Further research is needed to understand long-term clinical outcomes as well as cost-effectiveness. The main trial objective was to compare the rates of cervical intraepithelial neoplasia (CIN) grade 3 or greater (CIN3+) 48 months after baseline screening with primary HPV vs LBC. Conclusions and Relevance  We considered several variations for each approach.  PE, Schiffman A randomized controlled trial of human papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial). However, our model has been calibrated extensively and data from a meta-analysis were used for test characteristics, which were also fitted to observed rates of cytology test outcomes at a population level in Australia. Quiz Ref IDThis trial has several strengths. 2. Further research is needed to understand long-term … Optimal management strategies for primary HPV testing for cervical screening: cost-effectiveness evaluation for the National Cervical Screening Program in Australia. High-grade CIN Rates per 1000 Patients Detected at 48-Month Exit and Cumulatively.  et al.  et al.  P, There is limited information about the relative effectiveness of cervical cancer screening with primary human papillomavirus (HPV) testing alone compared with cytology in North American populations. Main Outcomes and Measures  5 July 2019 Added 'Cervical screening: pathway for acceptance of new HPV tests'. ASC-H=atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesion. At 48-month exit, both groups received HPV and LBC co-testing. J-BL, KTS, MAS, MH, XMX, MC, and KC contributed to model design and/or construction. Colposcopy referral rates (per 1000) in the intervention group were significantly higher in round 1 (intervention: 57.0 [95% CI, 52.5-61.9] vs control: 30.8 [95% CI, 27.5-34.5]; absolute difference between intervention and control: 26.2 [95% CI, 20.4-32.1]). Role of the Funder/Sponsor: As part of its review and approval of the funding application, CIHR approved the design, analysis, and conduct of the study. For imputation, enrollment screen results were dichotomized to be either negative (HPV or cytology negative) or positive (HPV or cytology positive [≥ASCUS]). 5 In another study, more than half of the women with CIN 2+ lesions including cervical cancer had a positive Pap test and negative HPV testing.  PE, Temin Australia was one of the first countries to implement a national, publicly funded, human papillomavirus (HPV) vaccination programme. R Core Team. Women in the intervention group received HPV testing; those whose results were negative returned at 48 months. All strategies were associated with further reductions in screening tests, follow-up tests, and precancer treatments compared with current practice (, Some other strategy variations affected results. B, Cumulative CIN2+ incidence for intervention and control groups for all participants attending 48-month exit screen. © 2017 The Author(s). The full trial protocol and statistical analysis plan are available in Supplement 1. ASCUS indicates atypical squamous cells of undetermined significance; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; LBC, liquid-based cytology; LSIL, low-grade squamous intraepithelial lesion. Our website uses cookies to enhance your experience. One of the concerns for adopting HPV-based screening is the lower CIN2+ specificity of HPV testing compared with cytology, leading to higher screen positive rates and the resulting need for more colposcopies and biopsies.  S,  et al; Joint European Cohort Study. When compared with current practice, for the renewed National Cervical Screening Program, a 36% long-term increase in the number of colposcopies would have occurred in unvaccinated women (after a transition period), by contrast with a 7% decrease for cohorts offered vaccination (, In the absence of HPV vaccination, the renewed National Cervical Screening Program was predicted to result in a 19% reduction in costs, equivalent to annual cost-savings of $41 million if steady-state rates are applied to the projected female Australian population in 2017 (.  CM, Solomon Although some evidence shows that HPV vaccines provide a degree of cross-protection against HPV types 31, 33, 45, and 58, their quantitative effect has yet to be defined, and the long-term duration of cross-protection has not been determined.  