We assessed 132 specific screening strategies, in unvaccinated women and in those offered vaccination.  J, Blake If LBC results were negative at this 24-month screen, participants were asked to return at 48 months for exit with HPV and LBC testing. We did the evaluation from a health services perspective. Walboomers  MH, Duarte-Franco If ASCUS and HPV positive at baseline, women were referred for immediate colposcopy.  KA, Chelmow J-BL, KTS, MAS, KC, MC, XMX, LSV, and Y-JK had access to raw data. HPV=human papillomavirus. Bars represent the range between minimum value and maximum value estimated for variants of each primary screening approach. Second, after a recommendation was made to adopt primary HPV screening with partial genotyping and direct referral to colposcopy of women positive for HPV16/18, we evaluated the final effect of HPV screening after incorporating new clinical guidelines for women positive for HPV. 2018;320(1):43–52. The risk ratio for CIN2+ at the exit round in the intervention group compared with control group was 0.47 (95% CI, 0.34-0.67). 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. For imputation, enrollment screen results were dichotomized to be either negative (HPV or cytology negative) or positive (HPV or cytology positive [≥ASCUS]). Findings  Conclusions and relevance: Among women undergoing cervical cancer screening, the use of primary HPV testing compared with cytology testing resulted in a significantly lower likelihood of CIN3+ at 48 months. A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: extended follow up in the ARTISTIC trial. Corresponding Author: Gina Suzanne Ogilvie, MD, FCFP, DrPH, BC Women’s Hospital and Health Centre, 4500 Oak St, Room H203G (Box 42), Vancouver, BC V6H 3N1, Canada (gina.ogilvie@cw.bc.ca).  PE, Temin Secondary trial end points included in this analysis are rates of CIN2+ at 48 months, the threshold for colposcopy referral and further evaluation, and evaluation of the impact of primary HPV testing on colposcopy services through evaluation of colposcopy referral rates in each group. All statistical tests were 2-sided with P < .05 considered statistically significant. First, as with every modelled evaluation, our findings are sensitive to specific assumptions—eg, unknown future adherence to screening behaviours, and test characteristics. All Rights Reserved. The CIN2+ risk ratio for the intervention compared with the control group was 0.36 (95% CI, 0.24-0.54). Optimal management strategies for primary HPV testing for cervical screening: cost-effectiveness evaluation for the National Cervical Screening Program in Australia. Meaning  R: A Language and Environment for Statistical Computing. High-Grade CIN Rates per 1000 (95% CI) Detected at Round 1 and 48-Month Exit Round, All Results, eTable 2. We report a comprehensive modelled assessment of the effectiveness, resource utilisation, and cost-effectiveness of several cervical screening approaches in the context of the National HPV Vaccination Program in Australia.  SK, Muñoz These design factors reduced bias and limited variation in clinical procedures within trial groups.14. Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial.  E.  Probable inference, the law of succession, and statistical inference. Further research is needed to understand long-term clinical outcomes as well as cost-effectiveness. 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). The known: In December 2017, the National Cervical Screening Program shifted from cytology‐based screening to primary human papillomavirus (HPV)‐based screening. As previously reported,14 in the first round of screening, significantly more CIN2+ cases were detected in the intervention group (HPV tested) compared with the control group. Cumulative incidence curves show that women who were HPV negative at baseline had a significantly lower risk of CIN2+ at 48 months compared with cytology-negative women (Figure 3B). The funder had no role in the collection, management, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.  M, Ramanakumar At baseline, if HPV positive and LBC negative, women were recalled in 12 months for HPV and LBC testing. 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]). Risk ratios were calculated using unconditional maximum likelihood with confidence intervals using normal approximation. (Referred to herein as “HPV Testing Alone.”) In British Columbia, all women are covered under the publicly funded health insurance program and cervical cancer screening is managed provincially by the BC Cervical Cancer Screening Program. Renewal of the National Cervical Screening Program: partner reference group e-newsletter. These results have demonstrated that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology. To have an unbiased verification of the extent of disease left undiagnosed at trial exit, this trial included HPV and cytology co-testing for all participants at the 48-month screen.25,26 As a result, with ongoing future monitoring of trial participants, it is anticipated some of the cervical cancer detected in the cytology group follow-up of other trials will be reduced in this trial, due to the fact that cytology-tested participants had added HPV testing at exit, permitting detection of lesions missed earlier in the trial. Methods An individual-based model of HPV acquisition, natural history, and cervical cancer screening was used to compare cytological screening and HPV testing with cytology triage for women aged 25–64 years (with either 3- or 5-year screening intervals for women aged under 50 years). Unnecessary colposcopies potentially cause unintended harm for women and increased costs to health care systems.22-24 In this trial, round 1 colposcopy rates in the HPV-tested group were significantly higher than the cytology-tested group. Human papillomavirus (HPV) DNA testing prevents more invasive cervical cancer than cytology screening alone, and should be used as the primary screening test. The absolute difference in the incidence rate was −4.03/1000 (95% CI, −5.88 to −2.41) for CIN3+. The primary endpoint was the cumulative incidence of CIN grade 3 or worse (CIN3+) 48 months after randomisation, and the cumulative incidence of CIN grade 2 or worse (CIN2+) at 48 months was a secondary outcome. J-BL, KTS, MAS, and KC designed the study. The Cervical Cancer Screening Program has 1 centralized registry that includes the cytology, histopathology, and treatment history for every woman ever screened in British Columbia.  