Dataset Information

Evaluation of human-papillomavirus screening for cervical cancer in China's rural population.

ABSTRACT:

Background and objective

Human papillomavirus (HPV) testing has become a preferred cervical cancer screening. However, most HPV infections are harmless and additional tests are required to screen HPV positive women. The objective of this study is to determine the optimal triage strategies for HPV positive women in China's rural population.

Methods

A population-based screening was performed at seven rural counties of Jiangxi province, between October 2014 to January 2016. A total of 18,000 women aged 35-64 years were enrolled in this study. The primary screening was performed using CareHPV, HC-2, Cobas ®4,800 or HybriMax. Positive women were further screened with five triage tests: (1) Liquid-based cytology test (LBC); (2) conventional Pap cytology test (Pap smear); (3) HPV16, 18 detection; (4) viral load; and (5) visual inspection with acetic acid and Lugol's iodine (VIA/VILI). Women who were tested positive were referred for colposcopy. The five triage tests were compared with respect to sensitivity, specificity, referral rate, cost and diagnostic time.

Results

Complete data were available for 17,782 women. The HPV prevalence was 13.6%. Referral rates for colposcopy were 4.5%, 2.8%, 2.8%, 6.6%, and 3.7% with LBC, Pap smear, HPV16/18, viral load, and VIA/VILI, respectively. The sensitivity of the above triage tests was 65.8%, 51.9%, 86.8%, 73.3%, and 41.7%, respectively. The specificity was 69.8%, 81.0%, 85.8%, 52.2% and 65.3%, respectively. The average time to diagnosis was significantly lower with HPV16/18, viral load and VIA/VILI than LBC and Pap smear. In addition, screening cost that leads to identify one HSIL+ woman was the lowest with viral load.

Conclusion

Our data indicate that HPV16/18 and viral load are the optimal triage strategies for HPV screening in China's rural population.

SUBMITTER: Li L

PROVIDER: S-EPMC6927345 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluation of human-papillomavirus screening for cervical cancer in China's rural population.

Li Ling L Zheng Ziwen Z Li Longyu L

PeerJ 20191220

<h4>Background and objective</h4>Human papillomavirus (HPV) testing has become a preferred cervical cancer screening. However, most HPV infections are harmless and additional tests are required to screen HPV positive women. The objective of this study is to determine the optimal triage strategies for HPV positive women in China's rural population.<h4>Methods</h4>A population-based screening was performed at seven rural counties of Jiangxi province, between October 2014 to January 2016. A total o ...[more]

PMID: 31875147

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Project description:Current US cervical cancer screening guidelines do not differentiate recommendations based on a woman's human papillomavirus (HPV) vaccination status. Changes to cervical cancer screening policies in HPV-vaccinated women should be evaluated. We utilized an individual-based mathematical model of HPV and cervical cancer in US women to project the health benefits, costs, and harms associated with screening strategies in women vaccinated with the bivalent, quadrivalent, or nonavalent vaccine. Strategies varied by the primary screening test, including cytology, HPV, and combined cytology and HPV "cotesting"; age of screening initiation and/or switching to a new test; and interval between routine screens. Cost-effectiveness analysis was conducted from the societal perspective to identify screening strategies that would be considered good value for money according to thresholds of $50 000 to $200 000 per quality-adjusted life-year (QALY) gained. Among women fully vaccinated with the bivalent or quadrivalent vaccine, optimal screening strategies involved either cytology or HPV testing alone every five years starting at age 25 or 30 years, with cost-effectiveness ratios ranging from $34 680 to $138 560 per QALY gained. Screening earlier or more frequently was either not cost-effective or associated with exceedingly high cost-effectiveness ratios. In women vaccinated with the nonavalent vaccine, only primary HPV testing was efficient, involving decreased frequency (ie, every 10 years) starting at either age 35 years ($40 210 per QALY) or age 30 years ($127 010 per QALY); with lower nonavalent vaccine efficacy, 10-year HPV testing starting at earlier ages of 25 or 30 years was optimal. Importantly, current US guidelines for screening were inefficient in HPV-vaccinated women. This model-based analysis suggests screening can be modified to start at later ages, occur at decreased frequency, and involve primary HPV testing in HPV-vaccinated women, providing more health benefit at lower harms and costs than current screening guidelines.