M, Garland Here, we aim to first present the initial evaluation of screening options, in which screening technology (conventional cytology, liquid-based cytology, HPV testing), screening interval, and age range were considered. Specifically, a strategy of primary HPV screening every 5 years, with partial genotyping and direct referral to colposcopy for women positive for HPV16/18, and liquid-based cytology triage for women who test positive for oncogenic HPV other than HPV16/18, aged 25–69 years with an exit test at age 70–74 years, is highly effective for cervical screening in unvaccinated and vaccinated cohorts. This trial, which compares primary HPV testing vs LBC with standardized triage and colposcopy follow-up, found primary HPV testing detected significantly more CIN3+ and CIN2+ cases in the first round and significantly reduced CIN3+ and CIN2+ rates 48 months later.  et al. Baseline HPV-negative women had a significantly lower cumulative incidence of CIN3+ at 48 months than cytology-negative women (CIN3+ incidence rate, 1.4/1000 [95% CI, 0.8-2.4]; CIN3+ risk ratio, 0.25 [95% CI, 0.13-0.48]). Randomization occurred at the central laboratory. Funding/Support: This study was funded by grant MCT82072 from the Canadian Institutes of Health Research (CIHR). Through the BC Cervical Cancer Screening Program, 76 422 women were identified as trial eligible; 51 199 were excluded (43 645 did not respond to the invite, 5644 formally declined, and 1910 did not meet inclusion criteria). Terms of Use| For 20 years, cervical cancer screening using HPV testing has been evaluated in a variety of settings. Primary HPV testing was followed by reflex LBC in women with positive HPV test results, and they received the same management as the intervention group. It was embedded in a well-established centralized cervical screening program, where all cytology in an entire Canadian province is analyzed at 1 certified laboratory by experienced staff, minimizing interobserver bias. The absolute difference in the incidence rate was −6.38/1000 (95% CI, −8.91 to −4.02) for CIN2+. Medical Services Advisory Committee (MSAC). The addition of cytology to HPV testing detected very few additional events. All statistical tests were 2-sided with P < .05 considered statistically significant. If the baseline reflex LBC result was greater than or equal to ASCUS, they were referred for immediate colposcopy and management.  J, Methods This study has several limitations. The 24-month screen round refers only to women in the control group because the intervention group did not receive 24-month screening, and this 24-month screen round included 24-month screen results and 36-month follow-up results. The comparator was the current National Cervical Screening Program in Australia (every 2 years, conventional cytology, in women aged 18–69 years, no HPV triage testing). We found that primary HPV testing with partial genotyping was one of the most effective strategies, and was less costly than the current programme entailing cytology screening every 2 years. KC oversaw all aspects of study design and conduct.  RL, Bentley We also thank Robert Walker for assistance in the development of the dynamic HPV model and running strategies in the dynamic HPV model. In our investigation of the effect of missing outcome data for participants not attending the exit screen through multiple imputation, we did not find any significant differences in comparison of control and intervention groups for trial primary and secondary end points (eTable 2 in Supplement 2). Cytology versus HPV testing for cervical cancer screening in the general population: a DTA Review from the Cochrane Gynaecological, Neuro-oncology and Orphan Cancers Group, (CGNOC) Cochrane Reviews are systematic reviews of research in health care and policy. Specifically, a strategy of primary HPV screening every 5 years, with partial genotyping and direct referral to colposcopy for women positive for HPV16/18, and liquid-based cytology triage for women who test positive for oncogenic HPV other than HPV16/18, aged 25–69 years with an exit test at age 70–74 years, is highly effective for cervical screening in unvaccinated and vaccinated cohorts. KC receives salary support from NHMRC Australia (Career Development Fellowship APP1082989). Second, we aim to present the updated evaluation of outcomes and cost-effectiveness of the selected screening approach recommended by MSAC in 2014, after incorporating new clinical management guidelines based on HPV screening with partial genotyping. A total of 19 009 women were randomized to the intervention (n = 9552) and control (n = 9457) groups. Dr Krajden also reported receiving grants from Siemens.  