{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Medical Statistics Group, University of Plymouth, Plymouth, UK"
      ],
      "name": "Crispin Musicha"
    },
    {
      "affiliations": [
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Helen Neilens"
    },
    {
      "affiliations": [
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Emily Stanyard"
    },
    {
      "affiliations": [
        "Medical Statistics Group, University of Plymouth, Plymouth, UK",
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Victoria Allgar"
    },
    {
      "affiliations": [
        "Medical Statistics Group, University of Plymouth, Plymouth, UK"
      ],
      "name": "Joe Lomax"
    },
    {
      "affiliations": [
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Ryan Ashford"
    },
    {
      "affiliations": [
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Helen Hambly"
    },
    {
      "affiliations": [
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Paigan Aspinall"
    },
    {
      "affiliations": [
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Emma O’Shaughnessy"
    },
    {
      "affiliations": [
        "Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK"
      ],
      "name": "Chris Rollinson"
    },
    {
      "affiliations": [
        "Cornwall Intellectual Disability Equitable Research (CIDER), Peninsula School of Medicine, University of Plymouth, Plymouth, UK",
        "Cornwall Partnership NHS Foundation Trust, Bodmin, UK"
      ],
      "name": "Sarah Lennard"
    },
    {
      "affiliations": [
        "Cornwall Intellectual Disability Equitable Research (CIDER), Peninsula School of Medicine, University of Plymouth, Plymouth, UK",
        "Cornwall Partnership NHS Foundation Trust, Bodmin, UK",
        "Royal Cornwall Hospitals NHS Trust, Truro, UK"
      ],
      "name": "Brendan Mclean"
    },
    {
      "affiliations": [
        "National Centre for Mental Health, Cardiff, UK"
      ],
      "name": "Anna Simpson"
    },
    {
      "affiliations": [
        "Medical School, University of Exeter, Exeter, UK",
        "NIHR Exeter Biomedical Research Centre, Exeter, UK"
      ],
      "name": "Pamela Bowman"
    },
    {
      "affiliations": [
        "Royal Free Hampstead NHS Trust, London, UK",
        "UCL Queen Square Institute of Neurology & St Mary’s University, London, UK"
      ],
      "name": "Heather Angus-Leppan"
    },
    {
      "affiliations": [
        "Cornwall Intellectual Disability Equitable Research (CIDER), Peninsula School of Medicine, University of Plymouth, Plymouth, UK",
        "Swansea Bay UHB – Psychiatry of Learning Disability, Swansea, UK"
      ],
      "name": "Lance Watkins"
    },
    {
      "affiliations": [
        "Cornwall Intellectual Disability Equitable Research (CIDER), Peninsula School of Medicine, University of Plymouth, Plymouth, UK",
        "Cornwall Partnership NHS Foundation Trust, Bodmin, UK"
      ],
      "name": "Richard Laugharne"
    },
    {
      "affiliations": [
        "Cornwall Intellectual Disability Equitable Research (CIDER), Peninsula School of Medicine, University of Plymouth, Plymouth, UK",
        "Cornwall Partnership NHS Foundation Trust, Bodmin, UK"
      ],
      "name": "Jon Allard"
    },
    {
      "affiliations": [
        "Cornwall Partnership NHS Foundation Trust, Bodmin, UK",
        "Peninsula School of Medicine, University of Plymouth, Plymouth, UK"
      ],
      "name": "Rohit Shankar"
    }
  ],
  "title": "Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol",
  "uid": "167ab3c1-8c17-5dae-82eb-ce2f3da94e08"
}