Abstract
BackgroundRandomized controlled trials have shown a higher sensitivity and longer negative predictive value of high-risk human papillomavirus (HPV) testing than cytology for cervical cancer screening; however, little is known about the effectiveness of HPV testing in middle-income countries. Understanding the characteristics of HPV testing may increase the priority of HPV testing in health policies. The study aims to evaluate the effectiveness of HPV testing in the national cervical cancer screening programme in China.MethodsWe performed a nationwide, population-based study using individual data from the national cervical cancer screening programme in rural China between 2015 and 2017. The analyses included 1,160,981 women aged 35–64 years who underwent cytology alone or high-risk HPV testing with cytology or genotyping triage. The main outcome was cervical intraepithelial neoplasia 2 or worse (CIN2+). We used multivariate logistic regressions and performed sensitivity analyses with propensity score matching to compare the screening positive, colposcopy referral, detection rate, and positive predictive value (PPV).ResultsThe screening positive rates for HPV testing and cytology were 10.1% and 4.0%, respectively. The per protocol colposcopy referral rate of HPV testing was significantly lower than that of cytology (3.5% vs 4.0%), and this difference was mostly due to the low referral threshold of cytology (≥ASC-US). Overall, HPV testing detected more CIN2+ (5.5 vs. 4.4 per 1000, adjusted odds ratio [aOR]=1.18, 95% confidence interval 1.11–1.25) and had a higher PPV (13.8% vs 10.9%, aOR 1.29, 95% CI 1.21–1.37) than cytology. The colposcopy referrals of HPV testing in comparison to cytology differed by income status; it significantly increased in lower-middle-income areas (3.7% vs 3.1%, aOR 1.21, 95% CI 1.17–1.25) and significantly decreased in upper-middle-income areas (3.4% vs 4.9%, aOR 0.69, 95% CI 0.67–0.71). Sensitivity analyses demonstrated the reliability and robustness of the results.ConclusionsThe introduction of HPV testing could improve both the CIN2+ detection rate and efficiency of cervical cancer screening programme, supporting the introduction of primary screening with high-risk HPV testing in China. Further study is needed to investigate the long-term effect of this change.
Highlights
Randomized controlled trials have shown a higher sensitivity and longer negative predictive value of high-risk human papillomavirus (HPV) testing than cytology for cervical cancer screening; little is known about the effectiveness of HPV testing in middle-income countries
HPV testing detected more CIN2+ (5.5 vs. 4.4 per 1000, adjusted odds ratio [aOR]=1.18, 95% confidence interval 1.11–1.25) and had a higher positive predictive value (PPV) (13.8% vs 10.9%, aOR 1.29, 95% Confidence interval (CI) 1.21–1.37) than cytology
The colposcopy referrals of HPV testing in comparison to cytology differed by income status; it significantly increased in lower-middle-income areas (3.7% vs 3.1%, aOR 1.21, 95% CI 1.17–1.25) and significantly decreased in upper-middle-income areas (3.4% vs 4.9%, aOR 0.69, 95% CI 0.67–0.71)
Summary
Randomized controlled trials have shown a higher sensitivity and longer negative predictive value of high-risk human papillomavirus (HPV) testing than cytology for cervical cancer screening; little is known about the effectiveness of HPV testing in middle-income countries. Some high-income countries have fully or partially switched from cytology-based screening to HPVbased screening [6], and the introduction of HPV testing in the Netherlands [7] and England [8] has been assessed. These studies compared the effectiveness of HPV testing with cytology triage to cytology with HPV triage, and as expected, both more colposcopy referrals (Netherlands, 3% vs 1%; England, 7% vs 5%) and approximately 1.5 times more CIN2+ detection were found with HPV-based screening than cytology-based screening. More colposcopy referrals may potentially lead to physical or psychological harm [9, 10], and this potential drawback should be considered before the introduction of HPV testing
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