Abstract
Despite extensive research and numerous publications biomarkers have yet to fulfill their promise as prognostic indicators that can be widely used in the care of patients with heart failure. Specific clinical applications need to be identified for informative analyses of data that emphasize the most directly applicable measures of predictive performance.
Highlights
A number of secondary analyses of data gathered during clinical trials and observational cohort studies have identified several biomarkers that have been touted as “powerful predictors” of morbid events and mortality in patients with heart failure [1, 2]
A prognostic indicator can be any variable or combination of variables that is measured to make probabilistic predictions about whether a defined clinical outcome will or will not occur. This definition includes risk factors that might be used to estimate the risk of developing heart failure and prognostic indicators that might be used to help determine the prognosis of patients who have an established diagnosis
If we were to use these available assessments to somehow estimate each patient’s 1-year mortality risk and select a group whose predicted risk during the first year is at least 10%, the most relevant measure of our prognostic performance would be whether the observed 1-year mortality in the selected group was at least 10%. This could be determined by estimating the positive predictive value (PPV), the observed percentage of subjects placed in the “higher-risk” group who die within one year
Summary
A number of secondary analyses of data gathered during clinical trials and observational cohort studies have identified several biomarkers that have been touted as “powerful predictors” of morbid events and mortality in patients with heart failure [1, 2]. In an era of evidence-based medicine when implementation of the results of funded research is very important, there has been a remarkable paucity of studies to make available forthright evidence that supports the clinical use of biomarkers as prognostic indicators in the care of patients with heart failure. Most published reports concerning the prognostic information provided by biomarkers including our own have not gone beyond merely using regression analyses to report associations between biomarkers and patient outcomes and posthoc discrimination of outcomes that are not directly applicable to prospective predictions needed for clinical practice. To support the clinical use of biomarkers as prognostic variables, investigators need to propose specific clinical applications, report more pertinent statistical analyses such as predictive values, and study patients typically encountered in clinical practice
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