Methods and recommendations for evaluating and reporting a new diagnostic test
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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.
KeywordsChlamydia Trachomatis Latent Class Analysis Reference Test Nucleic Acid Amplification Test Publication Recommendation
MS’s work on this article was supported by NIH grant 1K25AG034216.
ADH’s work on this article was supported by NIH grant 1K24AI079040-01A1.
Conflict of interest
JKJ has received funding from Becton Dickinson. The other authors declare that they have no conflict of interest.
- 2.Pfeifer J (ed) (2006) Molecular genetic testing in surgical pathology. Lippincott Williams & Wilkins, PhiladelphiaGoogle Scholar
- 3.Rosner BA (2006) Fundamentals of biostatistics, 6th edn. Thomson Brooks Cole, Belmont, CAGoogle Scholar
- 4.FDA (2011) Statistical guidance on reporting results from studies evaluating diagnostic tests. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071148.htm. Updated 6 January 2011; cited 8 December 2011
- 5.Royse D, Thyer BA, Padgett DK (2010) Program evaluation: An introduction, 5th edn. Wadsworth, Cengage Learning, Belmont, CAGoogle Scholar
- 6.Royse D (2008) Research methods in social work, 5th edn. Thomson Brooks Cole, Belmont, CAGoogle Scholar
- 7.Sullivan LM (2008) Essentials of biostatistics in public health, 1st edn. Jones and Bartlett, Sudbury, MAGoogle Scholar