Bias, Errors and Confounding

in Epidemiology

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 Definitions
Error:
A false or mistaken result obtained in a study or
experiment
Error types:
1. Random error (non-differential error, chance): is the
portion of variation in measurement that has no
apparent connection to any other measurement or
variable, generally regarded as due to chance
2. Systematic error (differential error or bias): which
often has a recognizable source, e.g., a faulty
measuring instrument, or pattern, e.g., it is
consistently wrong in a particular direction

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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

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 Types of biases

1. Selection bias
2. Measurement / mis-classification/information
bias
3. Confounding bias

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 Selection Bias

Errors due to systematic differences in characteristics

between those who are selected for study and those who are
not so they are not representative of the population from
those they were selected.

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 Selection Bias types
1. Ascertainment Bias
-Systematic failure to represent equally all classes of
cases or persons supposed to be represented in a
sample.
-This bias may arise because of the nature of the sources
from which the persons come, e.g., a specialized clinic;
from a diagnostic process influenced by culture..etc

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 Selection Bias types
1. Ascertainment Bias
Subjects: hospital cases under the care of a physician
Excluded:
2. Die before admission – acute/severe disease.
3. Not sick enough to require hospital care
4. Do not have access due to cost, distance etc.
Result: conclusions cannot be generalized

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 Selection Bias types
2. Publicity bias OR response bias
People referring themselves to the investigations following
publicity about the study and this self-referral may be associated
with the outcome to the study (it is a threat to study validity)
-Systematic error due to differences in characteristics between
those who choose or volunteer to take part in a study and those
who do not
-Volunteer either because they are unwell, or worried about an
exposure

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 Selection Bias types
3. Lost to follow up bias (migration bias)
In nearly all large studies some members of the original cohort drop
out of the study
If drop-outs occur randomly, such that characteristics of lost
subjects in one group are on an average similar to those who
remain in the group, no bias is introduced
If occur on a large scale, can affect validity of conclusions.

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 Selection Bias types
4. Healthy worker effect
A phenomenon observed initially in studies of
occupational diseases: workers usually exhibit lower
overall death rates than the general population, because
the severely ill and chronically disabled are ordinarily
excluded from employment. Death rates in the general
population may be inappropriate for comparison if this
effect is not taken into account.

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 Selection Bias types
4. Healthy worker effect

Question: association b/w formaldehyde exposure and

eye irritation
Subjects: factory workers exposed to formaldehyde
Bias: those who suffer most from eye irritation are likely
to leave the job at their own request or on medical advice
Result: remaining workers are less affected; association
effect is diluted

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 Selection Bias types
5. Diagnostic bias or workup bias

Radiologist aware of patient’s smoking status when

reading x-ray – may look more carefully for abnormalities
on x-ray and differentially select cases

-Legitimate for clinical decisions, inconvenient for

research

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 Information / Measurement / Misclassification Bias

Systematic error arising from inaccurate measurements (or

classification) of subjects or study variables.

Occurs when individual measurements or classifications of

disease or exposure are inaccurate (i.e. they do not measure
correctly what they are supposed to measure)

If patients in one group stand a better chance of having their

outcomes detected than those in another group.

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 Information / Measurement / Misclassification Bias

Exposure misclassification occurs when exposed subjects are

incorrectly classified as unexposed, or vice versa

Disease misclassification occurs when diseased subjects are

incorrectly classified as non-diseased, or vice versa

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 Information / Measurement / Misclassification Bias

Causes of mis-classifications:

1. Measurement bias: gap between the measured and the

true value of a variable
- Observer / interviewer bias
- Recall bias: case control studies, cases are more likely to
remember exposure
- Reporting bias: severe cases have complete records and
greater association found

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 Information / Measurement / Misclassification Bias

Causes of mis-classifications:

2. Gap between the theoretical and empirical definition of

exposure/disease (different definitions of MI or passive
smoking)

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 Controlling for Information Bias
1. Blinding
prevents investigators and interviewers from knowing case/control or
exposed/non-exposed status of a given participant including the analyzer
sometimes- Allocation concealment

