@article {Ruiz Nishikie001341, author = {Milagros Ruiz Nishiki and Melissa Cabecinha and Rachel Knowles and Catherine Peters and Helen Aitkenhead and Adeboye Ifederu and Nadia Schoenmakers and Neil J Sebire and Erin Walker and Pia Hardelid}, title = {Establishing risk factors and outcomes for congenital hypothyroidism with gland in situ using population-based data linkage methods: study protocol}, volume = {6}, number = {1}, elocation-id = {e001341}, year = {2022}, doi = {10.1136/bmjpo-2021-001341}, publisher = {BMJ Specialist Journals}, abstract = {Introduction There has been an increase in the birth prevalence of congenital hypothyroidism (CH) since the introduction of newborn screening, both globally and in the UK. This increase can be accounted for by an increase in CH with gland in situ (CH-GIS). It is not known why CH-GIS is becoming more common, nor how it affects the health, development and learning of children over the long term. Our study will use linked administrative health, education and clinical data to determine risk factors for CH-GIS and describe long-term health and education outcomes for affected children.Methods and analysis We will construct a birth cohort study based on linked, administrative data to determine what factors have contributed to the increase in the birth prevalence of CH-GIS in the UK. We will also set up a follow-up study of cases and controls to determine the health and education outcomes of children with and without CH-GIS. We will use logistic/multinomial regression models to establish risk factors for CH-GIS. Changes in the prevalence of risk factors over time will help to explain the increase in birth prevalence of CH-GIS. Multivariable generalised linear models or Cox proportional hazards regression models will be used to assess the association between type of CH and school performance or health outcomes.Ethics and dissemination This study has been approved by the London Queen Square Research Ethics Committee and the Health Research Authority{\textquoteright}s Confidentiality Advisory Group CAG. Approvals are also being sought from each data provider. Obtaining approvals from CAG, data providers and information governance bodies have caused considerable delays to the project. Our methods and findings will be published in peer-reviewed journals and presented at academic conferences.No data are available. Not applicable.}, URL = {https://bmjpaedsopen.bmj.com/content/6/1/e001341}, eprint = {https://bmjpaedsopen.bmj.com/content/6/1/e001341.full.pdf}, journal = {BMJ Paediatrics Open} }