ORCID

Abstract

Introduction This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.Methods and analysis A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.Ethics and dissemination Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.Trial registration number NCT06780501.

Publication Date

2025-11-26

Publication Title

BMJ Open

Volume

15

Issue

11

ISSN

2044-6055

Acceptance Date

2025-10-23

Deposit Date

2025-11-27

Funding

This work is being funded by Jazz Pharmaceuticals. PB is supported by the National Institute for Health and Care Research (NIHR) Exeter Biomedical Research Centre (BRC). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare the following: PB has received research grants from the NIHR and the Academy of Medical Sciences. RL has been a chief investigator for studies funded by Jansson and Boehringer Ingelheim. VA is a member of the statistical advisory board of BMJ Open. She did not take part in the review or decision-making process of this paper. RS has received research grants from the NIHR, EPSRC, Innovate Biocatalyst, Jazz, SBRI, Innovate UK, Baily Thomas Charitable Fund, Angelini, ESRC and LivaNova. LW has been paid speaker fees outside this work from UCB Pharma. RS has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing or educational events from LivaNova, UCB, Eisai, Neuraxpharm, Veriton Pharma, Bial, Angelini, UnEEG, Jazz/GW Pharma. RS participates on a data safety monitoring board or advisory board for LivaNova, UCB, Eisai, Neuraxpharm, Veriton, Pharma, Bial, Angelini, UnEEG and Jazz/GW Pharma.

Keywords

Schizophrenia & psychotic disorders, Epilepsy, Prescriptions

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