The Cardiovascular Health Study (CHS),
OMB No. 0925-0334, expiration 09/30/2007, is an NHLBI
contract-funded longitudinal observational study of the development
and progression of heart disease and stroke in the elderly
initiated in 1988. The primary objectives include quantifying
associations of risk factors with subclinical disease;
characterizing the natural history of CHD and stroke; and
identifying factors associated with clinical course. A random
sample of 5,201 men and women aged 65 years and older was recruited
from four communities between June 1989 and May 1990. An additional
687 African-Americans were recruited to the study between August
1992 and May 1993. This cohort was followed prospectively on a
semi-annual schedule of alternating clinic examinations and
telephone calls for development of new cardiovascular risk factors,
subclinical disease, and overt cardiovascular disease through May
1999, and by semi-annual phone calls after that time to continue
identification of clinical cardiovascular and cerebrovascular
disease events. The findings provide important information on
cardiovascular disease in an older U.S. population, including
specific subgroups of interest, and identification of factors that
may be important in disease prevention and treatment. Since June
2005, cohort follow-up has continued via investigator-initiated
grant support to three of the CHS field centers and a no-cost
extension of NHLBI's contract to the Pittsburgh field site. The
University of Pittsburgh is the only CHS field site still sponsored
by CHS contract funds to conduct new events ascertainment efforts.
This OMB submission supports a request for a reinstatement with
change until May 31, 2008 to perform additional morbidity and
mortality follow-up of the Pittsburgh field site cohort.
US Code:
42
USC 285b-3 Name of Law: Public Health Act
CHS event surveillance is an
ongoing collection of information. The program has been streamlined
since the 2004 Supporting Statement submission. As explained in A.1
above, only the Pittsburgh field site will continue to collect new
information under a no-cost extension of a CHS contract due to end
on May 31, 2008; the estimated number of respondents has been
adjusted accordingly. The data collection protocol has also been
simplified, such that the Acute Precipitants and Medications
questionnaires are no longer being administered in follow-up calls
to participants, and physicians are no longer being contacted for
information about potential non-hospitalized clinical outcomes.
Even so, the advanced age of the study participants and their
increasingly complicated hospitalization histories have required an
estimated greater time burden for participant and proxy responses.
The annualized cost to respondents has been calculated based upon
more realistic current hourly wage rate estimates. Average
annualized costs to the U.S. government have been adjusted to
reflect that only one CHS field site continues to collect data
under the contract.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form 2 Participants Call and Interview
Supporting Statement Part B.doc
ATT 6 - Pittsburgh IRB approval.pdf
Participants Call and Interview