2. Form of survey
mail may impose less “white coat tension” than a phone or face-to-face
interview

3. Questionnaire
use multiple questions that ask same information or double-check

4. Accuracy
multiple checks in medical records and gathering diagnosis data from multiple
sources

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 Controlling for Information Bias

5. Strict definition / standard definition for exposure / disease /

outcome

6. Equal efforts to discover events equally in all the groups

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 Confounding

When another exposure exists in the study

population (besides the one being studied)
and is associated both with disease and the
exposure being studied. If this extraneous
factor – itself a determinant of or risk factor
for health outcome is unequally distributed
b/w the exposure subgroups, it can lead to
confounding

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 Confounder … must be
1. Risk factor among the unexposed (itself a
determinant of disease)
2. Associated with the exposure under study
3. Unequally distributed among the exposed
and the unexposed groups

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 Examples … confounding

COFFEE DRINKING HEART DISEASE

(Smoking increases
(Coffee drinkers are the risk of heart ds)
more likely to smoke)

SMOKING
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 Examples … confounding

ALCOHOL MYOCARDIAL
INTAKE INFARCTION

(Men are more likely (Men are more at risk

to consume alcohol for MI)
than women)

SEX
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 Methods for controlling Selection Bias and
confounding
During Study Design
1. Restriction
2. Matching
3. Randomization
During analysis
4. Stratification
5. Adjustment
a) Simple / standardization
b) Multiple / multivariate adjustment

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 Restriction

• Subjects chosen for study are restricted to

only those possessing a narrow range of
characteristics, to equalize important
extraneous factors

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 Example… restriction

• Study: effect of age on prognosis of MI

• Restriction: Male / White / non-smokers
• Important extraneous factors controlled
for: sex / race / non-smoking
• Limitation: results not generalizable to
females, people of non-white community,
those with smoking status

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 Example… restriction
• Oral contraceptive pills example
Restrict study to women having at least one
child

• Colorectal cancer example

restrict patients to a particular staging

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 Matching
• The process of making a study group and a
comparison group comparable with respect to
extraneous factors

• Or, for each patient in one group there are one

or more patients in the comparison group with
same characteristics, except for the factor of
interest

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 Randomization
• The only way to equalize all extraneous
factors, or ‘everything else’ is to assign
patients to groups randomly so that each has
an equal chance of falling into the exposed or
unexposed group
• Equalizes even those factors which we might
not know about!
• But it is not possible always

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 Randomization
Allocation concealment
• The procedure for protecting the randomization
process so that the treatment to be allocated is not
known for patients and investigators in RCTs

• Because treatment related side-effects or adverse

events may be specific enough to reveal allocation
to investigators or patients thereby introducing
bias or influencing any subjective parameters
collected by investigators or requested from
subjects
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 Stratification
• The process of or the result of separating a
sample into several sub-samples according
to specified criteria such as age groups,
socio-economic status... etc.
• The effect of confounding variables may be
controlled by stratifying the analysis of
results
• After data are collected, they can be
analyzed and results presented according to
subgroups of patients, or strata, of similar
characteristics
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 Adjustment
A. standardization
1) Direct: What the rate would have been in
the study population if that population
had the same distribution as the standard
population

2) Indirect: What the rate would have been in

the study population if that population
had the same specific rates as the
standard population
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 Adjustment
B. Multivariate adjustment

• Simultaneously controlling the effects of

many variables to determine the independent
effects of one using advanced statistical
methods (eg., statistical multi-variate
modeling like regression)

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 Overall strategy

• Except for randomization, all ways of dealing

with extraneous differences b/w groups are
effective against only those factors that are
singled out for consideration

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 Evaluation of Diagnostic and
Screening Tests: Validity and
Reliability

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 Diagnostic Test and Screening Test

• Tests are used in medical diagnosis, screening, and

research
• How well is a subject classified into disease or non-
disease group?
– Ideally, all subjects who have the disease should be
classified as “having the disease” and vice versa
– Practically, the ability to classify individuals into the correct
disease status depends on the accuracy of the tests, among
other things
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 Diagnostic Test and Screening Test

