Primary cervical screening with high risk human papillomavirus testing: observational study.

To provide the first report on the main outcomes from the prevalence and incidence rounds of a large pilot of routine primary high risk human papillomavirus (hrHPV) testing in England, compared with contemporaneous primary liquid based cytology screening. Observational study. The English Cervical Screening Programme. 578 547 women undergoing cervical screening in primary care between May 2013 and December 2014, with follow-up until May 2017; 183 970 (32%) were screened with hrHPV testing. Routine cervical screening with hrHPV testing with liquid based cytology triage and two early recalls for women who were hrHPV positive and cytology negative, following the national screening age and interval recommendations. Frequency of referral for a colposcopy; adherence to early recall; and relative detection of cervical intraepithelial neoplasia grade 2 or worse from hrHPV testing compared with liquid based cytology in two consecutive screening rounds. Baseline hrHPV testing and early recall required approximately 80% more colposcopies, (adjusted odds ratio 1.77, 95% confidence interval 1.73 to 1.82), but detected substantially more cervical intraepithelial neoplasia than liquid based cytology (1.49 for cervical intraepithelial neoplasia grade 2 or worse, 1.43 to 1.55; 1.44 for cervical intraepithelial neoplasia grade 3 or worse, 1.36 to 1.51) and for cervical cancer (1.27, 0.99 to 1.63). Attendance at early recall and colposcopy referral were 80% and 95%, respectively. At the incidence screen, the 33 506 women screened with hrHPV testing had substantially less cervical intraepithelial neoplasia grade 3 or worse than the 77 017 women screened with liquid based cytology (0.14, 0.09 to 0.23). In England, routine primary hrHPV screening increased the detection of cervical intraepithelial neoplasia grade 3 or worse and cervical cancer by approximately 40% and 30%, respectively, compared with liquid based cytology. The very low incidence of cervical intraepithelial neoplasia grade 3 or worse after three years supports extending the screening interval.

Informations de copyright

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Déclaration de conflit d'intérêts

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: MR, CM, and SM received financing from Public Health England (PHE) for the epidemiological evaluation. MR attended meetings with various HPV assay manufacturers and received a fee for lecture from Hologic paid to employer. JR, KD, and RS were or are employed by PHE. JT received fees for lectures from Roche, Qiagen, and Hologic; conference registration, accommodation and travel from Sanofi Pasteur; consultancy fees and shareholder in Zilico; patent for electrical impedance spectroscopy in detection of cervical intraepithelial neoplasia with Zilico. KE received fees for lectures from Beckton Dickinson and Roche and conference accommodation and travel from Hologic, Abbott, Becton Dickinson, and Roche. JS received personal speaker bureau fees from Beckton Dickinson and personal medical advisory board fees from Zilico. KD, KE, CE, TG, VF, XT, AS, JP, MH, KH, PT, TL, and DS received funding from PHE to support the NHS screening laboratory activity for the pilot. VF is employed by Norfolk and Norwich University Hospitals NHS Foundation Trust and received the speaker fees from Roche for conferences and travel and accommodation from Roche and Hologic for training and user group meetings. AS received speaker fees from Roche, travel and accommodation from Roche for training, travel and accommodation from Abbott for a user group meeting, attended meetings with HPV assay manufacturers, and received kits for assay validation from Roche, Abbott, Hologic, Becton Dickinson, and Cepheid. HK is the Chair of the Advisory Committee for Cervical Screening (PHE), but the views expressed in this manuscript are those of the author and do not represent the view of PHE. There are no other relationships or activities that could appear to have influenced the submitted work.