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. Challenges in risk estimation using routinely collected clinical data: the example of estimating cervical cancer risks from electronic health-records. Human papillomavirus genotype specificity of Hybrid Capture 2. The 2019 ASCCP Risk-Based Management Consensus Guidelines (Perkins and Guido et al.) following colposcopy/biopsy finding less than CIN 2 (no treatment), Follow-up after Castle PE, Solomon D, Wheeler CM, et al. ASCCP Risk-Based Management Consensus Guidelines Committee Key Words: cervical cytology, HPV testing, management of abnormal cervical cancer screening tests, guidelines (J Low Genit Tract Dis 2020;24: 102 –131) SECTION A. cervical cancer screening tests and cancer precursors. Risk-based management tables are organized under the 5 clinical scenarios. In the 2019 ASCCP risk-based management consensus guidelines, HPV-based testing is the basis for risk estimation and laboratories will likely see a larger volume of HPV testing requests. 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. Management of current cotest results is described after a previous result of HPV-negative ASC-US (see Table 2A), HPV-negative LSIL (Table 2B), and HPV-positive NILM (Table 2C). CIN Risk Calculator App A new CIN Risk Calculator App is now available through the Apple and Android App Stores. Sex. Objective: To manage cervical screening abnormalities, the 2019 ASCCP management consensus guidelines will recommend clinical action on the basis of risk of cervical precancer and cancer. Reset All. Expedited treatment (i.e., without preceding colposcopy/biopsy) is preferred for patients with immediate CIN 3+ risk 60% or greater, treatment or colposcopy/biopsy is acceptable for risk 25% or greater and less than 60%, and colposcopy/biopsy is recommended for risk 4.0% or greater and less than 25%. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Cheung LC, Egemen D, Chen X, et al. 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. It addresses the need for simplicity and stability in clinical guidelines while anticipating continued technologic advances in cervical screening methods. in the subsequent columns. However, ancillary analyses considered CIN 2+ (CIN 2/CIN 3/AIS/cancer) as an alternative definition of precancer and cancer by itself as an alternative outcome (please refer to the comprehensive tables available online at https://CervixCa.nlm.nih.gov/RiskTables). J Lower Gen Tract Dis 2020;24:102–131. are listed. Please try again soon. These risk scores are obtained at time points, 0 (immediate), 1, 2, 3, 4, and 5 years. Following the risk estimates columns, recommended management and “Recommendation 2. The risk-based management tables shown in abbreviated form in this article underlie the 2019 ASCCP Risk-Based Consensus Management Guidelines. You may be trying to access this site from a secured browser on the server. Perkins RB, Guido RS, Castle PE, et al. Mixture models for undiagnosed prevalent disease and interval-censored incident disease: applications to a cohort assembled from electronic health records. Landy R, Cheung LC, Schiffman M, et al. This patient has colposcopy/biopsy result, therefore consult Table 3. Implementing the 2019 ASCCP Risk Based Management Guidelines for Abnormal Cervical Cancer Screening Tests in Your Practice Patty Cason, MS, FNP-BC Envision Sexual and Reproductive . This patient has a history of a low-grade screening test result, followed by a colposcopy where CIN 2+ was not found, and now presents with new follow-up test results, therefore consult the Table 4A. Examples of important results are highlighted; for example, the risk posed by most current abnormalities is greatly reduced if the prior screening round was HPV-negative. Journal of Lower Genital Tract Disease24(2):132-143, April 2020. ; HPV-positive NILM × 2, HPV-positive ASC-US, or HPV-positive LSIL) at which CIN 1 or less was confirmed via biopsy, minor abnormalities (e.g., HPV-positive ASC-US and HPV-positive LSIL) found on the first follow-up test are recommended to be followed in 1 year, rather than proceed immediately to colposcopy (see Table 4A). Cytology was performed at KPNC regional and local laboratories. For this patient, 1-year CIN 3+ risk is less than 4%, so the 5-year risk is used. Demarco M, Egemen D, Raine-Bennett TR, et al. Informative) are listed in the columns following the Wolters Kluwer Health J Low Genit Tract Dis 2020;24:132-43. At Initial Visit: Calculated using the ACC/AHA 2013 Pooled Cohort Equation, which predict the absolute 10-year ASCVD risk for a patient with the profile entered at initial visit. Egemen, Didem PhD1; Cheung, Li C. PhD1; Chen, Xiaojian MSc1; Demarco, Maria PhD1; Perkins, Rebecca B. MD, MSc2; Kinney, Walter MD3; Poitras, Nancy BSc4; Befano, Brian BSc5; Locke, Alexander MD4; Guido, Richard S. MD6; Wiser, Amy L. MD7; Gage, Julia C. PhD, MPH1; Katki, Hormuzd A. PhD1; Wentzensen, Nicolas MD, PhD, MS1; Castle, Philip E. PhD, MPH8; Schiffman, Mark MD, MPH1; Lorey, Thomas S. MD3, 1Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD, 2Department of Obstetrics and Gynecology, Boston University School of Medicine/Boston Medical Center, Boston, MA, 3Division of Gynecologic Oncology, Kaiser Permanente Medical Care