Introduction to Epidemiology

Dr. Sam Marconi MD DTM&H

After completing this session, you should be able to:

explain what epidemiology is and understand the concept of population in

epidemiology

explain the difference between descriptive and analytic studies, and between
observational and interventional epidemiology

understand the importance of epidemiology to public health practice

What is Epidemiology?
"The study of the occurrence and distribution of health-related events,
states, and processes in specified populations, including the study of
the determinants influencing such processes, and the application of
this knowledge to control

Epidemiologist are always interested in:

Measures of Frequency (prevalence and incidence)
Measures of Effect (ratios)
Measures of Impact (population attributable risk)

Population
- meaning,
what is the population from which the cases arose?

In epidemiology, we define our population as the collection of units

from which our sample is drawn. This could be people, institutions or
events.

In demography, we use the term 'population' to mean the inhabitants

of a particular country or area.
What is Epidemiology?
Greek word epidemos - epi meaning "upon" and demos meaning "people".

Hippocrates (born around 460 BC) - epidemeion to refer to diseases that visit
the community, meaning they occurred from time to time, in contrast
to endemeion, diseases which resided within the community.

The earliest use of the word "epidemiology" was probably in Spain: in 1598, a
book about plague called Epidemiologa was already in its second edition.

The first documented appearance of the English form of the word was in 1850
when the London Epidemiological Society was formed.

Fundamental of Epidemiology
The fundamental things we need to know about a disease in a population
are who, where, and when.

Person, place and time

For example, in describing HIV infection in Uganda,

"The prevalence of HIV infection among young women aged 15-24 in Uganda in
2014 was estimated at 3.7%"
 Fundamental of Epidemiology
Comparison is fundamental of epidemiology
By examining the differences between those people within a particular
population who have a disease and those who do not, we can improve
our understanding of the determinants of a disease.

.
Obstetrician Ignaz Semmelweis

Puerperal fever

Major differences in maternal mortality from puerperal

fever between two clinics within one hospital

The clinic with high mortality was used to train medical

students, and the clinic with the lower mortality was
used to train midwives.

Medical students performed genital examinations far

more often than midwives

Hand-washing was not routine

Students' unwashed hands transmitted infection from

woman to woman.
William Farr (father of Modern Statistics)

Registrar General's office for

England and Wales

Routine collection of data on the

number and causes of deaths and
other vital statistics

Farr used his data to compare the

mortality rates among different
populations

For example, he compared mortality rates

among people of different occupations
Historical Evolution of Epidemiology

During the 19th century, Cholera periodically

swept across Europe

In 1848-9 there was a severe cholera

epidemic in London, with 15,000 recorded
deaths

? the existence of microbes was hotly

contested

Historical evolution of Epidemiology

Drinking water was supplied to houses by private companies

Toilets were widely introduced in London between 1830 and 1850: main sewers were
introduced in the 1840s

The sewers emptied into the River Thames

During the epidemic, mortality from cholera was particularly high in the
districts supplied by two particular water companies, the Southwark & Vauxhall, and the
Lambeth companies.
Historical evolution of Epidemiology
The green area was served by
the Southwark and Vauxhall
company

the pink area by the Lambeth

company

the grey area in between is

where the two companies' pipes
were intermingled.

Historical evolution of Epidemiology

William Farr

He noticed that some areas of London

had far more cholera deaths than others

He found that there were more deaths

from cholera in the lower areas near the
river

caused by breathing unclean air at lower

altitudes.
Historical evolution of Epidemiology
There was no further cholera in London until 1853

The Lambeth company moved its source - the Thames upstream

of London (and thus uncontaminated by London sewage)

The Southwark and Vauxhall company - Thames in London

Historical evolution of Epidemiology

Cholera reappeared in London in June 1853

John Snow

The addresses of people who died of cholera in the

districts which received water supplies from both the
Southwark and Vauxhall and the Lambeth companies

Made home visits to know the company

Formulated a table
Historical evolution of Epidemiology
Source of Water No. of Deaths
Southwark & Vauxhall 286
Lambeth Company 14
Direct from river 22
Pumpwells 4
Ditches 4
Unknown 4

On the basis of these figures, which company is more likely to be transmitting "morbid matter"
causing cholera?

Historical evolution of Epidemiology

He managed to get information from 330 out of the 334
households

"shoe-leather epidemiology

Snow obtained information on the number of houses in London whose

water was supplied by each of the two water companies

No. of people died of cholera from 8th July to 26th August 1854
Historical evolution of Epidemiology
He obtained information on the numerator (the number of cholera
deaths) and the denominator (the number of people supplied with water)
Total Number
Source of No. Cholera
Houses
Water Deaths
He then went on to compare the death rates from cholera in the two Supplied
areas
Southwark 40,046 1263
He used this information to calculate how much more risky Southwark and Vauxhall
and Vauxhall water was compared to Lambeth water
Lambeth 26,107 98

Association between water source and the risk of death from cholera Other 256,423 1422

Analytical epidemiology - attempt to explain differences in patterns of

disease by examining associations, and identifying possible causes of
the disease

Exposures and Outcomes

The two key elements

The exposure (sometimes called risk factor or determinant) is any factor that may influence the outcome

The outcome is the disease, or event, or health-related state, that we are interested in
Exposures and Outcome
The outcome can be any health-related event or state - or it can be a risk factor for, or a
precursor to, a disease

Example
the effect of cigarette smoking on lung cancer

the effect of cigarette advertising on smoking

Observational Epidemiology

Observational epidemiology in which we describe patterns of health and

disease of a population, without doing anything to change the factors
which influence them

Observational epidemiology includes both descriptive and analytical

studies.
Observational Epidemiology
There may be more than one possible risk factor for an outcome

Factors may be related to each other confusion

Unless we take this problem into account, we cannot be sure that an association
observed between an exposure and an outcome is genuine, and not the consequence of
a third factor.
For example, William Farr found an association between elevation above sea level and the risk
of death from cholera

So the apparent association between elevation above sea level and cholera was in fact caused
by differences in water supply

Hall of Fame
James Lind

He was a physician in the early 18th

century

Scurvy was a major problem among

sailors on long sea voyages

cause not known

Bad air, congenital laziness and

indigestible food were all suggested
as possible causes
Interventional Epidemiology
Sailors' diet consisting of biscuits and
salted fish or meat

In 1747 he conducted an experiment at

sea with 12 patients suffering from scurvy

Lind divided the patients into six groups of

two

All received the same basic diet, in

addition to which he assigned different
supplements to each group over a six day
period.

Interventional Epidemiology
Interventional epidemiology (also known as experimental epidemiology)

Divided the population into groups and allocated different treatments to each

Allocated a specific exposure (type of food supplement) to each group and then observed
the outcome (whether or not scurvy improved)

Comparison or "control" groups of patients

Compare the outcome in those who received the intervention to those who did not
Interventional Epidemiology
Randomised trials

Participants are randomly assigned to receive the intervention or an alternative, either

a placebo or the standard treatment for the condition in question, which acts as a control

Randomised controlled trials were first used in the 1950s - effect of streptomycin in the
treatment of tuberculosis

Interventional Epidemiology
Quasi-experimental study

For example, a comparison of the incidence of measles before and after the introduction
of measles vaccine would be a quasi-experimental study
What is the role of epidemiology?
Epidemiology has four major functions:

to describe patterns of health and disease within populations

to interpret these differences

to apply our results to public health practice, and

to evaluate the effect of health-related interventions

What is the role of epidemiology?

Describe : the differences in the distribution of health and
disease within and between populations

Descriptive epidemiology

For example, we might use descriptive epidemiology

1. To examine how the birth-weight of babies has changed in a particular

country over the last 50 years

2. To describe differences in the prevalence of hypertension between men

and women

3. To compare the incidence of tuberculosis in different countries.

What is the role of Epidemiology?
Interpret the differences

Analytical epidemiology

Here we ask the question "does the

pattern of exposure to certain risk factors
among individuals with or without a
specific disease help us to work out the
cause of the disease?"

For example, compare maps of the global prevalence of hepatitis B infection and of the incidence of
primary liver cancer.

