A machine learning framework to adjust for learning effects in medical device safety evaluation.
Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning curves, and time-varying covariates, such as physician experience. To address these limitations, we sought to develop a machine learning (ML) framework to detect and adjust for operator learning effects.
Author(s): Koola, Jejo D, Ramesh, Karthik, Mao, Jialin, Ahn, Minyoung, Davis, Sharon E, Govindarajulu, Usha, Perkins, Amy M, Westerman, Dax, Ssemaganda, Henry, Speroff, Theodore, Ohno-Machado, Lucila, Ramsay, Craig R, Sedrakyan, Art, Resnic, Frederic S, Matheny, Michael E
DOI: 10.1093/jamia/ocae273