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Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.

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第一作者: Lotje A,Hoogervorst
第一单位: Department of Orthopaedics, Leiden Universitair Medisch Centrum, Leiden, The Netherlands.
作者单位: Department of Orthopaedics, Leiden Universitair Medisch Centrum, Leiden, The Netherlands. [1] Trinity College Dublin School of Medicine, Dublin, Ireland. [2] Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium. [3] Academic Cardiovascular Unit, James Cook University Hospital, Middlesbrough, UK.;Hull York Medical School, University of York, York, UK. [4] Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals, Geneva, Switzerland.;Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. [5] Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.;Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.;Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK. [6] Department of Applied Economics, University of Granada, Granada, Spain. [7] Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital, Copenhagen, Denmark.;Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. [8] School of Medicine, University of St Andrews, St Andrews, UK.;Department of Orthopaedic Surgery, Victoria Hospital Kirkcaldy, Kircaldy, UK. [9] Centre for Postgraduate Medical Education, Warsaw, Poland.;Clinical Cardiology Center, National Medicines Institute, Warsaw, Poland. [10] Department of Orthopaedics, University of Gothenburg Institute of Clinical Sciences, Gothenburg, Sweden.;Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden.;Department of Orthopaedics, Hässleholms Hosptial, Skane, Sweden. [11] Health Products Regulatory Authority, Dublin, Ireland.;Department of Surgery, Trinity College Dublin School of Medicine, Dublin, Ireland. [12] Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands. [13] Department of Cardiology, University Hospital of Wales, Cardiff, UK. [14] Safety & Security Science and Centre for Safety in Healthcare, Delft University of Technology, Delft, The Netherlands. [15]
DOI 10.1136/bmjsit-2024-000364
PMID 41180830
发布时间 2025-11-03
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BMJ surgery, interventions, & health technologies

BMJ surgery, interventions, & health technologies

2025年7卷1期

e000364页

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