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Basic Epidemiology
For Health Science Students
By:
Matiyos Lema (BSc , MPH in Epidemiology)
Wallaga University
Institute of Health Sciences
Department of Public Health

28-Dec-23
Introduction and basic concepts in Epidemiology
2 Contents
 Definition
 History of Epidemiology

 Use/applications of Epidemiology

 Scope of epidemiology

 Basic assumptions of epidemiology

 Theories disease causation

 Levels of disease occurrence

 Branches of Epidemiology

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Definition
3
o Epidemiology: The word Epidemiology’ stands for;
o Epi- Upon; Demo-Population/people; Logos-study

Epidemiology is the study of the frequency, distribution and


determinants of disease and other health related states or
events in specified population and the application of this
study to the promotion of health and prevention and control
of health problems.

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Definition …
Key terms from the above definition
4
Study: Epidemiology is a scientific discipline, sometimes called
“the basic science of public health”
 It has, at its foundation, sound methods of scientific inquiry

Frequency: Reminds us that epidemiology is quantitative


science which quantify occurrence of death and morbidity rates

Distribution: time, place, and person distribution of disease or


other health related events

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Definition …
5

Health related events: Epidemiology is only study of disease. It


also studies about health related conditions like: Injuries, Vital
events, Health related behaviors
Determinants: These are the factors which determine whether
or not a person will get diseases or in other words the
causative factor for diseases.
Population: In epidemiology, we study effects of diseases on
populations while in clinical medicine, we study effects of
diseases on individuals.
Application: It is an applied science with direct practical
applications.

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Use/applications of Epidemiology (Purposes Of
Epidemiology)
6

@ Elucidate the natural history of disease.


@ Describe the health status of the population.
@ Establish causation of disease.
@ Provide understanding of what causes or sustains disease in
populations.
@ Define standards and ranges for normal values of biological and
social measures.
@ Guide health and healthcare policy and planning.
@ Assist in the management and care of health and disease in
individuals.

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Scope of epidemiology

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Fundamental Assumptions In Epidemiology
8 A. “Disease occurrence in human population is not random”
 Disease is not randomly distributed throughout a population

 Epidemiology uses systematic approach to study the differences


in disease distribution in subgroup
 Why certain individuals/group acquire disease and others
not?
B. “Human disease has causal and preventive factors
 That can be identified through systematic investigation of
different population or sub group of individuals within a
population at different place or time”.
 Allows for study of causal and preventive factors

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Major categories of epidemiology
9
 Descriptive Epidemiology – Defines the amount and
distribution of health problems. It answers the questions:
Who, what and where.

 Analytic Epidemiology – Analyses the causes or


determinants of health and disease. Answers the
questions why and how.

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Theories/ principles of diseases causation
Disease causation
10

 The cause of a disease is an event, condition or characteristics that

precede the diseases event and without which the disease event
either would not have occurred at all or would not have occurred
some latter time.
 Not all associations between exposure and diseases are causal.

 If disease does not develop without the factor being present,


then we term the causative factor “necessary factor” if the
disease always result from the factor then we term the causative
factor “sufficient factor “

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 Example- Tubercle bacilli is a necessary factor for


tuberculosis
-Rabies virus is sufficient for developing clinical
rabies

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Necessary Causes vs. Sufficient Causes

12  If A is necessary for B (necessary cause) that means you will never


have B if you don't have A.
 In other words, of one thing is a necessary cause of another, then
that means that the outcome can never happen without the cause.
However, sometimes the cause occurs without the outcome.
 If A is sufficient for B (sufficient cause), that means that if you have
A, you will ALWAYS have B. In other words, if something is
a sufficient cause, then every time it happens the outcome will
follow. The outcome always follows the cause. However, the
outcome may occur without the cause.

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What does cause Disease?
There are different theories :
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 Supernatural

 Hippocratic

 Single germ

 Classic epidemiologic

 Ecological

 Multi-factorial causation

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Causal Relationships
20

A causal pathway may be direct or indirect:

 Direct causation, A causes B without intermediate effects

 Indirect causation, A causes B, but with intermediate


effects

 In human biology, intermediate steps are virtually always


present in any causal process

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The Epidemiologic Triad
21

HOST

AGENT ENVIRONMENT

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Malaria
22

Agent

Vector

Host Environment
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The epidemiologic triad Model
Host:
23 Intrinsic factors, genetic, physiologic factors,
psychological factors, immunity

Health
or
Illness
?

Agent:
Amount, infectivity, pathogenicity, Environment:
virulence, chemical composition,
Physical, biological, social
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cell reproduction
Web of Causation
24

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Web of Causation - CHD
25

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Example of a Web of Causation
26

Overcrowding Malnutrition

Exposure to
Mycobacterium

Susceptible Host Infection Tuberculosis

Tissue Invasion
and Reaction

Vaccination Genetic
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The Wheel of Causation
27

Biological Social
Environment Environment
Host
(human)

Genetic Core

Physical 28-Dec-23
Environment
Exercise
28

 Some of the risk factors for heart disease are smoking,


hypertension, obesity, diabetes, high cholesterol, inactivity,
stress, and type A personality.
 Are these risk factors necessary causes, sufficient causes?

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Natural History of Diseases
29

 The natural history of disease refers to the progression of


a disease process in an individual over time, in the
absence of intervention.
 The process begins with exposure to the causative agent
capable of causing disease & the process ends with
recovery, disability, or death.
 The Course of a disease may be halted at any point in
the progression by preventive and therapeutic measures,
host factors, and other influences.

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Stages of Natural History of Disease
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Stages of Natural . . .
31

 There are four stages in the natural history of a disease.


These are
1. Stage of susceptibility
 Disease has not yet developed, but the groundwork has
been laid by the presence of factors that favor its
occurrence.
 Example: unvaccinated child is susceptible to measles.
2. Stage of Pre-symptomatic (sub-clinical) disease
 There are no manifestations of the disease but pathologic
changes (damages) have started to occur in the body.
 The disease can only be detected through special tests.

 The stage may lead to the clinical stage, end in recovery.


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Stages of Natural . . .
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 Examples: Detection of antibodies against HIV in an


apparently healthy person.
 Ova of intestinal parasite in the stool of apparently healthy
children.
3. The Clinical 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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Stages of Natural . . .

34

4. Stage of disability or death


 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.

 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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Infectious disease process
35

 Infectious diseases result from the interaction of


infectious agent, susceptible host/reservoir and
environment that brings the host and the agent
together.
 Infection implies that the agent has achieved entry and
begun to develop or multiply, whether or not the
process leads to disease.
 A model used to understand the infection process is
called the chain of infection

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Components of Chain of Infection
36

 Causative Agent
 Reservoir host
 Portal of exit
 Mode of transmission
 Portal of entry
 Susceptible host.

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37

Chain of infection
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Chain of Disease Transmission
38

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The Infectious disease cycle…
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 Are chain of factors, that form links in the occurrence and


propagation of disease:
1. Infectious agent/etiology
 Is an organism that is capable of producing infection or infectious
disease
 The biological properties of the agent may play a major role in
its epidemiology
 In order to survive the agent must be able to:
 Multiply
 Emerge from the host
 Reach the new host
 Infect the new host

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Major components …
40

 These can generally be grouped into the following five major


taxonomic groups
1. Virus: e.g. HIV; measles; Polio Herpes, etc.
2. Bacteria: e.g. M. tuberculosi; N. meningitidis; N.
gonorrheae
3. Protozoa: e.g. Plasmodia species; E. histolytica; Giardia
lamblia, Leishmania species, etc.
4. Fungi: e.g. Candida albicans; Cryptococcus neoformans;
Histoplasma capsulatum
5. Metazoa: e.g. Helminths

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Intrinsic properties of Microorganisms
41

 Infectivity: is the ability of an agent to invade and multiply


(produce infection) in an exposed host
 Infectivity is a measure of the progression of an infectious agent from
exposure to infection
 It is the ability to cause infection in an exposed susceptible host, and is
measured by the infection rate (infectiousness).
 It is the proportion of exposed persons who become infected

Total Number of Infected People


Infection Rate  100%
Total Number of Suceptible People Exposed

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Intrinsic properties of Microorganisms…
42

Factors influence the infectivity of an agent.


 Host and environmental factors
 The dose,
 The route of entry,
 source of infection, and
 the strain of the agent

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Intrinsic properties of Microorganisms…Contd

43

 Pathogeneicity: is the ability of an agent to produce a


clinically manifest disease in susceptible host.
 It is measured by determining the proportion of infections
that result in clinically apparent disease

Total Number of CLINICAL Cases


Pathogenicity   100 %
Total Number of SUBCLINICA L Cases

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Intrinsic properties of Microorganisms…Contd

44

 Virulence: this is the ability of an agent to produce severe


disease.
 It is measured by determining the proportion of clinical cases
resulting in severe clinical manifestations.
 Some of measures of virulence as it applies to humans are the
case fatality rate (CFR)

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Intrinsic properties of Microorganisms…Contd
45
 Factors that influence the degree of infectivity, pathogenicity,
and virulence include:
 Strain of agent
 Dose of agent
 Route of infection
 Host factors like host age, host nutritional status; host
immune response;
 Treatment, especially on virulence; and
 Season, through influencing exposure to the agent and
other factors that enhance the entry of the agent into
the body and its transmission. 28-Dec-23
Major components …
46

2. Reservoir
 is the person or animal, arthropod, plant, soil or substance in
which an infectious agent can thrive and from where it can be
transmitted to another host
 Types of reservoir
 Man as a reservoir of infection-hepatitis B virus or Salmonella
typhi
 Animals as a reservoir of infection-brucellosis (cows and pigs),
anthrax (sheep), plague (rodents), trichinosis (swine), and
rabies (bats, raccoons, dogs, and other mammals).
 Non-living things as a reservoir of infection

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Major components …
47

3. Portal of exit
 Way in which the agent gets excreted from the host
 This is the site on the reservoir of infection through which the
infectious agent escapes from the reservoir. This includes:
 Gastrointestinal Tract (GIT) e.g. Typhoid fever, amoebiasis
etc.,
 Respiratory Tract e.g. Tuberculosis, common cold

 Skin and Mucous membrane e.g. STDS, Scabies, ring worm

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Major components …
48

4. Mode of spread (Transmission)


 Means of spread from reservoir to susceptible host
 This is the mechanism by which an infectious agent is
transferred from a reservoir of infection to a new host

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Major components …
49

Two main modes of transmission:


1. Direct
 Direct contact: no intervening agency from reservoir/source to
a susceptible host
e.g. STD, AIDS and scabies.
 Droplet infection: direct projection of droplets spray of saliva
or nasopharyngeal secretion 30-60cm.
 In to hosts nose or mouth by acts like sneezing coughing or
talking
e.g. common cold, diphtheria, TB, meningococcal meningitis.
Risks are overcrowding and lack of ventilation.

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Major components …
50

 Contact with soil: tetanus, mycosis


 Bite of animal: rabies
 Placental/vertical: syphilis, AIDS, German measles, drugs.
2. Indirect
 Vehicle: water, food, milk, milk products, ice, blood, serum, plasma
or other biological products.
 Vector: is an organism that transports an infectious agent to a
susceptible host or to a suitable vehicle.

