A new method to address verification bias in studies of clinical screening tests: Cervical cancer screening assays as an example

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

Objectives Studies to evaluate clinical screening tests often face the problem that the "gold standard" diagnostic approach is costly and/or invasive. It is therefore common to verify only a subset of negative screening tests using the gold standard method. However, undersampling the screen negatives can lead to substantial overestimation of the sensitivity and underestimation of the specificity of the diagnostic test. Our objective was to develop a simple and accurate statistical method to address this "verification bias." Study Design and Setting We developed a weighted generalized estimating equation approach to estimate, in a single model, the accuracy (eg, sensitivity/specificity) of multiple assays and simultaneously compare results between assays while addressing verification bias. This approach can be implemented using standard statistical software. Simulations were conducted to assess the proposed method. An example is provided using a cervical cancer screening trial that compared the accuracy of human papillomavirus and Pap tests, with histologic data as the gold standard. Results The proposed approach performed well in estimating and comparing the accuracy of multiple assays in the presence of verification bias. Conclusion The proposed approach is an easy to apply and accurate method for addressing verification bias in studies of multiple screening methods.

Original languageEnglish (US)
Pages (from-to)343-353
Number of pages11
JournalJournal of Clinical Epidemiology
Volume67
Issue number3
DOIs
StatePublished - Mar 1 2014

Keywords

  • Clinical screening tests
  • Positive and negative predictive values
  • Sensitivity
  • Specificity
  • Verification bias
  • Weighted generalized estimating equations

ASJC Scopus subject areas

  • Epidemiology

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