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A patient with a high probability of having a

disease will have a relatively low negative
predictive value.

NPV varies with the pretest probability of

A high sensitivity test is useful disease (which is directly related to disease
A high specificity test is useful prevalence)
for screening in diseases with low
for confirmation after a positive screening test
prevalence (sensitivity or specificity)

Are case-control studies useful for

measuring incidence and/or prevalence? Are cohort studies useful for
measuring incidence and/or prevalence?
Neither :)
Incidence
Accuracy may also be referred to as
validity

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At what cut-off value will the number of

false negatives be the highest?

Are cross-sectional studies useful for

measuring incidence and/or prevalence?

Prevalence
As the sample size increases, the standard
error decreases
false negatives increase when the cut-off
i.e. the data set mean is approaching the
level of a diagnostic test is raised
population mean

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Below is an example Below is an example Below is an example

of high precision and high accuracy: of high precision and low accuracy: of low precision and high accuracy:

Below is an example
of low precision and low accuracy:
Case-control studies are almost
always retro-spective
Both twin concordance and adoption studies are
useful for measuring "nature vs. nurture"

i.e. heritability versus the influence of

environmental factors

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Development of
an effective treatment for disease
causes no change
in incidence and decreased prevalence
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Development of an effective vaccine for disease
causes decreased incidence and decreased prevalence
For a normal distribution, approximately
95% of all values are within 2 standard
deviations from the mean.
68% for 1 standard deviation; 99.7% for 3
standard deviations
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How do the following values change when

moving the cutoff point of a screening test
from B to A?

Sensitivity: increased
Specificity: decreased
PPV: decreased
NPV: increased

For the results of a study to be statistically significant,

the 95% confidence interval must not contain zero
or the null value
For rare diseases (low prevalence), odds
ratio approximates relative risk

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How does the width of a 95%

confidence interval change with a
decreased sample size?

Increased width

the CI is dependent on
standard error, which
increases with decreased
sample size
If 2% of patients who receive a flu shot develop the
flu, while 8% of unvaccinated patients develop the
flu, absolute risk reduction is 6% (.06)
If 2% of patients who receive a flu shot
develop the flu, while 8% of unvaccinated
patients develop the flu, relative risk
reduction is 0.75
RRR = 1 - RR and RR = 2/8 = .25

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If people with a chronic disease live

longer, there is no change
in incidence and increased prevalence

If 21% of smokers develop lung

cancer versus only 1% of nonsmokers,
the attributable risk = 20 If 21% of smokers develop lung cancer versus
only 1% of nonsmokers, the relative risk = 21

21 - 1 = 20; 20% of the lung

cancer risk in smokers is 21/1 = 21
attributable to smoking

If relative risk < 1, exposure is

If relative risk = 1, there is no association between If relative risk > 1, exposure is associated
associated with decreased disease
exposure and disease with increased disease occurence
occurence

In what scenario does the odds ratio of a

Increased precision is associated Increased precision is associated
case-control study closely approximate
with decreased standard deviation with increased statistical power (1 - β)
the relative risk?

Low disease incidence and prevalence

("rare disease assumption")

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Increased prevalence results in

increased positive predictive value
Increased prevalence results Increased prevalence results
in decreased negative predictive value in decreased negative predictive value

Phase III of clinical

trials assesses efficacy compared to
the standard of care, as well as adverse
Increased prevalence results in Negative LR < 0.1 is an indicator of a very useful effects
increased positive predictive value diagnostic test

Phase III of clinical trials uses

a large number of patients randomly Phase II of clinical trials assesses optimal dosing, Phase II of clinical trials uses
assigned either to a treatment under treatment efficacy, and adverse effects a small number of patients with a disease of
investigation or the best available interest
treatment (or placebo)

