Biostats Flashcards
Case Control Study
Looks for prior exposure or risk factor and asks ‘what happened?’ observational and retrospective (odds ratio)
Cohort Study
compares a group with a given exposure or risk factor to a group without. Can be prospective or retrospective relative tisk
What do cohort studies look to answer?
does an increased exposure increase the likelihood of disease? ‘Smokers has a higher risk of developing COPD than nonsmokers’
Cross-sectional study
collects data from a group of people to assess frequency of disease (and related risk factors) * at a particular point in time* (disease prevalence)
T or F. Cross-sectional studies can show risk factor association with disease but does not establish casualty
T.
What is the study sample in a phase I clinical trial?
small no. of healthy volunteers
What is the purpose of a phase I clinical trial?
assesses safety, toxicity, and pharmacokinetics (ADME)
What is the study sample in a phase II clinical trial?
small no. of patients with the disease of interest
What is the purpose of a phase II clinical trial?
assesses treatment efficacy, optimal dosing, and adverse effects
What is the study sample in a phase III clinical trial?
large no. of patients randomly assigned
What is the purpose of a phase III clinical trial?
compares new treatment to the current standard of care
What is the study sample in a phase IV clinical trial?
post-market surveillance
What is the purpose of a phase IV clinical trial?
detects rare or long-term AEs
2x2 Table

What is sensitivity?
The proportion of all people with disease who test positive (or the probability that a test detects disease when it is present)
=TP/(TP+FN)
=1-false negative rate
T or F. A Sensitivity approaching 1 is good for RULING OUT disease
T. SNOUT
What is specificity?
Proportion of all people without disease who test negative
=TN/(TN+FP)
What is specificity good for determining?
ruling IN disease. SPIN
It is used as a confirmatory test a positive screening test
Ex. HIV Testing. Screen with ELISA (sensitive, high false-positive rate though). Follow up with a Western Blot (specific)
What is positive predictive value?
Proportion of positive test results that are true positives
=TP/(TP+FP)
What is negative predicitive value?
Proportion of negative test results that are real negatives
=TN/(TN+FN)
Which predictive value (positive or negative) increases with increased disease prevelance?
Positive
NOTE: Unlike specificity and sensitivity, PPV and NPV vary with prevelance. If prevelance is low, even tests with high sensitivity or specificity will have low PPV)
What is the difference between prevalence and incidence?
Prevalence is the no. of total cases in a population/population whereas incidence is the no. of NEW cases/population
Shortcut eqn for prevalence
=incidence X disease duration
Eqn for odds ratio (for case-control studies)
OR= (a/b)/(c/d) or ad/bc