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Major components …
51

 Man-arthropod: malaria
 Mammal or bird-arthropod: plague,

 Air (droplet nuclei): TB, influenza, chicken pox, measles and Q-


fever/dust=TB, streptococcal infection.
 Fomites: inanimate things other than food, water or milk

e.g. cloths (soiled), towels, handkerchiefs, cups, spoons, toys, pencils,


door handle, lavatory chains, syringes and surgical dressings
diphtheria, typhoid, bacillary dysentery, eye and skin infections

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Major components …
52

5. Portal of entry
 Route through which infectious agent enters the host.
 Gastrointestinal Tract (GIT) e.g. Typhoid fever, amoebiasis etc.
 Respiratory Tract e.g. Tuberculosis, common cold
 Skin and Mucous membrane e.g. STDS, Scabies, ring worm
6. Susceptible host
 This is a person who is highly likely to acquire infection when
exposed to the agent
 Host- a person or animal that harbors an infectious agent under natural
conditions

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Time course of an infectious disease

53

 The time lines of infection begin with the successful


infection of the susceptible host by infectious agent.
 The time line of infectiousness includes:
 Latent period: the time interval from infection to
development of infectiousness
 The period of infectiousness: during which time the host
could infect another susceptible host.
 Non-infectious period: either by recover from the infection
or by death.
 The host can also become non-infectious while still alive and still
harboring the parasite.
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Time course of an . . .
54
 The time line of disease within the host includes:
 Incubationperiod: the time from infection to development
of symptoms of the disease.
 The symptomatic period.
 The probability of developing symptoms or disease after
becoming infected is referred as pathogenicity (time of
pathogenicity).
 Asymptomatic period: The host eventually becomes
asymptomatic either by recovering from the symptoms or by
death.
 Carrierstate develops when the person become asymptomatic
but remains infectious.
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Levels of Disease Prevention
55

1.Primary prevention is defined as those measures


provided to individuals to prevent the onset of a
targeted condition.
Objective is to:
 promote health,
 prevent exposure and
 prevent disease.

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57

 2. Secondary Prevention: is described as measures as


those that “identify and treat asymptomatic persons
who have already developed risk factors or preclinical
disease but in whom the condition is not clinically
apparent.

Objective:
 is either to stop or to slow the progression of disease

so that to prevent or to limit permanent damage,


through the early detection and treatment of disease.
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58

 3. Tertiary Prevention: It is limitation of disability and


rehabilitation.

Objective:

 is to limit the physical, psychological, social and economical


impact of disability.

Tertiary prevention activities involve the care of established disease,


with attempts made to restore to highest function, minimize the
negative effects of disease, and prevent disease-related
complications.
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Basic measurements in Epidemiology

Measures of frequency,
Disease occurrence/Morbidity and Mortality

59 28-Dec-23
 Objectives:
60 • After completing this chapter, the student will be able to:
 To define, calculate and differentiate Number, ratio,
proportion, and rate and understand their practical applications
and interpretations.

 To calculate and interpret measures of morbidity such as


incidence and prevalence rates

 To calculate and interpret measures of mortality such as crude,


specific rates and perform Standardization of rates.

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Why Do We Measure Disease Frequency ?
61

 Fundamental to epidemiology:
♦ Distribution of disease and to make comparisons
♦ Monitoring the health status of the population and planning
health services

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Tools in Measures of frequency

62

♦ Counts
♦ Ratio
♦ Proportion
♦ Rate

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Counts
63

♦ Common descriptive measure


♦ First step in calculating rates
♦ Essential for service delivery, planning
♦ It is simple counting of cases of a disease

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Ratio

64
 Used to compare two quantities.
 It expresses the relationship between two numbers in the form

of X: Y or X/Y
 The value of X and Y may be completely independent, or x

may be included in y.
Commonly used ratios:
♦ Ratio of male to female births (Male : Female)

♦ Age dependency ratio

♦ Maternal mortality ratio

♦ The ratio of people with tuberculosis to those without


tuberculosis

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Proportion
65
♦ A specific type of ratio in which the numerator (X) is
included in the denominator (Y), usually presented as a
percentage.
Examples:
- Male/Both sexes (proportion of male in a community)
- Number of infants who are immunized in E/Wollega =
Total eligible infants for immunization in E/ Wollega
55,000
 73.3%
75,000

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Rate
♦ Special form of proportion that includes a specification of
time.
66
♦ Rates are often proportions.
♦ Rates must:
1) include persons in the denominator who reflect the population
from which the cases in the numerator arose;
2) include counts in the numerator which are for the same time
period as those from the denominator; and
3) include only persons in the denominator who are "at risk" for
the event.
• Example: Measles cases in under five in 2015
Under five children in 2015

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Summary
67

 All rates are proportions!

 All rates are ratios too!

 All proportions are ratios!

 But all proportions are not rates!

 All ratios are not proportions!


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Table1.1 Neonatal sepsis, Hospital A, Ethiopia, 2003

68

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Exercise 1/Home take 1
The
69
line listing in the Table 1.1 presents some of the
information collected on infants born at Hospital A with
neonatal sepsis.
1. What is the ratio of males to females?
2. What proportion of infants lived?
3. What rate of infants were delivered in a delivery room?
4. What is the ratio of operating room deliveries to delivery
room deliveries?

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Measures of Morbidity/disease occurrence
70
1. Prevalence
– burden

2. Incidence
– risk

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Prevalence
 Measures the number of people in a population who have the
71
disease at a given point/period in time.
• A measure of disease status/disease burden.

Types of Prevalence:
a. Point Prevalence: number of cases that exist at a given point
in time.
b. Period Prevalence: number of cases that exist in a population
during a specified period of time.

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 The “Point in time” at which prevalence is determined may
refer to any of several time scales. Examples:
72
 Calendar time – e.g., prevalence of HIV infections in
Nekemte on January 1, 2005.

 Time since some event – e.g., prevalence of depression


among widows/widowers 6 months after the death of a
spouse.

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Example
73
Two surveys were done in the same community 12 months apart.
Of 5,000 people surveyed the first time, 25 had antibodies to
histoplasmosis. Twelve months later, 35 had antibodies,
including the original 25. Calculate the prevalence at the
second survey, and compare the prevalence with the 1-year
incidence.
1. Prevalence at the second survey:
x = antibody positive at second survey = 35
y = population = 5,000
x/y X10n = 35/5,000 x 1,000 = 7 per 1,000
2. Incidence during the 12-month period:
x = number of new positives during the 12-month period = 35 - 25 = 10
y = population at risk = 5,000 - 25 = 4,975
x/y x10n = 10/4,975 x1,000 = 2 per 1,000
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Exercise 1
In a study population of 900 inhabitants there are 50 cases of
74
tuberculosis and 18 cases of hypertension. During the first six months
there are 15 new cases of tuberculosis and 6 new cases of
hypertension. At the end of the year the total of new cases is 25 for
tuberculosis and 11 for hypertension. During the same period, 6 new
cases of tuberculosis died and 6 were cured. In the same period, 3
cases of hypertension died and no case of hypertension was cured.
Calculate the following rates
-Prevalence rate at the beginning of the study
-Incidence rate of tuberculosis and hypertension at the end of the first
six months
-Incidence rate of tuberculosis at the end of the year
-Prevalence rate of tuberculosis and hypertension at the end of the year

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Factors Affecting Prevalence
Decreased by:
-Shorter duration of
disease
Increased by:
-High case-fatality rate
-Longer duration of the disease
from disease
-Decrease in new cases
-Prolongation of life of
(decrease in incidence)
patients without cure
-In-migration of healthy
-Increase in new cases
people
(increase in incidence)
-Out-migration of cases
-In-migration of cases
-Improved cure rate of
cases
-Out-migration of healthy people

-In-migration of susceptible people

-Improved diagnostic facilities


75 (better reporting) 28-Dec-23
Incidence
76 • Quantifies number of new cases of disease that develop in
a population at risk during a specified time period.

 Two types of populations, based on whether membership


is permanent or transient:
– Fixed population: membership is permanent
– Dynamic population: membership is transient

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Incidence: Types
77

a. Cumulative Incidence (CI)


- Incidence proportion
- Closed population

b. Incidence Density (ID)


- Incidence Rate (IR)
- Dynamic and open population

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Cumulative Incidence (CI)
78
o The proportion of a closed population at risk that becomes
diseased within a given period of time.
o Is an estimate of average risk.

CI = No. of new cases of disease during a given period


Total population at risk during the given period

Example: During a 1-year period, 10 out of 100


“at risk” persons develop the disease of interest.

CI = 10/100 = 0.10 or 10.0 cases of disease per 100


population at risk
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Cumulative incidence
79

Incidence proportion (IP). During a 2-year period, 3 out of 5


28-Dec-23
subjects developed the disease; IP = 3/5 = 0.6
Cumulative Incidence (CI)
o To accurately calculate cumulative incidence, we need to follow
the entire population for the specified time interval. Often
times, this does not fully occur.

o Cumulative incidence provides an estimate of the probability


(risk) that an individual will develop a disease during a specified
period of time.

 Over any appreciable period of time, it is usually technically


impossible to measure risk.

 This is because if a population is followed over a period of time,


some people in the population will die from causes other than
the outcome under study.

 The phenomenon of being removed from a study through death


80 or from other causes is referred to as ”competing
28-Dec-23
risks”.
Exercise
• On January 1, 2000 there were 20 medical students with
81
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 prevalence of Influenza A on January 1, 2000?


b. What was the period prevalence of influenza A?
c. What was the cumulative incidence of Influenza A from
January 2, 2000 through April 2, 2000?

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Incidence Density (ID)
82

o Other things being equal, the number of disease events


observed in a population over times varies directly with the
number of people at risk and the amount of time over which
they are observed.

ID = No. new cases of disease during a given period


Total “person-time” of observation

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Incidence density…
83

 Often you can't follow everyone for entire time period.


 In a dynamic population, individuals enter population
over different times, become lost, etc.
• length of follow-up is not uniform for all .
 Incidence rates do not make assumption of complete
follow-up.

Since the number of cases is divided by a measure of time of


observation, rather than people, this helps address the
problem of competing risks.

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Person-Time
Jan Jan Jan
1980 1989 1999

Subject 1 ------------------x 10 Person-Years (PY)

Subject 2 ------------------x 10 PY

Subject 3 ------------------------------------ 20 PY
40 PY

X = outcome of interest, thus the incident rate


is 2/40 PY
84 28-Dec-23
Ex. Cohort study of the risk of breast
cancer among women with
hyperthyroidism
 Followed 1,762 women ---> 30,324 py

 Average of 17 years of follow-up per


woman

 Ascertained 61 cases of breast cancer

 Incidence rate = 61/30,324 py =


.00201/py
85 = 201/100,000
28-Dec-23 py
Special Types of Incidence: Attack Rate
86
o Variant of cumulative incidence
 Narrowly defined population

 Observed for a limited time (e.g. epidemic).

o Usually expressed as a percent.

Attack rate = Number of new cases among the


population during the period x 100
Population at risk at the
beginning of the period

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Attack Rate: Example
87

 Of 75 persons who attended a church picnic, 46 subsequently


developed gastroenteritis.
a) Calculate the attack rate of gastroenteritis :
x = Cases of gastroenteritis occurring within the incubation period
for gastroenteritis among persons who attended the picnic = 46
y = Number of persons at the picnic = 75
AR= 46/75 x 100%

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Special Types of Incidence:
Secondary Attack Rate
88

o A measure of the frequency of new cases of a disease among the


contacts of known cases. The formula is as follows:
o Secondary attack rate =Number of cases among contacts of
primary cases during the period x100
total number of contacts

To calculate the total number of household contacts,


Subtract the number of primary cases from the
total number of people residing in those households.
28-Dec-23
Secondary Attack Rate: Example
89
 Seven cases of hepatitis A occurred among 70 children attending
a child care center. Each infected child came from a different
family. The total number of persons in the 7 affected families was
32. One incubation period later, 5 family members of the 7
infected children also developed hepatitis A.
 Calculate the attack rate in the child care center and the
secondary attack rate among family contacts of those cases.

28-Dec-23
90

28-Dec-23
Relationship of Incidence to Prevalence
91

 Prevalence depends on both incidence rate and


duration of disease

Prevalence = Incidence X Duration

 Because prevalence is affected by factors such as


migration and duration,

 incidence is preferred for studying etiology.


28-Dec-23
Relationship between Incidence, Prevalence
and Disease Duration
92

Incidence

Deaths,
Prevalence
Cure,
28-Dec-23
Lost to follow up
MEASURES OF MORTALITY
93

“Mortality is the fundamental factor in the dynamics of


population growth and causes of death.”
 Mortality in a population can be monitored through a variety

of measures:
 Crude death rates

 Category specific death rate

 Standardized death rate

28-Dec-23
Measures of Mortality: Crude Rates
94

 The number of deaths in a population over a given period of


time, usually a calendar year.

