E-mail: [email protected]. Abnormal Screening The comprehensive risk database is stored at the National Institutes of Health, publicly accessible through this link: https://CervixCa.nlm.nih.gov/RiskTables. 3. Egemen D, Cheung LC, Chen X, et al. The HPV–negative ASC-US is also a reassuring history result (see Table 2A). 13, 14 The term HPV-based testing is used in the 2019 ASCCP guidelines to refer to use of either primary HPV testing alone or HPV testing in conjunction with cervical cytology (cotesting). To apply these clinical action thresholds using the tables in this article, the first step is to determine whether the risk denoted in the “CIN 3+ immediate risk” column is greater than or less than 4%. Cytology was performed at KPNC regional and local laboratories. (b) What past results affect the risk estimate for the current results? Moving from result-based to risk-based guidelines, it is important for the clinician to understand how these risk estimates were obtained and how to use them in clinical management of cervical screening. She presents for follow-up at 1 year and her cotest result is HPV-positive ASC-US. Although we had high statistical confidence in most of our estimates, the measure “Recommendation confidence score” is given more as a warning when the percentage is low, signifying lack of confidence in the recommendation because of data limitations (lack of observations or small number of observed cases). The risk-based management tables shown in abbreviated form in this article underlie the 2019 ASCCP Risk-Based Consensus Management Guidelines. The 25- to 29-year age group frequency reflects KPNC initiation of cotesting starting at age 25 in 2013. We restricted the analytic sample to 1,546,462 screened individuals with both HPV and cytology results, excluding those with a prior hysterectomy, histopathologic CIN 2+ diagnosis, missing HPV results or with cytology reports of missing, uncertain, or not cervical. 4. Li Cheung, PhD . for the HPV genotyping test results as explained in the article Demarco et al. In Table 3, “history” refers to the precolposcopy test results. Informative) are listed in the columns following the Her 5-year risk is 0.91%, which is above the 0.55% threshold for a 3-year return, so the recommended management is 1-year follow-up. 7. A documented negative HPV test result before HPV-positive ASC-US and LSIL almost halves the immediate CIN 3+ risk (4.4%, 4.3%–2.0%, 2.1%, respectively) and changes the recommended management from immediate colposcopy to 1-year follow-up (see Table 1B). 2019 ASCCP risk-based management consensus guidelines: methods for risk estimation, recommended management, and validation. 5. From 2003 to 2017 at Kaiser Permanente Northern California (KPNC), 1.5 million individuals aged 25 to 65 years were screened with human papillomavirus (HPV) and cytology cotesting scheduled every 3 years. The Next Generation of Guidelines: It’s All About Risk . of colposcopy/biopsy results, Surveillance visit Basically, the heart attack can be predicted using this calculator. The new risk-based guidelines present recommendations for the management of abnormal screening test and histology results; the key risk estimates supporting guidelines are presented in this article. Your message has been successfully sent to your colleague. Landy R, Cheung LC, Schiffman M, et al. and N.W.) Table 4B describes CIN 3+ risks when the index cotest was high grade (i.e., ASC-H, AGC, HSIL+). The only instance in which HPV-negative is not reassuring is when cytology is HSIL+. April 2020; Journal of Lower Genital Tract Disease 24(2):132-143; DOI: 10.1097/LGT.0000000000000529. These risk scores are obtained at time points, 0 (immediate), 1, 2, 3, 4, and 5 years. The 2019 ASCCP Risk-Based Management Consensus Guidelines (Perkins and Guido et al.) 2020 Apr;24(2):132-143. doi: 10.1097/LGT.0000000000000529. Immediate and 5-Year Risks of CIN 3+ for Abnormal Screening Results, When There Are No Known Prior, Immediate and 5-Year Risks of CIN 3+ After a Prior, Immediate and 5-Year Risks of CIN 3+ for Results Obtained in Follow-up of, Immediate and 5-year risks of CIN 3+ for results obtained in follow-up of, CIN 3+ 1-Year and 5-Year Risks Upon Receipt of Colposcopy/Biopsy Result, Immediate and 5-Year Risks of CIN 3+ Postcolposcopy at Which CIN 2+ Was Not Found, After Referral for Low-Grade Results, Immediate and 5-Year Risks of CIN 3+ Postcolposcopy at Which CIN 2+ Was Not Found, After Referral for High-Grade Results, Immediate and 5-Year Risks After Treatment for CIN 2 or CIN 3, Long-Term Follow-up When There Are 2 or 3 Negative Follow-up Test Results After Treatment of CIN 2 or CIN 3. treatment for CIN 2 or CIN 3. A high percent suggests statistical precision, defined as adequate numbers of CIN 3+ events to generate a stable risk estimate and confidence that the estimate is yielding the correct recommendation based on the KPNC data. Demarco M, Egemen D, Raine-Bennett TR, et al. following