Notice the similarity in the distribution of the high risk areas, suggesting that the two diseases are
associated.

Hepatitis B infection Primary Liver Cancer

What is the role of Epidemiology?
Apply our results

Evaluate the effectiveness of interventions and strategies of health-care delivery

With observational epidemiology, we can assess the impact of health services on

the health of a community
With interventional epidemiology, we can assess the effect of a specific health
intervention.
For example, we can use individually-randomised controlled trials to compare a new treatment with
an established one

Randomise at the level of the community rather than the individual

For example, in a study in Tanzania to investigate the effect of improved services for treatment
of STIs on the incidence of HIV infection, communities rather than individuals were randomised

So in this case, a number of suitable villages were selected, and then each village (with all its
inhabitants) was randomised to receive either improved STD services or the usual services

Challenges in Epidemiology
Do not make these comparisons in a highly-controlled environment, such as a laboratory

In a real life situation, compare exposures and outcomes in situations where there may be
many sources of confusion and error

Epidemiology understand how such mistakes may arise and to know how to minimise
them
Challenges in Epidemiology

Epidemiologists too narrow a focus

"who, where and when"?

Identify and measure risk factors for a particular outcome,

but social context of those risk factors are ignored

"and in what social context

Epidemiological findings about risk factors are not

translated into effective disease prevention

These social contexts may vary from one population to

another, and this may need to be taken into account in
developing strategies to control disease.

At the end of August 1854 -severe outbreak

of cholera in Soho, nearer the centre of
London

616 fatal cases which had their onset

between 19 August and 30 September 1854
John Snow also observed that:
None of the workers at the Broad
Street brewery had cholera

An elderly lady and her niece in West

Hampstead liked the taste of Broad Broad street
Street water, so they had a bottle
brought to them every day from the
pump. They both died of cholera

Broad Street pump

He persuaded the local authorities

to remove the pump handle on the
8th September 1854.

Broad street pump

John Snow had the pump
handle removed on 8th
September 1854.

His observations and deductions led him to clear descriptions

and valid theories about the nature and the mode of
communication of cholera

He applied his findings with a control intervention, and went on

to make recommendations for prevention
John Snow formulated an hypothesis on the nature and mode of communication of
cholera:

that cholera can be communicated from the sick to the healthy

that disease is communicated by "morbid matter" which has the property of multiplying in the
body of the person it attacks

that the morbid matter producing cholera must be introduced into the alimentary canal

water supplies appeared to be able to disseminate the morbid matter from the sick to the
healthy

Summary
The study of the occurrence and distribution of health-related
events, states, and processes in specified populations,
including the study of the determinants influencing such
processes, and the application of this knowledge to control
relevant health problems
Thank you!

Types of epidemiological Investigations

 Overview of approach to causation and
epidemiological study designs

Objectives of Epidemiology
To identify the etiology or cause of a disease and the risk factors

To determine the extent of a disease in the community

To study the natural history and prognosis of a disease

Need for epidemiological studies

To evaluation both existing and new preventive and therapeutic measures.

Evaluation of diagnostic and screening tests

Evaluation of Health programme

Theories of disease causation

Older theories

Examples

Religious concepts of disease

Ayurvedha : “Tridoshas”

Four humours theory of Greek Medicine

Chinese medicine

Germ theory of diseases

Louis Pasteur, presence of bacteria in air in 1860.

Robert Koch – anthrax caused by bacteria, Koch’s postulates.

One to one relationship between causal agent and disease.

Disease agent → Man → Disease

The cause must be :

a. necessary, and

b. sufficient for the occurrence of disease before it can qualify as cause of disease.

Limitations of Koch’s postulates:

Most diseases are dose related, subclinical and without symptoms.

If the organisms enter into our body, but in small quantities, we may not get disease

Not taking into account multifactorial causation, environmental and host factors.
Multifactorial Causation

Pettenkofer of Munich ( 1819-1901)

Disease is due to multiple factors.

Eg : tuberculosis, coronary heart disease , cancer.

Prioritize various factors to ameliorate or modify to prevent or control disease.

Web of causation
 MacMahon and Pugh, “Epidemiologic principles and Methods”
 Chronic disease: agent not known, but is the outcome of interaction of multiple
factors.
 Considers all predisposing factors and their complex interrelationship.
 Removal or elimination of just only one link or chain sufficient to control disease
provided link is sufficiently important in pathogenic process.

Association and causation

Descriptive studies → suggest aetiological hypothesis

Analytical studies → test hypothesis

Association

Defined as the concurrence of two variables more often than would be expected by chance
i.e they occur more frequently together than one would expect by chance.
Does not necessarily imply causation
  Spurious association

 Indirect association

 Direct (causal) association

o One-to-one causal association

o Multifactorial causation

Spurious association
 An observed association between a disease and suspected factor may not be real

 A study in UK of 5174 births at home and 11,156 births in hospitals showed

perinatal mortality rates of 5.4 per 1000 in the home births, and 27 .8 per 1000 in the
hospital births.*

 Hospitals attract women at high risk for delivery ; differences in age, parity, prenatal
care, general health and disease state between the study and control groups

 "like" is not compared with "like“ (selection bias) →a spurious association or an

association when none actually existed

 *Moses, LE. et al (1984). Annual Rev. P.H., 5:267-92.

Indirect association
The indirect association is a statistical association between a characteristic (or
variable) of interest and a disease due to the presence of another factor, known or unknown,
that is common to both the characteristic and the disease.

This third factor (i.e., the common factor) is also known as the "confounding"
variable. Since it is related both to the disease and to the variable, it might explain the
statistical association between disease and a characteristic wholly or in part.
Sometimes knowledge of indirect associations can be applied towards reducing disease risk.
Before the discovery of the cholera vibrio, elimination of certain water supplies achieved a
marked decrease in new cases of the disease. Such indirect associations must be pursued, for
it is likely that they may provide aetiological clues.

Direct (causal) association – One to one association

Two variables are stated to be causally related (AB) if a change in A is followed by a change
in B. If it does not, then their relationship cannot be causal. This is known as "one to-one"
causal relationship. This model suggests that when the factor A is present, the disease B
must result. E.g. Measles
The proponents of the germ theory of disease insisted that the cause must be :
a. necessary, and
b. sufficient for the occurrence of disease before it can qualify as cause of disease.
But tuberculosis -not always isolated. Other risk factors are needed
One cause may lead to more than one outcome

Direct (causal) Association – Multifactorial causation

There are alternative causal factors (Factors 1, 2 and 3), each acting independently.
Eg: lung cancer where more than one aetiological factor (e.g., smoking, air pollution,
exposure to asbestos) can produce the disease independently.
The causal factors act cumulatively to produce disease. This is probably the correct model
for many diseases. It is possible that each of the several factors act independently, but when
an individual is exposed to 2 or more factors, there may be a synergistic effect.

Causal "guidelines" suggested by Sir AB Hill (1965)

1. Strength of the association
2. Consistency
3. Specificity
4. Temporality
5. Biological gradient
6. Plausibility
7. Coherence
8. Experiment
9. Analogy

Purpose: Guidelines to help determine if associations are causal

not intended for these "viewpoints" to be used as “hard and fast rules.”

1. Strength of the association

The larger the association, the more likely the exposure is causing the disease.
Example: Relative risk of lung cancer in smokers vs. non-smokers = 9; Relative risk of lung
cancer in heavy vs. non-smokers = 20

2. Consistency
The association is observed repeatedly in different persons, places, times, and
circumstances.

Example: Smoking has been associated with lung cancer in at least 29 retrospective
and 7 prospective studies.

3. Specificity
 A single exposure should cause a single disease.
There are many exceptions to this.
Example: Smoking is associated with lung cancer as well as many other diseases. In
addition, lung cancer results from smoking as well as other exposures.

4. Temporality
The causal factor must precede the disease in time.

This is the only one of Hill's criteria that everyone agrees with.

