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Peculiarities of Diagnostic Test Accuracy Studies

  • Giuseppe Biondi-Zoccai
  • Simona Mastrangeli
  • Mariangela Peruzzi
  • Giacomo Frati
Chapter

Abstract

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.

Keywords

Accuracy Bias Diagnosis Sensitivity Specificity Validity 

References

  1. 1.
    Cochrane collaboration: handbook for diagnostic test accuracy reviews. http://methods.cochrane.org/sdt/handbook-dta-reviews. Accessed 28 June 2018.
  2. 2.
  3. 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. 4.
    Biondi-Zoccai G, editor. Network meta-analysis: evidence synthesis with mixed treatment comparison. Hauppauge, NY: Nova Science Publishers; 2014.Google Scholar
  5. 5.
    Biondi-Zoccai G. Umbrella reviews. Evidence synthesis with overviews of reviews and meta-epidemiologic studies. Springer International: Cham, Switzerland; 2016.Google Scholar
  6. 6.
    Bossuyt PM, Irwig L, Craig J, Glasziou P. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ. 2006;332:1089–92.CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    Deeks JJ, Macaskill P, Irwig L. The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed. J Clin Epidemiol. 2005;58:882–93.CrossRefPubMedGoogle Scholar
  8. 8.
    Dinnes J, Deeks J, Kirby J, Roderick P. A methodological review of how heterogeneity has been examined in systematic reviews of diagnostic test accuracy. Health Technol Assess. 2005;9:1–113.CrossRefPubMedGoogle Scholar
  9. 9.
    Irwig L, Tosteson AN, Gatsonis C, Lau J, Colditz G, Chalmers TC, Mosteller F. Guidelines for meta-analyses evaluating diagnostic tests. Ann Intern Med. 1994;120:667–76.CrossRefPubMedGoogle Scholar
  10. 10.
    Siontis KC, Siontis GC, Contopoulos-Ioannidis DG, Ioannidis JP. Diagnostic tests often fail to lead to changes in patient outcomes. J Clin Epidemiol. 2014;67:612–21.CrossRefPubMedGoogle Scholar
  11. 11.
    Whiting PF, Rutjes AW, Westwood ME, Mallett S, QUADAS-2 Steering Group. A systematic review classifies sources of bias and variation in diagnostic test accuracy studies. J Clin Epidemiol. 2013;66:1093–104.CrossRefPubMedGoogle Scholar
  12. 12.
    Jarvik JG. The research framework. AJR Am J Roentgenol. 2001;176:873–8.CrossRefPubMedGoogle Scholar
  13. 13.
    Krupinski EA, Jiang Y. Anniversary paper: evaluation of medical imaging systems. Med Phys. 2008;35:645–59.CrossRefPubMedGoogle Scholar
  14. 14.
    Thornbury JR. Eugene W. Caldwell lecture. Clinical efficacy of diagnostic imaging: love it or leave it. AJR Am J Roentgenol. 1994;162:1–8.CrossRefPubMedGoogle Scholar
  15. 15.
    Kim KW, Lee J, Choi SH, Huh J, Park SH. Systematic review and meta-analysis of studies evaluating diagnostic test accuracy: a practical review for clinical researchers-part I. General guidance and tips. Korean J Radiol. 2015;16:1175–87.CrossRefPubMedPubMedCentralGoogle Scholar
  16. 16.
    Lins S, Icks A, Meyer G. Understanding, comprehensibility and acceptance of an evidence-based consumer information brochure on fall prevention in old age: a focus group study. BMC Geriatr. 2011;11:26.CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Spencer-Bonilla G, Singh Ospina N, Rodriguez-Gutierrez R, Brito JP, Iñiguez-Ariza N, Tamhane S, Erwin PJ, Murad MH, Montori VM. Systematic reviews of diagnostic tests in endocrinology: an audit of methods, reporting, and performance. Endocrine. 2017;57:18–34.CrossRefPubMedGoogle Scholar
  18. 18.
    Pewsner D, Battaglia M, Minder C, Marx A, Bucher HC, Egger M. Ruling a diagnosis in or out with “SpPIn” and “SnNOut”: a note of caution. BMJ. 2004;329:209–13.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307–10.CrossRefPubMedGoogle Scholar
  20. 20.
    Novara M, D’Ascenzo F, Gonella A, Bollati M, Biondi-Zoccai G, Moretti C, Omedè P, Sciuto F, Sheiban I, Gaita F. Changing of SYNTAX score performing fractional flow reserve in multivessel coronary artery disease. J Cardiovasc Med (Hagerstown). 2012;13:368–75.CrossRefGoogle Scholar
  21. 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

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Giuseppe Biondi-Zoccai
    • 1
    • 2
  • Simona Mastrangeli
    • 3
  • Mariangela Peruzzi
    • 1
  • Giacomo Frati
    • 1
    • 2
  1. 1.Department of Medico-Surgical Sciences and BiotechnologiesSapienza University of RomeLatinaItaly
  2. 2.Department of AngioCardioNeurologyIRCCS NeuromedPozzilliItaly
  3. 3.Superior School of Advanced StudiesSapienza University of RomeRomeItaly

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