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Drug Lit
Definitions
43
Literature
Professional
09/21/2013

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Term
Accepting that there is a difference when there really
isn’t one; false positive
Definition
Type 1 error
Term
Accepting that there is no difference when there
really is one; false negative
Definition
Type 2 error
Term
A measure or endpoint that represents another endpoint
Definition
Surrogate outcome
Term
Beginning in the present and evaluating events as they occur in the future
Definition
Prospective
Term
level of statistical significance; reflects the probability a result is due to chance
Definition
P-value
Term
probability of correctly identifying a difference between treatment groups when a difference really exists in the population
Definition
Power
Term
process of assigning patients to a study group such that each patient has an equal and independent chance of being assigned to any of the groups
Definition
Randomization
Term
Range with a high probability of containing the true population value
Definition
confidence interval
Term
study assignment in a study is not apparent to the individual enrolling subjects into the study
Definition
concealed allocation
Term
the endpoint for which the study is powered
Definition
primary outcome
Term
series of questions that can estimate the probability that a particular
adverse event in a specific patient was caused by the drug in question
Definition
Naranjo algorithm
Term
Can be completed more quickly;
Less impact form study dropouts;
Easier to conduct
Definition
parallel study compared to crossover study
Term
The author may not be disclosing other information about less favorable outcomes observed in
other patients, or other drug or disease factors that could have influenced the results observed
Definition
selective reporting
Term
The hypothesis that there is no
difference between interventions
Definition
Null hypothesis
Term
Range with a high probability of
containing the true population value
Definition
confidence interval
Term
the average of all data points
Definition
mean
Term
the middle value within a set of data points
Definition
median
Term
sample size calculation
Definition
power analysis
Term
an assessment of variability around the mean
Definition
standard deviation
Term
Retrospective study design in which
subjects are matched with controls with
similar characteristics except the
disease state or condition in question
Definition
case-control study
Term
Study design in which subjects with and
without a particular risk factor are
followed for a period of time to see if
they develop a particular condition
Definition
cohort study
Term
prospective study design in which subjects serve as their own control
Definition
crossover study
Term
both the subject and the investigator are unaware of the subject's study group assignment in a study
Definition
double-blind
Term
blinding method using multiple placebos to match the active interventions when they vary in appearance or method of administration
Definition
double-dummy
Term
characteristics that would make a person ineligible for participation in a study
Definition
exclusion criteria
Term
characteristics a person must have to be eligible for participation in a study
Definition
inclusion criteria
Term
study endpoint for which the study is powered
Definition
primary outcome
Term
study with an alpha of 0.05
Definition
there is a risk of up to 5% that the result is due to chance
Term
Purpose of the Naranjo algorithm
Definition
assess the probability that an adverse reaction is due to the drug in question
Term
PICO
Definition
Patient/Problem, intervention, comoparison, outcome
Term
no restrictions
Definition
open drug formulary
Term
system using some types of restrictions (tiers, generic first, limited access to some drugs)
Definition
closed drug formulary
Term
analyze the way the mean of a variable is affected by different types or combinations of factors
Definition
ANOVA
Term
study design that can influence the generalizability of the results
Definition
external validity
Term
study design variables that translate to reliable results
Definition
internal validity
Term
study designs that enrolls only one patient
Definition
N-of-1 Trials
Term
A ratio describes the probability that a patient in an exposed group had an event relative to the probability that a patient in the control group had that event
Definition
Odds Ratio
Term
A study design where all arms of the study enroll patients and occur at the same time
Definition
Parallel design
Term
assessment of the patient cohort that completed the clinical trial with no major violations or dropouts
Definition
per protocol analysis
Term
analysis of experimental data for patterns that were not specified prior to the start of the study
Definition
post hoc analysis
Term
study endpoint for which the study is powered
Definition
primary outcome
Term
variability of sample means in population
Definition
standard error of the mean
Term
laboratory value or physical sign measured as a substitute for a clinical endpoint
Definition
surrogate outcome
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