SEN support from the start of school and its impact on unplanned hospital utilisation in children with cleft lip and palate: a demonstration target trial emulation protocol using ECHILD

Abstract Special Educational Needs (SEN) provision for school children provides extra support and reasonable adjustments for children and young people with additional educational, behavioural or health needs to ensure equal education opportunities; for example those born with a healthcare need such as cleft lip and palate may be provided SEN to aid with challenges in communications. However, there is limited knowledge of whether SEN provisions impact academic or health outcomes in such a population and conducting a randomised controlled trial to establish this evidence is not plausible. In lieu of randomised controlled trials, target trial emulation methods can be used in attempt to answer causal questions using observational data whilst reducing confounding and other biases likely to arise with such data. The Education and Child Health Insights from Linked Data (ECHILD) dataset could be used as part of trial emulation methods to understand the impact of SEN provisions on academic and healthcare outcomes. ECHILD is the first dataset to hold longitudinal school, health and social care data on all pupils in England, obtained by linking the National Pupil Database (NPD) with Hospital Episode Statistics (HES). In this protocol, we describe how the ECHILD dataset could be used to explore and conduct a target trial emulation to evaluate whether children who were born with cleft lip and palate would have different unplanned hospital utilisation if they received or did not receive SEN provisions by Year 1 (specifically by January in their second year of school) when they are aged 5 or 6. Methods Focussing on the population of children who are identified as having been born with cleft lip and palate, an intervention of varying levels of SEN provision (including no SEN provision) by January of the second year of school, and an outcome of unplanned hospital utilisation, we apply a trial emulation design to reduce confounding when using observational data to investigate the causal impact of SEN on unplanned hospital admissions. Our target population is children born 2001-2014 who had a recording of cleft lip and palate in HES and who started their second year of primary school (Year 1) in a state school between 2006 and 2019; children with a first recording of cleft lip and palate after Year 1 were excluded (these were pupils who likely immigrated to England after birth). We intend to use a time window of SEN provision assignment between the start of school (reception) and by the January school census in Year 1. Using target trial emulation, we aim to estimate the average treatment effect of SEN provision on the number of unplanned hospital admissions (including admissions to accident and emergency) between the January school census in Year 1 and Year 6 (the end of primary school, when children are 10-11 years old). Ethics and dissemination Permissions to use linked, de-identified data from Hospital Episode Statistics and the National Public Database were granted by DfE (DR200604.02B) and NHS Digital (DARS-NIC-381972). Ethical approval for the ECHILD project was granted by the National Research Ethics Service (17/LO/1494), NHS Health Research Authority Research Ethics Committee (20/EE/0180) and UCL Great Ormond Street Institute of Child Health Joint Research and Development Office (20PE06). Stakeholders (academics, clinicians, educators and child/young people advocacy groups) will consistently be consulted to refine populations, interventions and outcomes of studies that use the ECHILD dataset to conduct target trial emulation. Scientific, lay and policy briefings will be produced to inform public health policy through partners in the Department of Education and the Department of Health and Social Care.