Possible to study with cohort studies

Example: A prospective cohort study of smokers and non-smokers starts with the
two groups when they are healthy and follows them to determine the occurrence of
subsequent lung cancer

5. Biological Gradient
A “dose-response” relationship between exposure and disease. Persons who have
increasingly higher exposure levels have increasingly higher risks of disease.
Example: Lung cancer death rates rise with the number of cigarettes smoked.
Some exposures might not have a "dose-response" effect but rather a "threshold
effect" below which these are no adverse outcomes.

6/7. Plausibility / Coherence

Biological or social model exists to explain the association. Association does not conflict
with current knowledge of natural history and biology of disease.
Example: Cigarettes contain many carcinogenic substances.

8. Experiment

Investigator-initiated intervention that modifies the exposure through prevention,

treatment, or removal should result in less disease.
Example: Smoking cessation programs result in lower lung cancer rates.
Provides strong evidence for causation, but most epidemiologic studies are
observational.

9. Analogy

Has a similar relationship been observed with another exposure and/ or disease?
Example: Effects of Thalidomide and Rubella on the fetus provide analogy for effects of
similar substances on the fetus.

Epidemiologic study designs

Types of Studies
A. Observational-no manipulation of study ‘exposure’ factor by the investigator
B. Experimental-study factor (intervention) is manipulated by the investigator

Observational studies
 Descriptive approach (Describes the occurrence of disease)

Time, Place & Person

 Analytic approach (Describe association between exposure and the outcome)

Find cause –How & Why

Descriptive study designs

 Case reports
 Case series
 Ecological studies (Correlational studies) –Groups
 Descriptive cross-sectional studies
Case Report

Detailed presentation of a single case.

Generally report a new or unique finding

Example:
 previous un described disease
 unexpected link between diseases
 unexpected new therapeutic effect
 adverse events
 The first statement of clinical hypothesis

Case Series

The case series design is an extension of the case report.

Experience of a group of patients with a similar diagnosis
Generally report on new/unique condition

Case Reports & Case Series

Strengths Limitations
Informative for very rare diseases Lack of an appropriate comparison group
Used as an early means to identify the Presence of any association may be purely
beginning or presence of an epidemic coincidental

Ecologic Studies

Represent characteristics of entire populations

Used to describe disease
Compares exposure rates and disease rates among different groups.
 Limitations:

•Cannot link exposure-disease relationship at the individual level

Strengths:

•Cheap, quick, and simple (generally make use of secondary data)

Analytical Cross-Sectional Studies

Snapshot of the health status of populations at a certain point in time

For each subject, exposure and disease outcome are assessed simultaneously

Also called as “prevalence study”

Compare prevalence of disease in persons with and without the exposure of interest
Examples of case control studies

 Investigation of an outbreak (cholera)

 Investigate the risk factors for a rare disease (Scrub Typhus)
 Find association between tobacco use and oral cancer (Long latent period)
Experimental Studies

 akin to laboratory experiments except Human beings are the subjects

 “Gold standard” of research designs
 Evaluate new interventions
 Investigator “controls” the “exposure”
 generally involves random assignment to Treatment and control groups
Field trials(Preventive trials)

 Field trials, involve people who are healthy.

 data collection takes place usually among non-hospitalized people in the general
population.
 Field trials can be used to evaluate interventions aimed at reducing exposure.
 E.x –Vaccine trials

Community trials

 The treatment groups are communities rather than individuals.

 This is particularly appropriate for diseases that are influenced by social conditions
 For which prevention efforts target group behaviour.
 E.x –Smoking cessation programme

Problems inherent in designs

 Each study design has its own strengths and limits

 Each study design type has associated problems that can distort your conclusions and
lead you astray!

 E.x – loss to follow up

Getting control group
Ethical issues

How do I choose a study type?

 There is no clear-cut answer to which study design to use.

 Often two or more designs are possible
 "how much time and money do I have?" and "which study will give better results?"
help to make the choice.
 The ability to choose a useful study design is an art.

References

Parks Textbook of Preventive and Social Medicine

Gordis Epidemiology –6thedition

 Epidemiologic approach to Diseases

Levels of Prevention Dr.Prashanth

•HEALTH ?
•DISEASE?

Health—WHO
•"Health is a state of complete physical, mental and social well-being and not merely the
absence of disease or infirmity."

DISEASE= Dis…Ease

“An abnormal state in which part or all of the body is not properly adjusted or incapable of
performing its normal function”
•Pathology –the scientific study of disease
•1-Etiology –cause of disease
•Etiologic agent –virus, fungi, bacteria, protozoa
•2-Pathogenesis –the manner in which a disease develops

1
Definitions

•Infection –the invasion or colonization of the body by a pathogenic microorganism

•May exist in absence of disease
•Pathogen –disease causing microorganism
•Disease –occurs when an infection results in any change from a state of health

•Disease — physiological or psychological dysfunction

•Illness — subjective state of the person who feels aware of not being well.
•Sickness — state of social dysfunction, i.e. a role individual assumes when ill.

2
Microbiota

•In utero free of microorganisms

•Vaginal lactobacilli proliferate prior to parturition

•Lactobacilli colonize and predominate intestine of newborn

•More bacteria introduced with breathing and feeding start

•E. coli colonize lower intestine
•Other microorganisms
•Normal microbiota (Normal flora) –microorganisms that establish more or less permanent
residence (colonizes) but that do not produce disease under normal conditions
•1 X 10 14 bacterial cells in body
•Transient microbiota –may be present for several days or months and disappear

Locations of microbiota
• Eyes

• Nose and throat

• Mouth

• Skin

• Large intestine

• Urinary and genital systems

• Vagina
• Urethra

3
Microbial Antagonism
•Microbial antagonism –normal microbiota can benefit the host by preventing the
overgrowth of harmful microorganisms
•Competition among microorganisms
•Nutrients
•Producing substance harmful to invading bacteria
•Altering pH and available oxygen
•Examples
•Vagina
•Normal flora maintain pH of 3.5 –4.5
•Inhibits growth of Candida albicans
•Antibiotics, excessive douching pH rises to neutral
•Candida albicans overgrowth causes vaginitis (yeast)
•Mouth
•Streptococci produce compounds that prevent growth of g+ and g-cocci
•Large intestine
•E. coliproduce bacterocins
•Proteins inhibit growth of other bacteria
•Inhibits Shigella and Salmonella

Definitions
• Symbiosis
•Two organisms that live together
•Microbiota and host

• Commensalism
•A symbiotic relationship between two organisms
•One organism benefits (microbiota)
•One organism is unaffected

4
 • Mutualism
•A symbiotic relationship between two organisms
•Both organisms benefit from relationship
•E. coli in large intestine
•Synthesize B and K vitamins (host benefits)
•Supply nutrients to normal flora (flora benefits)

Parasitism
•A symbiotic relationship between two organisms

•One organism benefits (tapeworm, bacteria, etc)

•One organism is harmed (host)

•Opportunists(Opportunistic pathogens)

•Under proper conditions mutualistic organisms may become pathogens

•E. coli in large intestine relatively harmless

•E. coliin other parts causes disease

•Urinary bladder –cystitis, CSF -meningitis

Opportunistic Pathogen
•Examples
• Staphylococcus aureus normal inhabitant of skin
•Cut or wound allow bacteria to cause disease
•Abscess
•Immunocompromised individuals
• Pneumocystis jiroveci pnuemonia

5
Concept Of Causation
Germ theory of Disease

Disease agent-Man –Disease

Epidemiological triad

Agent-Host-Environment

Multifactorial Causation -Pettenkofer

Web of Causation-MacMohanand Pugh

Koch’s Postulates
•Koch

•German physician

•Late 1800’s

•Worked with anthrax

•Developed a framework for studying the etiology of infectious diseases

Koch’s Postulates

1. The same pathogen must be

present in every case of the disease
2. The pathogen must be isolated
from the diseased host and grown in pure
culture

3. The pathogen from the pure

culture must cause the disease when it is
inoculated into a healthy, susceptible
laboratory animal.

