Validation of the 2019 American Society of Colposcopy and Cervical Pathology Online Cervical Cancer Screening Program via 9 Large-Cohort Data of Chinese Women

Wenkui Dai & Ruifang Wu et al. · 2024-10-22

Objective

The aim of the study is to validate the applicability and performance of the 2019 US risk-based guideline for Chinese women.

Materials and Methods

The authors analyzed 10,055 cases with data on human papillomavirus testing, cytology, and pathologically confirmed diagnosis (analysis-set). According to the 2019 US risk-based guideline, the authors recorded the risk value and triage recommendations for each case. Then, they assessed the concordance of the guideline triage recommendations with pathology diagnosis for the relevant case from the real-world projects.

Results

Among the analysis-set, 9,495 cases with an estimated risk value were identified as analysis cohort while the remaining 560 cases were cataloged as “special cases.” Among the analysis cohort, 960 and 526 cases were pathologically confirmed as cervical intraepithelial neoplasia (CIN) 2+ and CIN3+, respectively. The US risk-based guideline recommended colposcopy or more aggressive interventions (Colp+) for 86.8% (833/960) of the CIN2+ and 95.8% (504/526) of the CIN3+ cases, with 87.1% sensitivity and 82.5% specificity for CIN3+ cases (AUC = 0.926, p < .0001). The US risk-based recommended no-Colp for 98.0% (6,142/6,269) of the pathologically confirmed CIN1 or benign cases. In addition, 97.3% (545/560) of the “special cases” cases were recommended as Colp+.

Conclusions

The 2019 US risk-based guideline works well with satisfied clinical sensitivity for CIN2+ and CIN3+ and seems applicable for cervical cancer screening in China.

Authors
Wenkui Dai, Chunlei Guo, Qing Yang, Yi Zhang, Di Wu, Chun Wang, Jerome L. Belinson, Changzhong Li, Hui Du, Xinfeng Qu, Ruifang Wu