Cholesterol Decreases Mortality
Cardiovascular disease is one of the leading causes of mortality in the industrialized world. Each year, close to 950,000 Americans die of cardiovascular disease, while 61 million Americans have some form of cardiovascular disease. The financial costs of cardiovascular disease are high, with $351 billion spent on heart disease and stroke each year in the United States (Centers for Disease Control, Preventing Heart Disease).
At the same time, high blood cholesterol is known to be a risk factor for heart disease. Decreasing total blood cholesterol can have a profound effect, reducing the incidence of coronary heart disease by close to 30% (Centers for Disease Control, Heart Disease). Further, there is a wide variety of research that links blood cholesterol levels to heart disease and mortality. This study aims to add to this body of evidence by investigating the impact of decreased cholesterol consumption on mortality from cardiovascular disease.
Experimental Design
Hypothesis: Decreased cholesterol consumption is associated with reduced mortality from cardiovascular disease.
This qualitative study will incorporate a longitudinal design. The total length of the study is estimated to be approximately 80 years, or to the maximum lifespan of last remaining participant.
Ten different universities and hospitals will be taking part in this study, in order to allow for a diversity of subject participation. While the identities of these facilities have not yet been established conclusively, they will represent all major areas of the United States, including Alaska, Hawaii, the Midwest, the west coast, and the eastern coast.
In each facility, 1,000 research subjects will be recruited using voluntary recruitment procedures. Advertisements for volunteers will be placed in local newspapers, community message boards, and clinic and emergency waiting rooms. Subjects will range in age upwards from 21 years of age. Subjects will not be excluded from the study on any medical or other grounds. This wide range of subjects and large sample size will allow researchers to correlate cholesterol intake with a number of other factors, including age, sex, race, place of residence, and other medical conditions.
All subjects will be assessed at two-year intervals throughout the study. To assess cholesterol consumption, subjects will be asked to fill out a nutritional questionnaire designed to estimate cholesterol intake. Subjects will also be given a blood test to assess cholesterol levels. Subjects will also be asked to fill out a questionnaire that contains a number of variables, including age, sex, race, place of residence, other medical conditions, and dietary needs (Muslim, allergies or vegetarian, for example). Weight will also be assessed at each two-year interval, and subjects will be given a medical examination. Data will be collected by registered nurses or MDs, in all cases. Questionnaires, blood tests, and medical examinations will be standardized. At each two-year period, mortality rates and causes of death will be assessed.
As noted previously, data from each facility will be collected at two-year intervals. Results from each separate facility will be forwarded for analysis to the central study headquarters. Data will be analyzed at central study headquarters by researchers specifically trained for this purpose. Given the large amount of data collected (10 facilities with 1,000 participants, for a total of 100,000 subjects), data will be collected and stored in a centralized computing environment.
Several statistical approaches will be taken to analyze the data. Data will be analyzed at each two-year interval, and an interim research report will be generated. Further, ten years of data will also be analyzed at each ten-year anniversary of the study. This report will also be available. In addition, data will also be analyzed cumulatively, with analysis including all data reported to the study.
Results
This study is expected to reveal a positive correlation between cholesterol intake and mortality. Further, it is anticipated that the study will reveal some correlations between mortality and other variables such as dietary needs, race, and gender. Similarly, it is anticipated that this study will draw relationships between cholesterol intake and variables such as gender, geographic location, and race.
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