Peculiarities of Diagnostic Test Accuracy Studies
The performance of a diagnostic test is always appraised in comparison to one or several other competing tests, which may be other index or reference tests. The continuum in results of such tests is typically simplified using one or more threshold, eventually leading to a contingency table (e.g., a 2×2 table). Such format is the formal basis for the computation of several dimensions of comparative diagnostic accuracy, from sensitivity, to specificity, predictive values, likelihood ratios, and area under the curve of receiver operating curve, among the others. This is at odds with incidence studies, prognostic research, and controlled trials, which instead lead to more common measures of effect such as odds ratios, relative risks, and hazard ratios, among the others. Sources of bias and threats to the internal and external validity of diagnostic test accuracy studies also differ substantially from methodological issues pertinent to incidence studies, prognostic research, and controlled trials. The key design features, the complex interplay between index and reference test, and the theoretical distance between test results and clinical outcomes characterize the key peculiarities of diagnostic test accuracy studies. The present chapter provides an overview of design and analytical aspects of such studies, including a sample dataset and computing code for detailed and comprehensive analyses. Thorough knowledge and mastery of such peculiarities is crucial before facing a plethora of similar studies on diagnostic test accuracy when envisioning a systematic review and meta-analysis of the scholarly literature.
KeywordsAccuracy Bias Diagnosis Sensitivity Specificity Validity
- 1.Cochrane collaboration: handbook for diagnostic test accuracy reviews. http://methods.cochrane.org/sdt/handbook-dta-reviews. Accessed 28 June 2018.
- 2.EUnetHTA guideline: meta-analysis of diagnostic test accuracy studies. http://www.eunethta.eu/sites/default/files/sites/5026.fedimbo.belgium.be/files/Meta-analysis%20of%20Diagnostic%20Test%20Accuracy%20Studies_Guideline_Final%20Nov%202014.pdf. Accessed 28 June 2018.
- 3.Guyatt G, Rennie D, Meade MO, Cook DJ. Users’ guides to the medical literature: a manual for evidence-based clinical practice. New York, NY: McGraw-Hill Education; 2014.Google Scholar
- 4.Biondi-Zoccai G, editor. Network meta-analysis: evidence synthesis with mixed treatment comparison. Hauppauge, NY: Nova Science Publishers; 2014.Google Scholar
- 5.Biondi-Zoccai G. Umbrella reviews. Evidence synthesis with overviews of reviews and meta-epidemiologic studies. Springer International: Cham, Switzerland; 2016.Google Scholar
- 21.Nudi F, Lotrionte M, Biasucci LM, Peruzzi M, Marullo AG, Frati G, Valenti V, Giordano A, Biondi-Zoccai G. Comparative safety and effectiveness of coronary computed tomography: systematic review and meta-analysis including 11 randomized controlled trials and 19,957 patients. Int J Cardiol. 2016;222:352–8.CrossRefPubMedGoogle Scholar