Abstract
BackgroundThis cross-sectional pilot study evaluates diagnostic accuracy of live colposcopy versus static image Swede-score evaluation for detecting significant precancerous cervical lesions greater than, or equal to grade 2 severity (CIN2+).MethodsVIA or HrHPV positive women were examined using a mobile colposcope, in a rural clinic in Kolkata, India. Live versus static Swede-score colposcopy assessments were made independently. All assessments were by gynecologists, junior or expert. Static image assessors were blinded to live scoring, patient information and final histopathology result. Primary outcome was the ability to detect CIN2+ lesions verified by directed biopsies. Diagnostic accuracy was calculated for live versus static Swede-score in detecting CIN2+ lesions, as well as for interclass correlation.Results495 images from 94 VIA positive women were evaluated in this study. Thirteen women (13.9%) had CIN2+ on biopsy. No significant difference was found in the detection of CIN2+ lesions between live and static assessors (area under curve = 0.69 versus 0.71, p = 0.63). A Swede-score of 4+, had a sensitivity of 76.9% (95% CI 46.2–95.0%) and 84.6% (95% CI 54.6–98.1%), for live- and static-image assessment respectively. The corresponding positive predictive values were found to be 90.9% (95% CI 75.7–98.1%) and 92.6% (95% CI 75.7–99.1%). The interclass correlation was good (kappa statistic = 0.60) for the senior static assessors.ConclusionsSwede-score evaluation of static colposcopy images was found to reliably detect CIN2+ lesions in this study. Larger studies are needed to further develop the colposcopy telemedicine concept which may offer reliable guidance in management where direct specialist input is not available.Trial registrationEthical approval of the study was obtained by the Chittaranjan National Cancer Institute (CNCI) Human Research Ethics Committee (4.311/27/2014). The trial was retrospectively registered in the Clinical Trails Registry of India CTRI/2018/03/012470.
Highlights
This cross-sectional pilot study evaluates diagnostic accuracy of live colposcopy versus static image Swede-score evaluation for detecting significant precancerous cervical lesions greater than, or equal to grade 2 severity (CIN2+)
We investigate the differences in accuracy between live specialist assessment and static image assessment using the Gynocular colposcope and its mobile phone application
The incidence of CIN2+ was 13.8%, as expected in an unscreened general population [10]. This was mostly detectable by Visual Inspection with Acetic acid (VIA) (n = 12/13 CIN2+ lesions were VIA positive, 92.3%)
Summary
This cross-sectional pilot study evaluates diagnostic accuracy of live colposcopy versus static image Swede-score evaluation for detecting significant precancerous cervical lesions greater than, or equal to grade 2 severity (CIN2+). Almost 9 out of 10 deaths from cervical cancer occur in low- and middle-income countries (LMIC) [3]. This is largely due to a lack of organised screening programs, shortage of specially trained clinicians, as well as the high costs and immobility of diagnostic equipment [4, 5]. While not specific to cervical cancer screening, previous studies have found a positive association between telemedicine and increased access to specialized care, decreased costs to patient, reduced treatment costs at earlier stage of disease, and overall increased socioeconomic returns [7]. With increasing access to internet and mobile phone connectivity, telemedicine offers potential solutions for improving access and quality of cervical screening for women in low-resource settings as well as those who have reduced access to screening services due to geographical station [8,9,10,11,12]
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