• A diagnostic test is used to determine the

presence or absence of a disease when a subject
shows signs or symptoms of the disease
• A screening test: identifies asymptomatic
individuals who may have the disease
• The diagnostic test is performed after a positive
screening test to establish a definitive diagnosis

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 Some Common Screening Tests

• Fasting blood cholesterol for heart disease

• Fasting blood sugar for diabetes
• Blood pressure for hypertension
• Mammography for breast cancer
• PSA test for prostate cancer
• Fecal occult blood for colon cancer
• Ocular pressure for glaucoma
• PKU test for phenolketonuria in newborns
• TSH for hypothyroid and hyperthyroid
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 Validity
• Validity: The degree to which a measurement
measures what it intended to measure

• It is the ability of a test to indicate which

individuals have the disease and which do not

• Also known as ‘Accuracy’

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 Reliability
• The degree of stability expected when a measurement
is repeated under identical conditions (degree of
replicated results)

• Also known as ‘Reproducibility’ and ‘Precision’

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 Reliability, Reproducibility, Repeatability,

• Reproducibility, repeatability, reliability: all mean that the results of a test or

measure are identical or closely similar each time it is conducted
• Because of variation in laboratory procedures, observers, or changing
conditions of test subjects (such as time, location), a test may not
consistently yield the same result when repeated

• Reliability coefficients ranges from 0-1 (much error to no error).

• Different types of variation

-Intra-subject variation
-Intra-observer variation
-Inter-observer variation
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 Reliability vs. Validity

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 Validity divided into:
Sensitivity and Specificity

• Sensitivity: The ability of the test to identify

correctly those who have the disease

• Specificity: The ability of the test to identify

correctly those who do not have the disease

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 Determining the Sensitivity, Specificity of a
New Test

• Gold standard: test is the best test available

-It is often invasive or expensive

• A new test is, for example, a new screening

test or a less expensive diagnostic test
• Use a 2 x 2 table to compare the performance
of the new test to the gold standard test
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 Comparison of Disease Status: Gold
Standard Test and New Test

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 Sensitivity
• Sensitivity: is the ability of the test to identify
correctly those who have the disease (a)
from all individuals with the disease (a+c)

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 Specificity
• Specificity: is the ability of the test to identify
correctly those who do not have the disease
(d) from all individuals free from the disease
(b+d)

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 Applying Concept of Sensitivity and
Specificity to a Screening Test
• Assume a population of 1,000 people
• 100 have a disease
• 900 do not have the disease
• A screening test is used to identify the 100
people with the disease

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 Applying Concept of Sensitivity and
Specificity to a Screening Test
• The results of the screening appears in this
table

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 Calculating Sensitivity and Specificity

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 NOTE
• For screening: we should chose a test that
avoid false negative and give very high
sensitivity

• For clinical and medical practice we should

chose a test that avoid false positive and with
very high specificity

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 Screening
• Screening refers to secondary prevention and
early detection
• It is the process of using tests to distinguish
apparently healthy persons who probably
have a disease from those who probably do
not have that disease to prevent the adverse
outcomes

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 Screening
• Mass: for whole population
• Multiple or multi-phasic: several screening
tests at the same time
• Targeted: for groups with specific
characteristics and risk factors
• Case-finding or opportunistic: for patients who
consult a health practitioner for some other
purpose

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 Predictive Values
• Positive predictive value (PPV):
-The proportion of patients who test
positive who actually have the disease
• Negative predictive value (NPV):
-The proportion of patients who test
negative who are actually free of the disease

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 Another Interpretation of PPV

• If a person tests positive, what is the

probability that he or she has the disease?
• (And if that person tests negative, what is the
probability that he or she does not have the
disease?)