28-Dec-23
CRUDE DEATH RATE (CDR)
95
 The number of deaths in a given interval (usually a year)
divided by the population at mid-year.
 usually expressed per 1000 population.

Problem: CDRs can be higher in the more advanced


countries than in some of the developing countries
because the crude death rate is insensitive to the effects of
age composition.

 Age structure must be taken into account if we are to obtain a


clear picture of the true level of mortality in a country or any
population of interest.

28-Dec-23
Measures of Mortality…
 Category Specific rates:
96

 Used to construct rates for specific segments of the


population; so we can compare among strata or between
groups (used especially for age, race, ethnicity, gender)

 We can also construct cause-specific rates to compare rates


among causes.
 Examples:
 Age-specific rates

 Gender-specific rates

 Race-specific rates

 Cause-specific rates

28-Dec-23
AGE-SPECIFIC DEATH RATE
97

 The number of deaths of persons of a given age divided by


the mid-year population in that same age category.
ASDR = [ da/pa] X1000
Where,
ASDR=death rate for a specific age group
da and pa correspond to the deaths and the mid-year
population for age category a, respectively.

28-Dec-23
Mortality Measures…

Number of deaths of neonates


(28 days or less) in a given
Neonatal interval
Mortality Rate = X 1,000
Number of live births during
the same interval

Estimates events immediately after birth, primarily congenital


malformations, prematurity and low birth weight
98 28-Dec-23
Mortality Measures …

Number of deaths under 1


Infant Mortality year during a given interval
Rate = X 1,000
Number of live births during
the same interval

Used for international comparisons; high rates indicate


unmet public health needs and poor socioeconomic and
environmental conditions
99 28-Dec-23
Mortality Measures: Cause Specific Rates

Number of deaths assigned to


Maternal
causes related to pregnancy during
Mortality
a given interval
Ratio = X 100,000
Number of live births during the
same interval

Reflect health care access and socioeconomic factors


100 28-Dec-23
Mortality measures…
101

Cause Specific Death Rate

# Of deaths from a specified


cause in a year
CSDR=----------------------------------------x 100,000
Average population in the same period

Identifies the proportion of people who died due to disease X.

28-Dec-23
Mortality measures…

PMR* = No. of deaths from a sp. Cause


during a given time x 100
Total no. of deaths from all other causes
in the same time

* Proportionate mortality ratio

What proportion of deaths as compared to other causes of death


is due to disease X ?

102 28-Dec-23
Mortality measures…
103

Case Fatality = No. of deaths from a sp. disease


Rate (CFR) during a given time __x 100
No. of cases of that disease
during the same time
 What proportion of total cases die from disease X ?

 CFR tells the virulence of the organism.

 Sex- specific mortality rate = No. of deaths in a specific


sex during a given time X 1000
Estimated mid interval population of same
sex

28-Dec-23
Frequently used measures of mortality

104

28-Dec-23
Frequently used mortality measures..
measure numerator denominator expressed
105 per number at risk

28-Dec-23
Many Thanks!

106 28-Dec-23
Epidemiological study designs
107

 Epidemiology is primarily concerned with the


distribution and determinants of disease in human
populations.
 In addressing these issues there are many approaches
applied in Epidemiology.

28-Dec-23
Schematic presentation of the classification of epidemiological study designs.

108

28-Dec-23
A. Descriptive studies
109

 Are mainly concerned with the distribution of diseases with respect to


time, place and person.

 Provide useful information for health managers


 to allocate resource and to plan effective prevention programs.

 Generate epidemiological hypothesis.

 Can use information collected routinely which are readily available in


many places.

 are less expensive and less time-consuming than analytic studies.

 Are the most common type of epidemiological design strategies in


medical literature.

28-Dec-23
Purpose of descriptive studies
110

 To evaluate trends in health and disease and allow


comparisons among countries and subgroups among
countries;
 To provide basis for planning, provision and
evaluation of services;
 To identify problems to be studied by analytic
methods and to test hypotheses related to these
problems.

28-Dec-23
111

 There are three main types of descriptive studies:


 Correlational/ecological

 Case report or case series


 Cross-sectional

28-Dec-23
Correlational or Ecological
112

 Uses data from entire population to compare disease


frequencies.
 Does not provide individual data, rather presents average
exposure level in the community.
 Cause could not be ascertained.
 E.g
 Gross national product,
 Air quality measures,
 lead in water,
 the weather,
 Type of political structure
 Density of population

28-Dec-23
Strength and limitation
113

 Strength: can be done quickly and inexpensively,


often using available data.
 Limitation
 Inability to link exposure with disease. association
found with aggregate data may not apply to
individuals (ecological fallacy)
 Lack of ability to control for effects of potential
confounding factors.
 It may mask a non-linear relationship between
exposure and disease.
28-Dec-23
Case Report and Case Series
114

 Describes the experience of a single or a group of


patients with similar diagnosis or health problem.
 derived from the practice of one or more health care
professionals or a defined health care setting.

28-Dec-23
Important inputs in making better use of the
case series study
115
 Defining the disease or health problem clearly
 Recording the date when the disease/death occurred
(Time)
 Recording where the person lived, worked…
(Place).
 Recording personal characteristics of the person
such as age and sex (Person)
 Explore the opportunities for collecting additional
data from records or the person directly.
 Estimating the size and the characteristics of the
population at risk.
28-Dec-23
116

 E.g. The 5 young homosexual men with PCP seen


between Oct. 1980 and May 1981 in Los Angeles
created a serious concern among physicians since PCP
among young adults is not common.

 One case of pulmonary embolism observed 5 weeks


after a woman started using oral contraceptive was the
first clue to the association between oral contraception
and increased risk of venous thromboembolism.

28-Dec-23
Strength and Limitations
117

Strength:
 useful for studying signs and symptoms and creating

case definitions for epidemiological studies


 case-series that include cases at various stages of an

illness from mild cases to dead supplemented by


investigation build a picture of the natural history of a
disease.
 Very useful in providing critical information, for

hypothesis generation

28-Dec-23
Limitations:
118

 Report is based on single or few patients, which could


happen just by coincidence.
 Lack of an appropriate comparison group.
 Detailed and complete risk factor information is
difficult to obtain for all cases from records.
 Studies are prone to atomistic fallacy.

28-Dec-23
Cross Sectional Studies (Survey)
119

• Investigate disease and risk factor (exposure) in a


representative sample of a population in a narrowly
defined time period.
• Findings from cross-sectional study of a sample
population can be generalized cautiously if basic
characteristics of the populations are similar.
• Provide the most reliable estimate of burden of disease in
a population by estimating prevalence.
• Useful in raising the question of the presence of an
association rather than testing hypothesis.
28-Dec-23
Strength and Limitations
120

Strength
 Easy to conduct

 Not time consuming

 Can be used to compare population with different Cxs

as in comparative cross sectional


Limitation:
 "chicken or egg" dilemma.

 Survivor bias

28-Dec-23
ANALYTIC STUDIES
121

 Focuses on the determinants of a disease by testing


the hypothesis formulated from descriptive studies
 Broadly classified into: observational and
interventional studies.
 Both types use "control group"

28-Dec-23
Observational studies
122

 Information is obtained by observation of events.


 No intervention is done,
 no deliberate interference with natural course of
disease.

E.g. Cohort and case-control studies.

28-Dec-23
A. Case-control studies
123

 Two study groups are selected on their disease status.


 Designed in response to the difficulty of studying
diseases with very long latency period.
 Is capable of evaluating the association of a disease to
exposure many years after the actual exposure.
 Due to efficiency in time and cost, case-control
studies have became the most common analytic
design in medical literature.

28-Dec-23
124

 Case-control is the most focused on establishing


causation and least on measuring burden of disease
or risk factors.

28-Dec-23
Design and conduct of case-control studies
125

 always seek for the comparability between cases and


controls; this is the basis for valid conclusion.
1. Defining Cases:
 Establish a clear operational definition or use standard

definition of disease (outcome) of interest.


2. Selection of Cases:
 Do not always go for random representation of cases,
rather cases on which you can get complete and reliable
information.
 Select controls which are comparable to the cases
28-Dec-23
Hospital Vs population-based cases
126

 Hospital-based:
easy and inexpensive to conduct
but it is prone for selection bias.
 Population-based:
avoids selection bias,
allows the description of a disease in the
entire popn and the
 direct computation of rates of disease in
exposed and non-exposed persons.
28-Dec-23
Incident Vs Prevalent cases
 Prevalent cases:
127  Increase sample size available for rare disease.
 Difficult to establish temporal sequence between
exposure and outcome.
 Use is unavoidable in certain situations, like in
studying congenital malformations which are
rare to find.
 Incident cases:
Helpful to establish temporal relationship
between exposure and outcome
Records are easily obtainable and recall is not
a serious problem.

28-Dec-23
3. Selection of controls
128

• There is no control group that is optimal for all situations.


• are made for a particular group of cases,
• do not try to represent the entire non-diseased population
rather try to achieve comparability between the cases and
controls.
• Should also consider practicability and economic impact.
• The control series is intended to provide an estimate of the
exposure rate that would be expected to occur in the cases if
there were no association between the study disease and
exposure.

28-Dec-23
Sources of controls

129

1. Hospital Controls
 Advantages:
 Easily identified and readily available in sufficient number with
reduced cost.
 More likely than healthy individuals to be aware of antecedent
exposures or events --> minimize recall bias.
 More likely to be cooperative because they anticipate benefit
from their involvement or might think that its related with their
illness --->reduce bias due to non-response.
 Disadvantages:
 Because they are ill they are different from healthy individuals in
many ways.
 There is danger of altering the direction of association or
masking a true association.
28-Dec-23
130

2. General population controls


 Advantages:

 Generalizability is possible
 Good when cases are selected to represent affected
individuals in a defined population.
 Disadvantages:
 Costly and time-consuming
 Recall bias, since they may not be seriously concerned
about their illness.
 People might be less motivated to participate
28-Dec-23
3. Special controls
131

 are individuals related to the cases in some way. These are


friends, household members (siblings,...), neighbours,...
 Advantages:
 they are healthy.
 more likely to be cooperative than members of the general
population, because of their interest in the cases.
 offer a degree of control over some confounding factors., such as
ethnicity, socioeconomic status, or environment.
 Disadvantage:
 If the study factor is likely to be similar to the cases, an
underestimate of the true effect of the exposure of interest may
result.
E.g. if the study factor is diet, it will be similar for both cases
and controls, if controls are siblings.

28-Dec-23
Case-control ratio
132

 A single control group is optimal in most of the times.


 Add more control groups only when
 not confident with the control group
 There is a clear deficiency in control group

 there is a clear advantage by adding another control.

28-Dec-23
b. Cohort Study
133

 It is also called follow up, longitudinal, prospective


study.
 The word cohort is used to designate a group of
people who share a common experience.
 A Birth cohort, a cohort of smokers, a cohort of
Health Officer graduates in 2010, etc.
 It is an observational study that measures the
incidence.

28-Dec-23
134

 Subjects are selected by exposure(determinants of


interest), and followed to see if they develop the
disease or outcome of interest.
E.g. Take districts with trained manager and
untrained managers and follow them to see which
group will do better to increase coverage.
Follow 100 children who received BCG vaccination
and another 100 who didn't get BCG vaccination
and see how many of them get tuberculosis.

28-Dec-23
135

28-Dec-23
Types of cohort study
136

 On the basis of initiation of study and the


occurrence of disease, two forms of cohort study.
 Classical (Prospective) cohort
 „The exposure may or may not have occurred at
the time when the study begin, but the outcome
has certainly not yet occurred.
 Historical (Retrospective) Cohort
 „Both the exposure and outcome have already
occurred when the study is initiated.

