The aim of the study was to determine, in a wide “real-world” setting, whether digital colposcopy with adjunctive dynamic spectral imaging (DSI) mapping increases the detection of women with high-grade cervical intraepithelial neoplasia (CIN).Materials and Methods
A multicenter, two-arm, observational, cross-sectional study that recruited women 21 years and older, having colposcopy after a low-grade abnormality screening result. The prospective arm collected outcomes of digital colposcopy with DSI used for identifying biopsy sites at the colposcopists' discretion. The retrospective control arm (number of subjects matched 1:1 per colposcopist) collected outcomes of standard colposcopy. The primary outcome was histopathological detection of women with CIN 2+ by colposcopic biopsy.Results
The study included 1,788 women in the retrospective and 1,857 in the prospective arm from 39 US community-based clinics. Subject characteristics were comparable. A total of 71.6% of the women in the retrospective and 71.5% in the prospective arm underwent biopsy. The average number of biopsies increased from 1.032 (retrospective) to 1.256 (prospective). The yield of CIN 2+ patients was 7.21% in the retrospective and 9.48% in the prospective arm, a 2.27% difference (95% confidence interval = 0.47%–4.07%, p = .014) and 31.4% relative increase. The yield of CIN 3+ patients was 2.07% in the retrospective and 3.23% in the prospective arm, a 1.16% (95% confidence interval = 0.12%–2.24%, p = .031) absolute difference and 56.1% relative increase. The false-positive rates for biopsied patients were comparable (64.43% vs 62.04%, p = .139).Conclusions
Digital colposcopy with the adjunctive DSI increased CIN 2+ and CIN 3+ detection in low-grade referrals compared with standard colposcopy, with a similar number of women undergoing biopsy.