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.
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