Epidemiology/Biostatistics Flashcards
Case-control study
Compares a group of people with disease to a group without disease. Looks for prior exposure to risk factor
Asks, “What happened?”
Measures: OR
Example: patients with COPD had higher OR of a history of smoking than those without COPD
Cohort Study
Compares a group with a give exposure or risk factor to a group without such exposure. Looks to see if exposure affects the likelihood of a disease.
Prospective: Who will develop disease?
Historical: Who developed disease?
Measures: Relative Risk
Example: smokers had a higher risk of developing COPD than non-smokers
Twin concordance study
Compares the frequency with which both monozygotic or both dizygotic twins develop the same disease.
Measures: heritability and influence of environmental factors
Adoption Study
Compares siblings raised by biological vs. adoptive parents
Measures: heritability and influence of environmental factors
Clinical Trial
Experimental study involving humans. Compares therapeutic benefits of 2 or more treatments, or of treatment and placebo. Study quality improves when the study is randomized, controlled and double-blinded (triple blinded - researchers blinded as well)
Drug Trial: Phase I
Small number of healthy volunteers
Purpose: is it safe? Assess safety, toxicity, PK & PD
Drug Trial: Phase II
Small number of pts with disease of interest
Purpose: does it work? Assesses treatment efficacy, optimal dosing, adverse effects
Drug Trial: Phase III
Large number of pts, randomly assigned either to the treatment under investigation or to the best available treatment currently (or placebo)
Purpose: is it as good or better? Compares the new treatment to the current standard of care
Drug Trial: Phase IV
Post marketing surveillance of pts after treatment has been approved
Purpose: Can it stay? Detects rare or long-term adverse effects. An result in treatment being withdrawn from the market
Evaluation of diagnostic tests
2x2 table comparing test results with the actual presence of disease.
TP, FP, TN, FN
Sensitivity and specificity are fixed properties of a test
PPV and NPV vary depending on disease prevalence
Sensitivity (TP rate)
Proportion of all people with disease who test positive, or the probability that when the disease is present, the test is positive
Value approaching 100% is desirable for RULING OUT disease and indicates a low FN rate. High sensitivity is used for screening in diseases with low prevalence.
Sensitivity = TP/ (TP+FN)
SNOUT - highly sensitivity test, when negative, rules out disease
Specificity (TN rate)
Proportion of all people without disease who test negative, or probability that when the disease is absent the test is negative.
Value approaching 100% is desirable for ruling in disease and indicates a low FP rate. High specificity used for confirmation after a positive screening test.
Specificity = TN/ (TN + FP)
SPIN - highly specific test, when positive, rules in disease
Positive Predictive Value
Proportion of positive test results that are true positive.
Probability that a person who has a positive test result actually has the disease
PPV = TP/(TP+FP)
PPV varies directly with pretest probability (High PP = High PPV)
Negative Predictive Value
Proportion of negative test results that are true negative.
Probability that a person with a negative test result actually does not have the disease
NPV=TN/(TN+FN)
NPV varies inversely with prevalence or pretest probability
Incidence Rate
IR = # of new cases/# of people at risk
During a specified time period
Incidence looks at new cases (incidents)
Prevalence
Prevalence = # of existing cases/total # of people in a population
At a point in time
Prevalence looks at all current cases
Prevalence vs. Incidence
Prevalence = Incidence for a short duration disease (e.g. Cold)
Prevalence > incidence for chronic diseases, due to large # of existing cases (e.g. Diabetes)
Odds Ratio (OR)
Typically used in case control study
Odds that the group with disease was exposed to a risk factor divided by the odds that the group without the disease was exposed
OR = AD/BC
Relative Risk
Typically used in cohort studies
Risk of developing disease in the exposed group divided by risk in the unexposed group.
E.g. If 21% of smokers develop lung cancer vs. 1% of non-smokers RR=21/1=21
RR= a/(a+b) / c/(c+d)
Attributable Risk
The difference in risk between exposed and unexposed groups, or the proportion of disease occurrences that are attributable to the exposure
E.g. If risk of lung cancer in smokers is 21% and risk in non-smokers is 1%, then 20% of lung cancer risk in smokers is attributable to smoking
AR = a/a+b - c/c+d