Program, Oakland, CA (contributed before retirement), 4Regional Laboratory, Kaiser Permanente Northern California, Berkeley, CA, 5Information Management Services Inc, Information Management, Calverton, NY, 6Department of Obstetrics, Gynecology and Reproductive Sciences, UPMC Magee-Women's Hospital, Pittsburgh, PA, 7Department of Family Medicine, Oregon Health and Science University, Portland, OR, 8Albert Einstein College of Medicine, Bronx, NY, Reprint requests to: Didem Egemen, PhD, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 9609 Medical Center Dr, Rm 7E610 Rockville, MD 20892. The immediate and 5-year risks of CIN 3+ used to decide clinical management are shown. The length and size of the program, and its indisputable high quality, lend confidence to the internal comparisons of risk after different test results. This calculator assumes that you have not had a prior heart attack or stroke. The total number of CIN 3+ detected from the initial screen until the end of follow-up is presented in column “CIN 3+ cases.” Columns “CIN 3+ immediate risk, %” and “CIN 3+ 5-y risk, %” give the estimated immediate and 5-year CIN 3+ risks (as percent probabilities). The risk remains higher for treated CIN 3 compared with CIN 2 scenarios. For information on cookies and how you can disable them visit our Privacy and Cookie Policy. A study of partial human papillomavirus genotyping in support 11:10 AM – 11:35 AM: The Clinical Power of Updated Management Guidelines: Personalized Management of Your Patients. It presents the average risk of people with the same risk factors as those entered for that person. Management recommendations for the new guidelines were updated based on data from significantly larger databases than were previously available. Risk estimates supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines. Patient 4: A 32-year-old woman has a history of an HPV-positive LSIL result. Patient 3: A 32-year-old woman presents for follow-up. Table 1A addresses patients without a documented recent HPV test result. 10. Even after 3 negative HPV tests or cotests, risks remain well above the 0.15% 5-year CIN 3+ risk threshold needed to return to screening at 5-year intervals, leading to a recommendation of continued follow-up at 3-year intervals. Patient 1: A 32-year-old woman presents for screening, she denies having colposcopy or treatment in the past, but her medical records are not available so her history is unknown. This study was partly supported by the Intramural Research Program of the US National Institutes of Health (NIH)/National Cancer Institute (NCI). Total number of observed CIN 2+, CIN 3+, and cancer cases are displayed together with the Kaiser Permanente of Northern California (KPNC)/National Cancer Institute Guidelines Cohort has been previously described.3–5 In brief, from 2003 to 2017, cervical cancer screening was conducted among individuals aged 25 to 65 years, using HPV testing with Hybrid Capture 2 (HC2; Qiagen, Germantown, MD) and cytology. Disclosures Cason Member board of directors ASCCP. Phone: 301-857-7877 However, to maximize safety after treatment of precancer, management is recommended based on the risks of patients treated for CIN 3. Welcome to the QRISK ® 3-2018 risk calculator. This patient has a history of treated CIN 3, therefore consult Table 5A. Histopathology was also centralized. As a result, every year in KPNC screening participants became age eligible for cotesting resulting in a peak at the age group 30 to 34 years and, starting in 2013, the same effect in those aged 25 to 29 years. 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. In the KPNC database, 18,254 women had this result combination, among whom 242 had CIN 3+. 30 mins. This patient's immediate CIN 3+ risk is less than 4%, so the 5-year risk is used to determine the recommended management. Her current test results are HPV-positive ASC-US. A negative cotest after HPV-negative ASC-US warrants return to screening at 5-year intervals (5-year CIN 3+ risk is 0.14%, which is less than the 0.15% 5-year surveillance threshold). Risk calculation can be achieved by using a mobile phone App or a free web-based risk calculator available on the ASCCP website, as well as by referring to the tables published in Engemen et al. 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%. If you have, generally it is recommended that you discuss with your doctor about starting aspirin and a statin. Any abnormality on any follow-up test leads to re-referral to colposcopy, including HPV-negative ASC-US/LSIL cytology, HPV-negative high-grade cytology, and all HPV-positive results (see Table 5A). Dr. Lee Goldman on original Goldman Cardiac Risk Index for MDCalc: The Revised Cardiac Risk Index was published 22 years after the original index became the first multifactorial approach to assessing the cardiac risk of non-cardiac surgery and one of the first such … 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. 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. of colposcopy/biopsy results, Surveillance visit J Low Genit Tract Dis 2020;24:90–101. Demarco M, Egemen D, Raine-Bennett TR, et al. She presents for follow-up at 1 year and her cotest result is HPV-positive ASC-US. In the KPNC database, 2,379 women had this result combination, among whom 12 had CIN 3+, leading to a recommendation confidence score of 91%. Therefore, a prior HPV-negative test leads to lower risks (see Table 1B) than unknown history (see Table 1A). 