Bias
Bias
1
Learning Objectives
By the end of this session the student is expected to be able to:
1. Define bias and differentiate between selection bias,
misclassification/information bias, and confounding bias
2. Define and identify selection bias
3. Define and identify non-differential misclassification of disease
and exposure
4. Define and identify differential misclassification of exposure in a
case-control study (recall bias)
5. Identify the effect that a particular bias can have on a particular
study
6. Identify which types of studies are prone to which types of bias
7. Identify common sources of bias
Why do we conduct epidemiologic studies?
Consideration of the Consideration of decreasing
random error, which can lead
exposure and disease
to a false association by
of interest. “chance.”
Goal:
To determine the relationship between an exposure and an
outcome with validity, precision, and efficiency.
Consideration of cost
Consideration of decreasing and time in
bias and confounding that conducting a study.
would otherwise distort the
results.
Goal in Epidemiologic Studies
• Obtain an accurate measure of association
• Sources of inaccuracy
– Systematic Error (lack of validity)
– Random Error (lack of precision)
Sources of Error
in Epidemiologic Research
Random Systematic
Bias Confounding
Information Selection
Bias Bias
Bias
Bias
Definition: A systematic error that causes an incorrect or invalid
estimate of an association
Random Systematic
Bias Confounding
Information Selection
Bias Bias
Where in 2x2 table? Who is included in 2x2 table?
D+ D- D+ D-
?
E+ E+
E- E-
Non-Differential or Differential?
Errors (who gets in, or what gets
recorded) can be: OFTEN (but not
always) leads to
– NON-DIFFERENTIAL: Extent of errors is the biased results
SAME for both people with and without
disease (or for cases and controls); or for
exposed and unexposed groups
Sources:
Case-Control Study: Selection/participation of cases and controls related to
exposure status.
Cohort Study: Selection of exposed and unexposed subjects (or follow-up of
exposed and unexposed) related to outcome.
Effects: Lead to a result that is different from what would have been obtained
from the entire population targeted for the study.
Cases 150 75
This bias occurs when controls fail to represent the exposure distribution in
the source population from which the cases were identified because controls
do not accurately represent the same source population as the cases
door-to-door survey
conducted in the evening
Problem: Who is at home during the day? Solution: Use of identical selection criteria
People at home during the day are more helps ensure that cases and controls come
likely unemployed or older (retired). The from the same source population as the
likelihood of being included as a control is cases.
therefore related to the exposure (SES).
19
Control-Selection Bias (cont.)
Selected controls have lower SES than cases:
40% of controls in source population (true) have low SES (100/250=40%)
60% of controls in selected population have low SES (150/250=60%)
True Observed
OR = 2.25 (Biased) OR = 1.5
Self-Selection Bias
Bias that can occur if willingness or ability to participate is related
to both exposure and disease status
In a case-control study, cases and controls should be selected
independent of exposure status
Goal is to have comparable rates of participation in all categories of
disease and exposure
True Observed
OR = 2.0 (Biased) OR = 2.7
Surveillance, Diagnostic, & Referral Bias
Bias that can occur if patients who are exposed are more likely
to be diagnosed with a disease
This bias occurs when the people who play a role in, or are responsible for,
disease ascertainment base their diagnosis on whether or not the
participant has the exposure of interest
True Observed
OR = 1.0 (Biased) OR = 2.0
Selection Bias in Case-Control Studies
Bias Effect Prevention
Control Selection Toward or Use identical selection criteria for
Away from Null cases and controls (recall purpose
of controls)
1,008 1,012
True RR = 2.0 Observed (Biased) RR = 9.0
Differential Loss to Follow-Up – Losses are related to both exposure and disease
Loss to Follow-Up (cont.)
Example: Association between OC use and thromboembolism (TE)
TE+ 20 10 TE+ 4 9
1,008 1,012
True RR = 2.0 Observed (Biased) RR = 0.4
Differential loss to follow-up results in unpredictable direction of
measure of association.
