Mesa B

Request for OMB Approval for

the Multi-Ethnic Study of Atherosclerosis (MESA)

Event Surveillance

OMB Number: 0925-0493

Contact:

Jean Olson, MD, MPH

Project Officer, Multi-Ethnic Study of Atherosclerosis

II Rockledge Centre

6701 Rockledge Drive, MSC 7936

Bethesda, MD 20892-7936

Telephone: 301-435-0397

Fax: 301-480-1667

E-Mail: [email protected]

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

B.1. Respondent Universe and Sampling Methods

Data will be collected on all morbid and mortal events that occur in MESA participants; thus, no sampling will be employed.

B.2. Procedures for the Collection of Information

Telephone follow-up of the MESA cohort every 9-12 months will be used to maintain contact, to correct addresses of participants, and to ascertain medical events that occur during the period of cohort follow-up. Though most of these interviews take place with the study participant, if the participant cannot be located or is otherwise unable to complete the interview, his or her designated proxy (spouse, other relative, or friend) will be contacted. A proxy is also contacted if the participant is unable to provide information about a CVD morbid event or in the case of a participant’s death from CVD.

Participants who screen positive for newly diagnosed angina, claudication, or congestive heart failure in the medical history have the appropriate supplemental questionnaire administered (angina, CHF or claudication). Again, proxies will occasionally be used to collect this information.

For deaths that occur outside of a hospital or other clinical setting and for morbid events that occur in an outpatient setting, physicians will be contacted for further information about the diagnosis. A proxy will be contacted to obtain additional information in the case of a participant’s CVD-related death.

In order to classify CVD events, information collected from these sources will be compiled, along with information from public files (death certificates), medical records from hospitalizations, autopsy reports, and interviews from participants. Criteria for classification of events and algorithms have been developed.

All instruments used for these data collections are in Attachment 6.

B.3. Methods to Maximize Response Rates and Deal with Nonresponse

Care has been taken to minimize the burden on physicians and proxies. Requests made to physicians’ offices are formatted for easy completion and are provided with return postage in place. Interviewers will be appropriately trained and encouraged to express a personal interest in and be sensitive to the circumstances necessitating the proxy contact (i.e., illness or death of a close friend or relative). Should more than one proxy contact be necessary, an attempt is made to have the same staff member make all contacts in order to increase rapport. By emphasizing concern and making proxy contacts as positive as possible, response rates and data quality will be maximized. Physicians and participant proxies are approached up to three times for information to maximize response rates. Experience to date in MESA has been that information is able to be obtained from the great majority of respondents using these methods.

B.4. Test of Procedures or Methods to be Undertaken

Rigid standardization of procedures has been developed and implemented, and MESA events staff have been centrally trained prior to the start of surveillance and as necessary thereafter. All events questionnaires and procedures have been successfully employed in MESA surveillance since the study’s onset. To verify timing and test questions in interviews, a pretest of nine (maximum) volunteers per site was done following construction of data collection instruments.

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

All individuals consulted or collecting/analyzing data in MESA are listed in Attachment 9.

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