Breast Cancer Surveillance Consortium: Progress in Screening Delivery and Early Detection

1. Breast Cancer Surveillance Consortium: Progress in Understanding Screening Delivery and Early Detection Rachel Ballard-Barbash, MD, MPH, Associate Director, NCI/DCCPS/ARP National Cancer Institute

2. Establishing the Breast Cancer Surveillance Consortium • Origins and Purpose of the BCSC and SCC • Complexities of creating the Consortium • Resource for research • Research Evidence • Key factors for success • Challenges and opportunities remain

3. Establishing the BCSC and SCC • In the beginning, much was unknown • No community measures of mammography quality and no source of national data • Limited experience collecting data in the course of care – required protection for providers as research subjects • Many challenges to establishing the BCSC • Shifted from independent RO1 to coordinated pooled data, mapping to CDE, new statistical methods for complex data • Moved from paper to electronic data capture in early years • Field of delivery research in practice was new and many of the Principal Investigators were new researchers

4. Scenes from the Beginning Safety First Editor Extraordinaire A Daunting Task IBSN meeting

5. Breast Cancer Legislation and Funding • The BCSC began as mammography screening was increasing • 1990, CDC’s National Breast and Cervical Early Detection Program • 1991, Department of Defense Breast Cancer Research Program • 1991, NIH launches Women's Health Initiative • Mammography Quality Standards Act of 1992 (MQSA) mandated NCI to develop a breast cancer screening surveillance system • NCI Response • Pilot studies in SEER registries supported development of 1993 RFA • Expanded with 1994 RFA (new sites and Statistical Coordinating Center) to address racial/ethnic, geographic, and health system diversity in screening • BCSC renewed in 2000 and 2005

6. BCSC Purpose • Evaluate performance of mammography screening in practice • Individual, health professional and system level factors • Increase capacity to examine provider and system factors • Define biologic characteristics of cancers that influence detection • Quantify population effect of screening • Longer term survival and mortality • Track new technologies in screening • Imaging, tissue, molecular markers, proteomics

7. BCSC Structure Cancer Cancer Cancer Radiology Cancer Facilities Registry Geographic Site Pathology Facilities Multiple Research Uses

8. BCSC Sites

9. BCSC Local Facilities (N=164) NH NC SCC GHRI VT SF

10. Demographics of Women 7,335,521mammograms from 1994- 2008

11. Cumulative Number of Mammograms by Submission Year

12. Cumulative Number of Cancer Cases by Submission Year

13. Core Pooled BCSC Data: Women & Physician Level Variables & Outcomes Women Radiologists Tumor registry & Pathology lab Self-administered questionnaire Direct data entry or questionnaire Annual linkage

14. BCSC as a Research Resource • Since 1994, BCSC collected data on a cohort of over 2 million women • 8,374,024 million mammograms (2,323,252 unique women) • 86,700 breast cancers (65,313 invasive and 13,263 In Situ) • Screening data linked to Medicare data • 107 radiology facilities and 1300 radiologists • Collective insight of BCSC PIs about breast cancer risk factors, screening, and related outcomes • Data complexity • Statistical methods • Research utilizing the core BCSC data focuses on delivery, performance and quality of care

15. Uses of Pooled BCSC Research Resources • Research and modeling • Data source for simulation models (CISNET) • Investigators have collaboratively published 374 papers • Engaged new and junior investigators • 36 publications by junior investigators (2005-8) – most non-BCSC • Three career development awards • Enabled new grants • Supported the generation of more than 65 research grants from many agencies – many investigators from outside the BCSC • New data linkages – BCSC-Medicare linked data

16. Selected Ancillary Studies • Assessing and Improving Mammography (AIM) • Assesses accuracy of interpretation of mammograms • Develops tools and guidance for training of radiologists • Co-funded by ACS (Longaberger funds) and NCI (Breast Cancer Stamp ) • Factors Affecting Variability Of Radiologists (FAVOR) • R01 utilizing BCSC data to study the variability in radiologists in community mammography settings (PI Joann Elmore) • Comparative Effectiveness Research • Comparative Effectiveness of Breast Imaging Strategies in Community Practice – GO Grant (ARRA funds, PI Diana Miglioretti) • Collaboration to evaluate digital vs. film-screen mammography – BCSC-CISNET-EPC (ARRA funds, PI Diana Miglioretti)

17. Use of BCSC Research Evidence • Delivery research generates questions for discovery and development research • Within the BCSC, special research projects at individual sites used for discovery and development questions • Address targeted translation issues • Eg: Develop quantitative, automated method for measurement of breast density • Individuals sought as members of panels related to breast cancer on a diversity of topics (IOM, ACR) • Contributed evidence to federal reports and policy • IOM, GAO, WHO

18. Factors for Success Team Science approach, utilized variety of disciplines within each site A secure, centralized resource, shared by many Incorporation of collecting patient data for research purposes into clinical care practice Anticipate and understand the complexities of building a longitudinal dataset Creating new ways to provide feedback on performance

19. Challenges Remain… • Delivery, performance and quality of care is dynamic – need ongoing data reflecting current clinical practice • Requires prospective, longitudinal data • Evaluate longer term outcomes beyond process measures • Large, multiregional data to answer questions in specific groups • Growth in investigator-initiated research utilizing the BCSC research resource indicates an enormous potential for addressing questions in delivery beyond the current scope • Comparative effectiveness of digital and screen-film • Innovative template for the future