Epidemiology and Biostatistics

Measurement of health & disease
University of Gondar
Dep’t of Epidemiology and Biostatistics
By Koku S. (BSc, MPH)

Course objective
• At the end of this course students will be able to apply public

health methods for measurement of health and disease at
population level
Course contents
• Introduction to public health

• Epidemiological concepts of disease causation
• Epidemiological studies and measurements of
association
• Public health surveillance
• Outbreak investigation and management
• Handling data
Assessment Methods
❑Continuous Assessment: Class Participation,
Assignments , Quizzes, Tests/mid-examination, and
etc – 50%
❑Final Written Examination – 50%
4
Chapter One
Introduction to Public health
Definitions of terms:
Health is a difficult concept to define.
WHO in 1948 defined health as “A state of complete
physical, mental and social well being and not merely the
absence of disease or infirmity.”
Public health - a science and an art of preventing

disease, prolonging life, and promoting health and
efficiency through organized community effort for
sanitation, control of communicable disease, health
education, etc.
Clinical versus community medicine:
Clinical medicine is concerned with diagnosing

and treating diseases in individual patients,
while community medicine is concerned with
diagnosing the health problems of a
community, and with planning and managing
community health services.
Methods of Community Diagnosis:
❖Discussion with community leaders and health

workers
❖Survey of available health records
❖Field survey.
❖Compilation and analysis of the data.
7
➢ It is impossible to address all the identified problems
at the same time because of resource scarcity.
➢ Therefore the problems should be put in the order of

priority using a set criterion.
8
Criteria for priority setting
❖Magnitude (amount or frequency) of the problem
❖Severity (to what extent is the problem disabling,
fatal)
❖Feasibility (availability of financial and material
resource, effective control method)
❖Community concern (whether it is a felt problem of
the community)
❖Government concern (policy support, political
commitment)
9
Health p1 2 3 4
Magnitude
Severity
Feasibility
Community
concern
Gov’t concern
Total
10
EPIDEMIOLOGY
It can be defined as the study of the
frequency,
distribution and
determinants of diseases and health related states
or events in specified human populations and the
application of this study to the promotion of
health and to the prevention and control of major
health problems
11
Components of the definition
➢“Population” the focus of epidemiology is mainly on
the population rather than individuals.
➢ “Frequency” shows epidemiology is mainly a
quantitative science.
❖Epidemiology is concerned with the frequency of diseases
and other health related conditions.
❖Frequency of diseases and deaths are measured by
morbidity rates and mortality rates.
12
➢ “Health related conditions” are conditions which
directly or indirectly affect or influence health.
These may be injuries, vital events, health related
behaviors, social factors, economic factors etc.
➢ “Distribution” Refers to the distribution of

diseases in time, place and person.
13
❖The part of epidemiology concerned with the
frequency and distribution of diseases by time, person
and place is named Descriptive Epidemiology.
❖It asks the questions: How many? Where? When?

What?
14
➢Determinants” are factors which determine whether
or not a person will get a disease.
❖The part of epidemiology dealing with the causes and

determinants of diseases is Analytical Epidemiology.
❖It asks the questions: how? Why?
15
Scope of Epidemiology
➢ Originally, epidemiology was concerned with epidemics
of communicable diseases and epidemic investigations.
➢ Later it was extended to endemic communicable
diseases and non-communicable diseases
16
At present epidemiologic methods are being applied
to:
➢Infectious and non infectious diseases

➢Injuries and accidents
➢Nutritional deficiencies
➢Mental disorders
➢ Maternal and child health
➢Congenital anomalies
➢Cancer
➢Occupational health
➢Environmental health
➢Health behaviors
➢Violence etc.
all disease conditions and other health related events.
17
Purpose/Use of Epidemiology
➢The ultimate purpose of Epidemiology is prevention
and control of disease, in an effort to improve the
health status of populations.
➢This is realized through:
1. Elucidation of the natural history of disease
2. Description of the health status of the population
3. Establishing the determinants/causation of disease
4. Evaluation of intervention
18
Fundamental Assumptions in
Epidemiology
There are two basic assumptions in epidemiology.
1. Non random distribution of diseases i.e. the
distribution of disease in human population is
not random or by chance and
2. Human diseases have causal and preventive
factors that can be identified through systematic
investigations of different populations.
❖Epidemiology uses systematic approach to study the
differences in disease distribution in subgroups
19
Risk Factors:
• Any factor associated with an increased or decreased
occurrence of disease.
• A factor associated with an increased occurrence of a
disease is risk factor for the exposed group; and a
factor associated with a decreased occurrence of a
disease is a risk factor for the non exposed group.
20
Risk factors could be:
➢ Factors related to the agent: Strain difference
➢ Factors related to the human host: Lack of specific
immunity.
➢ Factors related to the environment: Overcrowding, Lack of
ventilation
Risk factors may further be classified as:
• Factors susceptible to change: smoking habit, alcohol
drinking habit
• Factors not amenable to change: age, sex, family
history
21
✓ In order to be able to prevent disease, it is vital to
identify factors that can be changed.
✓ For some diseases, the specific causes are not known.
In such cases it is very important to identify risk
factors, especially those that can be changed and act
on them.
✓ Epidemiology is mainly interested in those risk factors
that are amenable to change as its ultimate purpose is
to prevent and control disease and promote the health
of the population.
22
Chapter Two
Epidemiological concept of disease causation
Session objectives
➢ At the end of this chapter the student is expected

to:
Discuss the concept of disease causation
Describe the theories & Models of disease causation
24
HOW THE DISEASE IS CAUSED?
➢ 20th century theories
1. Supernatural theory of disease
2. Ecological theory
3. Germ theory
4. Multifactorial causation theory
25
1. SUPERNATURAL THEORY OF DISEASE
• At least 10% of the people in developed countries and 30% in

developing countries still believe in supernatural origin
• Even today superstitions are becoming major obstacles in

disease control
• Most of the literates view that disease is the result of microbes
• Most of the uneducated people (90%) believe that disease is due

to bad physical environment
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2. ECOLOGICAL THEORY
• Around 463 BC, hippocrates is the first epidemiologist
who advised to search the environment for the cause
of the disease.
• Mckeown has pointed out, improved health owes less
to advances in medical science than to the operation of
natural ecological laws
• He rightly advised to search air, water and places for
the cause of a disease
• In ecological approach an agent is considered necessary
but not sufficient cause of a disease.
27
3. GERM THEORY
Germ theory: Microbes (germs)
were found to be the cause for
many known diseases.
Pasteur, Henle and Koch were the

strong proponents of microbial
theory after they discovered the
micro-organisms in the patients’
ROBERT KOCH
secretions or excretions.
28
HENLE-KOCH’S POSTULATES
➢ Koch's Postulate : a set of rules for determination of causation,
states that:-
1. The organism must be present in every case.
2. The organism must be isolated and grown in culture.
3. The organism must, when inoculated into a susceptible animal,

cause the specific disease.
4. The organism must then be recovered from the animal.
29
➢The requirement that more than one factor be present for
disease to develop is referred to as multiple causation or
multifactorial etiology
30
31
DISEASE CAUSATION MODELS
• How do diseases develop?

• Epidemiology helps researchers visualize disease
and injury etiology through models. Best known
disease causation models are
1. Epidemiological triangle
2. Web of causation
3. Wheel model
1. The epidemiologic triangle
Agent
Host Environment
• The most familiar disease model, the epidemiologic triad (triangle),

depicts a relationship among three key factors in the occurrence of
disease or injury.
Epidemiological triad model con’t…
• An agent is a factor whose presence or absence,
excess or deficit is necessary for a particular disease
or injury to occur.
• General classes of disease agents include;
1. Chemicals such as benzene, oxygen, and asbestos;
2. Microorganisms such as bacteria, viruses, fungi, and
protozoa; and
3. Physical energy sources such as electricity and
radiation.
• Many diseases and injuries have multiple agents.
• The environment includes all external factors, other
than the agent, that can influence health. These
factors are further categorized according to whether
they belong in the social, physical, or biological
environments.
• The social environment including availability of

medical care and health insurance; cultural “dos” and
“don’ts” regarding diet and so on.
• The physical environment:- climatic conditions,
pollution…
• The biological environment:- vectors, humans and
plants and animals acting as a reservoir
• The host is the actual or potential recipient or
victim of disease or injury. Although the agent and
environment combine to “cause” the illness or injury
if the host is not susceptible disease will not occur.
• According to this model Disease and injury occur
only when the interaction between the three factors
is altered.
2. The web of causation model
• It was developed especially to enhance understanding of
chronic disease, such as cardiovascular disease. However, it
can also be applied to the study of injury and communicable
diseases
Stress diet
Hormones physical inactivity
Smoking obesity heredity

Blood clotting hardening of arteries
Heart disease stroke hypertension
3. The Wheel model The wheel consists of a hub (the host
or human), which has genetic makeup as its core. Surrounding the
host is the environment. The size of each part varies according to
the type of disease shown.
Social
Physical environment
environment
Host (man)
vc
Genetic core
Biologic environment
Natural History of Disease and Levels
of Prevention
39
Natural history of disease
❑ Is the course of a disease over time without any
treatment or intervention.
• Help for better to understand and plan intervention

measures including prevention and control of
diseases.
40
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There are four stages in the natural history of
a disease.
These are:
❑Stage of susceptibility/exposure
❑Stage of pre-symptomatic (sub-clinical) disease
❑Stage of clinical disease and
❑Stage of disability or death
42
1. Stage of susceptibility
Disease has not yet developed, but there are factors that
favor its occurrence
Examples:
❑ A person practicing casual and unprotected sex has a
high risk of getting HIV infection.
❑ An unvaccinated child is susceptible to measles.
❑ High cholesterol level increases the risk of coronary
heart disease.
43
2.Stage of Pre-symptomatic (sub-clinical)
disease
In this stage there is no manifestation of the disease
but pathogenic changes have started to occur.
There are no detectable signs or symptoms.
The disease can only be detected through special
tests.
Examples:
❑Detection of antibodies against HIV in an apparently
healthy person.
❑Ova of intestinal parasite in the stool of apparently
healthy children.
44
3. The Clinical stage
➢ By this stage the person has developed signs and
symptoms of the disease.
➢ The clinical stage of different diseases differs in duration,
severity and outcome.
➢ The outcomes of this stage may be recovery, disability
or death.
Examples:
❑ Common cold has a short and mild clinical stage and
almost everyone recovers quickly.
❑ Polio has a severe clinical stage and many patients
develop paralysis becoming disabled for the rest of
their lives.
❑ Rabies has a relatively short but severe clinical stage and
almost always results in death.
❑ HIV/ AIDS has a relatively longer clinical stage and
eventually results in death. 45
4. Stage of disability or death
➢ The disease has occurred and left damage to the
body that limits the activity of the victim(disability)
or has ended with the death of the victim
Examples:
❑ Trachoma may cause blindness
❑ Meningitis may result in blindness, deafness or

