Early on the BCSC investigators identified data elements needed to evaluate mammography screening performance in community settings. We established a set of core variables and definitions for analysis. Data for the core variables are collected by questionnaires completed by the woman at her mammogram and by the radiologist or technician who evaluates the mammogram. These data are linked with breast disease outcomes from pathology reports and population-based cancer registries and with vital status data.
CORE Data Elements
Patient Demographics and Health History
Demographics
- Unique, anonymous identifier for the woman
- Age
- Race and Hispanic ethnicity
- Education
- Health insurance
- Zip code
Health History
- Age at birth of first child
- Family history of breast cancer
- Personal history of breast cancer
- Personal history of breast biopsy, surgery, radiation
Screening History
- Ever screened by mammography
- Time since last mammogram
Current Health
- Menopausal status
- Hormone therapy use
- Presence of breast symptoms
- Main reason for visit (routine screening, follow-up after screening, concerns about breast problems)
Radiologic exam
- Unique, anonymous identifier for the radiology facility and radiologist
- Exam date
- Availability and date of previous exam for comparison
- Indication for exam (screening, evaluation of breast problem, additional evaluation following recent mammogram, short interval follow-up)
- Exam type (film mammogram, digital mammogram, tomosynthesis, MRI, ultrasound, etc)
- Exam laterality and views
- Breast density (BI-RADS categories: entirely fatty, scattered fibroglandular densities, heterogeneously dense, extremely dense)
- Assessment (incomplete assessment, normal, normal with benign finding, probably benign, suspicious abnormality, highly suggestive for malignancy)
- Recommendation (normal interval follow-up, additional views, sonography, short interval follow-up, fine-needle aspiration, core biopsy, consider biopsy or surgical evaluation, clinical evaluation)
Follow Up
- Follow-up imaging
- Date, type, laterality, assessment, recommendation
- Pathology
- Date, procedure, laterality, result
- Benign breast disease
- Tumor characteristics
- Cancer registry
- Breast cancer diagnosis, date, laterality
- Tumor characteristics (histopathology, stage, grade, size, nodal involvement, estrogen and progesterone receptor status, HER2 status)
- First course of therapy (surgery, radiation, chemotherapy, hormonal therapy)
- Vital status data
- Death date and cause
- Date of last follow-up if alive
Sample Questionnaires
Unlike clinical trials that use a common protocol and common data collection instruments, the research projects in the BCSC operate within "usual care" and existing health care systems. Data are collected from a range of delivery systems including traditional fee-for-service practices, managed care organizations, mammography centers, hospital-based radiology practices, and nonradiology practices.
To facilitate data pooling and analysis, BCSC has created standardized questionnaires. BCSC sites may modify the questionnaires to suit their site, such as including optional questions in addition to the core variables. Sites and radiology facilities also select their data collection method, such as having the patient fill out a regular paper form, scannable form, or an electronic form on a laptop or tablet.
Sample questionnaires are provided here. Some of the questions may change over time. Updated questionnaires will be posted when available.