Implementation of a Research-Robust Colposcopy Management Program within the Electronic Medical Record System

Transcription

1 Implementation of a Research-Robust Colposcopy Management Program within the Electronic Medical Record System Lonky NM*, Cannizzaro N, Xu L, Castaneda A, Stowe T, Hawk S, Chao C Southern California Permanente Medical Group, Southern California Permanente Medical Group and national information Technology, Kaiser Permanente Orange County, Pasadena, Sacramento California

2 Disclosures NM Lonky: IRB approved Research Grant Support: Merck Vaccine Study - Kaiser Permanente as of 2017, Shareholder/Inventor/Manager- Histologics LLC product(s) not discussed or studied in this presentation C Chao : IRB approved Research Grant Support: Amgen, Seattle Genetics, Merck Vaccine Study S Hawk, T Stowe, L Xu, A Castaneda No financial relationships or conflict of interest to disclose

3 AIMS OF REGISTRY IN CLINICAL CARE AND RESEARCH Team of experts review latest peer reviewed research and guidelines prebuild to set touch points for care and outcomes to be optimized under evaluation. Pilot with100 physicians in Orange County, 80 whom are colposcopists, 12 whom are high volume and worked the development phase Over 3000 colposcopy and/or therapy outpatient visits Aim to use tool first in OC, then Southern California, then National KP Evaluate Historical Variables, Demographics, history related to neoplasia risk, screening and cytology/histology evidence, colposcopic biopsy practice, with respect to predicting risk or enhancing outcomes related to colposcopy care.

4 GOALS OF REGISTRY BUILD AND DEPLOYMENT 1) streamline care (2) standardize documentation, (3) facilitate communication between clinicians, nurse coordinators and patients, (4) enable research to guide evidence-based practice Can a prospective Registry compare effectiveness of integrating data from clinical practice to create new models or guidelines that are more personalized to the case at hand? Creating an evidence based Risk Score for intervention, screening intervals, use of ancillary technology?

5 TOUCH POINTS FOR COLPOSCOPY CARE FOR REGISTRY BUILD New colposcopy cases usually after abnormal screening predominantly cervical but entire lower genital tract is addressed in the Registry Return or surveillance cases Unresolved diagnosis due to recurrent abnormal screen in untreated cohort Women with low grade lesions being followed Post-treatment cases Treatment visits Usually excision or cryotherapy, rarely conization, laser therapy or other modality

6 POTENTIAL INDEPENDENT VARIABLES Utility of screening test results in predicting high risk, reassuring low risk Patient Factors: Impact of demographics like age, race, gravity, parity, immune status, tobacco use, sexual history, *vaccination history, coincident medical conditions, prior biopsy or therapy Provider Factors: Colposcopic findings, lesion targeting, colposcopy. Ancillary technology or biopsy practice/tools, biopsy number, utility of endocervical evaluation Pathology Factors: use of genotyping, biomarker use in evaluation of cytology and histology

7 POTENTIAL DEPENDENT VARIABLES / OUTCOMES TO BE OPTIMIZED Utility of Cytology, HPV testing, Co-Testing to predict risk of CIN 2+, CIN 3+ Utility of HPV vaccination on risk across the continuum of care ; can vaccination optimized to age and sexual history alter not only cancer risk but utilization of resources /guidelines? What risk score based on multivariate analysis predicts benefit from shorter intervals of follow up, more aggressive therapy? Can we predict treatment failures? Can we predict which cohort benefits from multiple, random, larger biopsies or use of endocervical curettage Is biopsy therapy? Regression rates compared based on colposcopy practice. Other outcomes under evaluation to follow.

