UNIVERSITY OF GONDAR

GCMHS
INSTITUTE OF PUPLIC
HEALTH
1

TEMESGEN Y

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Course objective
2

After completion of the course, students will be able:

o to describe principles of epidemiology, major

modes of transmission and preventive methods of

disease and distinguish descriptive and analytical
epidemiology and be able to take part in
surveillance, outbreak investigation, disease control
, screening program and epidemiological research
for prevention of diseases of public health
importance
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Course contents
3

1) Introduction to epidemiology
2) Natural history of disease & level of prevention
3) Infectious disease epidemiology
4) Measures of morbidity & mortality
5) Sources of epidemiological data
6) Descriptive epidemiology
7) Analytic epidemiology
8) Measures of association
9) Establishing causation
10) Public health surveillance system
11) Outbreak investigation & control
12) Screening & diagnostic tests
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Teaching methods
4

Illustrated & interactive Lecture

Seminar presentations
Group activity and discussion
Home take assignment
Questioning & answering

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Evaluation methods
5

1) Continuous assessment=50%
o) Attendance
o) Quiz
o) Test/mid exam
o) Assignment
o) Class participation

2) Summative assessment=50%
o) Final written examination from all chapters of
the course
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REFERENCES
6

Meseret S. and Haile Fanta. Epidemiology a manual

for students and health workers in Ethiopia 1990

MOH
Kifle Wolde Michael, Yigzaw Kebede, Kidist Lulu.
Epidemiology for Health Science Students, Lecture
Note Series November 2003
M. Fletcher. Principles and practice of Epidemiology.
August 1992.
Charless H. Hennekens. Epidemiology in medicine.
Clinical epidemiology and biostatics
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Chapter one
7

Introduction

to Epidemiology

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objectives
8

At the end of this course, the students will be able to:

define epidemiology
describe the basic concepts in epidemiology
discuss purposes of epidemiology,
Describe the basic assumption in epidemiology

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Epidemiology
Definition, scope, uses and assumptions

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EPIDEMIOLOGY
10

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

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Components of the definition

11

Population the focus of epidemiology is mainly

on the population rather than individuals.

Frequency shows epidemiology is mainly a
quantitative science.
o

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.

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Contd
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.

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Contd
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?

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Contd
14

Determinants are factors which determine whether or

not a person will get a disease.

Disease determinants are factors that bring about a
change in a persons healththat is, factors that either
cause a healthy individual to become sick or cause a sick
person to recover.
include both causal and preventive factors
The part of epidemiology dealing with the causes and
determinants of diseases is Analytical Epidemiology.
It asks the questions: how? Why?
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Contd
15

Application.to the prevention and control of

health problems.

Epidemiology is an applied science ,with direct practical

applications.
An important aim in studying the frequency, distribution, and
determinant of a disease, is to identify effective disease
prevention and control strategies.

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History of Epidemiology
16

Although epidemiological thinking has been traced

to the time of Hippocrates, who lived around 5th

century B.C., the discipline did not flourish until the
1940s.

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Contd
17

Hippocrates (400 B.C.) attempted to explain

disease occurrence from a rational instead of a

supernatural viewpoint. In his essay entitled On
Airs, Waters, and Places,
Hippocrates suggested that environmental and host

factors such as behaviours might influence the

development of disease.

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Contd
18

The most important advances in epidemiology is attributed

to the English man John Grant (1620 1674).

He was the first to quantify patterns of birth, death, and
disease occurrence, noting male-female disparities, high
infant mortality, urban rural differences, and seasonal
variations
His research laid the groundwork for the disciplines of
both epidemiology and demography. His work is
summarized in the Natural and Political Observations.
Upon the Bills of Mortality, which was first published in
England in 1662
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Contd
19

In 1747, Lind used an experimental approach

to prove the cause of scurvy by showing it

could be treated effectively with fresh fruit.

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Contd
20

In 1839, William Farr, an English physician,

established the tradition of application of vital

statistical data for the evaluation of health problems.

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Contd
21

Far, considered the father of modern vital statistics

and surveillance, developed many of the basic

practices used today in vital statistics and disease
classification.
He extended the epidemiologic analysis of morbidity

and mortality data, looking at the effects of marital

status, occupation, and altitude. He also developed
many epidemiologic concepts and techniques still in
use today.
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Contd
22

In

1849, John Snow an English physician

formulated and tested a hypothesis concerning the
origin of an epidemic of cholera in London. Snow
postulated that cholera was transmitted by
contaminated water.

Twenty

years before the development of the

microscope, Snow conducted studies of cholera
outbreaks both to discover the cause of disease and
to prevent its recurrence.
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Contd
23

Snow conducted his classic study in 1854 when an

epidemic of cholera developed in the Golden Square

of London.
He began his investigation by determining where in

this area persons with cholera lived and worked. He

then used this information to map the distribution of
cases on what epidemiologists call a spot map.

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Scope of Epidemiology
24

Originally,

epidemiology was concerned with

epidemics of communicable diseases and
epidemic investigations.
Later it was extended to endemic communicable
diseases and non-communicable diseases

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Contd
25

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.

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Purpose/Use of Epidemiology
26

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
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Fundamental Assumptions in Epidemiology

27

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

differences in disease distribution in subgroups

study

the

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Some Basic Concepts

28

Health is a difficult concept to define.

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.
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.
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Clinical vs comminity medicine

29

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Contd
30

Information on the health and disease of a defined

community is gathered through Community

Diagnosis.
Community
Diagnosis - the process of
identification and detailed description of the most
important health problems of a given community.

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Methods of Community Diagnosis

31

Discussion with community leaders and health

workers
Survey of available health records
Field survey.
Compilation and analysis of the data.

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Contd
32

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

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Criteria for priority setting

33

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)

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Disease, Illness and Sickness

34

Disease, illness and sickness are loosely

interchangeable terms but are better regarded as

wholly synonymous.
Disease is literally the opposite of ease. It is
physiological or psychological dysfunction.
Illness is the subjective state of a person who feels

aware of not being well .

Sickness is a state of social dysfunction; i.e. a role
that an individual assumes when ill.
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Contd
35

Many different diseases occur in the community.

Some diseases usually last a short time: days or

weeks. Examples are most diarrheal diseases,
measles, and pneumonia. These are called acute
diseases.
Others last much longer, often for many months or
years. These are called chronic diseases. Examples
are tuberculosis, leprosy, diabetes, heart disease and
cancer.

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Risk Factors:
36 an increased or
any factor associated with

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.
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 11/26/16
of

Contd
37

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
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.
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38

Thank u!
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Chapter Two
39

Principles of Disease causation and Models

Cause of a disease

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40

Cause of a disease: is an event, condition, or

characteristic that preceded the disease event and

without which the disease event either would not
have occurred at all, or would not have occurred
until some later time

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Contd
41

The cause of a disease can be classified in two

A. primary causes:
. these are the factors which are necessary for a

disease to occur, in those absence the disease

will not occur.
.Etiological agent can be used instead of primary

cause for infectious diseases.

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Contd
42

B.

Risk

factor(

aggravating,

predisposing

,contributing factor):

These are not the necessary causes of disease but they are
important for a disease to occur.

Risk factors could be related to the agent, the host and the
environment.

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Principle of Causation

There are five principles of disease causation.

Namely:

43

Supernatural theory
Hippocratic theory
The single germ theory (Henle-Koch postulate)
Classic epidemiological theory
The ecological approach

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The Germ theory

44

Luis

Pasteur

isolated

microorganism.

This

discovery led to Koch's postulate in 1877. It was a

set rule for the determination of causation.
Koch's Postulate states that:
The organism must be present in every case.
The organism must be isolated and grown in

culture
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ROBERT KOCH
45

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Contd
46

The organism must be isolated and grown in

culture.
The

organism must, when inoculated into a

susceptible animal, cause the specific disease.

The organism must then be recovered from the

animal

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47

Disease is simply an outcome of exposure to an

infectious agent.

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The Ecological approach

48

Ecology is defined as the study of the relationship of

organisms to each other as well as to all other aspects

of the environment.
Disease is a product of complex interaction b/n human

population and their physical, biological, socioeconomic,

political and cultural envt.

Disease arise in the ecosystem.

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Contd
49

The requirement that more than one factor be

present for disease to develop is referred to as

multiple causation or multi-factorial etiology.
For infectious diseases to occur there are three
essential factors,
1.etiologic agent;
2.suitable environment for propagation and
growth of the agent
3.susceptible host to invade, multiply and produce
disease.
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Contd
50

In the ecological view, an agent is considered to

be necessary but not sufficient cause of disease

because

the

conditions

of

the

host

and

environment must also be optimal for a disease to

develop.

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Contd
51

Sufficient cause:
A set of conditions without any one of which

the disease would not have occurred.

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Contd
52

If disease does not develop without the factor

being present, then we term the causative factor

necessary.
A sufficient cause, which means a complete
causal mechanism, can be defined as a set of
minimal conditions and events that inevitably
produce disease; minimal implies that all of the
conditions or events are necessary.
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Etiology of disease
53

All factors that contribute to the occurrence of a

disease.
These factors are related to agent, host and

environment.
The Agent:

is a factor whose presence or

absence, excess or deficit is necessary for a

particular disease or injury to occur.
11/26/16

Contd

Nutritive

element:

54

Excessive(

Cholesterol),

Deficiency (Vitamin, Protein)

Chemical Agents: Poison (Carbon monoxide)

Physical Agents: Radiation

Infectious

Agents:

Metazoa

(Hookworm,

Schistosomiasis), Protozoa (Amoeba), Bacteria

(M.Tb), Fungus(Candidiasis),Virus (Measles)

11/26/16

Contd
55

Host Factors: Influence exposure, susceptibility

or response to agents.
Genetic, Age, Sex, Physiologic state, Pregnancy,
Puberty, stress
Immunologic condition(Active immunity & Passive
immunity)
Human behavior; Hygiene, Diet handling
* Host factors result from the interaction of genetic
endowment with the environment.
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Environmental Factors
Influence

56

the existence of the agent, exposure, or susceptibility to

agent
A.

