Background Cluster randomised trials (CRTs) are increasingly used to evaluate non-pharmacological interventions for improving child health. Although methodological challenges of CRTs are well documented, the characteristics of school-based CRTs with pupil health outcomes have not been systematically described. Our objective was to describe methodological characteristics of these studies in the United Kingdom (UK). Methods MEDLINE was systematically searched from inception to 30th June 2020. Included studies used the CRT design in schools and measured primary outcomes on pupils. Study characteristics were described using descriptive statistics. Results Of 3138 articles identified, 64 were included. CRTs with pupil health outcomes have been increasingly used in the UK school setting since the earliest included paper was published in 1993; 37 (58%) studies were published after 2010. Of the 44 studies that reported information, 93% included state-funded schools. Thirty six (56%) were exclusively in primary schools and 24 (38%) exclusively in secondary schools. Schools were randomised in 56 studies, classrooms in 6 studies, and year groups in 2 studies. Eighty percent of studies used restricted randomisation to balance cluster-level characteristics between trial arms, but few provided justification for their choice of balancing factors. Interventions covered 11 different health areas; 53 (83%) included components that were necessarily administered to entire clusters. The median (interquartile range) number of clusters and pupils recruited was 31.5 (21 to 50) and 1308 (604 to 3201), respectively. In half the studies, at least one cluster dropped out. Only 26 (41%) studies reported the intra-cluster correlation coefficient (ICC) of the primary outcome from the analysis; this was often markedly different to the assumed ICC in the sample size calculation. The median (range) ICC for school clusters was 0.028 (0.0005 to 0.21). Conclusions The increasing pool of school-based CRTs examining pupil health outcomes provides methodological knowledge and highlights design challenges. Data from these studies should be used to identify the best school-level characteristics for balancing the randomisation. Better information on the ICC of pupil health outcomes is required to aid the planning of future CRTs. Improved reporting of the recruitment process will help to identify barriers to obtaining representative samples of schools.

Insecticide impregnated bed nets are being tested in many tropical areas as a major tool to control malaria. In a few African countries, there is a history of local bed net production and use, while in most others, ownership of commercially-produced nets is rare due to high costs relative to local income. Such variations in pre-existing bed net use behavior must be studied prior to designing new intervention trials. A "baseline" diagnostic study in Nsukka Local Government of Enugu State, Nigeria, found that local beliefs about malaria causation, which include heat from the sun and hard work, may reduce the perceived efficacy of bed nets as an appropriate malaria control action. While the belief that mosquitos can cause malaria increased with level of formal education, the study also documented that educated people simultaneously hold both indigenous and scientific perceptions about malaria. Although the project provided bed nets, curtains and residual house spray for free, long-term sustainability may be influenced by the main constraint to current ownership of a bed net, i.e., cost. Issues, such as concern about feeling hot under the nets, a tendency to sleep outside during the hot dry season, and variations in people's ideas about what constitutes a malaria episode, point to the need to monitor the bed net intervention. This is recommended as a means of learning how people perceive the efficacy of the nets, whether they use them correctly and whether the intervention can be sustained and integrated into local primary health care programs.

IntroductionCluster randomised trials (CRTs) are studies in which groups (clusters) of participants rather than the individuals themselves are randomised to trial arms. CRTs are becoming increasingly relevant for evaluating interventions delivered in school settings for improving the health of children. Schools are a convenient setting for health interventions targeted at children and the CRT design respects the clustered structure in schools (ie, pupils within classrooms/teachers within schools). Some of the methodological challenges of CRTs, such as ethical considerations for enrolment of children into trials and how best to handle the analysis of data from participants (pupils) that change clusters (schools), may be more salient for the school setting. A better understanding of the characteristics and methodological considerations of school-based CRTs of health interventions would inform the design of future similar studies. To our knowledge, this is the only systematic review to focus specifically on the characteristics and methodological practices of CRTs delivered in schools to evaluate interventions for improving health outcomes in pupils in the UK.Methods and analysisWe will search for CRTs published from inception to 30 June 2020 inclusively indexed in MEDLINE (Ovid). We will identify relevant articles through title and abstract screening, and subsequent full-text screening for eligibility against predefined inclusion criteria. Disagreements will be resolved through discussion. Two independent reviewers will extract data for each study using a prepiloted data extraction form. Findings will be summarised using descriptive statistics and graphs.Ethics and disseminationThis methodological systematic review does not require ethical approval as only secondary data extracted from papers will be analysed and the data are not linked to individual participants. After completion of the systematic review, the data will be analysed, and the findings disseminated through peer-reviewed publications and scientific meetings.PROSPERO registration numberCRD42020201792.

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Background 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.