[Federal Register: March 11, 2005 (Volume 70, Number 47)]
[Notices]
[Page 12219-12220]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr05-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-05-0424X]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 371-5976 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Human
Resources and Housing Branch by fax to (202) 395-6974. Written comments
should be received within 30 days of this notice.
Proposed Project
Evaluating Tools for Health Promotion and Disease Prevention--New--
Office of Genomics and Disease Prevention (OGDP), Centers for Disease
Control and Prevention (CDC).
Background
Although family history is a risk factor for most chronic diseases
of public health significance, it is underutilized in the practice of
preventive medicine and public health for assessing disease risk and
influencing early detection and prevention strategies. It has been
known for years that people who have close relatives with certain
diseases (such as heart disease, diabetes, and cancers), are more
likely to develop those diseases themselves. Geneticists have long
recognized the value of family history for discovering inherited
disorders, usually the result of single gene mutations. Although single
gene disorders are typically associated with a large magnitude of risk,
they account for a small proportion of individuals with a genetic risk
for common, chronic diseases. Most of the genetic susceptibility to
these disorders is the result of multiple genes interacting with
multiple environmental factors. Family history is more than genetics;
it reflects the consequences of inherited genetic susceptibilities,
shared environment, shared cultures and common behaviors. All of these
factors are important when estimating disease risk. In early 2002, the
CDC Office of Genomics and Disease Prevention (OGDP) in collaboration
with several CDC programs and NIH institutes began an initiative to
develop a family history tool for identifying apparently healthy people
who may be at increased risk for a number of common diseases. The major
activities of this initiative have included: (1) Reviews of the
literature for approximately 25 diseases; (2) assessments of family
history tools currently in use or under development; (3) a meeting of
experts to provide input into the process; (4) development of criteria
for determining which diseases to include in the tool; (5) development
of a framework for evaluating a family history tool and the development
of a tool.
As a result of this initiative, a personal computer-based familial
risk assessment tool was developed to be used as a public health
strategy to improve health and prevent disease. The assessment tool is
called, ``Family Healthware.'' This tool will be used to collect
information about the disease history of a person's first- and second-
degree relatives (mother, father, children, siblings, grandparents,
aunts, and uncles), use family history information to assess risk for
common diseases of adulthood, and influence early detection and
prevention strategies. The current version of the tool focuses on six
diseases--heart disease, stroke, diabetes, and colorectal, breast, and
ovarian cancers.
The proposed project is a study to evaluate the clinical utility of
the ``Family Healthware'' tool by determining whether family history
risk assessment, stratification, and personalized prevention messages
have any impact on health behaviors, and use of medical services. In
2003, CDC awarded funding to three research centers to collaborate on a
study set in primary care clinics to assess the clinical utility of the
family history tool. Eligibility for the study will be determined by a
brief screening test completed by patients from the primary care
clinic. It is anticipated that only a small number will be ineligible
to continue since the majority of patients will be pre-screened for
eligibility based on a medical record review prior to the screening
test.
The primary care clinics affiliated with the three research centers
will be randomized into two groups. Patients participating in the study
will all complete the pre-test, post-test and family history tool,
however, the order in which they do so is dependent upon the group to
which they are randomized. In the intervention group, patients
attending the primary care clinics will be asked to complete the family
history tool and a pre-test that includes an assessment of risk
factors, preventive behaviors, use of medical services, and perception
of risk. The patients will be provided with an assessment of their
familial risk (average, above average, much above average) for each of
the six diseases and information about preventive measures (e.g., diet,
exercise, screening tests) that is tailored to their level of familial
risk for each of the six diseases. After 6 months, the patients will be
asked to complete a post-test that assesses their risk factors, use of
medical services, interest in modifying health behaviors, and changes
in risk perception. In the control group, patients will initially
complete the pre-test only (not the family history tool) and will be
given standard public health messages about preventing the six diseases
of interest (messages will not be tailored to risk level). After 6
months, the patients in the control group will also complete the post-
test and the family history tool. Physicians will complete a post-visit
assessment if they have a visit with a participating patient during the
course of the study.
The purpose of having patients in the control group complete the
family history tool post intervention is so that the analysis can be
stratified by familial risk level in both patient groups. The
hypothesis to be tested in this study is that patients who are provided
with personalized prevention messages based on an assessment of their
family history of disease will be more motivated to make behavior
changes and use preventive health services. There is no cost to
respondents participating in this
[[Page 12220]]
study other than their time. The estimated annualized burden is 5,922
hours.
Annualized Burden Table
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Average time
Type of respondents Number of Type of response Frequency of per response
respondents response (in hrs)
----------------------------------------------------------------------------------------------------------------
Patients.............................. 4180 Screening............... 1 2/60
.............. Questionnaire (pre-test 2 30/60
and post-test).
.............. Family HealthwareTM Tool 1 20/60
Physicians............................ 140 Post Visit Assessment... 30 3/60
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Dated: March 7, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-4803 Filed 3-10-05; 8:45 am]
BILLING CODE 4163-18-P