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Phase IV of clinical
trials detects rare or long-term adverse
Phase IV of clinical trials is the postmarketing Phase I of clinical trials assesses safety,
effects surveillance of patients after a treatment is approved toxicity, pharmacokinetics, and
pharmacodynamics
asks "can the treatment stay?";
primarily monitored by personal
physician

Phase I of clinical trials uses a small

number of healthy volunteers Positive LR > 10 is an indicator of a very useful Precision may also be referred to as
diagnostic test reliability

Prevalence is greater than incidence for Prevalence is similar to incidence for short duration Relative risk reduction is equal to 1 -
chronic diseases (e.g. diabetes) disease (e.g. chronic cold) relative risk

due to large # of existing cases

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Sensitivity values approaching 100% is

desirable for ruling OUT disease (in or
out)
"SNOUT: highly SeNsitive test
rules OUT disease"; e.g. if a
highly sensitive test is negative,
it rules out that disease
Specificity values approaching 100% is desirable
for ruling IN disease (in or out)
The attributable risk percent can be
derived from the relative risk using the
"SPIN: highly SPecific test formula ARP = (RR - 1)/RR
i.e. if the RR is 4, ARP = (4 - 1)/4 = 75%
rules IN disease"; e.g. if a highly specific
test is positive, it rules IN that disease

The most effective interventions to reduce adverse
events related to medications at times of transition
of care (e.g. between inpatient and outpatient
The confidence interval of a study facilities) involve pharmacy personnel and high-
narrows as the sample size increases risk patients
e.g. a patient who develops syncope after being put on
multiple beta-blockers at different facilities
The number needed to harm (NNH) is
equal to 1/AR
i.e. the number of patients who need
to be exposed for 1 patient to be
harmed; higher number = safer
exposure

The power of a study is calculated by 1- beta

The number needed to treat (NNT) is

equal to 1/ARR.
The power of a study
is increased with increased expected effect
i.e. the number of patients who size
need to be treated for 1 patient
to benefit; lower number = better
treatment

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The probability of making a type 1 error is

represented by alpha

typically set a 0.05; i.e. there is less

than 5% chance that the data will
show something that is not really
there
The power of a study
The power of a study is
is increased with increased precision of
increased with increased sample size
measurement

The probability of making a type

2 error is represented by beta

typically set a 0.20; i.e. there is The false negative rate of a test is equal to 1
less than 20% chance that the - sensitivity
data will NOT show something
that is really there
The external validity of a study pertains to the thus when sensitivity is 100%, FN
applicability of the study results to other populations rate is zero (A)
also known as generalizability

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The false negative rate of a test is equal The false positive rate of a test is equal to 1 -
The false positive rate of a test is equal to 1
to 1 - sensitivity specificity - specificity

thus thus when specificity is 100%, FP thus when specificity is 100%, FP

when sensitivity is 100%, FN rate is zero (C) rate is zero (C)
rate is zero (A)

What equation is used to

calculate attributable risk using the table
below?
What equation is used to calculate attributable
What bias may arise when the treatment
risk using the table below?
regimen selected for a patient depends
on the severity of the patient's
condition?

Susceptibility bias (a type of selection

bias)

e.g. indications for medical therapy vs

CABG (if a patient on medical therapy
requires CABG, analyzing them in the
CABG group leads to bias since those
patients may have underlying
confounders worsening their condition);
an intention-to-treat analysis compares
the initial randomized treatment groups
regardless of the eventual treatment Attributable risk is the proportion of
cases in exposed individuals that
can be attributed to the exposure
-Risk in exposed - risk in unexposed