Biological environment

Infectious

agents
Reservoirs (man, animal, soil)
Vectors (flies, mosquitoes)
B.

Social environment

Socioeconomic

and political organizations affect the level of medical

care.
Eg. types of food eaten; practice of wearing shoes; general level of
receptivity to new ideas;
C. Physical environment
.

Heat,

Light, Water, Air

Industrial wastes
Chemical agents of all kinds
Indoor air pollution

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Contd
57

It is the interaction of the above factors (agent,

host, and environment) which determines

whether or not a disease develops, and this can
be illustrated using different models.
How do diseases develop? Epidemiology helps
researchers visualize disease and injury etiology
through models.
the epidemiologic triangle, the web of causation,
and the wheel are among the best known of
these models.
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1. Epidemiologic triangle model

58

Agent

Host

Environment

The most familiar disease model,

depicts a relationship among three key

factors in the occurrence of disease or

injury: agent, environment, and host.
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59

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60

11/26/16

Contd
61

From the perspective of epidemiologic triad, the

host,

agent,

and

environment

can

coexist

harmoniously.
Disease and injury occur only when there is

interaction or altered equilibrium between them.

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Contd
62

But if an agent, in combination with environmental

factors, can act on susceptible host to create

disease, then disruption of any link among these
three factors can also prevent disease.

11/26/16

Contd
Agent: needs suitable63environment to grow and

multiply and thus to spread and infect others.

Host: is affected by the environment: also affects
the environment by modifying/changing it. E.g.
drainage of swamps
When there is a balance between all these
factors there will be steady no. of people with
disease all the time called endemic.
When the balance inclines to/in favor of the
agent, many more individuals will have the
disease resulting in an epidemic.
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2. web of causation model

64

The web of causation 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.

11/26/16

Contd
65

Using this model, scientists can diagram how

factors such as stress, diet, heredity, and

physical activity relate to the onset of the three
major types of cardiovascular disease: coronary
heart disease, cerebro-vascular disease (stroke),
and hypertensive disease.
In addition, the approach reveals that each of
these diseases has a precursor, for example,
hypertension, that can alert a diagnostician to the
danger of a more serious underlying condition.
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Cont
d
66

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67

A complex interaction of causative factors in the

production of disease is called web of causation.

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3. Wheel model
68

A model that uses the wheel is another approach

to depict human environment relations.

The

wheel consists of a hub (the host or human), which

has genetic makeup as its core. Surrounding the
host is the environment, schematically divided into
biological, social, and physical.

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Contd

69

11/26/16

Contd
70

The relative sizes of the different components of

the wheel depend upon the specific disease

problem under consideration.
For hereditary diseases, the genetic core would
be relatively large. For conditions like measles
the genetic core would be of lesser importance;
the state of immunity of the host and the
biological sector would contribute more heavily.

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Contd
71

In contrast to the web of causation, the wheel

model does encourage separate delineation of

host and environmental factors, a distinction useful
for epidemiologic analyses.

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72

THANK YOU
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Chapter Three
73

. Natural

History of Disease
and Levels of Prevention

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1 Natural history of disease

74

The natural history of disease refers to the

progression of disease process in an individual

over time, in the absence of intervention.
Each disease has its own life history, and thus,

any general formulation of this process is arbitrary.

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75

However, it is useful to develop a schematic

picture of the natural history of diseases as a

frame work within which to understand and plan
intervention measures including prevention and
control of diseases.

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There are four stages in76 the natural history of a

disease. These are:

Stage of susceptibility
Stage of pre-symptomatic (sub-clinical) disease
Stage of clinical disease and
Stage of disability or death

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77

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Stage of susceptibility

In this stage, disease has

78 not yet developed, but the
groundwork has been laid by the presence of 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.

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Stage of Pre-symptomatic (subclinical) disease

79

In this stage there is no manifestation of 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.
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80
The
Clinical
By this
stage 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.

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Contd
81

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.
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Stage of disability or death

82

Some diseases run their course and then resolve

completely either spontaneously or by treatment.

In others the disease may result in a residual
defect, leaving the person disabled for a short or
longer duration. Still, other diseases will end in
death.

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83

Disability is limitation of a person's activities

including his role as a parent, wage earner, etc

Examples:
Trachoma may cause blindness
Meningitis may result in blindness or deafness.

Meningitis may also result in death.

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84
Healthy person

Sub clinical disease

Recovery

Recovery

Clinical disease

Disability

Death

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Infection versus Disease

Infection is defined as the
85 entry and development or

multiplication of an infectious agent in a host, whether or

not this process results in disease.
Infection may remain asymptomatic or may appear as a
disease.
Infectiousness( from exposure to infection)- is the
ability to cause infection in an exposed susceptible host. Pathogenicity( from infection to disease)- is the ability
to cause disease in a susceptible host.
Virulence( from disease to disease outcome) - is the
ability to cause severe disease in a susceptible host.
Immunogenicity:
The infection's ability to produce
specific immunity.
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Disease progression
86

Exposure

Infection

Infectiousnes
s
(Infection
Rate)

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Disease

Pathogenecity
(clinical :
subclinical)

Disease
outcome
Virulence
(CFR, HR)

87

Factors influencing the development of disease:

1. Strain of agent
2. Dose of agent
3. Route of infection
4. Host age
5. Host nutritional status
6. Host immune response

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Levels of Disease Prevention

88

The

major purpose in investigating the

epidemiology of diseases is to learn how to
prevent and control them.
Epidemiology plays a central role in disease
prevention by identifying those modifiable
causes.
Disease prevention means to interrupt or slow

the progression of disease.

There are three levels of prevention
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1. Primary prevention
89

Is

aimed at preventing healthy people from

becoming sick.
Primary prevention keeps the disease process
from becoming established by eliminating
causes of disease or increasing resistance to
disease
The main objectives of primary prevention are
promoting health, preventing exposure and
preventing disease.

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90

A. 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 examples of health
promotion

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91

B. 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.

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92

C. Prevention of disease:- is the prevention of

disease development after the individual has

become exposed to the disease causing
factors.
Example: Immunization

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2. Secondary prevention
93

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
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3. Tertiary prevention
94

is a type of prevention after the disease has already

occurred and left residual damage.

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.
This consists of limitation of disability and rehabilitation.
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95

Rehabilitation refers to the retaining of remaining

functions for maximal effectiveness.

Limitation of disability helps to limit or stop the
damage and impact of damage.
The impact can be physical, psychological, social
(e.g., social stigma) and financial.

11/26/16

Quiz
96

Which type of prevention(s) is involved in the

following sentences?
1. INH prophylaxis for TB people living with HIV
2. Doxcycycline prophylaxis for malaria
3. Nutritional counseling for malnourished individual
4. TT vaccination for a pregnant women
5. Passive joint movement for polio to prevent
deformity

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97

. THANK

YOU

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Chapter Four
98

Infectious disease Process

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Learning objectives
99

By the end of this session, students will be expected to:

List the major components of the infectious disease cycle
Describe natural history and time course of an infectious

disease
Identify factors that affect person-to-person infectious
disease transmission
Describe the type of carriers and roles in the infectious
disease transmission

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What are infectious diseases?

100

Infectious diseases are caused by pathogens that

are transmitted either directly between persons or

indirectly via a vector or the environment

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Chain of disease transmission

(components of infectious process)
101

Definition: Logical sequence of factors or links of a

chain that is essential to the development of

infectious agent and to propagation of disease.

The infectious process (components of infectious

disease process)
components:

includes

the

following

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Components of Chain of disease transmission

102

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1. Agent
103

This is an organism capable causing infection or

infectious disease .
E.g
metazoan ,protozoa , bacteria , fungus
,Virus.
o The agent causes infection and disease depending
on its basic biological characteristics
o The outcomes of exposure to infectious agent can
be depends on:
Infectiousness
Pathogenecity
Immunogenicity
Virulence

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104

Factors that influence disease development other than

infectivity, Pathogenicity, immunogenicity and virulence of

the agent are:
o Strain of agent
o Dose of agent
o Route of infection
o Influence of human host age
o Influence of human host nutritional status
o Influence of human host immune response
o Influence of treatment
o Influence of seasonal variation, etc
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2. The reservoir

105

o Reservoir is the habitat in which an infectious

agent lives, grows, transforms and/or multiplies

itself
Examples:
Human beings: Measles, Mumps, Pertusis,
Poliomyelitis etc
Animals: Mosquito for plasmodium specious etc
Environment (plant, soil, water): tetanus etc
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As a general rule, the greater the number of different

reservoirs for a given 106disease, the greater the
difficulty in controlling that disease. (e.g., malaria)

Types of reservoirs:
A. Man
Measles, smallpox, typhoid, N.meningitis,
gonorrhea, syphilis
The cycle of transmission is from man to man.