death.
46
Healthy person
Sub clinical disease
Recovery
Clinical disease
Recovery Death
Disability
47
Disease Prevention
❑The major purpose in investigating the epidemiology
of diseases is to learn how to prevent and control
them.
❑ Disease prevention means to interrupt or slow the
progression of disease.
❑Epidemiology plays a central role in disease

prevention by identifying those modifiable causes.
48
Levels of disease prevention
1. Primary
❑health promotion
❑Prevention of exposure
❑Prevention of disease
2. Secondary prevention
❑Screening
❑Early detection and treatment
3. Tertiary prevention
❑Rehabilitation
49
1. Primary prevention
❑ Is aimed at preventing healthy people from
becoming sick.
❑ The main objectives of primary prevention are

promoting health, preventing exposure and
preventing disease.
❑ Primary prevention keeps the disease process from

becoming established by eliminating causes of
disease or increasing resistance to disease.
50
1.1 - Health promotion
▪ Consists of general non-specific interventions that
enhance health and the body's ability to resist disease.
▪ Improvement of socioeconomic status, provision of

adequate food, housing, clothing, and education are
good examples of health promotion.
51
1.2 - Prevention of exposure
❑is the avoidance of factors which may cause
disease if an individual is exposed to them.
❑ Examples can be provision of safe and

adequate water, proper excreta disposal, and
vector control.
52
1.3 - Prevention of disease
▪ Is the prevention of disease development after the
individual has become exposed to the disease
causing factors.
▪ The timing is between exposure and biological

onset.
▪ Post-exposure prophylaxis for HIV exposed individuals
53
2. Secondary prevention
❑ Detecting people who already have the disease as
early as possible and treat them.
❑ It is carried out after the biological onset of the
disease, but before permanent damage sets in.
❑ The objective of secondary prevention is to stop or
slow the progression of disease and to prevent or
limit permanent damage.
Examples:
❑ Prevention of blindness from Trachoma
❑ Early detection and treatment of breast cancer to
prevent its progression to the invasive stage
54
3. Tertiary prevention
❑ Is targeted towards people with chronic diseases and
disabilities that cannot be cured.
❑ Tertiary prevention is needed in some diseases
because primary and secondary prevention have
failed, and in others because primary and secondary
prevention are not effective.
55
Tertiary prevention cont’d
It has two objectives:
❑ Treatment to prevent further disability or death
and
❑ To limit the physical, psychological, social, and
financial impact of disability, thereby improving the
quality of life.
❑ This can be done through rehabilitation, which is
the retaining of the remaining functions for
maximal effectiveness.
56
Level of prevention Point of intervention
Natural history of disease
Primary Health promotion

Prevention of exposure
exposure
Prevention of disease
Secondary Biological onset
Early detection &treatment =screening
(prevention of clinical onset )
incubation period
Clinical onset
Early treatment
(prevention of permanent damage )
Tertiary Limitation of disability Permanent

damage
Rehabilitation (prevention of deterioration

in quality o f life ) Death 57
QUIZ#1
For each of the following intervention, indicate what level
of prevention is involved
1. Special education for the handicapped children.
2. Treatment of people with a diagnosis of active TB.
3. Screening donated blood to exclude
contaminating with causation agent of HBV.
4. Promoting awareness in high school students of
self-protective measure against HIV/AIDS.
5. Counseling AIDS patients and their families with
the objective of helping them find ways of relieving
their mental stress and financial burden imposed
by the illness.
58
Thank you!
59
CHAPTER THREE
Measurement of Disease and Death
Measurements of Disease
In Epidemiology there are two ways of measuring
morbidity
1. Incidence rate
2. Prevalence rates
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Incidence Rate
➢ The incidence of a disease is defined as the number
of new cases of a disease that occur during a
specified period of time in a population at risk for
developing the disease.
• Because incidence is a measure of new events (i.e.

transition from a non-diseased to a diseased state),
It is a measure of risk.
Types of incidence
1. Cumulative Incidence (CI)
➢ An incidence rate that is calculated from a population
that is more or less stable (little fluctuation over the
interval considered), by taking the population at the
beginning of the time period as denominator.
➢ The cumulative incidence assumes that the entire
population at risk at the beginning of the study period
has been followed for the specified time interval for
the development of the outcome under investigation
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CI = Number of new cases of a disease
during a given period of time X 1000
Total population at risk
Example A: In the study of diabetics, 100 of the 189 diabetic

men died during the 13-year follow-up period.
➢ Calculate the risk of death for these men.
Numerator = 100 deaths among the diabetic men
Denominator = 189 diabetic men
Risk = (100 / 189) x 100 = 52.9%
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2.Incidence Density
➢ An incidence rate whose denominator is calculated using person-
time units.
➢ Similar to other measure of incidence, the numerator of the

incidence density is the number of new cases in the population.
➢ The denominator, however, is the sum of each individual’s time at

risk or the sum of the time that each person remained under
observation, i.e., person – time denominator.
➢ This is particularly when one is studying a group whose members

are observed for different lengths of time.
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➢ ID =Number of new cases during a x10n
given period
Time each person was observed, totaled for all
❖ 1 individual is followed for 1 yr = 1pyr

❖ 1 individual is followed for 4 years = 4pyr
❖ 4 individuals followed for 1 = 4pyr
❖ 1 individual is followed for 1 yr = 12 pmonth=365pday
❖ 1individual is followed for 6month=6pmonth=1/2pyr
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Lab tech rotation to hematology section
Total number of students
Stay in hematology lab person year
contrib. 60
20 students for 3 months 20X1/4
20 students for 6 months 20X1/2
20 students for 1 year 20X1
35 person yr
If 10 students develop hepatitis=(10/35)X100
= 28.57 new infections /100 person years of
observation
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Example 1 : The diabetes follow-up study included 218 diabetic women and
3,823 non diabetic women. By the end of the study, 72 of the diabetic
women and 511 of the non diabetic women had died. The diabetic
women were observed for a total of 1,862 person-years; the non
diabetic women were observed for a total of 36,653 person-years.
➢ Calculate the incidence rates of death for the diabetic and non-diabetic
women.
- For diabetic women, numerator = 72 and denominator = 1,862 Person-
time
= 72 / 1,862
= 0.0386 deaths per person-year
IR = 38.6 deaths per 1,000 person-years
➢ For non diabetic women, numerator = 511 and denominator = 36,653
Person-time
= 511 / 36,653 = 0.0139 deaths per person-year
IR= 13.9 deaths per 1,000 person-years
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Person-Time – example 2
Jan Jan Jan

1980 1989 1999
Subject 1 ------------------x 9 Person-Years (PY)
Subject 2 10 PY
------------------x
Subject 3 19 PY
------------------------------------ 38 PY
X = outcome of interest, thus the incident rate is 2/38 PY

2. Prevalence rate
➢ Prevalence rate measures the number of people in a
population who have a disease at a given time.
➢ It includes both new and old cases.
There are two types of prevalence rates.

1. Period Prevalence rate
2. Point Prevalence rate
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1. Period prevalence rate
❖Period Prevalence rate measures the proportion of a
population that is affected with a certain condition during
a specified period of time.
PPR = # people with a condition during a specific period of time X10n

average population
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Point Prevalence rate
❖ Measures the proportion of a population with a
certain condition at a given point in time.
❖This is not a true rate; rather it is a simple
proportion.
➢ PtPR=All persons with a specific condition at

a point in time *1000
Total population
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Exercise 1
❑Each horizontal line in the next figure represents one
of 10 persons who had giardiasis (a parasitic intestinal
infection which doesn’t confer immunity against
subsequent infections) in a population of 100.
❑The date of onset and duration of each episode
indicated by a line of X’s .the vertical lines indicate
specific dates.
❑Calculate the following
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a. Population at risk for giardiasis on Jan 1, 1990
b. Incidence rate of giardiasis in 1990
c. Point prevalence rate of giardiasis on Jan 1 1990
d. The period prevalence of giardiasis in 1990
e. The point prevalence of giardiasis on July1, 1990
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• A=98
• B=6/98*1000=6.1per1000
• C=20per 1000
• D=80per 1000
• E=40per 1000
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Relationship between incidence and point
prevalence
➢ Since point prevalence rate includes both new and
pre-existing cases, it is directly related to the
incidence rate.
➢ Point prevalence rate is directly proportional both to
the incidence rate and to the average duration of the
disease.
▪ Point Prevalence rate = IR x D
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Factors influencing prevalence rate
a) severity of illness - for highly fatal (lethal) diseases
the prevalence rate is low.
b) duration of illness - short duration of disease leads
to low prevalence rates.
c) the number of new cases - the higher the number
of new cases the higher will be the prevalence.
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Prevalence can be increased by
❑Longer duration of the disease

❑Prolongation of life of patients without cure
❑Increase in new cases (increase in incidence)
❑In-migration of cases
❑Out-migration of healthy people
❑Improved diagnostic facilities and better reporting
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Prevalence can be decreased by
❑Shorter duration of disease
❑High case - fatality rate
❑Decrease in new cases
❑In-migration of healthy people
❑Out-migration of cases
❑Improved cure rate of cases
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Prevalence rate is not a helpful measure to provide
strong evidence of causation and risk of development
of a disease.
Prevalence rates are important particularly for

❑Chronic disease studies
❑Planning health facilities and manpower
❑Monitoring disease control programs
❑Tracking changes in disease patterns over time
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Incidence rate is important as
❑A fundamental tool for etiologic studies of acute
and chronic diseases
❑A direct measure of risk
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Limitations of prevalence studies
➢ Prevalence studies favor inclusion of chronic over
acute cases.
➢ Disease status and attribute are measured at the
same time; hence, temporal relations cannot be
established.
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Measurements of Death
Mortality rates and ratios
• Mortality rates and ratios measure the occurrence of
deaths in a population using different ways.
• Below are given some formulas for the commonly
used mortality rates and ratios.
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Crude Death rate (CDR)
➢CDR= Total no. of deaths reported X 1000
during a given time interval
Estimated mid interval population
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Age- specific mortality rate
= No. of deaths in a specific age group during a given time X1000

