Objective: Determine if additional non-random biopsies beyond clinician directed biopsy enhance the detection of high-grade cervical disease.
Methods: A cervical imaging system (CIS) was used as an adjunct to colposcopy in an academic colposcopy clinic between July 2008 and October 2010 in an IRB approved post-FDA approval study. A post hoc analysis explored if additional biopsies through the CIS added diagnostic value to the clinician’s biopsies.
Results: Of 181 women with complete analysis, 50 (27.6%) were found to have CIN2+ disease. Clinician directed biopsy detected 45 of 50 (90%) of CIN2+. CIS directed biopsy detected an additional 5 of 50 (10%) of CIN2+.
Clinicians directed 180 total biopsies meaning that 1 of every 4 clinician biopsies detected CIN2+ disease, whereas CIS directed an additional 68 biopsies resulting in a yield of one case of CIN2+ disease for approximately 14 additional biopsies.
Conclusion: Additional non-random biopsies based on CIS increased the detection of high-grade disease in cases where clinicians did not identify high-grade disease. As noted by others, both random and non-random additional biopsies increase the sensitivity of traditional colposcopy. What is not clear is whether the additional cases identified represent clinically significant disease. Our study is particularly relevant as colposcopists explore standardizing high yield diagnostic techniques.
Colposcopy, cervical imaging system, cytology, Pap smear, cervical intraepithelial neoplasia, cervical dysplasia, cervical cancer screening
The authors report no conflict of interest.
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