title: Evaluation of heart failure biomarker tests: a survey of statistical considerations.
abstract: Biomarkers assessing cardiovascular function can encompass a wide range of biochemical or physiological measurements. Medical tests that measure biomarkers are typically evaluated for measurement validation and clinical performance in the context of their intended use. General statistical principles for the evaluation of medical tests are discussed in this paper in the context of heart failure. Statistical aspects of study design and analysis to be considered while assessing the quality of measurements and the clinical performance of tests are highlighted. A discussion of statistical considerations for specific clinical uses is also provided. The remarks in this paper mainly focus on methods and considerations for statistical evaluation of medical tests from the perspective of bias and precision. With such an evaluation of performance, healthcare professionals could have information that leads to a better understanding on the strengths and limitations of tests related to heart failure.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 66, Silver Spring, MD 20993, USA. arkendra.de@fda.hhs.gov
authors.forename: Arkendra
authors.initials: A
authors.lastname: De
authors.forename: Kristen
authors.initials: K
authors.lastname: Meier
authors.forename: Rong
authors.initials: R
authors.lastname: Tang
authors.forename: Meijuan
authors.initials: M
authors.lastname: Li
authors.forename: Thomas
authors.initials: T
authors.lastname: Gwise
authors.forename: Shanti
authors.initials: S
authors.lastname: Gomatam
authors.forename: Gene
authors.initials: G
authors.lastname: Pennello
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D003627:Data Interpretation, Statistical; D005069:Evaluation Studies as Topic; D005819:Genetic Markers; D005820:Genetic Testing / Q000706:statistics & numerical data; D006333:Heart Failure / Q000175:diagnosis* / Q000235:genetics / Q000378:metabolism; D006801:Humans; D008403:Mass Screening / Q000379:methods / Q000706:statistics & numerical data*; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D012107:Research Design / Q000706:statistics & numerical data*; D057170:Translational Research, Biomedical / Q000706:statistics & numerical data*
chemical_list: D015415:Biomarkers; D005819:Genetic Markers