Extension of cervical screening intervals with primary human papillomavirus testing: observational study of English screening pilot data

Footnotes

• Contributors: CM and FP contributed equally. KD and HK contributed equally. The HPV pilot steering group designed the pilot study. MR undertook statistical analyses, wrote the original draft, and finalised the manuscript, was involved in the decision to submit, and is the guarantor. CM provided data management, reviewed the manuscript, and was involved in the decision to submit. FP helped with the statistical analyses, reviewed the manuscript, and was involved in the decision to submit. KC, KD, and HK reviewed the manuscript, and were involved in the decision to submit. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

• Funding: Public Health England supported the epidemiological evaluation of the HPV pilot (reference ODR1718_428). Public Health England had a role in designing the pilot, in the collection of the data, and commented on the manuscript. MR (fully) and CM (partly) were supported by Cancer Research UK (reference: C8162/A27047). FP was supported by Cancer Research UK (reference C8162/A25356). Cancer Research UK had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication.

• Competing interests: All authors have completed the ICMJE uniform disclosure form at ww.icmje.org/coi_disclosure.pdf and declare: MR was provided Public Health England funding for the epidemiological evaluation of the pilot, and an unrelated study; is a member of the Public Health England Laboratory Technology Group, HPV Development Group, and HPV Self-sampling Operational Steering Group and Project Board; attended meetings with various HPV assay manufacturers; declares fee for lecture from Hologic, paid to employer. KC declares research funding or consumables to support research from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis Seegene, Roche, Abbott, and Hologic, paid to employer; is a professional clinical advisor to Public Health England; is a member of Public Health England Laboratory Technology Group and HPV Self-sampling Operational Steering Group. CM held an honorary appointment at Public Health England to process the data for the pilot. FP declares no competing interests. KD is an adviser to Public Health England (this position is funded by Public Health England as a secondment from her main employment); chairs the Public Health England Laboratory Clinical Professional Group, the HPV Development Group, and several groups related to the evaluation of self-sampling; was a consultant to the Scally Review of cervical screening in Ireland and the RCOG review of cervical cancer audit in Ireland, both completed in 2019; has provided expert medicolegal reports prepared for claimants and defendants including in cases of cervical cancer; received support with travel expenses to attend an international meeting in May 2019 from Hologic, a company manufacturing equipment and consumables for cytology and HPV testing. HK is former chair of the Public Health England Advisory Committee for Cervical Screening. We report no other relationships or activities that could appear to have influenced the submitted work. The views expressed in this manuscript are those of the authors and do not represent the view of Public Health England.

• Patient consent: Women participating in the HPV primary screening pilot were invited to make an informed choice on participating in the cervical screening programme. A decision is made to accept or decline a screening test based on access to accurate and up-to-date information on the condition being screened for, the testing process and potential outcomes. Specific information was provided at the invitation stage allowing for personalised informed choice. Further opportunity was given to reflect on what the test and its results might mean when women attended for screening with the clinician taking the sample. Regulation 5, Health Service Regulations 2002, Confidentiality Advisory Group Reference 15/CAG/0207, was the legal basis to process the data.

• The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as originally planned (and, if relevant, registered) have been explained.

• Dissemination to participants and related patient and public communities: The findings from the pilot study will continue to be disseminated at scientific conferences and other professional meetings. The dissemination to organisations and professional groups such as the English Cervical Screening Programme, UK National Screening Committee, British Society for Colposcopy and Clinical Pathology, and the British Association for Cytopathology have formed the basis for approval and implementation of changes in policy recommendations. The findings have been discussed with patient charities such as Jo’s Cervical Cancer Trust. As a leading cervical cancer charity supporting and advising women, Jo’s Cervical Cancer Trust have been active in supporting cervical screening programmes in Wales and Scotland in communication around interval extension. The findings will be, furthermore, publicised on social media belonging to the authors and/or their employers.

• Provenance and peer review: Not commissioned; externally peer reviewed.