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observational studies
used to gain and understand of disease prevalence and treatment effectiveness
NOT efficacy!!!!
real world studies
more representative of populations
allow inclusions that are usually excluded
short time frame
effectiveness vs efficacy
effectiveness: does the drug work and do what it is supposed to in the real world (look at compliance, side effects, cost, dosing schedule)
efficacy: does the drug mechanism work in an ideal population
5 observational studies
case report
case series
case- control
cross sectional
cohort
Case Report
aka descriptive
describes some newsworthy clinical occurrence
can alert others to look out for the same occurrence
hypothesis generating
clinical narrative
not primary literature
Case Series
aka descriptive but with a few people
certain characteristics of a group of pt are described and published
short period of time
no controls
hypothesis generating
Case Series
Advantages and Disadvantage
easy to write and the observations may be useful to investigators designing a study to evaluate causes or explinations
good after a product launch
very bias= not conclusive
analytic studies
studies that are undertaken to test 1 or more specific hypothesis about an exposure and disease risk
exposure------outcome
Case Control
asks what happened- retrospective
bengin with absence or presence of an outcome and look back in time to see possible risk factors
select case based off disease
select controls based off no disease
case control
select cases and controls from same population
good for hypothesis generating and testing!
matching is often used to associate controles with cases on age and gender
confounding
dont want to make wrong associations or conclusions
Case Control Advantages
good for rare diseases or events, examing conditions that develop over a long period of time and for primary hypothesis
quick and least evepsive for preliminary data
Case Control Disadvantages
depend completely on high quality existing records
require compromises between what rresearch wantes to study
selection of control group hard
largest number biases
Cross Sectional Study
asks whats happening (a survey)
not based on a period of time, one point in time analysis
exposure and outcome are taken at the same point in time
can address questions that come about from case series
Cross section advantages and disadvantages
quick and cheap
good for determining the status quo of a disease or condition or diagnostic procedures
only a snapshot in time- could be misleading information
cohort study
asks what will happen= prospective
group of people who have something in common and who reain part of a group over an extended period of time
select by some defining characteristics that is thought to be a precursor
examine what happens to the disease over time
Cohort Study
2 groups of people (1 has exposure and other does not have exposure)
investigator follows each group to measure disease incidence
historical cohort study
cohort study where information is collected in the past and kept in records
aka retrospective cohort study
cohort study advantages and disadvantages
design of choice for studying the cause of a condition, course of the disease or the risk factors
cause cannot be proven because only observatins and no intervention
many years needed- can loose patients
Author
marinir
ID
177826
Card Set
drug lit
Description
lassila observational
Updated
2012-10-15T20:47:36Z
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