Breast Cancer Surveillance Breast Cancer Surveillance Consortium:Consortium:

Progress in Understanding Progress in Understanding Screening Delivery and Early DetectionScreening Delivery and Early Detection

Rachel Ballard-Barbash, MD, MPH, Associate Director, NCI/DCCPS/ARPNational Cancer Institute

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

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

Scenes from the Beginning

A Daunting Task

Editor Extraordinaire

IBSN meeting

Safety First

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

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

BCSC Structure

Cancer Cancer Cancer

Multiple Research Uses

RadiologyFacilities

Geographic Site

Pathology Facilities

Cancer Registry

BCSC Sites

BCSC Local Facilities (N=164)

SCC

VT

NC

SF

GHRI

NH

Demographics of Women

7,335,521 mammograms from 1994- 2008Age BCSC - N (%) US population 2008 – N (%)

35-39 314,294 (4.3%) 11,387,968 (16%) 40-49 2,164,444 (29.%) 21,515,659 (30%) 50-59 2,208,148 (30.1%) 15,938,332 (22%) 60-69 1,465,980 (20%) 10,802,003 (15%) 70-79 961,472 (13%) 9,134,000 (13%) 80-84 221,183 (3%) 3,110,470 (4%)

Race/Ethnicity BCSC - N (%) US population 2008 – N (%) White, non-Hispanic 5,218,642 (71%) 57,167,145 (71%) African American, non-Hispanic 424,840 (5.8%) 9,460,539 (11.8%) Asian, non-Hispanic 453,569 (6.2%) 3,637,776 (4.5%) Hispanic 636,119 (8.7%) 8,716,664 (10.4%) Native Hawaiian or Pacific Islander 3,073 (< 1%) 114,817 (< 1%) American Indian or Alaska Native 92,044 (1.3%) 653,440 (1%) Mixed (Two or more) 54,974 (0.7%) 766,436 (1%) Other 31,872 (0.4%) n/a

Unknown 420,388 (5.7%) n/a

Cumulative Number of Mammograms by Submission Year

Cumulative Number of Cancer Cases by Submission Year

Core Pooled BCSC Data: Women & Physician Level Variables & Outcomes

Self-administeredquestionnaire

Direct data entry orquestionnaire

Annual linkage

WomenWomen RadiologistsRadiologists Tumor registry &Tumor registry & Pathology labPathology lab

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

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

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)

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

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

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