8 SECTIONS TO THE COLPOSCOPY REGISTRY Age, Race, Gravity, Parity, LMP, are all retrievable in KP Health Connect Guideline compliant list of Referral Reason for New or Repeat Colposcopy Detailed Medical History, Sexual History Vaccination Status History of Lower Genital Tract Disease and Procedures Drug Exposure history and Tobacco/Substance Use History Colposcopic Practice Elements, Biopsy Practice Elements, Treatment Modality (sites, intent, devices) On addendum, Pathology Results per biopsy site and Disposition

9 COLPOSCOPY REGISTRY FIELDS: FIRST COLPOSCOPY VISIT

10 COLPOSCOPY REGISTRY FIELDS: FIRST COLPOSCOPY VISIT

11 COLPOSCOPY FIELDS : FOLLOW-UP/SURVEILLANCE COLPOSCOPY

12 COLPOSCOPY FIELDS : TREATMENT VISIT/COLPOSCOPY

13 SMART LINKS-TO ENHANCE DATA USE IN DIAGNOSIS, DISPOSITION, AND PRACTICE Smart links extract data from the Registry to incorporate into Procedure notes Communications to peers Communications to patients Communications to Nurse Colposcopy Coordinators Smart links can be embedded into note templates to SAVE TIME for the colposcopists as not to double document colposcopy procedures and evidence.

14 COLPOSCOPY FIELDS : PATHOLOGY RESULTS Streamline Disposition w/ Colposcopy Coordinator using Smart Phrase

15 PILOT STUDY 12 colposcopists from our group tested and refined colposcopy registry built by team authors. IRB approved study, no informed consent as this documented usual practice Analysis of Variables Related to Outcome of diagnosis category ranging from Normal to Cancer IRB support from Merck already engaged to analyze relationship between vaccination status related to cases documenting CIN 2+ in workup and therapy Multivariate analysis related to study variables Sexual history and number of vaccinations and age defined Optimal, Suboptimal Vaccination Status **Biopsy blocks analyzed at USC for HPV subtype Hypothesis: Compared to non vaccinated cohort; vaccinated cohort will have a different pathology and HPV subtype profile. Guidelines based on HPV vaccination status affect on CIN 2+ risk might be used to manage cases. CIN 2+ cases with optimal vaccination and High Risk subtypes found biopsy specimens of those who received Gardasil 4 (16,18) what co-variables portent vaccination failure? Gardasil 9 is early in its use in KP in 2017.

16 PRELIMINARY RESULTS: VISITS Table 1: Visit Types (N = 576) Visit Type Frequency Percent (%) First/Diagnostic colposcopy Follow-up/Surveillance or Post-Treatment Colposcopy Visit Therapeutic Visit 50 9

17 PRELIMINARY RESULTS: REFERRAL FOR FIRST DIAGNOSTIC COLPOSCOPY VISIT Table 2: First Diagnostic Colposcopy Visit and Biopsy (N=304) Reason for Visit Frequency Percent (%) AGC Other 1 0 ASC-H 9 3 ASCUS (<24 & 2 prior) 1 0 ASCUS x2/ (-) HPV 4 1 ASCUS/ (+) HPV HSIL 3 1 LSIL (+) HPV LSIL (-) HPV 8 3 LSIL (<24 & 2 prior) 1 0 Negative PAP but persistant HPV Other 9 3 Missing Value =.32% % first visit high grade: 13/ %

18 PRELIMINARY RESULTS: PATHOLOGY RESULTS Table 3: Visit Types & Pathology Results (N=576) Pathology Results Visit Types Biopsy Not Performed Normal CIN 1 CIN 2 CIN3 / Carcinoma in Situ Adenocarcinoma in Situ Other Total First/Diagnostic colposcopy Follow-up/Surveillance or Post- Treatment Colposcopy Visit Therapeutic Visit Total % first visit high grade biopsy rate: 65/ %, Surveillance = 12.6%, Treatment 64%

19 SUMMARY MORE PERSONALIZED EVIDENCE-BASED MANAGEMENT USING A REGISTRY APPROACH Existing Guidelines for screening, triage and treatment stratified by Age as predominant variable Comparative effectiveness of colposcopy practice relative to patient demographics, medical and surgical history, colposcopic findings, and test results is feasible and operational in our practice using and EMR Registry. The use of a smart form platform within the EMR is user friendly and welcomed by colposcopists to record essential data for multivariate analysis. Program will automate note writing and communication to colposcopy coordinators. IRB approval is planned for this and all future Registries so that findings are suitable for submission for peer reviewed publication and presentation. This model of research will allow for multivariate analysis with factors that can more personalize Colposcopy and Cervical Screening guidelines related to sexual history, co-morbidity and vaccination status among other factors.