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Systematic review of the characteristics of school-based feasibility cluster randomised trials of interventions for improving the health of pupils in the UK.

cam.issuedOnline2022-07-02
dc.contributor.authorParker, Kitty
dc.contributor.authorEddy, Saskia
dc.contributor.authorNunns, Michael
dc.contributor.authorXiao, ZhiMin
dc.contributor.authorFord, Tamsin
dc.contributor.authorEldridge, Sandra
dc.contributor.authorUkoumunne, Obioha C
dc.contributor.orcidParker, Kitty [0000-0003-2319-8227]
dc.date.accessioned2022-07-02T15:00:19Z
dc.date.available2022-07-02T15:00:19Z
dc.date.issued2022-07-02
dc.date.submitted2021-10-20
dc.date.updated2022-07-02T15:00:19Z
dc.descriptionFunder: National Institute for Health Research Applied Research Collaboration South West Peninsula
dc.description.abstractBACKGROUND: The last 20 years have seen a marked increase in the use of cluster randomised trials (CRTs) in schools to evaluate interventions for improving pupil health outcomes. Schools have limited resources and participating in full-scale trials can be challenging and costly, given their main purpose is education. Feasibility studies can be used to identify challenges with implementing interventions and delivering trials. This systematic review summarises methodological characteristics and objectives of school-based cluster randomised feasibility studies in the United Kingdom (UK). METHODS: We systematically searched MEDLINE from inception to 31 December 2020. Eligible papers were school-based feasibility CRTs that included health outcomes measured on pupils. RESULTS: Of 3285 articles identified, 24 were included. School-based feasibility CRTs have been increasingly used in the UK since the first publication in 2008. Five (21%) studies provided justification for the use of the CRT design. Three (13%) studies provided details of a formal sample size calculation, with only one of these allowing for clustering. The median (IQR; range) recruited sample size was 7.5 (4.5 to 9; 2 to 37) schools and 274 (179 to 557; 29 to 1567) pupils. The most common feasibility objectives were to estimate the potential effectiveness of the intervention (n = 17; 71%), assess acceptability of the intervention (n = 16; 67%), and estimate the recruitment/retention rates (n = 15; 63%). Only one study was used to assess whether cluster randomisation was appropriate, and none of the studies that randomised clusters before recruiting pupils assessed the possibility of recruitment bias. Besides potential effectiveness, cost-effectiveness, and the intra-cluster correlation coefficient, no studies quantified the precision of the feasibility parameter estimates. CONCLUSIONS: Feasibility CRTs are increasingly used in schools prior to definitive trials of interventions for improving health in pupils. The average sample size of studies included in this review would be large enough to estimate pupil-level feasibility parameters (e.g., percentage followed up) with reasonable precision. The review highlights the need for clearer sample size justification and better reporting of the precision with which feasibility parameters are estimated. Better use could be made of feasibility CRTs to assess challenges that are specific to the cluster design. TRIAL REGISTRATION: PROSPERO: CRD42020218993.
dc.identifier.citationPilot and Feasibility Studies, volume 8, issue 1, article-number 132
dc.identifier.doi10.17863/CAM.86120
dc.identifier.eissn2055-5784
dc.identifier.issn2055-5784
dc.identifier.others40814-022-01098-w
dc.identifier.other1098
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/338707
dc.languageen
dc.publisherSpringer Science and Business Media LLC
dc.subjectReview
dc.subjectChildren
dc.subjectCluster randomised trials
dc.subjectFeasibility study
dc.subjectPilot study
dc.subjectPublic health
dc.subjectRandomised trials
dc.subjectResearch methods
dc.subjectSchools
dc.subjectSystematic review
dc.subjectTrial methodology
dc.titleSystematic review of the characteristics of school-based feasibility cluster randomised trials of interventions for improving the health of pupils in the UK.
dc.typeArticle
dcterms.dateAccepted2022-06-20
prism.publicationNamePilot Feasibility Stud
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1186/s40814-022-01098-w

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