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. junction or the lesion(s) are not fully visualized (see Figure 8). and Demarco et al. Cytology. Moreover, these women are at higher risk of cervical cancer compared with the general population, even after adequate treatment . If CIN 2 or unspecified histologic. is recommended (BIII). New for these, guidelines, a positive a positive primary HPV screening test should, trigger both a reflex genotyping test (to determine the presence/, absence of HPV 16/18 if that information is not included in the initial, primary test result) and also a reflex cytology test to determine. The 0.55%, CIN 3+ risk corresponds to an HPV positivity of 9% among NILM, cytology results and is close to the 0.52% risk estimated in the New, thresholds for a 5-year return, the surveillance group used the. This is by far one of the largest retrospective studies to analyze the histological follow‐up results of ASC‐US women with positive hrHPV tested by Aptima hrHPV mRNA assay. Working groups met regularly from sum-, for management. To solicit provider feedback, we surveyed attendees at the 2019 ASCCP annual meeting regarding readiness to adopt proposed changes and used a web-based public comment period to gauge agreement/disagreement with preliminary guidelines. Negative, results on HPV tests that are not FDA approved for primary, cervical cancer screening should not be considered valid in, the absence of adequate cytology (Section F, cytology in 3 years is acceptable if HPV testing is not per-, ical Action Thresholds according to 2019 consensus guidelines, cated a lower risk of CIN 3+ for patients with absent transformation, recommendation to manage these results similarly, ing is preferred in women 30 years or older to facilitate subsequent, 2019 on whether the absence of a transformation zone component, NILM cytology slides affected patients' subsequent risks of histo-, logic HSIL (CIN 2, CIN 3) diagnoses showed no e, opausal patients with endometrial cells on cytology but did not, indicate increased endometrial cancer risk for premenopausal pa-, tients with benign endometrial cells in the absence abnormal uterine, The literature review was updated using a PubMed, search for recent publications since 2012 that address benign-, appearing endometrial cells in postmenopausal and glandular cells, in posthysterectomy individuals. Consistent with the 2012 consen-, screening tests showing minimal abnormalities: HPV, history (immediate risks 2.1% and 1.1% respectively, veillance is also recommended after colposcopy with biopsies of, find that the risk of CIN 3+ is substantially reduced after a doc-, umented negative HPV primary screening test or cotest or nor-, mal colposcopic examination with biopsy confirmation of less, ative HPV test or cotest within an appropriate screening interval, (approximately 5 years) or colposcopic examination less than. Introduction. For detecting pathological high-grade squamous intraepithelial lesion or worse (HSIL+), CAIADS showed higher sensitivity than the use of colposcopies interpreted by colposcopists at either biopsy threshold (low-grade or worse 90.5%, 95% CI 88.9–91.4% versus 83.5%, 81.5–85.3%; high-grade or worse 71.9%, 69.5–74.2% versus 60.4%, 57.9–62.9%; all p < 0.001), whereas the specificities were similar (low-grade or worse 51.8%, 49.8–53.8% versus 52.0%, 50.0–54.1%; high-grade or worse 93.9%, 92.9–94.9% versus 94.9%, 93.9–95.7%; all p > 0.05). 2019 ASCCP risk-based management consensus guidelines for abnormal cervical cancer screening tests and cancer precursors. Developing tailored interventions to address bottlenecks in the care cascade and improve cervical screening outcomes will be central to eliminating cervical cancer. (A recommendation) The USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years with hrHPV testing alone, or every 5 years with hrHPV testing in combination with cytology (cotesting) in women aged 30 to 65 years. Conclusions: Among the 1549 HPV-positive women in this study, the mean age at enrollment was 42.2 years, and the median follow-up time was 3.7 years (range, 0.2-5.4 years). Results: We aimed to determine the benefits of HPV vaccination in patients undergoing conization for HSIL in real-life conditions and evaluate vaccination compliance associated with different funding policies. HPV 18 positivity must be considered as a special situation because of established disproportionate risk of invasive cancer. Methods: New guidelines for managing cervical precancer among women in the United States use risk directly to guide clinical actions for individuals who are being screened. We calculated risk of CIN 3+ to assess how identification of HPV 16, HPV 18, or 12 other "high-risk" HPV types would influence recommended clinical management of new abnormal screening results, taking into account current cytologic results and recent screening history. By describing the steps used to develop these guidelines, the methods presented in this article can provide a basis for future extensions of the risk-based guidelines. (D recommendation). Current screening strategies for individuals older than 30 years include cytology (Papanicolaou tests), testing for high-risk (oncogenic) types of human papillomavirus (hrHPV), or both (co-testing).