SynthesisBMC medical research methodology2006
The stepped wedge trial design: a systematic review.
Synthesis in BMC medical research methodology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 11 registered trials, which are not on this map. Cited by 456 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Data-driven Quality Improvement in Primary Care: Cluster Randomised Controlled Trial to Test the Effectiveness of a Multifaceted Intervention in Reducing High Risk Prescribing of Non-steroidal Anti-inflammatory Drugs and Antiplatelet Agents
Effects of Checklists in Surgical Care - a Study on Morbidity, Mortality and Data Quality
CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory
PREPARE, Prematurity Reduction by Pre-eclampsia Care
Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. Controlled Clinical Trial, Randomized Triple Blind by Clusters (PREVICHARM Study)
Relaxation Intervention in Patients With Diabetic Foot Ulcer: A Pilot Randomized Controlled Trial With a Nested Qualitative Study
Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer, in Physiological Indicators of Healing Prognosis and Quality of Life: a Randomized Longitudinal Trial With a Nested Qualitative Study of Effectiveness Assessment
A Stepped Wedge Cluster Randomized Trial Designed to Evaluate the Effects of SurgeCon: A Quality Improvement Surge Management Platform
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock
Satisfaction With Life and Quality of Life in Adults With Depressive and Anxious Symptoms: A Pilot Randomized Clinical Trial
Who cites it
456 citing papers in PubMed, 8 syntheses or guidelines pooled it, 921 citations in OpenAlex.
- Screening and Interventions for Elder Mistreatment: Geriatric Emergency Department Guidelines 2.0 Systematic Review.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026Pooled it
- Reported problems and responses during the conduct of stepped-wedge cluster randomized trials in healthcare settings: a qualitative systematic review.International journal of epidemiology · 2026Pooled it
- A systematic review and network meta-analysis of pharmaceutical interventions used to manage chronic pain.Scientific reports · 2024Pooled it
- Combining systems thinking approaches and implementation science constructs within community-based prevention: a systematic review.Health research policy and systems · 2023Pooled it
- A Systematic Review of Antimicrobial Stewardship Interventions to Improve Management of Bacteriuria in Hospitalized Adults.The Annals of pharmacotherapy · 2023Pooled it
- Accuracy of pre-hospital triage tools for major trauma: a systematic review with meta-analysis and net clinical benefit.World journal of emergency surgery : WJES · 2021Pooled it
- Health Economic Evaluation Alongside Stepped Wedge Trials: A Methodological Systematic Review.PharmacoEconomics · 2021Pooled it
- The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review.BMC medical research methodology · 2019Pooled it
- Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery: The ENRICH-US Stepped-Wedge Cluster-Randomized Trial.JAMA surgery · 2026Trial
- Novel Web-Based Technology to Promote Goal-Setting in Complex Chronic Illness: Randomized Controlled Trial.JMIR human factors · 2026Trial
- Effectiveness of Exercise in Older Adults Discharged From the ER After Minor Injuries: The CEDeComS Stepped-Wedge Trial.Journal of the American Geriatrics Society · 2026Trial
- Reduced Chronic Obstructive Pulmonary Disease-Related Utilization of Health Care Services and Increased Social Activities by Patients Offered a 24/7 Accessible Telehealth Service Based on the Epital Care Model: Pragmatic Modified Stepped Wedge Randomized Controlled Trial.Journal of medical Internet research · 2025Trial
- Trial
- Mono-Professional Simulation-Based Obstetric Training in a Low-Resource Setting: Stepped-Wedge Cluster Randomized Trial.JMIR medical education · 2025Trial
- Impact of the Wood-BurningEnvironmental health perspectives · 2025Trial
- Effects of neck-exercise and health promotion on headache outcomes in office workers: secondary analysis of the NEXpro stepped wedge cluster randomised controlled trial.The journal of headache and pain · 2025Trial
- The effect of peer group management intervention on chronic pain intensity, number of areas of pain, and pain self-efficacy.Scandinavian journal of pain · 2025Trial
- Depression and loneliness among Sub-Saharan immigrants living in the greater Paris area: results from the MAKASI empowerment stepped wedge cluster randomised controlled trial.Social psychiatry and psychiatric epidemiology · 2024Trial
- Fidelity of Enhanced Recovery Protocol Implementation With Assessment of Hospital-Specific Materials.The Journal of surgical research · 2024Trial
- Optimising personal continuity for older patients in general practice: a cluster randomised stepped wedge pragmatic trial.BMJ open · 2024Trial
396 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStepped 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.
methodsComprehensive 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.
resultsThe 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.
conclusionWhile 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.