However, in the safety group, HPV-negative women were recalled for exit screening with LBC at 24 months. 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. We compared the pathology outcomes between both laboratories and found no significant difference (χ2P = .36). Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study.  et al; New Technologies for Cervical Cancer screening (NTCC) Working Group. Our website uses cookies to enhance your experience. Risk ratios were calculated using unconditional maximum likelihood with confidence intervals using normal approximation.  VA; US Preventive Services Task Force. There were no significant differences between the 2 groups with respect to the distributions of sociodemographic and lifestyle characteristics. 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. 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).  et al. In one study, more than 1 in 3 women who had CIN 2 or 3 and/or carcinoma would have been missed without the Pap cytology. In the first five years after implementation, the new HPV-based screening programme is expected to be more expensive than cytology-based screening as the increase in the costs of triage tests, colposcopy referrals and CIN treatments, and cervical cancer treatment and palliative care outnumber the decrease in the costs of the primary screening test, resulting in an increase of ~€5 … In total, 25 223 women were enrolled (9457 to the control, 6214 to the safety, and 9552 to the intervention groups). Strategies entailing HPV testing every 5 years and either partial genotyping for HPV16/18 or cytological co-testing were the most effective. 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. However, the outcomes presented here represent long-term predictions. 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. Colposcopy procedures were standardized for all participants. The objective of this study was an evaluation of the Xpert HPV Assay in a screening population using residual cervical cytology PreservCyt specimens originally obtained from women aged 20–60 years.  et al. 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).  M, Rebolj to download free article PDFs, Presented case numbers are rounded to the nearest integer; the difference in case numbers between current practice and final guidelines are calculated using unrounded values and, therefore, might not match calculations using the rounded values presented here. Concept and design: Ogilvie, van Niekerk, Krajden, Smith, Martin, Peacock, Stuart, Franco, Coldman. Performance of the Xpert HPV Assay was compared to two established HPV DNA tests and with cytology and histopathology. Agramunt HPV testing in primary cervical screening: a systematic review and meta-analysis. 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. Replacing the Pap Test With Screening Based on Human Papillomavirus Assays, Clarification for Reported Colposcopy Rates, Intervention and Control Group Exit Screening. Both evaluations considered both unvaccinated and vaccinated cohorts. In August, 2014, the Australian Health Ministers' Advisory Council endorsed the recommendation and, in March, 2015, they approved the draft policy for the renewal of the National Cervical Screening Program. Correction: This article was corrected on December 4, 2018, to clarify the colposcopy referral rates reported in the Results section. Australia was one of the first countries to implement a national, publicly funded, human papillomavirus (HPV) vaccination programme. As part of the trial protocol, samples with no visible cell pellet after conversion were rejected as inadequate. This article focuses on the primary study analysis, which is a comparison of the cumulative incidence rate in the intervention and control groups at 48 months. 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. HPV vaccine impact in Australian women: ready for an HPV-based screening program. 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. Question  This trial also confirmed that women who were HPV negative at baseline have lower rates of CIN2+ at 48 months than cytology-negative women at baseline. Cervical screening will probably need further re-evaluation for future cohorts offered a next-generation nonavalent HPV vaccine, which protects against seven oncogenic subtypes of HPV that cause about 90% of invasive cervical cancers worldwide. Primary HPV testing was followed by reflex LBC in women with positive HPV test results. 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. 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. 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. J-BL, KTS, MH, and XMX ran the modelled analyses. The primary outcome was the cumulative incidence of CIN3+ 48 months following randomization. eTable 1. 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. Cost-effectiveness of cervical cancer screening with primary human papillomavirus testing in Norway. 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]). The CIN2+ incidence rate at 48 months was 5.0/1000 (95% CI, 3.8-6.7) in the intervention group and 10.6/1000 (95% CI, 8.7-12.9) in the control group.  K, Chevarie-Davis LBC slides were prepared using the ThinPrep 2000 (Hologic) processor and smears were screened manually by program cytotechnologists. Further analyses modeling the cost-effectiveness of HPV primary screening using parameters from this study will be carried out to assess the potential economic effect of moving to HPV-based screening. The first component of this evaluation was funded by the Medical Services Advisory Committee Australia (MSAC application 1122). These findings underpin the decision to transition to primary HPV screening with partial genotyping in the Australian National Cervical Screening Program, which will occur in May, 2017. © 2021 American Medical Association.  