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dc.contributor.authorELDRIDGE, SM
dc.contributor.authorKristunas, CA
dc.contributor.authorHemming, K
dc.contributor.authorEborall, H
dc.contributor.authorGray, LJ
dc.date.accessioned2019-01-30T11:33:35Z
dc.date.available2019-01-02
dc.date.available2019-01-30T11:33:35Z
dc.date.issued2019-01-10
dc.identifier.citationKristunas CA, Hemming K, Eborall HC, et al The use of feasibility studies for stepped-wedge cluster randomised trials: protocol for a review of impact and scope BMJ Open 2017;7:e017290. doi: 10.1136/bmjopen-2017-017290en_US
dc.identifier.issn1471-2288
dc.identifier.urihttps://qmro.qmul.ac.uk/xmlui/handle/123456789/55008
dc.description.abstractAbstract 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 To also identify and gain information on unpublished feasibility studies the following will be contacted: authors of published SW-CRTs (identified from the most recent systematic reviews); contacts for registered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 The researchers involved in the unpublished feasibility studies will be contacted to elicit the same information.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.en_US
dc.description.sponsorshipNational 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 Leicesteren_US
dc.language.isoenen_US
dc.publisherBioMed Centralen_US
dc.relation.ispartofBMC Medical Research Methodology
dc.rightsCreative Commons Attribution License
dc.subjectstepped-wedge cluster randomised trialsen_US
dc.subjectFeasibility studiesen_US
dc.titleThe current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic reviewen_US
dc.typeArticleen_US
dc.rights.holderThe authors (2017)
dc.identifier.doi10.1186/s12874-019-0658-3
pubs.issue1en_US
pubs.notesNo embargoen_US
pubs.publication-statusPublisheden_US
pubs.volume19en_US
dcterms.dateAccepted2019-01-02
rioxxterms.funderDefault funderen_US
rioxxterms.identifier.projectDefault projecten_US


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