Criteria for Evaluation of Novel Markers of Cardiovascular Risk

TLDR

Interest in novel cardiovascular risk markers has grown, creating a need to evaluate their value. The statement reviews risk‑evaluation concepts and proposes standards for critically appraising risk‑assessment methods. Evaluating a novel marker requires rigorous study design, representative populations, sufficient events, reporting added prognostic value, using discrimination and accuracy metrics, and assessing impact on management, outcomes, and cost‑effectiveness across multiple validation phases.

Abstract

There is increasing interest in utilizing novel markers of cardiovascular disease risk, and consequently, there is a need to assess the value of their use. This scientific statement reviews current concepts of risk evaluation and proposes standards for the critical appraisal of risk assessment methods. An adequate evaluation of a novel risk marker requires a sound research design, a representative at-risk population, and an adequate number of outcome events. Studies of a novel marker should report the degree to which it adds to the prognostic information provided by standard risk markers. No single statistical measure provides all the information needed to assess a novel marker, so measures of both discrimination and accuracy should be reported. The clinical value of a marker should be assessed by its effect on patient management and outcomes. In general, a novel risk marker should be evaluated in several phases, including initial proof of concept, prospective validation in independent populations, documentation of incremental information when added to standard risk markers, assessment of effects on patient management and outcomes, and ultimately, cost-effectiveness.