Establishing a national linked database for fetal alcohol spectrum disorder (FASD) in the UK: multi-method public and professional involvement to determine acceptability and feasibility

Objective: to conduct public and professional involvement work to establish stakeholder views on the feasibility, acceptability, key purposes, and design of a national linked longitudinal research database for fetal alcohol spectrum disorder (FASD) in the UK.  Methods: Following stakeholder-mapping, we identified contributors through collaborator networks and online searches. We consulted with stakeholders using online workshops (one for adults with FASD [and their supporters] N=5; one for caregivers of people with FASD N=7), 1:1/small-team video calls/email communication twith clinicians, policymakers, data-governance experts, third-sector representatives, and researchers [N=35]), and one hybrid clinical workshop (N=17). Discussions covered data availability, benefits, challenges, and design preferences for a national pseudonymised linked database for FASD. We derived key themes from the notes and recordings collected across all involvement activities.   Results: Our tailored, multi-method approach generated high levels of stakeholder engagement. Stakeholders expressed strong support for a pseudonymised national linked database for FASD. Key anticipated benefits were the potential for: increased awareness and understanding of FASD, leading to better support; new insights into clinical profiles, leading to greater diagnostic efficiency; facilitating international collaboration; and increased knowledge of the long-term impacts of FASD on health, social care, education, economic and criminal justice outcomes. Policymakers noted clear alignment with contemporary FASD and digital transformation priorities. Given the rich data infrastructure established in the UK, stakeholders expressed that a national linked FASD database could be world-leading. Common stakeholder concerns were around privacy and data-sharing and the importance of retaining space for clinical judgement alongside insights gained from quantitative analyses. Conclusions: Multi-method and multidisciplinary public and professional involvement activities demonstrated the feasibility and acceptability of establishing a national linked database for FASD in the UK. Perceived benefits and challenges varied by stakeholder group, demonstrating that flexible, diverse, embedded stakeholder collaboration will be essential as we establish this database. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was funded by Jean Golding Institute (JGI) Seed Corn Funding (awarded to CM for PPI activities with professional stakeholders), Elizabeth Blackwell PPI funding through the Wellcome Trust Grant 204813/Z/16/Z (awarded to CM for lived experience workshops) and for National Institute for Health Research Biomedical Research Centre in Bristol (for project team data expertise funding and conference attendance) this funded SH and BS to do this work and SH was additionally supported by National Institute for Health Research Applied Research Collaboration West (NIHR ARC West). During this work, CM was supported by the National Institute for Health and Care Research (NIHR) School for Public Health Research (SPHR) (Grant Reference Number PD-SPH-2015). AB was additionally supported by the Health Data Research UK (Ref: HDRUK2023) which is the UKs Health Data Research institute (which is funded by UK Research and Innovation, the Medical Research Council, the British Heart Foundation, Cancer Research UK, the National Institute for Health and Care Research, the Economic and Social Research Council, the Engineering and Physical Sciences Research Council, Health and Care Research Wales, Health and Social Care Research and Development Division (Public Health Agency, Northern Ireland), Chief Scientist Office of the Scottish Government Health and Social Care Directorate). SB was employed by The National Organisation for FASD and supported by the Sylvia Adams Charitable Trust, Four Acres Trust, Contact/Pears, Diageo and other supporters. PC was supported by the NIHR and the Oglesby Charitable Trust and the University of Salford. RM was primarily funded by the NHS but also receives funding from NIHR and Ogelsby Trust for FASD. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes 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 All data produced in the present study are available upon reasonable request to the authors