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Meichin Hsieh, PhD, MSPH, CTR

Evaluating the Utilization of Lower Anogenital Squamous Terminology (LAST) Two-tiered Classification for High-Grade Preinvasive Cervical Lesions and Its Impact on Reporting. Meichin Hsieh, PhD, MSPH, CTR

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Meichin Hsieh, PhD, MSPH, CTR

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  1. Evaluating the Utilization of Lower Anogenital Squamous Terminology (LAST) Two-tiered Classification for High-Grade Preinvasive Cervical Lesions and Its Impact on Reporting Meichin Hsieh, PhD, MSPH, CTR Louisiana Tumor Registry/Epidemiology Program, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA NAACCR/IACR 2019 Conference, Vancouver, BC, Canada June 13, 2019

  2. Background • Abstracting in situ of cervical cancer was no longer required by the standard setters in the United States since 1996. • Worldwide, over 95% of cervical neoplasia are HPV-related • In 2006, HPV vaccination was approved by FDA for females aged 9-26 first. • In 2011, CDC funded 4 state registries to participate in the Pre-invasive Cervical Cancer Surveillance (PCCS) Pilot Project • Assess the association of HPV vaccine usage with precancerous cervical lesion incidence in statewide populations • Collect pre-invasive cervical cancer including CIN3 (3-tiered classification system), CIS, AIS, and severe dysplasia diagnosed in 2009 and 2010 • High-grade neoplasm/lesion NOS was not reportable term • CDC continue to fund 4 state registries to collect cervical in situ cancer as routine since then

  3. Background cont’d • In 2012, LAST Standardization Project recommended the 2-tiered classification system, low-grade and high-grade squamous intraepithelial lesions (SIL), for documenting HPV-associated non-invasive cervical lesions in the pathology reports and using p16 IHC staining to verify high-grade as needed. • Cervical lesions classified exclusively as high-grade SIL using this system were not initially reportable as pre-invasive cervical cancer in the PCCS project. • In 2018, Louisiana Tumor Registry (LTR) conducted an audit to evaluate the use of this classification and p16 IHC test in pathology labs and reports.

  4. Objectives • Investigate the use of the 2-tiered terminology and p16 IHC testing on cervical biopsy specimens by laboratories; • Assess the search criteria needed to identify advanced pre-invasive cervical lesions; and • Assess the impact of underreporting cervical lesions caused by terminology changes.

  5. Methods • Survey on pathology labs • Selected 10 labs with a high volume of precancerous cervical cases in Louisiana • Survey was conducted via a phone interview • Survey questions

  6. Audit Software and Sampling Pathology Reports • AIM E-Path Reporter and audit software • Natural language processing (NLP) to interpret the content of pathology reports based on the provided terminologies (search terms) • Artificial intelligence (AI) engines perform content coding and report selection • 5 Laboratories that used both the 2-tiered and 3-tiered term and also used the AIM E-Path reporting system were chosen for the QC audit • Pathology reports received in 2015 with a cervical specimen from a biopsy were included in the sample selection • Randomly selected equal number of positive and negative pathology reports with maximum up to 500 reports from each lab

  7. Screening Pathology Reports • Eligibility and search criteria Pre-2019 Criteria 2019 Criteria • Search Criteria • ICD-O-3: C53.x • Cervical biopsy specimen • CIN3, CIS, AIS, grade 3, any in situ epithelial tumors, and/or severe dysplasia documented • Search Criteria • Pre-2019 criteria • high-grade, high-grade squamous intraepithelial lesions (HSIL or HGSIL), CIN2, CIN2-3 (or CIN2/3), p16 IHC test with cervix • Reportable Terms • CIN3 • CIS • AIS • Severe dysplasia • Reportable Terms • Pre-2019 terms • HSIL/HGSIL • High-grade • CIN2-3 with p16+ • CIN2 with p16+

  8. Manual Review Processing • Positive and negative pathology reports flagged by AIM software were reviewed by a clinician and/or a certified tumor registrar (CTR) • Recoded positive (reportable) terms based on 2019 criteria for each reportable report • Collected and recorded the presence of p16 IHC testing and the subsequent results of p16 IHC staining. • Categorized into three terminology subgroups: • Terms based on pre-2019 reportable terms only (CIN3, CIS, AIS, and severe dysplasia); • Terms based on new reportable terms only (HSIL, High-grade, and CIN2 or CIN2-3 with positive p16 IHC staining); and • Combination.