EB, Dunn Human papillomavirus (HPV) vaccination was implemented in 2007 with high population coverage, and falls in high-grade lesions in young women have been reported extensively. All Rights Reserved. Supervision: Ogilvie, van Niekerk, Krajden, Quinlan, Peacock, Coldman. LBC=liquid-based cytology. • HPV testing, similar to traditional cytology testing (Pap smear), requires an organized program in which high screening coverage, follow-up care and quality control are achieved. High-Grade CIN Rates per 1000 (95% CI) Detected at Round 1 and 48-Month Exit Round, All Results, eTable 2.  et al. Loopik Women who were negative on both LBC and HPV co-testing at 48 months were deemed negative for CIN2+. Our study was a modelled evaluation. Garland 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. CR=set of screening adherence assumptions assuming a call-and-recall programme (proactive invitation). Our evaluation has several strengths. Two primary laboratories were responsible for screening of histopathology samples, 1 each in Vancouver and Victoria, British Columbia. Quiz Ref IDIn this trial, by 48 months, among women screened for cervical cancer with HPV testing without cytology, there were significantly fewer CIN3+ and CIN2+ cases compared with women who were screened with cytology alone at baseline. Drs Krajden and Coldman were principal investigators, and Drs Ogilvie, van Niekerk, and Franco and Mr Cook were coinvestigators on investigator-led, industry-funded (Hologic Inc and Roche) adjunct studies to the HPV FOCAL trial, designed to compare the performance of different HPV assays. Cervical screening in Australia 2012–2013: cancer series no 93—cat no CAN 91. the International HPV screening working group, IARC Working Group on the Evaluation of Cancer. Our analysis has some limitations. Ogilvie GS, van Niekerk D, Krajden M, et al. Coupled HPV typing and colposcopy proved to be the most efficient combination, increasing sensitivity to 97.2% and negative prognostic value to 92.3%. 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. 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. Further research is needed to understand long-term … Almost all screening strategies were less costly than current practice and many were also more effective, in both unvaccinated and vaccinated cohorts (. If cases were CIN3+ (in panel A) or CIN2+ (in panel B) at the initial screen but did not attend the exit screen, they contribute as an event at that time point. 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.  WK, Ault Adding a high‐risk HPV test to cytology for primary cervical screening led to earlier detection of clinically significant preinvasive lesions, resulting in a reduced detection of CIN2+ lesions in subsequent rounds and an increased rate of colposcopy. Recruitment occurred from January 2008 through May 2012. The standard screening method is cervical cytology, also called “Pap test”.  M, Previous studies found the benefit of HPV and cytology co-testing was based primarily on the contribution of HPV,21 which this trial now prospectively validates. We assessed 132 specific screening strategies, in unvaccinated women and in those offered vaccination. 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. Second, although the women from this clinical trial are participants in the population-based screening program, there is the potential for selection bias. Traditional population-based cervical screening programs, based on cytology, have successfully reduced the burden of cervical cancer. We considered several variations for each approach. Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. High-Grade CIN Rates per 1,000 Detected at 48 Month Exit and Cumulatively With Multiple Imputation; Results Reported Are an Average of Point Estimates From 25 Imputations. The primary objective of this study was to evaluate primary HPV testing for cervical cancer screening in an organized program setting. We did a literature search of the UK National Health Service Economic Evaluation Database (NHS EED), Medline, and Embase between January, 2008, and June–July, 2013, to identify published economic evaluations of cervical screening strategies. 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. Image, Download Hi-res  P, Carozzi  SL, Havrilesky 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]).  et al. Rates of CIN3+ at 48 months in the intervention and control groups were the primary end points. Incidence of CIN3+ (A) and CIN2+ (B) for baseline HPV and cytology-negative participants attending 48-month exit screen. Women who were HPV negative at baseline were significantly less likely to have CIN3+ and CIN2+ at 48 months compared with women who were cytology negative at baseline. The results, which indicate that primary HPV testing is a more early and accurate detector of cervical neoplasia than cytology, bucks trends surrounding such testing. The absolute difference in the incidence rate was −4.03/1000 (95% CI, −5.88 to −2.41) for CIN3+. The CIN2+ risk ratio for the intervention compared with the control group was 0.36 (95% CI, 0.24-0.54). At 48 months, significantly fewer CIN3+ and CIN2+ were detected in the intervention vs control group. 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). Arbyn HPV=human papillomavirus. KC and MS are co-principal investigators of an investigator-initiated trial of cytology and primary HPV screening in Australia (Compass; ACTRN12613001207707 and.  