A pilot study of mobile digital colposcopy in Japanese patients with cervical intraepithelial neoplasm

Digital colposcopy built around a smartphone is becoming common, and this has advantages for telemedicine and data sharing by taking advantage of smartphone characteristics. However, digital colposcopy itself is not allowed in clinical practice in Japan. The aim of the present study was to investigate the feasibility of mobile digital colposcopy incorporating a smartphone for management of cervical screening in Japanese patients. Patients who underwent colposcopy at Saitama Medical University International Medical Center between July 2019 and February 2020 were enrolled in the present study. The inclusion criteria were women aged 21-65 years old referred for colposcopy following the Japanese standard of care. Written informed consent was obtained from all patients. A total of 40 patients (52 tests) were included in the study. Following the standard of care, acetic acid was applied to the cervix, which was then visualized using a traditional colposcope, with biopsies collected as necessary. The cervix was then visualized and an imaged was captured using a mobile digital colposcope incorporating a smartphone (EVA System; Mobile ODT). All images were collected before biopsy. Images were stored on a secure cloud portal for subsequent evaluation by the provider who performed the conventional colposcopy, and the diagnoses were compared. The present study was approved by the Institutional Review Board of Saitama Medical University International Medical Center (Hidaka, Japan). The match rates for diagnoses were 75%. The match rates for the actual (from conventional colposcopy) and assumed (from digital colposcopy) biopsy sites were 61, 16 and 23%, based on definitions of the ‘same’, ‘almost the same’ and ‘different’, respectively. The present results indicated that ≥75% cases were equivalent in digital colposcopy and conventional colposcopy. This suggests that digital colposcopy may not be inferior to conventional colposcopy.