  9. Data Analysis • Proportion of positive terminologies for reportable precancerous cervical cases and percentages of pathology reports with the p16 test performed by pathology laboratory were generated. • Kappa statistic, positive predictive value (PPV) and negative predictive value (NPV) based on AIM auto-coding versus manual coding (as the gold standard) were computed to assess the agreement, predictability and degree of discrepancy for reportability. • Used chi-square test to assess the association between p16 IHC testing and terminology group.

  10. Flowchart of audit processing Phone Interview 9 labs Select 5 labs for audit Use pre-2019 search criteria in AIM filter Randomly sample: 987 positive & 987 negative Add new search criteria in AIM filter AIM auto-coded: Positive: 1,273; Negative: 701 Manual review End Non-reportable Reportable Combination New terms Pre-2019 terms

  11. Results: Survey

  12. Agreement between AIM auto-coded and manual-coded • Based on 2019 new search criteria (pre-2019 plus high-grade term) • AIM auto-coded: 1,273 reportable & 701 non-reportable cases • Manual review: 822 reportable & 1,152 non-reportable • 822 reportable cases, 475 (57.8%) identified by pre-2019 terms and 347 (42.2%) solely by new terms • Percentage of agreement is 77.2% with Kappa statistic of 0.5642 (moderate agreement). • PPV 0.65 (95% CI: 0.62-0.67) • NPV 1.00 ((5% CI: 0.99-1.00)

  13. Frequency distribution of positive (reportable) terminology by pathology laboratory (N=822) Pre-2019 2019 terms New terms

  14. Percentage of reportable term by subgroup and pathology laboratories in Louisiana (n=822) • For all labs combined, 84% of reportable pathology reports contained new terminology • Half (42.2%) were solely based on new terms • Rang of reportable terms use • Pre-2019 terms only: 3.9% - 49.1% • New terms only: 19.3% - 47.3% • Combination: 27.7%-54.9%. • Labs 4&5 were less likely to use pre-2019 terms only. *Combination (2019 reportable terms) indicates that both pre-2019 and new terms documented in the pathology report.

  15. Proportion of p16 IHC testing by terminology group P<0.0001

  16. Summary of Results • After adding the HSIL (HGSIL)/ high-grade term in search criteria, positive reports increased by 29% for manual review. • 84% of reportable pathology reports received in 2015 contained the 2-tiered terms. • Percentage of cervical biopsy specimens that had a p16 IHC test performed was 13.6% • Almost all new cases based on new terminology can be identified either by HSIL/HGSIL or high-grade term. • By including new terminologies, we were able to add 347 new cases with 73% increase in reportable advanced precancerous cervical lesions.

  17. Conclusions • The Audits findings helped to • Define the new eligibility criteria for reportable precancerous cervical cases • Highlight that both the 2-tiered and 3-tiered nomenclature are needed to ensure complete identification of all advanced precancerous cervical cases • Although the term HSIL/high-grade lesion include CIN2 (CIN2-3) or moderate dysplasia, its association with HPV and likelihood to predict cervical cancer progression makes it important to collect. • In order to align with the current practice and be able to compare data collected before 2019 and after, the 2019 reportable terms include • Pre-2019 reportable terms (AIS, CIN3, CIS, severe dysplasia) • HSIL/high-grade • CIN2 or CIN2-3 with positive p16 IHC tests

  18. Co-authors • LTR • Xiao-Cheng Wu, MD, MPH • Christina Lefante, MPH • Mary Anne Lynch, MPH • Natalie Gomez, BSN, RN • Brent Mumphrey, BS • Lauren Maniscalco, MPH • Rachna Jetly-Shridhar, MD • CDC • Elizabeth Van Dyne, MD, MPH • Jean A. Shapiro, PhD • Paran Pordell, MPH • Mona Saraiya, MD, MPH

  19. Acknowledgments • Louisiana hospital reference and free-standing pathology laboratories and pathologists • Funding source: • Centers for Disease Control and Prevention under National Program of Cancer Registries Component #2 cooperative agreement number U58DP006332.

  20. Contact Information: mhsieh@lsuhsc.edu

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