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

Crispin Musicha ¹, Helen Neilens ², Emily Stanyard ²

¹Medical Statistics Group, University of Plymouth, Plymouth, UK.
²Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.
³Cornwall Intellectual Disability Equitable Research (CIDER), Peninsula School of Medicine, University of Plymouth, Plymouth, UK.
⁴Cornwall Partnership NHS Foundation Trust, Bodmin, UK.
⁵Royal Cornwall Hospitals NHS Trust, Truro, UK.
⁶National Centre for Mental Health, Cardiff, UK.
⁷Medical School, University of Exeter, Exeter, UK.
⁸NIHR Exeter Biomedical Research Centre, Exeter, UK.
⁹Royal Free Hampstead NHS Trust, London, UK.
¹⁰UCL Queen Square Institute of Neurology & St Mary's University, London, UK.
¹¹Swansea Bay UHB - Psychiatry of Learning Disability, Swansea, UK.
¹²Cornwall Partnership NHS Foundation Trust, Bodmin, UK rohit.shankar@plymouth.ac.uk.
¹³Peninsula School of Medicine, University of Plymouth, Plymouth, UK.

⁰Medical Statistics Group, University of Plymouth, Plymouth, UK.

Bmj Open +

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November 26, 2025

View abstract on PubMed

Summary

This study assesses the feasibility of creating a de-identified database and research register for individuals with intellectual disabilities and epilepsy. The project aims to systematically collect and analyze clinical data for better monitoring and reporting.

Area Of Science

Neuroscience and Clinical Data Management
Intellectual Disabilities Research
Epilepsy Clinical Data Analysis

Background

Establishing a de-identified database (DiD) and Research Register (RR) is crucial for collecting and analyzing clinical data in individuals with intellectual disabilities (PwIDs) and epilepsy.
Existing data collection methods may lack systematic approaches for this specific patient population.
There is a need for a centralized, de-identified repository to facilitate research and improve patient care.

Purpose Of The Study

To explore the feasibility of establishing a de-identified database (DiD) and a Research Register (RR).
To systematically collect, analyze, monitor, and report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.
To determine the potential for creating a national register based on project outcomes.

Main Methods

A multicentre project involving three adult intellectual disability specialist services in England and Wales.
De-identified data collection from clinical records for the DiD, and development of an RR for PwID with epilepsy.
Utilizing Research Electronic Data Capture (REDCap) for data entry and descriptive statistics for feasibility outcomes analysis.

Main Results

Feasibility outcomes such as screening and recruitment rates will be summarized using descriptive statistics.
Participant characteristics, including demographics, ID classification, clinical history, epilepsy history, and antiseizure medication, will be descriptively summarized.
Progression to a national register will be assessed using Red/Amber/Green stop-go criteria.

Conclusions

The project's findings will inform the potential establishment of a national register for PwID and epilepsy.
Successful implementation of the DiD and RR could significantly enhance research capabilities in this field.
The study provides a framework for systematic data collection and analysis in a vulnerable patient group.

Keywords:

Epilepsy Prescriptions Schizophrenia & psychotic disorders