R.S.G. Because we know the colposcopy/biopsy results of the patient, calculating immediate CIN 3+ risks is meaningless. This patient has an abnormal current result and history of a documented negative HPV and cytology cotest, therefore consult Table 1B (although Table 1B is for negative HPV—without cytology—history, the CIN 3+ risks are very similar with cotest negative history). 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. However, this test combination is extremely rare (0.01% of overall screens in Tables 1A, B). Castle PE, Kinney WK, Cheung LC, et al. Li Cheung, PhD . This article supports the main guidelines presentation1 by presenting and explaining the risk estimates that supported the guidelines. Patient 5: A 32-year-old woman has a history of an HPV-positive LSIL result, followed by a colposcopic biopsy showing CIN 1. With this strong caveat, a recommendation confidence score above 80% is suggested as a helpful guide by the statisticians directing the analyses to represent good reassurance for the recommended management, although again there is no absolute threshold for such a statistical intuition. Wolters Kluwer Health She presents for follow-up and her second HPV test result is also negative. The 25- to 29-year age group frequency reflects KPNC initiation of cotesting starting at age 25 in 2013. 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. 30 mins. Patient 4: A 32-year-old woman has a history of an HPV-positive LSIL result. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors J Low Genit Tract Dis. breakdown of prevalence, incidence, and unknown prevalence/incidence Her current test results are HPV-positive ASC-US. [email protected]. The 2019 ASCCP Guidelines are substantially different from earlier versions and reflect increased understanding of the natural history of HPV infections and progression to high grade lesions. In addition, the risks for some rare combinations could not be estimated with confidence. test results. cervical cancer screening abnormalities recommend 1 of Welcome to the QRISK ® 3-2018 Web Calculator. J Low Genit Tract Dis 2020;24:132–43. The immediate and 5-year risks of CIN 3+ used to decide clinical management are shown. 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. Risk Estimates Supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines. for the HPV genotyping test results as explained in the article Demarco et al. 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. cervical cancer screening tests and cancer precursors. The HPV–negative ASC-US is also a reassuring history result (see Table 2A). In the KPNC database, 585 women had this result combination, among whom 11 had CIN 3+, leading to a recommendation confidence score of 100%. Patient 3: A 32-year-old woman presents for follow-up. The other authors have declared they have no conflicts of interest. In the KPNC database, 30,506 women had this result combination, among whom 1,378 had CIN 3+ (detected from initial screen through the end of follow-up), leading to a recommendation confidence score rounding to 100%. Each risk estimate is 6. 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. In Tables 5A and 5B, “history” refers to treatment for CIN 2 or CIN 3, and “current results” are HPV test results or cotest results after treatment. CIN Risk Calculator App A new CIN Risk Calculator App is now available through the Apple and Android App Stores. April 2020; Journal of Lower Genital Tract Disease 24(2):132-143; DOI: 10.1097/LGT.0000000000000529. The 2019 American Society for Colposcopy and Cervical Pathology (ASCCP) Risk-Based Management Consensus Guidelines describe 6 clinical actions that providers can use when managing patients with abnormal cervical cancer screening test results: treatment; optional treatment or colposcopy/biopsy; colposcopy/biopsy; 1-year surveillance; 3-year surveillance; and return to 5-year regular screening.1 These clinical actions are recommended based on a patient's risk of either currently having or subsequently de… Assessing the risk of cervical precancer at the colposcopy visit allows for modification of colposcopy procedures consistent with a woman's risk. result as a percentage (%) of total screened, the total number of patients informative in risk estimation (N Journal of Lower Genital Tract Disease24(2):132-143, April 2020. 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). 5. The unique KPNC screening experience, and the long-term collaborative dedication of our KPNC colleagues, permitted this detailed examination of risks. 3 The approach to managing test results has evolved as well. Confidence Score” (for more details about this score please refer Published by RenalGuard Solutions, this app is an easy-to-use clinical tool intended for use by healthcare professionals to help predict the risk of contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI). 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 total sample size (N) in each category and each screening The new iOS & Android mobile apps and the Web application, to streamline navigation of the guidelines, have launched. Guidelines. The comprehensive risk database is stored at the National Institutes of Health, publicly accessible through this link: https://CervixCa.nlm.nih.gov/RiskTables. ; 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). Generation of these risk estimates was supported by the Intramural Research Program of the National Cancer Institute. You may search for similar articles that contain these same keywords or you may The calculator keeps a check on the functioning of your heart. Her result today is HPV-negative ASC-US. In Tables 2A–C, “history” refers to the abnormal screening test result preceding the current result: HPV-negative ASC-US (Table 2A), HPV-negative LSIL (Table 2B), and HPV-positive NILM (Table 2C). your express consent. 