Abstract
Improving the quality of care for hip arthroplasty (replacement) patients requires the systematic evaluation of clinical performance of implants and the identification of “outlier” devices that have an especially high risk of reoperation (“revision”). Postmarket surveillance of arthroplasty implants, which rests on the analysis of large patient registries, has been effective in identifying outlier implants such as the ASR metal-on-metal hip resurfacing device that was recalled. Although identifying an implant as an outlier implies a causal relationship between the implant and revision risk, traditional signal detection methods use classical biostatistical methods. The field of probabilistic graphical modeling of causal relationships has developed tools for rigorous analysis of causal relationships in observational data. The purpose of this study was to evaluate one causal discovery algorithm (PC) to determine its suitability for hip arthroplasty implant signal detection. Simulated data were generated using distributions of patient and implant characteristics, and causal discovery was performed using the TETRAD software package. Two sizes of registries were simulated: (1) a statewide registry in Michigan and (2) a nationwide registry in the United Kingdom. The results showed that the algorithm performed better for the simulation of a large national registry. The conclusion is that the causal discovery algorithm used in this study may be a useful tool for implant signal detection for large arthroplasty registries; regional registries may only be able to only detect implants that perform especially poorly.
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