Maternal and Infant Research Electronic Data Analysis (MIREDA): A protocol for creating a common data model for federated analysis of UK birth cohorts and the life course.

Introduction Birth cohorts are valuable resources for studying early life, the determinants of health, disease, and development. They are essential for studying life course. Electronic cohorts are live, dynamic longitudinal cohorts using anonymised, routinely collected data. There is no selection bias through direct recruitment, but they are limited to health and administrative system data and may lack contextual information. The MIREDA (Maternal and Infant Research Electronic Data Analysis) partnership creates a UK-wide birth cohort by aligning existing electronic birth cohorts to have the same structure, content, and vocabularies, enabling UK-wide federated analyses. Objectives 1) Create a core dynamic, live UK-wide electronic birth cohort with approximately 100,000 new births per year using a common data model (CDM). 2) Provide data linkage and automation for long-term follow up of births from MuM-PreDiCT and the Born-in initiatives of Bradford, Wales, Scotland, and South London for comparable analyses. Methods We will establish core data content and collate linkable data. Use a suite of extraction, transformation, and load (ETL) tools will be used to transform the data for each birth cohort into the CDM. Transformed datasets will remain within each cohorts trusted research environment (TRE). Metadata will be uploaded for the public to the Health Data Research (HDRUK) Innovation Gateway. We will develop a single online data access request for researchers. A cohort profile will be developed for researchers to reference the resource. Ethics Each cohort has approval from their TRE through compliance with their project application processes and information governance. Dissemination We will engage with researchers in the field to promote our resource through partnership networking, publication, research collaborations, conferences, social media, and marketing communications strategies. Keywords: Birth Cohort, Life Course Perspective, Data Science, Data Curation, Routinely Collected Health Data, Electronic Health Records, Unified Medical Language System. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by an MRC Partnership Grant [MR/X02055X/1], MatCHNet pump-priming [U20005/302873] and an MRC Programme Grant [MR/X009742/1]. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Access to data is granted according to the information governance requirements of each TRE. The Data Protection Act 2018 is not applicable to anonymised data and the OMOP CDM will be anonymised and provide aggregated data and statistics only. Each TRE has ethical approval for its operation and use, thus no additional ethical approval was required beyond the standard project approval by official channels. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data will be available upon reasonable request through the Health Data Research (HDRUK) Innovation Gateway.