Abstrakt

Development of objective performance goals for peripheral vascular interventions using real world data sources

Daniel J. Bertges

Objective Performance Goals (OPGs) and Objective Performance Criteria (OPCs) are intended to guide regulatory decisions of medical devices, inform clinical trial designs and may help inform clinical practice guidelines. In the Peripheral Vascular Intervention (PVI) space the wide variety of devices and evolving technologies have made OPC and OPG development challenging. Medical decision-making is complicated by the incremental evolution of devices marketed for the treatment of similar lesions. Difference in specialty training and individual physician bias further complicate treatment decisions including device selection. In addition, the lack of consistent definitions for both common and peripheral arterial disease specific covariates and outcomes has made it difficult to compare the safety and efficacy of devices. This has resulted in heterogeneous treatment pathways for different specialties, an inadequate evidence base for comparative effectiveness, and no clear consensus on the standard of care for peripheral arterial devices. This review discusses the current state of OPGs for PVI. The review focuses on the potential use of coordinated data networks such as clinical registries for new OPG development. The viewpoint proposes a new pathway for the development of “fit-for-purpose” OPGs that harnesses the power of real world data sources.