4. The pathogen must be isolated

from the inoculated animal and must be
shown to be the original organism

6
Exceptions to Koch’s Postulates

•Microbes that have unique culture requirements

•Treponema pallidum–syphilis

•Virulent strains never grown cultured on artificial media

•Mycobacterium leprae–leprosy

•Never grown on artificial media

•Rickettsial and viral pathogen

•Require living cells to multiply

•Modification or alteration of postulates

•Legionellosis (Legionnaire’s disease)

•Unable to identify organism directly from victims

•Infected lung tissue inoculated into guinea pigs

•Tissue of diseased guinea pigs cultured in yolk sacs of embryos

•EM showed rod –shaped bacteria

•Legionella pneumophilia

•Human disease have no other host than humans

• HIV

• Ethical questions

• Should humans be intentionally inoculated with infectious agents.

• King George I

•Smallpox

7
An external agent can cause diseases on a susceptible host when there is a conducive
environment.

Agent
1. Biological-Viruses, Bacteria, Protozoa

2. Nutrient-PEM, Anaemia, goiter,

3. Physical-Heat, cold, radiation, sound,

4. Chemical — a) endogenous-urea, bilirubin, b) exogenous-dust, insecticides

5. Mechanical — chronic Friction, crush, tear

6. Social-poverty, drug abuse, social isolation

Host Factors — Intrinsic

•Human host is referred to as “soil” and the disease agent as “seed”

•Demographic — age, sex, ethnicity

•Biological-genetic, levels in blood, B.P,

•Social and Economic — SES,

Education, occupation

•Life style factors-personality traits,

habits, exercise

8
Environmental Factors-Extrinsic
•Physical — air, water, soil, housing, climate, radiation, noise, heat, light…..

•Biological — insects, rodents, microbial agents, animals, deforestation

•Psychosocial — cultural values, customs, religion, migration, bereavement

Definitions Associated with Diseases

•Symptoms – changes in body functions, that are subjective and not apparent to an observer
•Pain
•Malaise
•Signs –changes that can be measured or observed by a physician. They are objective.
•Fever
•Lesions –any change in tissue
•Signalment – overview of patient
•Age / Gender /Race
9
•Syndrome – specific group of symptoms or signs that always accompany
•Diagnosis – conclusion or classification of a type of disease
•Diagnosis is made by
•Evaluation of signs and symptoms
•Laboratory tests

Example
•Signalment
•45 year old female Caucasian
•Symptoms
•Malaise / Increased thirst
•Signs
•Blood glucose of 300 mg /dl

•Presence of ketones in urine

•Diagnosis
•Diabetes

Classifications of Disease
•Communicable disease –any disease that spreads from one host to another, either directly
or indirectly

•Chickenpox, measles, genital herpes

•Contagious disease –a disease that is easily spread from one host to another

•Chickenpox, measles, tuberculosis

•Non-communicable disease -a disease that is not spread from one host to another.

•Hypertension, Diabetes

10
Occurrence of Disease
•Incidence –number of people who develop a disease during a particular time period.

•An indicator of spread of disease

•Prevalence–number of people who have a disease, regardless of when they appeared.

•AIDS

•1999 the incidence of AIDS was 45,000

•1999 the prevalence of AIDS was 700,000

Frequency of Disease
•Sporadic disease – a disease that occurs occasionally in a population.
•Typhoid fever
•Endemic disease – a disease is constantly present in a population.
•Common cold / Rabies in skunk, bats
•Epidemic disease – a disease that acquired by many in a population over a short period of
time.
•Influenza
•Pandemic disease –an epidemic disease that occurs worldwide
• SARS, COVID

Duration of Disease
•Acute disease –a disease that develops rapidly but last only a short time.

•Influenza

•Chronic disease–a disease that develops more slowly.

•Body reactions tend to be less severe

•Disease tends to be more continual or recurrent for long periods

•Mononucleosis, Tuberculosis, Hepatitis B

11
•Subacute disease –intermediate disease between acute and chronic
•Subacute sclerosing panencephalitis
•Caused by measles virus (rubeola)
•Latent disease –causative agent of disease remains inactive for a time, then becomes active
to produce symptoms
•Chickenpox (Varicella–Zoster)

•Shingles is the latent disease

Extent of Infection
•Local infection

•Infection of a microorganism that is confined to a small region of the body

•Systemic or generalized infection

•Microorganisms are spread throughout the body via blood or lymph

•Focal infection

•After an microorganism spreads they become confined to specific areas of the body

•Teeth, tonsils, sinuses

•Bacteremia
•Presence of bacteria in the blood
•Anthrax (remember Koch)
•Sepsis
•Replication of bacteria in the blood
•Toxemia

12
 •Presence of toxins in blood
•Tetanus
•Viremia
•Presence of viral particles in blood
•HIV

Types of Infection
• Primary infection
•An acute infection that causes initial illness
• Secondary infection
•An infection caused by an opportunistic after a primary infection has weakened
defenses
•Can be more dangerous than primary infections
•Pneumocystis in AIDS patients
•Streptococcal bronchopneumonia following influenza
• Inapparent (subclinical) infection
•Infection that does not cause noticeable disease
•Polio, hepatitis A

Disease
•Predisposing Factors
•Anything that makes the body more susceptible to a disease
•Gender -cystitis

•Genetic background -Sickle cell anemia

•Climate and weather -Respiratory disease

•Inadequate nutrition

•Fatigue

•Age

• Environment

13
 •Habits, lifestyle, occupation, pre-existing illness, chemotherapy,
emotional disturbances

Development of Disease
•Progression of disease

•Incubation period

•Time between introduction of microorganism into host and first appearance

of signs

•Varies between organism

•Depends of number of microorganism and host defenses

•Can pass disease

14
Chain Of Transmission

. Prodromal period

•Early mild symptoms

•General symptoms
•Malaise
•Fever
•Between incubation and illness periods

• Period of illness

•Disease is most acute

•Exhibits signs of disease

•Fever, chills
•Muscle pain (myalgia)
•Photophobia
•Sore throat (tonsillitis)
•Swollen lymph nodes (lymphadenopathy)
•Outcomes
•Disease overcome
•Patient dies
•Reservoirs of infections
15
 • Period of decline

•Signs and symptoms begin to diminish

•Fever declines

•24 hours to days in duration

•Most susceptible to secondary infection

•Period of convalescence

•Body returns to normal state

•Can spread infection

Spread of infection
• Reservoirs of infection

• Supplies continual source of microorganism

• Adequate environment for microorganism to survive

• May be human, animal or non living

•Human reservoirs

•Carriers –those who harbor pathogens, but do not become ill or show signs of illness

•May have inapparent illness

•Symptom free stage

•AIDS, diphtheria, typhoid fever, hepatitis, gonorrhea, amoebic dysentery, and

streptococcal infections

•Animal reservoirs

•Domestic and wild

•Zoonoses

•Diseases in animals that can be transmitted to humans

•Rabies, brucellosis, ringworm, Lyme disease, plague

16
17
•Non living reservoirs
•Soil
•Clostridium tetani
•Clostridium botulinum

•Water

•Contaminated by feces

•Vibrio cholerae

•Salmonella typhi

•Food

•Improperly stored

•Trichinosis, salmonellosis

Transmission of Disease
•Three routes of transmission

•Contact transmission

•Vehicle transmission

•Vector transmission

18
• Contact transmission
1 — direct contact (person to person)

•Physical contact between source of infection and susceptible host

•Touching, kissing, sexual intercourse

•Common cold, staphylococcal infections, hepatitis B, STIs (STDs), measles, AIDS

•Gloves and universal precautions prevent spread

2 — indirect transmission

•Infectious agent transmitted from reservoir to a non-living object (fomite)

•Towels, bedding, eating utensils, money, toys, contaminated needles

•AIDS, hepatitis B

3 — droplet transmission
•Microbes discharged in mucus droplets
•Coughing, sneezing, laughing, talking
•Influenza, pneumonia, pertussis

•Vehicle transmission

1 – Water borne transmission

•Microorganisms spread through poorly or untreated sewage

•Cholera, leptospirosis, shigellosis

2 - Food borne transmission

•Poorly or undercooked foods

•Poorly stored foods

•Food poisoning

•Tapeworms

3 - Air borne transmission

•Can travel mucus droplet or duct > 1 meter

•Tuberculosis, histoplasmosis, measles

19
•Vector transmission

•A vector is an animal that carries infection from one organism to another

•Most arthropods

1- mechanical transmission

•Passive transport (i.e. feet of vector)