28-Dec-23
137

28-Dec-23
138

 The two groups should be free of the study outcome


 Starts by establishing baseline data.
 Provide information on the incidence and to describe
natural history of disease.
 If the cohort study is based on a defined and
characterized population the incidence rates can often
be generalized to similar populations.

28-Dec-23
Exposure ascertainment
139

1. Using Pre-existing records: from hospital,


employers record…
Advantages:
 can make available information for high
proportion of cohort.
 relatively inexpensive to obtain.
 allow objective and unbiased classification
of exposure status.

28-Dec-23
140

Disadvantages:
information on exposure level may be
insufficient.
may not contain adequate information on
potential confounders.

28-Dec-23
141

2. By conducting Interview and filling questionnaire


Advantages:
 Enables to record exposure information that are not
routinely recorded, particularly lifestyle factors.
Disadvantages:
 potential for recall bias

28-Dec-23
Outcome ascertainment

142
The aim is to obtain complete, comparable and unbiased
information on the subsequent health experience of every
study subject.
• sources of outcome could be:

• Routine surveillance,
• death certificate,
• periodic health examination,
• Autopsy records,
• hospital records, etc.
• Always try to have a firm outcome criteria and
standard diagnostic procedure which are equally
applied for exposed and non-exposed individuals.
28-Dec-23
Analysis
143
 The basic analysis in cohort studies are:
Calculation and comparison of rates of the
incidence of the outcome for exposed and
non-exposed.
Comparison of the two groups with baseline
characteristic to ensure similarity.

28-Dec-23
Advantages and Limitations of Cohort and Case-Control
Study Designs.
144

• Case-Control • Cohort
Advantages Advantages
• optimal for the evaluation • valuable when the exposure
of RARE diseases is rare
• can examine multiple • can examine multiple effects
etiologic factors for a of a single exposure
single disease • can elucidate temporal
• quick and inexpensive relationship
• relatively simple to carry • allows direct measurement
out of risk
• guarantee the number of • minimize bias in
persons with cases ascertainment of exposure

28-Dec-23
Limitations
145
 inefficient for the evaluation of  inefficient in evaluation
rare exposure of rare diseases
 can not directly compute risk  expensive
 difficult to establish temporal  time consuming
relationship
 loss to follow-up
 determining exposure will create problem
often depend on memory
 persons who die as a result of
disease caused by the
determinant may not be known
to the study

28-Dec-23
INTERVENTION STUDIES
146

 Defn: An experiment is a set of observations,


conducted under controlled circumstances, in which
the scientist manipulates the conditions to ascertain
the effect.
 can produce high quality data if done properly

Key Features of Experimental Design


 Investigator manipulates the condition under study

 Always prospective

28-Dec-23
Intervention (Experimental) Design
147

28-Dec-23
148

28-Dec-23
149

28-Dec-23
Classification of Intervention
Studies: Based on population
150

 Clinical trial - usually performed in clinical setting


and the subjects are patients.

 Field trial- used in testing medicine for preventive


purpose and the subjects are healthy people.

 Community trial - a field trial in which the unit of the


study is group of people/community.

28-Dec-23
Classification of Intervention
Studies: Based on design
151

 Uncontrolled trial - no control group. control will be


past experience (history).

 Non-randomized controlled - there is control group


but allocation into either group is not randomized.

 Randomized controlled - there is control group and


allocation into either group is randomized.

28-Dec-23
Classification of Intervention
Studies: Based on Trial Objective
152
 Phase I - trial on small subjects to test a new drug with
small dosage to determine the toxic effect.

 Phase II - trial on small group to determine the


therapeutic effect.

 Phase III - study on large population to test


effectiveness.

28-Dec-23
The Quality of “Gold Standard"
156

Randomization: Maximize the chance of comparability


of study groups at baseline.
 Ideally, both groups are at the same stage of the
natural history of disease
 Ideally, only one factor affecting the outcome of
interest would vary between the study groups
Blinding
 Minimize bias related to assignment, assessment, or
compliance
 Minimize the potential for observation bias in reporting
of side effects and in assessing outcome
28-Dec-23
• Placebo: are inert treatments intended to have no
effect other than the psychological benefit of offering
157
treatment.
• Can only be used if there is no accepted treatment for
the condition under study.
• Minimizes the bias in the ascertainment of both
subjective disease outcomes and side effects.
• It facilitates that both groups in the study gain equal
attention.
• Placebo effect: tendency for individuals to report
favorable response to any therapy regardless of the
physiologic efficacy of what they received.
28-Dec-23
Major Problems Related to Intervention Studies
158

• Feasibility/ Practical Issues


– Subject recruitment
• getting adequate individuals
• Field trials particularly require greater number of subjects.
– Loss to follow-up
• Cost
– Large number of subjects
– Expenses for visits
• Ethical Issues
28-Dec-23
Measures of Association
159

Exposure Outcome

Is there a relationship between the


exposure and outcome of interest?

28-Dec-23
Measures of . . . . . . .
160
 Variables can be related or unrelated to one
another

 If related, variables can be

 positively or negatively related

 strongly or weakly related (one variable can have large or


small effect on the other)

28-Dec-23
Relationships between variables: Related or unrelated?

161

2.00 10
Dependent variable

8
1.50

Dependent variable
6

1.00
4

0.50 2

0
0.00
0.00 0.20 0.40 0.60 0.80 1.00 1.20 0.00 20.00 40.00 60.00
Independent Variable
Independent variable

Related unrelated
28-Dec-23
Relationships between variables —
162
Positive and negative association?
10 10

Y Y

0 0

0 X 1 0 X 1

Positive Negative
28-Dec-23
Relationships between variables —
163
Large or small effect?
10 10

Y Y

0 0

0 X 1 0 X 1

Small
Large
28-Dec-23
Measures of . . . . . . .

164Epidemiologic data are often presented in the form
of two-by-two (contingency) table
 2X2 table contains 4 cells  A, B, C, D
E Disease
X Yes No Total
P Yes a b a+b
O No c d c+d
S
Total a+c b+d a+b+c+d
U
R
E 28-Dec-23
Measures of . . . . . . .
165

 Statistical tests like Chi-square show mainly the


presence or absence of association.
 The strength of association is assessed by
calculating Relative Risk (RR), Odds Ratio (OR) or
other measures of association.

28-Dec-23
Measures of . . . . . . .
166

 Risk is a proportion
The chances of something happening
The chances of all things happening

 Odds is a ratio
The chances of something happening
The chances that it is not happening

28-Dec-23
A. Relative Risk (RR) or Risk Ratio

167 RR shows the magnitude of association between
exposure & disease or any other outcome
 It compares the risk of a health-related events
(disease) in two groups.
 It directly compares new occurrence (incidence)
disease among exposed and non-exposed
 It estimates the likelihood of developing disease
in exposed relative to non-exposed.

28-Dec-23
Relative Risk
incidence of a disease among exposed = (a/(a+b)) Re
RR =
168
incidence of a disease among non-exposed (c/(c+d)) Ro

RR = Re / Ro Disease
Yes (+) No (-)
. a .
Exposure a b
RR = . a+b .
Yes (+)
a+b

. c .
c d
No (-) c+d
c +d

 It is a direct measurement of a risk

 It is usually used in Cohort and Experimental study


design
28-Dec-23
Relative Risk cont…
169

 Risk Ratio
 Cumulative incidence ratio
 Cumulative incidence in exposed
Cumulative incidence in non exposed

= CIe/CIo

28-Dec-23
Relative Risk cont…
170

 Rate ratio
 Incidence density ratio
 Incidence density in exposed
Incidence density in non exposed

IDe/IDo = a/PY1
c/PY0 ( PY = Person year)

28-Dec-23
Example 1
171

 Among 2390 women aged 16 to 49 years who


were free from bacteriuria, 482 were OC users at
the initial survey in 1973, while 1908 were not. At
a second survey in 1976, 27 of the OC users had
developed bacteriuria, as had 77 of the non users.
Calculate the measure of association and interpret
it.

28-Dec-23
Example:
172

Bacteruria
Yes No Total
O
C Yes 27 455 482

U No 77 1831 1908
S
E Total 104 2286 2390

28-Dec-23
173

 Calculate RR

RR = Ie = 27
lo 482 = 1.4
77
1908

 Interpretation: women who used oral contraceptive had


1.4 times higher risk of developing bacteruria when
compared to non-users.

28-Dec-23
Example 2
174

 A study on postmenopausal hormone use and


coronary heart disease among postmenopausal
female nurses showed that after a total of 54,308.7
person-years of follow-up, 30 women who reported
that they had used hormones developed CHD. For the
“never users”, 60 developed CHD among 51,477.5
person-years of follow-up. Draw a two-by-two table
and calculate the measure of association.

28-Dec-23
175

Hormone CHD Person-Years


use
Yes No
Yes 30 - 54,308.7
No 60 - 51,477.5
Total 90 105,786.2

28-Dec-23
Relative Risk cont…
176
 Ie/Io = IDe/IDo = a/PY1
c/PYo
= 30/54,308.7
60/51,477.5
= 0.5
Interpretation:
 The risk ratio is less than 1.0, indicating a decreased risk or protective effect
for the exposed (Using hormone) postmenopausal female nurses.
 The Incidence density ratio of 0.5 indicates that postmenopausal hormone using
female nurses were only half as likely (50%) to develop CHD as were not
using.

28-Dec-23
Relative Risk cont…
177

• The further away from 1, the stronger the association


between exposure and disease

• Can only calculate Risk Ratio from cohort study and


experimental studies

28-Dec-23
Odds ratio, cross product ratio
178
 It is an indirect measure of a risk in a disease
of rare occurrence.

 It is usually used in a case-control study designs

 Cases and controls are predetermined and we


are calculating to determine whether cases or
controls are more exposed to a postulated risk
factor.

28-Dec-23
Odds ratio
. Odds of exposed among cases = (a/c) Oe
179

OR = Odds of exposed among controls (b/d) Oo

OR = Oe /Oo

Disease
Yes (+) No (-)
. a/c .
OR = b/d Exposure
a b
Yes (+)
ad/bc c d
No (-)

a+c b+d

28-Dec-23
Odds Ratio
Assuming it is a
as Cross-Product Ratio
180 case control study

Dead Alive
Diabetic 100 89
Nondiabetic 811 2340

OR = ad / bc

OR = ad = 100 x 2340 = 3.2


bc 89 x 811

28-Dec-23
When Can the Odds Ratio be Used
to Approximate the Relative Risk?
181
D+ D- Total Risk

E+ a b a+b a/a+b

E- c d c+d c/c+d
a a
RR = a+b ≈ b ≈ ad = OR
c c bc
c+d d
For a rare disease, a <<< b, so a+b ≈ b
c <<< d, so c+d ≈ d

28-Dec-23
Example of the “Rare Disease”
Assumption
182

D+ D- Total Risk

E+ 90 499,950 500,040 0.00018


E– 10 499,950 499,960 0.00002

RR = 90/ 500,040 = 0.00018 = 9.0


10/ 499,960 0.00002

OR = ad = (90)(499,950) = 9.0
bc (499,950)(10)

28-Dec-23
Example of the “Rare Disease”
183 Assumption
D+ D- Total Risk

E+ 90 50 140 0.643

E- 10 50 60 0.167

RR = 90/140 = 0.643 = 3.9


10/60 0.167

OR = ad = (90)(50) = 9.0
bc (50)(10)
28-Dec-23
Example 3
184

 Of 156 women with Myocardial Infarction (MI), 23


were current OC users at the time of their hospital
admission. Of the 3120 control women without MI,
304 were current OC users. Calculate the measure
of association and interpret it.