results not requiring immediate colposcopic referral, Receipt The 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines for the management of cervical cancer screening abnormalities recommend 1 of 6 clinical actions (treatment, optional treatment or colposcopy/biopsy, colposcopy/biopsy, 1-year surveillance, 3-year surveillance, 5-year return to regular screening) based on the risk of cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ, or cancer (CIN 3+) for the many different combinations of current and recent past screening results. Results, Surveillance This calculation is the same as it is in the ASCVD Risk Estimator. For immediate assistance, contact Customer Service: Journal of Lower Genital Tract Disease24(2):132-143, April 2020. However, this test combination is extremely rare (0.01% of overall screens in Tables 1A, B). 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Her immediate CIN 3+ risk is less than 4%, so the 5-year risk is used. Welcome to the QRISK ® 3-2018 Web Calculator. At a population level, the risk of CIN 3+ for screening participants at any given age is highest at the time of the initial HPV-based screen (0.45% immediate CIN 3+ risk for patients new to HPV testing in KPNC aged 25–65 years). the many different combinations of current and recent 1. ASCVD Risk Estimator Intended for patients with LDL-C 190 mg/dL (4.92 mmol/L), without ASCVD, not on LDL-C lowering therapy. 6 clinical actions (treatment, optional treatment or colposcopy/biopsy, colposcopy/biopsy, 1-year surveillance, ASCVD Risk Calculator. Lifetime Risk Calculator only provides lifetime risk estimates for individuals 20 to 59 years of age. Risk Estimates Supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines J Low Genit Tract Dis. This article explains risk-based management tables under 5 different clinical scenarios that comprise most management visits and decisions. This article details the methods used to estimate risk, to determine the risk-based management, and to validate that the risk-based recommendations are of general use in different settings. Rather, a continuation of 3-year follow-up is recommended long term, based on the follow-up data we currently have available (see Table 5B), as well as longer-term follow-up from population-based studies.1. (2020) 2019 ASCCP Risk-Based Management Consensus Guidelines … CIN 2 was de-emphasized because it is a less reliable histopathologic definition of precancer. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors J Low Genit Tract Dis. Updated US consensus guidelines for management of cervical screening abnormalities are needed to accommodate the 3 available cervical screening strategies: primary human papillomavirus (HPV) screening, cotesting with HPV testing and cervical cytology, and cervical cytologyalone. Comprehensive risk estimates are freely available online at https://CervixCa.nlm.nih.gov/RiskTables. The risk estimates are in the public domain in the United States of America and are made freely available elsewhere. J Low Genit Tract Dis 2020;24:102–31. The HPV status was based on HC2 testing performed on a second cervical specimen (collected at the same time as the cytology specimen) at the KPNC regional laboratory. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. 2019 ASCCP risk-based management consensus guidelines for abnormal cervical cancer screening tests and cancer precursors. No such perfect prediction is possible or implied; the measure is given more as a warning when the percentage is low, signifying lack of confidence in the recommendation. Therefore, in this scenario, we are rather interested in 1- and 5-year CIN 3+ risks of the patients. 3. Michael Policar, MD, MPH CA Prevention Training Center. 9. Note that these data demonstrate that multiple negative cotest results after a CIN 2 or CIN 3 treatment are not enough to exit posttreatment surveillance. One example would be changes in the risk score of the vaccinated population. Wolters Kluwer Health ASCCP c/o SHS Services, LLC 131 Rollins Ave, Suite 2 Rockville, MD 20852. The new iOS & Android mobile apps and the Web application, to streamline navigation of the guidelines, have launched. Guidelines. The item(s) has been successfully added to ", This article has been saved into your User Account, in the Favorites area, under the new folder. Certain high-risk situations are managed based on factors other than risk estimates and denoted as “Special Situations.” These included rare result combinations for which insufficient data caused risk estimates to be unstable and those for which the cancer risk estimates and/or scientific literature indicated disproportionately high cancer risks relative to CIN 3+ risks, leading to recommendations for more aggressive management. This calculator is for use only in adult patients without known ASCVD and LDL 70-189 mg/dL (1.81-4.90 mmol/L). Therefore, patients with a negative cytology history will still be managed by Table 1A. p16 and Other Epithelial Cancer Biomarkers. She presents for follow-up and her second HPV test result is also negative. 