Concordance Between the Generation 3 Point-of-Care Tampon (Pocket) Digital Colposcope and Standard-of-Care Colposcope Using Acetic Acid and Lugol’s Iodine Images in Lima, Peru

Abstract

Cervical cancer is the second leading cause of death for women worldwide with 85% of deaths occurring in low and middle-income countries, despite being both preventable and treatable if detected early enough. The burden of disease persists primarily due to a lack of access to early diagnostics and significant proportion lost to follow-up. In Peru specifically, the mortality rates of cervical cancer are among the highest in the world with an annual incidence of 48.2 per 100,000. To provide low-cost and accessible colposcopy while maintaining image quality, the point of care tampon like (Pocket) digital colposcope is being developed in the Tissue Optical Spectroscopy (TOpS) Lab at Duke University. As part of the ongoing Pocket colposcope development and validation, the Generation 3 Pocket colposcope was tested for concordance to the standard-of-care Goldway SLC-2000 digital colposcope in a pilot study conducted in Lima, Peru. The goal of this study is to demonstrate equivalence in clinical diagnostic performance of the Generation 3 Pocket colposcope versus the standard-of-care digital colposcope. 100 patients were enrolled under the IRB approved study protocol Pro00052865. Paired images of cervices were collected with the standard digital colposcope and the Pocket colposcope for each patient using acetic acid and Lugol’s iodine as contrast agents. Biopsies were taken as part of standard-of-care whenever required. The paired images were blinded by device, randomized, and sent with an electronic survey to three Duke affiliated physicians who are highly trained in colposcopy. The primary outcome measured was level of agreement using an unweighted kappa statistic between 1) overall diagnosis and 2) Reid Colposcopic Index scores for the Generation 3 Pocket colposcope and Goldway colposcope. The secondary outcome measured was sensitivity, specificity, positive predictive value, and negative predictive value. The percent agreement for all physicians combined between systems for the overall diagnosis was 83.78% with a kappa of 0.5786 and p-value of <0.0000, and the percent agreement for the Reid Colposcopic Index score comparison was 72.3% with a kappa of 0.4366 and p-value of <0.0000 indicating strong concordance. Both systems performed similarly when compared to gold-standard pathology, with level of agreement ~66% and a kappa statistic of ~0.3, and p-values <0.0000. The Generation 3 Pocket colposcope performed similarly to the standard Goldway colposcope and can be used to increase access to colposcopy, thereby reducing the burden of cervical cancer morbidity and mortality in Peru and around the world.