Estimated mid interval population of sp. age group
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Sex- specific mortality rate
= No. of deaths in a specific sex during a given time X 1000
Estimated mid interval population of same sex
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Cause- specific mortality rate
CSDR= No. of deaths from a specific
cause during a given time X 100,000
Estimated mid interval population
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Proportionate mortality ratio
PMR= No. of deaths from a sp. cause during a given time x 100
Total no. of deaths from all causes in the same time
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Case Fatality Rate
CFR= No. of deaths from a sp. disease during a given time x 100
No. of cases of that disease during the same time
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Perinatal Mortality Rate
PMR= No. of fetal deaths of 28 wks or more gestation

Plus no. of infant deaths under 7 days
Still birth plus the no. of live births during the same
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Neonatal Mortality Rate
NMR= No. of deaths under 28 days of age reported

during a given time x 1000
No. of live births in the same area& during the same year
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Infant mortality rate
IMR= No. of deaths under 1 yr during a given time X 1000
No. of live births in the same area& during the same yr
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Child mortality rate
= No. of deaths of 1-4 yrs of age during a given time X 1000
Average (mid-interval) population of same age at same time
Under- five mortality rate

= No. of deaths of 0-5 yrs of age during a given time X 1000
Average (mid-interval) population of the same age
at same time
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Maternal Mortality Ratio
MMR=Total no of female deaths due to complications of pregnancy,
child birth & puerprium in an area in a year x 100,000
No. of live births in the same area & year
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➢ When calculating (using) mortality rates it is important to
understand their interpretations and how they differ from
each other.
➢ For example case fatality rate; proportionate mortality ratio,

and cause specific death rates are often confused.
➢ They all have the same numerator, i.e. number of deaths

from a specified cause, occurring in a specified population,
over a specified period of time.
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➢ The case fatality rate asks the question: “what proportion of
the people with the disease die of the disease?”
➢ The proportionate mortality ratio asks the question:” out of

all the deaths occurring in that area, what proportion are
due to the cause under study?”
➢ The cause specific death rate asks the question: “out of the
total population, what proportion dies from a certain
disease within a specified period of time?”
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SCREENING AND SCREENING
PROGRAM EVALUATION
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Definition
• Screening is the search for unrecognized disease or defect by
means of rapidly applied tests, examinations or other
procedures in apparently healthy individuals.
• A screening test is not intended to be diagnostic.
• Screening is an initial examination only, and positive

responders require a second, diagnostic examination
• When screening tests are applied to large, unselected

populations, the process is called mass screening.
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Case finding (diagnosis)
• Occurs when clinicians search for diseases with tests among
their own patients who are consulting them for
symptoms/complaints
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Objective of Screening Tests
• To lower morbidity and mortality of the disease in a
population.
• Screening provides access to the medical care system
which is not an actual goal of screening, but is a benefit.
To reverse, halt, or slow the progression of a disease to

its severe form and to improve quality of life
o Research: study on natural history of disease
o Selection of healthy individuals usually for employment
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Primary requirements for screening
1. Pre-clinical disease left untreated typically

progresses to clinically-evident disease (e.g. no
spontaneous regression).
2. The disease should be serious (relates to cost
effectiveness, ethics, and prognosis).
3. Prevalence of pre-clinical disease should be
relatively high among those screened.
4. Treatment given before symptoms develop should
be more beneficial in terms of reducing morbidity
or mortality than that given after they develop
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An ideal screening test should be
1. Inexpensive,
2. Easy to administer,
3. impose minimal discomfort on the patients,
4. Valid and reliable.
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Validity of a screening test
• How good is the screening test compared with

the confirmatory diagnostic test?
• Validity of a test is the ability to differentiate

accurately between those who have the
disease and those who do not.
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Sensitivity and Specificity of a screening test
A. Sensitivity - is the ability of a test to identify

correctly those who have the disease. The
test will actually classify a diseased person as
likely to have the condition.
B. Specificity - is the ability of a test to identify

correctly those who do not have the disease.
The test will actually classify a non-diseased
person as unlikely to have the condition.
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Test Definitive diagnosis
result Diseased Non Total

diseased
Positive TP (a) FP (b) TP+FP
Negative FN (c) TN (d) TN+FN
Total TP+FN TN+FP TP+FP+TN+FN
10/30/2019 108
• Sensitivity: The probability of testing positive if
the disease is truly present
Sensitivity = a / (a + c)
= TP X 100
TP+FN
• Specificity: The probability of screening negative
if the disease is truly absent
Specificity = d / (b + d)
= TN X100
TN + FP
• Accuracy= a+d/a+b+c+d
10/30/2019 109
Predictive Value of a Screening Test
• Predictive value is the ability of a test to predict

the presence or absence of disease from test results.
• Predictive Value of a Positive Test (PVPT) or

Positive Predictive Values shows the probability that
the person tested positive by this specific test truly
has the disease.
PVPT = TP X 100%
TP + FP
10/30/2019 110
– Predictive Value of a Negative Test (PVNT) or
Negative Predictive Value Shows the degree of
confidence the disease can be ruled out by using
this specific test.
PVNT = TN X 100%
TN+FN
10/30/2019 111
• Predictive value of a test is determined by Sensitivity,
Specificity and the Prevalence of the disease.
• The higher the prevalence, the more likely it is that a
positive test is predictive of the diseases i.e. PVPT will
be high.
• The more sensitive a test, the less likely it is that an

individual with a negative test will have the disease and
thus the greater the predictive value negative.
• The more specific the test, the less likely an individual

with a positive test will be to be free from the disease
and the greater the predictive value positive.
10/30/2019 112
Reliability (Precision) of Screening Test
• A reliable screening test is one that gives consistent

results when the test is performed more than once
on the same individual under the same conditions.
• Two major factors affect consistency of results: the

variation inherent in the method and observer
variation (observer error).
10/30/2019 113
1. The variability of a method- depends on such
factors as the stability of the reagents used and
fluctuation in the substance being measured ( e.g in
relation to meals, diurnal variation).
2. Observer variation- can stem from differences

among observers (inter-observer variation) and also
from variation in readings by the same observer on
separate occasions (intra-observer variation).
10/30/2019 114
• These variations can usually be reduced by:
1. Careful standardization of procedures

2. An intensive training period for all
observers (or interviewers)
3. Periodic checks on their work
4.The use of two or more observers making
independent observations.
10/30/2019 115
Evaluation of screening program
• Evaluation of a screening program involves
consideration of two issues:
– Whether the program is feasible, and
– Whether it is effective.
10/30/2019 116
Feasibility
The feasibility of a screening program is determined by
• The acceptability of the program to the potential
screenees,
• Cost-effectiveness,
• The subsequent diagnosis and treatment of
individuals who test positive,
• The yield of cases.
10/30/2019 117
Feasibility
Persons with the disease

• Yield = detected by the test X 100
Total screened
• Yield = TP X 100
TP + FN + TN + FP
10/30/2019 118
Effectiveness
➢ The evaluation of the effectiveness of a screening
program must be based on measures that reflect the
impact of a program on the course of a disease.
➢ An effective screening program should result in

reduction of morbidity, mortality and disability.
10/30/2019 119
Exercise
Diagnostic(Gold standard Test)
Positive Negative Total
350 50 400
Positive
Screening
Test
150 450 600
Negative
500 500 1000

Total
10/30/2019 120
Exercise .... Calculate and Interpret
from the above table
1. Sensitivity
2. Specificity
3. PPVT
4. NPVT and
5. Yield of the screening test
10/30/2019 121
10/30/2019
CHAPTER FOUR
EPIDEMIOLOGIC STUDIES
10/30/2019 123
Epidemiological design strategies
o Epidemiology is primarily concerned with the distribution

and determinants of disease in human populations
o The basic design strategies in epidemiologic research are

categorized into two according to their focus of
investigation
124
Epidemiologic approaches
1. DESCRIPTIVE
Used to describe health and disease in the community by….
What? Who? When? Where?
What are the How many people Over what Where do the
health problems are affected? period of time? affected people
of the community? live, work or
spend leisure
time?
2. ANALYTIC
Used to identify etiology, prognosis and for program evaluation
Why? How?
What are the causal agents? By what mechanism
What factors affect outcome? do they operate?
125
126
Descriptive studies
o Descriptive study is one of the basic types of
epidemiology describing the frequency and distribution
of diseases by time, place and person
o Analytic studies focus in elucidating the determinants of

disease
127
What?
Cases
Person Time
25
Place 20
15
10
0
1 2 3 4 5 6 7 8 9 10
Who? Where? When?

128
Category of descriptive studies
❑ If population as study subjects

o Correlational /ecological studies
❑ If individual as study subjects

o Case report
o Case series
o Cross-sectional survey
129
Case report
o It is the study of health profile of a single individual

using a careful and detail report by one or more
clinicians
o Report is usually documented if there is unusual

medical occurrence, thus it may be first clue for
identification of a new disease occurrences
o It is useful in constructing a natural history of

individual disease
130
Case series
o Individual case report can be expanded to a case series, which
describes characteristics of a number of patients with the
same diagnosis
o Similar to case report, it is usually made on cases having new

or unusual disease (giving interest to clinicians)
o It is often used to detect the emergence of new disease or an

epidemic occurrences
131
Example 1:-
o Five young, previously healthy homosexual men were diagnosed

as having Pneumocystis carinii pneumonia at Los Angeles hospital
during a six month period from 1980 to 1981
o This form of pneumonia had been seen almost exclusively among

older men and women whose immune systems were suppressed
o This unusual circumstance suggested that these individuals were

actually suffering with a previously unknown disease,
subsequently it was called AIDS
132
Example 2:-
A 40-year old pre-menopausal woman developed pulmonary

embolism 5 weeks after beginning to use an oral
contraceptive preparation to treat endometriosis.
What is unusual in this report? Pulmonary embolism is

common in older, postmenopausal women. The investigator
postulated that the drug may have been responsible for this
rare occurrence
133
Advantages of case reports and series
Used as bridge between clinical medicine and public health
First clues in the identification of new disease or adverse effect of

exposure /drug
To identify outbreak occurrence or emergence of new disease
Useful for constructing of the natural history of a disease
Both case report and case series are able to formulate

epidemiologic hypothesis
134
Disadvantages of case reports and series
Unable to test for statistical association between exposure and

outcome variables because of lack of comparison group
Fundamental limitation of case report is inability to avoid a roll of

chance
Rates can not be calculated since the population corresponding to

the source of cases can not be well defined
They are prone to atomistic fallacy (cannot be inferred to the

