Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.

<h4>Background</h4>Clinical trials in the research setting have demonstrated that primary human papillomavirus (HPV)-based screening results in greater protection against cervical cancer compared with cytology, but evidence from real-life implementation was missing. To evaluate the effec...

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Autores principales:	K Miriam Elfström, Carina Eklund, Helena Lamin, Daniel Öhman, Maria Hortlund, Kristina Elfgren, Karin Sundström, Joakim Dillner
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/84318018bd084149bed7e65d93180117
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spelling	oai:doaj.org-article:84318018bd084149bed7e65d931801172021-12-02T19:55:38ZOrganized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.1549-12771549-167610.1371/journal.pmed.1003748https://doaj.org/article/84318018bd084149bed7e65d931801172021-08-01T00:00:00Zhttps://doi.org/10.1371/journal.pmed.1003748https://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>Clinical trials in the research setting have demonstrated that primary human papillomavirus (HPV)-based screening results in greater protection against cervical cancer compared with cytology, but evidence from real-life implementation was missing. To evaluate the effectiveness of HPV-based cervical screening within a real-life screening program, the organized, population-based cervical screening program in the capital region of Sweden offered either HPV- or cytology-based screening in a randomized manner through a randomized healthcare policy (RHP).<h4>Methods and findings</h4>A total of 395,725 women aged 30 to 64 years that were invited for their routine cervical screening visit were randomized without blinding to either cytology-based screening with HPV triage (n = 183,309) or HPV-based screening, with cytology triage (n = 212,416 women) between September 1, 2014 and September 30, 2016 and follow-up through June 30, 2017. The main outcome was non-inferior detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary outcomes included superiority in CIN2+ detection, screening attendance, and referral to histology. In total, 120,240 had a cervical screening sample on record in the study period in the HPV arm and 99,340 in the cytology arm and were followed for the outcomes of interest. In per-protocol (PP) analyses, the detection rate of CIN2+ was 1.03% (95% confidence interval (CI) 0.98 to 1.10) in the HPV arm and 0.93% (0.87 to 0.99) in the cytology arm (p for non-inferiority <0.0001; odds ratio (OR) 1.11 (95% CI 1.02 to 1.22)). There were 46 cervical cancers detected in the HPV arm (0.04% (0.03 to 0.06)) and 48 cancers detected in the cytology arm (0.05% (0.04 to 0.07)) (p for non-inferiority <0.0001; OR 0.79 (0.53 to 1.18)). Intention-to-screen (ITS) analyses found few differences. In the HPV arm, there was a modestly increased attendance after new invitations (68.56% (68.31 to 68.80) vs. 67.71% (67.43 to 67.98); OR 1.02 (1.00 to 1.03)) and increased rate of referral with completed biopsy (3.89% (3.79 to 4.00) vs. 3.53% (3.42 to 3.65); OR 1.10 (1.05 to 1.15)). The main limitations of this analysis are that only the baseline results are presented, and there was an imbalance in invitations between the study arms.<h4>Conclusions</h4>In this study, we observed that a real-life RHP of primary HPV-based screening was acceptable and effective when evaluated against cytology-based screening, as indicated by comparable participation, referral, and detection rates.<h4>Trial registration</h4>ClinicalTrials.gov NCT01511328.K Miriam ElfströmCarina EklundHelena LaminDaniel ÖhmanMaria HortlundKristina ElfgrenKarin SundströmJoakim DillnerPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 18, Iss 8, p e1003748 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R K Miriam Elfström Carina Eklund Helena Lamin Daniel Öhman Maria Hortlund Kristina Elfgren Karin Sundström Joakim Dillner Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.
description	<h4>Background</h4>Clinical trials in the research setting have demonstrated that primary human papillomavirus (HPV)-based screening results in greater protection against cervical cancer compared with cytology, but evidence from real-life implementation was missing. To evaluate the effectiveness of HPV-based cervical screening within a real-life screening program, the organized, population-based cervical screening program in the capital region of Sweden offered either HPV- or cytology-based screening in a randomized manner through a randomized healthcare policy (RHP).<h4>Methods and findings</h4>A total of 395,725 women aged 30 to 64 years that were invited for their routine cervical screening visit were randomized without blinding to either cytology-based screening with HPV triage (n = 183,309) or HPV-based screening, with cytology triage (n = 212,416 women) between September 1, 2014 and September 30, 2016 and follow-up through June 30, 2017. The main outcome was non-inferior detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary outcomes included superiority in CIN2+ detection, screening attendance, and referral to histology. In total, 120,240 had a cervical screening sample on record in the study period in the HPV arm and 99,340 in the cytology arm and were followed for the outcomes of interest. In per-protocol (PP) analyses, the detection rate of CIN2+ was 1.03% (95% confidence interval (CI) 0.98 to 1.10) in the HPV arm and 0.93% (0.87 to 0.99) in the cytology arm (p for non-inferiority <0.0001; odds ratio (OR) 1.11 (95% CI 1.02 to 1.22)). There were 46 cervical cancers detected in the HPV arm (0.04% (0.03 to 0.06)) and 48 cancers detected in the cytology arm (0.05% (0.04 to 0.07)) (p for non-inferiority <0.0001; OR 0.79 (0.53 to 1.18)). Intention-to-screen (ITS) analyses found few differences. In the HPV arm, there was a modestly increased attendance after new invitations (68.56% (68.31 to 68.80) vs. 67.71% (67.43 to 67.98); OR 1.02 (1.00 to 1.03)) and increased rate of referral with completed biopsy (3.89% (3.79 to 4.00) vs. 3.53% (3.42 to 3.65); OR 1.10 (1.05 to 1.15)). The main limitations of this analysis are that only the baseline results are presented, and there was an imbalance in invitations between the study arms.<h4>Conclusions</h4>In this study, we observed that a real-life RHP of primary HPV-based screening was acceptable and effective when evaluated against cytology-based screening, as indicated by comparable participation, referral, and detection rates.<h4>Trial registration</h4>ClinicalTrials.gov NCT01511328.
format	article
author	K Miriam Elfström Carina Eklund Helena Lamin Daniel Öhman Maria Hortlund Kristina Elfgren Karin Sundström Joakim Dillner
author_facet	K Miriam Elfström Carina Eklund Helena Lamin Daniel Öhman Maria Hortlund Kristina Elfgren Karin Sundström Joakim Dillner
author_sort	K Miriam Elfström
title	Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.
title_short	Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.
title_full	Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.
title_fullStr	Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.
title_full_unstemmed	Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.
title_sort	organized primary human papillomavirus-based cervical screening: a randomized healthcare policy trial.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/84318018bd084149bed7e65d93180117
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Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.

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