The 2019 guidelines are designed to be enduring, unlike prior versions which required major updates every 5-10 years to adjust with emerging evidence. As a result, guidelines can become out of date rapidly—years before the scheduled next cycle. With an enduring consensus committee, the principle of ‘equal management for equal risk’, and the Clinical Action Thresholds of the 2019 guidelines, new technologies and approaches can be incorporated into the new guidelines framework as they become available. A standing consensus committee, including representatives from professional medical societies, federal agencies, and patient advocacy organizations, will continue to evaluate and ratify risk estimations and review population characteristics as they may change with the increasing impact of vaccination. The committee publishes updates to the risk tables and facilitates the dissemination of the new data to clinicians.
Who developed these guidelines?
The ASCCP Risk-Based Management Consensus Guidelines represented a consensus of 19 professional organizations and patient advocates, convened by ASCCP; they are designed to safely triage individuals with abnormal cervical cancer screening results. See the full list of organizations (below) that participated in the consensus process.
How are these guidelines different?
The 2019 ASCCP Risk-Based Management Consensus Guidelines have several important differences from the 2012 Guidelines, while retaining many of principles, such as the principle of equal management for equal risk.
Rather than consider screening test results in isolation, the new guidelines use current and past results, and other factors, to create individualized assessments of a patient’s immediate risk of precancer (CIN3+), or 5-year risk of progressing to precancer or cancer. The goals of the ASCCP Risk-Based Management Consensus Guidelines are to increase accuracy and reduce complexity for providers and patients while maintaining a high degree of safety for patients.
Do the new guidelines still use algorithms?
The 2012 Guidelines relied on algorithms to map management for individual patients based on current test results.
The new guidelines rely on individualized assessment of risk for precancer (CIN3+), taking into account past history and current results. Specifics are laid out in a series of scientific articles published in the Journal of Lower Genital Tract Diseases. The ability to adjust to the rapidly emerging science is critical for the long-term utility of the guidelines.
Why were the guidelines revised in 2019?
The management guidelines were revised to reflect the availability of sufficient data from the United States showing that the risk-based approach can provide more appropriate and personalized management for an individual patient based on their current results and past history. Risk-based management allows clinicians to better identify which patients will likely go on to develop pre-cancer and which patients can return to surveillance.
Cervical cancer screening recommendations have changed since the 2012 guidelines. For example, primary HPV is a screening option for patients 25 years of age and older. Updated guidelines were needed to incorporate these changes.
Importantly, changing the paradigm of management from results-based to risk-based allows for incorporation of future technologies.
When will the new guidelines be ready for implementation?
The guidelines were published in the Journal of Lower Genital Tract Diseases in April 2020 and are available for use now. An app to streamline navigation of the guidelines will be available soon. Find out more.
How did you create the risk calculations? How are the guidelines generalizable to all patients?
Risk estimates were calculated using electronic health record data from patients in the Kaiser Permanente of Northern California cohort. Studies have demonstrated that the KPNC population has lower rates of cervical cancer than the general US population. To ensure the risk estimates generated from KPNC data are generalizable (portable), we also estimated risks using data from the Centers for Disease Control and Prevention (CDC), the New Mexico Pap Study, and two clinical trials. Our analysis demonstrated that the risk-based recommendations can be applied to diverse settings across the United States. (citation: Cheung et al., JLGTD Apr 2020)
Details of the statistical methods are described in the publication Li C., et al. [https://journals.lww.com/jlgtd/Fulltext/2020/04000/2019_ASCCP_Risk_Based_Management_Consensus.2.aspx].
How will Pathology laboratories support the implementation of the 2019 ASCCP Guidelines?
Pathology professional organizations participated in every aspect of the guidelines development with two pathologists on the Steering committee and a total of 11 pathologists were members of various Guideline working groups. They have been very active in disseminating these guidelines, via a detailed publication “Moving forward the 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors and beyond: implications and suggestions for laboratories” and a number of presentations at national meetings and via webinars, etc in any effort to educate and encourage appropriate ordering, testing and reporting of cytology and histology that are consistent with use of validated/approved tests for screening, standardized reporting recommendations and the ASCCP management guidelines.
My laboratory does not offer HPV genotyping. Do I need to ask for genotyping to be sent out?
The value of partial genotyping for clinical management of abnormal screening results is well established in the literature. Identification of HPV 16 at the first visit including HPV testing elevated immediate risk of diagnosing CIN 3+ sufficiently to mandate colposcopic referral even when cytology was Negative for Intraepithelial Lesions or Malignancy and to support a preference for treatment of cytologic high-grade squamous intraepithelial lesion. Thus additional risk stratification with partial genotyping, when available, is another useful risk stratifier to determine an individual woman’s risk estimate in the 2019 ASCCP Guidelines. The value of genotyping, particularly for 16, is handled in the risk estimation section of the ASCCP guideline publications (e.g. HPV 16+ NILM has a risk greater than 4% and needs colposcopy, HPV 16+ HSIL has risk >60% and needs expedited treatment). The value of genotyping for surveillance in different clinical settings (post colposcopy and posttreatment) and the additional risk stratification of more detailed genotyping are being assessed and guidance will follow in subsequent updates of the Guidelines.