¹ However, various possible combinations of test results have led to complex management algorithms, especially for test results considered to be minimally abnormal, defined as results for which it is unclear whether the next step should be colposcopy (a magnified view of the cervix, often with biopsies) or close follow-up. should be used according to their regulatory approval. CIN 2 within the past year (see Figure 2). For non-pregnant patients 25 years or older, e, 60%, and is acceptable for those with risk, ar intervals for at least 25 years is recommended after treatment, 2, CIN 3, or AIS. A negative testing history may alter risk of the following positive screening results, caused by a new HPV infection, and therefore its optimal management. 6 months with colposcopy and ECC is acceptable (BIII). Colposcopist experience, specifically in the evaluation of the pregnant patient, is, known to affect the ability tovisually distinguish cancers from, in women with prior negative HPV testing or colp, aminations at which CIN2+ was not found. Quantitative results were analyzed using descriptive statistics; qualitative results were analyzed using content analysis. CIN 2+ in both the postcolposcopy and posttreatment settings. Objective: Perkins and colleagues reported their experience with the introduction of this guideline and highlighted a reduction from 55% to 18% in the use of LLETZ to treat moderate dysplasia in women aged 18 to 23 years. Cytology. The sensitivity of the DSI color map was found to be 48.1% (95% CI 41.1–55.1) in finding CIN grade 2 or worse (CIN2 +) when compared to the histological diagnosis of the DSI directed biopsy. record documentation of a preceding negative HPV test or cotest, surveillance of previous abnormal screening test results that did, not require immediate colposcopic referral (, sults, and follow-up surveillance tests after colposcopy or after treat-, ment for, or resolution of, high-grade abnormalities (, having or developing CIN 3+ is estimated based on curre. whether the patient would be a candidate for expedited management. Human papillomavirus genotypes may be ranked into 3 tiers (immediate colposcopy, follow-up testing, return to routine screening), according to associated risk of persistence for high-grade CIN and to prevailing clinical action thresholds. Components include the following: pre-, sentations at national, regional and local meetings, social media, outreach to engage clinicians and medical societies, and devel-, opment of promotional materials to answer frequently asked, questions. Note that "unknown genotype" refers to both HPV testing without genotyping, and HPV testing where genotyping is negative for HPV 16 and 18 but positive for other high-risk HPV types. risk of a patient developing cervical cancer, estimated by the surro-, gate end point of the 5-year risk of cervical intraepithelial neoplasia, (CIN) grade 3 (CIN 3) or more severe diagnoses (CIN 3+), regard-, less of which test combinations yielded this risk level. fection with any of the 13 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) and also inadvertently detects. Although these, they also help inform how portable risks and risk-based manag. Cytology. HPV vaccination of sexually active populations does not prevent cancer. Subsequently, we adapted signaling questions to indications of cervical cancer screening and management. Screening with cervical cytology alone, primary hrHPV testing alone, or cotesting can detect high-grade precancerous cervical lesions and cervical cancer. HPV Unknown. Conclusions: Six, patients in the KPNC cohort developed cervical cancer, half of, potential risk of adverse obstetric outcomes after excisional or, logic LSIL (CIN 1) or less, either an immediate diagnostic exci-, the initial colposcopic examination fully visualized the, squamocolumnar junction and the upper limit of any lesion, and, that the endocervical sampling, if