•Common house fly

2- biological transmission

•Active process

•Vector bites or sucks blood of infected host and ingests pathogen

•Acts as multiplier for pathogen

•Pathogen can be passed in vector stool, salivary gland

•Often involved in protozoa or helminth life cycles

•Nosocomial infection

•No evidence upon admittance to hospital, but is acquired during stay

•Also used for nursing homes and other health care facilities

•5-15 % of all hospitalized

patients (CDC)

•3 factors

•Microorganisms present
in hospital environment

•Compromised individuals

•Chain of transmission in
hospital

20
•Microorganisms in hospital environment

•Disinfection, sterilization constant in hospital

•Most are opportunistic organisms
•Staphylococcus
•E. coli
•Pseudomonas
•Enterococcus

•Compromised host

•Resistance to infection is diminished by disease, therapy, or burns

•Broken skin

•Burns, surgical wounds, trauma, injections, IV, catheters, other invasive

techniques

•Suppressed immune system

•T cells kill microbes

•Antibodies neutralize toxins, inhibiting attachment, lysing pathogens

•Drugs, radiation, chemotherapy, steroids, burns, diabetes mellitus,

malnutrition, AIDS

•Chain of Transmission
•Direct contact from staff to patient
•Patient to patient
•Indirect contact through fomites
•Catheters
•Fluids
•Needles

21
 Frequency of nosocomial infections

Control of Nosocomial infections

•Reduce number of pathogens patient is exposed to

•Aseptic technique

•Careful handling of contaminated materials

•Frequent hand washing

•31%
•Disinfect tubs, respirators

•Single use intubation tubes, bandages, instruments

•Avoiding invasive procedures

•Minimize immunosuppressive drugs

•Avoid overuse of antibiotics

22
Iceberg Phenomenon Of Disease

Emerging Infectious Diseases

•A disease that is showing in increase incidence in the recent past, or a potential to increase
in the near future

Factors Leading to Emergence

1 - A new serovar (evolution of an organism) Vibrio cholerae O139

2 - Over use of antibiotics and pesticides leading to increased resistance
•Pediculosis
3 - Changes in weather patterns allowing more survival of reservoirs and vectors
•Malaria
•Hantavirus
4 - Animal control
•Lyme disease
5 – Modern transportation
•West Nile virus

23
Disease control
•The disease agent is permitted to exist in the community at a level where it ceases to be as
public health problem.
•Aims at reducing:
•i. Incidence of disease
•ii. Duration of disease
•iii. Risk of transmission of infection
•iv. Financial burden to the community.

Disease Elimination
•Interruption of transmission of disease from large geographic regions or areas.
•• An important precursor for eradication.
•• e.g. Measles, Polio.

Disease Eradication
•Termination of all transmission of infection by extermination of the infectious agent.
•• Tear out by roots.
•• Cessation of infection and disease from the whole world. • e.g. Small pox.
•• Potential candidates: Polio, Measles, Dracunculiasis.

•Epidemiology
• the science that studies when and where disease occur and its transmission
• Famous epidemiologists
•John Snow –cholera
•Ignaz Semmelweis –puerperal sepsis
•Florence Nightingale -typhus

24
Determine
•Etiology
•Predisposing factors
•Prevention of outbreaks
•Predicting outbreaks (seasonal)
•Controlling disease
•Chemotherapy –drugs
•Immunization

Reportable Diseases
•Case reporting
•Requires health care workers to report the diagnosis and occurrence of specific disease to
local, state, and national health officials.
•A reportable disease
•IDSP

Notifiable Diseases

25
•Center for Disease Control (CDC)
•Located in Atlanta, GA
•Branch of the US Public Health
•Center for epidemiological center
•Publishes Morbidity and Mortality
Weekly Report (MMWR)
•www.cdc.gov

•Morbidity rate

•Number of people affected by a disease in a given period of time in relation to the total
population

•Mortality rate

•Number of deaths from a specific disease in a population in a given period of time in

relation to the total population

26
“Prevention is better than cure”-DesideriusErasmus(1500)

•There are mainly four levels of prevention

•Primordial prevention
•Primary prevention
•Secondary prevention
•Tertiary prevention

27
1. Primordial prevention

• to reduce the development of risk factors before their appearance.

•The main action in primordial prevention is providing health education and awareness to
people on how to live a healthy lifestyle.
•Chronic conditions like diabetes, hypertension and obesity are preventable through the
adoption of a healthy lifestyle like taking nutritious food, avoiding smoking alcohol,
exercising regularly etc.
•“Genes load the gun. Lifestyle pulls the trigger” -Dr.Elliot Joslin
•consists of actions and measures that inhibit the emergence of risk factors in the form of
environmental, economic, social, and behavioral conditions and cultural patterns of living
etc.

•It is the prevention of the emergence or development of risk factors in countries or

population groups in which they have not yet appeared

•For example, many adult health problems (e.g., obesity, hypertension) have their early
origins in childhood, because this is the time when lifestyles are formed (for example,
smoking, eating patterns, physical exercise)

28
2.Primary prevention

•Can be defined as the action taken prior to the onset of disease, which removes the
possibility that the disease will ever occur.
•It signifies intervention in the pre-pathogenesis phase of a disease or health problem
•Based on the “positive health” concept
•Accomplished by measures of “Health Promotion” and “Specific Protection”
•Elimination or modification of risk factors.

Health promotion

The process of adoption of healthy behaviour and a positive attitude for maintaining a
healthy lifestyle. Health promotional activities are
•Health Education-most cost-effective

•Environmental Modification-safe water, sanitary latrines, control of insects and

rodents

•Nutritional Intervention-Food fortification, special feeding programs,

•Lifestyle and Behavioural changes-target groups or at risk individuals

Specific Protection

Provides protection against specific disease and group

•immunisation,
•chemoprophylaxis,
•use of specific nutrition and supplements,
•the safety of food and drugs
•control of environmental hazards
•Protection against occupational hazards and accidents

•• Immunization e.g. Vaccine preventable diseases.

•• Specific nutrient e.g. Iron.
•• Protection against injuries (helmet, seat belt)
•• Chemoprophylaxis e.g. against Malaria.
•Control of consumer product quality and safety of foods, drugs, cosmetics etc
29
• WHO recommends two approaches for primary intervention and prevention of chronic
diseases
•a) Population strategy
•b) High-risk strategy.

3. Secondary prevention

•Stop the disease process and restore health by seeking out unrecognised disease and
treating it before it reaches the irreversible pathological stage.
•Intervention in early pathogenesis phase.
•This prevention is taken up by early diagnosis and screening.
•Early diagnosis recognises the disease at early stages and help to provide adequate
treatment.

Largely the domain of a clinical medicine.

•Drawbacks: –
•Already there is suffering of mental anguish, pain.
•Loss of productivity
•More expensive and less effective

4. Tertiary prevention

•“All the measures taken to reduce, limit impairment, disability and promote patient
adjustment to the current situation.”
•aims at disability limitation and rehabilitation.

•Impairment - Any loss or abnormality of psychological, physiological or anatomical

structure or function.
•Disability - unable to carry out certain activities considered normal for age and gender
30
•Handicap - disadvantage for an individual that limits or prevents the fulfillment of a role.

Accident-Disease (or disorder)

•Loss of foot-Impairment
•Cannot walk-Disability (objectified)
•Unemployed-Handicap (socialized)

Rehabilitation

•Attain highest possible level of functional ability

•Medical rehabilitation-restoration of function
•Vocational rehab-earn livelihood
•Social rehab-family and social relationships
•Psychological-personal dignity and confidence

•To remember easily the activity of three levels of prevention, one can use
•Primary = Prevention,
•Secondary = Screening
•Tertiary = Treatment.

