PILOT STUDY TO EVALUATE PERFORMANCE OF A LOW-COST, LOCALLY DEVELOPED DIGITAL PORTABLE COLPOSCOPE AND CONVENTIONAL COLPOSCOPE IN CERVICAL CANCER SCREENING

Abstract

Abstract

Introduction: Cervical cancer is the second most common cancer observed in women. The majority of cases occur in resource-poor countries where there is inaccessibility to effective screening methods. Numerous effective screening methods are available, including Pap smear, LBC (liquid-based cytology), VIA (visual inspection of the cervix with acetic acid), VILI (visual inspection of the cervix with Lugol’s iodine), HPV (human papillomavirus) testing, digital cervicography, and colposcopy. Colposcopy is a reliable and precise method for identifying and treating pre-malignant cervical lesions. However, conventional colposcopes are costly, and they require a well-equipped setup with trained personnel, making them unfeasible for community-based screening of cervical cancer. Considering this, we designed and developed a low-cost, locally manufactured, and portable digital colposcope suitable for community-based screening. We conducted a pilot study to assess the diagnostic accuracy, sensitivity, and specificity of the locally developed colposcope for screening cervical cancer in comparison with the conventional colposcopes.

Methods: This study was conducted at Jawaharlal Nehru Medical College, Sawangi (M), Wardha, from June 15 through December 15, 2021. Initially, a low-cost, locally developed, and portable digital colposcope was designed, and a prototype was created. We enrolled women between 25 and 65 years of age who met the inclusion criteria and voluntarily consented. Colposcopy was performed using both a conventional colposcope and the low-cost, Images captured, Swede scoring, and marking of biopsy sites by both colposcopes were compared by a reviewer blinded to the device assignments. Cervical lesions were biopsied and evaluated using gold-standard histopathological methods to confirm diagnoses.

Results: The mean age of the study participants was 41.1 years. There was substantial concordance between the devices, with a Cohen’s kappa coefficient of 0.999 (95% CI: 0.998, 1.000) (p < 0.0001) suggesting that the low-cost colposcope can perform on par with the conventional colposcope. The sensitivity was 100% (95% CI: 90.26-100%), while the specificity was 8.33% (95% CI: 0.21-38.48%). The accuracy was 77.08% (95% CI: 62.69-87.97%). The locally developed colposcope performed better in terms of the visibility of the cervix, sharpness, and brightness of the image, with mean scores of 4.6, 4.8, and 4.9, respectively, vs. 4.1, 3.6, and 3.8 for the conventional colposcope on a 5-point scale.

Conclusions: This pilot study assessed the performance of a newly developed, low-cost, locally manufactured, and portable digital colposcope and compared it with a conventional colposcope. The findings will serve as the foundation for conducting large-scale, multicenter trials to determine whether the low-cost colposcope can enhance cervical cancer screening at the community level in low- and middle-income countries, thus facilitating the achievement of the World Health Organization’s target of screening 70% of women by the age of 45.