First Aid - Epidemiology and Biostatistics Flashcards
Cross-sectional study
Measures what?
Cross-sectional study
Disease prevalence.
Can show risk factor association with disease, but
does not establish causality.
Cross-sectional study
Design of the Study?
Cross-sectional study
Frequency of disease and frequency of riskrelated
factors are assessed in the present.
Asks, “What is happening?”
Case-control study
Design of the Study?
Case-control study
Compares a group of people with disease to a
group without disease.
Looks to see if odds of prior exposure or risk
factor differ by disease state.
Asks, “What happened?”
Case-control study
Measures what?
Case-control study
Odds ratio (OR).
Patients with COPD had higher odds of a
smoking history than those without COPD.
Cohort study
Measures What?
Cohort study
Relative risk (RR).
Smokers had a higher risk of developing COPD
than nonsmokers.
Cohort = relative risk.
Cohort study
Measures What?
Cohort study
Relative risk (RR).
Smokers had a higher risk of developing COPD
than nonsmokers.
Cohort = relative risk.
Crossover study
Design of the Study?
Crossover study
Compares the effect of a series of ≥2 treatments
on a participant.
Order in which participants receive treatments
is randomized. Washout period occurs
between each treatment.
Crossover study
Advantage of the Study?
Crossover study
Allows participants to serve as their own
controls.
Twin concordance study
Measures What?
Twin concordance study
Measures heritability and influence of environmental factors (“nature vs nurture”).
Twin concordance study
Design of the Study?
Twin concordance study
Compares the frequency with which both
monozygotic twins vs both dizygotic twins
develop the same disease.
Adoption study
Measures What?
Adoption study
Measures heritability and influence of
environmental factors.
Adoption study
Design of Study?
Adoption study
Compares siblings raised by biological vs
adoptive parents
Clinical Trials
Experimental study involving humans. Compares therapeutic benefits of ≥2 treatments, or of
treatment and placebo. Study quality improves when study is randomized, controlled, and _________
(ie, neither patient nor doctor knows whether the patient is in the treatment or control
group). Triple-blind refers to the additional blinding of the researchers analyzing the data.
Four phases (“Does the drug SWIM?”).
Clinical Trials
Experimental study involving humans. Compares therapeutic benefits of ≥2 treatments, or of
treatment and placebo. Study quality improves when study is randomized, controlled, and doubleblinded
(ie, neither patient nor doctor knows whether the patient is in the treatment or control
group). Triple-blind refers to the additional blinding of the researchers analyzing the data.
Four phases (“Does the drug SWIM?”).
Clinical Trials
Experimental study involving humans. Compares therapeutic benefits of ≥2 treatments, or of treatment and placebo. Study quality improves when study is randomized, controlled, and doubleblinded. \_\_\_\_\_\_\_\_ refers to the additional blinding of the researchers analyzing the data. Four phases (“Does the drug SWIM?”).
Clinical Trials
Experimental study involving humans. Compares therapeutic benefits of ≥2 treatments, or of treatment and placebo. Study quality improves when study is randomized, controlled, and doubleblinded. **Triple-blind** refers to the additional blinding of the researchers analyzing the data. Four phases (“Does the drug SWIM?”).
Clinical Trials
Four phases (“Does the drug ____?”).
Clinical Trials
Four phases (“Does the drug SWIM?”).
Safe, Works, Improves, postMarketing safe
Clinical Trials - Phase I
Typical study sample?
Clinical Trials - Phase I
Small number of either healthy volunteers or
patients with disease of interest
Clinical Trials - Phase I
PURPOSE?
(SWIM)
Clinical Trials - Phase I
“Is it Safe?” Assesses safety, toxicity,
pharmacokinetics, and pharmacodynamics.
Clinical Trials - Phase II
PURPOSE
(SWIM)
Clinical Trials - Phase II
“Does it Work?” Assesses treatment efficacy,
optimal dosing, and adverse effects
Clinical Trials - Phase II
Typical study sample?
Clinical Trials - Phase II
Moderate number of patients with disease of
interest.
Clinical Trials - Phase III
Typical study sample?
Clinical Trials - Phase III
Large number of patients randomly assigned
either to the treatment under investigation or
to the standard of care (or placebo).
Clinical Trials - Phase III
PURPOSE?
(SWIM)
Clinical Trials - Phase III
“Is it as good or better?” Compares the new
treatment to the current standard of care (any
Improvement?).
Clinical Trials - Phase IV
PURPOSE?
Clinical Trials - Phase IV
“Can it stay?” Detects rare or long-term adverse
effects (eg, black box warnings). Can result in
treatment being withdrawn from Market.
Clinical Trials - Phase IV
Typical Study Sample?
Clinical Trials - Phase IV
Postmarketing surveillance of patients after
treatment is approved.
Evaluation of Diagnostic tests
Sensitivity and specificity are ____ properties
of a test
Evaluation of Diagnostic tests
Sensitivity and specificity are fixed properties
of a test