Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance
Reporting all items from the minimum checklist will facilitate judgment of the utility of registry data to evaluate medical devices during post-market surveillance.
Authors
- Robert E. Geertsma (ORCID: https://orcid.org/0000-0003-0979-9077)
- Lotje A. Hoogervorst (ORCID: https://orcid.org/0000-0001-5343-6965)
- Søren Overgaard (ORCID: https://orcid.org/0000-0001-6829-4787)
- Chris Wilkinson (ORCID: https://orcid.org/0000-0003-0748-0150)
- Rob G. H. H. Nelissen (ORCID: https://orcid.org/0000-0003-1228-4162)
- Donal B O’Connor (ORCID: https://orcid.org/0000-0001-5475-8675)
- Perla J. Marang‐van de Mheen (ORCID: https://orcid.org/0000-0003-1439-0989)
- Alan G. Fraser (ORCID: https://orcid.org/0000-0001-7083-6995)
- Chris P Gale (ORCID: https://orcid.org/0000-0003-4732-382X)
- David Epstein
- Anne Lübbeke (ORCID: https://orcid.org/0000-0002-6905-6120)
- Paul Piscoi
- Maziar Mohaddes (ORCID: https://orcid.org/0000-0003-1848-9054)
- Tom Melvin (ORCID: https://orcid.org/0000-0001-6370-4177)
- Piotr Szymański (ORCID: https://orcid.org/0000-0001-9486-7892)
- Phil Walmsley
- Joëlle M. Hoebert
Institutions
- Leiden University (NL)
- University of Copenhagen (DK)
- University of Leeds (GB)
- University of St Andrews (GB)
- Universidad de Granada (ES)
- Trinity College Dublin (IE)
- Leeds Teaching Hospitals NHS Trust (GB)
- Leiden University Medical Center (NL)
- University Hospital of Wales (GB)
- Sahlgrenska University Hospital (SE)
- James Cook University Hospital (GB)
- Directorate-General for Health and Food Safety (BE)
- Nuffield Orthopaedic Centre (GB)
- Copenhagen University Hospital (DK)
- University of Oxford (GB)
- Hässleholms Sjukhus (SE)
- Health and Safety Authority (IE)
- National Institute for Public Health and the Environment (NL)
- University Hospital of Geneva (CH)
- Victoria Hospital (GB)
- Postgraduate School of Molecular Medicine (PL)
- Institute of Cardiology (PL)
- Narodowy Instytut Leków (PL)
- University of York (GB)
- Hull York Medical School (GB)
- University of Gothenburg (SE)
- Delft University of Technology (NL)
Publication Details
- Journal
- BMJ Surgery Interventions & Health Technologies
- Published
- 2025-10-01
- DOI
- https://doi.org/10.1136/bmjsit-2024-000364
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- European Commission