11/26/16

Contd
107

B. Animals - cause zoonotic diseases

bovine TB -cow to man

brucellosis cows, pigs and goats to man
anthrax -cattle, ship, goats, horses to man
rabies -dogs, foxes and other wild animals to man

11/26/16

Contd
108

C. Non-living things
Usually saprophytes living in soil
e.g. clostridium tetani
clostridium botulinum etc
A person who does not have apparent clinical

disease, but is a potential source of infection to

other people is called a Carrier.

11/26/16

Type of carriers
109

. Asymptomatic carriers: transmitting infection

without ever showing manifestation of the disease

. Incubatory carriers: transmitting infection by
shedding the agent before the onset of clinical
manifestations
.
Example: HIV/AIDS

11/26/16

110

Convalescent carriers: transmitting infection

during convalescence, from the time of recovery
until the time the agent stops shedding
Example: Typhoid fever

Chronic carriers: shedding the agent for a long

period of time or even indefinite time
Example: Hepatitis-B infection
typhoid fever
.

111

Carriers are the challenges of public health

Professional in that they are more tapher in

spreading disease more than the clinically apparent
ones

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Ice-berg /hippopotamus/ effect of carriers

112

Case
s
Carriers

11/26/16

Roles of carriers in disease transmission

113

Non detectability
Chronicity
Mobility
Number

11/26/16

3. Portals of exit
114

The portal of exit is the route by which the

infectious agent leaves the infectious hosts or

reservoirs
All body secretions and discharges, such as:
mucus, saliva, tears, breast milk;
vaginal, cervical and urethral discharges;
semen, pus, exudates from wounds are the
usual portals of exit.

11/26/16

Portal of exit
115

11/26/16

Contd
116

GIT: Typhoid fever, bacillary dysentry, amoebic

dysentry, cholera, ascariasis

Respiratory: through exhalation, talking and
coughing:
e.g. TB, Common cold,
Skin and mucus membranes: syphilis
Blood and tissues (placenta)

11/26/16

4. Modes of Transmission
117

Mode of transmission is the mechanism by which

the infectious agent escapes from a reservoir and

enters into a susceptible human host
There are two major mechanisms of transmission:

Direct transmission
Indirect Transmission

11/26/16

Direct transmission
118

consists immediate transfer of infectious agents

from infected host or reservoir to appropriate

portal of entry. It includes:
Transmission by direct contact
Transmission by direct projection
Trans-placental transmission
Blood transfusion
Organ transplantation

11/26/16

a) Transmission by direct contact

119

Occurs through skin-to-skin contact, kissing, and sexual

intercourse.
Direct contact also refers to contact with soil or vegetation
harboring infectious organisms:

o
o
o
o

Touching:

Trachoma (eye-hand-eye)
Common cold (nose-hand-eye)
Shigellosis (feces-hand-mouth)
Viral hepatitis and HIV (through breaks in skin)
Sexual intercourse: HIV/AIDS
kissing : mononucleosis
Passing through birth canal: Gonorrhea
11/26/16

b) Transmission by direct projection

120

Transmission by direct projection of saliva droplets

created by breathing, coughing, sneezing, spitting,

talking, singing etc
Example: common cold

11/26/16

c) Trans-placental transmission
121

Trans-placental transmission of infectious agent is

transmission from mother to fetus via the placental

membrane
Examples:
o HIV/AIDS
o Syphilis
o Toxoplasmosis
o Malaria etc...

11/26/16

Indirect transmission
122

a) Airborne transmission
b) Vehicle borne transmission
c) Vector borne transmission

11/26/16

a) Airborne transmission
123

It is the transmission of infectious agents by either

suspended dust or droplet nuclei suspended in air for

relatively long period of time
Examples:
Measles, for example, has occurred in children who
came into a physicians office after a child with
measles had left, because the measles virus remained
suspended in the air

11/26/16

b) Vehicle borne transmission

.:
124
A vehicle is any non-living
substance or object
by which an infectious agent can be
transported into a host through a suitable
portal of entry.
Examples: food, milk, water, soil, etc.

Fomites (or contaminated objects, such as

towels,
cloths,
bedding,
handkerchiefs,
cooking and eating utensils, toys, syringes and
needles, surgical instruments and dressings).

Biological products: blood and products for

transfusion, tissues and organs or transplant
and semen used in artificial insemination
11/26/16

c) Vector borne transmission

125

It is the transmission of infectious agents by a vector

Vector: is an organism usually an arthropod, such

Vector: is an organism usually an arthropod, such as
as insect, tick, mite, which transports an infectious
insect, tick, mite, which transports an infectious agent to
agent
to a susceptible
host orvehicle
to a suitable
a susceptible
human hosthuman
or to a suitable
vehicle
A vector is responsible for introducing the agent into
the susceptible human host through a suitable portal
of entry
Biological vector: salivarian transmission (malaria
by mosquito)
Mechanical vector: trachoma by common fly
11/26/16

d) A non-vector intermediate host

126

These

are hosts which are important for

development of the infectious agent but dont play an
active role in transporting the agent to the
susceptible human host

Example: Aquatic snail for schistosomiasis

Note
- A disease may often have several modes of
transmissions
11/26/16

127

Often,

diseases have several modes of

transmission, hence it's often necessary to
distinguish between the predominant modes of
transmission and those which are of secondary
importance.

11/26/16

5. Portal of Entry
128

Portal of entry is the route through which a

microorganism enters into the susceptible human
host

Whether an agent will establish infection depends

on the suitable portal of entry

Example: No harm in ingesting the Clostridium
tetani (it is in fact the normal flora of GIT system )
11/26/16

Portal of entry
129

11/26/16

130

Portal of entry includes:

Conjunctiva (trachoma, common cold)
Nasal or upper respiratory tract (common cold,
diphtheria)
Lower respiratory tract (TB)
Percutaneous (tetanus, hookworm)
GIT (typhoid fever)
Viganal (STDs/HIV/AIDS)
Anal (STDs/HIV/AIDS) etc

11/26/16

6. The susceptible human host

131

person lacking sufficient resistance to a

particular pathogenic agent to prevent disease if
exposed.
The concept of host susceptibility or resistance
can be seen at two levels, individual and that of
the population.

11/26/16

At the individual level: The state of the host at

132 interaction of genetic
any given time is the
endowment with the environment over the entire
life span. The relative contributions of genetics
and environmental factors in the susceptibility of
the host for diseases are not always clear.
Examples
Genetic factors: sex, blood type, ethnicity etc.
Environmental factors: immunity acquired as a
result of past infection

11/26/16

 At the community level: Host resistance at the

133 level is called
community (population)
herd
immunity.

Herd immunity can be defined as the resistance of

a community (group) to invasion and spread of an

infectious agent, based on the immunity of a high
proportion of individuals in the community.

The high proportion of immunes prevents

transmission by highly decreasing the probability
of contact between reservoirs and susceptible
hosts.
11/26/16

Prerequisite for herd immunity

134
1. Single reservoir (the human host ).
2. Direct transition (direct contact or direct
projection ).
3. Total immunity :partial immune hosts may
continue to shed the agent .
4. No shedding of agents by immune hosts (no
carrier state ) .
5. Uniform distribution of immunes.
6. No over crowding.

11/26/16

infectious disease transmission

135

11/26/16

Time course of an infectious disease

136

Prepatent period - This is the time interval

between infection (or biological onset) and the

point at which the infection can first be detected,
as measured by the time of first shedding of the
agent by the host.
e.g. The agent can shed into the blood stream,
where it can be picked up by vectors or in blood
transfusion (as in malaria) or through the other
portals of exist (faces, body secretio ns, etc).
In

some conditions, like the AIDS, it is the so

called "window period".
11/26/16

Incubation period

137

It is the time interval between infection and the

first clinical manifestation of disease

The time interval between biological onset and

clinical onset

11/26/16

Communicable period
138

It is the period during which an infected host can

transmit the infection to other host

It can be measured by the time interval during

which the agent is shed by the host

It extends from the point of the first shedding up to

the last shedding of the infectious agent by the

infectious host
11/26/16

Latent period
139

It is the time interval between recovery and the

occurrence of a relapse in clinical disease

Example: Typhus and malaria have latent period
because they relapse after some time

11/26/16

ss

140

11/26/16

141

11/26/16

Principles of communicable diseases control

142

Defn: reduction of incidence and prevalence of

communicable diseases to a level where it can not

be a major public health problem.
There are three broad areas of prevention and
control:1. Attacking the source (reservoir) of infection.
That is to reduce the number of infective organisms.
11/26/16

143

This is done by:

a. Treatment of cases and carriers through mass
treatment, as in typhoid fever, schistosomiasis,
tuberculosis.
b. Isolation: separation of infected persons for a

period of communicability.
N.B. Isolation is indicated when diseases:
have high mortality and morbidity.
have high infectivity
11/26/16

144

c.

Quarantine: limitation of movement of person or

animal who has been exposed to infectious disease
for a maximum incubation period for the disease.

d.

Reservoir control: by mass vaccination to cattle

and sheep and killing & burning infected animals
(rabies, anthrax).

e.

Active surveillance of contacts

Effective reporting system

f.

11/26/16

2. Interrupting the chain of transmission: is

145
control of modes of transmission
from reservoir to
the new host.
a. Environnemental sanitation: - intestinal
parasites control.

b. Personal hygiene: - trachoma and scabies control.

c. Vector control (mosquito and snails control)
malaria and schistosomiasis.
d. Disinfection and sterilization: - purification of
potable water, pasteurization of milk, disinfection of
air.
11/26/16

146

3. Reducing host susceptibility:

a. Immunization - herd immunity
b. Better and improved nutrition
c. Health education
d. Chemoprophylaxis:-malaria, meningitis, tuberculosis
e. Person protection: - mosquito nets, clothing, repellents,
shoes, etc.