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What equation is used to calculate odds
What equation is used to calculate relative risk using
ratio using the table below?
i.e. the odds an event (e.g.
disease) occuring given a
certain exposure vs. the odds of
an event in the absence of that
exposure
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What is the approximate sensitivity and
specificity (high or low) on the receiver
operating characteristic curve below?
Sensitivity: high
Specificity: low
the table below?
sensitivity is directly proportional to true
positive rate; specificity is inversely
proportional to true negative rate
i.e. the risk of developing disease in the
exposed group divided by risk in the
unexposed group
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What is the equation for standard
error?
What is
the relationship between prevalence and incidence?
prevalence / (1 - prevalence) = incidence * average
duration of disease
i.e. if people with a disease live longer, the
prevalence will increase
What measure of association is typically What selection bias occurs when
used in case-control studies? specifically selecting healthy people?
exposure odds ratio Healthy worker effect
e.g. a study that compares a certain
exposure of people with the disease
the study population is healthier than the
(cases) vs the exposure of people
without the disease (controls) general population
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What issue is partially eliminated when using
matching during the design of a case-control
study?
Confounding
e.g. a case-control study exploring the
relationship between alcohol consumption
and breast cancer begins with interviewing
cancer patients about alcohol use. Neighbors
of the patients that are the same age and
race are then interviewed and used as
controls. These neighbor "controls" were
matched to "cases" by age and race.
What selection bias occurs when
specifically selecting patients from a
hospital?
Berkson bias
hospital patients are generally less
healthy than the general
population
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What statistical method is typically used

to compare proportions of a
categorized outcome?
What statistical test is used
Chi-square to check differences between the means of
What statistical method is typically used to compare THREE or more groups?
e.g. CRP is categorized as "high" and two means?
"normal" and then presented with the analysis of variance (ANOVA)
exposure ("HRT" or "no HRT") Two-sample t test

ANOVA is used to compare 3 or more means e.g. comparing the mean blood
pressure between members of
three different ethnic groups

What statistical test is used to check What statistical test is used to test the association What study design is best for determining the
differences between the means of TWO between two categorical variables? incidence of disease?
groups?
Chi-squared Cohort
t-test

e.g. comparing the percentage of members

e.g. comparing the mean blood of 3 different ethnic groups who have
pressure between men and essential hypertension
women

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What study design is best for

determining the prevalence of disease?

Cross-sectional

What type of bias is caused by early detection being

confused with increased survival? What type of bias is caused by increased
detection of diseases (e.g. cancer) with a
Lead-time bias more benign course?

Lag-time bias
early detection makes it seem as though
survival has increased

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What type of bias occurs in prospective studies when

there is a large loss to follow-up?

Attrition bias (a type of selection bias)

study may over- or underestimate the association

between exposure and disease
What type of bias is likely to occur in
when asking patients with What type of bias occurs when a new
disease versus patients without screening test appears to prolong the
disease about prior risk factors? survival of patients with a poor prognosis
disease (e.g. pancreatic cancer)?
Recall bias
Lead-time bias
patients with disease are more what actually happened is the disease was
likely to recall exposures; detected at an earlier time, but prognosis
reduce this bias by decreasing didn't change
time from exposure to follow-up

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What type of bias/phenomenon is explained

by the following: crude analysis of a study
suggests a significant association between
oral contraceptives and breast cancer (RR
1.5, p = 0.03). Further analysis shows that
only women with a family history of breast
cancer have increased risk of cancer with
oral contraceptives (RR = 2.10, p = 0.01). In
women with no family history, no effect was
observed (RR = 1.05, p = 0.80).
What type of bias occurs when patients
What type of bias occurs when the subjects of a study
change their behavior in response to Effect modification
change their behavior because they are aware they
their awareness of being observed?
are under observation?
when an external variable negatively or
Hawthorne bias positively impacts the effect of a risk factor
Hawthorne effect
on disease it is effect modification (versus
confounding, see image below)