28-Dec-23
Example:
 Table 6: This table shows data from case control study of oral
185 contraceptive (OC) use & myocardial infarction in pre-
menopausal female nurses

Myocardial infarction
yes No Total

Yes 23 304 327


Current
No 133 2816 2949
OC use

total 156 3120 3276


28-Dec-23
Odds ratio cont…
186

Calculate OR
OR = ad = (23) (2816) = 1.6
bc (304) (133)

Interpretation: Women who were current OC users had 1.6 times higher risk
developing myocardial infarction when compared to non-users of OC

RR can be estimated by OR if the following conditions are fulfilled:


 The controls are representative of the general population

 The selected cases are representative of all cases

 The disease is rare

28-Dec-23
Impact Measures
187

 Attributable Risk (AR)


 Attributable Risk Percent (ARP)
 Population Attributable Risk (PAR)
 Population Attributable Risk Percent (PARP)

28-Dec-23
Attributable Risk (AR) / Risk Difference (RD)
188  AR provides information about the absolute effect of the
exposure or the excess risk of disease in those exposed.

 AR = Incidence among exposed (Ie) _


Incidence among non-exposed (Io)

 AR quantifies the risk of disease in the exposed group


that is attributable to the exposure by removing the risk
of disease that occurs due to other causes.

28-Dec-23
Alternative Naming of AR
189

 Risk difference
 Rate difference
 Cumulative incidence difference
 Incidence density difference

28-Dec-23
Example:
190

Bacteruria
Yes No Total
O
C Yes 27 455 482

U No 77 1831 1908
S
E Total 104 2286 2390

28-Dec-23
Example: Refer to example 1 and calculate AR
AR =
191
27 _ 77
482 1908
=0.0156=1566 per 100,000 OC users

Interpretation: The excess occurrence of bacteruria among OC users


attributable to their OC use is 1566 per 100,000 OC users
In a population of 100,000 OC users, 5602 would be expected to
develop bacteruria, 1566 of those who developed bacteruria
being related to OC use & the remainder, 4036, to other factors

28-Dec-23
Exercise:
Mortality rates per 100,000 person-years from Lung ca and coronary
artery disease:
192
(person year calculated in cohort study)

Smokers Nonsmokers Ratio Difference

RR AR

Lung Ca 48.3 4.5 10.8 44

CAD 294.7 169.5 1.7 125

28-Dec-23
Exercise
193

 Which disease mortality is more strongly associated


with cigarette smoking? Why?

 If the number of deaths attributable to smoking is


used as an index of public health importance which
disease has more significance?

28-Dec-23
Attributable Risk Percent
194

 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) X 100


Ie

28-Dec-23
Example:
195 Refer to example 1 and calculate AR%
AR % = 1566/105 X 100 =27.96 %
27/482
AR % = Ie –Io/Ie X 100
 Interpretation: If OC use causes bacteruria, 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

28-Dec-23
Population Attributable Risk (PAR)
196
 PAR shows the effect of eliminating the exposure on 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

 PAR = AR X prevalence rate of the exposure

28-Dec-23
Example:
197

 Cigarette smoking and death from lung cancer.

 AR = 89 per 100,000 per year


 Prevalence rate of cigarette smoking = 20 %
 Calculate PAR.
 PAR = 89 per 100,000 per year X 20 %
= 17.8 per 100,000 per year

28-Dec-23
Interpretation:
198

 In a population of 100,000 smokers, 89 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).

28-Dec-23
PAR cont…
199

 Both AR and PAR are used to estimate the effect on disease


incidence of eliminating a given risk factor,

 AR estimates reduction in disease incidence only in those


exposed,

 PAR estimates reduction in disease incidence in the population


as a whole.

 PAR = Incidence rate in total population minus


incidence rate in non-exposed population

28-Dec-23
Population Attributable Risk Percent (PARP)
200 PAR % = PAR X 100
Incidence rate in total population

Example: PAR = 17.8 per 100,000 per year


Mortality rate in non-smokers = 7 per 105
Mortality rate in the total population = 24.8 per 10 5 per year

Calculate PAR %
PAR % = 17.8 per 105 per year X 100 =71.8%
24.8 per 105 per year

Interpretation: 72% of deaths from lung cancer occurring in the general


population could be prevented by eliminating cigarette smoking.

28-Dec-23
POSSIBLE OUTCOMES IN STUDYING THE
RELATIONSHIP
201

 No association between exposure and disease


AR=0, RR=1
 Positive association between exposure and disease
(more exposure, more disease)
AR>0, RR>1
 Negative association between exposure and disease

(more exposure, less disease)


AR<0 (negative), RR <1(fraction)

28-Dec-23
202

PUBLIC HEALTH SURVEILLANCE

28-Dec-23
Definition of Surveillance
203

 Surveillance is an on-going systematic collection, analysis,


interpretation and dissemination of health-related data essential
to the planning, implementation, and evaluation of public health
practice.
 Provides “Information for Action”

28-Dec-23
Purpose of surveillance
204

 To be able to identify diseases, injuries, hazards and other


health related factors as early as possible, i.e. prediction and
early detection of outbreaks.
 To provide scientific baseline data and information for priority
setting, planning, implementing and evaluating disease control
program for both communicable and non-communicable health
problems.
 To define the magnitude and distribution of diseases by time,
person and place dimension.

28-Dec-23
Basic Principle
205

Main function of public health surveillance is to serve as an


“early warning system”

 Providing timely information needed for action

28-Dec-23
Surveillance Activities
206

 Core Activities:
 Detection
 Registration
 Confirmation (epidemiological and laboratory confirmation)
 Reporting (early warning)
 Analysis and interpretation (detecting outbreaks, changes in disease
patterns)
 Response (preventive and control measures, outbreak investigation,
programme adjustment, changes in policy and planning)
 Feedback
 Evaluation and monitoring
28-Dec-23
Surveillance Activities (cont’d)
207

 Supportive Activities:
 Setting standards (e.g., case definitions, standard case
management guidelines, standard procedures for investigation)
 Training (surveillance, epidemiology, laboratory)
 Supervision

 Communication systems (e.g. radio, fax, e-mail, phone, health


updates)
 Providing resources (human – appropriate number with
adequate skills and competencies; material - vehicles, laboratory
equipment, supplies etc; financial).

28-Dec-23
Uses of Public Health Surveillance
208

 Estimate magnitude of the problem


 Determine geographic distribution of illness
 Early recognition of epidemics - detect sudden changes in
disease occurrence
 Identify changes: in agents, host factors and health practices
 Follow secular (long-term) trends
 Projections of future trends
 Evaluate public health programs
 Generate hypotheses, stimulate research

28-Dec-23
Uses of Public Health Surveillance (cont’d)

Information for Action


209

Public Health Action


Surveillance
Priority setting
Collection Planning, implementing,
Analysis and evaluating disease
Interpretation  investigation
Dissemination  control
 prevention

Although surveillance is meant to guide a larger action it also


provides the basis for identifying individuals who need
treatment and preventive services.
28-Dec-23
Key (Selected) Sources of Surveillance Data
210
 Census data
 Mortality reports (birth and death certificates, autopsy reports)
 Morbidity reports (notifiable disease reports)
 Hospital data (discharge, diagnoses, surgical logs, hospital infection reports)
 Absenteeism records (school, workplace, compensation claims)
 Epidemic reports
 Laboratory test utilization and result reports
 Drug utilization records
 Adverse drug reaction reports
 Special surveys (e.g., research data, serologic surveys)
 Police records (especially for injury, alcohol-related crime)
 Information on animal reservoirs and vectors (e.g., for rabies, plague,
Lyme disease)
 Environmental data (hazard surveillance, water and food testing)
 Special surveillance systems (e.g., for injury and occupational illness…)
28-Dec-23
Selection Criteria of Disease for Surveillance
211

 Magnitude of the disease


 Feasibility of control measures
 Need for monitoring and evaluating the performance
of a control program
 Resource availability

28-Dec-23
Types of Surveillance
212

 Two types (By type of method used in collecting the


necessary data)

1. PASSIVE: Surveillance where reports are awaited


and no attempts are made to seek reports actively
from the participants in the system. (Provider-
initiated, based on a known set of rules and
regulations)

28-Dec-23
Advantages of passive surveillance
213

 Covers a wide range of problems


 Does not require special arrangement
 It is relatively cheap
 Covers a wider area

28-Dec-23
The disadvantages of passive surveillance
214

 The information generated is to a large extent unreliable, incomplete


and inaccurate

 Most of the time, data from passive surveillance is not available on


time

 Most of the time, you may not get the kind of information you desire

 It lacks representativeness of the whole population since passive


surveillance is mainly based on health institution reports

28-Dec-23
Types of Surveillance (cont’d)
215

2. ACTIVE: Surveillance where public health officers seek reports


from participants in the surveillance system on a regular basis,
rather than waiting for the reports. e.g. by telephoning/contacting
each participant twice a week, monthly... (Health Department-
initiated)
 In contrast to passive surveillance:
 usually limited to specific diseases over a limited period of time,
such as after a community exposure or during an epidemic.
 Can not be used for routine purposes
 relatively expensive
 Usually complete/accurate

28-Dec-23
Types of Surveillance (cont’d)
216

 Indications of Active surveillance:


 For periodic evaluation of ongoing programs
E.g. HIV/AIDS, EPI...
 For programs which have time limit of operation
E.g. Small pox
 With the occurrence of unusual situations:
 when a new disease/event discovered
 when investigating a new mode of transmission
 when a high-risk period is recognized
 when a disease appears in a new geographic area or found to affect a
new subgroup of the population
 when previously eradicated disease reappear or low incidence disease
occur at a higher level of endemicity

28-Dec-23
Active surv…
217

 The advantages of active surveillance


 The collected data is complete and accurate
 Information collected is timely.
 The disadvantages of active surveillance
 It requires good organization
 It is expensive

 It requires skilled human power

 It is for short period of time(not a continuous process)

 It is directed towards specific disease conditions

28-Dec-23
Features of good surveillance System
218

 Uses a combination of passive and active mechanisms


 Collects the minimum data in a simplest possible way
 Collects data in a manner useful for the workers who collect the
data (To assure quality and enhance compliance)
 Timely reporting
 Provide timely and comprehensive response/action (Action targeted to
case detection and treatment and as well as to the control of the disease)
 Incorporate strong laboratory services for accurate
diagnosis

28-Dec-23
Reporting & Feedback at International Level

219

 Surveillance systems are networks of people and activities that


maintain the process and may function at a range of levels, from
local to international. 28-Dec-23
Critical Information in Surveillance
220

 Person: Age, sex


 Time: onset of disease, reporting period
 Place: woreda, region
 Risk factors
 Number of cases (magnitude)
 Treatment outcome: deaths, recovery (seriousness)
 Mode of treatment: inpatient/outpatient

28-Dec-23
Case definition
221
 Case definition
 Standard set of criteria for deciding whether an individual
should be classified as having the health condition of interest
 It includes
– Criteria: Signs and symptoms with or without a laboratory test
– Restriction by time, place and person can be done depending on the
nature of the disease
• Classification of case definition
1. Confirmed: a case definition by appropriate lab. Test
2. Probable: a case with typical clinical features of the disease
without laboratory confirmation
3. Possible/ Suspect: a case with few of the typical clinical
features.
 Use case definition consistently!! 28-Dec-23
Major advantages of case definition
222

 Facilitate early detection and prompt management of cases

 Useful in areas where there is no laboratory

 Facilitate observation of trends

 Facilitate comparison more accurately from area to area

28-Dec-23
Surveillance system should determine:
223

Who? What? When? Where? How?


