Development of objective performance goals for peripheral vascular interventions using real world data sources
2021
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.
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