population)
135
Ecological studies
o Uses data from entire population to compare disease frequencies –
– between different groups during the same period of time, or
– in the same population at different points in time(TIME TREND)
o Unit of data source and unit of analysis is population
== > Population level exposure Vs population level outcome
o They use aggregate data and do not measure outcomes and risk
factors at individual level
136
Strength
Can be done quickly and inexpensively, often using available data.
May be best design to study health effects of environmental
exposures, eg
- Do heat waves increase death rate?
- Does soft drinks increase heart disease?
- Do economic recessions increase suicide rate?
Such questions only sensibly addressed at population (or
community) level
137
Limitation
1. Inability to link exposure with disease.
- Data on exposure and outcome are not linked at the individual level;
- Correlation found with aggregate data may not apply to individuals
(this is referred as ecological fallacy)
2. Lack of ability to control for effects of potential confounding factors
- A correlation found between the high per capita color TV and
mortality from CHD, again here it is obvious that color TV owning
is not a good reason for increased mortality from CHD
3. It may mask a non-linear relationship between exposure and
disease while it is exist
4. Inability to test hypothesis
5. Roll of chance can not be avoided
138
Cross sectional study
Cross-sectional studies
It is also called prevalence study (survey study)
It is the major type of descriptive study designs
Survey is conducted in a population, to find prevalence of a disease

and risk factor at a point in time
Exposure and disease status are assessed simultaneously among

individuals at a point in time
Point in time does not indicates the speed of data collection i.e.
Data collection process can take days, weeks, months, years but
the measurement takes place only once
140
Functions of cross-sectional studies
It helps administrators in assessing the health status and health
care needs of a population
The purpose is for effective health care planning, priority setting,

resource allocation and administration
Used to assess prevalence of acute and chronic diseases,

disabilities and utilization of health care resources
- prevalence of common cold in kebele 8 of Gondar town is 23%
- Prevalence of DM in kebele 8 of Gondar town is 10.45%
141
➢Example of cross-sectional study undertaken in
Ethiopia
• Census – house hold level
• Ethiopian demographic and health survey(EDHS)

– house hold level
• National immunization survey
142
Advantages
Good design for hypothesis generation
Can estimate overall and specific disease prevalence
Can estimate exposure proportions in the population – proportion of cigarette
smokers in Gondar town, latrine utilization proportion
Can study multiple exposures or multiple outcomes or diseases- malaria and
diarrhea morbidity Vs proportion of latrine and ITN utilization
Relatively easy, quick and inexpensive

Best suited to studying unchanged factors overtime (eye color, sex, blood-type)
– prevalence of malaria by blood type
Often good first step to employ analytical study designs
Highly generalizable
143
Disadvantage
Impractical for rare diseases and rare exposure – because we need to take very
large sample size
Not a useful type of study for establishing causal relationships – chicken and
egg dilemma
example- diarrhea Vs vitamin A defficiency = which comes first
Miss diseases still in latent period -
Recall of previous exposure may be difficult -
144
Analytical Study Designs
145
Learning objectives
After the end of this session, students will be able to:
o Describe purpose of analytical studies

o Differentiate observational and interventional studies
146
Introduction to analytic studies
Application:
❑ To search for cause - effect relationship and mechanism
o Why?
o How?
❑ It focuses on determinants of disease by testing hypothesis

regarding exposure and outcome of interest
❑ To quantify the association between exposure and outcome of

interest
147
Analytic studies...
Basic features:
❑ Key feature of analytic epidemiology is comparison group
❑ Appropriate comparison group needed:
o Exposed versus non-exposed
o Case versus control
o Experimental versus non-experimental
❑ It is the use of comparison group that allows testing of

epidemiologic hypotheses
148
Analytic studies...
Two types of analytic studies:
o Observational studies
o Interventional studies
149
Analytic studies...
Observational studies
o An investigator observes the natural course of an event
o An investigator measures but does not intervene
Interventional studies
o An investigator assigns study subjects to exposed and non-
exposed and follows to measure for disease occurrence
o An investigator manipulates the intervention
150
Observational analytic studies
Two basic observational analytic studies:
o Cohort studies
o Case-control studies
o Cross-sectional studies?
151
Case-control Studies
152
Definition of case-control studies
❑ A case control study is one in which persons with a

condition (“cases”) and suitable comparison subjects
(“controls”) are identified, and then the two groups are
compared with respect to prior exposure to risk factors
– Subjects are sampled by their outcome status
153
Definition of case-control studies…
o The investigator looks back in time to measure exposure of the
study subjects to the risk factors
o The exposure to the risk factors is then compared among cases

and controls
o To determine if the exposure to the risk factors could account for

the health condition of the cases
154
155
Steps of case-control studies
1. Define cases and controls
2. Identify group of cases
3. Identify group of controls
4. Asses both groups for previous history of exposure to risk factors under
study
5. Measure frequency of exposure to risk factors occurrence in both
groups
6. Compare frequency of exposure to risk factors between cases and
controls
7. Conclude that previous history of exposure to risk factors contributed
for the cases more than controls or not
156
What is case?
o It is the outcome of interest under study
o It can be:
– A disease
E.g. HIV status, malaria status
– A behavior
E.g. Alcohol drinking habit(yes/no), cigarette
smoking(yes/no)
- Event – traffic accident
157
What is control?
o It is the comparison group (reference)
o It should be free of the disease (outcome of interest under study)
o It should be as similar as the cases in all aspects except for the

disease of interest under study
o Controls must have the same opportunity of getting exposure to

risk factors as cases and should be subjected to the same
inclusion and exclusion criteria
158
Selection of case and control
o Define ‘disease’ and how it will be measured
o Selecting the source population for cases (homogeneous cases)
o Sources of cases are commonly:
– Population based - All persons with the disease in a population

during a specific time of period
– Hospital based - All persons with the disease seen at a

particular facility (e.g. a hospital) in a specific time period
– Incidents cases
– Chronic/prevalent cases
159
160
Measuring exposure of interest
o Exposure status could be ascertained by interview (patient,
relative), hospital records, laboratory analysis etc…
o May include analysis of pre-diagnostic biological specimens

(nested case-control approach)
Comparison is made primarily by estimating the relative risk as

computed by the odds ratio.
161
Common bias in case-control studies
o Information bias
- recall bias
- non-response bias
o Selection bias
- using different criteria to select cases and controls
- the probability of selecting a real case and control
162
Strengths of case-control studies
o To investigate rare disease (less than 10%)
o Suitable for the evaluation of diseases with long latency period
o Quick with time and in-expensive
o Relatively efficient with small sample size comparing with cohort

studies
o No problem with attrition of study subjects
o Can examine multiple etiologic exposures for single outcome
o Less ethical problems

163
Limitation of case-control studies
o In-efficient for rare exposures
o In some situations, the temporal relationship between

exposure and disease may be difficult to establish
o Prone to selection and information bias
o Selection of controls difficult some times
164
Cohort Studies
165
What is cohort?
❑ Any designated group of persons who are followed or traced over a
period of time
Examples of cohort:
o Birth cohort
o Marriage cohort
o Immigration cohort
o Treatment cohort
o Exposure cohort
166
Definition of cohort studies
❑ A cohort study is an observational research design which begins
when a cohort initially free of disease (outcome of interest) are
classified according to a given exposure and then followed (traced)
over time
❑ The investigator compares whether the sub-sequent

development of a new cases of disease (other outcome of interest)
differs between the exposed and non-exposed cohorts
❑ For example if a researcher want to investigate weather drinking

more than five cup of coffee/exposure per day in pregnancy
resulted in fetal abnormality/outcome 167
Design of cohort studies
= == > If we want to know weather exposure to drinking coffee during
pregnancy will result in abnormal birth
Diseased
Exposed Give abnormal
Drink more baby
than five cup of
Coffee per day Not diseased
People
without Give normal baby
Population
at risk the Diseased
outcome Not Exposed Give abnormal
Pregnant baby
Not drink
mothers any coffee
Not diseased
Give normal baby
Time
Direction of enquiry
168
Basic features of cohort studies
“Disease free” or “without outcome” population at entry
Selected by exposure status rather than outcome status
Exposure example – driving after drinking alcohol
- sleeping without using bed net
- feeding kids without washing our hands
- not using glove during injection
Follow up is needed to determine the incidence of the outcome
Compares incidence rates among exposed against non-exposed

groups
169
Types of cohort studies
❑ Cohort studies can be classified depending on the
temporal relationship between the initiation of the
study and the occurrence of the outcome of interest
– Prospective cohort studies
– Retrospective cohort studies
170
Types of cohort study design
Classical (prospective)
1. measure exposure 2. measure outcome
Historical (retrospective)
1. Record of exposure 2. measure outcome
171
1. Prospective cohort studies
o Study participants are grouped on the basis of past or current
exposure status
o Both groups are followed into the future in order to observe the
outcome of interest
o At the beginning of the study the outcome has not yet occurred
o Regarded as more reliable than the retrospective, if the sample

size is large and follow-up is complete
172
2. Retrospective cohort studies
o Both exposure and outcome status have occurred at the

beginning of the study
o Studies only prior outcomes and not future ones
o A historical cohort study depends upon the availability of data or

records that allow reconstruction of the exposure of cohorts to a
suspected risk factor and follow-up of their mortality or
morbidity over time
173
Retrospective cohort studies…
o Suitable for studies of rare exposures, or where the latent period

between exposure and disease is long
o In other words, although the investigator was not present when

the exposure was first identified, s/he reconstructs exposed and
non-exposed populations from records, and then proceeds as
though s/he had been present throughout the study
o What is the difference b/n case control and retrospective cohort

174
Which type of cohort studies should be used?
❑ The decision to conduct a retrospective or prospective study

depends on:
o The research question – If very valid outcome is required

o Nature of the outcome of interest – long/short latent period
o Practical constraints such as time and money- if yes/no…..
o Availability of suitable study population and records – if yes….
175
Data to be collected in cohort studies
o Data on the exposure of interest to the study hypotheses –
o Exposure is any risk factor that can associated with the occurrence of
that disease
Example - chat chewing habit, alcohol drinking habit
o Data on the outcome of interest to the study hypotheses –
- Development of the disease of interest specific to the exposure
Example- depression, poor academic performance
o Characteristics of the cohort that might confound the association under

study
o Other socio demographic variables like age, sex, income----

176
Sources of exposure and outcome information
o Pre-existing records- hospital records
o Information supplied by the study subjects- interview
o Direct physical examination or screening tests
o Death certificate
o Laboratory sample analysis
177
Follow up period of cohort studies
o The follow-up is the most critical and demanding part of a cohort
study.
o Lost to follow-up should be kept to an absolute minimum (< 10-