 Specimen and Data collection

 Transfer of Specimen and data

 Feedback

28-Dec-23
Example: Setting up AFP surveillance

224

 Who? All health facilities (begin with major ones)


 What? Case investigation/specimen collection
-Active surveillance
 When? Immediate notification of AFP
 Where? Data - hierarchical flow
Specimens - directly to laboratory
 How? Determine method (paper, phone, radio, fax,
diskette, modem?)
-Reverse cold chain for specimens

28-Dec-23
Evaluating Public Health Surveillance system
225

Aspects of a Surveillance System to be Assessed


(In justifying, designing or evaluating it)
1) The public health importance of the health event
under surveillance
 Incidence and prevalence
 Severity (case-fatality or death-to-case ratio)
 Mortality (overall and age-specific mortality rates, years of
potential life lost)
 Health care costs
 Potential for spread
 Preventability

28-Dec-23
Aspects of a Surveillance System to be
Assessed… (Cont’d)
226

2) The objectives and operation of the system


 The case definition of the health event
 The population under surveillance
 The time period for data collection (weekly, monthly, annually)
 What information is collected (Is it what programs need?)
 The reporting sources
 How data are handled (transfers, delays, confidentiality)
 How data are analyzed (by whom? frequency, thoroughness)
 How data are disseminated

28-Dec-23
Aspects of a Surveillance System to be
Assessed… (Cont’d)
227

3) The system’s usefulness

 Action taken to date as a result of the information

 future or potential uses

28-Dec-23
Aspects of a Surveillance System to be Assessed…
(Cont’d)
228

4) Attributes or qualities of the surveillance system


 Simplicity
 Flexibility (with changes in case definition or funding, to add
new diseases)
 Acceptability (often judged by proportion who report,
completeness of forms)
 Sensitivity (ability to detect events it is intended to detect)
 Predictive value positive (proportion of reported cases
which truly are cases, or of epidemics which are actual
epidemics)
 Representativeness (extent to which one can generalize or
draw conclusions from surveillance data, such as for
calculating rates)
 Timeliness
5) Cost or resource requirements for system operation
28-Dec-23
The Most Common Limitations of Surveillance Systems
229

 Under reporting
 Lack of representativeness of reported cases
 Lack of timeliness
 Inconsistency of case-definitions
 Lack and shortage of qualified staff
 Lack of motivation

28-Dec-23
The Most Common Means of Strengthening
Surveillance System
230

 Improving awareness of practitioners


 Simplification of the process of reporting
 Frequent feedback to those reporting
 Widening the "net"
(e.g. obtaining reports from laboratories or schools, rather than
relying on physicians)
 Using active (rather than passive) surveillance.
 Remember to "share the data, share the responsibility, and share
the credit"

28-Dec-23
Sentinel Surveillance System
231

 Uses a pre-arranged sample of reporting sources to report all


cases of one or more conditions.
 Means of monitoring trends of health events in chosen
population groups and chosen sites in a regular and consistent
(Uniform) way.
 Need not be representative:
 However it is very important to keep sites, facilities, procedures and
populations remain similar
 Selection of study population must be with minimal bias
 Sufficient demographic data must be collected to detect
changes in population composition

28-Dec-23
Main Purposes of Sentinel Surveillance
232

 To detect changes
 To direct and focus control efforts
 To develop intervention strategies
 To promote further investigations
 Provide the basis for evaluating preventive strategies
and activities

28-Dec-23
Surveillance Vs survey
233
Surveillance Survey
 Relatively cheap – can often  More in-depth data could be
use existing systems and health collected
personnel  More accurate assessment of
 Allows monitoring of trends of true incidence and prevalence
disease over time  Can identify those which don’t
 Ongoing collection produce warrant medical care
enough cases for study But…
But…  Costly
 Quality control may be the  Represents only single point in
major problem time- does not show changes
 May not provide over time
representative data  Recall bias can be introduced
(retrospective data)
28-Dec-23
Analysis of surveillance data
234

 Descriptive analysis: distribution by time, place and person


– Frequency of events
– Calculate rates- need proper denominator
 Observe trends: comparison current data with expected value,
identify differences, and assess the relevance of the difference
– Draw graphs to show long term (secular) trends

28-Dec-23
Dissemination of surveillance data
235

 Disseminate surveillance data to all stakeholders


– Those who provide the reports (health providers)
– The community – affected/potentially affected
– Decision makers
 Disseminate report locally, nationally or globally; as deemed
necessary
 Disseminate report timely and regularly

 Disseminate through appropriate media: newsletter or bulletin


(paper or electronic)

28-Dec-23
Improving Public Health Surveillance in Africa/ Ethiopia
Using IDSR strategy
236

Integrated Disease Surveillance and Response (IDSR)


 IDSR is an approach adapted to strengthen national disease
surveillance systems by coordinating and streamlining all
surveillance activities and ensuring timely provision of
surveillance data to all disease prevention and control
programmes in order to initiate timely response (intervention)

28-Dec-23
IDSR (cont’d)
237

 Objective: to improve the ability of health workers to detect and


respond to priority communicable diseases at the woreda level.
 IDSR initiative was launched by the WHO-AFRO (Africa regional
office for WHO) in the second half of the 1990’s.
 Then has been adapted by many African countries including
Ethiopia.
 Data collection and reporting using the IDSR guideline and
forms is also initiated.

28-Dec-23
IDSR (cont’d)
238

 Simplified tools for data collection and analysis, common channels


for reporting and feedback

 Strengthening the capacity to detect and respond to communicable


disease threats and emergencies

 Integration to maximize effective utilization of scarce resources

28-Dec-23
Diseases included in the integrated disease
surveillance system
239

 Among the most prevalent health problems 21 (twenty one)


communicable diseases and conditions are selected for
integrated disease surveillance to be implemented in Ethiopia.
 The diseases are recommended because they fall into one or
more of the following categories:
 Are top causes of high morbidity and mortality in Ethiopia
(for example, malaria, pneumonia, diarrheal diseases,
tuberculosis, and HIV/AIDS)
 Have epidemic potential (for example yellow fever and
cholera)
 Surveillance required internationally (for example plague,
yellow fever and cholera)
28-Dec-23
Diseases included in the integrated disease
surveillance system(cont’d)
240

 Have available effective control and prevention interventions


for addressing the public health problem they pose (for
example Schistosomiasis, onchocerciasis,
trypanosomiasis)
 Can easily be identified using simple case definition; and

 Have intervention programs for prevention, control,


eradication or elimination of the diseases (for example EPI
and Integrated Management of Childhood Illness Strategy
(IMCI)

28-Dec-23
List of Priority Diseases for Surveillance in Ethiopia
241

Epidemic-prone diseases Diseases targeted for eradication


1. Cholera 12.Acute flaccid paralysis (Polio)
2. Diarrhea with blood 13.Dracunculiasis (Guinea worm)
(Shigellosis)
3. Measles 14.Leprosy
4. Meningitis 15.Neonatal Tetanus
5. Plague Other diseases of public health
6. Viral hemorrhagic fevers importance
7. Yellow fever 16.Pneumonia in children
8. Typhoid fever 17.Diarrhea in children
9. Relapsing fever 18.New AIDS cases
10.Epidemic typhus 19.Onchocerciasis
11.Malaria 20.Sexually transmitted diseases
21.Tuberculosis
28-Dec-23
. Evaluating an association

.
 If we observe an exposure/disease association, we must consider:

1. Is the association valid?


(do the study findings reflect the true relationship between the exposure and
disease?)

2. Is the association causal?


(Is there sufficient evidence to infer that a causal association exists between the
exposure and the disease?)

28-Dec-23
242
Purpose of Evaluation of Evidence
243

To determine if what is observed is a reflection of


the truth?

Observed:
Are they true?
Prevalence Are there alternative explanations?
Incidence
Relative Risk
Odds Ratio…

28-Dec-23
Judging Observed Association
,
Could it be due to selection or measurement bias?
No
Could it be due to confounding?
No
Could it be A result of chance?
Probably NOT
Could it be Causal?

Apply the criteria and make judgment of causality


28-Dec-23
244
Common Problems in observed findings

 Inadequacy of the observed sample

 Inappropriate selection of study subjects

 Inappropriate/unfair data collection methods

28-Dec-23
245
Alternative explanations for the observed
association other than cause and effect relationships
246

A. The association may be the result of chance


B. The association may be the result of bias
C. Association can be the result of a confounding effect.
D. An apparent cause can be an effect, rather than a cause
(reverse causation)
E. Cause can be both a cause effect (reciprocal causation)
e.g Vitamin A deficiency can cause diarrhoea or diarrhoea can
cause Vitamin A deficiency

28-Dec-23
Validity of epidemiological studies
247

 Validity: is a measure of the degree to which something truly


represents what it is being measured.
Two types of validity - internal and external.
A. Internal validity - is the degree to which the results of the study
are correct for the particular group of people studied

b. External validity (Generalizability) - is the extent to which the


results of study apply to people not in it.

28-Dec-23
The role of chance
 we can draw inferences about the experience of an entire
population based on evaluation of only a sample.

 One of the major problems in drawing such inference is that the play
of chance may always affect the results observed simply because of
random variation from sample to sample.

 One of the major determinants of the degree to which chance


affects the findings in any particular study is sample size
 The smaller the sample , the more variability there will be in the
estimates and the less likely the findings will reflect the
experience of the total population.

28-Dec-23
248
Role of chance..
249

 The larger the sample on which the estimate is based, the less
variability and the more reliable the inference.
 It is important to quantify the degree to which chance
variability may account for the results observed in any
individual study.
 This is done by performing an appropriate test of statistical
significance.
 A measure that is often reported from all tests of statistical
significance is the P value.
 P < 0.05 - statistically significant.
 P> 0.05 – no statistically significant association ( chance can not be excluded
as a likely explanation)

28-Dec-23
Hypothesis Testing ( Test of statistical Significance)
250

1. Make explicit statement of hypothesis


 Null Hypothesis
H0: P1 = P2 (p= proportion developed outcome of interest)
H0: RR = 1

 Alternate Hypothesis
H1: P1  P2
H1: RR  1

28-Dec-23
Hypothesis Testing
Perform Test of Significance
 Use appropriate test
 P-value  0.05  Chance is unlikely explanation
 Reject the null hypothesis
 There is Statistically significant difference
 It is always advisable to report the actual P value rather
than merely that the results did or did not achieve statistical
significance.
 confidence interval (CI) is far more informative measure
than P value to evaluate the role of chance
28-Dec-23
251
Confidence Interval
252

1. Provide information that p-value gives.


 If null value is included in a 95% CI, by definition the
corresponding P-value is >0.05.

2. Indicate the amount of variability (effect of sample


size) by the width of the CI
 This information can not be obtained from p-value.

28-Dec-23
Interpretation of CI
253

Wide CI

indicate greater variability

suggest inadequacy of the sample size

Particularly important in interpreting non-significant results

Narrow CI suggest that truly there is no association

Wide CIsuggest inadequacy of sample size to have adequate statistical


power
28-Dec-23
The role of bias
254

 Bias - is any systematic error in the design, conduct, or analysis of


a study that results in a distorted estimate measurement
 The key word in the understanding of the concept of bias is
“different”.
Two main types of bias:
A. Selection bias
B. Information (Observation) bias

28-Dec-23
Selection Bias (examples)
255

 Invitational (who gets invited into the study?)


 Acceptance (who . accepted the invitation?)
 Loss to follow-up
 Volunteer/Compliance bias
 Non-response bias

Selection bias is a particular problem in case


control and retrospective cohort studies

28-Dec-23
selection bias
256

1. Diagnostic bias
 Diagnostic bias occurs when a disease is more likely to be
diagnosed in some one with exposure to a suspected risk factor.
 For example women who take oral contraceptives (OCs) may be
screened more often for breast cancer than women who do not take
OCs because of the suspected link between OCs and breast cancer.
 This would result in breast cancer being diagnosed more readily in
those who are exposed to Ocs.
2. Self selection/ Volunteer bias/ Compliance bias
 People who accept to participate in a study, or people who
refuse to participate are often quite different from the general
population.
28-Dec-23
selection bias cont…
257

3. Non-response bias
 It reduces the effective sample size, resulting in loss of
precision of the survey estimates.
4. Loss to follow up
 It is major source of bias in cohort &intervention studies
 it is also a problem in intervention studies before outcome of
interest occurs
5. Healthy worker bias
 Bias in occupational health studies which tend to underestimate
the risk associated with an occupation due to the fact that
employed people tend to be healthier than the general
population
28-Dec-23
Ways of minimizing selection bias
258

 Population-based studies are preferable


 Avoid the inclusions as study subjects of people who have
volunteered on their own
 In case-control , select several different control groups.
 In hospital-based case control study, controls are usually selected
among patients with disease other than the disease studied.
 keep losses to follow-up to an absolute minimum.
 For those who are lost, an assessment of as much outcome data as
possible.

