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Article
Net Benefit of Diagnostic Tests for Multistate Diseases: an Indicator Variables Approach
Journal of Biopharmaceutical Statistics
  • Hani Samawi, Georgia Southern University, Jiann-Ping Hsu College of Public Health
  • Ferdous Ahmeda, Georgia Southern University, Jiann-Ping Hsu College of Public Health
  • Gene Pennello, Food and Drug Administration
  • Jingjing Yin, Georgia Southern University, Jiann-Ping Hsu College of Public Health
Document Type
Article
Publication Date
1-29-2023
DOI
10.1080/10543406.2023.2169928
Disciplines
Abstract

A limitation of the common measures of diagnostic test performance, such as sensitivity and specificity, is that they do not consider the relative importance of false negative and false positive test results, which are likely to have different clinical consequences. Therefore, the use of classification or prediction measures alone to compare diagnostic tests or biomarkers can be inconclusive for clinicians. Comparing tests on net benefit can be more conclusive because clinical consequences of misdiagnoses are considered. The literature suggested evaluating the binary diagnostic tests based on net benefit, but did not consider diagnostic tests that classify more than two disease states, e.g., stroke subtype (large-artery atherosclerosis, cardioembolism, small-vessel occlusion, stroke of other determined etiology, stroke of undetermined etiology), skin lesion subtype, breast cancer subtypes (benign, mass, calcification, architectural distortion, etc.), METAVIR liver fibrosis state (F0- F4), histopathological classification of cervical intraepithelial neoplasia (CIN), prostate Gleason grade, brain injury (intracranial hemorrhage, mass effect, midline shift, cranial fracture) . Other diseases have more than two stages, such as Alzheimer's disease (dementia due to Alzheimer's disease, mild cognitive disability (MCI) due to Alzheimer's disease, and preclinical presymptomatics due to Alzheimer's disease). In diseases with more than two states, the benefits and risks may vary between states. This paper extends the net-benefit approach of evaluating binary diagnostic tests to multi-state clinical conditions to rule-in or rule-out a clinical condition based on adverse consequences of work-up delay (due to false negative test result) and unnecessary workup (due to false positive test result). We demonstrate our approach with numerical examples and real data.

Citation Information
Hani Samawi, Ferdous Ahmeda, Gene Pennello and Jingjing Yin. "Net Benefit of Diagnostic Tests for Multistate Diseases: an Indicator Variables Approach" Journal of Biopharmaceutical Statistics (2023)
Available at: http://works.bepress.com/hani_samawi/298/