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 Behind the Test Results

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 What the Test Shows

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 Predictive Value

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 Applying Concept of Predictive Values to
Screening Test
• Assume a population of 1,000 people
• 100 have a disease
• 900 do not have the disease
• A screening test is used to identify the 100 people with the
disease
• The results of the screening appear in this table

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 Calculating Predictive Values

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 Calculating Predictive Values

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 Important:

• Sensitivity and specificity do not vary

according to the prevalence of the
disease in the population.
• Predictive value of a test, however is
HIGHLY DEPENDENT on the prevalence
of the disease in the population
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 Intra-subject variation
Intra-subject variation is a variation in the
results of a test conducted over a short
period of time on the same individual due to
the changes (such as physiological,
environmental, etc.) occurring to that
individual over that time period

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 Inter-Observer and Intra-Observer
Variation
• Inter-observer variation is a variation in the result
of a test due to multiple observers examining the
result (inter = between)
• Intra-observer variation is a variation in the result
of a test due to the same observer examining the
result at different times (intra = within)
• The difference is due to the extent to which
observer(s) agree or disagree when interpreting
the same test result

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Agreement between Two Observers (Or Two
Observations)
-A perfect agreement occurs when:
b=0
c=0

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 Example

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 Chain of Infection

 The interaction of agent, host, and environment

 Transmission occurs when the agent leaves its

reservoir or host through a portal of exit, and is
conveyed by some mode of transmission, and enters
through an appropriate portal of entry to infect a
susceptible host.

 Fig.??

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 Chain of Infection

Figure: Chain of infection

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 Chain of Infection

 Reservoir:

 Human (carriers, persons with symptomatic illness;

e.g., measles, mumps)
 Animal (Brucellosis)
 Environmental (Plants, water, soil)

 Portal of exit: path by which an agent leaves the

source host (e.g., Respiratory tract)

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 Chain of Infection

 Modes of transmission:

Direct

Direct contact

Droplet spread

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 Chain of Infection

 Modes of transmission:
Indirect
Airborne: particles that are suspended in air
Vehicleborne: inanimate like food, water, biologic
products (blood)
Vectorborne: animate like mosquitos
o Mechanical: agent does not multiply or undergo
physiologic changes in the vector
o Biological: agent undergoes part of its life cycle inside
a vector before being transmitted to a new host

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 Chain of Infection

 Portal of entry: provide access to tissues in which

the agent can multiply or a toxin can act on the
host (e.g., Mouth, skin, blood)

 Host: Discussed previously!

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 Chain of Infection

 The chain of infection may be interrupted when an

agent does not find a susceptible host
 Herd immunity: For infectious diseases…

 High proportion of individuals in a population is resistant

to an agent. These persons limit spread to the relatively few
who are susceptible by reducing the probability of contact
between infected and susceptible persons
 In theory, herd immunity means that not everyone in a
community needs to be resistant (immune) to prevent
disease spread and occurrence of an outbreak.

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 Chain of Infection

 Herd immunity: For infectious diseases…

 Degree of herd immunity necessary to prevent or abort an

outbreak varies by disease

 Herd immunity has not prevented outbreaks of measles and

rubella in populations with immunity levels as high as 85
to 90%

 For some other disease 90% is sufficient for example!

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 Introduction to Non-
Comunicable Diseases

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 Introduction
• Non-communicable diseases (NCDs) are responsible for nearly
40 million deaths each year which represents almost 75% of
all deaths worldwide

• This includes deaths caused by injuries from motor vehicle

accidents, and chronic diseases, such as cardiovascular
disease, cancer, diabetes, and chronic respiratory diseases.

• The majority of these deaths occur in low- and middle-income

countries where the number of people affected by NCDs is
growing and health systems are often not equipped to
respond effectively.

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10 Leading Causes of Death in the World

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 DEMOGRAPHIC AND EPIDEMIOLOGIC
TRANSITION

Demographic Transition
Epidemiologic Transition
A change in the population dynamics of
A transition from predominance
a country as it moves from high fertility
of infectious diseases to chronic
and mortality rates to low fertility and
or degenerative diseases
mortality rates.

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 Health Promotion

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Health promotion:
 Health promotion is a guiding concept
involving activities intended to enhance
individual and community health well-
being
 It seeks to increase involvement and
control of the individual and the community
in their own health

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Key Terms in the definition
A. Health promotion is a key element
in public health and is applicable in
the community, clinics or hospitals,
and in all other service settings
 Raising awareness and informing
people about health and lifestyle
factors that might put them at risk
requires teaching
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 Public Health Surveillance

 The mechanism that public health agencies use to

monitor the health of their communities

 Purpose is to set priorities, plan programs, and take

actions to promote and protect the public’s health.

