EBM Day 5 Flashcards
when not best to perform RCT (4)
- unnecesary
- inappropraite
- impossible
- inadequate (not best test design)
equipose
not sure which treatment is better
RCT sampling
decrease variation
- reduce internal error
- incrae internal validity
- reduces external validiy
exclusion criteria
comorbidty limited longevity adherence/retention concerns non-cooperation highly selected-not much like everyday patient
random allocation
avoid potential confounding
factors related to prog are distriburted if groups are large enough
problems after randomization
cross over
co interntion
nonadherence
4 levels of blinding
allocation concealment
blinding subjects
bliding treating physicians
blining investigators
Open trial
no blinding
ideal for test that can’t have blinding (surgury)
Outcomes
primary
secondary-too many cause t1 error
composite-evaluate secondary components sep and together
NNT
1-abs risk reduction
How many patients one would we need to treat, on average, to prevent one outcome event
Abs risk reduction
incidence affected %- incidence unaffected%
Efficacy vs effectiveness
does trx work under ideal conditions vs under circumstances of care
Intention to treat vs per protocol analysis
Analyze in group should be in
- preserves original randomization
- answers which trx choice is best
analyze only who completed study per protocol
- answers does actually taken trx instead of being offered make better
- concern about bias
superiority, equivalnce, noninferiority trials
equivalence is different in any direction
Type 2 error causes
small sample size, poor adherence, co-interventions, crossing over, loss to follow up , differential/nondifferential measurement error