28-Dec-23
Ways of minimizing cont…
259

 Loss to follow up
 Calculate estimates of the exposure-disease association
assuming the most extreme situations.
 Assumptions:
 all those who were lost to follow up developed the outcome
of interest
 none developed the outcome of interest.

 The results of these calculations provide a range


within which the true association will lie.

28-Dec-23
B. Information bias /Observation bias
260

 Refers to bias which arises during the data collection process


 It occurs b/c of mistakes in categorizing study subjects with
respect to their exposure or disease status
1. Investigator bias/ Interviewer bias/ Observer bias
 Occurs when investigators collect information differently in
different comparison groups
2. Response bias/ Recall bias
 Occurs as a result of difficulty to recall prior exposures

28-Dec-23
Information bias cont…
261

3. Social desirability bias


 Occurs because subjects are systematically more likely to
provide a socially acceptable response.
4. Placebo effect
 In experimental studies which are not placebo controlled,
observed changes may be ascribed to the positive effect of the
subjects belief that the intervention will be beneficial.
5. Hawthorn effect
 Refers to the change in the dependent variable which may be
due to the process of measurement or observation itself

28-Dec-23
Ways of minimizing information bias
262

1. Blinding: Three types of blinding


 Single blind
 Double blind
 Triple blind

28-Dec-23
Ways of minimizing ….
263

2. Use of Placebo
 Placebos are inert treatments intended to have no effect
other than the psychological benefit of offering treatment.
 Can only be used if there is no accepted treatment for the
condition under study.
 Use of placebo minimizes the bias in the ascertainment of
both subjective disease outcomes and side effects.
 It facilitates that both groups in the study gain equal attention.

 Placebo effect: tendency for individuals to report


favourable response to any therapy regardless of the
physiologic efficacy of what they received.

28-Dec-23
Ways of minimizing ….
264

2. same standard procedures, instruments, questionnaires,


interviewing techniques should be used for data collection in both
comparison groups

3. Classification of study subjects according to their outcome &


exposure status should be based on the most objective &
accurate methods available

4. when exposure status is determined by interview, it should be


assessed in several different ways for both groups

28-Dec-23
The role of confounding
265

 Confounding is distortion of the estimated effect of an exposure


on an outcome, caused by the presence of an extraneous factor
associated both with the exposure and the outcome,

 Confounding variable, confounder is a variable that can cause


or prevent the outcome of interest, is not an intermediate variable,
and is associated with the factor under investigation.

28-Dec-23
CONFOUNDING
266
E
Confounding IS D
present

CF
Confounding NOT
present E ?CF D

28-Dec-23
The role of confounding cont…
267

Example of confounding effect.


• An observed association between consumption of coffee and increased risk of MI
could be due, at least in part, to the effect of cigarette smoking, since coffee drinking
is associated with smoking and, independent of coffee consumption, smoking is a risk
factor for MI.

28-Dec-23
Effect of Confounding
268

1. Totally or partially accounts for the apparent effect

2. Mask an underlying true association

3. Reverse the actual direction of the association

 Confounding must be dealt as quantitative problem; the amount


of confounding rather than mere presence or absence that is
important to evaluate.

28-Dec-23
Control for Confounding Variables
269

In the design:


 Randomization
 Restriction
 Matching (at design and analysis stage)
During analysis:
 Standardization
 Stratification
 Multivariate analysis

28-Dec-23
CONFOUNDING…………
270
Hypothesis: High alcohol consumption is associated with stomach cancer (case-
control study)

OR = (62 / 68) / (35 / 95)


D+ D-
OR = 2.47
E+ 62 35 97
E- 68 95 163
130 130 260
•The odds of being exposed to high alcohol consumption appear to 2.47 times higher for
stomach cancer cases as compared to controls

•The risk of stomach cancer is 2.47 times higher in persons with high alcohol
consumption as compared to persons without high alcohol consumption

28-Dec-23
Stratified analysis cont…
271

But what about smoking?


 Perhaps the cases were more likely to be smokers than the control
subjects since heavy consumers of alcohol may also be likely to be
smokers.
 In other words, may be high alcohol consumption has little to do with the
risk of stomach cancer independent of smoking.

28-Dec-23
Stratified analysis cont…
272 NON-SMOKERS SMOKERS
,
D+ D- D+ D-
E+ 18 20 38 E+ 44 15 59
E- 42 80 122 E- 26 15 41
60 100 160 70 30 100
OR = (18 / 42) / (20 / 80) OR = (44 / 26) / (15 / 15)

OR = 1.71 OR = 1.69

Is there evidence that smoking confounds the relationship between alcohol consumption
and stomach cancer?

28-Dec-23
Epidemiological criteria (guidelines) for causality
273

 An association rarely reflects a causal relationship but it may.

 Criteria for causality provide a way of reaching judgements


on the likelihood of an association being causal.

28-Dec-23
Hill’s Criteria for Causal Relation or JUDGMENT OF CAUSALITY
/Brand – hill Criteria/
274

1. Strength of the association


 Refers to RR: the larger the RR, the greater the likelihood that the factor is
causally related to the outcome
2. Dose-response relationship
 risk of disease increases with increasing exposure with the causal agent
3. Consistency of the relationship
 This criterion requires that an association uncovered in one study persist on
testing under other circumstances, with other study population, and with
different study methods
4. Temporal relationship
 exposure to the suspected factor must antedate the onset of
disease
28-Dec-23
Hill’s Criteria for Causal Relation ….
275

5. Specificity of the association


 the association is more likely causal if a single exposure is linked to a single disease
6. Biological plausibility (coherence with existing information)
 Additional support for the causal nature of an association exists if a causal
interpretation is plausible in terms of current knowledge about the factor & dx
7. Prevention
 If the exposure is a cause of the disease, then eliminating the exposure
(or modifying host response to the exposure, for example through
immunization ) should be followed by a decrease in the incidence rate
of the disease

28-Dec-23
Judging the causal basis of the association
276

 No single study is sufficient for causal inference


 It is always necessary to consider multiple alternate
explanations before making conclusions about the causal
relationship between any two items under investigation.
 Causal inference is not a simple process
 consider weight of evidence
 requires judgment and interpretation

28-Dec-23
277

Screening and outbreak investigation

28-Dec-23
SCREENING IN DISEASE CONTROL
278

Definition:-
 Screening is a public health intervention intended to improve the
health of a precisely defined target population.
 The presumptive identification of unrecognized disease by
application of rapid tests or examinations.
 The early detection of disease
 Precursors of disease
 Susceptibility to disease in individuals who do not show any
signs of disease

28-Dec-23
Definition…
279

 Detecting disease or risk factors in asymptomatic individuals


 The examination of asymptomatic people in order to classify
them as likely or unlikely to have the diseases of interest.
 Diagnosis is not equal to Screening

 Screening sort out apparently well persons who


probably have a disease from those probably do not.

28-Dec-23
280

28-Dec-23
Main Aim of Screening
281

 To reverse, halt, or slow the progression of disease more


effectively than would probably normally happen.

 To alter the natural course of disease for a better outcome for


individuals affected.
 Reduce morbidity and mortality through early detection and
treatment

28-Dec-23
Why might we screen?
282

 To reduce morbidity and mortality


 To protect the general public
 To protect an institution
 To make identification of cases in epidemiological studies
 To prevent or delay occurrence of disease or improve its prognosis
 To prevent transmission of disease
 To determine the frequency or natural history of health related
condition
 Examples : - by x-ray, cytology, BP, serologic tests

28-Dec-23
Screening…..
283

 Screening is only useful for disease which can be detected in their


early, pre-clinical stage, and for which early treatment significantly
improves the outcome

 Screening can also be of useful for the communicable disease


control, such as trachoma, Schistosomiasis, or TB, for which early
treatment helps to prevent transmission

28-Dec-23
Criteria for establishing screening program
284

1. The condition should be an important health problem (Life-


threatening diseases)

2. There should be a treatment for the condition.

3. Facilities for diagnosis and treatment should be available.

4. There should be a latent stage of the disease.

5. A suitable screening test must be available

28-Dec-23
Types of screening
285

Selective Vs Mass.
– Selective – screening of people with selective exposure
– Mass – screening of people without reference to specific
exposure
• Single Vs Multiple
• Multiple-Parallel Vs Series
– Parallel testing – applying two screening tests and a positive
result on either test is sufficient to be labeled as positive E.g. –
Breast ca screening
– Series testing – applying two screening tests and both must
be positive in order to prompt action
E.g. – HIV testing, Syphilis

28-Dec-23
Modified Wilson criteria for introducing a screening program
286

1. The disease condition


 Important health condition (prevalent, serious)
 Has early stage
 Highprevalence at asymptomatic stage
 Adequately understood natural history

2. The test
 Simple, precise, validated
 Acceptable to population
 Agreed diagnostic test(s)
 Available, adequate, effective and acceptable
 Sensitive, specific, reliable, simple, cheap, safe
28-Dec-23
Modified Wilson criteria, cont..
287

3. The treatment
 Effectivetreatment Available, adequate, and
acceptable
 Evidence based policies on whom to treat

4. The program
 Acceptable to public and professionals
 Benefits outweigh risks

 Available facilities and staff

 Overall costs assessed

28-Dec-23
Characteristics to be evaluated
288

 These characteristics are:


1. Validity
2. Predictive value
3. Reliability
4. Yield
1. Validity is analogous to accuracy
 The validity of a screening test is how well the given screening
test reflects another test of known greater accuracy
 Validity assumes that there is a gold standard to which a test
can be compared
 Validity- does it truly measure what it sets out to measure?
 Variability/reliability -does it gives the same measurement each time
28-Dec-23
Characteristics of a screening test
289

Validity of a categorical test


Definitive Diagnosis(Gold Standard)
Diseased Non diseased Total
Positive True Positive False Positive TP + FP
(TP) (FP)
Test
result Negative False True Negative TN + FN
negative (TN)
(FN)

Total TP + FN FP + TN TP +FP +
TN + FN
28-Dec-23
Screening…,
290

 Sensitivity (detection rate) =a/a+c =(Tp/Tp+Fn)X100


 Proportion of true positive with diseases
 Specificity=d/d+b=(Tn/Tn+Fp)X100
 Proportion of true negatives identified
Predictive value of a test
 Predictive value positive= PVPT=(a/a+b) X100
 Proportion of screening test positives who are truly positive
 Predictive value negative=PVNT=(d/d+c)X100
 Proportion of screening test negatives who are truly negative

28-Dec-23
Screening Test Trade-offs
291

Sensitivity and specificity are affected by the ‘cut-off’ value of measure at


which a test is defined as positive.
28-Dec-23
Yield
292

 The number of cases of the condition detected by screening


test in relation to the total number of persons screened
Tp
Yeild  100%
Tn  Tp  Fn  Fp

 Affected by sensitivity, prevalence of unrecognized cases,


number of tests employed, frequency of screening and
participation of people in screening and follow-up

persons with the dx detected by the test


Yeild  100%
Total screened
28-Dec-23
,
Yields of screening test
293

Reference test

positive negative total

+ve 1555 988 2543


Screening test
-ve 514 1394 1908

T 2069 2382 4451

28-Dec-23
Example…,
294

Sensitivity =1555/2069 =75.2%

Specificity=1394/2382 =58.5%

PVPT=1555/2543 = 61.1%

PVNT=1394/1908 =_____

Yield=1555/4451=______

28-Dec-23
Validity…
295

 Ideally a screening test is expected to be 100% sensitive and


100% specific.
 In practice this doesn’t occur, rather sensitivity and specificity are
inversely related
 Values depend on cutoff point; can gain one at expense of other

28-Dec-23
Validity…
296

 Optimal cutoff depends on relative costs of false positives and


false negatives
 Validity is also affected by host factors like stage of the
condition and concomitant presence of other conditions
 Not affected by prevalence, if severity is constant
 Not directly useful to clinician

28-Dec-23
RELIABILITY
297

 The ability of a test to give consistent results when it is


performed more than once on the same individual under the
similar conditions

 Affected by variation in the method, observer and the


characteristic to be measured

28-Dec-23
298

 The reliability of a dichotomous test can be


described using a 2×2 table in which the first and
second test results are presented on the left-hand
side and top of the table, respectively.