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Rose hypothesis: The prevention paradox

•“A preventive measure which brings much benefit to the population often offers little to each
participating individual”

32
 Measures of Disease Frequency – Morbidity
Morbidity
• Morbidity -as any departure, subjective or objective, from a state of physiological
or psychological well-being (disease, injury, and disability)
• Measures of morbidity frequency characterize the number of persons in a
population who become ill (incidence) or are ill at a given time (prevalence)
• Epidemiologist consider 3 factors while measuring disease occurrence:
1. The number of people that are affected by the disease
2. The size of the population
3. The length of time that the population is followed

Indices Used to Summarize measures of disease occurrence

Common frequency measures:
ratios, proportions, and rates
All three frequency measures have the same basic form
Numerator × 10n
denominator
Ratio
• Relative magnitude of two quantities or a comparison of any two values
• Calculated by dividing one variable by another (division of two unrelated numbers)
• If ‘a’ and ‘b’ refer to the frequency of some event or occurrence, then the ratio will be a
fraction of the form a/b
• The numerator and denominator need not be related
• Often a ratio is rescaled by multiplying by a constant k − Where k is a number such as
10, 100, 1,000, or 10,000

• Number or rate of events, items, persons, etc. in one group

• Number or rate of events, items, persons, etc. in another group

Examples:
- Sex ratio: ratio to compare the number of females in a population with the number of
males
-Ratio of nurse to population: number of Nurses / population size
Suppose there are 4 Nurses for 20,000 people, the ratio is 0.0002 Nurses per person or 2
Nurses per 10,000 people
Ratio of non-diabetics to diabetics in a study population

Ratio -exercise
Examples:
An urban block with 2000,000 persons has 300 health posts.
Calculate the number of health post per person
2500/2000,000 = 0.000125 health post per person
0.000125*10000 = 1.25 health post per 10000 persons or 1 health post
8000 people

Examples
Infant mortality rate during the year 2010 in a rural block in Tamil Nadu was 10.7 per
1000 live births. During the same year, the infant mortality rate in neighboring tribal area
was 3.8 per 1000 live births.
Calculate the ratio of infant mortality rate in rural Tamil Nadu to tribal area.
10.7/3.8 *1= 2.8:1

The tribal area’s infant mortality rate was 2.8 times as high as that of rural area.

Proportion
• A proportion is the comparison of a part to the whole.
• It is a type of ratio in which the numerator is included in the denominator
Example: to describe what fraction of antenatal women tested positive for HIV, or
what percentage of the population is younger than 25 years of age.
• A proportion may be expressed as a decimal, a fraction, or a percentage.

Method for calculating a proportion

Number of persons or events with a particular characteristic×10 n
Total number of persons or events, of which the numerator is a subset
For a proportion, 10n is usually 100 (or n= 2) and is often expressed as a percentage.
Example:
There were 4000 male participants in a study and 200 of them had diabetes.
Calculate the proportion of men in this study who had diabetes.
Numerator = 200 men with diabetes Denominator = Total number of men =
4000 (200 men with diabetes and 3800 men without diabetes
Proportion = (200 ⁄ 4000) ×100 = 5%
Notice that the numerator (200 men with diabetes) is a subset of the denominator.
A proportion can be expressed as a fraction, a decimal, or a percentage. The statements
“one fifth of the residents became ill” and “twenty percent of the residents became ill”
are equivalent

Example:
The proportion of children in a village vaccinated against measles
The proportion of health care workers in a medical centre infected with COVID 19
In a proportion, the numerator must be included in denominator
Proportions can easily be converted to ratios.

If the numerator is the number of women (179) who attended a clinic and the
denominator is all the clinic attendees (341), the proportion of clinic attendees who are
women is
179 ⁄ 341, or 52%
To convert to a ratio, subtract the numerator from the denominator to get the number of
clinic patients who are not women.
The ratio of women to men could be calculated from the proportion as:
Ratio = 179 ⁄ (341 − 179) ×1= 179 ⁄ 162 = 1.1 to 1 female-to-male ratio

Rate
• Rate is a measure of the frequency with which an event occurs in a defined
population over a specified period of time.
• The calendar time period is the same in both the numerator and denominator of a
rate
• A rate expresses the relative frequency of an event per unit time Examples:
 • Birth rate: (total number births in a calendar year/ total mid-year
population)*1000
• Infant mortality rate (IMR) = number of infant deaths per 1,000 live births during
a calendar year.
• As rates put disease frequency in the perspective of the size of the population,
rates are particularly useful for comparing disease frequency in different locations,
at different times, or among different groups of persons with potentially different
sized populations
• Eg: Attack rate of influenza (proportion of the population that has influenza like
illness) at a point in time in 2 cities (70 influenza like illness cases reported in City
A with 100000 population and 150 cases in City B with 150000 population during
March 2020).
• Attack rate -the proportion of the population that develops illness during an
outbreak. For example, 20 of 130 persons developed diarrhea after attending a
birth day party
• Prevalence rate-the proportion of the population that has a health condition at a
point in time.
• Case fatality rate -the proportion of persons with the disease who die from it.

Indices of disease occurrence

Type of calculation Characteristics
Ratio Division of 2 unrelated numbers
Proportion Division of 2 related numbers
(numerator is a subset of denominator)
Rate Division of 2 numbers
Events during a specified time period

Frequently used measures of morbidity

•Incidence proportion (or attack rate or risk)
•Secondary attack rate
•Incidence rate (or person-time rate)
•Point prevalence
•Period prevalence

4
Incidence
• Refers to the occurrence of new cases of disease or injury in a population over a
specified period of time in a community or per unit of population
• Two types of incidence:
• Incidence proportion
• Incidence rate

Incidence proportion or Risk or cumulative incidence

If in a population of 100 people, 10 people develop the disease during a period of 3
months time (t), then the proportion 10/100 represents the average risk of disease in that
population during the time ‘t’ (which is 3 months here).
This assumes that all 100 people are followed for the entire time ‘t’ (3 months)
The average risk in the group is also known as

incidence proportion or
cumulative incidence or
attack rate in case of an infectious disease or
probability of getting disease.

Incidence proportion or risk (Cumulative incidence)

Proportion of an initially disease-free population that develops disease or injury or
death during a specified (usually limited) period of time
The numerator: includes only new cases of those who developed the disease (from the
denominator)
The denominator of an incidence proportion: the number of persons at the start of the
observation period.
–The denominator should be limited to the “population at risk” for developing
disease, i.e., persons who have the potential to get the disease be included in the
numerator.
The numerator and denominator should be disease free in the beginning.
Incidence proportion is a proportion because the persons in the numerator, those who
develop disease, are all included in the denominator (the entire population).

5
 In an outbreak of gastroenteritis in a hostel, 200 students ate salad, 30 of whom
developed gastroenteritis. Calculate the risk of illness among persons who ate salad.

Numerator = 30 persons who ate salad and developed gastroenteritis

Denominator = 200 persons who ate salad
Incidence risk = (30 ⁄ 200) ×100 = 0.15 ×100 = 15%
Incidence of COVD 19 among health care workers who are exposed to patients with
COVID 19 (over 3 months)
Incidence of diabetic retinopathy among patients with diabetes

Attack rate
In the outbreak setting, the term attack rate is often used as a synonym for risk.
risk of getting the disease during a specified period, such as the duration of an outbreak
Overall attack rate is the total number of new cases divided by the total population
(eg: COVID 19)
Secondary attack rate:
Number of cases among contacts of primary cases*100
Total number of contacts
The total number of contacts in the denominator is calculated as the total population in
the households of the primary cases, minus the number of primary cases.
Usually expressed in %

In an outbreak of Influenza,

-In a village with a population size of 1000 people, 18 persons from 18 different
households became ill (totally 86 people were there in these 18 houses)
-overall attack rate:
18 ⁄ 1,000 ×100% = 1.8%
-One incubation period later, 17 persons in the same households with the
“primary” cases developed influenza.
-Secondary attack rate:
[17 ⁄ (86 − 18)] ×100 = (17 ⁄ 68) ×100 = 25%

6
Incidence proportion or Risk or cumulative incidence
If in a population of N people, A people develop the disease during a period of time t,
then the proportion A/ N represents the average risk of disease in that population during
the time ‘t’.
Risk varies from 0 to 100%.
Time period is necessary to interpret the risk.
Over a short period of time, the risk of any particular disease if very low (exception –
pandemics or any infection in which the incubation period is short and transmission is
high).
To measure risk, we have to avoid all losses to follow up

Incidence Rate
To calculate the incidence rate, the numerator is the number of new cases in the group
The denominator is the sum of the entire time at risk for the study group.