et al. If the baseline reflex LBC result was greater than or equal to ASCUS, they were referred for immediate colposcopy and management. At 48 months, 8296 women (86.9%) completed the intervention and 8078 women (85.4%) completed the control exit screenings (Figure 1). For our evaluation, we assumed that no screening occurs in women younger than 25 years. Replacing the Pap Test With Screening Based on Human Papillomavirus Assays, Clarification for Reported Colposcopy Rates, Intervention and Control Group Exit Screening. Customize your JAMA Network experience by selecting one or more topics from the list below. 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. (B) A cohort offered vaccination, all except current practice ending screening at age 64 years. For 20 years, cervical cancer screening using HPV testing has been evaluated in a variety of settings.6,7 Meta-analyses have shown that inclusion of HPV testing alone or combined with cytology (co-testing) for screening, compared with cytology alone, is associated with increased detection of precancerous lesions in the first screening round, followed by a subsequent reduction in precancerous lesions.6,7 Although these findings have led to recommendations in favor of primary HPV-based cervical cancer screening, agencies such as the American Society of Clinical Oncology, US Preventive Services Task Force, and American Society for Colposcopy and Cervical Pathology have called for clinical trials with primary HPV testing alone with more than 1 round of screening to further inform the implementation of primary HPV screening.5,8-10.  GS, Krajden  et al; Joint European Cohort Study. KC receives salary support from NHMRC Australia (Career Development Fellowship APP1082989). For cervical cancer screening, HPV testing vs cytology testing led to a significantly lower likelihood of CIN3+ at 48 months, but more research is needed … For 20 years, cervical cancer screening using HPV testing has been evaluated in a variety of settings. Trial Registration  Consensus in US cervical cancer screening guidelines currently state that Pap plus human papillomavirus (HPV) testing for women aged 30 to 65 years is recommended; cytology alone is recommended for women aged 21 to 29. Please enter a term before submitting your search. 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.  KM, The 48-month exit round refers to 48-month exit screening results (plus 24-month results for the control group) and associated outcomes for both the intervention and control groups (eFigure in Supplement 2). At 48-month exit, both groups received HPV and LBC co-testing. 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. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. Cost-effectiveness of cervical cancer screening with human papillomavirus DNA testing and HPV-16,18 vaccination. HPV-based screening resulted in lower likelihood of CIN3+ than cytology after 48 months, but further research is needed to understand long-term clinical outcomes as well as cost-effectiveness. You can discuss it with your doctor as needed. Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Time to censoring was the difference between the date the participant became ineligible and the randomization date. We found that the renewed Australian National Cervical Screening Program will reduce cervical cancer incidence and mortality and is cost-saving when compared with the current programme. No other disclosures were reported.  et al; New Technologies for Cervical Cancer screening (NTCC) Working Group.  J, Elfström One of the most effective and cost-effective strategies comprised primary HPV screening with referral of women positive for oncogenic HPV16/18 direct to colposcopy, with reflex cytological triage for women with other oncogenic types and direct referral for those in this group with high-grade cytological findings. Among baseline HPV or LBC-negative women, rates of CIN3+ at 48 months were significantly higher across all age groups in the control compared with the intervention group (Table 2). Cervical Cancer Screening Using Primary Cervical HPV Testing Compared With Cytology, Figure 1. The CIN2+ risk ratio was 0.47 (95% CI, 0.34-0.67).  EL, Ferenczy LSIL=low-grade squamous intraepithelial lesion as predicted by cytology. Author Contributions: Drs Ogilvie and Coldman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Objectives In England, human papillomavirus (HPV) testing is to replace cytological screening by 2019–2020. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. If a participant had an event (histopathology-confirmed CIN2+), the time to incidence was calculated as the difference between the date of disease detection and the randomization date. Inclusion criteria were women in British Columbia, Canada, with a personal health number, aged 25 to 65 years who had not had a Papanicolaou test in the previous 12 months, were not pregnant, were not HIV positive or receiving immunosuppressive therapy, and had no history of CIN2+ in the past 5 years; did not have invasive cervical cancer; or did not have total hysterectomy. Taken together with evidence from international studies, including findings of a subsequent reanalysis of four European trials, published after we began our study, in which better protection was shown against invasive cervical cancer in women who underwent HPV screening versus those who had cytological analysis, our findings support the upcoming national implementation of primary HPV DNA screening in both unvaccinated women and in those who have been offered HPV vaccination. JAMA. Mayrand Supervision: Ogilvie, van Niekerk, Krajden, Quinlan, Peacock, Coldman. Participants underwent a pelvic examination, and cervical specimens were placed in a ThinPrep vial (Hologic Inc). Coldman R Core Team. Cumulative disease incidence was plotted using 1 minus Kaplan-Meier estimates of disease-free probability.  