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Jessica Jardine
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Cards (37)
What is selection bias?
when there are
systematic differences
between
comparison groups
Type 2 error
The
failure
to
reject
the
null hypothesis
when it is
false.
Phase 2 trial
Testing of
drug
on
large group
of
patients
to assess
efficacy
and
safety
How does randomisation of subjects make a randomised controlled trial more rigorous?
reduces
the
risk
of
selection bias
List the components of the ‘evidence pyramid’ going from strongest to weakest form of evidence.
Meta-analysis
Systematic Review
Randomized Controlled Trial
Cohort Studies
Case-control studies
Cross-sectional studies
Case reports
Expert Opinion
Risk ratio
probability
of an
event occurring
in an
exposed group
compared to the
probability occurring
in a
non-exposed group
How to calculate the Number Needed to Treat?
Number Needed to Treat is
inversely proportional
to the
Absolute risk reduction (%
)
E.g. if
ARR
is
4
% , then
NNT
is
1/4 x 100
=
25
NNT = 25. What does this mean?
An average of
25 people
will have to
receive
the
intervention
for
1
of them to
benefit
compared to someone
not receiving
the
intervention
Pre-clinical trial
Animal
/
cell testing
to gather
information
about
efficacy
and
toxicity
Phase 0 trial
Sometimes
not done
small group
of
volunteers
, used to assess
pharmacodynamics
and
pharmacokinetics
Phase 1 trial
Testing of
drug
on
healthy volunteers
to find
appropriate dosing
Phase 3 trial
Testing of drug on a
large group of patients
to
confirm effectiveness, safety
and comparing to
existing interventions
How to calculate sensitivity?
t
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\frac{true\ positive}{true\ postive\ +\ false\ negative}
t
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+
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se
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os
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How to calculate specificity?
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g
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\frac{true\ negative}{true\ negative\ +\ false\ positive}
t
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n
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+
f
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l
se
p
os
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a
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How to calculate positive predictive value?
t
r
u
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o
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t
i
v
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r
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s
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e
+
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a
l
s
e
p
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v
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\frac{true\ positive}{true\ positive\ +\ false\ positive}
t
r
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os
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e
+
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a
l
se
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How to calculate negative predictive value?
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\frac{true\ negative}{true\ negative\ +\ false\ negative}
t
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se
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r
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g
a
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i
v
e
How to calculate false positive rate?
1 - specificity
How to calculate false negative rate?
1 - sensitivity
Rate ratio
Also known as
incidence ratio
Measure of
association
which
compares
the
incidence rate
in an
exposed group
to the
incidence rate
in a
non-exposed group
Confidence interval
Range
within which the
true treatment effect
is likely to
lie
Selection bias
When there are
systematic differences
between
comparison groups
Which studies commonly use the odds ratio as a measure of association?
Case-control studies
May also be used in
cross-sectional studies
What is the main disadvantage of cross-sectional studies?
Do not show
causality
or
account
for
confounding factors
which may
influence data
So, associations may be
difficult to interpret
Attributable risk
Measure of association
Amount
of
proportion
of
disease incidence
(
disease risk
) that can be attributed to the
exposure
Cross-sectional study
Collection
of
data
from a
population
in a
specific time point
Type 1 error
Incorrect rejection
of the
null hypothesis
when it is
true
Calculating relative risk
r
i
s
k
o
f
p
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o
r
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t
c
o
m
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s
i
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n
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m
e
s
i
n
t
h
e
c
o
n
t
r
o
l
g
r
o
u
p
\frac{risk\ of\ poor\ outcomes\ in\ intervention\ group}{risk\ of\ poor\ outcomes\ in\ the\ control\ group}
r
i
s
k
o
f
p
oor
o
u
t
co
m
es
in
t
h
e
co
n
t
ro
l
g
ro
u
p
r
i
s
k
o
f
p
oor
o
u
t
co
m
es
in
in
t
er
v
e
n
t
i
o
n
g
ro
u
p
Measurement bias
Error due to
data collection
during
measurement
Can occur in both
qualitative
&
quantitative
studies
Odds ratio calculation
A
D
B
C
\frac{AD}{BC}
BC
A
D
Interventional studies
Participants receive 1 or more intervention or treatment
Types
randomised control trial
pre-post study
Observational studies
Participants are observed without an intervention
Types
cohort
case-control
What is the Bradford-Hill Criteria?
9
viewpoints to help determine if
observed epidemiological associations
are casual
strength
->
strong associations
consistency
->
repeated observation
of an association in
different populations
under
different circumstances
specificity
-> cause leads to a
single effect
(not
multiple
)
temporality
-> cause
precede
the
effect
in
time
biologic gradient
->
unidirectional dose responsive curve
plausibility
->
biologic plausibility
of hypothesis
coherence
-> interpretation does not
conflict
with known
natural history
&
biology
experimental evidence
analogy
Odds ratio
Probability
that an
event
will
occur
given an
exposure
, compared to the
probability
that that
event
will
occur
absent
the
exposure
Used in
case-control studies
, may be used in
cross-sectional studies
Interpretation of odd ratio
OR = 1
exposure
will
not affect outcome
OR < 1
exposure
is
associated
with
lower probability
of
outcome
OR > 1
exposure
is
associated
with
higher probability
of
outcome
Absolute risk reduction (AAR)
Absolute difference in risk
between
control group
&
experimental group
ARR
=
Risk(control group)
-
Risk(experimental group)
Relative risk reduction (RRR)
Proportional reduction
in
risk
bestowed by the
intervention
compared to the
control situation
RRR =
1 - (Risk(experimental group) / Risk(control group)
Selection bias
Selection
of
individuals
,
groups
or
data
for analysis in such a way that
proper randomization
is
not achieved
, thereby ensuring that the sample obtained is
not representative
of the population intended to be analysed
Types
sampling
time interval
susceptibility
attrition