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Review
. 2021 May 16;57(5):503.
doi: 10.3390/medicina57050503.

Foundational Statistical Principles in Medical Research: Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value

Thomas F Monaghan  1 , Syed N Rahman  2 , Christina W Agudelo  3 , Alan J Wein  4 , Jason M Lazar  3 , Karel Everaert  5 , Roger R Dmochowski  6
Affiliations
Review

Foundational Statistical Principles in Medical Research: Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value

Thomas F Monaghan et al. Medicina (Kaunas). .

Abstract

Sensitivity, which denotes the proportion of subjects correctly given a positive assignment out of all subjects who are actually positive for the outcome, indicates how well a test can classify subjects who truly have the outcome of interest. Specificity, which denotes the proportion of subjects correctly given a negative assignment out of all subjects who are actually negative for the outcome, indicates how well a test can classify subjects who truly do not have the outcome of interest. Positive predictive value reflects the proportion of subjects with a positive test result who truly have the outcome of interest. Negative predictive value reflects the proportion of subjects with a negative test result who truly do not have the outcome of interest. Sensitivity and specificity are inversely related, wherein one increases as the other decreases, but are generally considered stable for a given test, whereas positive and negative predictive values do inherently vary with pre-test probability (e.g., changes in population disease prevalence). This article will further detail the concepts of sensitivity, specificity, and predictive values using a recent real-world example from the medical literature.

Keywords: basics; biostatistics; diagnosis; fundamentals; introduction; methodology; overview; screening; statistics; tutorial.

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Conflict of interest statement

Thomas F. Monaghan has no direct or indirect commercial incentive associated with publishing this article and certifies that all conflicts of interest relevant to the subject matter discussed in the manuscript are the following: Alan J. Wein has served as a consultant for Medtronic, Urovant, Antares, and Viveve, outside the submitted work. Karel Everaert is a consultant and lecturer for Medtronic and Ferring and reports institutional grants from Allergan, Ferring, Astellas, and Medtronic, outside the submitted work. The additional authors have nothing to disclose.

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