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)