Abstract
Purpose
Many limited-resourced countries have either introduced cervical cancer screening programs or are contemplating to do so using visual inspection after acetic acid application (VIA) or human papillomavirus (HPV) detection tests. Both tests have high false-positivity and a suitable triaging strategy is required. Colposcopy triaging is not practicable in most resource-limited settings due to several reasons. We evaluated a portable, battery-operated, magnifying device (GynocularTM) to triage screen positive women in community setting in India.
Methods
Women positive on VIA or oncogenic HPV test were examined with Gynocular by clinicians in primary health clinics. Findings were documented using the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Swede score was also calculated. Biopsy was performed irrespective of Gynocular findings. The accuracy of Gynocular to detect high-grade lesions or cancer (HSIL+) was estimated. The suitability of Gynocular to correctly triage screen positive cases for immediate ablative treatment was also evaluated by creating simulated scenarios.
Results
Sensitivity and specificity of Gynocular were 96.4 and 47.1 %, respectively, to detect HSIL + at the threshold of IFCPC grade 1 findings. Increasing threshold to grade 2 changed sensitivity and specificity to 92.9 and 94.1 %, respectively. Optimum combination of sensitivity and specificity as determined by the receiver operating curve analysis was at the cut-off Swede score of 5. Triaging of VIA/HPV positive women to treatment using grade 2 criteria would have resulted in modest overtreatment and missing of very few high-grade lesions.
Conclusion
Gynocular can be used as an effective triaging device for VIA/HPV positive women.
Similar content being viewed by others
References
Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F (2013) GLOBOCAN 2012 v1.0, cancer incidence and mortality worldwide: IARC CancerBase No. 11. International Agency for Research on Cancer, Lyon. http://globocan.iarc.fr
Sahasrabuddhe VV, Parham GP, Mwanahamuntu MH, Vermund SH (2012) Cervical cancer prevention in low- and middle-income countries: feasible, affordable, essential. Cancer Prev Res 5(1):11–17
Sankaranarayanan R, Gaffikin L, Jacob M, Sellors J, Robles S (2005) A critical assessment of screening methods for cervical neoplasia. Int J Gynaecol Obstet 89:S4–S12
Sankaranarayanan R (2014) Screening for cancer in low- and middle-income countries. Ann Glob Health 80(5):412–417
Sankaranarayanan R, Wesley RS (2003) A practical manual on visual screening for cervical neoplasia. IARC Technical Publication; No. 41. International Agency for Research on Cancer, Lyon, France
Bornstein J, Bentley J, Bösze P, Girardi F, Haefner H, Menton M, Perrotta M, Prendiville W, Russell P, Sideri M, Strander B, Tatti S, Torne A, Walker P (2012) 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol 120(1):166–172
Bowring J, Strander B, Young M, Evans H, Walker P (2010) The Swede score: evaluation of a scoring system designed to improve the predictive value of colposcopy. J Low Genit Tract Dis. 14(4):301–305
Strander B, Ellström-Andersson A, Franzén S, Milsom I, Radberg T (2005) The performance of a new scoring system for colposcopy in detecting high-grade dysplasia in the uterine cervix. Acta Obstet Gynecol Scand 84:1013–1017
dos Santos Silva I (1999) Cancer epidemiology: principles and methods. IARC Press, Lyon
Wright TC Jr, Cox JT, Massad LS, Twiggs LB, Wilkinson EJ (2002) ASCCP-Sponsored Consensus Conference. 2001 Consensus Guidelines for the management of women with cervical cytological abnormalities. JAMA 287:2120–2129
Control Comprehensive Cervical Cancer (2014) A guide to essential practice, 2nd edn. World Health Organization, Geneva
Basu P, Mittal S, Banerjee D, Singh P, Panda C, Dutta S, Mandal R, Das P, Biswas J, Muwonge R, Sankaranarayanan R (2015) Diagnostic accuracy of VIA and HPV detection as primary and sequential screening tests in a cervical cancer screening demonstration project in India. Int J Cancer 137(4):859–867
Ghosh I, Mittal S, Banerjee D, Singh P, Dasgupta S, Chatterjee S, Biswas J, Panda C, Basu P (2014) Study of accuracy of colposcopy in VIA and HPV detection-based cervical cancer screening program. Aust N Z J Obstet Gynaecol 54:570–575
Sankaranarayanan R, Shastri SS, Basu P, Mahé C, Mandal R, Amin G, Roy C, Muwonge R, Goswami S, Das P, Chinoy R, Frappart L, Patil S, Choudhury D, Mukherjee T, Dinshaw K (2004) The role of low-level magnification in visual inspection with acetic acid for the early detection of cervical neoplasia. Cancer Detect Prev 28(5):345–351
Nessa A, Roy JS, Chowdhury MA, Khanam Q, Afroz R, Wistrand C, Thuresson M, Thorsell M, Shemer I, Wikström Shemer EA (2014) Evaluation of the accuracy in detecting cervical lesions by nurses versus doctors using a stationary colposcope and Gynocular in a low-resource setting. BMJ Open 4(11):e005313. doi:10.1136/bmjopen-2014-005313
Ngonzi J, Bajunirwe F, Wistrand C, Mayanja R, Altman D, Thorsell M, Wikström Shemer EA (2013) Agreement of colposcope and gynocular in assessment of cervical lesions by swede score: a randomized, crossover pilot trial. J Low Genit Tract Dis. 17(4):372–377. doi:10.1097/LGT.0b013e31827ba7c5
Nessa A, Wistrand C, Begum SA, Thuresson M, Shemer I, Thorsell M, Shemer EA (2014) Evaluation of stationary colposcope and the Gynocular, by the Swede score systematic colposcopic system in VIA positive women: a crossover randomized trial. Int J Gynecol Cancer 24(2):339–345. doi:10.1097/IGC
Acknowledgments
Gynius AB, Stockholm, Sweden, donated the two Gynocular instruments used in the study. However, they did not have any role in preparing the project protocol, conduct of the study, data analysis, and preparation of manuscript.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Basu, P., Banerjee, D., Mittal, S. et al. Evaluation of a compact, rechargeable, magnifying device to triage VIA and HPV positive women in a cervical cancer screening program in rural India. Cancer Causes Control 27, 1253–1259 (2016). https://doi.org/10.1007/s10552-016-0805-7
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10552-016-0805-7