title: Methods and recommendations for evaluating and reporting a new diagnostic test.
abstract: No standardized guidelines exist for the biostatistical methods appropriate for studies evaluating diagnostic tests. Publication recommendations such as the STARD statement provide guidance for the analysis of data, but biostatistical advice is minimal and application is inconsistent. This article aims to provide a self-contained, accessible resource on the biostatistical aspects of study design and reporting for investigators. For all dichotomous diagnostic tests, estimates of sensitivity and specificity should be reported with confidence intervals. Power calculations are strongly recommended to ensure that investigators achieve desired levels of precision. In the absence of a gold standard reference test, the composite reference standard method is recommended for improving estimates of the sensitivity and specificity of the test under evaluation.
authors.affiliation: University of Maryland School of Medicine, Baltimore, MD, USA. ahess@epi.umaryland.edu
authors.forename: A S
authors.initials: AS
authors.lastname: Hess
authors.forename: M
authors.initials: M
authors.lastname: Shardell
authors.forename: J K
authors.initials: JK
authors.lastname: Johnson
authors.forename: K A
authors.initials: KA
authors.lastname: Thom
authors.forename: P
authors.initials: P
authors.lastname: Strassle
authors.forename: G
authors.initials: G
authors.lastname: Netzer
authors.forename: A D
authors.initials: AD
authors.lastname: Harris
mesh_terms: D056808:Biostatistics / Q000379:methods; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005069:Evaluation Studies as Topic; D006801:Humans