Downloaded from http://journals.lww.com/jlgtd by BhDMf5ePHKbH4TTImqenVAPwFBsBoeDVBZ6MKvkJgrSkGTlZRf2qJB5+rgjs1EZ6 on 10/24/2020 Is There a Place for the Introduction of Colposcopy Quality Standards? Sandy Bornstein, BSc, 1 Eduardo Schejter, MD, 2 Gabriel Chodick, PhD, 1,3 Orly Yakir, MA, 4 and Jacob Bornstein, MD, MPA 5,6 Objectives: The aims of the study were to examine the degree of compli- ance with international quality measures for colposcopy in Israel, which does not currently have formal guidelines and to compare the achievement of quality measures between clinical settings. Methods: This is a retrospective cohort study, in a hospital, a community clinic, and 2 private colposcopy clinics in Israel, including women aged 1870 years presenting for colposcopy after abnormal Pap results. Compli- ance was compared between clinical sites regarding 6 international stan- dards: documentation of reason for referral, type of transformation zone, biopsy location, and grade; proportion of women with high-degree cytological abnormalities (atypical squamous cells - cannot exclude high grade squamous intraepithelial lesion and above) receiving a colposcopy within 4 weeks; and the positive predictive value of colposcopy to detect cervical intraepithelial neoplasia 2 and above. Results: Documentation of reason for referral (1.3% of target), transfor- mation zone type (22.6% of target), biopsy location (18% of target), and le- sion grade (31% of target) all failed to meet international standards, as did the proportion of patients with high-degree cytological abnormalities who underwent colposcopy within 4 weeks (32.9% of the target). The positive predictive value of colposcopy exceeded standards (30% above target). Dif- ferences existed between clinical settings. Conclusions: In Israel, there is a considerable shortfall in performance and documentation of most international quality measures for colposcopy. Quality measures for cervical examinations and colposcopy should be con- sidered for inclusion in the National Program for Quality Measures. Key Words: colposcopy, quality of care, cervical cancer, international guidelines (J Low Genit Tract Dis 2020;24: 375380) T he importance of colposcopy and its widespread use high- lights the need for clear guidelines and quality standards that encourage consistency and clarity in performance and interpreta- tion of the examination. Such standardization allows comparisons between countries and clinics and also allows for better quality control, as well as for assessment of procedural changes and im- provements and intertherapist communication. The evolution of colposcopy as a diagnostic tool has coincided with the establish- ment of organizations responsible for generating and publishing guidelines and quality standards for physicians, including the In- ternational Foundation of Cervical Pathology and Colposcopy. 14 One of its main aims is to standardize terminology to increase the procedure's uniformity. Recently, numerous studies and guidelines have published quality standards for cervical cancer detection and prevention. Or- ganizations have developed regulations according to their local populations and clinical practices. In 2004, the National Health Service Cervical Screening Programme (NHSCSP), together with the British Society for Colposcopy and Cervical Pathology, pub- lished regulatory guidelines concerning diagnosis and prevention of cervical cancer, including quality standards for colposcopy; these guidelines were updated in 2016. 5 In 2013, the European Federation of Colposcopy was the first to publish such quality control regulations for Europe. 6 Guidelines have also been pub- lished in Ireland 7 and in the United States. 8 In addition, several investigators have evaluated compliance with internationally recommended standards in the United Kingdom, 9 Germany, 10 and Thailand. 11 However, these issues have not been addressed in Israel, which has no quality standard guide- lines regarding cervical cancer screening or colposcopy. This is de- spite the fact that colposcopy is common practice, and there is a well-established Israeli Society of Colposcopy and Cervical and Vulvar Pathology. Our objectives were to examine whether col- poscopy practices in Israel, as a representative of countries where quality measures have not been implemented, achieve interna- tional standards in terms of various quality measures, and to com- pare the achievement of quality standards in hospital, community clinic, and private clinic settings. METHODS Design This was a retrospective cohort study. Data were collected from patient charts at colposcopy clinics, including a community clinic (Cervix clinic, Maccabi Healthcare Services, Hashalom branch); a hospital clinic (Galilee Medical Center); and 2 private clinics. All of the medical doctors involved in the study are attend- ing physicians who have specialized in colposcopy and have more than 20 years of experience. The aim of this project is to develop core outcome sets for studies concerning colposcopy use for pre- vention of cervical cancer. Subjects Study subjects included women aged 1870 years who were referred to colposcopy after abnormal Pap results from 2015 to 2018. Women who underwent colposcopy for reasons other than abnormal Pap smears; who had a history of vaginal surgery, hys- terectomy, or any cervical treatment; or cases where the physician knew the final tissue diagnosis were excluded. Systematic sam- pling was done from the 3 clinic types. We examined a total of 300 records, 100 from each clinical setting. Patients were not in- volved in this research. 1 Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; 2 Department of Obstetrics and Gynecology, Maccabi Health, Tel Aviv, Israel; 3 Department of Epidemiology, Tel Aviv University School of Public Health, Tel Aviv, Israel; 4 Department of Statistics, Galilee Medical Center, Nahariya, Israel; 5 Depart- ment of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; and 6 Department of Obstetrics and Gynecology, Azrieli Faculty of Medicine, Bar-Ilan University, Ramat Gan, Israel Correspondence to: Jacob Bornstein, Chairman, Department of Obstetrics & Gynecology Galilee Medical Center - Nahariya, Israel. E-mail: mdjacob@gmail.com The authors have declared they have no conflicts of interest. The procedures of the study received institutional review board approval from the Galilee Medical Center Helsinki Committee on June, 27, 2018 (Authorization No. 0058-18-NHR) and from the Maccabi Health Management Organization Helsinki Committee on May 23, 2018 (Authorization No. 0020-18-BBL). © 2020, ASCCP DOI: 10.1097/LGT.0000000000000557 ORIGINAL RESEARCH ARTICLE:CERVIX AND HPV Journal of Lower Genital Tract Disease Volume 24, Number 4, October 2020 375 Copyright © 2020 ASCCP. Unauthorized reproduction of this article is prohibited.