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What do you do with your selected population in RCTs?
randomly divide them into groups such as new vs old drug or placebo vs drug
Why must you use a control group?
Control group necessary to determine whether an
observed outcome is a true effect of the treatment
or would have occurred in the absence of the
therapy under evaluation.
What can happen if you do not have a concurrent control group?
changes in patient characteristics
• changes in the natural history of disease
• changes in diagnostic criteria or therapy
• improvements in health care
What does randomization allow?
a higher likelihood that the groups are comparable in both known and unknown characteristics
- gives validity
Why blind data analysts?
prevents the use of particular statistical methods in order to favor one group or the other
When would you use stratification?
when you know of a particular trait that will affect the outcome - gender, age, etc
randomized -> new treatment vs current treatment -> pts are then switched to the opposite treatment
the time for the effects of the first treatment option to subside before crossing over
randomized - tx option 1 vs tx option 2 -> pts them switch due to various factors
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