3-year surveillance, 5-year return to regular screening) Assessing the risk of cervical precancer at the colposcopy visit allows for modification of colposcopy procedures consistent with a woman's risk. history of the patient while the rightmost column(s) (among the test results) displays the current test result. Patient 5: A 32-year-old woman has a history of an HPV-positive LSIL result, followed by a colposcopic biopsy showing CIN 1. Lippincott Journals Subscribers, use your username or email along with your password to log in. For instance, a “Recommendation confidence score” of 95% for a recommendation of 1-year surveillance means 95% statistical confidence that the recommended management is correct when considering the KPNC data, rather than colposcopy or 3-year surveillance. 8. Results are similar when cotesting is considered rather than primary HPV testing. These results are reported separately by Demarco et al.7. The 2019 revision of the ASCCP Risk-Based Management Consensus Guidelines expands upon the “risk-based” approach introduced in 2012. Table 4A describes CIN 3+ risks when the index cotest was low grade (i.e., LSIL, ASC-US, or HPV-positive NILM). CIN Risk Calculator App A new CIN Risk Calculator App is now available through the Apple and Android App Stores. The age distribution of the study cohort at the first visit at which they received cotesting (i.e., enrollment) is shown in Figure 1. PDF | On Apr 1, 2020, Rebecca B. Perkins and others published 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors | … The other authors have declared they have no conflicts of interest. This patient's immediate CIN 3+ risk is less than 4%, so the 5-year risk is used to determine the recommended management. The first screening round will detect most prevalent CIN 3+ and reduce the risk of CIN 3+ in future screening rounds. Estimated 10 Year ASCVD Risk. Management recommendations for the new guidelines were updated based on data from significantly larger databases than were previously available. Thus, the management recommendations apply to both treated CIN 2 and CIN 3. your express consent. It presents the average risk of people with the same risk factors as those entered for that person. We will illustrate how risk estimates are used to determine management using hypothetical patient examples. After HPV-positive NILM, a negative cotest is recommended to be followed-up in 1 year rather than 3 years (since 5-year CIN 3+ risk is 0.9%, higher than the 0.55% 3-year surveillance threshold, see Table 2C), as was recommended in 2012 guidelines.2 Only after 2 negative cotests can the screening interval can be safely extended to 3 years because the 5-year CIN 3+ risk drops to 0.29% (see Table 2C). J Low Genit Tract Dis 2020;24:144–7. NCI-Kaiser Permanente Northern California (KPNC) Persistence and Progression (PaP) study have been reapproved yearly by both KPNC and NCI Institutional Review Board review committees. Among the 8% of the population that initially tested HPV positive, immediate CIN 3+ risks ranged from 2.1% for HPV-positive NILM (below the colposcopy threshold), to 4.3% and 4.4% for HPV-positive ASC-US and LSIL, respectively (defining the colposcopy threshold), to 25% and 26% for HPV-negative HSIL+ and HPV-positive ASC-H, respectively (defining the treatment or colposcopy threshold), to 49% for HPV-positive HSIL+. 2. Search for Similar Articles Risk estimates supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines. The 2019 ASCCP Risk-Based Management Consensus Guidelines (Perkins and Guido et al.) This situation is exemplified by patients entering an HPV-based screening program for the first time. may email you for journal alerts and information, but is committed The raw sample sizes (without the sampling weights) are presented at the rightmost columns of each table. Risk Estimates Supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines. Katki HA, Wacholder S, Solomon D, et al. This patient has colposcopy/biopsy result, therefore consult Table 3. Please enable scripts and reload this page. In the future, we anticipate additional scenarios will be added as needed. Patient 3: A 32-year-old woman presents for follow-up. This patient has an abnormal current result and an unknown/undocumented history, therefore consult Table 1A. The length and size of the program, and its indisputable high quality, lend confidence to the internal comparisons of risk after different test results. Calculate your 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. Perkins RB, Guido RS, Castle PE, et al. Her immediate CIN 3+ risk is 5.6%. This study was partly supported by the Intramural Research Program of the US National Institutes of Health (NIH)/National Cancer Institute (NCI). are listed. Histopathology was also centralized. 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