15%)
o Changes in the level of exposure to key risk factors, after the initial
survey and during the follow-up period, are a potentially important
source of random bias
178
Ascertainment of outcome of interest
• The aim of good case ascertainment is to ensure that the process
of finding cases, whether deaths, illness episodes, or people with
a characteristic, is as complete as possible
• Must have a firm outcome criteria and standard diagnostic

procedure which are equally applied for exposed and non-
exposed individuals
o Any outcome measurement should be done equally both to the

exposed and non-exposed groups
179
Strength of cohort studies:
o Particularly efficient when exposure is rare
o Can examine multiple effects of a single exposure
o Minimize bias in outcome measurement if prospective
o Allows direct measurement of incidence (risk)
o Can elucidate temporal relationship between exposure and

outcome of interest (if prospective )
180
Limitation of cohort studies:
o Costly and time consuming if disease is rare and/or long latency
period (if prospective)
o Validity of the results can be seriously affected by loss to follow up

(if prospective)
o Relatively statistically inefficient unless disease is common (need

large sample size)
o If retrospective, requires availability of adequate records
o Exposure status may change during the course of study
181
Experimental
(Intervention studies)
By koku S. (BSc, MPH)

Definition
An experiment is a set of observations,

conducted under controlled circumstances, in which
the scientist manipulates the conditions to
ascertain what effect such manipulation has on the
observations.
Key Features of Experimental Design
1) Investigator manipulates the condition

under study
2) Always prospective
Types of intervention studies
Generally considered either therapeutic or preventive
1.Therapeutic (secondary prevention) trials
conducted among patients with a particular disease to

determine the ability of an agent or procedure to diminish
symptoms, prevent recurrence, or decrease risk of death
from that disease
Types of intervention studies cont..
2. Preventive (primary prevention) trial
• involves the evaluation of whether an agent or

procedure reduces the risk of developing disease
among those free from that condition at enrollment
• Can be studied among either individuals (Field trial)

or entire populations (Community trial).
Intervention (Experimental) Design
With outcome
Received
Intervention Without outcome
Eligible B P
R
Individuals With outcome
Not-received
Intervention
Without outcome
R=randomization B=double blinding P=placebo

Prevention Trial
With outcome
Vaccinated
Without outcome
Health B P
R
Individuals With outcome
Not-
Vaccinated
Without outcome
R=randomization B=double blinding P=placebo

Other ways of classifying intervention studies
A. Classification based on the population studied

A.1 Clinical trial
• usually performed in clinical settings
• the subjects are patients
A.2 Field trial
• used in testing medicine for preventive purpose
• subjects are healthy people e.g. vaccine trial
A.3 Community trial
• unit of the study is group of people/community e.g.
fluoridation of water to prevent dental caries
B. Classification based on design
B.1 Uncontrolled trial

• No control group
• Control will be past experience (history)
B.2 Non-randomized controlled
• There is control group
• Allocation to either group is not randomized
B.3 Randomized controlled
• There is control group
• There is random allocation of subjects to either
group
C. Classification based on objective
C.1 Phase I
Trial on small number of subjects to test a new drug
with small dosage to determine the toxic effect
C.2 Phase II
Trial on small group of people to determine the
therapeutic effect
C.3 Phase III
• Study on large population
• Usually randomized controlled trial
Problems of interventional studies
1. Ethical problem
• An independent group must be established.
• Purpose:
– Safety of subjects
– Maintaining the quality of the study
– Maintain objectivity
2)Cost
• Intervention studies are expensive
3) Feasibility/ Practical Issues
• Subject recruitment
– getting adequate individuals to enroll into the study is
not easy.
– Field trials particularly require greater number of
subjects since the risk of contracting a given disease
for the first time is small.
• Loss to follow-up
– Select population who are both interested and
reliable.
– Arrange frequent contacts with individuals
– Use incentives, such as providing medical information
Main steps in an RCT
1. Identify new drug/intervention/prevention
2. Identify comparison – e.g standard treatment versus
placebo
3. Define eligible patient population/ exclusions (i.e the

sampling frame)
4. Define the outcomes and how to assess them
5. Write the protocol

Main steps in an RCT cont…
6. Obtain research ethics committee approval
7. Recruit & consent required sample of patients
8. Randomise to treatment, then treat
9. Follow-up & compare/analyse outcome data
10. Publish/disseminate findings

Selection of study population
Assessment of compliance
• Self-report
• Pills count
• Biochemical tests
Stopping Rules
• If the data indicate a clear and extreme benefit,

• or if one treatment is clearly harmful, then early
termination of the trial must be considered
• it would also seem unethical to stop a trial
prematurely based solely on the emerging trends
from a small number of patients.
• Such findings might well be only transient and
disappear or even reverse after data have
accumulated from a large sample
Stopping Rules cont…
• The first requirement for even considering
modification or early termination of an ongoing trial is
the observation of a sustained statistical association
that is so extreme, and there fore, so highly significant,
that it is virtually impossible to arise by chance alone.
• The observed association must then be considered in

the context of the totality of evidence
Accumulation of Adequate End Points
• Selection of a high-risk population
• Selection of adequate length of follow-up period

The Quality of “Gold Standard"
• Randomization
• Blinding
• Use of Placebo
MEASURES OF ASSOCIATION
10/30/2019 202
Learning objectives
• After the end of this session, students will be
expected to:
– List common measures of association and measures of
public health impact
– Calculate and interpret
• relative risk
• odds ratio
• attributable and population attributable risk and their
percent
10/30/2019 203
Definition of association
▪ An association is said to exist between two variables
when a change in one variable parallels or coincides
with a change in another ones
▪ An association is said to be causal when it can be
proved that a change in the exposure variable produces
a change in the outcome variable
▪ More appropriately, a causal relationship exists when
exposure enters into the causation of disease
10/30/2019 204
o Statistical relationship between two or more
variables
o A causal association exists when the risk factor
causes change in the disease
10/30/2019 205
Measuring an association
✓ Quantifies the strength of the relationship between
an "exposure" and “outcome” of interest
✓ Quantifies the difference in occurrence of disease or

death between two groups of people who differ on
“exposure status”
10/30/2019 206
Two main options for comparison
❑ Calculate ratio of two measures of disease
frequency
o Relative comparison
o Strength of relationship between exposure and
outcome
❑ Calculate difference between two measures of
disease frequency
o Absolute comparison (attributable risk)
o Public health impact of exposure (population
attributable risk)
10/30/2019 207
How strong is the association?
The strength of the association is commonly
measured by the relative risk, odds ratio, attributable
risk and population attributable risk and their
percents
10/30/2019 208
1. Relative Risk (RR) or Risk Ratio
➢ RR shows the magnitude of association between
exposure & disease
➢ Indicates the likelihood of developing the disease in

exposed group relative to those who are not
exposed
➢ RR can also be used to compare risks of death, injury,

and other possible outcomes of the exposure.
10/30/2019 209
. Incidence of a disease among exposed (a/(a+b))
RR =
Incidence of a disease among non-exposed (c/(c+d))
Disease
. a .
Yes (+) No (-)
Exposure
RR =
.
a+b
Yes (+) a b a+b
.
. c
c +d No (-) c d c+d
– It is a direct measurement of a risk to develop the

outcome of interest
– It is usually used in cohort and experimental studies
10/30/2019 210
210
Example
Table 1: data from a cohort study of oral contraceptive
(OC) use and bacteruria among women aged 16-49
years
Bacteruria
Yes No Total
Current OC use
Yes 27 455 482
No 77 1831 1908
Total 104 2286 2390
10/30/2019 211
❖Calculate RR??????? Ans:- 1.4
❖Interpretation: women who used oral contraceptive

had 1.4 times higher risk of developing bacteruria
when compared to non-users.
10/30/2019 212
Interpretation
▪ The disease or health related out come is RR times
more likely to occur among the exposed to the
suspected risk factor than among those with no such
exposure.
▪ The larger the Value of RR, the stronger the association
between the disease in question and exposure to the
risk factor.
▪ Values if RR close to 1 indicates that the disease and
exposure to the risk factor are unrelated.
10/30/2019 213
• Values of RR less than one 1 indicate a negative
association between the risk factor and the
disease.(i.e. protective )
• In general the strength of association can be

considered:
• High - if the RR is 3.0 or more
• Moderate – if the RR is from 1.5 to 2.9
• Weak – if the RR is from 1.2 to 1.4
10/30/2019 214
2. Odds Ratio (OR)
o Odds: The ratio of the probability of an event's

occurring to the probability of its not occurring
o Odds Ratio:The ratio of two odds
10/30/2019 215
Cont’d…
➢ In case control studies, it is usually not possible to

calculate the rate of development of disease in the
exposed and non-exposed group.
➢ Hence, it is difficult to calculate the RR.
➢ The RR can be estimated, however, by calculating the

ratio of the odds of exposure among the cases to
that among the controls i.e. the OR
10/30/2019 216
• Odds Ratio: Odds of case being exposed
Odds of control being exposed
OR = a/c = ad
b/d bc
• OR indicates the likelihood of having

been exposed among cases relative to
controls.
10/30/2019 217
Example
Table 3: Data from a case-control study of current
oral contraceptive (OC) use and MI in pre-
menopausal female nurses
Myocardial infarction
Yes No Total
Current OC use
Yes 23 304 327
No 133 2816 2949
Total 156 3120 3276
10/30/2019 218
Calculate OR
OR = ad = (23) (2816)= 1.6
bc (304) (133)
Interpretation: the odds of having MI is 1.6

times higher among OCP users as compared
to that of the non OCP users.
10/30/2019 219
Interpretation of the Odds Ratio…
• OR = 1 then exposure Not related to disease
• OR >1 then exposure Positively related to disease
• OR <1 then exposure Negatively related to disease
10/30/2019 220
Interpretation
• The odds of having the disease in question are OR
times greater among those exposed to the suspected
risk factor than among those with no such exposure.
10/30/2019 221
Exercise
• Suppose study was conducted in US in order to find out
weather mother’s use of hormone during pregnancy
influenced her son’s risk of testicular cancer in later life.
Investigator selected 500 peoples with cancer and 1000
without cancer. The study found 90 mothers in cases and 50
mothers in controls had used hormones during pregnancy.
• What study design were used
• Prepare 22 Table
• Calculate appropriate measure of association

