the study of the USE AND EFFECTS of drugs in large numbers of people - Answers
Pharmacoepidemiology
the study of patterns and causes of disease in populations - Answers Epidemiology
- incidence and prevalence
- NO control groups
- hypothesis generating - Answers descriptive epidemiology
- observational studies
- measures an association between two variables
- compare an exposed w/ a control and usually designed as hypothesis testing studies - Answers analytic
epidemiology
- limited sample size
- relatively short duration
- limited comparison groups
- restricted patient characteristics
- specific indications
- artificial research conditions - Answers what are the drug approval limitations?
continuous monitoring for safety problems with medications during general use - Answers
pharmacovigilance
" does the treatment work?" - Answers efficacy
" do the treatment's benefits outweigh its liabilities for those to whom it is offered in clinical practice?" -
Answers effectiveness
the degree to which a test measures what it was designed to test - Answers validity
- efficacy
- experimental study designs (RCT) - Answers internal validity
- effectiveness
- observational study designs (case-control, cohort) - Answers external validity (generalizability)
, - observational, descriptive
- outcome and exposure status are measured simultaneously
- "snapshot"
- no cause and effect - Answers cross-sectional studies
- observational, analytical
- presence/absence of of suspected causative factor "risk factor" - Answers cohort
- observational, analytical
- presence/absence of suspected outcome "problem"
- retrospective
- cases have the outcome, controls do not - Answers case-control
control group - Answers What increases the internal validity in case-control studies?
- (a/c)/(b/d)
- odds of exposure among cases compared to odds of exposure among controls
- 1.0 is the equivalence point - Answers odds ratio
- exposure groups are defined and followed forward in time to determine if the outcome develops
- Pros: high quality design
- Cons: takes a lot of time - Answers Prospective
- previously compiled data are examined to determine exposure groups at some earlier point in time
and subsequent development of the outcome
- Pros: quicker and less expensive
- Cons: quality depends on quality of data previously collected - Answers Retrospective
- excess risk associated with the measured exposure
- 0 is the value of equality
- important for determining public health implications - Answers attributable risk
- ratio of risk in exposed compared to unexposed
- RR = [a(a+b)] / [c/(c+d)]