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What type of bias/phenomenon is
explained by the following: patients are
randomly assigned to moderate- or high-
dose statins. At 3 months, the adverse
cardiovascular event rate in the high-
dose group compared to the moderate
group is insignificant (0.98, p = 0.80).
At 1 year, the RRR was 0.67 with a p =
0.01.
Latency period
exposure to risk modifiers may need to
be continuous over a certain period of
time before influencing the outcome
Some diseases have a long latency
period (cancer, heart disease).
Sometimes, a significant amount of time
must pass before exposure to a risk
modifier (statin) has a clinically evident
effect on the disease process.
What type of non-normal distribution is
suggestive of two different
populations (e.g. slow vs. fast
acetylators)?
Bimodal
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What type of error is stating that there is NO
effect when one DOES exists?
Type II (false-negative error)
i.e. telling a pregnant woman she's not
pregnant
What type of study design describes the following
study? Researchers are studying the relationship
between a blood genotype and atherosclerosis. They
randomly select patients and obtain blood samples for
genotyping and perform ultrasound to assess for
atherosclerosis.
Cross-sectional
exposure and outcome are measured
simultaneously at a particular point in time
("snapshot study")
What type of error is stating that there is an
effect when none exists?
Type I (false-positive error)
i.e. telling a man he's pregnant
What type of study design describes the
following study? Researchers identify
patients with multidrug-resistant and
pansensitive tuberculosis. They then review
the patients past records for associated risk
factors.
Case control
case control studies determine the outcome
first and then look for associated risk
factors; retrospective cohort studies
determine risk factor exposure first and then
look for outcomes
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What type of study design is

characterized by multiple experimental
interventions, each with two or more
variables that are studied
independently? What type of study is at the pinnacle of the hierarchy What type of study uses subjects as their
of medical evidence? own controls?
Factorial design
Meta analysis Crossover studies
e.g. a study in which patients are
randomized to three different blood
pressure medications and each BP helps eliminate confounding bias
medication group is then randomized to
higher and lower BP goals

A parallel study group randomized one

treatment to one group and a different
treatment to the other group

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What type of study uses subjects as
their own controls?
Crossover studies
e.g. receive a drug and receive a
placebo in two separate periods
seperated by a wash out
period; helps eliminate confounding
bias
When lowering the cutoff point for a
disease, the sensitivity and NPV will
increase
i.e. lowering the blood glucose
cutoff level for which a patient is
diagnosed
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When discussing HIPAA information with employees,
it is required to have verbal or written
authorization.
HIPPA does not require the provider to obtain proof
of identity of phone callers.
The best practice when giving HIPAA info is to
disclose only the minimum necessary information.
When lowering the cutoff point for a disease,
the specificity and PPV will decrease
i.e. lowering the blood glucose cutoff level
for which a patient is diagnosed
When lowering the cutoff point for a disease,
the sensitivity and NPV will increase
i.e. lowering the blood glucose cutoff
level for which a patient is
diagnosed
When lowering the cutoff point for a disease,
the specificity and PPV will decrease
i.e. lowering the blood glucose cutoff
level for which a patient is
diagnosed
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When raising the cutoff point for a
disease, the sensitivity and NPV will
decrease.
i.e. raising the blood glucose cutoff level for
i.e. raising the blood glucose
cutoff level for which a patient is
diagnosed
When raising the cutoff point for a
disease,
the specificity and PPV will increase
i.e. raising the blood glucose
cutoff level for which a patient is
diagnosed
the standard deviation is taken from a data
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When raising the cutoff point for a disease,
the sensitivity and NPV will decrease.
which a patient is diagnosed
Which measure of dispersion measures the
variability in a set of values?
Standard deviation
set, NOT the population
When raising the cutoff point for a disease,
the specificity and PPV will increase
i.e. raising the blood glucose cutoff
level for which a patient is
diagnosed
Which measure of dispersion measures
the variability of a set of sample means
around the true population mean?
Standard error
takes the sample size into account
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Which type of observational study can
be retro- or prospective?
Cohort study
Which type of observational study is best for studying
Accuracy (validity) is the trueness of
test measurements
Case-control studies are observational
studies that compare a group of people
with disease to a group without
disease
looks to see if odds of prior
exposure or risk factor differs by
disease state; asks, "What
happened?"
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rare diseases?
Case-control studies
Adoption studies are observational studies that
compare
siblings raised by biological versus adoptive
parents
Cohort studies are observational studies that
compares groups with a given exposure or risk
factor to a group without such exposure
looks to see if exposure or risk factor is
associated with later development of
disease
Absolute risk reduction is the difference in
risk attributable to an intervention compared
to a control
Attributable risk is defined as
the difference in
risk between exposed and unexposed groups
i.e. the proportion of disease
occurences that are attributable to
the exposure
Cohort studies are useful for calculating
relative risk (RR)
"smokers had a higher risk of
developing COPD than
nonsmokers"
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Cross-sectional studies are observational studies that

