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ABSTRACT: Introduction: Colposcopy is important for triaging any abnormal cervical screening test. Scarcity of trained colposcopists and colposcopy centers is a big hurdle to screening programs in low- and middle-income countries. Objectives of the Study: The objective was to assess the performance of the artificial intelligence incorporated into the mobile optical device technologies (ODT) Enhanced Visual Assessment (EVA visual check) against physician colposcopic diagnosis and the gold standard of histopathology. Materials and Methods: It was a cross-sectional observational study conducted on women referred to a colposcopy clinic following an abnormal screening test. Colposcopic examination was performed by colposcopists using the MobileODT EVA system. Physician's impression and Visual Check analysis were compared with the final histopathological analysis or cytology. Cases with normal cytology and normal colposcopy did not undergo biopsy, and these were considered normal. Results: A total of 2050 women were screened, and 147 screen-positive women were recruited in the study. EVA Visual Check had a sensitivity of 86.8% (75–95), specificity of 28.7% (20–39), positive predictive value (PPV) of 40.7% (32–50), negative predictive value (NPV) of 79.4% (62–91), and diagnostic accuracy of 49.7% (41–58) for diagnosing cervical intraepithelial neoplasia (CIN) 1+ lesions. EVA Visual Check has a sensitivity of 89.3% (72–98), specificity of 26.1% (18–35), PPV of 22.1% (15–31), NPV of 91.2% (76–98), and diagnostic accuracy of 38.1% (30–46) for CIN 2+ lesions. Conclusion: MobileODT EVA colposcope with AI has sensitivity comparable to physician's diagnosis, whereas specificity, PPV, and NPV were less than that of physician's diagnosis. It could prove valuable for triage of screen-positive women for further management. [ABSTRACT FROM AUTHOR]

In low-resource settings, a point-of-care test for cervical cancer screening that can give an immediate result to guide management is urgently needed. A transvaginal digital device, "Smart Scope®" (SS), with an artificial intelligence-enabled auto-image-assessment (SS-AI) feature, was developed. In a single-arm observational study, eligible consenting women underwent a Smart Scope®-aided VIA-VILI test. Images of the cervix were captured using SS and categorized by SS-AI in four groups (green, amber, high-risk amber (HRA), red) based on risk assessment. Green and amber were classified as SS-AI negative while HRA and red were classified as SS-AI positive. The SS-AI-positive women were advised colposcopy and guided biopsy. The cervix images of SS-AI-negative cases were evaluated by an expert colposcopist (SS-M); those suspected of being positive were also recommended colposcopy and guided biopsy. Histopathology was considered a gold standard. Data on 877 SS-AI, 485 colposcopy, and 213 histopathology were available for analysis. The SS-AI showed high sensitivity (90.3%), specificity (75.3%), accuracy (84.04%), and correlation coefficient (0.670, p = 0.0) in comparison with histology at the CINI+ cutoff. In conclusion, the AI-enabled Smart Scope® test is a good alternative to the existing screening tests as it gives a real-time accurate assessment of cervical health and an opportunity for immediate triaging with visual evidence. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the role of p16Ink4a immunostaining for the detection of cervical intraepithelial neoplasia (CIN2+) in women who had a positive screening test using visual inspection with acetic acid (VIA). Methods: Opportunistic screening of women (30–50 years) coming to the gynecology clinic by VIA was performed; the screen-positive women were included in the study which had the institutional review board (IRB) approval. A cytology slide for p16Ink4a immunostaining, colposcopy, and biopsy was then performed sequentially. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of p16Ink4a immunocytochemistry were evaluated with histopathology as the gold standard. Results: p16Ink4a positivity showed a linear correlation with the increasing grade of CIN. p16Ink4a positivity was seen in 6% of CIN 1, 80% of CIN 2, 100% of CIN 3, and squamous cell carcinoma. The sensitivity and specificity of p16Ink4a immunocytochemistry for detecting CIN 2 or more was 87.5% (95%CI 61.65–98.45) and 97.06% (95%CI 84.67–99.93). Colposcopy had an equal sensitivity of 87.5% (95% CI 61.65–98.45) and specificity of 50% (95% CI 32.43–67.57), respectively. Conclusion: With high sensitivity and specificity, p16Ink4a immunocytochemistry could be a viable option for triaging VIA-positive women. [ABSTRACT FROM AUTHOR]

In India, there are marked variations in resources for cervical cancer screening. For the first time, resource‐stratified screening guidelines have been developed that will be suitable for low middle‐income countries with similar diversities. The current article describes the process and outcomes of these resource stratified guidelines for screening and treatment of preinvasive lesions of cervix. Evidence from literature was collated and various guidelines were reviewed by an expert panel. Based on the level of evidence, guidelines were developed for screening by human papillomavirus (HPV) testing, cytology and visual inspection after application of acetic acid (VIA), and management of screen positive lesions in different resource settings. Expert opinion was used for certain country‐specific situations. The healthcare system was stratified into two resource settings – good or limited. The mode of screening and treatment for each was described. HPV testing is the preferred method for cervical cancer screening. VIA by trained providers is especially suitable for low resource settings until an affordable HPV test becomes available. Healthcare providers can choose the most appropriate screening and treatment modality. A single visit approach is encouraged and treatment may be offered based on colposcopy diagnosis ('see and treat') or even on the basis of HPV test or VIA results ('screen and treat'), if compliance cannot be ensured. The Federation of Obsterician and Gynaecologists of India Good Clinical Practice Recommendations (FOGSI) GCPR are appropriately designed for countries with varied resource situations to ensure an acceptable cervical cancer prevention strategy. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study was to compare visual inspection with acetic acid (VIA) with cervical cytology for cervical cancer screening in pregnant women. Settings and Design: A prospective cohort study was conducted after institutional ethical committee approval in a tertiary care hospital in Northern India. Pregnant women of gestational age <28 weeks were randomly recruited from the antenatal clinic. Subjects and Methods: All eligible women had a Pap smear followed by VIA; colposcopy was performed if either test was positive. Swede score was used for grading of the acetowhite lesion; biopsy was planned if Swede score was ≥8. Statistical Analysis Used: The sensitivity, specificity, and predictive values for both screening methods were compared with colposcopy as the reference standard. Results: There were 370 low‑risk pregnant women in the age group of 20-36 years in the study with a mean parity was 2.1, and the median period of gestation of 14.6 weeks. Abnormal Pap cytology was seen in 5.9% (n = 22) of patients; the abnormalities were ASCUS in 13 (59%), LSIL in 4 (18.2%), and AGC-NOS in 5 (22.7%) patients. VIA positivity was found in 8.4% (n = 31). The positive predictive value was 31.8% for cervical cytology and 48.4% for VIA (P = 0.001). No invasive lesion was detected. Positive predictive value of VIA was significantly higher than Pap cytology for detection of abnormal lesions. Conclusions: VIA is a cost‑effective method with better predictive value than Pap smear for cervical cancer screening in pregnant women. [ABSTRACT FROM AUTHOR]