Incidence rate or person-time rate is a measure of incidence that incorporates time

directly into the denominator (if 100 people are followed up for 3 months, it is 300
person-months of observation).
A person-time rate is generally calculated from a long-term cohort follow-up study,
wherein enrollees are followed over time and the occurrence of new cases of disease is
documented.
Typically, each person is observed from an established starting time until one of four
“end points” is reached: onset of disease, death, migration out of the study (“lost to
follow-up”), or the end of the study.
The numerator of the incidence rate is the number of new cases identified during the
period of observation
The denominator is the sum of the time each person was observed and totaled for all
persons.
This denominator represents the total time the population was at risk of and being
watched for disease.

Number of new cases of disease or injury during specified period* 100

Time each person was observed, totaled for all persons

7
Person times and incidence rates
• Individuals may be exposed to the risk of an event for varying amounts of time
during a total time period of a certain length due to:
− Entering the time period later
− Leaving the time period earlier
− Experiencing the event of interest
• Is a calculation combining persons and time
-Is the sum of the individual units of time that people have been exposed to the
risk of an event
• Incidence rate = number of events / total person−time of exposure

Example:
During a two-year period of time, 10 episodes of diarrhea at a Balwadi were reported.
30 children attended the balwadi, for varying fractions of the two-year period, for a total
of 50 child-years
R =10 diarrhea episodes /50 child−years of observation
R = 0.20 episodes per child-year

What does 100 “Person-Years” mean?

•Observe 100 people for 1 y each.
•Observe 10 people for 10 y each.
•Observe 50 people for 1 y each and another 25 people for 2 y each.
•Any other combination of people & observation times that add up to a total of
100 y

8
Example: Incidence rate

Example (cont.)
From the example, the incidence rate is 3 divided by 107.7 person-years (0.028 cases of
stroke per person-year).
9
IR can be expressed in person-months, person-week, person-days [3 / (107.7x365)],
etc.

• Epidemiologists commonly calculate incidence rates based on a numerator of

cases observed or reported and a denominator based on the mid-year population.
• This type of incident rate turns out to be comparable to a person-time rate.
• Incidence rate can be calculated as:
-number of events / total person −time of exposure
Or
-New events / mid-year population

Incidence rate
In 2003, 9 new cases of acquired immunodeficiency syndrome (AIDS) were reported in
a rural block. The estimated mid-year population of that rural block in 2003 was
approximately 150000. Calculate the incidence rate of AIDS in 2003.
Numerator = 9new cases of AIDS
Denominator = 150000 estimated mid-year population
Calculate incidence rate per 100,000 population (10n= 100,000)
Incidence rate = (9 ⁄ 150000) ×100,000= 6 new cases of AIDS per 100,000
population

Prevalence rate
•The proportion of persons in a population who have a particular disease or attribute at a
specified point in time or over a specified period of time
•Prevalence differs from incidence in that prevalence includes all cases, both new and
preexisting, in the population at the specified time, whereas incidence is limited to new
cases only.
Prevalence
Point prevalence: The prevalence measured at a particular point in time
proportion of persons with a particular disease or attribute on a particular date
Period prevalence: Prevalence measured over an interval of time.
It is the proportion of persons with a particular disease or attribute at any time
during the interval

10
 Persons having a particular attribute during a given time period × 10n
Population during the same time period

•Example: Among 10 people in an office, 3 are diagnosed with diabetes in Jan 1, 2003.
•Prevalence of diabetes at that time is 3/10 (30%)

Prevalence is influenced by several factors:

1. Rate of disease occurrence (incidence rate)
2. Duration of the disease (the longer the duration, the higher the prevalence)
Duration depends on cure (natural or by intervention), mortality, stage in which
diagnosis is made (screening)
Prevalence is important in measuring the burden of disease on people (decision making
process).

There were 10 new cases of illness over about 15 months in a population of 20 persons.
•Each horizontal line represents one person.

Calculate the incidence rate from October 1, 2004, to September 30, 2005, using the
midpoint population (population alive on April 1, 2005) as the denominator. Express the rate
per 100 population.

11
Numerator= number of new cases between October 1 and September 30 = 4 (the other
6 all had onsets before October 1, and are not included)
Denominator= April 1 population (mid-year population)= 18 (persons 2 and 8 died
before April 1)
Incidence rate = (4 ⁄ 18) ×100= 22 new cases per 100 population

•There were 10 new cases of illness over about 15 months in a population of 20 persons.
•Each horizontal line represents one person.

Calculate the point prevalence on April 1, 2005.

Point prevalence is the number of persons ill on the date divided by the population on
that date. On April 1, seven persons (persons 1, 4, 5, 6, 7, 9, and 10) were ill.
Point prevalence = (7 ⁄ 18) ×100= 38.89%

Calculate the period prevalence from October 1, 2004, to September 30, 2005.
The numerator of period prevalence includes anyone who was ill any time during the
period. In this Figure , the first 10 persons were all ill at some time during the period.
Period prevalence = (10 ⁄ 20) ×100= 50.0%

12
Exercise: 4
In 1985 all the school children near Vellore were examined for evidence of leprosy. The
procedure was repeated again in 1986. The following were the results.
1985
a. No. of children on the rolls: 52,600
b. No. of children examined: 48,000
c. No. of children found to have active leprosy: 288
1986:
d. No. of children on the rolls: 54,000
e. No. of children examined for the first time: 6,000
f. No. of active cases among the above: 46
g. No. of children re-examined: 40,000
h. No. of old cases among them : 40
i. No. of new cases among the re-examined children : 80

QUESTIONS:

1.What was the prevalence of leprosy?

a. in 1985 b. in 1986
2.What was the incidence of leprosy during 1985-1986?

13
 Outbreak Investigation and Surveillance of Infectious
Diseases
Dr.Shalini
Assistant Professor
Dept.of Community Health
CMC, Vellore

Outline of the session

1. Outbreaks and epidemics
2. Outbreak detection
3. Outbreak investigation
4. Managerial aspects of outbreak investigations

Endemic versus epidemic

•Endemicity
–Disease occurring in a population regularly at a usual level
•Tuberculosis, Malaria
•Epidemics
–Unusual occurrence of the disease in excess of its normal expectation
•In a geographical location

•At a given point of time

e.g. Hepatitis E, measles, cholera

Outbreaks versus epidemics

•Occurrence of cases of an illness in excess of expected numbers
•Scale
–Outbreak
•Limited to a small area, within one district or few blocks
–Epidemic
•Covers larger geographic areas
•Linked to control measures in district/state
•Be aware of legal implications of the use of the term “Epidemic” in India
(Epidemic disease act, being revised)

Sources of information to detect outbreaks

1
•Event-based surveillance
–Rumour register
•To be kept in standardized format in each institution

•Rumours need to be investigated

–Community informants
•Private and public sector
–Media
•Important source of information, not to neglect
•Case-based surveillance
–Review of routine surveillance data and triggers

Early warning signals for an outbreak

•Clustering of cases or deaths
•Increases in cases or deaths
•Single case of disease of epidemic potential
•Acute febrile illness of an unknown etiology
•Two or more linked cases of disease with outbreak potential
–(e.g., Measles, Cholera, Dengue, Japanese encephalitis or plague)
•Unusual isolate (Cholera O 139)
•Shifting in age distribution of cases (Cholera O 139)
•High vector density
•Natural disasters

Importance of timely action: The first information report (Form C)

•Filled by the reporting unit
•Submitted to the District Surveillance Officer as soon as the suspected outbreak is
verified
•Sent by the fastest route of information available
–Telephone
–Fax
–E-mail
The rapid response team
•Composition
–Epidemiologist, clinician and microbiologist
2
 •Entomologist when vector-borne disease
–Gathered on ad hoc basis when needed
•Role
–Confirm and investigate outbreaks
•Responsibility
–Assist in the investigation and response
–Primary responsibility rests with local health staff

