EBM Flashcards
External Validity
The confidence with which the results can be accurately generalized to the population
What do Inclusion and Exclusion Criteria do to validity?
Improves internal validity by controlling variability
Decreases external validity by limiting generalizability
Probability Sampling
When each member of the population has a known chance to be included in the research
Stratified random sampling
To ensure that critical variables are represented in the sample, subjects are stratified by traits and then randomly sampled
Systematic sampling
A type of random sampling done when subjects are put in order. For example, the 3rd person from each letter of the alphabet can be chosen. Can incorporate stratification if there is a meaningful order (i.e. Weight or age)
Purposive sampling
Hand-picked patients. Purpose might be to gather different perspectives
Quota sampling
Convenience sampling, with specific quotas included. This is like stratification
Healthy-User Bias
May occur with convenience samples because healthier people are more likely to volunteer, or be seeking healthcare
Berkson’s Bias
Population selected from an impaired or diseased group (like hospitalized pts)
Exclusion Bias
Excluding patients with certain characteristics. I.e comorbidities, racial groups, socioeconomic groups, people who have dropped out of a study
Internal validity
Internal health of the study. How free it is from bias and chance.
External validity
The degree to which you can generalize the results of the study back to the population of interest.
How to prevent selection bias
Random or stratified random assignment
Equivalence can be double-checked for suspicious factors by obtaining relevant demographic or baseline data
Extraneous factors
Other variables in the study that may affect the relationship between the independent and dependent variables
Example: Researchers examined whether relaxation therapy was better than drug therapy for reducing the number of tension headaches in medical students.
Extraneous Factors to control or account for
1. Diet
2. Other medications
3. Severity of tension headaches
Measurement bias
Occurs when measurements are made unequally between treatment groups
Confounding bias
Occurs when 2 factors are associated and the effect of one is confused with or distorted by the effect of the other
Investigator bias
When the investigator ‘knows’ the expected results, so the investigator treats groups differently
Allocation concealment
Prevents investigator bias. The ppl randomizing individuals into groups are blinded as to which subjects go into which group. E.g. Subjects are given numbers (de-identified from researcher) or a 3rd party interacts with subjects during allocation
Investigator blinding
Prevents investigator bias. E.g. Investigator who is providing treatment or making measurements is blinded as to the group.
Hawthorne effect
Subject bias where people change behavior in a study. Effects both internal and external validity
Subject blinding
Solution to hawthorne effect
Placebo group
Subjects don’t know what group they’re in
BUT blinding doesn’t work for long if there is an obvious physical change
Absolute risk
Incidence # of ppl with disease/total number of people at risk for getting disease
Relative Risk/Risk Ratio
‘How many times more likely are exposed persons to get the disease relative to non-exposed persons?’
- Incidence in exposed/incidence in unexposed
- Common metric in studies with similar risk factors but with different baseline incidence rates.
Cross-over trials
Advantages:
- Subjects are their own controls, which reduces inter-subject variability
- Randomization removes order effect
- Statistical advantages
Disadvantages:
- Inappropriate when time has an effect (e.g. Recovery from surgery)
- Inappropriate when order effect is lasting
Absolute Risk Difference/attributable risk
How much extra disease is actually caused by an exposure or risk factor
Subtract absolute risk of unexposed from absolute risk of exposed
Relative Risk
Ratio between absolute risk of exposed and absolute risk of non exposed
I.e. Ratio between incidence of exposed and incidence of non exposed
“Big Data” Studies
Subtype of retrospective cohort
Very large N
Data from various sources, though gathered usually without medical intent (billing)
-BEST method for looking for rare side effects or outcomes