Data Elements, Questionnaires & Standard Definitions

• Summary Listing of Data Elements
• Sample Standardized Questionnaires
• Standard Definitions

When the Consortium was established in 1994, one of its first tasks was to identify the data elements that were necessary to evaluate mammography screening performance in diverse community settings. This necessitated consensus on a standard set of core variables, definitions for analysis, and a standard definition of a screening mammographic examination. Data on these core variables are collected through questionnaires given to women when they come for a mammogram and to the radiologist or technician who evaluates the mammogram at the screening facility. The data are being used to build three databases that can be linked with each other and with pathology data on cancer outcomes from population-based cancer registries:

• patient demographic and health history;
• radiologic history; and
• follow-up data.

The variables for each of these databases are shown in the Summary Listing of Data Elements.

Summary Listing of Data Elements

• Patient Demographic and Health History Data
• Demographic Variables
• Unique anonymous identification number
• Zip code
• Date of birth
• Race (white, black, Asian or Pacific Islander, Native American, other); ethnicity (Hispanic)
• Education (1-11 years, 12, 13-15 years, 16 years, 16+ completed years of education)
• Health insurance (Medicare, Medicaid, other, none)
• Health History
• Age at birth of first child (year)
• First-degree family history of breast cancer (mother, sister, daughter) and age: <50, >50
• Personal history of breast cancer (yes, no)
• Personal history of breast biopsy, surgery, or radiation (yes, no)
• Procedure history per breast (implants, needle biopsy, surgical biopsy, lumpectomy, mastectomy, radiation therapy, and reconstruction)
• Screening History
• Ever screened by mammography (yes, no)
• Time since last mammogram (within last year, 1-2 years, 3-4 years, 5 or more years)
• Current Health
• Menopausal status at examination (pre-, peri-, postmenopausal)
• Hormone use at time of examination (yes, no)
• Presence of symptoms in last 3 months (nipple discharge or lump; right or left breast)
• Main reason for current visit (routine screening exam, follow-up to routine screening exam, concerns about breast problems)
• Radiologic History Data
• Radiologic Site and Interpreting Mammographer Identification
• Variables are encrypted to protect confidentiality.
• Dates of Current Examination and Comparison Film
• Use of Comparison Mammogram at Time of Evaluation (yes, no)
• Indication for Examination
• Screening (asymptomatic), evaluation of breast problem (symptomatic), additional evaluation of recent mammogram, short interval follow-up
• Type of Examination(s) Performed
• Standard screening views, additional diagnostic views, sonography, other breast imaging
• Breast Density (American College of Radiology lexicon)
• Entirely fat, scattered fibroglandular densities, heterogeneously dense, extremely dense
• Assessment per Woman
• Incomplete assessment, normal, normal with benign finding, probably benign, suspicious abnormality, highly suggestive for malignancy
• Recommendation
• Mammography in normal interval follow-up, additional views, sonography, short-term follow-up, fine-needle aspiration, core biopsy, consider biopsy or surgical evaluation, clinical evaluation for further diagnostic evaluation
• Follow-Up Data
• Follow-Up Performed (summarized per woman)
• Date and result (include right versus left breast): additional views, short-interval follow-up mammogram
• Date and laterality required, laterality result recorded if available: clinical examination, sonography, fine-needle aspiration, core biopsy, excisional biopsy
• Pathologic Variables
• Carcinoma pathology (as obtained in SEER registries)
• Type of procedure, reporting source, laterality
• Staging: size, histopathology, grade, tumor size, number of positive nodes, metastasis present (TNM), American Joint Committee on Cancer stage, extension*, nodal involvement* (number examined and postive), tumor sequence*, estrogen and progesterone receptor status*
• Therapy (data first initiated): surgery, radiation, chemotherapy, hormonal, biologic modification, no surgery reason*
• Follow-up status*: date of last follow-up, vital status last follow-up*, cause of death
• Benign pathology*
• Type of Procedure
• Reporting source
• Laterality
• Histopathology (as recorded and also categorized into major groups: atypical hyperplasia, ductal hyperplasia, fibroadenoma, phyllodes tumor, benign, normal, inconclusive

* Variables with asterisks are optional for sites using non-Surveillance, Epidemiology, and End Results (SEER) Program registries.

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Sample Standardized Questionnaires

Unlike multicenter clinical trials that use a common protocol and common data collection instruments, the research projects in the BCSC must operate within existing health care systems. Data are being collected from a range of delivery systems, including traditional fee-for-service, solo and group radiology practices, managed care organizations, free-standing mammography centers, mobile van programs, hospital-based radiology practices, and nonradiology practices.

To facilitate pooling data across sites as well as to allow direct comparison of different regions, the Consortium has standardized the questions included on the questionnaires. The Consortium is working with the American College of Radiology BI-RADS™ Committee to determine how data collected in these two systems might be made more compatible. The standardization is aimed at how the questions are asked and answered. Centers can develop their own instruments and choose their data collection method -- scannable questionnaires, computer responses, or simple form completion.

Because of the diversity of data collection sites and varying availability of data, the Consortium decided to allow some flexibility in the data that are collected, with some variables considered "core (required)" and others "optional." Sites also can choose whether to include questions on the optional variables and can include additional questions for their own use.

The sample questionnaires, with core and optional items are provided here (as PDF files). Optional items are shown in shaded boxes in the sample forms. As our understanding evolves of which mammography screening factors should be examined, some of these questions may change. New versions of the questions will be posted here as they become available.

• Short Patient Form
• Long Patient Form
• Short Radiologist Form
• Long Radiologist Form

Recent site-specific questionnaires are available below in PDF format.

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Standard Definitions

The following document details the terms and definitions used in the BCSC database.  It also includes variable names to help identify the definition with the data variable.  This document is designed to help researchers better understand the variables and definitions in the BCSC database.

BCSC Standard Definitions (PDF)

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