title: Promise versus reality: optimism bias in package inserts for tuberculosis diagnostics.
abstract: Laboratorians and clinicians often rely on package inserts of diagnostic tests to assess their accuracy. We compared test accuracy for tuberculosis diagnostics reported in 19 package inserts against estimates in published meta-analyses and found that package inserts generally report overoptimistic accuracy estimates. However, package inserts of most tests approved by the U.S. Food and Drug Administration (FDA) or endorsed by the World Health Organization provide more realistic estimates that agree with meta-analyses.
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Denkinger
authors.forename: Jasmine
authors.initials: J
authors.lastname: Grenier
authors.forename: Jessica
authors.initials: J
authors.lastname: Minion
authors.forename: Madhukar
authors.initials: M
authors.lastname: Pai
mesh_terms: D001431:Bacteriological Techniques / Q000379:methods*; D015982:Bias; D006801:Humans; D011356:Product Labeling; D014376:Tuberculosis / Q000175:diagnosis*; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization