title: A distributed health data network analysis of survival outcomes: the International Consortium of Orthopaedic Registries perspective.
abstract: The International Consortium for Orthopaedic Registries is a multinational initiative established by the United States Food and Drug Administration to develop a health data network aimed at providing a robust infrastructure to facilitate evidence-based decision-making on performance of medical devices. Through the International Consortium for Orthopaedic Registries, individual data holders have complete control of their data and can choose to participate in studies of their choice. In this article, we present an overview of the data extraction process and the analytic strategy employed to answer several device performance-related questions in total hip arthroplasty and total knee arthroplasty. In the process, we discuss some nuances pertinent to International Consortium for Orthopaedic Registries data that pose certain statistical challenges, and we briefly suggest strategies to be adopted to address them.
authors.affiliation: Weill Cornell Medical College, 402 East 67th Street, New York, NY 10065.
authors.forename: Samprit
authors.initials: S
authors.lastname: Banerjee
authors.affiliation: Surgical Outcomes & Analysis Department, Kaiser Permanente, 8954 Rio San Diego Drive, Suite 406, San Diego, CA 92108.
authors.forename: Guy
authors.initials: G
authors.lastname: Cafri
authors.affiliation: Weill Cornell Medical College, 402 East 67th Street, New York, NY 10065.
authors.forename: Abby J
authors.initials: AJ
authors.lastname: Isaacs
authors.affiliation: Australian Orthopaedic Association National Joint Replacement Registry, Discipline of Public Health, MDP DX 650 511, University of Adelaide, Adelaide, SA 5005, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Graves
authors.affiliation: Surgical Outcomes & Analysis Department, Kaiser Permanente, 8954 Rio San Diego Drive, Suite 406, San Diego, CA 92108.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Paxton
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.affiliation: Weill Cornell Medical College, 402 East 67th Street, New York, NY 10065.
authors.forename: Art
authors.initials: A
authors.lastname: Sedrakyan
mesh_terms: D019644:Arthroplasty, Replacement, Hip; D019645:Arthroplasty, Replacement, Knee; D057225:Data Mining; D006622:Hip Prosthesis; D006801:Humans; D007720:Knee Prosthesis; D009985:Orthopedics; D011474:Prosthesis Design; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration