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

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 no...

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Autores principales: Kristunas, Caroline A., Hemming, Karla, Eborall, Helen, Eldridge, Sandra, Gray, Laura J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6327386/
https://www.ncbi.nlm.nih.gov/pubmed/30630416
http://dx.doi.org/10.1186/s12874-019-0658-3
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author Kristunas, Caroline A.
Hemming, Karla
Eborall, Helen
Eldridge, Sandra
Gray, Laura J.
author_facet Kristunas, Caroline A.
Hemming, Karla
Eborall, Helen
Eldridge, Sandra
Gray, Laura J.
author_sort Kristunas, Caroline A.
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12874-019-0658-3) contains supplementary material, which is available to authorized users.
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spelling pubmed-63273862019-01-15 The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review Kristunas, Caroline A. Hemming, Karla Eborall, Helen Eldridge, Sandra Gray, Laura J. BMC Med Res Methodol Research Article 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12874-019-0658-3) contains supplementary material, which is available to authorized users. BioMed Central 2019-01-10 /pmc/articles/PMC6327386/ /pubmed/30630416 http://dx.doi.org/10.1186/s12874-019-0658-3 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Kristunas, Caroline A.
Hemming, Karla
Eborall, Helen
Eldridge, Sandra
Gray, Laura J.
The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review
title The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review
title_full The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review
title_fullStr The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review
title_full_unstemmed The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review
title_short The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review
title_sort current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6327386/
https://www.ncbi.nlm.nih.gov/pubmed/30630416
http://dx.doi.org/10.1186/s12874-019-0658-3
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