title: Comparative performance of novel self-sampling methods in detecting high-risk human papillomavirus in 30,130 women not attending cervical screening.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynaecology, Radboud University Medical Center, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Remko P
authors.initials: RP
authors.lastname: Bosgraaf
authors.forename: Viola M J
authors.initials: VM
authors.lastname: Verhoef
authors.forename: Leon F A G
authors.initials: LF
authors.lastname: Massuger
authors.forename: Albert G
authors.initials: AG
authors.lastname: Siebers
authors.forename: Johan
authors.initials: J
authors.lastname: Bulten
authors.forename: Gabriëlle M
authors.initials: GM
authors.lastname: de Kuyper-de Ridder
authors.forename: Chris J M
authors.initials: CJ
authors.lastname: Meijer
authors.forename: Peter J F
authors.initials: PJ
authors.lastname: Snijders
authors.forename: Daniëlle A M
authors.initials: DA
authors.lastname: Heideman
authors.forename: Joanna
authors.initials: J
authors.lastname: IntHout
authors.forename: Folkert J
authors.initials: FJ
authors.lastname: van Kemenade
authors.forename: Willem J G
authors.initials: WJ
authors.lastname: Melchers
authors.forename: Ruud L M
authors.initials: RL
authors.lastname: Bekkers
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000821:virology*; D055088:Early Detection of Cancer; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D002583:Uterine Cervical Neoplasms / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000821:virology
keywords: cervical intraepithelial neoplasia; human papillomavirus; non-responders; participation; population-based cervical screening; self-sampling