Sparsely clustered survival data: application to the evaluation of the safety and effectiveness of medical devices

Abstract

ABSTRACTThe effectiveness and safety of implantable medical devices is a critical public health concern. We consider analysis of data in which it is of interest to compare devices but some individuals may be implanted with two or more devices. Our motivating example is based on orthopedic devices, where the same individual can be implanted with as many as two devices for the same joint but on different sides of the body, referred to as bilateral cases. Different methods of analysis are considered in a simulation study and real data example, including both marginal and conditional survival models, fitting single and separate models for bilateral and non-bilateral cases, and combining estimates from these two models. The results of simulations suggest that in the context of orthopedic devices, where implants failures are rare, models fit on both bilateral and non-bilateral cases simultaneously could be quite misleading, and that combined estimates from fitting two separate models performed better under homogeneity. A real data example illustrates the issues surrounding analysis of orthopedic device data with bilateral cases. Our findings suggest that research studies of orthopedic devices should at minimum consider fitting separate models to bilateral and non-bilateral cases.