Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks

Art Sedrakyan, Department of Population Health Sciences; Medical Devices Epidemiology Network (MDEpiNet) Coordinating Center, Weill Cornell Medical College, New York, New York, USA.
Danica Marinac-Dabic, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
Bruce Campbell, Vascular Surgery, University of Exeter Medical School, Exter, UK.
Suvekshya Aryal, Department of Population Health Sciences; Medical Devices Epidemiology Network (MDEpiNet) Coordinating Center, Weill Cornell Medical College, New York, New York, USA.
Courtney E. Baird, Health Services, Policy and Practice, Brown University School of Public Health, Providence, Rhode Island, USA.
Philip Goodney, Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Jack L. Cronenwett, Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Adam W. Beck, Division of Vascular Surgery and Endovascular Therapy, University of Alabama, Birmingham, Alabama, USA.
Elizabeth W. Paxton, Surgical Outcomes and Analysis, Kaiser Permanente, Harbor City, California, USA.
Jim Hu, Department of Urology, Weill Cornell Medical College, New York, New York, USA.
Ralph Brindis, Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, USA.
Kevin Baskin, Vascular and Interventional Radiology, Conemaugh Memorial Medical Center, Johnstown, Pennsylvania, USA.
Terrie Cowley, The TMJ Association, Milwaukee, Wisconsin, USA.
Jeffery Levy, Robotic Surgery, Institute of Surgical Excellence, Philadelphia, Pennsylvania, USA.
David S. Liebeskind, Department of Neurology, Stroke Center, University of California Los Angeles, Los Angeles, California, USA.
Benjamin K. Poulose, Center for Abdominal Core Health, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Charles R. Rardin, Department of Obstetrics and Gyencology, Women and Infants Hospital of Rhode Island, Providence, Rhode Island, USA.
Frederic S. Resnic, Department of Cardiology, Comparative Effective Research Institute, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.

Abstract

Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design setting and participants: We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures: Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results: Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions: We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.