Cardiovascular Diseases — Behavioral Factors in Coronary Heart Disease
Citation(s)
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Harrell FE Jr, Lee KL, Mark DB Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996 Feb 28;15(4):361-87. Review.
Lipkus IM, Barefoot JC, Williams RB, Siegler IC Personality measures as predictors of smoking initiation and cessation in the UNC Alumni Heart Study. Health Psychol. 1994 Mar;13(2):149-55.
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Suarez EC, Williams RB Jr The relationships between dimensions of hostility and cardiovascular reactivity as a function of task characteristics. Psychosom Med. 1990 Sep-Oct;52(5):558-70.
Von Dras DD, Siegler IC, Barefoot JC, Williams RB, Mark DB Coronary catherization patient and wife's perceptions of social support: effects due to characteristics of recipient, provider, and their interaction. Int J Aging Hum Dev. 2000;50(2):97-125.
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Williams RB Invited commentary: socioeconomic status, hostility, and health behaviors--does it matter which comes first? Am J Epidemiol. 2003 Oct 15;158(8):743-6.
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Williams RB Treating depression after myocardial infarction: can selecting patients on the basis of genetic susceptibility improve psychiatric and medical outcomes? Am Heart J. 2005 Oct;150(4):617-9.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.