Experimental studies

Increase the #older people

progress healt care

increase in levels of wealth

better nutrition

reduced fertility rates

from reasearch to decision -making 5 stages

  1. EBM (evidence based medicine)
  1. outcome analysis (benefit-risk ratio)
  1. costs
  1. cost vs efectivness analysis
  1. ethical & legal analysis

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

design

analytic

observational

experimental (needs ethical approval)

uncontrolled

controlled

Randomized (RCT)

non-randomized

cohort

case-control

cross-sectional (prevalence)

to test

formulation of a clinical question

efficacy (explanatory trials) ⇒ ideal

effectivness (pragamatic trials) ⇒ real world clinical settings

structure

in 2 groups by randomization

experimental

control

  1. population of eligible patients

inclusion cryteria

exclusion cryteria

  1. group of patient
  1. at least 2 tratment groups
  1. allocation by randomization
  1. comparison of outcome measures

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

interventions (how & when)

primary ⇒ to calculate the sample size

time point of primary interest

Health-Related Quality of Life

Quality-adjusted life years (quality & quantity) ⇒ cost-utility analysis

estimation of th eclinical difference between groups

Significance level⇒ tipe I error (reject H0 when is true)

Statistical power ⇒ tipe II error (not reject H0 when is false)

stdv (continuos outcomes)

dropout rate

blinding

who

patient

assessor

operator ( difficult for rehab)

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)

parametrics test (continuos variables, normal distrib)

non-parametric (categorical variables)

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.

bias

selection

allocation

assessment

publication

stopping