Comparative Effectiveness Research (CER) Specialized Registries
Texas is one of ten specialized registries with the new Comparative Effectiveness Research (CER) Specialized Registry designation. Comparative effectiveness research is designed to inform health-care decisions by providing evidence of effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, surgeries, or ways to deliver healthcare. CER Specialized Registries will help collect detailed data to address key CER questions on colorectal cancers, breast cancers, and chronic myeloid leukemia (CML). The CDC working together with the Agency for Healthcare Research and Quality (AHRQ) identified four Comparative Effectiveness Research questions to address through this data collection effort:
- Are colorectal cancer patients tested for KRAS and are the results used appropriately to determine treatment? What impact does KRAS testing have on 2-3 year survival among colorectal cancer patients?
- Are chronic myeloid leukemia (CML) patients being tested for the BCR-ABL2 gene and receiving appropriate treatment according to those results?
- Are women with breast cancer being tested appropriately for HER2, progesterone receptor (PR), and estrogen receptor (ER) status and are they being treated appropriately?
- Are rectal cancer patients receiving radiotherapy and what is the timing of radiotherapy? Are disparities apparent in the appropriate neo-adjuvant use of radiotherapy among these patients?
Some of the major activities required by CER registries include an emphasis on data collection through data linkages, building electronic reporting capacity, and the development of non-hospital reporting sources with the goal of expanding sustainable activities to other registries over time.
A number of additional fields with higher quality data are being collected by the TCR for cancer cases diagnosed January 1 through December 31, 2011. This includes both data collected from hospital sources and data acquired through linkages with large datasets such as the Breast and Cervical Cancer Early Detection Program and the National Death Index. Additional fields for diagnosis year 2011 cases include:
• Additional staging
• Treatment - focusing specifically on colorectal cancers, breast cancers and CML
• Biomarkers for some sites
• Comorbidities for all sites
• Smoking history for all sites
• Height and weight for all sites
• Occupation for all sites
The greatest amount of additional information required from cancer reporters is in the area of treatment. Detailed information is required for breast, colorectal and CML cases. This includes:
• Chemotherapy- including up to six courses with NSC number (available on Seer Rx), doses planned and received, start and end dates and chemo completion status
• Granulocyte CSF Status
• Erythrocyte Growth Factor Status
• Thrombocyte Growth Factor Status
• Hormone Therapy - up to two courses with NSC number
• Biological Response modifiers - up to two courses with NSC number
• Subsequent Treatment - as available for breast, colorectal and CML
A complete listing of the revisions with section and page number is located in the online version of the 2011 TCR Handbook. The Treatment B section of the TCR Handbook describes the CER treatment fields and provides concise coding instructions. If you have additional questions or need assistance with CER data collection, please contact your regional office or central office at 1-800-252-8059. TCR staff members are available to assist in any way possible.
The following table lists newly designated NSC numbers for chemotherapy drugs: NSC Report (.pdf, 13 KB).
CDC Letter to States (.pdf, 36 KB)
Graphic of CER States (.pdf, 218 KB)
References:
1. "What is Comparative Effectiveness Research?" AHRQ Effective Health Care Program. Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Accessed on 10/10/2011. http://www.effectivehealthcare.ahrq.gov/index.cfm/what-is-comparative-effectiveness-research1/
2. 2011 Cancer Reporting Handbook. Publication No. E10-10677. Updated: July 2011 with September Revisions. http://www.dshs.state.tx.us/2011-Cancer-Reporting-Handbook.aspx
CER Coding Corner
Guidelines for coding specific CER fields are available in the following resources:
All Fields: http://www.dshs.state.tx.us/2011-Cancer-Reporting-Handbook.aspx
CER Mini-Book: File (.pdf, 400 KB)
Treatment: Body Surface Area (BSA) Calculator for Medication Dosages (.pdf, 18 KB)
Exercises (with answers) for Calculating Planned and Received Medication Dosages:
CER Planned Dose Exercise(.pdf, 12 KB)
CER Received Dose Exercise(.pdf, 12 KB)
CER Received Dose Reduction Exercise(.pdf, 12 KB)
CER Planned Dose Answers(.pdf, 12 KB)
CER Received Dose Answers(.pdf, 12 KB)
CER Received Dose Reduction Answers(.pdf, 12 KB)
Comorbidities and Complications: http://www.facs.org/cancer/coc/fords/fords-2012b.pdf
Biomarker collection by site: http://www.cancerstaging.org/cstage/schema.html
Clinical TNM Staging: http://www.cancerstaging.org/products/ajccproducts.html
AJCC Cancer Staging Manual, 7th edition; Chapter 32; Breast, pg 347 and Chapter 14; Rectum, pg. 143
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