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 A Daunting Task Editor Extraordinaire IBSN meeting Safety First

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 Multiple Research Uses Radiology Facilities Geographic Site Pathology Facilities Cancer Registry

8. BCSC Sites

9. BCSC Local Facilities (N=164)

10. Demographics of Women 7,335,521 mammograms from 1994- 2008 AgeBCSC - N (%)US population 2008 – N (%) 35-39314,294 (4.3%)11,387,968 (16%) 40-492,164,444 (29.%)21,515,659 (30%) 50-592,208,148 (30.1%)15,938,332 (22%) 60-691,465,980 (20%)10,802,003 (15%) 70-79961,472 (13%)9,134,000 (13%) 80-84221,183 (3%)3,110,470 (4%) Race/Ethnicity BCSC - N (%)US population 2008 – N (%) White, non-Hispanic5,218,642 (71%)57,167,145 (71%) African American, non-Hispanic424,840 (5.8%)9,460,539 (11.8%) Asian, non-Hispanic453,569 (6.2%)3,637,776 (4.5%) Hispanic636,119 (8.7%)8,716,664 (10.4%) Native Hawaiian or Pacific Islander3,073 (< 1%)114,817 (< 1%) American Indian or Alaska Native92,044 (1.3%)653,440 (1%) Mixed (Two or more)54,974 (0.7%) 766,436 (1%) Other31,872 (0.4%)n/a Unknown420,388 (5.7%)n/a

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 Self-administered questionnaire Direct data entry or questionnaire Annual linkage WomenRadiologists Tumor registry & Pathology lab

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