11/26/16

147

THANK YOU !!!

11/26/16

Quiz
148

1)suppose 20 Midwife students have gone to Humera for field work.

Unfortunately 12 and 8 of them found to have malaria and kalazar
infection with laboratory investigation respectively. Among malaria
infected individuals 5 developed disease and 4 of them died. Among
kalazar infected individuals 4 developed disease and 3 of died.
Based on the above case scenario
a) Which is more pathogenic?
b)Which is more infectious?
c)Which is more virulent?
2)Write factors that affect the spread of disease through person to person
transmition?

11/26/16

149

11/26/16

150

CHAPTER 5

11/26/16

Measures of Morbidity and Mortality

151

Epidemiology is mainly a quantitative science.

Measures of disease frequency are the basic tools

of the epidemiological approach.

Health status of a community is assessed by the

collection, compilation, analysis and interpretation

of data on illness (morbidity), on death (mortality),
disability and utilization of health services.

11/26/16

Frequency measures
Ratios, Proportions and Rates
152

11/26/16

153

Ratio
A ratio quantifies the magnitude of one occurrence

or condition to another. It expresses the

relationship between two numbers in the form of
x/y or x:y.
Example: The ratio of males to females in this class
room.

11/26/16

Proportion

154

o A proportion is the comparison of a part to the

whole values
o It is a type of ratio in which the numerator is
included in the denominator
o Proportion may be expressed as a decimal, a
fraction, or a percentage
o In a proportion, the numerator must be included in
the denominator
o Its result ranges between 0 and 1 or (0100%)
11/26/16

Rate
155

It is a measure of the frequency with which an event

occurs in a defined population over a specified period of

time
Most commonly used in epidemiology because it most

clearly expresses probability or risk of disease or other

events in a defined population over a specified period of
time
Examples:
o Fertility rates
o Morbidity rates
o Mortality rates

11/26/16

156

o Rate is a special form of proportion, with an added

time dimension

o Measures occurrence of an event in a population

over time

11/26/16

Type of rates
157

Crude rate

total population (e.g. crude birth rate)

Specific rate

population subgroups (e.g. age-group specific death rate)

Standardized rate

rates after adjusting for a specific grouping

(age, sex, etc.)

11/26/16

Crude rates
158

o Summary rates
o Based on numbers of events

e.g. births, deaths

Crude birth rate =

# of live births to residents in an area

in a calendar year
average # population in the area in
that year

X 1000

11/26/16

Mortality rates
159

o A mortality rate is a measure of the frequency of

occurrence of death in a defined population during

a specified time interval

o For a defined population, over a specified period

of time

11/26/16

Crude mortality rate

160

11/26/16

Advantages

161

Actual summary rates

Calculable from minimum information
Widely used for international comparison despite limitations

Disadvantages

Difficult to interpret due to variation in composition (e.g. age)

Obscure significant differences in risk between subgroups

11/26/16

Specific rates
162

Specific rates apply to specific subgroups in the

population, such as a specific age group, sex,

occupation, marital status, etc.
When calculating specific rates, except for cause-

specific rates, the denominator should be the

population in that specific group (NOT the total
population).

11/26/16

163

* Do not add age specific rates to get crude rate,

take the weighted average.
Example: Infant Mortality Rate (IMR), Neonatal
Mortality Rate (NMR), post neonatal mortality rates

11/26/16

164

Advantages

The rates apply to homogenous subgroups

The rates are detailed and useful for epidemiological and
public health purposes.

Disadvantages

It is cumbersome to compare many subgroups of two or more

populations

11/26/16

Adjusted rates
165

Adjusted rates are summary rates that have

undergone statistical transformation, to permit

fair comparison between groups differing in some
characteristics that may affect risk of disease.
Advantages

Summary rates
Permit unbiased comparison
Easy to interpret

11/26/16

166

Disadvantages

Fictitious rates
Absolute magnitude depends on standard population
Opposing trends in subgroups masked.

11/26/16

Aims of standardization
167

o It can be done to increase comparability between

exposure groups
o Accounts

for the differing distributions

underlying characteristics (exposures like age)

of

11/26/16

Types of standardization
168

Direct method Weights/population structure come

from the standard population and specific rates
come from the study population
Indirect method Specific rates come from the
standard population and weights/population
structure from the study population

11/26/16

Standardization of rates by the

direct method
169

o In direct standardization the stratum-specific rates

of study populations are applied to the age

distribution of a standard population

o It requires:
1. Standard population to which the estimated

specific rates are applied

2. Specific rates of event for the study population

11/26/16

Steps in direct standardization

170

Step 1 - List resident deaths and the population

(for year/years being studied/compared) by the

age categories for the county:
COUNTY I
AGE

Column A
DEATHS

Column B
POPULATION

<1

12

22,487

85+

271

3,094

11/26/16

171

Step 2 - Calculate the age-specific rates by

dividing Column A by Column B:

(12 / 22,487) = 0.000534

This is done for every age category in the

population.

11/26/16

 Step 3 - List the "standard" population as Column D.

Step 4 - Multiply each age specific rate (Column C) by

the number in each of the corresponding age groups of

172
the "standard" population (Column D). Expected
deaths

Column C
.000534

Column D
X

15,343

Column E
=

8.193

.087589

2,770

242.622
11/26/16

Contd
173

AGE

(A)
D
E
A
T
H
S

<1

12

85+

(B)
COUN
TY
POPU
LATIO
N
/

271 /

22,487

3,094

(C)
AGESPEC
IFIC
RATE
S
=

.000534

.087589

(D)
STAND
ARD
POPUL
ATION
X

15,343

2,770

(E)
EXPE
CTED
DEAT
HS
=

8.193

= 242.622
11/26/16

Contd

174

Step 5 - Sum the expected deaths (Column E) and

standard population (Column D) for all age
categories.
Step 6 - To get the age-adjusted rate per
100,000 population, simply divide the total
expected deaths (Column E) by the total
standard population (Column D) and then
multiply by 100,000:
(4916.748 / 1,000,000) x 100,000 = 491.7 = ageadjusted death rate for County 1 per 100,000
1940 U.S. standard million population
11/26/16

175

o Adjusted rates are derived by applying category-specific

rates observed in each population to a single standard

population
o The adjusted rate represents the hypothetical rate that
would have been observed if each population had the same
distribution on the confounding factor of concern (i.e. age)

11/26/16

The standard population is based on convention, the

intended and potential comparisons, and various other

176
considerations
1.
2.
3.
4.
5.
6.
7.

US 1940 population
US 2000 population
European standard population
WHO world population
National population/general population
One of the study populations (larger population)
Sum of the study populations
11/26/16

direct standardization
177

11/26/16

Population A in 1995
Age

Popul.

# Deaths

% of Popul.

Death Rate

0 to 14

190,703

174

21.4%

0.0009

15 to 24

115,928

115

13.0%

0.0010

25 to 44

289,441

620

32.4%

0.0021

45 to 64

180,396

1,435

20.2%

0.0080

65 +

116,406

5,657

13.0%

0.0486

TOTAL

892,874

8,001

100.0%

0.0090

178

11/26/16

Population B in 1995
179

Age

Popul.

# Deaths

% of Popul.

Death Rate

0 to 14

138,986

116

15.9%

0.0008

15 to 24

83,815

63

9.6%

0.0008

25 to 44

239,396

498

27.3%

0.0021

45 to 64

190,427

1,421

21.7%

0.0075

65 +

223,576

10,326

25.5%

0.0462

TOTAL

876,200

12,424

100.0%

0.0142

11/26/16

o We can then apply the category-specific death

180
rates to the standard population
to calculate and
compare the expected number of deaths in each
population

o One way to select the standard population is to

combine population counts from the populations

11/26/16

the population composition are the same in

A & B
181

A + B

Death Rate

Expected Deaths

Age

Population

0 to 14

329,689

.0009

.0008

296

263

15 to 24

199,743

.0010

.0008

199

159

25 to 44

528,837

.0021

.0021

1,110

1,110

45 to 64

370,823

.0080

.0075

2,966

2,781

65 +

339,982

.0486

.0462

16,523

15,707

TOTAL

1,769,074

-----

-----

21,094

20,020
11/26/16

Calculate the Adjusted Death

182 Rates for A & B
populations
A + B

Death Rate

Expected Deaths

Age

Populatio
n

0 to 14

329,689

.0009

.0008

296

263

15 to 24

199,743

.0010

.0008

199

159

25 to 44

528,837

.0021

.0021

1,110

1,110

45 to 64

370,823

.0080

.0075

2,966

2,781

65 +

339,982

.0486

.0462

16,523

15,707

Total

1,769,074

-----

-----

21,094

20,020

11/26/16

Solutions
183

Adjusted Death Rate (A) = 21094 / 1,769,074 = 1,192 per 10 5

Adjusted Death Rate (B) = 20020 / 1,769,074 = 1,132 per 105

Standardized Rate Ratio (SRR) = 1,192 / 1,132 = 1.05

Using (A + B) population as the standard population
The age-adjusted 1995 death rate appears to be

approximately 5% higher in population A compared to

population B
11/26/16

Exercise -1
184

11/26/16

Measure of mortality
185

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.

