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Abstract
Introduction The stepped-wedge cluster randomised trial (SW-CRT) is a complex design, for which many decisions about key design parameters must be made during the planning. These include the number of steps and the duration of time needed to embed the intervention. Feasibility studies are likely to be useful for informing these decisions and increasing the likelihood of the main trial's success. However, the number of feasibility studies being conducted for SW-CRTs is currently unknown. This review aims to establish the number of feasibility studies being conducted for SW-CRTs and determine which feasibility issues are commonly investigated.
Methods and analysis Fully published feasibility studies for SW-CRTs will be identified, according to predefined inclusion criteria, from searches conducted in Ovid MEDLINE, Scopus, Embase and PsycINFO. To also identify and gain information on unpublished feasibility studies the following will be contacted: authors of published SW-CRTs (identified from the most recent systematic reviews); contacts for registered SW-CRTs (identified from clinical trials registries); lead statisticians of UK registered clinical trials units and researchers known to work in the area of SW-CRTs.
Data extraction will be conducted independently by two reviewers. For the fully published feasibility studies, data will be extracted on the study characteristics, the rationale for the study, the process for determining progression to a main trial, how the study informed the main trial and whether the main trial went ahead. The researchers involved in the unpublished feasibility studies will be contacted to elicit the same information.
A narrative synthesis will be conducted and provided alongside a descriptive analysis of the study characteristics.
Ethics and dissemination This review does not require ethical approval, as no individual patient data will be used. The results of this review will be published in an open-access peer-reviewed journal.
- stepped-wedge trial
- pilot and feasibility studies
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Footnotes
Contributors CAK conceptualised the review, the design of which was refined by incorporating comments from KH, HCE and LG. CAK drafted the manuscript and incorporated comments from KH, HCE and LG for all subsequent drafts. All authors approved the final version and agreed to be accountable for all aspects of the work.
Funding This report is independent research supported by the National Institute for Health Research (NIHR Doctoral Research Fellowship, Miss Caroline Kristunas, DRF-2016-09-025). The authors would also like to acknowledge support from the NIHR Collaboration for Leadership in Applied Health Research and Care—East Midlands (NIHR CLAHRC–EM), NIHR CLAHRC–West Midlands, the Leicester Clinical Trials Unit and the NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, which is a partnership between University Hospitals of Leicester NHS Trust, Loughborough University and the University of Leicester. The views expressed are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.