compare a frequency of disease and frequency of
risk related factors at one time point

asks, "what is happening?"; exposure and

outcome are determined simultaneously
Confidence intervals are a range of therefore no data on temporal Likelihood ratios can be multiplied with
values within which the true mean of the relationship between exposure and pretest odds of disease to estimate posttest
population is expected to fall, with a outcome odds
specified probability (usually 95%)

Negative predictive value is

the probability that when the test is
negative, the disease is absent Period prevalence refers to the amount of an existing Point prevalence refers to the amount of an
condition present in a population during a particular existing condition present in a population at a
time period single point in time
i.e. probability that person who
has a negative test actually does
not have the disease

Positive predictive value is

the probability that when the test is Relative risk reduction is the proportion of
Precision (reliability) is
positive, the disease is present risk reduction attributable to an intervention
the consistency and reproducibility of a test
compared to a control

i.e. probability that person who

has a positive test actually has
the disease

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Sensitivity is the probability that when
the disease is present, the test is
positive
i.e. the proportion of all people
with disease who test positive
(true-positive rate)
Accuracy is decreased by systematic
error in a test
thus the absence of systematic
error yields high accuracy
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Twin concordance studies are observational
Specificity is the probability that when
studies that compare the frequency with
the disease is absent, the test is negative
which monozygotic and dizygotic
twins develop the same disease
i.e. the proportion of all people without
disease who test negative (true-negative
rate)
Case-control studies are useful for
measuring odds ratio (OR)
e.g. patients with COPD had higher
Accuracy is decreased by systematic error in a test odds of a history of smoking than
those without COPD
thus the absence of systematic error yields
high accuracy
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Case-control studies are useful for
measuring odds ratio (OR)
e.g. patients with COPD had
higher odds of a history of
smoking than those without
COPD
Negative likelihood ratio = (1 -
sensitivity) / specificity
Negative predictive
value varies inversely with pretest
probability
i.e. high pretest probability
(prevalence) = low NPV
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Incidence rate = # of new cases / # of people at
risk during a specified time period
"incidence looks at new cases
(incidents)"
Negative likelihood ratio = (1 - sensitivity) /
specificity
Positive likelihood ratio = sensitivity / (1 -
specificity)
Incidence rate = # of new cases / # of
people at risk during a specified time period
"incidence looks at new cases
(incidents)"
Negative predictive
value varies inversely with pretest
probability
i.e. high pretest probability
(prevalence) = low NPV
Positive likelihood ratio = sensitivity / (1 -
specificity)
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Positive predictive
Positive predictive value varies directly with pretest Precision is decreased by random error in a
value varies directly with pretest
probability test
probability

i.e. high pretest probability (prevalence) = thus the absence of random

i.e. high pretest probability
(prevalence) = high PPV high PPV variation yields high precision

Prevalence = # of existing cases / total # of people Prevalence = # of existing cases / total # of

in a population at a point in time people in a population at a point in time
Precision is decreased by random
error in a test "prevalence looks at all current cases" "prevalence looks at all current
cases"
thus the absence of random
variation yields high precision

Prevalence is ~ equal to the pretest

Prevalence is ~ equal to the pretest probability
probability

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