A systematic review classifies sources of bias and variation in diagnostic test accuracy studies

Penny F Whiting, Anne W S Rutjes, Marie E Westwood, Susan Mallett, QUADAS-2 Steering Group

Research output: Contribution to journalArticlepeer-review

147 Citations (Scopus)


OBJECTIVE: To classify the sources of bias and variation and to provide an updated summary of the evidence of the effects of each source of bias and variation.

STUDY DESIGN AND SETTING: We conducted a systematic review of studies of any design with the main objective of addressing bias or variation in the results of diagnostic accuracy studies. We searched MEDLINE, EMBASE, BIOSIS, the Cochrane Methodology Register, and Database of Abstracts of Reviews of Effects (DARE) from 2001 to October 2011. Citation searches based on three key papers were conducted, and studies from our previous review (search to 2001) were eligible. One reviewer extracted data on the study design, objective, sources of bias and/or variation, and results. A second reviewer checked the extraction.

RESULTS: We summarized the number of studies providing evidence of an effect arising from each source of bias and variation on the estimates of sensitivity, specificity, and overall accuracy.

CONCLUSIONS: We found consistent evidence for the effects of case-control design, observer variability, availability of clinical information, reference standard, partial and differential verification bias, demographic features, and disease prevalence and severity. Effects were generally stronger for sensitivity than for specificity. Evidence for other sources of bias and variation was limited.

Original languageEnglish
Pages (from-to)1093-104
Number of pages12
JournalJournal of Clinical Epidemiology
Issue number10
Publication statusPublished - Oct 2013

Bibliographical note

Copyright © 2013 Elsevier Inc. All rights reserved.


  • Bias (Epidemiology)
  • Diagnostic Tests, Routine
  • Humans
  • Review Literature as Topic
  • Sensitivity and Specificity


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