SynthesisInternational journal of health policy and management2023
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.
Synthesis in International journal of health policy and management, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 22 citations in OpenAlex.
- Public Reporting Systems in Health Care and the Underconceptualized Technical Substrate, a Core Information Systems Dimension: Scoping Review.JMIR medical informatics · 2026Article
- From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development.JOR spine · 2026Review
- Flexible wearable medical devices: from material innovations and data processing to intelligent healthcare applications.Journal of advanced research · 2026Review
- Advancing Public Health Through Internationally Coordinated Medical Device Registries Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".International journal of health policy and management · 2026Article
- Analysis of the challenges in ensuring robust and effective clinical evaluation of AI-based digital medical devices.BMJ digital health & AI · 2026Review
- Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project.The Lancet regional health. Europe · 2025Review
- Developing a Classification of Spinal Medical Devices: Has the Time Come? Review of the Literature and a Proposal for Spine Registries.Bioengineering (Basel, Switzerland) · 2025Article
- Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses.Acta orthopaedica · 2025Article
- Cumulative risk of revision after primary total hip arthroplasty in registries internationally: systematic review and meta-analysis of selected hip stems and cups.EFORT open reviews · 2025Article
- Pooling data for primary total knee implants across national registries: is the same implant used in multiple registries and for the same patient group? An observational study.Acta orthopaedica · 2025Observational
- Article
- Arthroplasty registries at a glance: an initiative of the International Society of Arthroplasty Registries (ISAR) to facilitate access, understanding, and reporting of registry data from an international perspective.Acta orthopaedica · 2025Article
- A Prospective Clinical Study to Evaluate Safety and Performance of an Intra-Surgical Hydraulic Distractor During Spinal Surgeries.Medical devices (Auckland, N.Z.) · 2025Article
- Scoping review on regulation, implementation and postmarket surveillance of medical devices.PloS one · 2025Article
- Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.BMJ surgery, interventions, & health technologies · 2025Article
- From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".International journal of health policy and management · 2025Article
- Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.Acta orthopaedica · 2024Article
- Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.EFORT open reviews · 2023Article
- Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory.REC, interventional cardiologyReview
Corrections and comments
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Authors and funding
16 authors at 10 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.
methodsRegional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.
resultsOf the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.
conclusionEuropean cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.