Comparison of Visual-Based Cervical Cancer Screening Tests with Pap Smear in a North Indian Tertiary Centre: A Prospective Randomised Observational Study

Abstract

Cervical cancer is the second leading cause of female cancers in India. Considering the latency of the disease, screening of precancerous lesions of cervix forms a key aspect of disease prevention and control. Limited research has been conducted in the region of Uttarakhand where estimated incidence of cervical cancer is quite significant. There is no provision available for mass or regular screening for cervical cancer in the state as well. With this background, the present study was planned to compare the diagnostic accuracy of visual-based methods with conventional Pap smear in order to provide an affordable and feasible screening modality in the subserved population of hilly terrains of Uttarakhand. In the present study, we aim to study the comparability of diagnostic accuracy of visual-based screening tests (VIA, VILI) and Pap smear. Total 195 consenting participants were recruited from Gynaecology OPD, AIIMS Rishikesh from January to December 2018. All participants were subjected to standard Pap smear testing and then randomly allocated to 3 groups namely (A) Pap smear only group, (B) VIA group and (C) VILI group. Colposcopy was performed on all the participants as a standard diagnostic test to confirm the screening test findings keeping the cutoff as CIN 2 + lesions in the three groups, and guided biopsy was performed on those with Reid’s Colposcopic Index (RCI) ≥ 6. Observations were analysed using OpenEpi Version 7.0 software to compute the tests of validity for individual screening tests and combination of visual tests with Pap smear. The tests of validity for VIA, VILI, and Pap smear were as follows: sensitivity of, 50%, 50%, 25%, specificity of 95%, 98%, 95%, for VIA, VILI, and Pap smear, respectively. Diagnostic accuracy was 92.3%, 92.31%, and 90% for VIA, VILI and Pap smear, respectively. Visual-based screening tests demonstrated comparable accuracy as Pap smear. All three screening tests had diagnostic accuracy to the tune of 90%. Thus visual tests can be used in resource poor settings to screen cervical cancer where Pap smear is not feasible logistically without compromising accuracy.