In:
PLOS Medicine, Public Library of Science (PLoS), Vol. 18, No. 8 ( 2021-8-23), p. e1003748-
Abstract:
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). Methods and findings 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. Conclusions 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. Trial registration ClinicalTrials.gov NCT01511328
Type of Medium:
Online Resource
ISSN:
1549-1676
DOI:
10.1371/journal.pmed.1003748
DOI:
10.1371/journal.pmed.1003748.g001
DOI:
10.1371/journal.pmed.1003748.t001
DOI:
10.1371/journal.pmed.1003748.t002
DOI:
10.1371/journal.pmed.1003748.t003
DOI:
10.1371/journal.pmed.1003748.t004
DOI:
10.1371/journal.pmed.1003748.t005
DOI:
10.1371/journal.pmed.1003748.s001
DOI:
10.1371/journal.pmed.1003748.s002
DOI:
10.1371/journal.pmed.1003748.s003
DOI:
10.1371/journal.pmed.1003748.s004
DOI:
10.1371/journal.pmed.1003748.s005
DOI:
10.1371/journal.pmed.1003748.r001
DOI:
10.1371/journal.pmed.1003748.r002
DOI:
10.1371/journal.pmed.1003748.r003
DOI:
10.1371/journal.pmed.1003748.r004
DOI:
10.1371/journal.pmed.1003748.r005
DOI:
10.1371/journal.pmed.1003748.r006
DOI:
10.1371/journal.pmed.1003748.r007
DOI:
10.1371/journal.pmed.1003748.r008
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2021
detail.hit.zdb_id:
2164823-2
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