Related Editorial. Patient information: See related handout on HPV and Pap testing , written by the authors of this article. New data have emerged since publication of the American Society for Colposcopy and Cervical Pathology's consensus guidelines for management of abnormal cervical cytology and histology. The guidelines include recommendations for special populations i.
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Colleague's E-mail is Invalid. Your message has been successfully sent to your colleague. Save my selection. Perkins, Rebecca B. MD 2 ; Castle, Philip E. MD 7 ; Kim, Jane J. This article is open access, and reprints are available for download at asccp.
Participating organizations supported travel for their participating representatives. All participating consensus organizations, including the primary funders, had equal and balanced roles in the consensus process including data analysis and interpretation, writing of manuscript, and decision to submit for publication.
No industry funds were used in the development of these guidelines. The corresponding authors had final responsibility for the submission decision. The National Cancer Institute including M. Funding for these activities is for the research related costs of the trials. The other authors have declared they have no conflicts of interest. Disclaimer: The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the US Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the National Cancer Institute.
The work cannot be changed in any way or used commercially without permission from the journal. 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 cytology alone. New data indicate that a patient's risk of developing cervical precancer or cancer can be estimated using current screening test results and previous screening test and biopsy results, while considering personal factors such as age and immunosuppression.
Routine screening applies only to asymptomatic individuals who do not require surveillance for prior abnormal screening results. Introduction of risk-based guidelines in was a conceptual breakthrough, but the recommendations retained a continued reliance on complicated algorithms and insufficiently incorporated screening history. With a more nuanced understanding of how previous results affect risk, and more variables to consider, the guidelines further align management recommendations with current understanding of HPV natural history and cervical carcinogenesis.
More frequent surveillance, colposcopy, and treatment are recommended for patients at progressively higher risk, whereas those at lower risk can defer colposcopy, undergo follow-up at longer surveillance intervals, and, when at sufficiently low risk, return to routine screening.
The revised guidelines provide a framework for incorporating new data and technologies as ongoing incremental recommendation revisions, minimizing the time needed to implement changes that are beneficial to patient care. This is the fourth American Society of Colposcopy and Cervical Pathology ASCCP -sponsored consensus guidelines for management of cervical cancer screening abnormalities, after the original consensus conferences in 1 and subsequent updates in 2 and The key difference between guidelines and previous versions is the change from primarily test results—based algorithms e.
See Box 1 for essential changes. Tables of risk estimates for possible combinations of current screening test results and screening history including unknown history have been generated from a prospective longitudinal cohort of more than 1. All KPNC estimates of risk underlying guideline decisions are detailed in the accompanying article by Egemen et al.
Decision aids may facilitate use of the tables. Box 1. The minimum amount of data required to generate a recommendation will include the patient's age and current test results, as we recognize that previous screening history is often not known. Increased precision of management guidance will be possible if information is available on test results within the past 5 years and previous precancer treatment within the past 25 years.
Guidelines are based on several guiding principles. The first 4 guiding principles are new for , whereas the others are from the guidelines. As the guidelines are familiar to providers, we changed management recommendations only when new evidence favored an altered management strategy. Note that management guidelines apply only to patients with current or previous abnormal screening test results; screening guidelines for individuals in the general population, that are not being followed for a screening abnormality, are addressed elsewhere.
HPV—based testing is the basis for risk estimation. The term HPV-based testing is used throughout this document and refers to use of either primary HPV testing alone or HPV testing in conjunction with cervical cytology cotesting. Personalized risk-based management is possible with knowledge of current results and past history. Management recommendations use thresholds of risk. The lower threshold of each risk stratum, called Clinical Action Threshold, defines the level at which the management recommendation changes.
The Clinical Action Thresholds for each risk stratum were determined through the consensus process. Risks were estimated for all combination of current results and past history including unknown history for which adequate data were available at KPNC. Management can be determined via look-up tables, 5 and use of the tables can be facilitated using decision aids. The field of cervical cancer prevention is rapidly evolving, with new technologies being continually validated.
Data on the validation of new technologies are being published frequently, and risk reduction from HPV vaccination is increasing as vaccine coverage increases and vaccinated individuals age into screening cohorts. Up to now, guideline revisions have required full consensus conferences, which are time-consuming, expensive, and not compatible with the rapid evolution of the field.
The guidelines build a framework that allows incorporation of new technologies and modified strategies without requiring full consensus conferences, so that revisions may rapidly incorporate new findings and be quickly disseminated to optimize patient care.
Clinical Action Thresholds for management created through the consensus process will remain in place, but as new tests become available and more long-term data accrue, the test combinations used to reach these thresholds will change. For example, at the consensus conference, HPV vaccination levels in the United States population currently 25 years or older were deemed too low to warrant incorporating HPV vaccination into the management recommendations.
The framework outlined here will allow guideline modification as robust data become available and are publicized. Because Clinical Action Thresholds remain constant, new data can be added while the Clinical Action Thresholds remain unchanged.