1. Why does cervical cancer occur in a state-of-the-art screening program? Risk tables are presented for different clinical scenarios. 2019 ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors. Risk should be similar to that of negative Pap test in a screening population Five-year CIN3+ risks: 0.33% estimated in KPNC 0.45% projected in CDC breast and cervical cancer screening program Perkins RB, et al. Two central questions underlie risk estimations: (a) What are the current results? 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. The 2019 ASCCP Risk-Based Management Consensus Guidelines (Perkins and Guido et al.) The recommended management is colposcopy because her immediate estimated risk is greater than 4% (the colposcopy threshold) and less than 25% (the treatment or colposcopy threshold). Once enough data accrue on the vaccinated population, the risk scores will be re-evaluated to determine recommended management for the vaccinated population. Her 5-year risk is 6.0%, which is above the 0.55% threshold for a 3-year return, so the recommended management is 1-year follow-up. The risk estimates are in the public domain in the United States of America and are made freely available elsewhere. Hyun N, Cheung LC, Pan Q, et al. 9. 7. This patient has a history of an abnormal result that did not require colposcopy, therefore consult the Tables 2A–C section corresponding to her initial abnormal result. Therefore, the 2019 guidelines recommend referral for colposcopy for abnormal results occurring on subsequent rounds of follow-up testing. risk-based; management guidelines; cervical screening; HPV. ASCVD Risk Estimator Intended for patients with LDL-C 190 mg/dL (4.92 mmol/L), without ASCVD, not on LDL-C lowering therapy. The tables presented here display the risk estimates of CIN 3+, as well as CIN 2+ and The QRISK ® 3 algorithm calculates a person's risk of developing a heart attack or stroke over the next 10 years. This article explains risk-based management tables under 5 different clinical scenarios that comprise most management visits and decisions. Mark Einstein, MD, MS. ... ASCCP c/o SHS Services, LLC 131 Rollins Ave, Suite 2 Rockville, MD 20852. J Low Genit Tract Dis 2020;24:144–7. As history, a negative HPV test followed by a positive HPV test suggests a new or reappearing infection, which is lower risk than a persistent infection. For HPV-positive NILM, this is Table 2C (use Tables 2A, B for HPV-negative ASC-US and LSIL, respectively). ; for the 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. This exceeds the 4% colposcopy threshold but is below the threshold for offering colposcopy or treatment (25%), so the recommended management is colposcopy. Reaching the 60% threshold for preferring treatment requires an additional risk factor, such as HPV-16 infection7 or a history of not having been screened. For Tables 5A and 5B, the risk estimation in this scenario (i.e., posttreatment) derives specifically from treated CIN 3 and the test result at the follow-up visit after treatment. For HPV-positive ASC-US and LSIL, this reduction in risks leads to a change of recommended management. Abnormal Screening Your message has been successfully sent to your colleague. Scenario 4 describes management after a colposcopy at which CIN 2+ was not found (i.e., colposcopy/biopsy results were CIN 1 or normal). They employ HPV-based testing as the basis for risk estimation, allow for perso … 2019 ASCCP Risk-Based Management Consensus Guidelines: Methods for Risk Estimation, Recommended Management, and Validation April 2020 Journal of … leftmost column presents the oldest test result in the screening In the KPNC database, 290 women had this result combination, among whom 21 had CIN 3+, leading to a recommendation confidence score of 86%. 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. and upper (UL95) confidence interval. A study of partial human papillomavirus genotyping in support of the 2019 ASCCP risk-based management consensus guidelines. HPV vaccination is expected to decrease the prevalence rate in the young population (patients between ages 25–29 years), which might change the recommended management in different scenarios for this age group. result as a percentage (%) of total screened, the total number of patients informative in risk estimation (N Basically, the heart attack can be predicted using this calculator. 