PH+Reporting+User+Story+-+Cancer+Genetics+BRCA

include component="page" wikiName="siframework" page="PHRI Header" =User Story: Cancer Genetics - BRCA=

Contact Info:
Sarah Mange, MPH (manges@michigan.gov, phone: 517.373.2929) -- Clinical Cancer Genetics Epidemiologist, Division of Genomics, Perinatal Health, and Chronic Disease Epidemiology, Michigan Dept. of Community Health Janice Bach, MS, CGC (bachj@michigan.gov, phone: 517.335.8497) -- Acting Division Manager, Division of Genomics, Perinatal Health, and Chronic Disease Epidemiology, Michigan Dept. of Community Health

Date Received:
11/26/2011

Inherited mutations in the BRCA1 and BRCA2 genes are believed to be responsible for approximately 5-10% of all breast cancer cases and over 5% of ovarian cancer cases in the United States, and these cancers often occur at a relatively young age. Those with deleterious mutations have a variety of interventions available, including earlier and intensive surveillance, chemoprevention, and prophylactic mastectomy and/or oophorectomy. The potential reduction in mortality with appropriate intervention has lead to national recommendations for genetic counseling and testing. The United States Preventive Services Task Force (USPSTF) has recommended that “women whose family history is associated with an increased risk for deleterious mutations in BRCA1 or BRCA2 genes should be referred for genetic counseling and evaluation for BRCA testing.” (Grade B recommendation) The USPSTF also recommends against routine referral for women whose family history is not associated with increased risk. The National Comprehensive Cancer Network (NCCN) has guidelines that encompass both counseling and testing based on family and personal cancer history.
 * 1.1 Introduction**

Since 2008 the Michigan Department of Community Health (MDCH) Cancer Genomics Program has developed methods to promote the translation of evidence-based recommendations into clinical and public health practice as part of a cooperative agreement with the Centers for Disease Control and Prevention (CDC). This enabled MDCH to recruit all cancer genetics clinics offering genetic counseling by a board-certified provider in Michigan to participate in a network sharing de-identified data on patients presenting for BRCA counseling. This database now includes over 5,800 patients seen within the period of October 1, 2007 to March 31, 2011.

In October 2011, MDCH began a new three-year cooperative agreement with the CDC’s Division of Cancer Prevention and Control which will allow for sustained and expanded data collection utilizing the BRCA database. This award is part of a broader effort by CDC to support the Education and Awareness Requires Learning Young (EARLY) Act, section 10413 of the Patient Protection and Affordable Care Act (Public Law 111-148). The EARLY Act authorizes CDC to develop initiatives to increase knowledge of breast health and breast cancer among women, particularly among those under the age of 40 and those at heightened risk for developing the disease. The purpose of the program is to assist the adoption of evidence-based recommendations for breast cancer genomic tests and other related interventions into health practice in a manner that maximizes health benefits and minimizes harm to individuals and populations. This program addresses the ‘Healthy People 2020’ focus areas of Genomics and Cancer:
 * G-1 Increase the proportion of women with a family history of breast and/or ovarian cancer who receive genetic counseling
 * C-1 Reduce the overall cancer death rate
 * C-3 Reduce the female breast cancer death rate
 * C-11 Reduce late-stage female breast cancer

The ultimate goal of MDCH’s project is a reduction in breast cancer deaths at a young age and a reduction in ovarian cancer deaths in Michigan. The MDCH Cancer Genomics Program emphasizes using data for action with public health surveillance being central to policy and education activities. The current four program goals are supported through Michigan’s BRCA genetic counseling and testing surveillance data.
 * 1.2 User Story Narrative**
 * 1.2.1 Goal**
 * 1) Promote adoption of health plan policies to increase coverage of BRCA clinical services for high risk women
 * 2) Increase health care provider knowledge and use of BRCA clinical practices recommended by USPSTF and NCCN
 * 3) Expand surveillance of BRCA clinical practices to include counseling by a board-certified provider, testing, and related surgeries.
 * 4) Utilize data to inform clinical best practices, promote policy change, conduct program evaluation, and disseminate findings.

The evaluation of clinical best practices and national recommendations is especially important for healthcare practitioners. Many individual providers see a limited number of patients with deleterious BRCA mutations and must rely on recommendations for evidence-based practice. Most testing is done through Myriad Genetics, and there is a need for independent evaluation of testing strategies.

The BRCA database is currently used as an off-line Microsoft Access database. Manual data entry is completed by staff from each genetics clinic providing BRCA genetic counseling by a board-certified provider to patients residing in Michigan. All patients seen for this type of genetic counseling within the period of October 1, 2007 to March 31, 2011 are included in the data entry, and pertinent information is obtained from the medical record of patient counseling visits. While the database does include genetic testing information, patients are included based on the event of a genetic counseling visit, regardless of whether testing was pursued.
 * 1.2.2 Description of Data Reporting Events, Actors and Triggers**

While the majority of contributing institutions do have electronic medical records containing most of the required information, we have not been able to coordinate automatic data transfers to the BRCA database because of the time and expense needed for this type of technology. Data compiled in the Access database is mailed or emailed from each individual institution to MDCH approximately every six months. MDCH’s Clinical Cancer Genetics Epidemiologist then compiles the data into an aggregate Access database, runs data checks for cleaning, and communicates with each site about questions arising from this process.

MDCH is in the process of converting this data collection system into an online database. This would enable real-time collection of data from multiple sites without requiring data transfers.