DJ, The CIN3+ incidence rate was 2.3/1000 (95% CI, 1.5-3.5) in the intervention group and 5.5/1000 (95% CI, 4.2-7.2) in the control group. A, Cumulative CIN3+ incidence for intervention and control groups for all participants attending 48-month exit screen. A total of 19 009 women were randomized to the intervention (n = 9552) and control (n = 9457) groups. This article reports the 48-month exit round results of the Human Papillomavirus For Cervical Cancer screening trial (HPV FOCAL), a publicly funded Canadian trial designed to compare the effect of primary HPV testing alone with liquid-based cytology (LBC) screening for the prevention of cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) in the context of an organized screening program. After incorporating detailed clinical guidelines recommendations, this strategy is predicted to reduce cervical cancer incidence and mortality by 31% and 36%, respectively, in unvaccinated cohorts, and by 24% and 29%, respectively, in cohorts offered vaccination. To test the effectiveness of HPV primary screening in a real-world setting, researchers compared it to the current screening programme in 6 NHS laboratories in England. Groups are artificially divided at 48 months to show the incidence in same participants if they were to be tested using liquid-based cytology alone. Accessibility Statement, Visual Abstract.  K, Chevarie-Davis If ASCUS and HPV positive at baseline, women were referred for immediate colposcopy.  J, Blake Primary LBC testing was followed by reflex HPV testing for women with ASCUS. There were no significant differences between the 2 groups with respect to the distributions of sociodemographic and lifestyle characteristics. Detailed trial methods and results have been previously described.11-14 As outlined in Figure 1, round 1 refers to the baseline screen and any 12-month follow-up results in both the intervention and control groups. However, by 48 months, rates were lower in the intervention group compared with the control group for all ages (intervention: 49.2 [95% CI, 45.0-53.7]; control: 70.5 [95% CI, 65.5-75.8]; absolute difference between intervention and control: −21.3 [95% CI, −28.3 to −14.8]). In this trial, all women in the intervention and control groups had the same intervention at the 48-month exit (HPV and cytology co-testing). Approximately 99.7% of all cervical cancers are associated with a persistent cervical infection with an oncogenic human papillomavirus (HPV) genotype preceding the invasive tumor. LBC=liquid-based cytology. 31 Overall, the 4 trials found that hrHPV testing alone led to an increase in … Cost-effectiveness analysis on primary screening including clinical follow-up. Although cervical screening guidelines from a number of organizations8,17 have recommended primary HPV testing based on the natural history of cervical cancer,3 cross-sectional studies,18 studies where HPV-based screening was part of a screening group,7,19 or where studies ultimately evolved into primary HPV evaluations,19,20 none of these studies were designed specifically to examine HPV testing as the primary screening modality. We implemented a detailed simulation of all management pathways, from primary screening and triage, surveillance, colposcopy referral, and management, treatment, and post-treatment surveillance. Evidence from randomised controlled trials.  et al. All participants were invited to complete a demographic and behavioral questionnaire. The Lancet Regional Health – Western Pacific, Advancing women in science, medicine and global health, Effect of a price discount and consumer education strategy on food and beverage purchases in remote Indigenous Australia: a stepped-wedge randomised controlled trial, The effect of a reduction in alcohol consumption on blood pressure: a systematic review and meta-analysis, National HPV Vaccination Program Register. Controversial proposals for cervical cancer screening have engaged the medical community in an ongoing debate about the merits of co-testing with both Pap and human papillomavirus (HPV) tests compared to screening with an HPV test alone (where a positive HPV screening result may lead to further evaluation with cytology and/or colposcopy.) Women aged 25 to 65 years with no history of CIN2+ in the past 5 years, no history of invasive cervical cancer, or no history of hysterectomy; who have not received a Papanicolaou test within the past 12 months; and who were not receiving immunosuppressive therapy were eligible. Participants randomized to HPV testing alone (intervention group) with negative test results were recalled at 48 months for exit with HPV and LBC testing. Case numbers for the strategy “HPV: final guidelines” were calculated by applying the steady-state rates to the 2017 population and, therefore, assumes that women have been managed under the HPV-based programme for their entire lives. Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Human papillomavirus vaccine coverage among female Australian adolescents: success of the school-based approach. In a new study, a computer algorithm improved the accuracy and efficiency of cervical cancer screening compared with cytology (Pap test), the current standard for follow-up of women who test positive with primary human papillomavirus (HPV) screening. The HART trial15 found that the rate of CIN3+ detection in women screened by combined HPV and cytology who had previously been screened by cytology was 8.1 per 1000. By the end of trial follow-up (72 months), incidence was similar across both groups. Dillner HPV=human papillomavirus. As part of the trial protocol, samples with no visible cell pellet after conversion were rejected as inadequate. For loss to follow-up, demographics of women who were lost to follow-up were compared between the study groups and no significant differences were found. The Australian National Cervical Screening Program currently recommends conventional cytology every 2 years for sexually active women aged between 18–20 years and 69 years. A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: extended follow up in the ARTISTIC trial. To evaluate histologically confirmed cumulative incident cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) detected up to and including 48 months by primary HPV testing alone (intervention) or liquid-based cytology (control). Co-testing led to lower cumulative incidences of cervical cancer and CIN grade 3 or … KC and MS are co-principal investigators of an investigator-initiated trial of cytology and primary HPV screening in Australia (Compass; ACTRN12613001207707 and. The participation rate in cervical screening was significantly higher in the HPV self-sampling arm than in the Pap smear arm (47% vs. 39%, P < 0.001).In the HPV self-sampling arm, 7997 women returned a self-sample for HPV testing, of which 7443 (93%) were HPV-negative and considered as completely … Randomized clinical trial conducted in an organized Cervical Cancer Screening Program in Canada. MS, IH, and TB provided and coordinated expert input into clinical parameters and pathways. The Australian Government's MSAC's Protocol Advisory Subcommittee (on which KC sits)—developed the Decision Analytic Protocol for the original analysis. Furthermore, this strategy is predicted to reduce costs by up to 19% for unvaccinated cohorts and 26% for cohorts offered vaccination, compared with the current programme. Screening for cervical cancer has advantages and disadvantages. These design factors reduced bias and limited variation in clinical procedures within trial groups. Specifying a 2-sided α = .05 and power = 0.90, then 9400 participants were required per arm in the control and intervention groups. The primary analysis for this study focuses on the intervention and control groups. HPV testing was performed with the Hybrid Capture 2 High Risk HPV DNA test (Qiagen), which detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Therefore, the exit intervention was not the same as the baseline intervention. The CIN3+ risk ratio for the intervention group compared with the control group was 0.25 (95% CI, 0.13-0.48). Histopathological assessment was blinded to HPV and cytology results. As previously reported, we used modelling to inform the management of women with low-grade cytology who are positive for oncogenic HPV other than 16/18.  ER. Among 19 009 women who were randomized (mean age, 45 years [10th-90th percentile, 30-59]), 16 374 (8296 [86.9%] in the intervention group and 8078 [85.4%] in the control group) completed the study. HPV vaccine impact in Australian women: ready for an HPV-based screening program. High-Grade CIN Rates per 1000 (95% CI) Detected at Round 1 and 48-Month Exit Round, All Results, eTable 2. Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0), https://doi.org/10.1016/S2468-2667(17)30007-5, Primary HPV testing versus cytology-based cervical screening in women in Australia vaccinated for HPV and unvaccinated: effectiveness and economic assessment for the National Cervical Screening Program, http://www.hpvregister.org.au/research/coverage-data/HPV-Vaccination-Coverage-by-Dose-20132, http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/MSAC-recommendations, http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/E6A211A6FFC29E2CCA257CED007FB678/$File/Renewal%20Economic%20Evaluation.pdf, http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1276-public, View Large Please enter a term before submitting your search.  J, Castle  SL, Havrilesky Administration of the quadrivalent vaccine (Gardasil; CSL, Parkville, VIC, Australia) commenced in April, 2007, and entailed a catch-up programme for adolescent girls and young women aged 12–26 years until the end of 2009. 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