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Fallacies in Epidemiology
M. Tevfik DORAK
http://www.dorak.info/epi
BIAS
Definition
Types
Examples
Remedies
CONFOUNDING
Definition
Examples
Remedies
FALLACIES
Definition
(Effect Modification)
What is Bias?
Bias is one of the three major threats to internal
validity:
Bias
Confounding
Random error / chance
What is Bias?
Any trend in the collection, analysis, interpretation,
publication or review of data that can lead to
conclusions that are systematically different from
the truth (Last, 2001)
A process at any state of inference tending to
produce results that depart systematically from
the true values (Fletcher et al, 1988)
Systematic error in design or conduct of a study
(Szklo et al, 2000)
Random Error
Per Cent
WHO
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Systematic Error
Per Cent
WHO
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Chance vs Bias
Chance is caused by random error
Bias is caused by systematic error
Errors from chance will cancel each other out in the
long run (large sample size)
Errors from bias will not cancel each other out
whatever the sample size
Chance leads to imprecise results
Bias leads to inaccurate results
Types of Bias
Selection bias
Confounding bias
Selection Bias
Selective differences between comparison groups
that impacts on relationship between exposure
and outcome
Usually results from comparative groups not
coming from the same study base and not being
representative of the populations they come from
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Case-Control Studies:
Potential Bias
Types of Bias
Selection bias
Confounding bias
Information / Measurement /
Misclassification Bias
Method of gathering information is inappropriate and
yields systematic errors in measurement of exposures
or outcomes
If misclassification of exposure (or disease) is
unrelated to disease (or exposure) then the
misclassification is non-differential
If misclassification of exposure (or disease) is related
to disease (or exposure) then the misclassification is
differential
Distorts the true strength of association
Information / Measurement /
Misclassification Bias
Sources of information bias:
Subject variation
Observer variation
Deficiency of tools
Technical errors in measurement
Information / Measurement /
Misclassification Bias
Recall bias:
Those exposed have a greater sensitivity for recalling
exposure (reduced specificity)
- specifically important in case-control studies
- when exposure history is obtained retrospectively
cases may more closely scrutinize their past history
looking for ways to explain their illness
- controls, not feeling a burden of disease, may less
closely examine their past history
Those who develop a cold are more likely to identify
the exposure than those who do not differential
misclassification
- Case: Yes, I was sneezed on
- Control: No, cant remember any sneezing
Information / Measurement /
Misclassification Bias
Reporting bias:
Individuals with severe disease tends to have
complete records therefore more complete
information about exposures and greater association
found
Individuals who are aware of being participants of a
study behave differently (Hawthorne effect)
Types of Bias
Selection bias
** Confounding bias **
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Confounding
A third factor which is related to both
exposure and outcome, and which accounts
for some/all of the observed relationship
between the two
Confounder not a result of the exposure
e.g., association between childs birth rank
(exposure) and Down syndrome (outcome);
mothers age a confounder?
e.g., association between mothers age (exposure)
and Down syndrome (outcome); birth rank a
confounder?
Confounding
To be a confounding factor, two conditions must be met:
Exposure
Outcome
Third variable
Be associated with exposure
- without being the consequence of exposure
Be associated with outcome
- independently of exposure (not an intermediary)
Confounding
Birth Order
Down Syndrome
Maternal Age
Maternal age is correlated with birth
order and a risk factor even if birth order
is low
Confounding ?
Maternal Age
Down Syndrome
Birth Order
Birth order is correlated with maternal age
but not a risk factor in younger mothers
Confounding
Coffee
CHD
Smoking
Smoking is correlated with coffee
drinking and a risk factor even for those
who do not drink coffee
Confounding ?
Smoking
CHD
Coffee
Coffee drinking may be correlated with
smoking but is not a risk factor in nonsmokers
Confounding
Alcohol
Lung Cancer
Smoking
Smoking is correlated with alcohol
consumption and a risk factor even for
those who do not drink alcohol
Confounding ?
Smoking
CHD
Yellow fingers
Not related to the outcome
Not an independent risk factor
Confounding ?
Diet
CHD
Cholesterol
On the causal pathway
Confounding
Imagine you have repeated a positive finding of birth order
association in Down syndrome or association of coffee drinking
with CHD in another sample. Would you be able to replicate it?
If not why?
Imagine you have included only non-smokers in a study and
examined association of alcohol with lung cancer. Would you
find an association?