Odds Ratio as estimator of Relative Risk
OR is a valid estimator of RR if:
❖ Cases are incident and drawn from a known and defined

population
❖ Controls are drawn from the same defined population and

would have been in the case group if they had the disease
❖ Controls are selected in an unbiased way
❖ the disease is rare
10/30/2019 223
• What is the excess risk among exposed
individuals?
10/30/2019 224
Absolute Measures of Risk
o Absolute risk: a measure of association indicating on
an absolute scale how much greater the frequency of
diseases is in an exposed group than in an unexposed
group, assuming the association between the exposure
and disease is causal
o Attributable risk is also known as risk difference or

excess risk among exposed groups
10/30/2019 225
Attributable Risk (AR) / Risk Difference
(RD)
❑ Provides information about the absolute effect of the
exposure or the excess risk of disease in those exposed
compared with those non exposed.
❑ AR is the portion of the incidence of a disease in the

exposed that is due to the exposure.
❑ It is the incidence of a disease in the exposed that would

be eliminated if exposure were eliminated.
❑It takes into account the actual incidence rate of the

outcome.
10/30/2019 226
Attributable risk
➢It tells us how many cases of disease in exposed
people could have been prevented by eliminating the
exposure.
➢It is a measure of the impact of an association

on the exposed population.
➢AR = Incidence among exposed (Ie) - Incidence

among non-exposed (Io)
➢ For example in the study of OC use and bacteruria:

➔AR=27/482 – 77/1908 = 0.01566 = 1566/105
10/30/2019 228
Cont’d…
➢ Thus, the excess occurrence of bacteruria among
OC users attributable to their OC use is 1566 per
100,000.
➢ In other words, if we had prevented those 100,000
OC users from their use, we would have prevented
an estimated 1566 cases of bacteruria.
➢ AR is used to quantify the risk of disease in the
exposed group that can be considered attributable to
the exposure by removing the risk of disease that
would have occurred anyway due to other causes
(the risk in the non-exposed).
10/30/2019 229
Cont’d…
▪ The interpretation of the AR is dependent on the
assumption that a cause-effect relationship exists
between exposure and disease.
Discuss the interpretation when,
▪ AR = 0
▪ AR < 0
▪ AR >0
10/30/2019 230
Cont’d…
▪ AR=0 no association
▪ AR > 0 indicates positive association
 the number of cases of the disease among the
exposed that can be attributable to the exposure
itself, or
 alternatively, the number of cases of the disease
among the exposed that could be eliminated if the
exposure were eliminated
▪ Thus, the AR can be useful as a measure of the
public health impact of a particular exposure.
10/30/2019 231
• What proportion of cases is attributed to the
actual exposure among exposed people?
10/30/2019 232
Attributable Risk Percent (AR %)
➢ Estimates the proportion of the disease among the

exposed that is attributable to the exposure, or
➢ The proportion of the disease in the exposed group

that could be prevented by eliminating the exposure.
➢ AR % = (Ie - Io)/ Ie X 100

= AR X100
Ie
10/30/2019 233
Example: Refer the previous table and
calculate AR%
• AR % = (Ie - Io)/Ie X 100
• AR % = 1566/100,000 X 100
27/482
= 27.96 %
Interpretation: If OC use causes bacteruria (UTI),

about 28 % of bacteruria among women who use
OC can be attributed to their OC use and can be
eliminated if they did not use oral contraceptives.
10/30/2019 234
▪ For most case-control studies, the AR cannot be
calculated
▪ It is, however, possible to calculate the AR% using the
following formula
▪ AR% = (OR – 1) x 100
OR
▪ Example: From the data on OC use and MI, the OR
of MI associated with current OC use was 1.6,
yielding AR% of 37.5%.
▪ If OC use causes MI, nearly 38% of MIs among young
women who used OCs could be attributable to that
exposure or could be eliminated if they were to stop
using Ocs.
10/30/2019 235
• What is the excess risk among the general
population that is due to exposure of interest?
10/30/2019 236
Population Attributable Risk (PAR)
➢ Public health planners want to be able to anticipate
the effect of eliminating the exposure on the
population as a whole, rather than just on the
exposed part of the population.
➢ Even if the RR is very high, eliminating a very rare

exposure would not be expected to have much
impact on the health of the population as a whole.
➢ PAR takes into account not only the actual incidence

rate of the outcome but also the prevalence rate of
the exposure.
10/30/2019 237
▪ Estimates the proportion of disease occurring
in the total population attributable to the
exposure.
▪ PAR is the portion of the incidence of a disease in

the population (exposed and non exposed) that is
due to exposure.
▪ It is the incidence of a disease in the population that

would be eliminated if exposure were eliminated.
10/30/2019 238
• PAR = AR X prevalence rate of the exposure
Example: Research was conducted to assess the

association between cigarette smoking and death
from lung cancer.
• The following findings were obtained:
➢ AR = 89 per 100,000 per year
➢ Prevalence rate of cigarette smoking = 20 %
10/30/2019 239
 PAR = 89 per 100,000 per year X 20 %
= 17.8 per 100,000 per year
Interpretation:
 In a population of 100,000 smokers, 18 deaths from lung
cancer per year could have been avoided by preventing
them from smoking (this refers to AR).
 In a general population of 100,000 with a prevalence rate
of cigarette smoking of 20 %, about 18 deaths from lung
cancer per year would be prevented by eliminating
cigarette smoking (this refers to PAR).
10/30/2019 240
➢ Both AR and PAR are used to estimate the effect on
disease incidence of eliminating a given risk factor,
but while AR estimates reduction in disease
incidence only in those exposed, PAR
estimates reduction in disease incidence in
the population as a whole.
➢ The alternative formula for PAR is:
➢ PAR = Incidence rate in total population minus
incidence rate in non-exposed population
➢PAR = IT - Io
10/30/2019 241
• What proportion of cases is attributed to the
actual exposure among the general
population?
10/30/2019 242
Population Attributable Risk Percent (PAR %)
➢ Expresses the proportion of disease in the study
population that is attributable to the exposure and
thus could be eliminated if the exposure were
eliminated.
➢ PAR% is the percent of the incidence of a disease in
the population (exposed and non exposed) that is due
to exposure.
➢ PAR % = PAR X100
incidence rate in total population
Example:
▪ PAR = 17.8 per 100,000 per year
▪ Mortality rate in non-smokers = 7 per 100000
▪ Mortality rate in the total population = 24.8 per 105
per year
▪ Calculate PAR %
10/30/2019 243
• PAR % =17.8 per 105 per year X100
24.8 per 105 per year
=71.8%
• Interpretation: 72% of deaths from lung cancer

occurring in the general population could be
prevented by eliminating cigarette smoking.
10/30/2019 244
Possible Outcomes In Studying The Relationship
Between Disease And Exposure
1. No association between exposure and disease
AR=0, RR=1 ,OR=1
2. Positive association between exposure and disease
(more exposure, more disease)
AR>0, RR>1 ,OR>1
3. Negative association between exposure and disease
(more exposure, less disease)
AR<0 (negative), RR <1(fraction)OR<1
10/30/2019 245
Exercise
➢ There is some hint that coffee drinking causes peptic ulcer.
One epidemiologist wanted to make sure whether this is
true.
➢ He identified 600 people who drink coffee and 700 who do

not drink coffee. Initially all the study subjects were not
suffering from peptic ulcer. He followed them over 2 years
period. In this 2 years time 400 people who were drinking
coffee and 360 people who were not drinking coffee
developed peptic ulcer.
– What type of study design was used?

– Calculate and interpret the appropriate measures of
association
10/30/2019 246
Causation OR EVALUATION OF EVIDENCE

Purpose of evaluation of evidence
• To determine if what is observed is a

reflection of the truth?
• Observed:
• incidence are they true?
• Prevalence
• Relative Risk Are there alternative explanations?
• Odds Ratio…

Brain storming
If exposure X is associated with outcome Y…..then how

do we decide if X is a cause of Y or not?

Association Vs Causation
✓ The existence of an association doesn’t itself

constitute a proof for causation
✓ An observed association could be a fact or an
artifact
✓ Hence, an association is a necessary but not a
sufficient condition for causation
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Accuracy
=
Validity + precision
➢ Validity and reliability together makes up accuracy

➢ Validity - is the degree of closeness to the truth
➢ Reliability - is the degree of closeness between
repeated measurements of the same thing

Validity Vs Reliability

Validity of epidemiological studies
o Validity is the extent to which a measured value actually

reflects truth
o Next step of evaluation of study results is validation of

the findings
o An observed association is validated for bias, chance

and confounding factors

Types of validity
Internal validity:
=➔Is the degree to which a measured value is true
within the sample
External validity:
=➔ Is the extent to which a measured value apply
beyond the sample(source population)
- This is related to generalizability

Precision
➢ Precision measures the extent by which our study result is
similar (consistent) with other previous studies published on
the area by different scholars in different population, area
and methods.
➢ Precision is the extent to which random error alters the
measurement of effects
➢ Threats to validity of study:
- Random error (chance): is sampling error
- how we can avoid random error?
- Systematic error (bias): is error in the conduct of the study
Judgment of causality
Judgment of causality is a process by which we
assure whether the observed association is
causal or not for that outcome
=➔ Judgment of causality has two steps
1. Check whether the observed association
between exposure and disease is Valid (Rule out
chance, bias and confounding)
2. Check whether the observed association is
causal (Bradford hill criteria)
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The Bradford Hill Criteria
o It is the statement of epidemiological criteria of a causal
association formulated in 1965 by Sir Austin Bradford
Hill
1. Strength of association
2. Consistency of findings with other studies
3. Temporality
4. Biologic gradient
5. Biologic plausibility
6. Specificity of the association
7. Experimental evidence
Bradford……….
1. Strength of the Association - The stronger the association, the
more likely that it is causal.
2. Consistency of the Relationship - The same association should

be demonstrable in studies with different methods, conducted by
different investigators, and in different populations.
3. Specificity of the Association - The association is more likely

causal if a single exposure is linked to a single disease.
Single exposure Single disease
This works more to most living organisms as causes.