Selection Bias in Cohort Studies
Bias Effect Prevention
• You need to avoid it when you design the study. For example,
plan on:
– Using the same criteria for selecting cases and controls
– Obtaining high participation rates
– Taking into account diagnostic and referral patterns of
disease
– Obtaining all relevant subject records
Information (Observation) Bias
Information Bias
Definition: An error that arises from systematic differences in the way
information on exposure or disease is obtained from the study groups (aka
observation bias)
Sources: Both cohort and case-control studies are susceptible. Occurs after the
subjects have entered the study.
Case-Control Study: Different techniques are used to interview cases and
controls
Cohort Study: Different procedures are used to obtain outcome information on
exposed and unexposed.
Effects:
Results in participants who are incorrectly classified as either exposed or
unexposed or as diseased or not diseased. The misclassification can be
differential or non-differential.
• Interviewer/Recording Bias
True Observed
OR = 1.0 (Biased) OR = 2.3
Recall Bias: Solutions
• Use controls who are also sick to promote comparable recall
• Ask subjects about their knowledge of the study hypothesis (at end
of interview), and analyze data accordingly
Poor Recall vs. Recall Bias
Poor recall happens all the time
Bias only occurs when recall is different for people who do and
do not have disease (differential)
• 90% of cases and 90% of controls have accurate recall NO bias
• 90% of cases and 70% of controls have accurate recall bias
Interviewer Bias
Bias that can occur if there is a systematic difference in
soliciting, recording, or interpreting information
True Observed
RR = 2.0 (Biased) RR = 1.2
Interviewer/Recording Bias: Solutions
Think!
• Provide rigorous training (e.g. nondirective Are you sure
you didn’t
probing) take it…?
• Monitor interviewers
• Blind the interviewer/ abstractor to study
hypothesis and disease or exposure status of
subjects
• Use standardized questionnaires consisting of
closed-ended, easy questions with appropriate
response categories
• Use standardized methods of outcome (or
exposure) ascertainment
• Examine pre-existing data (e.g. medical or
employment records)
Reducing Information Bias
• Little (or nothing) can be done to fix
information bias once it has occurred
Effect:
Non-differential → bias towards the null
Differential → bias upward or downward
Non-Differential Misclassification
Non-differential means that the extent of the misclassification
is the same (not different) for both groups
E+ E- E+ E-
Disease a b Disease a b
No Disease c d No Disease c d
Non-Differential Misclassification
If EXPOSURE is the thing being misclassified, then the extent of the exposure
misclassification is the SAME for cases/controls or diseased/non-diseased
OR = 4.0 OR = 2.5
OR = 4.0 OR = 3.0
E+ E- E+ E-
Disease a b Disease a b
No Disease c d No Disease c d
Differential Misclassification
If EXPOSURE is the thing being misclassified, then the extent of the exposure
misclassification is DIFFERENT for cases/controls or diseased/non-diseased
OR = 4.0 OR = 10.0
OR = 4.0 OR = 1.0
Surveillance, diagnostic,
referral bias
Loss to follow-up
Recall bias
Information
Interviewer bias
Measurement error
(misclassification)
Questions to Ask Yourself When
Interpreting Study Results…
• Given the conditions of the study, could bias have
occurred? Which types?
This is another way of saying that controls had a higher level of exposure
than the source population, or that the number of exposed controls is too
high
Question 1
Population targeted for study Biased study sample
E+ E- E+ E-
Cases a b Cases a b
Controls c d Controls c d
C
OR = (a/C)/(b/d)
You suspect that the control women were less likely to remember that they had used a
spermicide-coated condom in the previous month than were the women with a UTI. If
such information bias occurred (assuming no other bias or confounding), it would have
led the investigators to observe an effect of spermicide-coated condom use on UTI that
was:
a. An overestimate of the true association (bias away from the null).
b. An underestimate of the true association (bias towards the null).
c. The same as the true association.
Question 3
Actual information for study Biased information collected
E+ E- E+ E-
Cases a b Cases a b
Controls c d Controls c d
OR = (a/c)/(b/d)