FINAL SUPPORTING STATEMENT PART B revised 12.15.09

Supporting Statement B for

The Jackson Heart Study (JHS): Annual Follow-up

with Third Party Respondents (NHLBI)

OMB# 0925-0491

November 23, 2009

Cheryl Nelson

6701 Rockledge Drive MSC 7934

Bethesda, MD 20892

Phone: 301-435-0451

FAX: 301-480-1667

E-Mail: NelsonC@NHLBI.NIH.GOV

Table of contents

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS…	4
B.1 RESPONDENT UNIVERSE AND SAMPLING METHODS……………………………….	4
B.2 PROCEDURES FOR THE COLLECTION OF INFORMATION…………………………..	5
B.3 METHODS TO MAXIMIZE RESPONSE RATES AND DEAL WITH NON-RESPONSE.	7
B.4 TEST OF PROCEDURES OR METHODS TO BE UNDERTAKEN……………………….	8
B.5 INDIVIDUALS CONSULTED ON STATISTICAL ASPECTS AND INDIVIDUALS COLLECTING AND/OR ANALYZING DATA…………………………………………….	8

List of Attachments

Attachment 8 ...……………………………………..………Known Informant Letter

Attachment 9 .…………………………………………....Unknown Informant Letter

Attachment 10 ...……………………………………Informant Interview (IFI) Form

Attachment 11 ..………………………………Physician Questionnaire (PHQ) Form

Attachment 12 ...………………………….Coroner-Medical Examiner (COR) Form

Attachment 13 ...…………………………………….Confidential Data (CFD) Form

Attachment 14 ...……..………………...Common Hospital Information (CHI) Form

Attachment 15 ...………………………...……….Hospital Abstraction (HRA) Form

Attachment 16 ……………………………………….Cohort Eligibility (CEL) Form

Attachment 17 ...……………….…………………...Stroke Abstraction (STR) Form

Attachment 18 ..…………………………………..Heart Failure Survey (HFS) Form

Attachment 19 …..………..…………………..Heart Failure Diagnosis (HDX) Form

Attachment 20 .……………Heart Failure Hospital Record Abstraction (HFA) Form

Attachment 21 ……………………..……..Heart Failure Abstraction (HFS-A) Form

Attachment 22 …………………………….Release Med. Info. by Next of Kin Form

B. Collections of Information Employing Statistical Methods

B.1. Respondent Universe and Sampling Methods

B.1.a. Design Summary

The JHS is a single-site prospective investigation of CVD among African-Americans from the Jackson, Mississippi metropolitan area. The JHS was designed to collect data in a single site, consisting of an all African-American geographically defined community. The goals of the JHS are to study CVD in an all African-American population (ages 35-84), including genetic components. 5,302 participants completed the baseline clinical Exam 1, including 1,601 Jackson ARIC Study participants , 2,228 new Jackson participants (924 randomly selected residents from three Jackson counties and 1304 volunteer participants who met demographic criteria) and 1,473 Jackson family member (from 200 probands).

On June 15, 2005, negotiations for the continuation of the JHS were completed. JHS Exam 2 began in October 2005, followed by a more comprehensive Exam 3 that began in February 2009. During clinical Exam 2, which ended in December 2008, 4205 JHS participants were examined. The data collection phase of Exam 3 is currently in progress. The target number of participants for the Exam 3 components are: 4250 participants for the Core examination (85% retention rate), 4500 participants for CT scans, and 2500 participants for the cardiac MRI studies.

B.1.b. Respondent Universe

In the Surveillance component, data will be examined based on specific diagnostic codes. The study will obtain information from hospitals, physicians and relatives on all fatal and non-fatal cases of CVD in the cohort. The cohort mortality rate is expected to be 200 deaths annually. The expected response rate for data collection from the respondent universe (physicians and next of kin) is 85%.

The communities selected for investigation in the JHS will provide information on the occurrence and trends in CVD in a unique environmental setting. The cohort samples will permit inferences to be made about risk factors and disease relationships from the population. The JHS will permit evaluation of the consistency of any observed association. It was important to select a community in which identification, repeated examinations, and surveillance of a cohort of individuals would be possible and linkage between CVD occurring in the community and in the cohort could be made.

B.2. Procedures for Information Collection

The next of kin will be contacted by letter requesting permission for an interview about the participant's existing medical situation at the time of death. There are two forms of this letter; one is sent to informants whose phone number is known and the other letter is sent to informants whose phone number is unknown (Attachments 8 and 9). The latter requests information on phone numbers, so informants can be contacted at a later date. These informants are then contacted by telephone to gather information about events surrounding the death of the participant (Informant Interview (IFI) form found in Attachment 10).

Physicians, familiar with the medical history or with the events preceding the death of a JHS participant, will be contacted by letter to help classify the death of the participant. They will be mailed a self-administered Physician Questionnaire (PHQ)[Attachment 11] to ascertain whether the deaths of the JHS participants, which occurred out of hospital emergency room or prior to arrival at hospital (DOA's) are due to cardiovascular disease.

