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

Background: 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.

Validation of the cobas 6800 human papillomavirus test in primary cervical screening.

Evaluation of Human Papillomavirus (HPV) testing systems suitable for large-scale organized cervical screening programs is required. We evaluated the cobas 6800 HPV test system for detection of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) when nested in an organized primary HPV screening program, using the cobas 4800 test as comparator. The Karolinska University Hospital Cervical Cytology Biobank, containing frozen cervical samples from >700,000 women participating in organized cervical screening, was linked to the Swedish national cervical screening registry to identify 470 stored cervical samples taken <180 days before histopathological diagnosis of CIN3+.

Colposcopic and histopathologic evaluation of women with HPV persistence exiting an organized screening program.

Background: Human papillomavirus-based screening has a higher sensitivity for precursors of cervical cancer compared with cytology-based screening. However, more evidence is needed on optimal management of human papillomavirus-positive women.

Objective: The objective of the study was to compare the risk of histopathologically confirmed cervical intraepithelial lesions grade 2 or worse after 1 and 3 years of human papillomavirus persistence, respectively, and evaluate the clinical management of human papillomavirus-positive women in the 56-60 year age group.

Increasing participation in cervical screening by targeting long-term nonattenders: Randomized health services study.

High screening participation in the population is essential for optimal prevention of cervical cancer. Offering a high-risk human papillomavirus (HPV) self-test has previously been shown to increase participation. In this randomized health services study, we evaluated four strategies with regard to participation.

HPV-mRNA and HPV-DNA detection in samples taken up to seven years before severe dysplasia of cervix uteri.

Randomized clinical trials using human papillomavirus (HPV) DNA testing have found increased protection against cervical cancer and HPV-based screening is globally recommended for women ≥30 years of age. HPV-mRNA is a promising alternative target for cervical screening tests, but assessing equivalence requires longitudinal evaluation over at least the length of a screening interval. Our aim is to analyze the longitudinal sensitivity of HPV-mRNA and HPV-DNA in cervical samples taken up to 7 years before severe cervical intraepithelial neoplasia or worse (CIN3+).

Nationwide comprehensive human papillomavirus (HPV) genotyping of invasive cervical cancer.

Background: The Swedish National Cervical Screening Registry collects and evaluates comprehensive, nationwide health data to optimise organised cervical cancer prevention. Since all cervical cancer specimens are saved in biobanks, population-based data from the specimens should be available for analysis and linkage with other health information.

Methods: We identified all cervical cancers diagnosed in Sweden during 2002-2011 (4254 confirmed cases) and requested the tissue blocks to retrieve human papillomavirus (HPV) genotype data using general primer PCR with Luminex genotyping and real-time PCR targeting the E6/E7 regions of HPV16/18.

Randomised healthcare policy evaluation of organised primary human papillomavirus screening of women aged 56-60.

Objective: The aim of this research is to implement and reliably evaluate primary human papillomavirus (HPV) screening in an established and routinely running organised, large-scale population-based screening programme.

Participants: Resident women in the Stockholm/Gotland region of Sweden, aged 56-60 years were randomised to either (1) screening with cervical cytology, with HPV test in triage of low-grade cytological abnormalities (old policy) or (2) screening with HPV testing, with cytology in triage of HPV positives (new policy).

Outcome: The primary evaluation was the detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).

Laboratory audit as part of the quality assessment of a primary HPV-screening program.

Background: As primary HPV screening programs are rolled out, methods are needed for routine quality assurance of HPV laboratory analyzes.

Objective: To explore the use of similar design for audit as currently used in cytology-based screening, to estimate the clinical sensitivity to identify women at risk for CIN 3 or worse (CIN3+).

Study Design: Population-based cohort study conducted within the cervical screening program in Stockholm, Sweden, in 2011-2012.