This data is used for a variety of activities and is a measure of Healthy People 2020 goal G-1. It allows us to assess the population accessing genetic counseling and testing in terms of demographics, family and patient history of cancer, insurance status and type, and referring provider. Information on why some patients do not pursue testing has helped identify barriers to testing such as insurance coverage, and has also demonstrated the importance of genetic counseling in determining the need for testing and for recommending appropriate testing strategies. This data is important from a cost-effectiveness perspective. Data on insurance coverage has been important in Michigan’s health policy work with insurers, provides evidence of coverage gaps and is a means of evaluating the program’s impact in this area. Statistics from the BRCA database are used in presentations, handouts, and publications intended for provider education. The information on genetic tests and results is an important resource for evaluating testing strategies and recommendations for referral to genetic counseling and testing. Finally, this database allows us to evaluate the impact of a variety of policy, education and surveillance efforts surrounding BRCA and the prevention of hereditary cancers.

Data currently collected on BRCA counseling and testing includes the following items:
 * 1.2.3 Data**

//Demographics//
 * De-identified patient code
 * Zip code of residence
 * Clinical institution where the patient was seen for counseling
 * Type of referring physician (family practice, obstetrics, etc.)
 * Gender
 * Race
 * Second Race (multiracial patients)
 * Other race (fill in the blank for those other than listed options)
 * Birth year
 * Whether the patient is of Ashkenazi Jewish heritage
 * Whether there is a known BRCA mutation in the patient’s family
 * Number of third-degree relatives with cancer
 * Whether the patient’s family history meets USPSTF guidelines (automatically calculated by database)

//Counseling visit information//
 * Date of counseling visit
 * Counseling visit type – initial or follow-up
 * Insurance type, including private insurance, Medicaid, and/or Medicare
 * Reason if BRCA genetic testing not pursued

//Cancer and genetic risk assessments//
 * Date of assessment
 * Assessment type (BRCA PRO, GAIL, and Myriad risk models)
 * Assessment score

//BRCA genetic tests//
 * Test date
 * Test type (comprehensive, BART, Ashkenazi, or site-specific BRCA tests)
 * Other test type (fill in the blank if not in ‘Test Type’ drop down list)
 * Result of test (positive, negative, or variant)
 * Result date

//Patient Cancer History//
 * Date cancer history recorded
 * Cancer type
 * Age at diagnosis

//Relatives’ cancer histories//
 * Relative relationship to patient
 * Date cancer history recorded
 * Cancer type
 * Age at diagnosis

//Data elements to be added to the online database://
 * Whether the patient’s personal and family history of cancer meets NCCN guidelines (automatically calculated by database)
 * Patient history of surgery (mastectomy or oophorectomy)
 * Timing of surgery (before after counseling/testing)
 * Reason for surgery (prophylactic, cancer treatment, other)


 * 1.2.4 Other Information**

While only Michigan is currently using the BRCA database on a statewide level, several other academic institutions and state health departments have expressed interest in beginning their own data collection using both the Access and web versions of the database. In the last three months, the Access version of the database has been disseminated free of charge to five states at their request. Many more institutions have expressed interest in using an online database, including the states of Ohio and Georgia. Both Ohio and Georgia would like to be able to share a single web-based database with Michigan, but funding and data access restraints may require separately hosted online systems for each state. We are currently exploring both of these options to determine costs and feasibility.

In addition, Ohio is planning to develop an online database for Lynch Syndrome, a hereditary cancer syndrome conferring increased risks for colorectal, endometrial, and other cancers. The Lynch Syndrome project is projected to be completed before June 2012 and will be based on the framework of the current BRCA database. Ideally, users of the online BRCA database will have access to a single online data entry system which will allow them to enter both BRCA and/or Lynch Syndrome patients.

There is interest in eventually creating a single data entry system that encompasses a variety of inherited cancer syndromes and could be shared with multiple state health departments and other entities.

Fourteen clinical sites in Michigan are participating in MDCH’s 3-year cooperative agreement with the CDC, which ends in 2014. Many of these sites have expressed interest in continuing this database and publishing results from the data collected. It is anticipated that as findings are published, more states will be interested in beginning similar collection systems and will look to MDCH for guidance. MDCH Genomics in partnership with the CDC is committed to continuing this data collection system until 2014.
 * 1.3 Stakeholder Commitment**

Pruthi S, Gostout BS, Lindor NM. Identification and Management of Women With BRCA Mutations or Hereditary Predisposition for Breast and Ovarian Cancer. //Mayo Clin Proc// 2010;85(12):1111-20. US Preventive Services Task Force. Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility: Recommendation Statement. Ann Intern Med //2005// Sep 6; 143:355-361. Healthy People 2020: @http://www.healthypeople.gov/2020/ Genomics: @http://www.healthypeople.gov/2020/topicsobjectives2020/pdfs/Genomics.pdf Cancer: @http://healthypeople.gov/2020/topicsobjectives2020/pdfs/Cancer.pdf
 * References and Resources**

Supporting Files:

 * **Description** || **File** ||
 * This document contains the initial draft user story submission. || [[file:Initial Draft Submission - Cancer Genetics BRCA - November 26 2011.docx]] ||  ||

Comments:
Please comment on this User Story using the "Discussion" tab at the top of the screen.

include component="page" wikiName="siframework" page="space.template.inc_contentleft_end"