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The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review.pdf (691.95 kB)

The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review.

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journal contribution
posted on 2019-05-20, 12:42 authored by CA Kristunas, K Hemming, H Eborall, S Eldridge, LJ Gray
BACKGROUND: Stepped-wedge cluster randomised trials (SW-CRTs) are a pragmatic trial design, providing an unprecedented opportunity to increase the robustness of evidence underpinning implementation and quality improvement interventions. Given the complexity of the SW-CRT, the likelihood of trials not delivering on their objectives will be mitigated if a feasibility study precedes the definitive trial. It is not currently known if feasibility studies are being conducted for SW-CRTs nor what the objectives of these studies are. METHODS: Searches were conducted of several databases to identify published feasibility studies which were designed to inform a future SW-CRT. For each eligible study, data were extracted on the characteristics of and rationale for the feasibility study; the process for determining progression to the main trial; how the feasibility study informed the main trial; and whether the main trial went ahead. A narrative synthesis and descriptive analysis are presented. RESULTS: Eleven feasibility studies were identified, which included eight completed study reports and three protocols. Three studies used a stepped-wedge design and these were the only studies to be randomised. Studies were predominantly of a mixed-methods design. Only one study assessed specific features related to the feasibility of using a SW-CRT and one investigated the time taken to complete the study procedures. The other studies were mostly assessing the feasibility and acceptability of the intervention. CONCLUSION: Published feasibility studies for SW-CRTs are scarce and those that are being reported do not investigate issues specific to the complexities of the trial design. When conducting feasibility studies in advance of a definitive SW-CRT, researchers should consider assessing the feasibility of study procedures, particularly those specific to the SW-CRT design, and ensure that the findings are published for the benefit of other researchers.


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.



BMC Medical Research Methodology, 2019, 19:12

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The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.



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