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). Perkins RB, Guido RS, Castle PE, et al. The “current results” are those for which the clinician is seeking guidance, either an HPV test or cotest result (see Tables 1A–2C4A–5B) or a colposcopy/biopsy result (see Table 3). Risk-based management tables are organized under the 5 clinical scenarios. cancer for every possible combinations of test result as the data permits. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Mark Einstein, MD, MS. ... ASCCP c/o SHS Services, LLC 131 Rollins Ave, Suite 2 Rockville, MD 20852. This article navigates the most relevant risk-based management tables that inform the new guidelines for clinicians. Demarco M, Egemen D, Raine-Bennett TR, et al. Frequency of women at their first cotest visit based on age groups: First visit age group 30- to 34-year frequency reflects initiation of cotesting at 30 years and older starting in 2003. We estimated immediate and 5-year risks of CIN 3+ for combinations of current test results paired with history of screening test and colposcopy/biopsy results. The accumulation of individuals in the 30- to 34-year age group reflects the start of cotesting at 30 years and older from 2003 until KPNC guidelines changed in 2013 to recommend beginning cotesting at age 25 years. 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. 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%. the many different combinations of current and recent EXECUTIVE SUMMARY B. Total number of observed CIN 2+, CIN 3+, and cancer cases are displayed together with the This exceeds the 4% colposcopy threshold but is below the threshold for offering colposcopy or treatment (25%), so the recommended management is colposcopy. To qualify for Table 1B, a patient's current abnormal screening test result must be preceded by a negative HPV test documented in the medical record within the past approximately 5 years (e.g., a normal screening interval). This situation is exemplified by patients entering an HPV-based screening program for the first time. past screening results. INTRODUCTION C. GUIDING PRINCIPLES 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. to Egemen et al.) It is the percent probability that the estimated risk, from a random sample of that size, would support the determined management option, rather than the neighboring options. 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. In the tables, the risk used to determine the recommended management is bolded. Abnormal Screening Sampling weights are used for the sample from which we obtained the risk estimates Her immediate CIN 3+ risk is 4.4%. 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. The 2019 ASCCP Risk-Based Management Consensus Guidelines (Perkins and Guido et al.) For HPV-positive ASC-US and LSIL, this reduction in risks leads to a change of recommended management. 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). 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. of the 2019 ASCCP risk-based management consensus guidelines. This patient has an abnormal current result and an unknown/undocumented history, therefore consult Table 1A. Basically, the heart attack can be predicted using this calculator. This study was partly supported by the Intramural Research Program of the US National Institutes of Health (NIH)/National Cancer Institute (NCI). Disclosures Cason Member board of directors ASCCP. presented with its corresponding standard error (SE) and 95% lower (LL95) 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. CIN 3+ immediate risk is the estimated probability of observing CIN 3+ if the patient were referred to colposcopy based on the current visit. For information on cookies and how you can disable them visit our Privacy and Cookie Policy. The past results that impact risk estimates are noted under “history.” Table 1A refers to patients without a recent documented HPV test or cotest result, so the history is simply “unknown.” In Table 1B, “history” refers to recent documented negative HPV test (management after a prior negative cotest is so similar that we do not show them, interested readers can consult the full tables online). See the full list of organizations (below) that participated in the consensus process. They employ HPV-based testing as the basis for risk estimation, allow for perso … based on the risk of cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ, or cancer (CIN 3+) for 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). Reset All. The largest age cohort included ages 30 to 34 years (25%), followed by 35 to 39 years (14%) and 25 to 29 years (13%). Generalizability to other clinical settings/populations is thought to be good, as outlined in the methods article.3 Nonetheless, the recommendation confidence score should not be misinterpreted as the true probability that a recommendation is absolutely correct. 4. NSQIP Risk Calculator . 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 tables presented here display the risk estimates of CIN 3+, as well as CIN 2+ and 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. 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). 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. In Table 4B, “history” again refers to both the colposcopy result (