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Open Access Research article

Bias associated with delayed verification in test accuracy studies: accuracy of tests for endometrial hyperplasia may be much higher than we think!

T Justin Clark1*, Gerben ter Riet2, Aravinthan Coomarasamy1 and Khalid S Khan1

Author Affiliations

1 Academic Department of Obstetrics & Gynaecology, Birmingham Women's Hospital, Birmingham, B15 2TG, UK

2 Academic Medical Center, Department of General Practice, 1105 AZ, Amsterdam, Netherlands

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BMC Medicine 2004, 2:18  doi:10.1186/1741-7015-2-18

Published: 11 May 2004

Abstract

Background

To empirically evaluate bias in estimation of accuracy associated with delay in verification of diagnosis among studies evaluating tests for predicting endometrial hyperplasia.

Methods

Systematic reviews of all published research on accuracy of miniature endometrial biopsy and endometr ial ultrasonography for diagnosing endometrial hyperplasia identified 27 test accuracy studies (2,982 subjects). Of these, 16 had immediate histological verification of diagnosis while 11 had verification delayed > 24 hrs after testing. The effect of delay in verification of diagnosis on estimates of accuracy was evaluated using meta-regression with diagnostic odds ratio (dOR) as the accuracy measure. This analysis was adjusted for study quality and type of test (miniature endometrial biopsy or endometrial ultrasound).

Results

Compared to studies with immediate verification of diagnosis (dOR 67.2, 95% CI 21.7–208.8), those with delayed verification (dOR 16.2, 95% CI 8.6–30.5) underestimated the diagnostic accuracy by 74% (95% CI 7%–99%; P value = 0.048).

Conclusion

Among studies of miniature endometrial biopsy and endometrial ultrasound, diagnostic accuracy is considerably underestimated if there is a delay in histological verification of diagnosis.