Systematic review of the characteristics of school-based feasibility cluster randomised trials of interventions for improving the health of pupils in the UK
dc.contributor.author | Parker, K | |
dc.contributor.author | Eddy, S | |
dc.contributor.author | Nunns, M | |
dc.contributor.author | Xiao, Z | |
dc.contributor.author | Ford, T | |
dc.contributor.author | Eldridge, S | |
dc.contributor.author | Ukoumunne, O | |
dc.date.accessioned | 2022-07-01T12:14:32Z | |
dc.date.issued | 2022-07-02 | |
dc.date.updated | 2022-07-01T10:27:01Z | |
dc.description.abstract | Background The last 20 years has 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 31st December 2020. Eligible papers were school-based feasibility CRTs that included health outcomes measured on pupils. Results Of 3,285 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 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 rate (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. | en_GB |
dc.description.sponsorship | National Institute for Health Research (NIHR) | en_GB |
dc.identifier.citation | Vol. 8, article 132 | en_GB |
dc.identifier.doi | 10.1186/s40814-022-01098-w | |
dc.identifier.grantnumber | NIHR200167 | en_GB |
dc.identifier.uri | http://hdl.handle.net/10871/130115 | |
dc.identifier | ORCID: 0000-0002-0551-9157 (Ukoumunne, Obioha) | |
dc.language.iso | en | en_GB |
dc.publisher | BMC | en_GB |
dc.rights | © The Author(s) 2022. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | |
dc.subject | Children | en_GB |
dc.subject | Cluster randomised trials | en_GB |
dc.subject | Feasibility study | en_GB |
dc.subject | Pilot study | en_GB |
dc.subject | Public health | en_GB |
dc.subject | Randomised trials | en_GB |
dc.subject | Research methods | en_GB |
dc.subject | Schools | en_GB |
dc.subject | Systematic review | en_GB |
dc.subject | Trial methodology | en_GB |
dc.title | Systematic review of the characteristics of school-based feasibility cluster randomised trials of interventions for improving the health of pupils in the UK | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2022-07-01T12:14:32Z | |
dc.identifier.issn | 2055-5784 | |
dc.description | This is the final version. Available on open access from BMC via the DOI in this record | en_GB |
dc.identifier.journal | Pilot and Feasibility Studies | en_GB |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | en_GB |
dcterms.dateAccepted | 2022-06-20 | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2022-06-20 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2022-07-01T10:27:04Z | |
refterms.versionFCD | AM | |
refterms.dateFOA | 2022-07-08T11:56:14Z | |
refterms.panel | A | en_GB |
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mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.