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Understanding Family-based Detection as a Strategy for Early Diagnosis of Hemochromatosis—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Hemochromatosis is a disease that occurs as a result of excess iron accumulation in the tissues and organs. The majority of Hemochromatosis cases are due to HFE gene mutations. Early Hemochromatosis symptoms are nonspecific and are often overlooked by physicians or mistaken for other conditions. Fortunately, Hemochromatosis can be detected with simple blood tests. When treatment by therapeutic phlebotomy is instituted early in the course of the disease, the many severe complications associated with Hemochromatosis (e.g. cirrhosis of the liver, liver cancer, cardiomyopathy, and heart failure) can be effectively prevented.
Hemochromatosis is a genetic disease, and blood relatives of Hemochromatosis patients are at increased risk. The public health strategy for early detection of hereditary Hemochromatosis is making patient family members aware of their increased risk and encouraging them to seek voluntary diagnostic testing (“family-based detection”). CDC wants to evaluate family-based detection as a strategy to identify people with Hemochromatosis. The proposed research project will examine the effectiveness of and barriers to the use of family-based detection as a public health strategy to reduce morbidity and mortality from genetic diseases, and in particular, Hemochromatosis.
To understand the effectiveness of family-based detection for Hemochromatosis the following will be evaluated:
- Barriers and motivators to family-based detection as a strategy for early diagnosis of Hemochromatosis. (Early detection facilitates early treatment to slow the course of disease.)
- How physicians communicate with patients about the importance of family-based detection and the need for patients to encourage biological siblings to seek testing.
- Factors that foster good communication among biological siblings about the importance of seeking medical testing by those at increased risk of Hemochromatosis.
- Factors that affect the willingness of biological siblings to take action to seek out and receive testing for Hemochromatosis.
- Information and key messages that motivate patients to advise their biological siblings about their increased risk for Hemochromatosis and need for diagnostic testing.
- How physicians use medical histories to identify people who should be tested because they have a relative with Hemochromatosis.
The proposed research to be undertaken by CDC will incorporate several types of qualitative data collection: structured one-on-one interviews, triads (small focus groups) and traditional focus groups. Subjects will include Hemochromatosis patients, biological siblings of patients, and physicians. Topics to be explored with each of the three subject groups include the knowledge, attitudes, perceptions, and behaviors related to family-based detection.
Patients will be recruited in Boston and Chicago from the following places (where Hemochromatosis patients often undergo treatment by therapeutic phlebotomy):
- Blood banks;
- Hospital laboratories;
- Other health care provider facilities.
Siblings will be recruited either through the patients or by self-referral. Health care providers will be recruited through publicly available lists of physicians, or recommendations from project staff, patients, biological siblings, blood banks, hospital laboratories, Hemochromatosis organizations, and health care providers knowledgeable about Hemochromatosis. Information about the study will be available on the CDC Web site. Hemochromatosis Start Printed Page 44537organizations will be invited to notify their members about this research. There are no costs to respondents. Of the 250 individuals screened through a telephone interview, 15 will be selected for individual interviews, 30 will be selected for triads and 80 will be selected for participation in focus groups. The estimated annualized burden is 311 hours.
Annualized Burden Table:
|Respondents||Number of respondents||Number of responses per respondent||Average response per respondent|
|Telephone call screener||250||1||6/60|
|Individual interviews (Physicians)||18||1||2|
|Individual interviews (Patients and siblings)||15||1||1 2|
|Focus Groups||80||1||3 2|
|1 Includes interview and exit survey.|
|2 Includes triad and exit survey.|
|3 Includes focus group and exit survey.|
Dated: July 19, 2004.
Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
[FR Doc. 04-16910 Filed 7-23-04; 8:45 am]
BILLING CODE 4163-18-P