Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association.

Hlatky MA, Greenland P, Arnett DK, Ballantyne CM, Criqui MH, Elkind MS, Go AS, Harrell FE, Hong Y, Howard BV, Howard VJ, Hsue PY, Kramer CM, McConnell JP, Normand SL, O'Donnell CJ, Smith SC, Wilson PW, American Heart Association Expert Panel on Subclinical Atherosclerotic Diseases and Emerging Risk Factors and the Stroke Council
Circulation. 2009 119 (17): 2408-16

PMID: 19364974 · PMCID: PMC2956982 · DOI:10.1161/CIRCULATIONAHA.109.192278

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.

MeSH Terms (9)

American Heart Association Biomarkers Cardiovascular Diseases Evaluation Studies as Topic Humans Prognosis Risk Assessment Sensitivity and Specificity United States

Connections (1)

This publication is referenced by other Labnodes entities:

Links