11/26/16

Crude Death rate (CDR)

186

CDR= Total no. of deaths reported X 1000

during a given time interval

Estimated mid interval population

11/26/16

Age- specific mortality rate

187

= No. of deaths in a specific age group during a given

time X1000
Estimated mid interval population of sp. age group

11/26/16

Sex- specific mortality rate

188

= No. of deaths in a specific sex during a given time X 1000

Estimated mid interval population of same sex

11/26/16

Cause- specific mortality rate

189

CSDR= No. of deaths from a specific

cause during a given time X 100,000
Estimated mid interval population

11/26/16

Proportionate mortality ratio

190

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

11/26/16

Case Fatality Rate

191

CFR= No. of deaths from a sp. disease during a given time x

100
No. of cases of that disease during the same time

11/26/16

Perinatal Mortality Rate

PMR= No. of fetal deaths192
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

11/26/16

Neonatal Mortality Rate

193

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

11/26/16

Infant mortality rate

194

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

11/26/16

Child mortality rate

195

= 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

11/26/16

Maternal Mortality Ratio

196

MMR=Total no of female deaths due to complications of pregnancy,

child birth & puerprium in an area in a year
x 100000
No. of live births in the same area & year

11/26/16

 When calculating (using) mortality rates it is

197
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.
11/26/16

 The case fatality rate asks

198the 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?

11/26/16

Measures of morbidity
199

o Morbidity has been defined as any departure,

subjective or objective, from a state

physiological or psychological wellbeing state

of

o Morbidity rates are rates that quantify disease

occurrences (frequencies)
o Morbidity encompasses disease, illness, injury,

disability or any disorder in public health practice

11/26/16

Measure of morbidity
200

o Incidence
o Prevalence

11/26/16

Incidence

201

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.

11/26/16

Contd
202

Number of new cases of a disease over a period of

time X 1000
Population at risk during the given period of time

11/26/16

 Because incidence is a measure of new events

(i.e. transition from a non-diseased

to a diseased
203
state), incidence is a measure of risk.
The appropriate denominator for incidence rate

is population at risk.
For incidence to be meaningful, any individual

who is included in the denominator must have

the potential to become part of the group that is
counted in the numerator.

11/26/16

Types of incidence
204

1. Cumulative Incidence (CI)

. defined as the proportion

of a candidate
population that becomes diseased over a
specified period of time

. An incidence 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.
11/26/16

Contd
205

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.
It provides an estimate of the probability, or risk, that an

individual will develop a disease during a specified

period of time. It is a measure of the probability or
risk of disease, i.e., what proportion of the
population will develop illness during the
specified time period.
11/26/16

Contd
206

CI = Number of new cases of a disease

during a given period of time X 1000
Total population at risk

11/26/16

Properties of incidence proportion

207

o It is a measure of the risk of disease or the probability

of developing the disease during the specified time

o As a measure of incidence, it includes only new cases

of disease in the numerator

o The denominator is the number of persons in the

population at risk at the start of the observation time

o Applicable for only static population of cohort
11/26/16

208
Example A: In the study of diabetics, 100 of the 189 diabetic men died during the 13year 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%
Example B: In an outbreak of gastroenteritis among attendees of a corporate picnic,
99 persons ate potato salad,30 of whom developed gastroenteritis.
Calculate the risk of illness among persons who ate potato salad.
Numerator = 30 persons who ate potato salad and developed
gastroenteritis
Denominator = 99 persons who ate potato salad
Risk = Food-specific attack rate = (30 / 99) x 100 = 0.303 x 100 =

= 30.3%
11/26/16

Cumulative incidence example

209

IP = 3/5 = 0.6

2. Incidence Density
210
An incidence rate whose denominator
is calculated using

person-time units.
the occurrence of new cases of disease that arise during
person- time of observation
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 individuals 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.

11/26/16

o The denominator is the population at risk

o Incidence rate is also called
incidence density
211
o It is the occurrence of new cases of disease per unit

of person-time observation
o The assumption is dynamic population at risk

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212

Incidence rate
Definition of incidence rate contains three

components:
o New cases
o Period of time time under follow up
o Population at risk

11/26/16

Contd
213

o It must take into account the followings:

Number of individuals who become ill in a population

Time periods experienced by member of the population during

follow up time

11/26/16

Incidence rate
214

The incidence rate indicates how quickly people

become ill measured in people per year

Incidence rate is a measure of incidence that

incorporates time directly into the denominator

Typically, each person is observed from an

established starting time until one of four end

points is reached:
o
o
o
o

onset of disease
death
lost to follow-up
end of the study
11/26/16

Contd
215

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Person-time
216

It is sum of length of time period passed free of

illness (at risk) by each individual member of study
It accounts for the amount of exposure time of
members
Dynamic cohort is a cohort of people leaving and
entering a study at different time of period
11/26/16

217

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 personyears.
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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Lab tech rotation to hematology section

218

Total number of students

Stay in hematology lab
contrib. 60
20 students for 3 months
20 students for 6 months
20 students for 1 year

person year

20X1/4
20X1/2
20X1
35 person yr
If 10 students develop hepatitis=(10/35)X100
= 28.57 new infections /100 person years of
observation
11/26/16

Person-Time example
219

Jan

1980

Jan
1989

------------------

Jan
1999

------------------x

-----------------------------------incident rate is 2/39 PY

220

It indicates how quickly people become ill measured

in people per year.

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221

1. Knowledge of the health status of the study

population
To be able to classify people as diseased" and
"not diseased", there should be adequate basis for
assessing the health of the individuals in a
population.
2. Time of Onset
Since incidence rates deal with newly developing
diseases, identifying the date of onset is necessary
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3. Specification of Numerator
Number of persons versus number of conditions.
222
Example: children may have more than one episode of
diarrhea in a one-year period. Hence, it is possible to
construct two types of incidence rates from this.

Number of children who developed diarrhea in one-year period

Number of children at risk

Number of episodes of diarrhea in children in one-year period

Number of children at risk

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4. Specification of Denominator
223
The denominator for incidence studies should
consist of a defined population that is at risk of
developing the disease under consideration.
It should not include those who have the

disease or those who are not susceptible

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5. Period of Observation
Incidence rates must be stated in terms of a
definite period of time.224
It can be any length of time. The time has to be
long enough to ensure stability of the
numerator.
Person-time denominator must be used for

unequal periods of observation.

This helps to weigh the contribution of each
study subjects when there is attrition because;
individuals die, move away or get lost to follow
up
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2. Prevalence rate
225

o It is the proportion of persons in a population who

have a particular disease or attribute at a specified

point in time or over a specified period of time
o

Prevalence differs from incidence in that

prevalence includes both new and pre-existing
cases in the population at the specified time

o It measures disease status (disease burden)

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226

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Types of prevalence
227

1. Period Prevalence rate

2.

Point Prevalence rate

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Point prevalence
o It

228
refers to the prevalence
measured at a
particular point in time

o It is proportion of a population that is affected by

disease at a given point in time

o The amount of disease in a population usually

changes constantly
o Thus, may not be useful for assessment of

diseases with short generation period

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Contd
229

PtPR=All persons with a specific condition at

a point in time *1000

Total population

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Period prevalence

230

o It refers to prevalence measured over an interval

of time
o It is the proportion of persons with a particular

disease or attribute at any time during the

interval time period

11/26/16

Contd
231

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

X10n average population

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Example-1
232 at risk of disease X,
A total of 100 people were
which has no life time immunity.

t1

t2

What is the prevalence of disease X at time t 1?

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Example
233

In a survey of 1,150 women who gave birth in Gondar town in

2000, a total of 468 reported taking a multivitamin at least
4 times a week during the month before becoming pregnant.
Is it a period or a point prevalence?
Calculate the prevalence of frequent multivitamin use in this group.
Numerator = 468 multivitamin users in the year
Denominator = 1,150 women gave birth in the year
Priode Prvalence = (468 / 1,150) x 100 = 0.407 x 100 = 40.7%

11/26/16

point prevalence
234

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

11/26/16

235

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Factors influencing prevalence rate

236

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.
11/26/16

Prevalence increased by
237

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

11/26/16

Prevalence decreased by
238

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

11/26/16

Prevalence rates are important particularly for

Chronic disease studies 239

Planning health facilities and manpower
Monitoring disease control programs
Tracking changes in disease patterns over time
prevalence is useful for estimating the needs of medical
facilities and for allocating resources for treating people who
already have a disease

11/26/16

Incidence rate is important as

240

A fundamental tool for etiologic studies of acute and chronic

diseases
A direct measure of risk
most useful for evaluating the effectiveness of programs
that try to prevent disease from occurring in the first place

11/26/16

241

11/26/16

QUIZ
242

On January 1, 2000 there were 20 medical students with Influenza A and

there were a total of 600 students in the class. = These 20 students were
immune from contracting Influenza A again during the next nine months.

From January 2, 2000 through April 2, 2000, 30 more students developed

Influenza A and the class size remained at 600.

A.

What was the cumulative incidence of Influenza A from January 2, 2000

through April 2, 2000?

B.

What was the prevalence of Influenza A on January 1, 2000?

C.

What was the period prevalence of influenza A?

- From Jan 1 to April 2,2000
- From Jan 2 to April 2,2000
11/26/16

243

THANK YOU

11/26/16

244

Chapter 6
Epidemiological Study Designs

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 Design :- is an arrangement of conditions for the

245

collection & analysis of data that leads to the

most accurate answer to the research question
and in the most economical way.
logical model that guides the investigator in the
various stages of the research process
overall structure of the study
Selection of study design
Selection of a design depends on:
1)State of knowledge on the problem
2)research questions

11/26/16

State
of Types of research
knowledge of the questions
problem

Study
design

Knowledge that problem

exists, but knowing little
about its characteristics
of possible causes

-Who is affected?
-How do the affected people
behave?
-what do they know, believe,
think about the problem?
-What is the magnitude of the
problem?

