This Test-Case used real-world evidence (RWE) in registries and claims data to explore OPC measures.
Dr. Art Sedrakyan, professor at Weill Cornell Medicine and Director of Medical Device Epidemiology Network’s (MDEpiNet) Coordinating Center, outlined the goals of this Test-Case and the data sources used in his presentation. “We had two goals; first, to develop performance criteria for all cause and cause-specific revisions for two years following primary hip and knee replacements. We used data from Kaiser Permanente and FORCE-TJR registry. We used claims data from the states of New York and California. We also performed a systematic analysis of literature by extracting data from studies conducted in the U.S. over the past ten years. The second goal was to use and develop objective performance criteria for patient-reported outcome measures at two years using the FORCE-TJR registry and literature data.”
Dr. Elizabeth Paxton, Director of Surgical Outcomes at Kaiser Permanente, presented on the registry evaluations for safety and effectiveness. Dr. Paxton noted, “For total hip replacements for all patients, the overall two-year revision rate was 2.1%. We also looked at age and gender; females had a slightly higher rate of revision, which was predominant in the younger age group.”
Figure 1 – Registry Data: Two-Year Revision Rate (Kaiser)