collected, was less than CIN 2, (BII). delay depends on the choice of other thresholds). Response to Letter to the Editor Regarding: 2019 ASCCP Risk-Based Management Consensus Guidelines fo... Risk of cervical precancer and cancer among uninsured and underserved women from 2009 to 2017. The low risk of cervical precancer in p16/Ki-67 DS–negative women permits safe extension of follow-up intervals for 3 years. A prospective evaluation of the DSI color map in a multi-biopsy clinical setting, Adherence to the American Society for Colposcopy and Cervical Pathology Guidelines: An Observational Study, Cervical Cancer Screening Guidelines in the Postvaccination Era: Review of the Literature, Early surgical treatment versus observational management for cervical intraepithelial neoplasia 2 (CIN2), The prevalence and distribution of human papillomavirus among 10,910 Chinese Han women, The Triage Effectiveness of an Extended High-Risk Human Papillomavirus Genotyping Assay for Women with Cytology Showing Atypical Squamous Cells of Undetermined Significance in China, Human Papillomavirus Same Genotype Persistence and Risk: A Systematic Review, Mapping the cervical cancer screening cascade among women living with HIV in Johannesburg, South Africa, Managing Minimally Abnormal Cervical Cancer Screening Test Results, Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests, Risk Estimates Supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines, 2019 ASCCP Risk-Based Management Consensus Guidelines: Methods for Risk Estimation, Recommended Management, and Validation, Relationships of p16 Immunohistochemistry and Other Biomarkers With Diagnoses of Cervical Abnormalities: Implications for LAST Terminology, A Study of Partial Human Papillomavirus Genotyping in Support of the 2019 ASCCP Risk-Based Management Consensus Guidelines, A Systematic Review of Tests for Postcolposcopy and Posttreatment Surveillance, Reporting and Assessing the Quality of Diagnostic Accuracy Studies for Cervical Cancer Screening and Management, Estimating the Benefits and Harms of p16 Utilization on Cervical Biopsy Interpretation in Routine Clinical Practice, Diagnosis and Management of Adenocarcinoma in Situ: A Society of Gynecologic Oncology Evidence-Based Review and Recommendations, Age-specific HPV type distribution in high-grade cervical disease in screened and unvaccinated women, U54 Supplement UPR/MDACC Partnership for Excellence in Cancer Research. HPV 18 less clearly elevated CIN 3+ risk. Results: This guideline replaces interim, guidance (2015) for the management of a positive result for, HPV primary screening, which recommended direct referral, ing confirmatory biopsy (see Section E.3). Cervical cancer is caused by persistent human papillomavirus (HPV) infection. 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. Methods There is moderately high-quality evidence to support the clinical utility of SGTP to improve risk discrimination for high-grade CIN compared with qualitative HPV testing without genotype-specific information. Portabil-, ity of the recommended risk-based management was assessed by. Patient and provider factors can affect guideline adoption. If surveillance testing is recommended for either a his-. These risk-based management guidelines have previously only been based on risks from a large integrated healthcare system. Based on our experience analysing EHR from cervical cancer screening, we previously proposed the logistic-Weibull model to address these issues. Conclusions: guidelines, which indicates that this assay can be considered clinically validated for cervical cancer screening purposes. Results: 153 (57.7%) women accepted vaccination (vaccinated group), and 112 (42.3%) refused the vaccine (non-vaccinated group). All rights reserved. Study Design The CAIADS has potential in assisting beginners and for improving the diagnostic quality of colposcopy and biopsy in the detection of cervical precancer/cancer. This figure describes the steps involved in clinical management of unsatisfactory cytology. Risk estimates were drawn from a subset of women in the Kaiser Permanente Northern California screening program, whose residual cervical specimens were HPV typed as part of the HPV Persistence and Progression study. USPSTF Cervical Cancer Screening Recommendations for Average-Risk. New Management Guidelines Are Here. HPV Unknown. Guidelines are being developed with the aim of reducing the number of tests a woman needs during her lifetime, in order to receive the maximum benefit from screening, while decreasing potential harms that may result with the use