-Qualitative(e.g.
FGD)
Or
Quantitative
(Descriptive)

Suspecting that certain

factors contribute to the
problem

-Are certain factors indeed

associated with the problem?

Analytic
(observational)

-Having sufficient
knowledge about the
cause
-to develop & assess an
intervention that would
prevent, control, or solve
the problem

-What is the effect of a particular

intervention?
-Which of the alternative
strategies gives better result?
-Are the results in proportion to
time/ money spent

Intervention
(experimental)

246

11/26/16

Classification
247

1.Descriptive study designs

case report and case series
correlation or ecological
cross-sectional

2.Analytic study designs

observational (cohort and case-control)
experimental or interventional

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Classification of Epidemiologic
study designs
248

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249

Descriptive Epidemiology

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Learning objectives
250

After the end of this session, students will be

expected to:
o Discuss the difference between descriptive and

analytical studies
o Describe the purpose of descriptive studies
o List type of descriptive studies
o State strength and limitation of descriptive studies

11/26/16

Descriptive studies
251

Descriptive studies focus on the frequency and

distribution of disease
Descriptive study is one of the basic types of

epidemiology describing the frequency and

distribution of diseases by time, place and person

11/26/16

Contd
252

Characterization

of the distribution of healthrelated states or events is one broad aspect of

epidemiology called descriptive epidemiology

Descriptive epidemiology provides the What, Who,

When, How many and Where of health-related

events

11/26/16

Contd
253

The 5Ws of descriptive epidemiology:

o What = health issue (case definition)
o How many=magnitude of the problem
o Who = person
o Where = place
o When = time

11/26/16

Time
254

The occurrence of health outcomes (disease)

changes over time

Some of these changes occur regularly, while

others are unpredictable

The common time change of diseases are secular,

cyclic (periodic) and sporadic occurrences

11/26/16

Place
255

Describing the occurrence of disease by place

provides insight into the geographic extent of the

problem and its geographic variation of disorders
Characterization by place refers not only to place

of residence but to any geographic location

relevant to disease occurrence

11/26/16

Person
256

Person attributes include age, sex, ethnicity and

socioeconomic status
Age and sex are included in almost all data sets

and are the two most commonly analyzed person

characteristics

11/26/16

Contd

o Personal

257
characteristics
may affect illness,
organization and analysis of data by person
may use:
o
o
o
o

inherent characteristics of people (age, sex, race)

biologic characteristics (immune status)
acquired characteristics (marital status)
Activities
(occupation,
leisure
activities,
use
of
medications/tobacco/drugs)
the conditions under which they live (socioeconomic status,
access to medical care

11/26/16

Purpose and characteristics of descriptive study Designs

258

Descriptive studies are mainly concerned with the

distribution of diseases with respect to time, place

and person.
1. They are useful for health managers to allocate
resources.
2. The information obtained from descriptive studies
is important for hypothesis generation.
3. Descriptive studies can use routinely collected
information. Hence, they are less time consuming
and less expensive.
11/26/16

Types of descriptive study designs

259

1.

Case report

consists of a careful, detailed report by one or

more clinicians of the profile of a single patient

more emphasis is given for unusual findings

11/26/16

260

Example: Case report in 1961

A 40-year old pre-menopausal woman developed
pulmonary embolism 5 weeks after beginning to
use an oral contraceptive preparation to treat
endometriosis.

11/26/16

2. Case series
261

describes the characteristics of a number of

patients with a given disease (same diagnosis)

Example:
Five
young,
previously
healthy
homosexual men were diagnosed as having
pneumocystis carinii pneumonia at 3 Los Angeles
hospitals during a 6 month period in 1980 to 1981.

11/26/16

Advantages of case reports and series

262

o First clues in the identification of new disease

or adverse effect of exposure /drug

o To identify outbreak occurrence or emergency
of new disease
o Both case report and case series are able to
formulate a epidemiologic hypothesis

11/26/16

D i s a d v a n t a g e s o f c a s e re p o r t s a n d
series
o Unable to test for 263statistical association
between exposure and outcome variables
o It is difficult to test for hypothesis because
there is no relevant comparison group
o Fundamental limitation of case report is
presence of a risk factor that is simply
chance
o Rates can not be calculated since the
population corresponding to the source of
cases can not be well defined
o Studies are prone to atomistic fallacy
(cannot be inferred to the population)
11/26/16

3. Ecological studies
264

The units of analysis are populations or groups of

people rather than an individual.

Ecological studies use data from the 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.

11/26/16

 To conduct ecological studies, average exposure

265

level of the communities is required, not exposure

status of each individual.
Example: Incidence of hypertension and average
per capita salt consumption compared between
two communities

11/26/16

Strength
can be done quickly and inexpensively, often
266
using already available information
LIMITATIONS

Because data are for groups, you cannot link disease and
exposure in individuals
You cannot control for potential confounders
Data represent average exposures rather than individual
exposures, so you cannot determine a dose-response
relationship
Caution must be taken to avoid drawing inappropriate
conclusions, or ecological fallacy

11/26/16

4. Cross sectional studies (survey)

267

o It is also called prevalence study (survey study)

o It is the major type of descriptive study designs
o Survey is conducted in a population, to find

prevalence of a disease and exposure at a point

in time
o Exposure and disease status are assessed
simultaneously among individuals at a point in
time
o Point in time indicates the speed of data
collection i.e. be days, weeks, months, years but
the measurement is takes place only once
11/26/16

Design of Cross-sectional Studies

268

11/26/16

Contd
269

o It helps administrators in assessing the health

status and health care needs of a population

o Used

to assess prevalence of acute and

chronic diseases, disabilities and utilization of
health care resources

o The

purpose is for effective health care

planning, priority setting, resource allocation
and administration
11/26/16

Advantages of cross sectional studies:

270

are a one-stop, one-time collection of data

are less expensive & more expedient to conduct
provide much information useful for planning health
services and medical programs
show relative distribution of conditions, disease, injury and
disability in groups and populations
studies are based on a sample of a major population and do
not rely on individuals that present themselves for medical
treatment

11/26/16

Disadvantages of cross sectional studies

271

It is difficult to know which occurred first, the exposure or the

outcome. This is known as "chicken or egg dilemma".

It may not show strong cause-effect relationships if sample size

is small.

11/26/16

272

Analytical Epidemiology

11/26/16

273

After the end of this session, students will

be expected to:
o Describe purpose of analytical studies
o Differentiate observational and interventional

studies
o List different types of analytical studies
o Discus the advantages and disadvantages of
each analytic study types

11/26/16

Definition
274

Analytic epidemiology is the second major type of

epidemiology, which is concerned with analyzing the

causes or determinants of disease.

11/26/16

275

Application:
To search for cause - effect relationship and
mechanism
o
o

Why?
How?

It focuses on determinants of disease by testing

hypothesis regarding exposure and outcome of interest

o

Proof versus sufficient evidence?

To quantify the association between exposure and

outcome of interest
o

Measures of association
11/26/16

276

Basic features:
Key feature of analytic epidemiology is comparison
group
Appropriate comparison group needed:
o
o
o

Exposed versus non-exposed

Case versus control
Experimental versus non-experimental

It is the use of comparison group that allows

testing of epidemiologic hypotheses

11/26/16

Study Design Tree

277

11/26/16

Two types of analytic studies:

278
o

Observational studies

Interventional studies

11/26/16

Observational studies

279

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, follows to measure for disease

occurrence
o An investigator manipulates the intervention

11/26/16

I. Observational analytic studies

280

The commonest types of observational analytic

studies
are:1. Case control
2. Cohort
3. Cross sectional

11/26/16

A) Case control studies

281

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

11/26/16

282

11/26/16

283

Case-control study examines the association

between disease and potential risk factors by taking:

o

Case group or series of patients who have a

disease of interest
Control (comparison) group of individuals
without the disease are selected for investigation
and then proportions with the exposure of interest
in each group are compared

11/26/16

284

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

11/26/16

Direction of case-control studies

285

Exposure to risk
factors

With
(Case)
outcome
Without
outcome
(Control)

Retrospective in
nature
11/26/16

Case-control studies
286

Direction of inquiry
Exposed
Cases
Non-exposed

Population
Exposed

Controls

Nonexposed

Time
11/26/16

287

Example: Is cigarette smoking a cause of lung cancer?

Case control design:
Identify people with lung cancer (cases) and people
without lung cancer (controls), then ask both groups
whether they are/were smokers.

11/26/16

288

If cigarette smoking is a cause of lung cancer, large

proportion of lung cancer cases will give history of

cigarette smoking compared to the normal
individuals (controls)

11/26/16

Steps in conducting case control study

289

Step 1: Define cases

One of the first issues to be considered in the
design of case control study is the definition of the
disease or outcome of interest
Establish a clear operational definition or use

standard definition of disease (outcome) of interest

in order to have a clear understanding of exposuredisease association

11/26/16

290

Cases: It is the outcome of interest Under study

o It can be:
A

disease
E.g. HIV status, malaria caseness
A behavior
E.g. Alcohol drinking habit, cigarette smoking
Occurrence of an event
E.g. migration
11/26/16

Step 2: Select cases

291

The investigator should select cases on which he/she

can get complete and reliable information

o Sources of cases are commonly:

All persons with the disease in a population during a specific

time of period
All persons with the disease seen at a particular facility (e.g. a
hospital) in a specific time period

11/26/16

292

Places where we can get cases:

1-Hospitals (health institutions)
easy & inexpensive
selection bias is one of the major problems

2-Population (community)
expensive
avoids selection bias

11/26/16

Step 3: Select controls

293

The controls should be similar with the cases except

that the cases have the disease or other outcome of

interest.
It is the comparison group (referent)

11/26/16

Sources of controls
294

1-Hospital controls
Advantage:

easily identified & readily available in sufficient number

less cost
more likely than healthy individuals to be aware of antecedent
exposures or events. This decreases recall bias
They are more likely to be cooperative

11/26/16

Disadvantages
295

They are different from healthy individuals in many ways

If the controls are patients with diseases known to be

associated with the exposure of interest (either positively or
negatively), there will be danger of altering the direction of
association or masking a true association between the exposure
and outcome.