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. Please enable scripts and reload this page. For immediate risks greater than 4%, the recommended management is determined by the immediate CIN 3+ risk. The total sample size (N) in each category and each screening In the tables, the risk used to determine the recommended management is bolded. for details).3. CIN 3+ 5-year risk is the probability of observing CIN 3+ within 5 years after the current visit. The column named “Recommendation confidence score, %” indicates the percent probability that the KPNC risk estimates fall within the risk range dictating the recommended management (based on the sample size and how close the estimated risks are to clinical action thresholds, Cheung et al.3). It is important to emphasize that for a given patient over time, a clinician is likely to consult various tables as the management scenarios are encountered, from initial abnormality to resolution. We used prevalence-incidence mixture models.8–10 The model is a mixture of logistic regression for events present at the time of the current visit (prevalent disease) and proportional hazards model for events occurring after the current visit (incident disease). Her immediate CIN 3+ risk is less than 4%, so the 5-year risk is used. Welcome to the QRISK ® 3-2018 Web Calculator. Because all repeat abnormalities were referred back to colposcopy at KPNC, we cannot estimate risks for additional rounds of follow-up. Keyword Highlighting modify the keyword list to augment your search. Risk estimation for the next generation of prevention programmes for cervical cancer. Search for Similar Articles An HPV-negative test is virtually as reassuring as a negative cotest. 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. The comprehensive risk database is stored at the National Institutes of Health, publicly accessible through this link: https://CervixCa.nlm.nih.gov/RiskTables. In the KPNC database, 7,794 women had this result combination, among whom 189 had CIN 3+, leading to a recommendation confidence score of 100%. Results are similar when cotesting is considered rather than primary HPV testing. treatment for CIN 2 or CIN 3. for the HPV genotyping test results as explained in the article Demarco et al. 3 The approach to managing test results has evolved as well. 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. Generation of these risk estimates was supported by the Intramural Research Program of the National Cancer Institute. Patient 7: A 32-year-old woman has a history of CIN 3 that was treated with diagnostic loop electrosurgical excisional procedure (LEEP), followed by 1 negative HPV test. may email you for journal alerts and information, but is committed For more information, please refer to our Privacy Policy. 1. This patient has a history of treated CIN 3 and more than 1 negative follow-up test, therefore consult Table 5B. Special situations are covered in Sections H and I of Perkins et al.1 and explained in the footnotes of the tables. Therefore, risk estimation subsequent to diagnoses of CIN 1 or less after these cytologic results were less reliable, and because of the concern for occult disease after any high-grade cytology, results are managed cautiously. Her 5-year risk is 3.8%, which is above the 0.55% threshold for a 3-year return, so the recommended management is 1-year follow-up. The National Cancer Institute (including M.S. CIN 3+ immediate risk is the estimated probability of observing CIN 3+ if the patient were referred to colposcopy based on the current visit. 6 clinical actions (treatment, optional treatment or colposcopy/biopsy, colposcopy/biopsy, 1-year surveillance, Patients with immediate CIN 3+ risks of less than 4.0% are recommended to have follow-up surveillance, and their deferred clinical management is guided by 5-year risks of CIN 3+: 1-year follow-up for risk 0.55% or greater (but under the colposcopy threshold of 4.0% immediate risk), 3-year follow-up for risk 0.15% or greater and less than 0.55%, and return to routine screening at 5-year intervals for risk less than 0.15%. Among 1,546,462 people at the first visit, 92% had a primary HPV-negative test result. April 2020; Journal of Lower Genital Tract Disease 24(2):132-143; DOI: 10.1097/LGT.0000000000000529. 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). Therefore, patients with a negative cytology history will still be managed by Table 1A. Suggested management is determined by matching a patient's risk estimate to a clinical action threshold (see Figure 2). Her immediate CIN 3+ risk is less than 4%, so the 5-year risk is used. However, documented negative cytology provides relatively less reduction in risk compared with a negative HPV or cotest as history. Demarco M, Egemen D, Raine-Bennett TR, et al. We will illustrate how risk estimates are used to determine management using hypothetical patient examples. Prior treatment for CIN 2 or CIN 3 increases risk. The calculator keeps a check on the functioning of your heart. (2020) 2019 ASCCP Risk-Based Management Consensus Guidelines … For immediate assistance, contact Customer Service: Observing one more negative HPV test result decreases this risk to 0.44%, which leads to 3-year follow-up (see Table 5B). Management recommendations are similar to the 2012 guidelines2 for patients with an unknown screening history but are modulated to be more or less intensive for patients with a documented prior negative HPV test results or prior colposcopy results showing CIN 1 or less (indicating lower risk) or prior HPV-positive results or treatment for CIN 3 (indicating higher risk). Incorrect sign in attempts and will be automatically unlocked in 30 mins risk Estimator Intended patients... A ) What past results affect the risk scores will be added as needed risk to! Extremely rare ( 0.01 % of overall screens in tables 1A, B ) What past affect! 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