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 Public Health Surveillance
 Definition: the ongoing systematic collection,
analysis, interpretation, and dissemination of health
data

 The cycle begins when cases of a disease occur and

are reported by health care providers to the public
health agencies

 Figure!!

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 Public Health Surveillance

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 Public Health Surveillance
 Therefore, the goal of surveillance is not merely to
collect data for analysis, but to guide public health
policy and action

 In other words “Information for Action”

 Figure!

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 Public Health Surveillance

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 Public Health Surveillance
 Two terms:

 Public health surveillance: monitoring health events

in populations

 Medical surveillance: monitoring potentially exposed

individuals to detect early symptoms

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 Public Health Surveillance

 More recently established surveillance systems

monitor a broader variety of health conditions,
including injuries, birth defects, chronic diseases, and
health behaviors

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 Uses of Surveillance

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 Sources of Data
 WHO key sources of surveillance data:


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 Establishing a Surveillance System
 Many situations might arise to induce health
authorities to establish a new surveillance system

 Examples: emergency settings such as a refugee

camp or when a serious new disease has been
identified

 Before establishing a new system we should consider

the following:

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 Establishing a Surveillance System
 Factors to consider when establishing a surveillance
system:
 Justification
 Objectives
 Case definition
 Operations (collection, analysis, interpretation, and
dissemination)
 Cooperation
 Implementation

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 Establishing a Surveillance System
 Two terms:

1. Passive surveillance (HCP-report to HD)

Provider initiated
2. Active surveillance (HD-contact persons to see cases to
request report)
Health department initiated
 Active surveillance is more better and emphasize a higher
quality and complete data!!
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 Palestinian Health Information Center
(PHIC)
• Palestinian Health
Information Center
(PHIC) is department
within the Palestinian
Ministry of Health
(MOH); Responsible for
Health Management
Information System in
Palestine

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National Notifiable Disease Surveillance
• Reporting mandated by state law/regulation
• Health care providers (hospitals and
professionals), laboratories, UNRWA, private
and public clinics, report to local HD
• HD submits reports to State ( Ministry of
health)
• Reports transmitted to CDC, WHO

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 National Notifiable Diseases Surveillance
System
A . Diseases to be notified IMMEDIATELY
1 – acute flaccid paralysis 2 – poliomyelitis
3 – aids / HIV 4 - cholera
5 – diphtheria 6 – food poisoning
7 – measles 8 – meningitis
9 – hemorrhagic fever 10 – plague
11 – Rabies 12 Tetanus(neonatal , adult ) .
13 – yellow fever 14 – Corona virus
15 – H1N1 16 - any emerging disease

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 National Notifiable Diseases Surveillance
System
B - Diseases to be notified WEEKLY

• 1. Brucellosis 2. Chemical
Poisoning
• 3 Encephalitis 4. Viral Meningitis
• 5. Viral Hepatitis 6. Leprosy
• 7. Leishmaniasis 8. Malaria
• 9. Whooping Cough 10 .Ickettsiosis
• 11 .Rubella 12 .Mumps
• 13 . STD’s 14 . Tuberculosis
• 15 . Typhoid & Paratyphoid Fever 16 . Salmonella
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 National Notifiable Diseases Surveillance
System
• C - Diseases to be notified MONTHLY
• 1 .bites
• 2 .chickenpox
• 3. herpes
• 4. hydated cyst
• 5. intestinal parasitic diseases (Ascariasis,
Oxyuriasis,Strangyloidiasis, eniasis, Amebiasi )
6. giardiasis
• 7. scabies
• 8. scarlet fever
• 9. septicemia
• 10. shigellosis
• 11. toxopasmosis
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 Investigating an Outbreak
 One of the most exciting and challenging tasks facing
an epidemiologist
 Frequently, the cause and source of the outbreak are
unknown
 People in the community are concerned and have
fears
 In this setting the epidemiologist must remain calm,
professional, and scientifically objective
 They provide the scientific basis for the population
and the prevention orientations that are needed

