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26 Cards in this Set

  • Front
  • Back
CASE CONTROL study
Observational & RETRO-spective.

"What happened?"

Measured by ODDS RATIO
COHORT study
Observational & PRO-spective.

"What will happen?"

Measured by RELATIVE RISK
CROSS-SECTIONAL study
Observational.

"What is happening?"

Measured by DISEASE PREVALENCE:
shows RF a/w dz but does NOT establish causality.
Clinical Trial
Phase ONE
To Ax:

SAFETY
TOXICITY
PHARMACOKINETICS
Clinical Trial
Phase TWO
To Ax:

Tx EFFICACY
OPTIMAL DOSING
ADVERSE EFFECTS
Clinical Trial
Phase THREE
COMPARES new Tx to CURRENT STANDARD of CARE.
SENSITIVITY

Definition
Sensitivity
= TP / (TP + FN)
= 1 - FN rate

Proportion of all ppl WITH dz who test POS. or

Ability of a test to detect a dz when it is present.
SENSITIVITY

Uses
Value close to 1 is good for ruling OUT dz (indicates low FN rate). [SNOUT]

Used for SCREENING in dz w/ low prevalence.
SPECIFICITY

Definition
Specificity
= TN / (TN + FP)
= 1 - FP rate

Proportion of all ppl WITHOUT dz who test NEG. or

Ability of a test to indicate no dz when it is absent.
SPECIFICITY

Uses
Value close to 1 is good for ruling IN dz (indicates low FP rate). [SPIN]

Used as a CONFIRMATORY test after a ⊕ screening test.
POSITIVE PREDICTIVE VALUE
(PPV)

Definition
PPV = TP / (TP + FP)

Proportion of POS test results that are TP.

Probability that person actually has the dz given a ⊕ result.
NEGATIVE PREDICTIVE VALUE
(NPV)

Definition
NPV = TN / (FN + TN)

Proportion of NEG test results that are TN.

Probability that person actually is dz-free given a ⊝ result.
PREVALENCE

Definition
Point prevalence =

(total cases in popln at a given time)
/
(total popln at risk at a given time)
INCIDENCE

Definition
Incidence = new incidents =

(NEW cases in popl over a given time period)
/
(total popln at risk during that time)

NB: ppl currently w/ dz or previously ⊕ for it are NOT considered at risk.
PREVALENCE
vs
INCIDENCE
Prevalence ≅ Incidence x dz duration

Prevalence > Incidence for CHRONIC dz

Prevalence = incidence for ACUTE dz
ODDS RATIO (OR)

Definition
OR
= (a/b) / (c/d)
= ad / bc

for CASE-CONTROL studies.

Odds of having dz in exposed gp vs unexposed gp.
RELATIVE RISK (RR)

Definition
RR
= [a / (a + b)] / [c / (c + d)]

for COHORT studies.

Relative probability of getting a dz in exposed gp vs unexposed gp.
ATTRIBUTABLE RISK

Definition
AR
= [a / (a + b)] -- [c / (c + d)]

Difference in risk btw exposed & unexposed gps
or
the proportion of dz occurrences that are attributable to the exposure.
ABSOLUTE RISK REDUCTION

Definition
Reduction in risk a/w a Tx as compared to a placebo.
NUMBER NEEDED TO TREAT (NNT)

Definition
NNT
= 1 / Absolute risk reduction
NUMBER NEEDED to HARM

Definition
NNH
= 1 / Attributable risk

AR = [a / (a + b)] -- [c / (c + d)]
BIAS

Ways to REDUCE
1. BLIND studies (double-blind better)

2. CROSSOVER studies: each subject acts as own control

3. PLACEBO responses

4. RANDOMISATION
SELECTION BIAS
NON-RANDOM assignment to study gp
RECALL BIAS
Knowledge of presence of dz alters recall by subjects
SAMPLING BIAS
subjects aren't REPRESENTATIVE
relative to general popln
so results aren't generalisable.
LATE-LOOK BIAS
info gathered at inappropriate time

e.g. using a survey to study a fatal dz - only pts still alive can answer.