Background: The 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. Methods: Regional, 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. Results: Of 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. Conclusion: European 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.

Aims To evaluate the extent to which publication of high-quality randomised controlled trials(RCTs) in 2018 was associated with a change in volume or trend of subacromial decompression(SAD) surgery in patients with subacromial pain syndrome(SAPS) treated in hospitals across various countries. Methods Routinely collected administrative data of the Global Health Data@work collaborative were used to identify SAPS patients who underwent SAD surgery in six hospitals from five countries (Australia, Belgium, Netherlands, United Kingdom, United States) between 01/2016 and 02/2020. Following a controlled interrupted time series design, segmented Poisson regression was used to compare trends in monthly SAD surgeries before(01/2016-01/2018) and after(02/2018-02/2020) publication of the RCTs. The control group consisted of musculoskeletal patients undergoing other procedures. Results A total of 3.046 SAD surgeries were performed among SAPS patients treated in five hospitals; one hospital did not perform any SAD surgeries. Overall, publication of trial results was associated with a significant reduction in the trend to use SAD surgery of 2% per month (Incidence rate ratio (IRR) 0.984[0.971–0.998]; P = 0.021), but with large variation between hospitals. No changes in the control group were observed. However, publication of trial results was also associated with a 2% monthly increased trend (IRR 1.019[1.004–1.034]; P = 0.014) towards other procedures performed in SAPS patients. Conclusion Publication of RCT results was associated with a significantly decreased trend in SAD surgery for SAPS patients, although large variation between participating hospitals existed and a possible shift in coding practices cannot be ruled out. This highlights the complexities of implementing recommendations to change routine clinical practice even if based on high-quality evidence.

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