Epidemiology/Biostatistics Flashcards
What are the different types of studies?
- Case control
- Cohort
- Cross-sectional
- Twin concordance
- Adoption
What type of study is a Case-control?
Observational & retrospective
What is the design of a case-control?
- Compares a group of people w/ dz to a group w/o dz
- Looks for prior exposure or RF
- Asks, “what happened?”
What do Case-control studies measure?
Odds ratio (OR)
What is an example of a case control study?
Pts w/ COPD had higher odds of a hx of smoking than those w/o COPD had
What type of study is a Cohort study?
Observational & prospective or retrospective
What is the design of a Cohort study?
- Compares a group w/ a given exposure or risk factor to a group w/o such exposure
- Looks to see if exposure inc the likelihood of dz
What do Cohort studies measure?
Relative risk (RR)
What is an example of a Cohort study?
Smokers had a higher risk of dev COPD than nonsmokers had
What type of study is a Cross-sectional study?
Observational
What is the design of a Cross-sectional study?
- Collects data from a group of people to assess freq of dz (& related RF) at a particular point in time
- Asks, “what is happening?”
What does a Cross-sectional study measure?
- Dz prevalence
- Can show RF assoc. w/ dz but doesn’t est causality
What is the design of a Twin concordance study?
Compares the freq w/ which both monozygotic twins or borh dizygotic twins dev sam dz
What do Twin concordance studies measure?
Heritability
What is the design of an Adoption study?
Compares siblings raised by biological vs adoptive parents
What do Adoption studies measure?
Heritability & influence of environmental factors
What is a clinical study?
Experimental study involving humans
What do clinical trials compare?
Therapeutic benefits of 2 or more tx or of tx & placebo
What improves the study quality of a clinical trial?
- Randomized
- Controlled
- Double-blinded
What is a double blind study?
Neither pt nor doctor knows whether the pt is in the tx or control group
What is a triple blind study?
Refers to the additional blinding of the researchers analyzing the data
What is the study sample of a Phase I clinical trial?
Small # of healthy volunteers
What is the purpose of a Phase I clinical trial?
Assess safety, toxicity & pharmacokinetics
What is the study sample of Phase II clinical trial?
Small # of pt w/ dz of interest
What is the purpose of a Phase II clinical trial?
Assess tx efficacy, optimal dosing & adverse effects
What is the study sample of a Phase III clinical trial?
Large # of pt randomly assigned either to the tx under investigation or to the best available tx (or placebo)
What is the purpose of a Phase III clinical trial?
Compares the new tx to the current standard of care
What is the study sample of a Phase IV clinical trial?
Postmarketing surveillance trial of pts after approval
What is the purpose of a Phase IV clinical trial?
Detects rare or LT adverse effects
What is an Evaluation of dx tests?
Uses 2x2 table comparing test results w/ the actual presence of dz
What are the components of evaluating dx tests?
- TP= True Positive
- FP= False Postiive
- TN= True Negative
- FN= False Negative
What are the fixed properties of evaluation dx tests?
Sensitivity & specificity
Which properties vary w/ prevalence or pretest probability?
PPV & NPV
What is Sensitivity (true-positive rate)?
Proportion of all people w/ dz who test positive or the probability that a test detects dz when dz is present
What does a value approaching 100% sensitivity mean?
Desirable for ruling out dz & indicates a low false-negative rate
What is sensitivity used for?
Screening in dz w/ low prevalence
What does sensitivity do?
- PID= Positive In Dz
- SNOUT= SeNsitivity rule OUT
What is Specificity (true-negative rate)?
Proportion of all people w/o dz who test negative or the probability that a test indicates non-dz when dz is absent