11/26/16

2-General population controls

296

Advantages:

Generalization is possible

If cases are selected from the population, it is

good to select controls from the population
too.

11/26/16

Disadvantages
297

Costly & time consuming

recall bias (may not be concerned about past exposure since

they are healthy)

people might be less motivated to participate

11/26/16

individuals both in the cases and

controls
298

Information regarding the exposure status can be

obtained by interview or from different records.

11/26/16

Step 5: Analysis
299

Prepare 2X2 table

calculate Odds Ratio (OR)
Perform statistical tests to check whether there is

significant association

11/26/16

Case-control studies
300

Advantages:

optimal for evaluation of rare disease

can examine multiple factors for a single disease
Quick & inexpensive
relatively simple to carry out

11/26/16

Limitations
301

In-efficient for rare exposures

No calculation of rates and risks possible
In some situations, the temporal relationship

between exposure and disease may be difficult to

establish
Temporal exposuredisease uncertainty

Prone to selection and information bias

Selection of controls difficult some times

11/26/16

302

B) Cohort studies

11/26/16

Definition
303

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

11/26/16

A study in which two or more groups of individuals

those are free of disease304(outcome of interest) and

differ according to the extent of exposure to a
factor of interest, are followed over a period of time
to see how their exposures affect their outcomes of
interest

11/26/16

Design of cohort studies

305

Diseased
Exposed
Population
at risk

People
without
the
outcome

Not diseased
Diseased
Not Exposed
Not diseased

Time
Direction of enquiry
11/26/16

Contd
306

Other terms used instead of cohort study are:

Follow up study
Incidence study
Longitudinal study

11/26/16

Basic elements of cohort studies

307

o Disease free or without outcome population at

entry
o Selected by exposure status rather than outcome
status
o Follow up is needed to determine the incidence of
the outcome
o Compares incidence rates among exposed against
non-exposed groups

11/26/16

Example: Is cigarette smoking a cause of lung

308
cancer?
Cohort design: Identify smokers (exposed) and non

smokers (not exposed) then follow both groups

over time (e.g. 10 years) and check for
development of lung cancer in both groups.
If cigarette smoking is a cause of lung cancer, large

proportion of smokers will develop lung cancer

compared to the non-smokers

11/26/16

Types of cohort studies

309

Classification is based on the temporal relationship

between the initiation of the study and the

occurrence of the disease.
1- prospective cohort study
2- retrospective cohort study

11/26/16

310

11/26/16

A) Prospective cohort study

311
at the beginning of the study
the outcome has not

yet occurred
Both groups are followed into the future in order
to observe the outcome of interest
is the commonest type (compared to the

retrospective cohort)
unless specified cohort study refers to the
prospective type of cohort
is regarded more reliable than the retrospective
cohort
11/26/16

Prospective vs. Retrospective

312

Selection of
Exposed & Unexposed
Participants

Follow - Up
2010

PROSPECTIVE
COHORT
STUDY

2005

Investigator
begins the
study

End of Follow
Up

2000
1990

End of Follow
Up

2005

RETROSPECTIVE
COHORT
STUDY

Investigator
begins the
study
11/26/16

cohort study
313

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

11/26/16

Contd
314

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

11/26/16

Steps in conducting cohort study

315

Step 1: Define exposure

Step 2: Select exposed group
During selection consider:
the frequency of the exposure in the population
the need to obtain accurate information
Exposure/outcome)
the ease to obtain relevant information and to follow
up

11/26/16

Step 3: Select controls (non-exposed)

316

control groups should be comparable to the

exposed group

11/26/16

Step 4: Identify sources of data for exposure and outcome

317

Possible sources of exposure data:

pre-existing records
conducting interview

Possible sources of outcome data:

routine surveillance
death certificate
periodic health examination
hospital records etc..

11/26/16

Step 5: collect data

318

Several methods are used to obtain the data, which

should be on a longitudinal basis

These methods include:
o interview surveys with follow-up procedures
o medical records monitored over time
o medical examinations and laboratory testing etc

11/26/16

Step 6: Analyze
data
291
prepare 2X2 table
calculate Relative Risk (RR)
perform statistical tests to check whether
there is statistical significant association

11/26/16

3. Cross sectional study

320

Even though the main purpose of cross sectional study

is for describing occurrence of disease by time, place

and person, it can be considered as both descriptive
and analytic study design.
The data collected by cross-sectional study design can

be analyzed in two ways, either by comparing the

prevalence rate of the outcome in exposed versus nonexposed people, or by comparing the prevalence rate of
the exposure in those with and with out the outcome.
11/26/16

o Cross-sectional

survey
could
provide
321 frequency of health
information about the
conditions by providing a snapshot at a
specified time
o In this study, measure of association is
made using odds ratio (OR) i.e. Prevalence
ratio
o Prevalence
ratio of exposure among
diseased to non-diseased or prevalence
ratio of disease among exposed to nonexposed groups

11/26/16

 One feature which distinguishes cross sectional

studies from other types

322 of observational analytic
studies is the timing of the subdivision of the study
population into comparison groups.
In cohort and case control studies, this takes place

prior to the data collection process.

In a cross sectional study, this takes place after the
information has been collected.

11/26/16

Summary: Advantages and limitations of cohort and case control study

Case control

Cohort

Advantages:

323
valuable when exposure is rare

optimal for evaluation of rare disease

can examine multiple factors
single disease

can examine multiple effects of a single

for a exposure
temporal relationship is known

Quick & inexpensive

allows direct measurement of risk

relatively simple to carry out

minimize
exposure

Limitations:

inefficient

inefficient
exposure

in

evaluation

of

establish

in

in

ascertainment

evaluation

of

of
rare

rare diseases
expensive

can not directly compute risk

difficult
to
relationship

bias

time consuming
temporal loss to follow up creates problem

determining exposure will often rely on

memory

11/26/16
323

II- Experimental/ Intervention studies

324

Defintion: An epidemiological experiment in which

subjects in a population are randomly allocated into

groups, usually called study and control groups to
receive and not receive an experimental preventive
or therapetuic procedure, maneuver, or
interventition (John M.Last, 2001)

11/26/16

 Individuals are allocated into experiment or

325

control group by the investigator.

The main distinction from other types of analytic
studies is that individuals are allocated into
experiment or control group by the investigators
If done properly, experimental studies can produce
high quality data.
Experimental is the gold standard study design

compared to other designs.

11/26/16

o An experimental design326
is a study design that gives

the most reliable proof for causation

o It is similar to cohort study that individuals are

enrolled on the basis of their exposure (natural

exposure)
o Investigator assigns subjects to exposure and non-

exposure and makes follow up to measure for the

occurrence of outcome of interest

11/26/16

327

Key Features of Experimental Design

1)

Investigator manipulates the condition

under study

2)

Always prospective

11/26/16

Study groups in interventional studies

328

The comparison groups in intervention study are known

as the intervention group and the control group

o The intervention group receives the test drug (the

preventive activity such as health education, diet and

physical exercise etc)
o The control group shall be offered the best known

alternative or placebo activity with no known effect on

the outcome variable

11/26/16

 Intervention studies can

329 generally be considered

either therapeutic or preventive.

a.
Therapeutic
(or
secondary
prevention) trials:
are 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.

11/26/16

Therapeutic Trial
330

New
Treatment
Sick
Individuals

Improved
outcome

No
improvement

Existing
Treatment

R=randomization

Improved
outcome
No
improvment

B=double blinding
11/26/16

331

b.