of a screening strategy (overdiagnosis, overtreatment, anxiety, and costs). The USPSTF concludes with high certainty that the benefits of screening every 3 years with cytology alone, every 5 years with hrHPV testing alone, or every 5 years with both tests (cotesting) in women aged 30 to 65 years outweigh the harms. Recent studies have shown that distinguishing CIN 2 and CIN 3, within the LAST histologic HSIL group is biologically and clinically, Although some studies have shown that p16 immuno-, histochemistry improves interpretation of cervical biopsies, others, have raised concerns about overuse and ov, HPV tests regardless of genotype is preferred (this includes tests pos-, itive for genotypes HPV 16/18) (CIII). Methods: All abnormal grades of CP-diagnosed biopsies were more likely to test p16 IHC positive with a higher HPV risk group ( P trend < .001), and testing p16 IHC positive was associated with higher HPV risk group than testing p16 IHC negative for each grade of CP-diagnosed biopsies ( P < .001). These guidelines harmonize with the ASCCP Risk-Based Management Consensus Guidelines and provide more specific guidance beyond that provided by the ASCCP guidelines. Option is the best (or one of the best) when there are, qualifying abnormal result, surveillance entails retesting at intervals, in Figure 1 and explained in detail hereinafter, surveillance recommendations, which are generally accepted as a, patients are familiar with these intervals, and review of evidence, did not reveal a compelling reason to change these intervals, these, colposcopy and repeat testing at 6-month intervals is recommend, risk, this Clinical Action Threshold corresponds to the 5-year CIN, Estimated 5-year CIN 3+ risks in the KPNC databa, after a negative HPV test and cotest are 0.14% (95% CI = 0.13%, CIN 3+ risk is examined. Management can be determined via look-up ta-. However in the age group 25 and under the algorithms have been carried forward, ... e latest recommendations from the Atlanta Centers for Disease Control and Prevention (CDC) (June 2015) clearly stated that the HPV test should not be recommended for screening for cervical cancer as a standalone test (i.e., without a concurrent Pap test) . Similarly, risks following an abnormal (ASC-US or worse) cytology result decreased from 6.6% (95% CI = 6.4% to 6.9%) to 1.1% (95% CI = 0.5% to 2.3%) (Ptrend < .001). The prevalence and distribution of human papillomavirus among 10,910 Chinese Han women, Risk of cervical precancer and cancer among uninsured and underserved women from 2009 to 2017, Managing Minimally Abnormal Cervical Cancer Screening Test Results, Clinical performance of the aptima HPV assay in 4196 women with positive high‐risk HPV and ASC‐US cytology: A large women hospital experience, 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors, Risk Estimates Supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines, The Onclarity Human Papillomavirus Trial: Design, methods, and baseline results, A Study of Partial Human Papillomavirus Genotyping in Support of the 2019 ASCCP Risk-Based Management Consensus Guidelines, Role of Screening History in Clinical Meaning and Optimal Management of Positive Cervical Screening Results, Cancer screening in the United States, 2019: A review of current American Cancer Society guidelines and current issues in cancer screening, Five-Year Risk of Cervical Precancer Following p16/Ki-67 Dual-Stain Triage of HPV-Positive Women, Impact of human papillomavirus vaccination on the clinical meaning of cervical screening results, Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement, Challenges in risk estimation using routinely collected clinical data: The example of estimating cervical cancer risks from electronic health-records. The new risk-based guidelines present management of abnormal cervical screening results. Age-specific type-distribution of high-risk human papillomavirus (hrHPV) in cervical precancerous lesions is subject to change in the HPV vaccination era. Of the referrals, 17.4% were discordant with the ASCCP guidelines. Vaccination policies have an important impact on vaccination compliance. The USPSTF concludes with moderate to high certainty that screening women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer, screening women younger than 21 years, and screening women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer does not result in a positive net benefit. Objective Women (≥18 years) living with HIV with an abnormal Pap result between January 2013 and May 2018 were included. 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