Comparative performance of novel self-sampling methods in detecting high-risk human papillomavirus in 30,130 women not attending cervical screening

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• 作者：Remko P. Bosgraaf ; Viola M.J. Verhoef ; Leon F.A.G. Massuger ; Albert G. Siebers ; Johan Bulten ; Gabrië ; lle M. de Kuyper-de Ridder ; Chris J.M. Meijer ; Peter J.F. Snijders ; Danië ; lle A.M. Heideman ; Joanna IntHout ; Folkert J. van Kemenade ; Willem J.G. Melchers and Ruud L.M. Bekkers
• 关键词：population-based cervical screening ; non-responders ; human papillomavirus ; cervical intraepithelial neoplasia ; participation ; self-sampling
• 刊名：International Journal of Cancer
• 出版年：2015
• 出版时间：1 February 2015
• 年：2015
• 卷：136
• 期：3
• 页码：646-655
• 全文大小：465K
• ISSN：1097-0215

文摘

We determined whether the participation rate for a brush-based cervicovaginal self-sampling device is noninferior to the participation rate for a lavage-based one for testing for hrHPV (high-risk human papillomavirus). Additionally, positivity rates for hrHPV, the detection rates for cervical intraepithelial neoplasia grades 2 and 3 or worse (CIN2+/3+), and user comfort were compared. A total of 35,477 non-responders of the regular cervical screening program aged 33–63 years were invited to participate. Eligible women (n = 30,130) were randomly assigned to receive either a brush-based or a lavage-based device, and a questionnaire for reporting user convenience. Self-sampling responders testing hrHPV-positive were invited for a physician-taken sample for cytology; triage-positive women were referred for colposcopy. A total of 5,218 women participated in the brush-based sampling group (34.6%) and 4809 women in the lavage-based group (31.9%), i.e. an absolute difference of 2.7% (95%CI 1.8–4.2). The hrHPV-positivity rates in the two groups were identical (8.3%, relative risk (RR) 0.99, 95%CI 0.87–1.13). The detection of CIN2+ and CIN3+ in the brush group (2.0% for CIN2+; 1.3% for CIN3+) was similar to that in the lavage group (1.9% for CIN2+; 1.0% for CIN3+) with a cumulative RR of 1.01, 95%CI 0.83–1.24 for CIN2+ and 1.25, 95%CI 0.92–1.70 for CIN3+. The two self-sampling devices performed similarly in user comfort. In conclusion, offering a brush-based device to non-responders is noninferior to offering a lavage-based device in terms of participation. The two self-sampling methods are equally effective in detecting hrHPV, CIN2+/CIN3+ and are both well accepted.