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
Evaluation of Diagnostic tests
PPV and NPV vary depending on
disease prevalence in population being tested.
Evaluation of Diagnostic tests
PPV and NPV vary depending on
disease _______ in population being tested.
Evaluation of Diagnostic tests
Positive Predictive Value is the number of ____ Positives Devided by the Number of ____ Positives and the Number of ____ Positives
Evaluation of Diagnostic tests
Positive Predictive Value is the number of True Positives Devided by the Number of True Positives and the Number of False Positives
(PPV=TP/(TP+FP)
Evaluation of Diagnostic tests
Positive Predictive Value is the number of ____ Positives Devided by the Number of ____ Positives and the Number of ____ Positives
Evaluation of Diagnostic tests
Positive Predictive Value is the number of True Positives Devided by the Number of True Positives and the Number of False Positives
(PPV=TP/(TP+FP)
Evaluation of Diagnostic tests
Negative Predictive Value - Definition
Evaluation of Diagnostic tests
Probability that a person with a negative test
result actually does not have the disease.
Evaluation of Diagnostic tests
Positive Predictive Value - Definition
Evaluation of Diagnostic tests
Probability that a person with a positive test
result actually has the disease.
Evaluation of Diagnostic tests
Sensitivity (True Positive Rate) is actually number of True Positives devided by the number of True ____ and the Number of ____ Negatives.
Evaluation of Diagnostic tests
Sensitivity (True Positive Rate) is actually number of True Positives devided by the number of True positives and the Number of False Negatives.
Sensitivity = TP / (TP + FN)
Evaluation of Diagnostic tests
Specificity (True Negative Rate) is actually number of True Negatives devided by the number of True ____ and the Number of ____ Positives.
Evaluation of Diagnostic tests
Specificity (True Negative Rate) is actually number of True Negatives devided by the number of True Negatives and the Number of False Positives.
Specificity = TN / (TN + FP)
Evaluation of Diagnostic tests
High Specificity indicates a Low ____ _____ Rate!
Evaluation of Diagnostic tests
High Specificity indicates a Low False Positive Rate!
(Specificity = True Negative Rate)
Evaluation of Diagnostic tests
High Sensitivity indicates a Low ____ _____ Rate!
Evaluation of Diagnostic tests
High Sensitivity indicates a Low False Negative Rate!
(Sensitivity = True Positive Rate)
Evaluation of Diagnostic tests
___ varies inversely with prevalence or pretest
probability
Evaluation of Diagnostic tests
NPV varies inversely with prevalence or pretest
probability
Evaluation of Diagnostic tests
Prevelance = (TP+FN)/(TP+FP+TN+FN)
Evaluation of Diagnostic tests
Prevelance = (TP+FN)/(TP+FP+TN+FN)
Evaluation of Diagnostic tests
___ varies directly with pretest probability
(baseline risk, such as prevalence of disease):
high pretest probability → high ___
Evaluation of Diagnostic tests
PPV varies directly with pretest probability
(baseline risk, such as prevalence of disease):
high pretest probability → high PPV
Evaluation of Diagnostic tests
A?
Evaluation of Diagnostic tests
A = 100% Sensitivity cutoff value
Evaluation of Diagnostic tests
C?
Evaluation of Diagnostic tests
C = 100% specificity cutoff value
Evaluation of Diagnostic tests
B?
Evaluation of Diagnostic tests
B = practical compromise cutoff between Specificity and Sensitivity
Evaluation of Diagnostic tests
Lowering the cutoff value: B→A
Will cause FP↑ and FN↓
What will happen to the Sensitivity?
Evaluation of Diagnostic tests
Sensitivity Rises!
Sensitivity↑ = TP / (TP + FN↓)
Evaluation of Diagnostic tests
Lowering the cutoff value: B→A
Will cause FP↑ and FN↓
What will happen to the Specificty?
Evaluation of Diagnostic tests
Specificty Falls!
Specificty↓ =TN / (TN + FP↑)
Evaluation of Diagnostic tests
Lowering the cutoff value: B→A
Will cause FP↑ and FN↓
What will happen to the NPV?
Evaluation of Diagnostic tests
NPV Rises!
NPV↑ = TN / (TN + FN↓)
Evaluation of Diagnostic tests
Lowering the cutoff value: B→A
Will cause FP↑ and FN↓
What will happen to the PPV?
Evaluation of Diagnostic tests
PPV Falls!
PPV↓ = TP / (TP + FP↑)
Evaluation of Diagnostic tests
Raising the cutoff value: B→C
Will cause FP↓ and FN↑
What will happen to the Specificity?
Evaluation of Diagnostic tests
Specificity Rises!
Specificity = TN / (TN + FP↓)
Evaluation of Diagnostic tests
Raising the cutoff value: B→C
Will cause FP↓ and FN↑
What will happen to the NPV?
Evaluation of Diagnostic tests
NPV Falls!
NPV = TN / (TN + FN↑)
Evaluation of Diagnostic tests
Raising the cutoff value: B→C
Will cause FP↓ and FN↑
What will happen to the PPV?
Evaluation of Diagnostic tests
PPV Rises!
PPV = TP / (TP + FP↓)
Evaluation of Diagnostic tests
Raising the cutoff value: B→C
Will cause FP↓ and FN↑
What will happen to the Sensitivity?
Evaluation of Diagnostic tests
Sensitivity Falls!
Sensitivity= TP / (TP + FN↑)
Likelihood ratio
What is it?
Likelihood ratio
Likelihood that a given test result would be
expected in a patient with the target disorder
compared to the likelihood that the same result
would be expected in a patient without the
target disorder.
Likelihood ratio
What does LR+>10 indicates?
Likelihood ratio
LR+ > 10 indicates a highly SPECIFIC test
Likelihood ratio
What does LR–< 0.1indicates?
Likelihood ratio
LR– < 0.1 indicates a highly SENSITIVE test.
Odds ratio
Typically used in Case-Control studies. Represents the odds of exposure among cases (_/c) vs odds of exposure among controls (_/d).
Odds ratio
Typically used in Case-Control studies. Represents the odds of exposure among cases (a/c) vs odds of exposure among controls (b/d).
Odds ratio
If in a case-control study, 20/30 lung cancer patients and 5/25 healthy individuals report smoking, the OR is _; so the lung cancer patients are _ times more likely to have a history of smoking.
Odds ratio
If in a case-control study, 20/30 lung cancer patients and 5/25 healthy individuals report smoking, the OR is 8; so the lung cancer patients are 8 times more likely to have a history of smoking.
OR = (20/10)/(5/20) = 8