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.
RCT Entities:
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.
Authors: Christopher T Lam; Marlee S Krieger; Jennifer E Gallagher; Betsy Asma; Lisa C Muasher; John W Schmitt; Nimmi Ramanujam Journal: PLoS One Date: 2015-09-02 Impact factor: 3.240
Authors: Ashrafun Nessa; Joya Shree Roy; Most Afroza Chowdhury; Quayuma Khanam; Romena Afroz; Charlotte Wistrand; Marcus Thuresson; Malin Thorsell; Isaac Shemer; Elisabeth Andrea Wikström Shemer Journal: BMJ Open Date: 2014-11-03 Impact factor: 2.692
Authors: Meng Li; Agnes Nyabigambo; Patricia Navvuga; Elly Nuwamanya; Afra Nuwasiima; Paschal Kaganda; Francis T Asiimwe; Elisabeth Vodicka; Noleb M Mugisha; Aggrey Mukose; Doris K Kwesiga; Solomon J Lubinga; Louis P Garrison; Joseph B Babigumira Journal: Papillomavirus Res Date: 2017-06-08
Authors: Ashrafun Nessa; Charlotte Wistrand; Shirin Akter Begum; Marcus Thuresson; Isaac Shemer; Malin Thorsell; Elisabeth Andrea Wikström Shemer Journal: Int J Gynecol Cancer Date: 2014-02 Impact factor: 3.437