S, The impact of a two- versus three-yearly cervical screening interval recommendation on cervical cancer incidence and mortality: an analysis of trends in Australia, New Zealand, and England. Even the age-standardized incidence rate (ASR) continue decreasing, it is still high (17.8/100,000) [].Nowadays, a comprehensive cervical cancer screening in Thailand includes two types; a cytology-based screening, and co-testing or combination of cytology plus human papillomavirus (HPV) testing. Histopathological assessment was blinded to HPV and cytology results. Conclusions and Relevance  For each screening strategy, we considered several outcomes: health outcomes; costs; use of resources, including HPV DNA tests, cytology tests, colposcopies, treatment for precancerous lesions, and the proportion of treatments for cervical intraepithelial neoplasia grade 3 (CIN3) compared with cervical intraepithelial neoplasia grade 2 (CIN2), which is a measure of more targeted treatment (CIN2 is known to be histologically heterogeneous, with some cases more comparable with CIN3, and others with cervical intraepithelial neoplasia grade 1 [CIN1]); and the relation between health outcomes and resource utilisation. Ogilvie Medical Services Advisory Committee recommendations. KC oversaw all aspects of study design and conduct. Cumulative Cervical Intraepithelial Neoplasia Grade 3 or Greater (CIN3+) and Grade 2 or Greater (CIN2+) Incidence for Baseline Human Papillomavirus (HPV) and Cytology-Negative Participants Attending 48-Month Exit Screen, Table 1. In an Italian evaluation.  L,  EL, Ferenczy Cumulative Cervical Intraepithelial Neoplasia Grade 3 or Greater (CIN3+) and Grade 2 or Greater (CIN2+) Incidence for All Intervention and Control Group Participants Attending 48-Month Exit, Figure 3. 2016. Women who were HPV negative at baseline were significantly less likely to have CIN3+ and CIN2+ at 48 months compared with women who were cytology negative at baseline. We used an extensively calibrated modelling platform to assess cervical screening strategies in both vaccinated and unvaccinated cohorts, did an analysis of many screening strategies, and undertook an extensive sensitivity analysis. Disease detection and resource use in the safety and control arms of the HPV FOCAL cervical cancer screening trial.  J,  MM, 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. HPV DNA testing had the highest positive prognostic value (84.9%; confidence interval, CI: 67.4%- 94.3%) and cytology the lowest (66.0%; CI: 51.2%- 78.4%). The cohort was highly educated and primarily from 2 geographic regions in the province with limited representation from rural and remote populations. Age-standardised rate (0–84 years), standardised to the 2001 Australian population and represented per 100 000 women. Quiz Ref IDRates of CIN3+ at 48 months in the intervention and control groups were the primary end points. As previously reported14 in the first round of screening, significantly more CIN3+ cases were detected in the intervention (HPV tested) compared with the control group.13 The round 1 risk ratio for CIN3+ was 1.61 (95% CI, 1.09 to 2.37) in the intervention vs control group and the absolute difference in the incidence rate was 2.67/1000 (95% CI, 0.53-4.88) (eTable 1 in Supplement 2). DOI: https://doi.org/10.1016/S2468-2667(17)30007-5, We use cookies to help provide and enhance our service and tailor content and ads. It was assumed that this rate would be applicable to the control group and the alternate hypothesis assumed that the rate in the intervention group would be 0.5 times this rate (ie, 4.0 per 1000). 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.  et al. In the HPV-tested group, the colposcopy rate decreased in the second round of screening, which more accurately reflects the ongoing impact of HPV-based screening on a colposcopy program. 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. Disease detection and colposcopy referral rates at 48 months included all referrals and disease detected after round 1 screening in both groups and are reported throughout as rate per 1000.  et al. Get free access to newly published articles. We did each cost and effectiveness calculation for each possible variation within each of the six primary screening approaches.  S, Checa Secondary prevention of cervical cancer: ASCO resource-stratified clinical practice guideline. Walboomers 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. All Rights Reserved, Challenges in Clinical Electrocardiography, Clinical Implications of Basic Neuroscience, Health Care Economics, Insurance, Payment, Scientific Discovery and the Future of Medicine, United States Preventive Services Task Force, 2018;320(1):43-52. doi:10.1001/jama.2018.7464.  JR.  Regression and progression predictors of CIN2 in women younger than 25 years. Same participants if they were referred to a cytopathologist for final interpretation and reporting Victoria were invited to participate conducted. −4.02 ) for baseline HPV and cytology results than current practice and were!, women in the context of HPV vaccination status, reproductive, gynecological, and KC the... Impact and cost-effectiveness of cervical intraepithelial neoplasia: a repeat cross-sectional study invitation combined a. This evaluation has supported Australia cervical cytology vs hpv testing National cervical screening Program, there is the potential selection. 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