Abstract P3-03-24: The WISDOM Study: Early Ascertainment of Breast Cancer Diagnoses by Utilizing Self-Reported Questionnaires and Data Warehouse Electronic Health Records

Abstract BACKGROUND WISDOM (Women Informed to Screen Depending on Measures of risk) is a pragmatic trial comparing the safety, efficacy, cost, and patient acceptability of personalized versus annual breast cancer screening in women ages 40-74 years with no personal history of breast cancer. Cancer registry reporting is considered the gold standard for ascertaining cancer diagnosis data; however, the time lag between diagnosis and reporting (1-2 years or more) by the California Cancer Registry (CCR) presents challenges. The WISDOM study must quickly ascertain and report accurate cancer diagnoses to the Data Safety Monitoring Board; delays could lead to preventable harm, unnecessary costs, and unwarranted early trial termination. To ascertain cancer diagnoses in a timely manner, we used multiple data collection methods and compared self-reported with Electronic Health Records (EHR) information, and in some cases verified with chart review. Specifically, we conducted a procedural study with WISDOM participants who sought care at a University of California (UC) health system by extracting their data from the University of California Data Warehouse (UCDW) to 1) verify self-reported breast cancer diagnoses in WISDOM; 2) ensure that all on-study breast cancer diagnoses have been captured within the WISDOM study cohort; and 3) assess the accuracy and reliability of self-reported data. The UCDW provides harmonized EHR data from the six University of California (UC) health systems and constitutes ~120 billion data points from 7.8 million patient records. METHODS We provided the UCDW with a list of WISDOM participants who indicated they had sought care from a UC health system. Participants with recorded breast cancer diagnostic code (ICD-10CM C50.) were matched with the WISDOM self-reported cancer dataset to uncover participants who had no recorded breast cancer diagnosis in the study system. For those individuals with no recorded self-report diagnosis, coordinators conducted manual chart review to determine whether the participants had been diagnosed with breast cancer. RESULTS This cohort included 11,314 enrolled WISDOM participants who self-reported care at a UC and had at least one diagnostic or procedural breast care code. Among these participants, 160 had a ICD-10-CM C50 breast cancer diagnostic code of which 132 breast cancer cases were confirmed: 111 were already self-reported through WISDOM and 21 additional confirmed breast cancer cases were identified through the UCDW. As a standard process, only WISDOM self-reported cancer cases that were confirmed by chart review are entered into the study database. The percentage of confirmed UCDW-identified cases that were not also self-reported was greater for recent diagnoses (16% overall and 6% for period prior to June 2020). Among the 11,314 participants in our cohort, the CCR identified 61 pre-June 2020 cancer diagnoses. Of these 61 diagnoses, 92% (56) were identified by the UCDW procedural process. If the UCDW had been used as the single source for cancer diagnosis, 21 participants without cancer and 7 participants with unclear status (unlocated or inaccessible records) would have been classified as cancer cases. DISCUSSION/CONCLUSION Self-reported data provides quick ascertainment with relative accuracy compared to cancer registry. Cancer ascertainment can be further improved by combining self-reported data with EHR data from a health system data warehouse registry, particularly for self-reported questionnaire issues such as timing and lack of response. Accuracy of self-reported cancer diagnosis from annually distributed questionnaires improves over time. Identifying cancer diagnosis discordance between data sources can inform processes to improve self-reported study accuracy. Citation Format: Katherine Leggat-Barr, Rita H. Ryu, Allison Stover Fiscalini, Tomiyuri Lewis, Rohini S. Bulusu, Samrrah A. Raouf, Hannah Lui Park, Alyssa N. Rocha, Liliana Johansen, Laura Van ’t Veer, Laura J. Esserman, Michael A. Hogarth. The WISDOM Study: Early Ascertainment of Breast Cancer Diagnoses by Utilizing Self-Reported Questionnaires and Data Warehouse Electronic Health Records [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-24.