The surveillance staff will complete the Coroner/Medical Examiner Form (COR) [Attachment 12] in consultation with the coroner/medical examiner familiar with the death of the participant, which occurred out-of-hospital emergency room or prior to arrival at hospital to determine if the deaths are due to cardiovascular disease. The surveillance staff will also utilize death certificate forms provided by the Mississippi State Department of Health to ascertain whether the deaths of JHS participants are due to cardiovascular disease. They will examine hospital databases and complete the Confidential Data (CFD) [Attachment 13], Common Hospital Information (CHI)[Attachment 14], and Hospital Record Abstraction (HRA)[Attachment 15] Forms to record information from hospital in-patient records in order to classify cardiovascular occurrences. Surveillance staff will examine hospital records to ascertain whether the deaths/hospitalizations of JHS participants are eligible for investigation through the use of the Cohort Event Eligibility Form (CEL)[Attachment 16]. The Cohort Stroke Abstraction (STR)[Attachment 17], Heart Failure Survey (HFS)[Attachment 18], Heart Failure Diagnosis (HDX)[Attachment 19], Heart Failure Abstraction (HFA)[Attachment 20] and Heart Failure Abstractions with Supplemental Information[Attachment 21] (HSF-A) Forms will be used to examine hospital records and classify stroke and heart failure events of JHS participants.

B.2.b. Community Surveillance Component Design

Surveillance of the JHS cohort will be used to ascertain medical events between each contact. The study will obtain a complete enumeration and valid diagnostic classification of the fatal CVD and hospitalized incidences of participants. Surveillance data gathering procedures will be based on a review of hospital records of all participants with either a diagnosis of cardiovascular disease or one of several screening diagnoses who were discharged from any of the acute care hospitals in the area. The JHS surveillance staff will conduct review and abstraction of hospital records.

The surveillance of CVD deaths in the cohort is accomplished by the review and abstraction of all age and residence eligible death certificates with various manifestations of CVD coded as the underlying cause of death during the study period. Sources of validation for out-of-hospital death, and dead-on-arrivals will include interviews with the next-of-kin, and personal physician, coroner or medical examiner reports, and hospital records. Deaths occurring in the hospital are classified by abstracting information from the medical record. All CVD deaths which cannot be positively classified by the diagnostic algorithm will undergo review by a classification panel. The information on hospitalizations and deaths will be reviewed and a determination of the occurrence of CVD and stroke will be made according to defined criteria. Cause of death will also be determined.

The death certificate will be obtained from the Vital Statistics registrars and the place of death determined. For in-hospital deaths, the hospital record is reviewed as indicated above. For out-of-hospital deaths and decedents admitted without a pulse rate or blood pressure, the participant’s family and physician will be contacted to provide information on the circumstances surrounding the death, if the participant gave prior consent.

B.3. Methods to Maximize Response Rates and Deal With Non-response

The procedures to maximize responses will focus on maintaining high-response rates to the surveillance questionnaires from the relatives and physicians of the participants. The number of completed questionnaires comprise the numerator, while the number of calls made to informants in addition to the number of PHQs mailed comprise the denominator. To maintain a high response rate to the surveillance phase of the JHS, the following procedures will be implemented (Attachment 22):

• A letter will be sent to the next-of-kin of the participants indicating that the participant had given permission to contact a relative for information (a copy of the consent form will be attached). The relative will also be informed that a JHS staff will make contact to ask medical questions relating to the participant to prepare the relative so that he or she may have information available for the JHS staff. A letter will also be sent thanking the relative for participating in the process.

• A letter will be sent to the participant’s physician requesting assistance in classifying the participant’s death in terms of heart disease and requesting completion of the Physician Questionnaire (PHQ).

• If the information for the surveillance component cannot be obtained, then a JHS Surveillance staff member completes the Coroner/Medical Examiner’s Form (COR) once the Medical Examiner’s Report of Death Investigation has been received from the Coroner’s Office.

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

There will be no new procedures or methods of data collection undertaken during the surveillance phase of the JHS. The procedures and methods of data collection have all been defined previously in the JHS to minimize burden and improve utility.

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

The following individuals were consulted on statistical aspects:

Michael Andrew, Ph.D. Center for Disease Control and Prevention

Morgantown, West Virginia

(301) 285-6189

George Howard, Ph.D. Department of Biostatistics

University of Alabama, Birmingham

(205) 934-4905

James Hosking, Ph.D. Department of Biostatistics

University of North Carolina, Chapel Hill

(919) 962-3085

The following individuals are responsible for data collection:

Herman A. Taylor, M.D. Director and Principal Investigator

Jackson Heart Study

University of MS Medical Center,

Department of Medicine/Cardiology

(601) 368-4644

Frances Henderson, Ph D. Deputy Director

Jackson Heart Study

University of MS Medical Center

(601) 979-8765

Ervin Fox, M.D. Associate Director for Data Acquisition

Jackson Heart Study

University of MS Medical Center

(601) 815-5050

The following individuals are responsible for data management:

Daniel F. Sarpong, Ph.D. Associate Director, Data Management

Jackson Heart Study

Jackson State University

(601) 979-8748

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