Cardiovascular Diseases Clinical Trial
To test hypotheses related to gender differences in cardiovascular mortality trends between 1980 and 1991 in two southeastern New England communities which were part of the Pawtucket Heart Health Program.
BACKGROUND:
The Pawtucket Heart Health Program was a community-based research and demonstration project
in cardiovascular disease prevention in the town of Pawtucket, Rhode Island and in the
non-intervention comparison town of New Bedford, Massachusetts. The study was initiated by
the NHLBI in August, 1980. See also Study 1022.
DESIGN NARRATIVE:
There were four major areas of analysis: 1) gender differences in trends from 1980 to 1991
in total event rates, hospital discharge rates, in-hospital case-fatality and out of
hospital deaths for coronary heart disease (CHD) and stroke; 2) gender specific analyses of
methodological issues which may affect the interpretation of morbidity and mortality
surveillance data; 3) gender differences in the presentation, diagnosis, and treatment of
CHD and stroke which may influence morbidity and mortality trends; and 4) gender differences
in the association between population trends in risk factors and morbidity and mortality
trends.
The study was conducted using morbidity and mortality data collected by the Pawtucket Heart
Health Program between 1980 and 1993, and risk factor data obtained through biennial
cross-sectional household health surveys conducted in random samples of residents in the two
study communities. Morbidity and mortality data were obtained according to standardized
epidemiologic surveillance methods. Hospitalized cases of coronary heart disease and stroke
were identified through hospital discharge records and were validated using a standardized
diagnostic algorithm based on data abstracted from medical records. Out-of-hospital deaths
identified through death certificate data were validated using an algorithm based upon
medical history data and information concerning the circumstances of death obtained from
informant interviews.
Gender specific trends in both age-adjusted and age specific morbidity and mortality were
compared. Trends in rates estimated from events classified according to ICD-9 discharge and
death certificate codes were contrasted with those estimated from cases validated by
standardized diagnostic algorithms. Data regarding circumstances of death and in-hospital
treatment were assessed in relation to potential influences on morbidity and mortality
trends. Absolute changes over time and average annual percent change over time were
evaluated using linear and log-linear regression regression techniques. Other analytic
methods included logistic regression and analysis of variance. Expected annual event rates
in men and women were estimated from risk factor data using equations based upon accelerated
failure time Weibull models, and the impact of risk factors on mortality rates was assessed
by comparing predicted with actual rates.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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