28-Dec-23
299

Second test

positive negative total


tests agree tests disagree
+ve
First test
tests disagree tests agree
-ve

28-Dec-23
300

 A simple way to summarize these findings is to calculate


the proportion of tests that agree:
 Percent agreement = Number of tests that agree
Total number of tests
 Percent agreement = a+d *100%
n
 However, test agreement due to chance alone is
possible, even with an imprecise test.
 The Kappa statistic is used to describe test agreement
beyond that expected from chance alone.
 Calculation of the Kappa statistic is presented below.

28-Dec-23
301

28-Dec-23
302

 The Kappa statistic ranges from +1 (perfect


agreement), to 0 (no agreement beyond that expected
from chance), to −1 (perfect disagreement).
 In general, a Kappa statistic <0.2 is considered poor
agreement, 0.2 – 0.6 is considered fair agreement, and
> 0.6 is considered good agreement.
 A common application of the Kappa statistic is to
measure agreement between two different testers who
evaluate a subjective test characteristic

28-Dec-23
Example
303

Second test

positive negative total


5 3
+ve 8
First test
2 30
-ve 32

T 7 33 40

28-Dec-23
PREDICTIVE VALUE
304

 The ability of the test results to predict the presence or absence


of disease
 Depends on the prevalence of the disease and validity of the test
 Immediately useful to clinician: they tell us about the population
and thus the patient
 Depend upon prevalence of disease, so test must be calibrated
for each clinical setting

28-Dec-23
Risk of screening
305

 True Positives
 “labeling effect” (classified as diseased from the time of the
test forward)
 False Positives
 anxiety
 fear of future tests

 Monetary expense

 False Negatives
 delayed intervention
 disregard of early signs or symptoms which may lead to
delayed diagnosis 28-Dec-23
Potential Source of Bias in Screening
306

 Self-selection (volunteer) bias


 Lead time bias (early diagnosis)
 Length Bias (chronicity and progression)

28-Dec-23
Self-selection (volunteer) bias
307

 Implies that those accepting screening are different from those


declining it.
 Comparing populations accepting and declining for all
relevant characteristics.

28-Dec-23
Lead time bias (early diagnosis)
308

 Bias caused by picking screened cases at an early


stage of the disease, i.e., before they develop signs
and symptoms of the disease

28-Dec-23
Length Bias (chronicity and progression):
309

 Related to the variation in the speed of progression of the disease.


 Cases picked up by a screening may be less severe, and slow
progressive compared with others.
 It is very important to be aware of such a possibility in interpreting
survival gains from a screening program.

28-Dec-23
Success Factors for Screening Programs
310

 The health problem should be important enough to be worth


detecting.
 Availability of an acceptable intervention which is effective.
 Presence of a recognizable latent or early "asymptomatic" stage.
 Presence of a suitable and acceptable test.

28-Dec-23
Success Factors…
311

 The natural history of the condition should be adequately


understood.
 Presence of policy regarding when the intervention is appropriate.
 The cost of detecting the problem and its remedy should be
reasonable.
 The screening program should be ongoing, and not a "one-time"
effort.

28-Dec-23
Study Design for Evaluation of Screening
312

 Ideally experimental
 Most commonly used is cohort

28-Dec-23
OUTBREAK INVESTIGATION AND MANAGEMENT
313

 Objectives
 Types of epidemics
 Steps of epidemic Investigation
 Epidemic control mechanisms
 Contents
 Patterns of disease occurrence
 Types of epidemics
 Investigation and control of epidemics

28-Dec-23
Patterns of disease occurrence
314

 Endemic- usual level of morbidity


 An endemic disease is a disease that occurs in a population with
predictable regularity and with only minor deviations from its
expected frequency of occurrence
E.g. - Tb, Malaria, Typhoid, dysentery, HIV, Malnutrition, Meningitis,
leshmaniasis, Trachoma, Scabies, Schistosomiasis, Onchocerciasis in
Ethiopia
 Patterns of endemicity
 Additional terms can be used to describe endemic diseases
according to their frequency of occurrence:
E.g. – Malaria – Holoendemic, Hyperendemic, Mesoendemic,
Hypoendemic

28-Dec-23
Patterns of disease…,
315

 Hyperendemic is an endemic disease that affects a high


proportion of the population at risk

 Holoendemic-situation in which there is high level of infection


among child population beginning early in life and adults show
less incidence e.g. malaria

 Mesoendemic is an endemic disease that affects a moderate


proportion of the population at risk.

 Hypoendemic is an endemic disease that affects a small proportion


of the population at risk.
28-Dec-23
Epidemic
316

 Definition - occurrence of health related condition in excess


of its expected frequency in a given population
 Health related condition-infectious and non-infectious conditions
 Expected frequency-magnitude for the given period, place and
population from previous data
E.g. - Malaria, Measles, Meningitis, Cholera , Shigelloses, Diarrhea
with dehydration, Plague, Typhoid fever, Relapsing fever, Epidemic
typhus
 Pandemic- global epidemic
E.g. - HIV/AIDS

28-Dec-23
Epidemics can have the following patterns
317

 Sporadic-irregular intervals E.g. – Plague


 Periodic/Cyclic-regular intervals E.g. –measles, diarrhea,
 Secular-slow changes over time E.g. – lung ca
 Epidemic lasting long may remain endemic
 Endemic disease can turn out to be epidemic
 Due to increase in susceptible, ecological changes,
increase in carries, new strains

28-Dec-23
Epidemics…,
318

 Outbreak: is an epidemic of shorter duration covering a limited


area.
 It is usually used interchangeably with Epidemic.

E.g. Outbreak of gastroenteritis after sharing a common meal at


an event
 Cluster: is an unusual aggregation of health events in a given

area over a particular period.


 The emphasis in case of a cluster is aggregation in a certain locality
than the actual number of cases.

28-Dec-23
Types of epidemic
319

 Two principal types are well known; these are the common source
and propagated/progressive

 The two types can be distinguished by plotting an epidemic


curve/time curve/

 An epidemic, which shows the features of both types, is referred


as mixed

28-Dec-23
Common source epidemic
320

 Caused by exposure of a group of people to a common


noxious influence, such as an infectious agent or a toxin.
 Depending on duration of exposure:
 Point source Vs Common source with continued exposure
 If the exposure to agent and simultaneous all with develop the
disease within one incubation period referred as point source
epidemic.
 Rapid rise and fall of an epidemic curve suggests a point source
epidemic called long normal distribution.

28-Dec-23
Types of epidemics cont…,
321

• Point source epidemics


– Exposure is brief and simultaneous
– Cases develop within one incubation period
– E.g. - food-borne outbreak
– Epidemic curve-rapid rise and fall of number of
cases

28-Dec-23
Common source…..
322

 Continuous common source epidemic mainly wide peak in the


epidemic curve, because of the range of exposures and range
of incubation periods.

 Intermittent common source-results in particular patterns of the


epidemic curve that reflects the intermittent nature of the
epidemic.

28-Dec-23
Types of epidemics cont.
323

• Common source epidemic with continuous or intermittent exposure


.
– Exposure continues over a period of time
– Lasts for more than one incubation period
– E.g. – Outbreak of hepatitis A from exposure to food handler intermittently or
continuously
– Epidemic curve-extended and irregular

28-Dec-23
Propagated/progressive epidemics
324

 Outbreak of this type can occur through direct person-to-person


transmission
 or the transmission could pass through a vector from infected to
healthy person.

 The epidemic curve would have a successive series of peaks


reflecting increasing numbers of cases in each generation.

28-Dec-23
Types of epidemics cont,
325

• Propagated/Progressive epidemics
• Occur as a result of transmission from person to person
• Lasts for more than one incubation period
• E.g. – Measles, Malaria, Shigellosis
• Epidemic curve-initial slow rise, succession of several peaks and usually sharp fall

28-Dec-23
Types of epidemics cont,
326

• Mixed
– Point source epidemic may be followed by
propagated epidemic
– E.g. – Shigelloses epidemic following exposure to
common contaminated food supply followed by
person-to-person spread

28-Dec-23
MIXED EPIDEMIC
327

Time
Intermittent common
Source- no clear pattern, may be a mixture of the two( e.g.
common source=>second day=>person to person spread

28-Dec-23
INVESTIGATION AND CONTROL OF OUTBREAK
328

Why do we investigate outbreaks?


1. Control and prevention measures
2. Evaluation of control programs e.g. EPI
3. Opportunity for research
4. Training opportunity
5. Public, political or legal concern

28-Dec-23
Epidemic investigation
329

 Epidemic investigations: study of outbreaks, in local


populations, to identify agent(s), transmission mode(s), and
possible control measure(s)
 Investigation-determining the causes so as to control
the epidemic
 Causes:
– Agent
– Source
– Mode of transmission
– Contributing factors

28-Dec-23
Steps in epidemic investigation
330

1. Prepare for fieldwork


A. Investigation related preparation
 Specific knowledge
 Supplies and equipment
 Literature review

B. Administration related
 Observe all administrative procedures such as transportation
and personal.
C. Consultation
 Clarify your and your team role in the field.
 Identify local contacts at the site.

28-Dec-23
steps…,
331

2. Verify the existence of an epidemic


 Verify the diagnosis

Case definition
 Is a standard set of criteria for deciding whether an individual
should be classified as having the health condition of the interest.
Types of the case definition:-
 Confirmed/definite-a case with lab. Verification.
 Probable –a case with typical clinical features of the disease without
lab. Confirmation.
 Possible-a case presented with fewer of the typical clinical features

28-Dec-23
Step-2…,
332
- Compare expected cases vs. observed
- Excess cases may be actual/real or artifactual
 Actual:
 Change in incidence
 Change in age composition
 Catastrophes

 Duration of illness

 Artifactual:
 Change in diagnostic methods
 Change in case detection
 Change in reporting
 Change in disease classification/ death
 Change in population count
28-Dec-23
steps….
333

3. Describe the epidemic with respect to time, place and


person.
 Epidemic curve-plots the cases by the time of onset and
provides a time frame for the outbreak investigation.
 Spot map-plots cases by location and shows the geographic
spreads of cases.
 Attack rates-calculate rates of illness in population at risk.

28-Dec-23
Steps…,
334

4. Formulate and test hypothesis


 Formulate hypothesis based on your characterization of

the epidemic by time, place and person


 The hypothesis should address:-
 The source of the agent
 The mode of transmission
 The exposure that cause the disease
 Determine the type of epidemic
 Define the population at risk

28-Dec-23
Steps….
335

5. Search for additional case.


- Epidemiological – case control (healthy individuals from same population)
- Laboratory analysis
- Medical examination
6. Do descriptive epidemiology and describe the
epidemic by PPT and do data analysis
7. Make a decision on the hypothesis tested
8. Intervention and follow up.
9. Report of the investigation/communicating finding

28-Dec-23
MANAGING OUTBREAK/EPIDEMIC
336
 Measures directed against the reservoir
 Domestic animals
 Immunization
 Distraction of infected animals
 Wild animals
 Post-exposure prophylaxis
 Humans
 Removal of the focus of infection.
 Isolation of infected person
 Treatment
 Disinfection of contaminated object
Quarantine –is the limitation of freedom of movement of
apparently healthy persons or animals who have been
exposing to a case of infectious diseases
28-Dec-23
MANAGING OUTBREAK/EPIDEMIC…,
337

 Measures that interrupt the transmission of organisms.


 Purification of water.
 Pasteurilization of milk.
 Inspection procedures designed to ensure safe food supply
 Improve housing condition

 Measures that reduce host susceptibility.


 Active immunization
 Passive immunization
 Chemoprophylaxis

28-Dec-23
338

28-Dec-23

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