Bradford…….
4. Temporal Relationship - The exposure to the factor must
precede the onset of the disease.
5. Dose-response Relationship - The risk of disease often

increases with increasing exposure to a causal agent
• 6. Study design- Study design;
It is most important to consider the design.
RCT > Cohort > Case control > Cross sectional >
Ecological >Case series/case report

7. Biological plausibility
Hypothesis should be coherent with what is known
about the disease; both biologically and using laboratory.
Knowledge about physiology, biology and pathology

should support the cause-effect relationship
If a finding doesn’t go with what is known, then it is

losing biological plausibility

Which Hill’s criteria are essential?
There are no completely reliable criteria for determining whether
an association is causal or not
In judging the different aspects of causation; not all criteria must
be fulfilled to establish scientific causation
The correct temporal relationship is more essential
risk factor/cause ---------------------→ outcome/effect
===➔ Once this has been found, weight should be given to:
– Strength of the association
– Biologic plausibility
– Consistency
– Dose-response relationship

Public Health Surveillance

What is surveillance?
❑Systematic, ongoing…
– Collection
– Analysis Health action
– Interpretation
✓investigation
– Dissemination
❑…of health outcome data ✓control
✓prevention

Components of Surveillance and Public
Health Action
Public Health Action

Component of ✓Priority setting
Surveillance
✓Planning,
o Collection
✓implementing and
o Analysis
✓evaluating disease
o Interpretation
occurrence in that
o Dissemination
community

Purpose of Surveillance
I. To be able to identify diseases, injuries, hazards and
other health related factors as early as possible.
prediction and early detection of outbreaks.
II. To provide scientific baseline data and information
for priority setting, planning, implementing and
evaluating disease control program for both
communicable and non-communicable health
problems.
III. To define the magnitude and distribution of
diseases by time, person and place dimension

Types of Surveillance
1. Active surveillance
2. Passive surveillance
3. Sentinel surveillance

Active Surveillance
❑ It is based on active case detection
❑ Active case detection - is an active search for cases by

special surveys, house to house visits or other methods
outside of the routine health service activities
❑ It is not routine activities because it is expensive
❑ However, it is more accurate and better representative as

community based data
E.g: Outbreak investigation and control

The advantages of active surveillance
➢ The collected data is complete and accurate
➢ Information collected is timely.
Disadvantages
➢ It requires good organization,
➢ It is expensive
➢ Requires skilled human power
➢ It is for short period of time(not a continuous process)
➢ It is directed towards specific disease conditions

Preconditions to institute an active surveillance system.
➢ For periodic evaluation of an ongoing program
➢ For programs with limited time of operation such as
eradication program.
➢ In unusual situations such as .
– New disease discovery
– New mode of transmission
– When a high-risk season/year is recognized.
– When a disease is found to affect a new subgroup of
the population.
– When a previously eradicated disease reappears

Passive Surveillance
▪ Based on passive case detection, and routine recording
and reporting activities
Passive case detection

▪ Cases detected in the course of the normal operation
of the health services, through the self reporting of
patients to health institutions
▪ The data is usually unreliable, incomplete, inaccurate,
unrepresentative and reported not timely
Advantages of passive surveillance
➢Covers a wide range of problems
➢Does not require special arrangements
➢It is relatively cheap
➢Covers a wider area
Disadvantages
➢The information generated is to a large extent
unreliable, incomplete and inaccurate
➢ Most of the time, data from passive surveillance is not
available on time
➢ Most of the time, you may not get the kind of
information you desire
➢ It lacks representativeness as it is mainly from health
institutions
➢ There is no feed back system
Sentinel Surveillance
➢ Sentinel surveillance involves the collection of data from
only part of the total population (from a sample of
providers) to learn something about the larger
population, such as trends in disease
➢ Under this strategy, health officials define homogenous
population and regions to be sampled

Sentinel Surveillance Con’t...
➢ The advantages of sentinel surveillance data are that

they can be less expensive to obtain than those gained
through active surveillance of the total population, and
the data can be of higher quality than those collected
through passive systems.
➢ In developing countries, sentinel surveillance provides
a practical alternative to population-based surveillance

Main Purposes of Sentinel Surveillance
➢ To detect changes
➢ To direct and focus control efforts
➢ To develop intervention strategies
➢ To promote further investigations
➢ To provide the basis for evaluating preventive strategies

Advantages of sentinel surveillance
➢ Relatively inexpensive
➢ Provides a practical alternative to population-based
surveillance
➢ Can make productive use of data collected for other
purposes
Disadvantages:
➢ The selected population may not be representative of the
whole population
➢ Use of secondary data may lead to data of lesser quality and
timeliness

Process of Public Health Surveillance
➢ Data collection and recording
➢ Reporting and notification
➢ Data compilation
➢ Data analysis
➢ Data interpretation
➢ Data dissemination
➢ Link to public health action

Criteria for selecting and prioritizing health conditions
for surveillance system includes:
➢ Public health importance of the problem:-
• incidence, prevalence,
• severity, sequela, disabilities,
• mortality caused by the problem,
• socioeconomic impact,
• communicability,
• potential for an outbreak,
• public perception and concern, and
• international requirements.

➢ If disease has epidemic potential
➢ If required internationally
➢ Have available effective control and prevention programs
➢ Can easily be identified using simple case definitions

Basic Principles of Surveillance
• Public health surveillance main function is to serve as
an “early warning system” providing timely
information needed for action (rapid reporting,
confirmation, decision making and response)

Elements of Surveillance
• Case definition
• Population under surveillance
• Cycle of surveillance
• Confidentiality
• Incentives

A) Case Definition
Case definition: is a set of criteria for deciding whether an
individual should be classified as having the health condition
of interest or if the case can be considered for reporting
and investigation
Case definition for cholera
- Acute watery diarrhea: three or more abnormal loose
or fluid stool within 24 hours with or without
dehydration
Standard case definition
❑ If the use of case definition is agreed by everyone in
the country or across boundaries or continents it is
standard case definition
o Surveillance using less specific criteria is sometimes

referred as syndromic surveillance
E.g: Polio (AFP)

Types of Case Definition
Confirmed case
o A case with laboratory verification
Probable case
o A case with typical clinical features of the disease without
laboratory confirmation
Suspected case/possible
o A case presented with fewer of the typical clinical
features of the disease without laboratory confirmation

Advantages of Case Definition
1) Facilitate early detection and prompt management

even if diagnosis is not confirmed by laboratory
2) Laboratory test is expensive, difficult to obtain
3) Observation of trends
4) Comparison from one area to another

B) Population Under Surveillance
Target population can be:
• Individuals at specific institutions
• Residents of a community
• Residents of a nation, etc.

C) Cycle of Surveillance

D) Confidentiality
• Personal identifying information is necessary to:
- identify duplicate reports
- obtain follow-up information when necessary
- provide services to individuals
- use surveillance as the basis for detailed investigations
• Protecting the physical security and confidentiality of

surveillance records is both an ethical responsibility and a
requirement for maintaining the trust of participants
E) Incentives to Participants
Providing information back to those who contribute to the
system
• This feed back may be in the form of reports and seminars
• Other incentives may be more immediate, such as payment

for case reports
• Individuals who participate may be paid for their time and

willingness to provide blood or other specimens

Public Health Emergency Management (PHEM)
❑ Public health emergencies are events or disasters that threaten
the health of communities at large
❑ Some examples are disease outbreaks (emerging and reemerging)
and pandemics, natural disasters such as earthquakes, floods,
droughts, volcanoes; biological terrorist attacks such as an anthrax
release
❑ PHEM is the process of anticipating, preventing, preparing for,
detecting, responding to, controlling and recovering from
consequences of public health threats in order that health and
economic impacts are minimized

Emergency Management Phases
Recovery Mitigation
Response Preparedness
Mitigation
❑ Pre-event planning and actions which are intended to
lessen the impact of a potential disaster
E.g: Risk identification / assessment and reduction

Preparedness
❑ Actions taken before an emergency to prepare for response
➢Develop emergency management plan
➢Develop communication plan
❑ The identification of a public health threat by closely and

frequently identified monitoring indicators and predicting the
risk it poses on the health of the public and the health
system (early warning phase)

Response
❑ Activities to address immediate and short-term effects of a
disaster
– Implement emergency management plan
o Save lives
o Meet basic human needs
Recovery
❑ Restore essential functions and normal operation
– Assess damage / impact of disaster
– Address psychological needs of patients and community
– Produce after action debriefing and report

Limitations of Surveillance System In Ethiopia
o Under reporting
o Lack of representativeness
o Lack of timeliness
o Inconsistency of case definitions
o Shortage of qualified staff
o Lack of motivation

List of Priority Reportable Diseases In Ethiopia
Epidemic-prone diseases Diseases targeted for
1. Cholera eradication
2. Diarrhea with blood 12. Acute flaccid paralysis (Polio)
(Shigellosis) 13. Dracunculiasis (Guinea
3. Measles worm)
4. Meningitis 14. Leprosy
5. Plague 15. Neonatal tetanus
6. Viral hemorrhagic fever
7. Yellow fever Diseases of public health
8. Typhoid fever
importance
9. Relapsing fever 16. Pneumonia in children
10. Epidemic typhus 17. Diarrhea in children
11. Malaria 18. New AIDS cases
19. Onchocerciasis
10/30/2019
20. Sexually transmitted diseases
Epedimiology course 295
Outbreak Investigation & Control
Level of disease occurrences
• Diseases occur in a community at different levels at a
particular point in time.
Occurrence at expected levels
• Endemic: Presence of a disease at more or less stable
level. --==➔Malaria is endemic in the lowland areas of
Ethiopia.
• Hyper endemic: Persistently high level of disease
occurrence.
• Sporadic: Occasional or irregular occurrence of a disease
Excess of what is expected
• Epidemic: The occurrence of health related
condition/disease in excess of the usual frequency
• Outbreak: Epidemics of shorter duration covering a
more limited area.
• Cluster: is an aggregation of cases in a given area over
a particular period without regard to whether the
number of cases is more than expected.
• Pandemic: An epidemic involving several countries or
continents affecting a large number of people.
example : HIV/AIDS is a pandemic.
What is outbreak occurrence?
What does outbreak investigation & control?
❑It is the process of identifying:
o The cause of the epidemic
o The source of the epidemic
o The mode of transmission and
o Taking preventive and control measures

Source of an outbreak information/how to
recognize epidemic
➢ Routine surveillance (Recently WHO recommends
global alert and response system or GAR)
➢ Health professionals (reporting from healthcare
settings, laboratories, and pharmacies)
➢ Affected community members

Goals of investigation
✓ Identify the etiologic agent
✓ Identify the reservoir(s)
✓ Identify the mode of transmission
✓ Apply control and preventive measures
✓ Eliminate the reservoir(s) and transmission
✓ Prevent future outbreaks

Types of Epidemics
➢ There are three principal types of epidemic
1. Common source – based on source of
exposure
2. Propagative - touches mode of transmission
3. Mixed epidemic – share characteristics of both
type
1. Common source epidemic
❑ It occurs as a result of the exposure of a group of
population to a common source (etiological agent)
o It can result from a single source/ exposure of the
population to the agent
E.g: contaminated water supply, or food in a
certain restaurant
➢ Three types
1. Point common source
2. Continuous common source
3. Intermittent common source
A) Point common source epidemic
o Single/ones/limited time exposure to the source
o All exposed hosts will develop disease within one
incubation period
o The epidemic usually decline after a few generations,
either because the number of susceptible hosts fall
below some critical level, or because intervention
measures become effective
o A rapid rise and gradual fall of an epidemic curve
suggests a point source epidemic
E.g. Food borne outbreak in a wedding feast
Commonly due to infectious

diseases or May be from
environmental pollution
Features of epidemic curve:

1-Rises and falls rapidly, no secondary
waves.
2-Tends to be explosive, with clustering
of cases within narrow interval of time.
3-All cases develop within one
incubation period.
B) Continuous common source epidemic
➢ If exposure to a common source continues over time for

days, weeks
➢ The epidemic curve has a plateau (multimodal epi curve)/
long peak
➢ Range of exposures and range of incubation periods is
different
1-The exposure from the same source
may be prolonged-continuous,
repeated or intermittent
2-No explosive rise in number of cases.
3-Cases occur over more than one
incubation period.
C) Intermittent common source epidemic
➢Results in an irregular pattern of the

epidemic curve that reflects the intermittent
nature of the exposure
E.g. waterborne outbreak

2. Propagative /progressive epidemic
o It occurs as a result of transmission of an infectious agent
from one person to another directly or indirectly
o There is a successive generations of cases
o The epidemic curve in a progressive epidemic is usually

presence of successive several peaks, a prolonged duration,
and usually a sharp fall
o Can show geographic spread of the case

– Example; Malaria outbreak and different vector born disease
Propagated Epidemics
3. Mixed Epidemic
o It shows the features of both types of epidemics
o It begins with a common source of infectious agent

with subsequent propagated spread because of
person – to- person transmission of the etiologic
agent
E.g. Majority of food borne outbreaks

Steps of outbreak investigation and control
1. Prepare to field work
2. Establish the existence of outbreak
3. Verifying the diagnosis
4. Case definition and case finding
5. Perform descriptive epidemiology
6. Formulate hypotheses
7. Testing hypotheses
8. Refine hypothesis and additional studies
9. Implementing prevention and control activities
10. Communicate findings
➢ In practice, however, several steps may be done at
the same time, or
➢ The circumstances of the outbreak may dictate that
a different order be followed
Step 1: Prepare for field work
❑ Before leaving for the field, an investigator must be well
prepared to under take the investigation:
o Investigation (Knowledge in epidemiology and the

disease of concern is important)
o Administrative (Logistics, administrative procedures,

travel arrangements)
o Consultation (Health workers should know their role,

and should participate in the planning phase)
Step 2: Establish the existence of outbreak
o An outbreak is the occurrence of more cases of
disease than expected level
o The investigator has to compare previous case load
with the current to assure the existence of the
outbreak
o But be careful, excess cases may not always indicate
an outbreak occurrence rather it may be because:
✓Change in population size
✓Change in case definition
✓Change in reporting procedure
Step 3: Verifying the diagnosis
o The initial report may be spurious and arise from
misinterpretation of the clinical features
o Review clinical and laboratory findings to establish diagnosis
o Goals in verifying the diagnosis includes:
✓ To ensure that the problem has been properly diagnosed
✓ To rule out laboratory error as a basis for the increase in

diagnosed cases
✓ To ensure the diagnosed disease is possibly epidemic

Step 4: A. Case definition and case
finding
• Define cases ( Establish case definition):
• Case definition should be broad enough to include
most, if not all, of the actual cases. (sensitive not
specific)
• Case definition must not include an exposure or risk
factor you want to test
• Case definition must be equally applied and without
bias to all persons under the investigation
Step 4: Case definition and case finding Cont…d
➢ Usually includes four components:

➢ Clinical information about the disease,
➢ Characteristics about the people who are affected,
➢ Information about the location or place, and
➢ A specification of time during which the outbreak occurred
Define cases ( Establish case definition):
1) Possible (suspected)
✓ Having fewer sign and symptoms
2) Probable
✓ Having typical sign and symptoms
3) Definite (confirmed)
✓ Laboratory confirmed
Example : A patient hospitalized in the ICU from 24th
November 2017, with new or worsening of cough, Fever
>38, with suggestive X-ray changes and cultures identify a
respiratory microorganism.
B. Identify cases (line listing)
o Identifying information
e.g. Hospital admission number, unit, name, address,
phone.
o Demographics
e.g. Age, sex, date of admission, date of surgery.
o Risk factor information
e.g. Type of surgery, co morbidity, catheters, implants
o Clinical data
• e.g. Onset of symptoms and signs, frequency and
duration of clinical features, treatments, devices, etc
Step 5: Performing Descriptive
Epidemiology
o Once data is collected, it should be analyzed by time, place and person
o The tools to be used when characterizing the epidemic are epidemic

curve, spot map and attack rate
o The characterization often provides clues about etiology, source and

modes of transmission that can be turned into testable epidemiologic
hypothesis
1. Analysis of epidemic by time
➢ We use epidemic curve to analyze by time taking

- The X- axis; indicating time of onset
-The y-axis; indicating the number of cases
appearing
➢ Epidemic curve can tell as
- nature of epidemic
- hint to etiologies – etiologic agent
- hint about source of exposure
Epidemic curve
Point source
2. Analysis of epidemic by place
– A spot map is a simple and useful technique for
illustrating where cases live, work or may have
been exposed
– Area map if large area is affected
– It is important to indicate source of outbreak

John Snow’s spot map of the distribution of cholera
cases Golden London square August-September 1848
3. Analysis of epidemic by person
o Characterizing an outbreak occurrence by person is how
we determine what populations are at risk for the disease
o Host characteristics: age, race, sex, or medical status and

exposures-occupation, leisure activities, use of medications,
tobacco and drug use etc…
o These influence susceptibility to disease and opportunities

for exposure to risk factors
o We use attack rates to identify high risk groups

Step 6: Formulating Hypothesis
➢ Depending on the outbreak, the hypothesis may address
o The exposures that caused the disease
o The agent and its reservoir
o Risk factors that caused disease
o The mode of transmission
➢ Using :
1. Subject-matter knowledge
2. Descriptive epidemiology
3. Talking with patients
4. Talking with local officials
❑ The hypotheses should be testable
Step 7: Testing the hypothesis
❖ Evaluate the credibility of your hypotheses
❖ Use analytic epidemiology and appropriate measure of

association(case control, odds ratio for cohort
design, relative risk)
❖ Significance of statistics should be done, (Chi-square is the

appropriate test, and P-value is estimated at 5 %) to
explore the role of chance
Factors that should also be considered when
evaluating possible causality:
• Testing statistical significance
• Consistency with other studies
• Temporality. Exposure to the factor precedes onset of disease.
• Biologic plausibility. Does the association make sense

biologically?
Step 8: Refining hypotheses and additional
studies
o When analytic epidemiological studies do not confirm
hypotheses, we need to reconsider hypotheses and look
for new vehicles or modes of transmission.
o Sometimes you will need to refine your hypotheses to
obtain more specific exposure histories or a more
specific control group.
o Laboratory and environmental studies

Step 9: Implementing control and prevention
In outbreak investigation, the primary goal is to control and

prevent the outbreak.
Implementing control measure should be done as soon as
possible
It should go in parallel to investigating the outbreak
Source/ Mode of Transmission
Causative
Agent
Control measures (do early)
1. Measures Directed Against the Reservoir:
– Reduce contact rate
– Reduce infectious sources- destruction of infected animal /isolation
– Reduce infectiousness- early treatment
2. Measures that interrupt the transmission of organisms

– Purification of water
– Pasteurization of milk
– Inspection procedures designed to ensure safe food supply.
– Improve housing conditions
3. Measures that reduce host susceptibility and Increase herd immunity
- Immunization
- Chemoprophylaxis - Use of antibiotics for known contacts of cases

DAY
DAY
Step 10: Communicating findings of
investigation
❑ The final responsibility of the investigative team is to prepare a
written report to document the investigations, findings and the
recommendations
❑ The written report should follow the scientific reporting format which
includes:
ointroduction
o methods
o results
o discussion
o conclusion, and
oRecommendations
Post-Epidemic Surveillance
o The efficacy of control measures should be assessed day to
day during the outbreak, a final assessment being made
after it has ended
o This will provide a logical basis for post-epidemic

surveillance, and preventive measures aimed at avoiding
similar outbreaks in the future
o Develop long term early warning system
o Monitor environmental risk factors

Epidemiology and Biostatistics

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Measurement of health & disease

By Koku S. (BSc, MPH)

• At the end of this course students will be able to apply public

• Introduction to public health

❑Final Written Examination – 50%

Public health - a science and an art of preventing

Clinical medicine is concerned with diagnosing

❖Discussion with community leaders and health

➢ Therefore the problems should be put in the order of

➢ “Distribution” Refers to the distribution of

❖It asks the questions: How many? Where? When?

❖The part of epidemiology dealing with the causes and

❖It asks the questions: how? Why?

➢Infectious and non infectious diseases

2. Description of the health status of the population

3. Establishing the determinants/causation of disease

➢ At the end of this chapter the student is expected

Discuss the concept of disease causation

Describe the theories & Models of disease causation

➢ 20th century theories

1. Supernatural theory of disease

4. Multifactorial causation theory

• At least 10% of the people in developed countries and 30% in

• Even today superstitions are becoming major obstacles in

• Most of the literates view that disease is the result of microbes

• Most of the uneducated people (90%) believe that disease is due

Pasteur, Henle and Koch were the

2. The organism must be isolated and grown in culture.

3. The organism must, when inoculated into a susceptible animal,

4. The organism must then be recovered from the animal.

• How do diseases develop?

• The most familiar disease model, the epidemiologic triad (triangle),

• The social environment including availability of

Hormones physical inactivity

Smoking obesity heredity

• Help for better to understand and plan intervention

❑ Trachoma may cause blindness

❑ Meningitis may result in blindness, deafness or

Sub clinical disease

❑Epidemiology plays a central role in disease

❑ The main objectives of primary prevention are

❑ Primary prevention keeps the disease process from

▪ Improvement of socioeconomic status, provision of

❑ Examples can be provision of safe and

▪ The timing is between exposure and biological

▪ Post-exposure prophylaxis for HIV exposed individuals

Primary Health promotion

Tertiary Limitation of disability Permanent

Rehabilitation (prevention of deterioration

• Because incidence is a measure of new events (i.e.

Example A: In the study of diabetics, 100 of the 189 diabetic

Risk = (100 / 189) x 100 = 52.9%

➢ Similar to other measure of incidence, the numerator of the

➢ The denominator, however, is the sum of each individual’s time at

➢ This is particularly when one is studying a group whose members

❖ 1 individual is followed for 1 yr = 1pyr

Jan Jan Jan

Subject 1 ------------------x 9 Person-Years (PY)

X = outcome of interest, thus the incident rate is 2/38 PY

➢ It includes both new and old cases.

There are two types of prevalence rates.

PPR = # people with a condition during a specific period of time X10n