Cardiovascular Diseases — Validation and Field Test for Risk Appraisal Instruments
Citation(s)
Avis NE, McKinlay JB, Smith KW Is cardiovascular risk factor knowledge sufficient to influence behavior? Am J Prev Med. 1990 May-Jun;6(3):137-44.
Avis NE, Smith KW, McKinlay JB Accuracy of perceptions of heart attack risk: what influences perceptions and can they be changed? Am J Public Health. 1989 Dec;79(12):1608-12.
Smith KW, McKinlay SM, McKinlay JB The reliability of health risk appraisals: a field trial of four instruments. Am J Public Health. 1989 Dec;79(12):1603-7.
Smith KW, McKinlay SM, Thorington BD The validity of health risk appraisal instruments for assessing coronary heart disease risk. Am J Public Health. 1987 Apr;77(4):419-24.
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.
