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Research Methodology and

Biostatistics Course, MD; PhD_ 2020

Fatma AA Hassan, PhD


Professor of Preventive Medicine
Community Medicine Department
Faculty of Medicine – Suez Canal University
Ismailia-Egypt
Measurements Errors

Bias and
Confounding
Measurements
Why does one perform measurement?
- To form a clearer definition of the concept
or object to gain a more profound
understanding and to be able to perform
further operations or calculations.
- To test a hypothesis.
The Result of the measurement
=
What?
True value or True value
+ errors
Bias
• A preference or an inclination.
• Bias refers to an effect at any stage of an
investigation or interference tending to
produce results which depart
systematically from the true value.
• It is a systematic error.
Classification of Bias

• Selection Bias
• Information Bias
• Confounding
• Intervention Bias
Selection Bias
• It occurs when there is a systematic
difference between the characteristics of
the people that are selected for the study
and those that are not.
• Selection biases affect the applicability
and usefulness of findings and make it
impossible to generalize the results to all
patients with the disorder of interest.
Selection Bias (Cont.)
• Example:
- Volunteer bias: If those who volunteer for
the study differ from those who refuse
participation, the results are affected.
- Non-response bias: when those who do not
respond to take part in a study differ in
important ways from those who respond.
Selection Bias (Cont.)
• Example:
- Loss to follow up bias: when those who
remain in the study differ from those “lost,” in
terms of personal characteristics and outcome
status.
- Survivor bias: when the study base consist
of those people who have survived long
enough to become members of the base.
Information Bias
• A distortion in the estimate of association
between risk factor and disease that is due to
systematic measurement error or
misclassification of subjects on one or more
variables, either risk factor or disease status.
• It occurs if data used in the study are
inaccurate or incomplete, thus influencing the
validity of the study conclusions.
Information Bias
Inaccurate measurement of study variables can lead
to bias.
Sources of inaccurate measurement:
*Subject error _ error within the individual for any
reason, e.g. imperfect recall of past exposures.
*Instrument error – e.g. equipment not properly
calibrated, wording of question.
*Observer error _error in use of instrument or
recording.
Information Bias (Cont.)
• Example:
- Recall bias: Recall or memory bias may be a
problem if outcomes being measured require
that subjects (cases and controls) recall past
events.
- Diagnosis bias: This bias occurs when the
disease being investigated is more likely to be
detected in people who are under frequent
medical surveillance than those receiving
routine medical attention.
Information Bias (Cont.)
• Example:
- Lead time bias: when
diagnosis of a condition is made
during its latency period, leading
to a longer duration of illness.
Intervention (exposure) bias

• This type of bias involves


differences in how the treatment
or intervention was carried out or
how subjects were exposed to the
factor of interest.
Intervention (exposure) bias (Cont.)
• Example:
- Compliance bias: Compliance bias occurs when
differences in subject adherence to the planned
treatment regimen or intervention affect the study
outcomes.
- Proficiency bias: Proficiency bias occurs when
treatments or interventions are not administered
equally to subjects. This may be due to skill or
training differences among personnel or differences in
resources or procedures used at different sites.
Intervention (exposure) bias (Cont.)
• Example:
- Contamination bias: occurs when
control group subjects inadvertently
receive the intervention or are exposed to
extraneous treatments, thus potentially
minimizing the difference in outcomes
between the cases and controls.
Confounding
• A situation in which the measure of
effect of exposure on disease is
distorted because of the association of
the study factor with other factors that
influence the outcome.
• These other factors are called
confounders.
Confounding (Cont.)

A B

C B
Confounding (Cont.)

Confounder

Exposure Disease

The effect of the first feature is mistakenly


attributed to the second feature.
Confounding (Cont.)

Example: Smoking is a confounder of the


association between coffee consumption
and ischemic heart disease.
Confounding (Cont.)

Example: A study found an association


between smoking and loss of hairs. The
study was confounded by age

Age

smoking loss of hairs


Confounding (Cont.)
• A variable is a confounder if:
1. it is an independent risk factor (cause)
of disease.
2. it is unevenly distributed among the
exposed and non-exposed.
3. it is not on the causal pathway between
exposure and disease.
Confounding (Cont.)

Confounders are true causes of


disease, whereas biases are
artifacts.
Strategies for Dealing with Bias
The causes of bias can be related to:
1.The manner in which study subjects are
chosen.
2. The method in which study variables are
collected or measured.
3. The attitudes or preferences of an investigator.
4. The lack of control of confounding variables.
Strategies for Dealing with Bias
*The key to decreasing bias is to
identify the possible areas that
could be affected and change
the design accordingly.
Minimizing selection bias
• Selection of study subjects
– clearly define study population in time and place.
– use sampling techniques that result in choosing
groups from the same population.
– use methods that result in high recruitment rates.
• Assignment of exposure status
– use random allocation (RCTs).
• Study subjects omitted from analysis
– use methods to minimize loss to follow up.
– review non-respondents.
Minimizing information bias
• Use valid reliable tools to measure all study
subjects.
• Train staff and monitor their use of research tools
• Regular quality checks of research tools.
• Blinding of study subjects and assessors.
• Subjects in Case-Control study unaware of study
hypothesis.
• Consider sub-study to determine validity and
reliability of measurements.
Controlling for confounders

Confounding is the only type of


bias that can be prevented or
adjusted for, provided that
confounding was anticipated
and the requisite information
was collected.
Controlling for confounders (Cont.)
• At the design phase
• restriction (limit the study to people with
one level of the potential confounder).
• stratified allocation within risk strata.
• matching.
• randomization – deals with known and
unknown.
Controlling for confounders (Cont.)
• At the analysis phase
• demonstrate comparability.
• data analyzed in strata of the
confounder.
• statistical modeling – useful to
control for multiple confounders.
Thank You
Short Biography
7/8/1953

Fatma AA Hassan, an Egyptian professor of Preventive


Medicine at Community Medicine Department, Suez Canal
University. Editor-in-Chief of Universal Journal of Public
Health (UJPH). The UICC GLOBALink Regional Coordinator
(Arabic). Former President of the IPIFA. Member in the
steering committee of WorldSAFE, INCLEN. Member in
ISPCAN. A member in the SCUCEU, INCLEN and many
other international and local scientific societies. In the
Editorial Board and reviewer for UJPH & SCUMJ. Evaluator
of ER-Africa protocols and reviewer for the National
Permanent Committee_2013-2019. PI for several international
collaborative researches. Have several international scientific
papers on tobacco use, injury, violence within the family
environment and medical education. Mentor PG students
locally and internationally.
The complete terms of the given
abbreviations in the short biography
• UICC GLOBALink = Union for International Cancer Control,
IPIFA = Injury Prevention Initiative for Africa supported by
WHO. WorldSAFE = World Studies on Abuse in Family
Environment. ISPCAN = International Society for Prevention
of Child Abuse and Neglect. SCUCEU = Suez Canal
University Clinical Epidemiology Unit. INCLEN=
International Clinical Epidemiology Network. UJPH =
Universal Journal of Public Health. SCUMJ= Suez Canal
University Medical Journal. ER-Africa = Euro Research
Africa. PI= Principal Investigator. My researches are on
tobacco or health, injury, violence within the family
environment, obesity and medical education.

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