DL, Doucette Castle Starting January 1, 2011, women were assigned 1:1 to the intervention or control when the safety group was closed.11-14 Women and clinicians were blinded to group assignment until 24 months or if the baseline screen results were positive and required follow-up. A total of 578,547 women aged between 24 and 64 years old were included in the study, each undergoing routine cervical screening with either HPV testing or cytology. 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]). Confidence intervals around absolute differences were constructed using the score intervals. 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. Concept and design: Ogilvie, van Niekerk, Krajden, Smith, Martin, Peacock, Stuart, Franco, Coldman. *To assist with management decisions at colposcopy, not to determine whether to refer to colposcopy. HSIL=high-grade squamous intraepithelial lesion as predicted by cytology. These results have demonstrated that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology. The addition of cytology to HPV testing detected very few additional events.  NW, Berkhof We considered several variations for each approach. First, we looked at alternate management options for women infected with HPV oncotypes other than 16/18 and cytological findings of low-grade squamous intraepithelial lesions or atypical squamous cells of undetermined significance (women at intermediate risk). When the transition from cytology every 2 years to HPV screening every 5 years occurs in 2017, fluctuations in outcomes are likely to occur for several years before reaching steady-state. Loopik Incidence at 18, 42, and 72 months is marked by a point and the confidence intervals around it are shown as the point range. J-BL, KTS, and MAS analysed or extracted data to inform model parameters. Hence, the number at risk is the same across partitions within primary groups. Schematic diagram of primary screening approach, Predicted age-specific cancer incidence and mortality for selected strategies, Cost-effectiveness of screening strategies compared with current practice with screening ending at age 64 years, Annual number of colposcopies for each primary screening approach with screening ending at age 64 years, Predicted incidence of cervical cancer and mortality, number of colposcopies and treatments for cervical intraepithelial neoplasia grades 2 and 3, and annual and discounted costs of the programme. Co-testing led to lower cumulative incidences of cervical cancer and CIN grade 3 or … 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.  et al. 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.) We thank the Renewal Steering Committee and the Cervical Cancer Screening Guidelines Working Party (of which IH is Chair) for their guidance in development of the clinical management pathways incorporated into the model. The CIN2+ risk ratio was 0.47 (95% CI, 0.34-0.67). Those in which an invitation was sent at age 25 years further reduced overall mortality by an additional 1–3% relative to the same strategy without an active invitation at age 25 years (, Further analyses were done to assess the effect of retaining a screening end-age of 69 years, for all strategies (, Extending the screening interval to 6 years for HPV screening strategies is predicted to increase incidence by 3–4% for both unvaccinated and vaccinated cohorts, relative to the same strategy with screening every 5 years. Bulkmans This decline prompted a major review of the National Cervical Screening Program and new clinical management guidelines, for which we undertook this analysis. INTRODUCTION. effectiveness of routine cytology versus HPV testing. We did each cost and effectiveness calculation for each possible variation within each of the six primary screening approaches. It compared the efficacy of three screening methods: HPV primary screening, cytology (Pap test), and a hybrid strategy (cytology for women aged 25 to 29 years and co-testing for women aged ≥30 years)—the latter of which matches the current guideline—in more than 40,000 women undergoing routine cervical … By 48 months, significantly fewer CIN3+ cases were detected overall and across all age groups in the intervention compared with the control group. Alternative assumptions were also assessed for the effect of call-and-recall on screening adherence for each primary screening approach (, The estimated cost of the existing National Cervical Screening Program in 2015 was $215 million. In the POBASCAM trial, almost 45,000 women were randomized to management based on initial screening with HPV DNA and cytology co-testing vs. cytology testing alone. Plots were truncated at 24 months after their 48-month screening and based on all women randomized regardless of attendance at all trial recommended screening. pdf files, Causal system modelling of cervical cancer screening, Cost-effectiveness estimates: the need for complete reporting, Cost-effectiveness estimates: the need for complete reporting – Authors' reply, Recommend Lancet journals to your librarian, Redistribute or republish the final article, Translate the article (private use only, not for distribution), Reuse portions or extracts from the article in other works, Distribute translations or adaptations of the article.  D, However, by 48 months, the colposcopy rate in the intervention group was reduced while the control group rate increased. 2016. Women in the control group received liquid-based cytology (LBC) testing; those whose results were negative returned at 24 months for LBC. 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.  et al. The round 1 risk ratio for CIN2+ in the intervention vs control group was 1.61 (95% CI, 1.24-2.09) and the absolute difference in the incidence rates was 5.84/1000 (95% CI, 2.70-9.07) for CIN2+ (eTable 1 in Supplement 2). 9457 ) groups in clinical procedures within trial groups the rate per is! 42 months compared with the total number of colposcopies per year was by. The 2001 Australian population and represented per 100 000 women for each screening approach Australia: a Language and for. At colposcopy, not to determine whether to refer to colposcopy was 0.47 ( 95 %,. Race/Ethnicity was captured based on this initial evaluation of primary HPV testing has been extensively! 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