclos, A., Rabilloud, M., Figon, S., Dubois, J.-P., Brami, J., Vial, T., & Colin, C. (2013) · Implementation Science · doi:10.1186/1748-5908-8-69 · Cited by 8
Choice of Design and Outcomes in Trials among Children with Moderate Acute Malnutrition
Friis, H., Michaelsen, K. F., & Wells, J. C. K. (2015) · Food and Nutrition Bulletin · doi:10.1177/15648265150361s106 · Cited by 7
Effects of Implementing the Short-Term Assessment of Risk and Treatability for Mechanical Restraint in a Forensic Male Population: A Stepped-Wedge, Cluster-Randomized Design
Hvidhjelm, J., Brandt‐Christensen, M., Delcomyn, C. L., Møllerhøj, J., Siersma, V., & Bak, J. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.822295 · Cited by 7
The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions
Saberi, P., Stoner, M. C. D., Ming, K., Lisha, N. E., Hojilla, J. C., Scott, H. M., Liu, A., Steward, W. T., Johnson, M. O., & Neilands, T. B. (2022) · AIDS · doi:10.1097/qad.0000000000003283 · Cited by 8
Design and analysis of crossover trials for investigating high-risk medical devices: A review
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Reducing malaria transmission in forest-going mobile and migrant populations in Lao PDR and Cambodia: protocol for stepped-wedge cluster-randomised controlled trial
Htike, W., Oo, W. H., Lynn, T., Sovanda, L., Agius, P. A., Oo, M. C., Galau, N. H., Thu, K. M., Zaw, A. K., Htwe, E. P., et al. (2022) · BMC Infectious Diseases · doi:10.1186/s12879-022-07724-5 · Cited by 7
Future research and methodological approaches
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Efficacy of temporary work modifications on disability related to musculoskeletal pain or depressive symptoms—study protocol for a controlled trial
Haukka, E., Martimo, K.-P., Kivekäs, T., Horppu, R., Lallukka, T. M., Solovieva, S. A., Shiri, R., Pehkonen, I., Takala, E., MacEachen, E., et al. (2015) · BMJ Open · doi:10.1136/bmjopen-2015-008300 · Cited by 7
Complex social intervention for multidisciplinary teams to improve patient referrals in obstetrical care: protocol for a stepped wedge study design
Romijn, A., de Bruijne, M. C., Teunissen, P. W., de Groot, C. J. M., & Wagner, C. (2016) · BMJ Open · doi:10.1136/bmjopen-2016-011443 · Cited by 8
The Art of Health Promotion
Harrington, S. (2016) · American Journal of Health Promotion · doi:10.4278/ajhp.30.3.tahp-2 · Cited by 7
Rationale and protocol paper for the Healthy Active Peaceful Playgrounds for Youth (HAPPY) study
Cotton, W., Dudley, D. A., Jackson, K., Winslade, M., & Atkin, J. (2017) · BMC Public Health · doi:10.1186/s12889-017-4445-y · Cited by 7
Developing Rigorous Programme Evaluation
Bywater, T. J. (2012) · Cambridge University Press eBooks · doi:10.1017/cbo9781139013949.006 · Cited by 7
Evaluating Complex Interventions
Tsiachristas, A., & Mölken, M. R. (2017) · Springer eBooks · doi:10.1007/978-3-319-56103-5_18 · Cited by 7
Methodological considerations in MVC epidemiological research
Fridman, L., Rothman, L., Howard, A. W., Hagel, B. E., & Macarthur, C. (2021) · Injury Prevention · doi:10.1136/injuryprev-2020-043987 · Cited by 6
The application of stepped-wedge cluster-randomized controlled trial study designs in oncology settings: A systematic review
Jongebloed, H., Chapman, A., Marshall, S., Orellana, L., WHITE, V. M., Livingston, P. L., & Ugalde, A. (2024) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2024.104547 · Cited by 6
Improving the Care of People with Long-Term Conditions in Primary Care: Protocol for the Enhance Pilot Trial
Healey, E. L., Jinks, C., Tan, V., Chew-Graham, C. A., Lawton, S., Nicholls, E. E., Finney, A. G., Porcheret, M., Cooper, V., Lewis, M., et al. (2015) · Journal of Comorbidity · doi:10.15256/joc.2015.5.60 · Cited by 7
Translational Research
Zoellner, J., & Porter, K. (2017) · Elsevier eBooks · doi:10.1016/b978-0-12-802928-2.00006-0 · Cited by 5
Effects of Grounding (Earthing) on Massage Therapists: An Exploratory Study
Chevalier, G., Patel, S., Weiss, L., Pruitt, C., Henry, B. L., Chopra, D., & Mills, P. J. (2018) · Health · doi:10.4236/health.2018.102019 · Cited by 6
How to Translate Self-Management Support Tools Into Clinical Practice
Simpson, M., Daly, J. M., Fernald, D. H., Westfall, J. M., Michaels, L. C., Levy, B. T., Hahn, D. L., Fagnan, L. J., & Nease, D. E. (2018) · Journal of patient-centered research and reviews · doi:10.17294/2330-0698.1636 · Cited by 6
Cost‐consequence analysis of an intervention for the management of neuropsychiatric symptoms in young‐onset dementia: Results from the BEYOND‐II study
den IJssel, J. C. L. V. D., Bakker, C., Smalbrugge, M., Zwijsen, S. A., Adang, E., Appelhof, B., Zuidema, S. U., de Vugt, M. E., Verhey, F. R. J., & Koopmans, R. T. C. M. (2019) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.5229 · Cited by 6
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) · BMC Family Practice · doi:10.1186/s12875-021-01511-y · Cited by 6
Patient safety: Needs and initiatives
Bion, J. (2008) · Indian Journal of Critical Care Medicine · doi:10.4103/0972-5229.42559 · Cited by 6
Implementation of protected mealtimes in the subacute setting: stepped wedge cluster trial protocol
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An Agenda for Naloxone Distribution Research and Practice: Meeting Report of the Surviving Opioid Overdose with Naloxone (SOON) International Working Group
Katherine, A. M. O., Klaiman, M., Buick, P. L. J. E., & Kouyoumdjian, F. G. (2015) · Journal of Addiction Research & Therapy · doi:10.4172/2155-6105.1000212 · Cited by 6

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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The stepped wedge trial design: a systematic review

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