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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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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. |
format | Online Article Text |
id | pubmed-6327386 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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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