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

Art Sedrakyan; Danica Marinac-Dabic; Bruce Campbell; Suvekshya Aryal; Courtney E Baird; Philip Goodney; Jack L Cronenwett; Adam W Beck; Elizabeth W Paxton; Jim Hu; Ralph Brindis; Kevin Baskin; Terrie Cowley; Jeffery Levy; David S Liebeskind; Benjamin K Poulose; Charles R Rardin; Frederic S Resnic; James Tcheng; Benjamin Fisher; Charles Viviano; Vincent Devlin; Murray Sheldon; Jens Eldrup-Jorgensen; Jesse A Berlin; Joseph Drozda; Michael E Matheny; Sanket S Dhruva; Timothy Feeney; Kristi Mitchell; Gregory Pappas

doi:10.1136/bmjsit-2021-000123

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

BMJ Surg Interv Health Technol. 2022 Nov 11;4(Suppl 1):e000123. doi: 10.1136/bmjsit-2021-000123. eCollection 2022.

Authors

Art Sedrakyan¹, Danica Marinac-Dabic², Bruce Campbell³, Suvekshya Aryal¹, Courtney E Baird⁴, Philip Goodney⁵, Jack L Cronenwett⁵, Adam W Beck⁶, Elizabeth W Paxton⁷, Jim Hu⁸, Ralph Brindis⁹, Kevin Baskin¹⁰, Terrie Cowley¹¹, Jeffery Levy¹², David S Liebeskind¹³, Benjamin K Poulose¹⁴, Charles R Rardin¹⁵, Frederic S Resnic¹⁶, James Tcheng¹⁷, Benjamin Fisher², Charles Viviano², Vincent Devlin², Murray Sheldon², Jens Eldrup-Jorgensen^{18

19}, Jesse A Berlin²⁰, Joseph Drozda²¹, Michael E Matheny²², Sanket S Dhruva²³, Timothy Feeney²⁴, Kristi Mitchell²⁵, Gregory Pappas²⁶

Affiliations

¹ Department of Population Health Sciences; Medical Devices Epidemiology Network (MDEpiNet) Coordinating Center, Weill Cornell Medical College, New York, New York, USA.
² Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
³ Vascular Surgery, University of Exeter Medical School, Exter, UK.
⁴ Health Services, Policy and Practice, Brown University School of Public Health, Providence, Rhode Island, USA.
⁵ Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
⁶ Division of Vascular Surgery and Endovascular Therapy, University of Alabama, Birmingham, Alabama, USA.
⁷ Surgical Outcomes and Analysis, Kaiser Permanente, Harbor City, California, USA.
⁸ Department of Urology, Weill Cornell Medical College, New York, New York, USA.
⁹ Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, USA.
¹⁰ Vascular and Interventional Radiology, Conemaugh Memorial Medical Center, Johnstown, Pennsylvania, USA.
¹¹ The TMJ Association, Milwaukee, Wisconsin, USA.
¹² Robotic Surgery, Institute of Surgical Excellence, Philadelphia, Pennsylvania, USA.
¹³ Department of Neurology, Stroke Center, University of California Los Angeles, Los Angeles, California, USA.
¹⁴ Center for Abdominal Core Health, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
¹⁵ Department of Obstetrics and Gyencology, Women and Infants Hospital of Rhode Island, Providence, Rhode Island, USA.
¹⁶ Department of Cardiology, Comparative Effective Research Institute, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.
¹⁷ Department of Medicine, Division of Cardiology, Duke University, Durham, North Carolina, USA.
¹⁸ Vascular Surgery, Maine Medical Center, Portland, Maine, USA.
¹⁹ Surgery, Tufts University School of Medicine, Boston, Massachusetts, USA.
²⁰ Global Epidemiology, Johnson and Johnson Limited, New Brunswick, New Jersey, USA.
²¹ Outcomes Research, Mercy Health, St. Louis, Missouri, USA.
²² Department of Biomedical Informatics and Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
²³ Department of Medicine, University of California San Francisco School of Medicine, San Francisco, California, USA.
²⁴ Department of Surgery, Boston University, Boston, Massachusetts, USA.
²⁵ Health Equity Outcomes, Avalere Health, Washington, DC, USA.
²⁶ Center for Biologicals Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, Maryland, 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.

Keywords: device safety; device surveillance; health care quality, access, and evaluation; health technology; real world evidence.

Grants and funding

U01 FD006936/FD/FDA HHS/United States