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.

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