Imagine you have stratified your dataset for smoking status in
the alcohol - lung cancer association study. Would the odds
ratios differ in the two strata?
Imagine you have tried to adjust your alcohol association for
smoking status (in a statistical model). Would you see an
association?
Confounding
Imagine you have repeated a positive finding of birth order
association in Down syndrome or association of coffee drinking
with CHD in another sample. Would you be able to replicate it?
If not why?
You would not necessarily be able to replicate the
original finding because it was a spurious association
due to confounding.
In another sample where all mothers are below 30 yr,
there would be no association with birth order.
In another sample in which there are few smokers,
the coffee association with CHD would not be
replicated.
Confounding
Imagine you have included only non-smokers in a study and
examined association of alcohol with lung cancer. Would you
find an association?
No because the first study was confounded. The
association with alcohol was actually due to smoking.
By restricting the study to non-smokers, we have
found the truth. Restriction is one way of preventing
confounding at the time of study design.
Confounding
Imagine you have stratified your dataset for smoking status in
the alcohol - lung cancer association study. Would the odds
ratios differ in the two strata?
The alcohol association would yield the similar odds
ratio in both strata and would be close to unity. In
confounding, the stratum-specific odds ratios should
be similar and different from the crude odds ratio by at
least 15%. Stratification is one way of identifying
confounding at the time of analysis.
Confounding
Imagine you have tried to adjust your alcohol association for
smoking status (in a statistical model). Would you see an
association?
If the smoking is included in the statistical model, the
alcohol association would lose its statistical
significance. Adjustment by multivariable modelling is
another method to identify confounders at the time of
data analysis.
Confounding
For confounding to occur, the confounders should be
differentially represented in the comparison groups.
Randomisation is an attempt to evenly distribute
potential (unknown) confounders in study groups. It
does not guarantee control of confounding.
Matching is another way of achieving the same. It
ensures equal representation of subjects with known
confounders in study groups. It has to be coupled with
matched analysis.
Restriction for potential confounders in design also
prevents confounding but causes loss of statistical
power (instead stratified analysis may be tried).
Confounding
Randomisation, matching and restriction can be tried at
the time of designing a study to reduce the risk of
confounding.
At the time of analysis:
Stratification and multivariable (adjusted) analysis can
achieve the same.
It is preferable to try something at the time of designing
the study.
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Confounding
Obesity
Mastitis
Age
In cows, older ones are heavier and older
age increases the risk for mastitis. This
association may appear as an obesity
association
Confounding
No Confounding
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BIAS
Definition
Types
Examples
Remedies
CONFOUNDING
Definition
Examples
Remedies
** (Effect Modification) **
FALLACIES
Definition
Leukaemia
Sex
Leukaemia
OR = 1.5
Sex
BOYS
Birth Weight
GIRLS
Birth Weight
//
Leukaemia
OR = 1.8
Leukaemia
OR = 0.9
Effect Modification
In an association study, if the strength of the
association varies over different categories of a third
variable, this is called effect modification. The third
variable is changing the effect of the exposure.
The effect modifier may be sex, age, an environmental
exposure or a genetic effect.
Effect modification is similar to interaction in statistics.
There is no adjustment for effect modification. Once it
is detected, stratified analysis can be used to obtain
stratum-specific odds ratios.
Effect modifier
Belongs to nature
Different effects in different strata
Simple
Useful
Increases knowledge of biological mechanism
Allows targeting of public health action
Confounding factor
Belongs to study
Adjusted OR/RR different from crude OR/RR
Distortion of effect
Creates confusion in data
Prevent (design)
Control (analysis)
BIAS
Definition
Types
Examples
Remedies
CONFOUNDING
Definition
Examples
Remedies
(Effect Modification)
** FALLACIES **
Definition
Fallacies
HISTORICAL FALLACY
ECOLOGICAL FALLACY
(Cross-Level Bias)
BERKSON'S FALLACY
(Selection Bias in Hospital-Based CC Studies)
HAWTHORNE EFFECT
(Participant Bias)
REGRESSION TO THE MEAN (Davis, 1976)
(Information Bias)
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Cause-and-Effect Relationship
http://www.dorak.info
M. Tevfik DORAK
Paediatric & Lifecourse Epidemiology Research Group
School of Clinical Medical Sciences (Child Health)
Newcastle University
England, U.K.
http://www.dorak.info