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Laboratory, reading center, and coordinating center data management methods in the Jackson Heart Study
Myra A Carpenter1, Richard Crow, Michael Steffes
1Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina at Chapel Hill 27514-4145, USA. myra_carpenter@unc.edu
Insights
The Jackson Heart Study (JHS) investigates cardiovascular disease (CVD) origins in African-Americans, who face higher CVD mortality risks. This study employs advanced methods to collect extensive data on over 5300 participants.
Area of Science:
- Cardiology and Public Health Research
- Epidemiology and Clinical Investigation
- Biomedical Data Science
Background:
- Cardiovascular disease (CVD) is a leading cause of mortality in the U.S.
- African-Americans exhibit a disproportionately higher risk of CVD mortality and adverse risk factor profiles compared to white populations.
- The Jackson Heart Study (JHS) was established to address the specific origins and natural progression of CVD within the African-American community.
Purpose of the Study:
- To investigate the underlying causes and long-term development of cardiovascular disease (CVD) in African-Americans.
- To identify and analyze a comprehensive range of risk factors contributing to CVD.
- To assess the prevalence, progression, and incidence of CVD and subclinical atherosclerosis.
Main Methods:
- Utilized a network of specialized reading centers for advanced diagnostic measurements (e.g., electrocardiograms, echocardiograms, carotid ultrasonograms).
- Employed high-quality laboratory analyses for blood and urine specimens, with secure storage for future research.
- Established a dedicated Coordinating Center for protocol development, data management, statistical analysis, and operational oversight, supported by an experienced coordinating center.
Main Results:
- Implemented state-of-the-science methodologies for comprehensive CVD and atherosclerosis assessment.
- Collected over 4000 data fields per participant for more than 5300 African-American individuals between November 2000 and March 2004.
- Gathered extensive data on CVD prevalence, progression, incidence, and associated risk factors.
Conclusions:
- The Jackson Heart Study successfully integrated specialized research agencies and advanced methodologies to gather critical data.
- The study highlights the necessity of diverse scientific disciplines for achieving comprehensive cardiovascular health research objectives.
- Methodologies employed ensure robust data accrual for understanding CVD in African-Americans.
Background:
Cardiovascular disease (CVD) is the leading cause of death in the United States. In comparison to whites, African-Americans have a higher risk of dying from CVD and have a worse risk factor profile. The Jackson Heart Study (JHS) is designed to investigate the origin and natural history of CVD in African-Americans.
Methods:
Reading centers for electrocardiograms, echocardiograms, carotid ultrasonograms, pulmonary function tests, and ambulatory blood pressure monitoring provide training for data accrual, quality assurance assessments, and specialized measurements for research objectives. Laboratories adhering to well-established quality assurance programs provide blood and urine analyses, as well as storage of specimens for future assays. A new Coordinating Center was created to perform functions analogous to those of coordinating centers for multisite studies, including protocol development, data management, statistical analyses, and operational support for the study. An established coordinating center serves as a resource to the JHS Coordinating Center, providing assistance in preparing procedure manuals and data collection forms. This group also designed and developed the JHS data management system.
Results:
This network of specialized research organizations is implementing state- of-the-science methodologies to assess prevalence, progression, and incidence of CVD and subclinical atherosclerosis, and to evaluate a myriad of risk factors. From November 2000 through March 2004, JHS collected 4000 data fields on each of more than 5300 African-American participants.
Conclusions:
This article describes the roles of specialized research agencies contributing to JHS, and the methodologies being utilized to accumulate study data. A diverse collection of scientific disciplines is required to collect the information needed to meet the objectives of the JHS.
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