Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol

Musicha, Crispin, Neilens, Helen, Stanyard, Emily, Allgar, Victoria, Lomax, Joe, Ashford, Ryan, Hambly, Helen, Aspinall, Paigan, O’Shaughnessy, Emma, Rollinson, Chris, Lennard, Sarah, Mclean, Brendan, Simpson, Anna, Bowman, Pamela, Angus-Leppan, Heather, Watkins, Lance, Laugharne, Richard, Allard, Jon and Shankar, Rohit 2025. Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol. BMJ Open 15 (11) , e108869. 10.1136/bmjopen-2025-108869

PDF - Published Version Download (547kB)

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.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Schools > Medicine Research Institutes & Centres > National Centre for Mental Health (NCMH)
Additional Information:	License information from Publisher: LICENSE 1: URL: https://creativecommons.org/licenses/by-nc/4.0/, Start Date: 2025-11-26, Type: open-access
Publisher:	BMJ Publishing Group
Date of First Compliant Deposit:	12 May 2026
Date of Acceptance:	23 October 2025
Last Modified:	12 May 2026 10:45
URI:	https://orca.cardiff.ac.uk/id/eprint/186954

Actions (repository staff only)

Edit Item