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Experimental studies (from reasearch to decision -making 5 stages (EBM…
Experimental studies
from reasearch to decision -making 5 stages
EBM (evidence based medicine)
divided in:
guidelines & polices
individual decision making
3 parts:
patient's values & expectations
individual clinical expertise (doctor)
beste available clinical evidence (efficacy)
observations in a systematic way (compile, organize, evaluate) ⇒
case series ⇒
systematic observations ⇒
meta-analysis
outcome analysis (benefit-risk ratio)
costs
cost vs efectivness analysis
ethical & legal analysis
bias
selection
allocation
assessment
publication
stopping
Increase the #older people
progress healt care
increase in levels of wealth
better nutrition
reduced fertility rates
design
analytic
observational
cohort
case-control
cross-sectional (prevalence)
experimental (needs ethical approval)
uncontrolled
controlled
Randomized (RCT)
to test
efficacy (explanatory trials) ⇒ ideal
effectivness (pragamatic trials) ⇒ real world clinical settings
formulation of a clinical question
structure
population of eligible patients
inclusion cryteria
exclusion cryteria
group of patient
at least 2 tratment groups
allocation by
randomization
comparison of outcome measures
in 2 groups by randomization
experimental
control
to test the mean behavior of a target population
CONSORT (consolidated standards of reporting trials)
methods
trial design
parallel
crossover
factorial
cluster trials
split body trials
superiority
equivalence
non-inferiority
participants
clear definition of inclusion /exlcusion cryteria + info on setting and locations ⇒ applicability & generalizability
outcomes
primary ⇒ to calculate the sample size
5 more items...
time point of primary interest
Health-Related Quality of Life
1 more item...
interventions (how & when)
blinding
who
3 more items...
double or single or complete
statistical methods
treatment effect ⇒ 95% confidence interval
statistical signifiance (P-value)
comparison of baseline values
logitudinal methods analysis (with follow-up)
2 more items...
results
continuos group
sym ⇒mean & stdev
asym ⇒median & interquartile range
discussion
underline the difference between significance & clinical importance
non_significace != equivalence
external validity (generalization)
internal validity (prerequisite for ext)
systematuc review
to compare results
specific research question
systematic methods to min bias
contains meta-analysis (estamate effects)
cochrane collaboration ⇒ well-informed decision about healt-care.
non-randomized