Project description:ImportanceAs cervical cancer screening transitions from Papanicolaou cytologic screening to primary human papillomavirus (HPV) testing worldwide, effective triage tests are needed to decide who among the HPV-positive women should receive further diagnostic evaluation to avoid unnecessary colposcopies and biopsies.ObjectiveTo evaluate the performance of the p16/Ki-67 dual stain (DS) and HPV16/18 genotyping for the triage of HPV-positive women.Design, setting, and participantsA prospective observational study was conducted within the cervical cancer screening program at Kaiser Permanente Northern California of 3225 HPV-positive women undergoing HPV and Papanicolaou cytologic testing with a valid DS result from September 16 to October 31, 2015, with follow-up through December 31, 2018.ExposuresHuman papillomavirus screening with partial genotyping and cytologic triage compared with DS triage.Main outcomes and measuresCervical intraepithelial neoplasia grade 3 or more severe (CIN3+) and grade 2 or more severe (CIN2+), diagnosed within 3 years after sample collection.ResultsA total of 3225 women (mean [SD] age, 37.9 [11.3] years) participated in the study. For triage of HPV-positive women with partial genotyping, DS showed better risk stratification for CIN3+ than did Papanicolaou cytologic testing, with women with positive DS results having a higher risk than women with positive Papanicolaou test results for CIN3+ (218 of 1818 [12.0%; 95% CI, 10.5%-13.5%] vs 219 of 2128 [10.3%; 95% CI, 9.0%-11.6%]; P = .005). Similarly, DS showed better risk stratification for CIN3+ compared with Papanicolaou cytologic testing in HPV-positive women, irrespective of genotyping. The greatest reassurance against CIN3+ was observed in HPV16/18-negative women with negative DS results, with a risk low enough to extend retesting intervals. Dual stain triage strategies required substantially fewer colposcopies per detection of CIN3+ compared with Papanicolaou cytologic testing, with a 32.1% (859 of 2677) reduction of colposcopies compared with the currently recommended triage strategy of HPV screening with Papanicolaou cytologic testing. Results for CIN2+ were very similar.Conclusions and relevanceTriage of HPV-positive women with DS was superior to Papanicolaou cytologic testing in this study, demonstrating equal immediate detection of precancerous lesions and substantially reduced referral to colposcopy. These findings suggest that DS can safely replace Papanicolaou cytologic testing as a triage strategy for primary HPV screening, and that retesting intervals in HPV16/18-negative women with negative DS results can be safely extended to 3 years.

Project description:ImportanceCervical cancer screening is a lifesaving intervention, with an array of approaches, including liquid-based cytology (LBC), molecular testing for human papillomavirus (HPV) infection, and combinations via parallel cotesting or sequential triage. Maximizing screening efficacy while minimizing overtreatment is vital, especially when considering how the HPV vaccine will affect the interpretation of results.ObjectivesTo estimate the likely outcomes of different screening modalities and to model how the increasing uptake of the HPV vaccine could affect the interpretation of screening results.Design, setting, and participantsThis decision analytic model established a simple Markov model to compare the outcomes of different cervical cancer screening modalities on a simulated population of women (aged ≥25 years), considering different levels of HPV vaccination.Main outcomes and measuresThe number of cases of cervical intraepithelial neoplasia (CIN) grade 2 and 3 detected and missed, the number of false positives, and the number of tests required to achieve a given level of accuracy. Positive and negative predictive values of different modalities were simulated under varying levels of HPV vaccination and therefore HPV prevalence.ResultsIn a simulated population of 1000 women aged 25 years and older with an HPV prevalence of 2%, HPV-based modalities outperformed LBC-based approaches, detecting 19% more true positives (HPV test sensitivity, 89.9% [95% CI, 88.6%-91.1%]; LBC test sensitivity, 75.5% [95% CI, 66.6%-82.7%]). While cotesting markedly reduced missed cases, detecting 29% more true positives than LBC alone (19.5 [95% CI, 19.3-19.7] per 1000 women screened vs 15.1 [95% CI, 13.3-16.5] per 1000 women screened), it unacceptably increased excess colposcopy referral by 94% (184.4 [95% CI, 181.8-188.0] false positives per 1000 women screened vs 95.1 [95% CI, 93.1-97.0] false positives per 1000 women screened). By contrast, triage testing with reflex screening substantially reduced false positives by a factor of approximately 10 (eg, HPV with LBC triage, 9.6 [95% CI, 9.3-10.0] per 1000 women screened). Over a lifetime of screening, reflex approaches with appropriate test intervals maximized therapeutic efficacy; as HPV vaccination rates increased, HPV-based screening approaches resulted in fewer unnecessary colposcopies than LBC approaches (HPV testing, 80% vaccine coverage: 44.1 [95% CI, 40-45.9] excess colposcopies; LBC testing, 80% vaccine coverage: 96.9 [95% CI, 96.8-97.0] excess colposcopies).Conclusions and relevanceIn this decision analytic model, the effectiveness of cervical cancer screening was dependent on the prevalence of cervical dysplasia and/or HPV infection or vaccination in a population as well as the sensitivity and specificity of various modalities. Although screening is lifesaving, overtesting or modalities inappropriate to the target population may cause significant harm, including overtreatment.

Dataset Information

Evaluation of human-papillomavirus screening for cervical cancer in China's rural population.

Background and objective

Methods

Results

Conclusion

Publications

Evaluation of human-papillomavirus screening for cervical cancer in China's rural population.

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