This design is intentional to reduce clinician confusion associated with frequently changing guidelines. Evidence-based practice recommends that biopsies be taken of all discrete acetowhite areas, usually 2 to 4 biopsies at each colposcopic examination. The primary goal of screening and management is cancer prevention through detection and treatment of cervical precancer. Management recommendations are guided by risk thresholds.
Guidelines apply to all individuals with a cervix. Guidelines apply to women and transgender men with a cervix, including individuals who have undergone supracervical hysterectomy. Risk estimates were validated in individuals of diverse racial, ethnic, and socioeconomic backgrounds and shown to be comparable.
Equal management for equal risk. Balancing benefits and harms. Providing the best care means balancing cancer prevention with overtesting and overtreatment.
Preventing all cervical cancers is unfortunately not an achievable goal. Interventions to prevent cervical cancer can cause harm. Guidelines apply to asymptomatic patients that require management of abnormal cervical screening test results.
Patients with symptoms such as abnormal uterine or vaginal bleeding or a visibly abnormal-appearing cervix require appropriate diagnostic testing as this may be a sign of cancer. Guidelines cannot cover all clinical situations and clinical judgment is advised, especially in those circumstances which are not covered by the guidelines.
Guidelines are intended for use in the United States. As with the previous , , and guidelines , 1—3 NCI produced risk data and other scientific support for the consensus guideline process. Stakeholder organizations representing best practice in the United States were identified and invited to participate.
These included medical professional societies, patient advocacy groups, and federal agencies integral to cervical cancer screening and management of abnormal results see Table 1. Participation of the stakeholder organizations included identifying organization representatives and, for nongovernment participants, sponsoring their travel to consensus conferences.
Representatives from 19 organizations attended the initial meeting in February At that time, 7 working groups were convened. In previous consensus conferences, working groups considered specific test outcomes e. In contrast, the 7 working groups for the guidelines were organized with the goal of establishing consensus Clinical Action Thresholds. Working groups were composed of 2 to 8 members, including representatives of participating stakeholder organizations, content experts, and nonclinician representatives of patient advocacy organizations.
Working groups met regularly from summer through fall to review data and develop guidelines for management. Because the guidelines represent a paradigm shift, the guidelines process included a deliberate and extensive process of stakeholder engagement.
These included patient and provider surveys, a consensus meeting to review preliminary guidelines , and a 6-week open public comment period before the final consensus voting meeting in October Cancers that are found in robust screening programs may represent cancers already prevalent at first screening, rare instances of aggressive or HPV-negative tumors not detectable by screening, or false negative results. Glandular lesions including AIS, lesions with HPV 16 and 18 infections, and those occurring in older patients have higher cancer risks than HPV-negative lesions and those occurring in younger patients.
Different nomenclatures for cervical histopathology are in use in the United States. Prior guidelines relied heavily on a large prospective data set including results of cytology, HPV testing , colposcopy, histology, and follow-up outcomes from KPNC, which adopted triennial cotesting as standard practice in For the guidelines , several additional databases were analyzed to ensure that results are applicable to patients of diverse racial, ethnic, and socioeconomic strata.
These joint models are designed to handle verification bias and interval censoring. These flexible models are designed to provide risk estimates without forcing the data into a rigid distribution assumption e. In these situations, a combination of published literature, previous guidelines , and expert consensus opinion were used to develop recommendations. Recommendation strength A—E and quality of evidence I—III were graded using the system that has been used for previous consensus guidelines Table 2.
Two types of evidence were considered to be strong enough to permit a level A recommendation: a systematic literature reviews of trials and observational studies, evaluated by the new technologies group using the QUADAS-2 adapted criteria to inform risk estimates for the guidelines 40 and b reliable risk estimates from the KPNC prospective longitudinal cohort study. Strong recommendations against a management option level E rarely had substantial evidence because the obvious risk of harm precluded a clinical trial e.
When neither primary data nor literature provided high-level evidence, previous guidelines or newly developed expert consensus opinions were used level 3 evidence , usually leading to a C recommendation.
Some recommendations are endorsements of guidelines from other organizations, which were not rated. When considering specific guideline recommendations, each group reviewed evidence derived from systematic reviews of published evidence and primary data from the KPNC cohort, assessed the strength and consistency of this evidence, and made recommendations based on quality of data and a balance of benefits and harms. This section explains the paradigm shift from results-based to risk-based guidelines.
We describe the primary Clinical Action Thresholds on which management recommendations are based and the clinical situations in which these Clinical Action Thresholds are applied. For most abnormal screening results and subsequent management visits, the recommendations are based on risks estimated and validated by prospective data from large cohorts. Sections G to K describe recommendations for rare clinical situations where management is based on factors other than risk estimates.
Management recommendations are based on Clinical Action Thresholds and correspond to risk strata see Figure 1 :.
Update on ASCCP Consensus Guidelines for Abnormal Cervical Screening Tests and Cervical Histology
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