International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope

Abstract

Objective Barriers to cervical cancer screening in low resource settings include lack of accessible high quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low cost intra-vaginal optical cervical imaging device, the Point of Care Tampon (POCkeT) colposcope, and evaluated whether its performance is comparable to a standard-of-care colposcope. Methods There were two protocols, which included 44 and 18 patients respectively. For the first protocol, white light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high, middle and low income countries. For the second protocol, green light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high and low income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs. Results For the first protocol, average percent agreement between devices was 70% across all physicians. POCkeT and standard-of-care colposcope images had 37% and 51% percent agreement respectively with pathology for high-grade squamous intraepithelial lesions (HSILs). Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the two devices achieved similar agreement to pathology for HSIL lesions (55%). Conclusions Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low cost, POCkeT colposcope was comparable to a standard-of-care colposcope.

Portable Pocket colposcopy performs comparably to standard‐of‐care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru

“…Second, referring facilities only provided cytology to la Liga Contra el Cáncer for 28% of patients; thus, cytology was unknown for a majority of cases in our study. Third, acetic acid was not re-applied immediately prior to imaging with the Pocket colposcope until the last 32 patients (22, 26). Revising the study protocol in future studies to re-apply acetic acid between imaging with the two colposcopes could improve visualization of aceto-whitening.…”

“…In order to assess if the addition of Lugol’s iodine improves the percent agreement between colposcopy and pathology, we analyzed data from two previous studies in which similar numbers of acetic acid images only were captured with the same versions of the Pocket colposcope (Generation 3 and 4) and reviewed by the same physician (22, 23). …”

“…Third, acetic acid was not re-applied immediately before imaging with the Pocket colposcope until the last 32 patients. 22,26 Revising the study protocol in future studies to re-apply acetic acid between imaging with the two colposcopes could improve visualisation of aceto-whitening. Fourth, confirmatory pathology was not acquired for all patients in our study.…”

“…Additionally, the Pocket colposcope can be connected to a smart phone for easy visualization of the image. Based on an exploratory study conducted at the Duke University Medical Center, physician interpretation of aceto-whitened cervix images acquired with the Pocket colposcope was comparable to a standard-of-care colposcope (22, 23). …”

“…Based on an exploratory study conducted at the Duke University Medical Center, physician interpretation of aceto-whitened cervix images acquired with the Pocket colposcope was comparable to those obtained using a standard-of-care colposcope. 22,23 Before introducing the Pocket colposcope into a screening setting in Peru, it is important to demonstrate that it can achieve comparable performance to a conventional standard-of-care colposcope in a referral setting within the same healthcare environment for which it is intended. Therefore, the performance of the Pocket and standard-ofcare colposcopes was compared in patients undergoing colposcopy at la Liga Contra el C ancer, a nongovernmental organisation that provides wide-scale screening and referral services for cervical cancer.…”