Objective: This study aimed to determine if criterion standard colposcopy could be provided by a pocket-sized battery-driven colposcope, the Gynocular.
Materials and Methods: The study was a randomized, crossover, pilot clinical trial for evaluating agreement of diagnosis of cervical lesions by colposcopy using a standard colposcope and a pocket-sized battery-driven colposcope, the Gynocular, in 69 women positive for visual inspection with acetic acid. Swede scores were used at the time of colposcopy and compared with the final histological diagnosis after directed cervical biopsy. To test the level of agreement between the colposcopy and Gynocular, we calculated the percentage agreement and the κ statistic. We calculated the detection rates of cervical lesions of the Gynocular and a standard colposcope using biopsy results as criterion standards. All included patients also underwent a Pap smear.
Results: The level of agreement of Swede score between the Gynocular and colposcope was 70.1% and the κ statistic was 0.65 (p < .001). Biopsy identified 4 women (6.7%) with cervical intraepithelial neoplasia 1 (CIN 1) and 1 woman (1.7%) with CIN 2; 2 women (3.4%) had CIN 3, and 2 women had invasive cervical cancer (CIN 3+). Pap smear detected 2 women (3.1%) with CIN 1 but did not identify any high-grade cervical lesion. Cervicitis was present in 17 (27.4%) of the Pap smears and in 34 (57.6%) of the biopsies.
Conclusions: The study shows that in visual inspection with acetic acid–positive women, a battery-driven, pocket-sized colposcope has a significant level of agreement with stationary colposcopy in assessing cervical lesions.
The study shows that in VIA-positive women, a battery-driven, pocket-sized colposcope has a significant level of agreement with stationary colposcopy in assessing cervical lesions.
Departments of 1Obstetrics and Gynecology, and 2Community Health Mbarara University of Science and Technology, Mbarara, Uganda; and Departments of 3Obstetrics and Gynecology, and 4Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden
Reprint requests to: Elisabeth Andrea Wikström Shemer, MD, Department of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden. E-mail: firstname.lastname@example.org
The authors have declared they have no conflicts of interest.
Funding for the study was obtained from the H&M anniversary foundation (to E.A.W.S.), the Swedish Society of Medicine (to D.A.) and Gynius AB. The study was performed by independent researchers without any commercial interest in the sponsor company.