Preventive (or primary prevention)

trials:
involves the evaluation of whether an agent or
procedure reduces the risk of developing disease
among those free from that condition at enrollment.
While therapeutic trials are virtually always conducted

among individuals, primary prevention measures can

be studied among either individuals (e.g. vaccine trial),
or entire population (Community trial).
11/26/16

Prevention Trial
332

With outcome

Vaccinated
Without
outcome
Healthy
Individuals

NotVaccinate
d
R=randomization

With outcome

Without
outcome

B=double blinding
11/26/16

Classification of interventional studies

333

A. Based on population studied:

1. Clinical trial

Usually performed in clinical setting and the subjects are

patients
Treatment is used as an exposure
Recovering (survival) from a disease is the outcome

11/26/16

334

Direction of inquiry

Population

Patients
with a
disease

Recover

Treatment

Not recovering

Recover

Placebo

Manipulation

Not recovering

Time
11/26/16

334

335

2. Field trial
Used

in testing medicine for preventive

purpose and the subjects are healthy people

Health

promotion (preventive
interventions) are used as an exposure

Occurrence

of new disease is the outcome

E.g. vaccine trial and prophylactic intervention

11/26/16

336

3. Community trial
Unit

of the study is the community

Communities

as study subjects

Health

promotion (preventive interventions)

are used as an exposure

Occurrence

of new disease is the outcome

E.g. fluoridation of water to prevent dental caries
11/26/16

337

Direction of inquiry

Community

Population

Disease

Intervention

No disease

without
a disease
(cluster)

Disease

Non intervention

Manipulatio
n

No disease

Time
11/26/16

337

B. Based on design

1. Uncontrolled trial 338

o There is no control group, control will be past
experience (history: after-before)
2. Non-randomized controlled trial
o There is control group but allocation into either
group is not randomized
3. Randomized controlled trial
o There is control group and allocation into either
group is randomized

11/26/16

C. Based on trial objective:

339

1 . Phase I

trial on small subjects to test a new drug with small dosage to

determine the toxic effect
20-80 healthy volunteers needed.
The objective is to determine a safe drug dose for
further studies of therapeutic efficacy

11/26/16

340

2. Phase II

trial on small group to determine the therapeutic effect

100-200 ill volunteers needed.
Approximately 70% drug trials proceed from phase I to phase
II
The purpose is to assess the effectiveness of the drug
or device, to determine the appropriate dosage, and to
investigate its safety and dose response relationship

11/26/16

3. Phase III

study on large population

341 trial
usually randomized controlled
100-1000 patients with disease
Objective: To compare efficacy of the new treatment
with the standard treatment regimen/placebo

11/26/16

4. Phase IV
o.The purpose

of this trial is to re-assess the

342
effectiveness, safety, acceptability and
continued use of the drugs
o.Post marketing surveillance may be
conducted to determine long- term safety
and efficacy of the drug

Objective: To get more information on long-term side

effects

Design:

Subjects: patients with disease using the treatment

no control group

11/26/16

Steps in conducting
experimental studies
Step 1. Identify new 343
drug/intervention/prevention
Step 2. Identify comparison - e.g. standard
treatment or placebo
Step 3. Define eligible population/ exclusions
Step 4. Define the outcomes and how to assess
them
Step 5. Write the protocol
Step 6. Obtain research ethics committee approval
Step 7. Recruit and consent required sample of
patients or subjects
Step 8. Allocate individuals into:
11/26/16

A. Experimental (study group)

group that will receive a drug, vaccine or other
344
procedure
B. Control group
group that will receive no treatment, a placebo, or
standard form of therapy
Random allocation of the subjects in to
experimental and control group is important

11/26/16

Randomization of study subjects

345

o There is a need of assignment of study population into

the two or more groups by randomization

o To help assure that groups are similar, subjects are

randomly assigned to experimental or control groups

o Randomization is performed to increase the likelihood

that groups would be similar in baseline characteristics

o Randomization is supposed to have the effect of

distributing confounders (both known and unknown

equally) between the intervention and control groups
11/26/16

Advantages of randomization
346

The potential for bias in allocation to study groups is

removed, it eliminates selection bias

On

average the study groups will be comparable

(confounders will be equally distributed controls
confounding effect ), study subjects will tend to be
comparable with respect to all variables except for the
interventions being studied.

favorable impression

by those reading the published

results of a trial.
11/26/16

Step 9. Collect data

347

Collect all relevant information including the

outcome
The knowledge of participant's treatment status
might influence the identification or reporting of
relevant events. This can be overcome by the use of
placebo.

11/26/16

348

The Gold standard is achieved through

Randomization
Blindness

Use

of placebo

11/26/16

o Blinding means that the subject, observers or

both do not know to what group a study subject is

349
assigned

o To combat this, blinding (also called masking) is

often used

o To make study subjects and/or observers blind, a

substance that resembles the drug called Placebo

is needed

11/26/16

350

o Placebo - A placebo is a biologically inactive substance

given to the control group so that they think they are

being treated equally as treatment group

o The placebo should be similar to the drug being tested in

respect to appearance (size, texture, odor, color and

taste)

Placebo effect - is the tendency of individuals to report

favorable response to any therapy regardless of the
physiologic efficacy of what they received
11/26/16

Contd
351

o Placebo

use permits study participants and

investigators to be masked, or unaware of the
participants treatment assignment

o Masking of subjects and observers helps prevent

biased ascertainment of the outcome, particularly

when end points involve subjective assessments

11/26/16

352

Step 10. Analyze the results

Analysis is similar to cohort study

Step 11. Publish/ disseminate findings

11/26/16

Problems related to experimental studies

353

Ethical considerations prevent evaluation of many

treatments or procedures using intervention studies

Some of the ethical issues:

Practices or substances already known to be harmful
should not be used in this study.
Therapies known to be beneficial should not be withheld
from any affected individuals in the study population.
Investigators have to have a complete knowledge of the
subject under study.

11/26/16

354

The researcher must have at least informed consent from each

study participant and subjects should be left free to withdraw
from the study at any time.
A written research protocol is a must

11/26/16

355
Feasibility / practical issues

subject recruitment, getting adequate individuals to

enroll into the study is not easy.
difficult to achieve satisfactory compliance.

Cost
Experimental studies are very expensive

11/26/16

356

The End!

11/26/16

Chapter-7

357

MEASURES OF ASSOCIATION

11/26/16

Learning objectives
358

After the end of this session, students will be

expected to:
o List common measures of association and measures
of public health impact
o Calculate and interpret
relative risk
odds ratio
attributable and population attributable risk and
their percent
11/26/16

Definition of association
359

An association is said to exist between two variables

when a change in one variable parallels or coincides

with a change in another ones
o 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
o More appropriately, a causal relationship exists
when exposure enters into the causation of disease

11/26/16

360

o Statistical relationship between two or more

variables
o A causal association exists when the risk factor
causes change in the disease

11/26/16

o Measuring an association
o Quantifies the strength361
of the relationship

between an "exposure" and outcome of interest

o Quantifies the difference in occurrence of disease
or death between two groups of people who differ
on exposure status

11/26/16

Two main options for comparison

362

Calculate ratio of two measures of disease

frequency
o
o

Relative comparison
Strength of relationship between exposure and outcome

Calculate difference between two measures of

disease frequency
o
o

Absolute comparison (attributable risk)

Public health impact of exposure (population attributable
risk)

11/26/16

363

How strong is the association?

11/26/16

364

The strength of the association is commonly

measured by the relative risk, odds ratio, attributable

risk and population attributable risk and their
percents

11/26/16

1. Relative Risk (RR) or Risk Ratio

365

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.

11/26/16

.
366

incidence
of a disease among exposed
RR
=

(a/(a+b))
incidence of a disease among non-exposed (c/
(c+d))

Disease

..

RR =

..

a+b

Exposu Yes (+) No

(-)
re
Yes (+)

.
.

.
.

c
c +d

.
.

No (-)

a
c

b a+
b
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

11/26/16

366

K
n
o
w
n

Example

367

Table 1: data from a cohort study of oral contraceptive (OC)

use and bacteruria among women aged 16-49 years
Bacteruria
Yes NoTotal
Current OC use
Yes 27 455 482
No77 1831 1908
Total
104 2286 2390

11/26/16

368

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.

11/26/16

Interpretation

369

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.

11/26/16

Values of RR less than one 1 indicate a negative

association between the risk factor and the disease.

370
(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

11/26/16

2. Odds Ratio (OR)

371

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

11/26/16

Contd
372

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

11/26/16

373

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.

11/26/16

Example
374

Table 3: Data from a case-control study of current oral

contraceptive (OC) use and MI in pre-menopausal
female nurses
Myocardial infarction
Yes NoTotal
Current OC use
Yes 23 304 327
No133 2816 2949
Total 156 3120 3276

11/26/16

375
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.

11/26/16

Interpretation of the Odds Ratio

376

OR = 1 then exposure NOT related to disease

OR >1

then exposure POSITIVELY

related to

disease
OR <1 then exposure NEGATIVELY related to
disease

11/26/16

Interpretation
377

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.

11/26/16

Risk
378

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

11/26/16

379

What is the excess risk among exposed

individuals?

11/26/16

Absolute Measures of Risk

380

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

11/26/16

Attributable Risk (AR) / Risk

Difference (RD)
381

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.
11/26/16

 It tells us how many cases of disease in exposed

people could have been prevented by eliminating

382
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
11/26/16

Contd
Thus, the excess occurrence
of bacteruria among
383

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). 11/26/16

Contd
384

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

11/26/16

Contd
385

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.
11/26/16

386

What proportion of cases is attributed to the

actual exposure among exposed people?

11/26/16

Attributable Risk Percent

(AR %)
387

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
11/26/16

Example: Refer the previous table

and calculate AR%
388

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.
11/26/16

 For most case-control studies, the AR cannot be

calculated
It is, however, possible to389
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.
11/26/16

390

What is the excess risk among the general

population that is due to exposure of

interest?

11/26/16

Population Attributable Risk (PAR)

391

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.
11/26/16

 Estimates

the proportion of disease

occurring in the total population
392
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.

11/26/16

PAR = AR X prevalence rate of the

exposure
393

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 %

11/26/16

PAR = 89 per 100,000 per year X 20 %

394 year
= 17.8 per 100,000 per

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).

11/26/16

 Both AR and PAR are used to estimate the effect

on disease incidence of395eliminating 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

= I T - Io
11/26/16

396

What proportion of cases is attributed to the

actual exposure among the general

population?

11/26/16

Population Attributable Risk Percent

(PAR %)
Expresses the proportion of disease in the study

397
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 10 5 per
year
Calculate PAR %
11/26/16

398

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.

11/26/16

Possible Outcomes In Studying The

Relationship Between Disease And Exposure
399

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

11/26/16

Exercise
400

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
11/26/16

401

Thank you!!!

11/26/16