The ATHENA human papillomavirus study: design, methods, and baseline results

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• 作者：Thomas C. Wright Jr ; MD^a ; Mark H. Stoler ; MD^b ; Catherine M. Behrens ; MD ; PhD^c ; ^{catherine_m.behrens@roche.com} ; Raymond Apple ; PhD^c ; Toniann Derion ; PhD^c ; Teresa L. Wright ; MD^c
• 关键词：Addressing the Need for Advanced HPV Diagnostics study ; cervical cancer screening ; cervical intraepithelial neoplasia ; genotype ; human papillomavirus deoxyribonucleic acid testing
• 刊名：American Journal of Obstetrics and Gynecology
• 出版年：2012
• 出版时间：January, 2012
• 年：2012
• 卷：206
• 期：1
• 页码：46.e1-46.e11
• 全文大小：1460 K

文摘

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Objective

The objective of the study was to describe baseline data from Addressing the Need for Advanced HPV Diagnostics, a prospective, multicenter US cervical cancer screening trial.

Study Design

A total of 47,208 women aged 21 years or older undergoing routine screening were enrolled; liquid-based cytology and human papillomavirus (HPV) testing were performed. Women with abnormal cytology underwent colposcopy, as did high-risk HPV (hrHPV)-positive women and a random subset of women negative by both tests aged 25 years or older. Verification bias adjustment was applied; 95 % confidence intervals were computed by the bootstrap method.

Results

The prevalence of cytologic abnormalities was 7.1 % . hrHPV, HPV 16, and HPV 18 were detected using the cobas HPV Test in 12.6 % , 2.8 % , and 1.0 % of women, respectively. Both cytologic abnormalities and hrHPV positivity declined with increasing age. The adjusted prevalence of cervical intraepithelial neoplasia grade 2 (CIN2) or greater in women aged 25-34 years was 2.3 % , decreasing to 1.5 % among older women.

Conclusion

The Addressing the Need for Advanced HPV Diagnostics study provides important estimates of the prevalence of cytologic abnormalities, hrHPV positivity, and CIN2 or greater in a US screening population.