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 Investigating an Outbreak
 An outbreak may be reported by a health provider or
community members
 The goal of investigation should be to get over the
OB or prevent further cases and/or to prevent future
OBs and to conduct research and identify the natural
history of the disease
 How extensively to investigate an outbreak is
influenced by:
 The severity of the illness
 The source or mode of transmission
 The availability of prevention/control measures
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 Steps of anOutbreak Investigation
 In the process of investigating an ongoing outbreak
working quickly and getting the right answer are
essential
 We should have a systematic forwarded investigation
without missing important steps along the way
 The following steps should be followed BUT in
practice two steps (for examples) may be taken
together with different order sometimes

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 Steps of anOutbreak Investigation

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 Vaccinations

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 What is vaccination?
• Vaccination: Is the administration of antigenic
material (a vaccine) to stimulate the immune
system of an individual to develop adaptive
immunity to a disease
• Immunization is an example on primary
prevention

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Immunization schedule for Palestine
(Last alteration was in July 2012)

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 Main Achievements in Palestine
• 1. Polio:
No cases of polio were reported since 1988.
The combined vaccination programme of Oral
Polio Vaccine (O.P.V.) and Inactivated Polio
Vaccine (I.P.V.) has been implemented since
1978. The national vaccination coverage is
almost 100%

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 Vaccine Program in Palestine
2: Measles
• Palestine is considered by WHO to be in the phase of
eliminating this disease
• Measles elimination means that no measles cases should
occur inside the country but cases could be imported from
other countries and the virus could circulate inside the
country without infection
• The serosurvey of 2005 showed that more than 98% of
children had high immunity against measles. Only sporadic
cases were reported in the last ten years. Measles diagnosis,
hospitalization and treatment are offered free of charge, as for
other vaccine-preventable diseases
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 Vaccine Program in Palestine
3. Neonatal tetanus:
• The global goal set by WHO to eliminate Neonatal
Tetanus (NT) was achieved in Palestine since 1990
• Elimination means that NT cases should be one case
or less reported for every 1,000 newborns per year
per district
• Two booster doses are given to all children, one at
school entry level and the other at age 15. Tetanus
toxoid is given to every pregnant woman more than
28 years of age
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 Vaccine Program in Palestine
• The aim of giving this vaccination is to; Protect new
born babies from getting tetanus
• This happens by increasing the anti body levels in the
mums, which in turn transfer to their babies
• According the Palestinian EPI if the mother never get
the TT vaccination she needs to be injected twice one
during her pregnancy, no matter the month, and
another after giving birth
• If the mother was previously given the TT, a pester
dose will be given to her every 10 years
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 Vaccine Program in Palestine
• 4. Hepatitis B
• The prevalence of Hepatitis B in Palestine was
dramatically reduced after the introducing of the
Hepatitis B vaccine in the national immunization
schedule in early 1992.
• The incidence of Hepatitis B in 1989 was around 7%
and in 2000 it was around 3.4%.
• While for 2006 was not exceed 2%, meaning that
Palestine passed from an intermediate to a low
endemic country
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 Public Health Program Evaluation

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Evaluation
1. Effectiveness: refers to the ability of a
program to produce the intended or
expected results in the field
2. Efficacy: is the ability to produce results
under ideal conditions
3. Efficiency refers to the ability of the program
to produce the intended results with a
minimum expenditure of time and resources

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 Global Health

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The Universal Declaration of
Human Rights
“Everyone has the right to a
standard of living adequate for
the health and well being of
himself and his family,
including food, clothing,
housing and medical care.”
Universal declaration of human rights,
1948

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What is Global Health?
"health problems, issues and
concerns that transcend national
boundaries, may be influenced by
circumstances or experiences in
other countries, and are best
addressed by cooperative actions
and solutions."

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Achievements of GH
1. Life Expectancy;

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Achievements of GH
2. Vaccination; eradication of smallpox;
And the elimination of other deadly
diseases through political commitment
under the supervision of the WHO
3. Exchange of medications, and health
care expertise

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Challenges of GH
1. Poverty
2. Emerge of new communicable
diseases
3. Non-Communicable diseases
4. Child Obesity
5. Injuries
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