Objectives of an outbreak investigation

1. Verify
2. Recognize the magnitude
3. Diagnose the agent
4. Identify the source and mode of transmission
5. Formulate prevention and control measures

An outbreak comes from a change in the way the host, the environment and the agent interact: This
interaction needs to be understood to propose recommendations

The balance between investigation and control while responding to an

outbreak

Source / transmission
Known Unknown
Etiology Known Control +++ Control +
Investigate + Investigate +++
Unknown Control +++ Control +
Investigate +++ Investigate +++

Steps in outbreak response

1. Verifying the outbreak
2. Sending the rapid response team
3. Monitoring the situation
4. Declaring the outbreak over
5. Reviewing the final report
3
Step 1: Verifying the outbreak
•Validate the source of information
?Change in the reporting system
?Change in the population size
?Acute reporting of old, chronic cases
•Check with the concerned medical officer:
?Abnormal increase in the number of cases
?Clustering of cases
?Epidemiological link between cases
?Triggering event
?Deaths

Step 2: Sending the rapid response team

•Review if the source and mode of transmission are known
•If not, constitute team with:
–Medical officer
–Epidemiologist
–Laboratory specialist
•Formulation of hypothesis on basis of the description by time, place and person
(Descriptive epidemiology)
?Does the hypothesis fits the fact
YES: Propose control measures
NO: Conduct analytical studies

Investigating an outbreak

4
Example: Outbreak of acute hepatitis (E)in Baripada, Orissa, 2003
•Identification of a cluster of acute hepatitis cases
•Diagnosis: HEV infection
•Use time, place and person analysis of surveillance data to suggests hypotheses
Cases of acute hepatitis (E) by date of onset, Baripada, January-March 2004
Time: A cluster a month after a strike in the water treatment centre

What hypotheses would you generate for the outbreak of acute hepatitis (E)in
Baripada, Orissa, 2003?
•Time:
–It happens a month after a strike in the water treatment plant
•Place:
–It is clustered around a water source that takes water from the river
•Person:
–Adults are mostly affected
The river water may have been supplied untreated in the area of the outbreak because of the strike at
the water treatment plant

Descriptive versus analytical investigations

•Descriptive investigations
–Based upon casesonly
–Look at time, place and person epidemiology
–Raise hypotheses
•Analytical investigations
–Based upon a study of the cases and non-cases
–Compare:
•Cases with controls with respect to exposure
•Exposed with unexposed with respect to incidence
–Test hypotheses
•How could we test the hypothesis for the Baripada investigation?

Steps of a full outbreak investigation using analytical epidemiology to identify the

source of infection
1. Determine the existence of an outbreak
2. Confirm the diagnosis
3. Define a case
4. Search for cases
5. Generate hypotheses using descriptive findings
5
6. Test hypotheses based upon an analytical study
7. Draw conclusions
8. Compare the hypothesis with established facts
9. Communicate findings
10. Execute prevention measures
Requires assistance from qualified field epidemiologist (FETP)

Consumption of pipeline water among acute hepatitis (E) cases and controls,
Baripada, Orissa, India, 2004

Acute Control Total

hepatitis
Drunk water from river bed 493 134 627
pump
Did not drink pump water 45 404 449
Total 538 538 1076

92% of cases (493/538) drunk water from suspected source versus 25% (134/538) of
controls

Analytical epidemiology compares cases and non cases or exposed versus unexposed to test the
hypothesis generated on the basis of the time, place and person description

3. Monitoring the situation

•Trends in cases and deaths
•Implementation of containment measures
•Stocks of vaccines and drugs
•Logistics
–Communication
–Vehicles
•Community involvement
•Media response

4. Declaring the outbreak over

•Role of the district surveillance officer / Medical health officer
•Criteria
–No new case during two incubation periods since onset of last case
•Implies careful case search to make sure no case are missed

6
5. Review of the final report
•Sent by medical officer of the primary health centre to the district surveillance officer /
medical and health officer within 10 days of the outbreak being declared over
•Review by the technical committee
–Identification of system failures
–Longer term recommendations

Outbreak preparedness: A summary of preparatory action

•Formation of rapid response team
•Training of the rapid response team
•Regular review of the data
•Identification of ‘outbreak seasons’
•Identification of ‘outbreak regions’
•Provision of necessary drugs and materials
•Identification and strengthening appropriate laboratories
•Designation of vehicles for outbreak investigation
•Establishment of communication channels in working conditions (e.g.,
Telephone)

Managerial aspects of outbreak response

•Logistics
–Human resources
–Medicines
–Equipment and supplies
–Vehicle and mobility
–Communication channels
•Information, education and communication
•Media
–Daily update

Control measures for an outbreak

•General measures
–Till source and route of transmission identified
•Specific measures, based upon the results of the investigation

7
 –Agent
•Removing the source
–Environment
•Interrupting transmission
–Host
•Protection (e.g., immunization)
•Case management

Take home messages

1. Do not ignore or hide outbreaks
2. Respond to early warning signals
3. Investigate outbreaks to:
–Control the current outbreak
–Learn about the disease in the local setting
4. Outbreaks require an organized, well managed response

Additional reading
•CDC text book on principles of epidemiology

•Section 5 of operations manual

•Module 8 of training manual

8
 Overview of Clinical Trials

Dr. Anu Oommen,

Professor,
Dept of Community Health

Overview of epidemiological aspects of clinical trials

1. What are clinical trials?
2. Epidemiological basis and usefulness
3. Methods: randomisation, blinding, control
4. Types

Studying causal associations in health

Objective Type of study

What are the risk factors for disease? Observational studies
Will elimination of risk factors prevent Experiments
disease?
Whether a preventive intervention (vaccine, Experiments
screening for a risk factor or disease, other
non-pharmacological intervention) can
decrease incidence of disease or reduce
mortality?
Which therapeutic intervention can improve Experiments
disease outcomes?

Clinical trials
Experiments performed on human beings for the purpose of assessing the safety and
efficacy (will it work) of new interventions

1
Epidemiological basis for RCTs
Understanding measurement of risk and risk ratios or relative risk

How do we study if a risk factor is causing disease?

Ideally through a cohort (observational) study

Measurement of risk (probability of disease) in each group:

Incidence in exposed = no. of events in exposed group out of number who were
followed-up

Incidence in unexposed = no. of events in unexposed out of number who were

followed-up

Measure statistical association:

Is incidence of disease in the exposed group with a particular risk factor > incidence in a
group without that exposure?
Relative Risk = Incidence in exposed/Incidence in unexposed

If RR > 1, this exposure is associated with development of disease

2
Relative risk (RR): relative measure of association between exposure and outcome

Disease No disease
Exposed to risk 30 70 Incidence in exposed = 30/100 = 30%
factor (e.g. smoking)
Unexposed 15 85 Incidence in unexposed = 15/100 = 15%

RR = 30% / 15% = 2
Those who were exposed to the risk factor were 2 times more likely to develop disease
as cf. with those who were unexposed

Difference in the two incidences (additive measure of association):

Incidence in exposed – Incidence in unexposed (Risk Difference RD)
This is an absolute measure of risk differences
e.g., If incidence of heart disease in smokers: 6.0% incidence in non-smokers: 1.5%
RD = Ie – Iu = 6.0-1.5 = 4.5%

RR and Risk Difference best understood by thinking of risk factors vs disease

•Same analytic epidemiology approach for clinical trials which evaluate beneficial factors
(preventive or therapeutic) vs disease reduction

Clinical trials:
Is a protective factor (e.g., vaccine) reducing disease incidence or a therapeutic intervention
(e.g., drug) reducing adverse disease outcomes?

Is Incidence of disease in those exposed to protective intervention (e.g., vaccine)

< Incidence in unexposed (control) arm?
(RR < 1 for negative outcomes such as death)

Is Incidence of positive outcome in those exposed to therapeutic intervention (e.g.,

drug) > Incidence in unexposed/control arm?

(Is RR > 1 for positive outcomes such as cure)

Study 1 Cure No cure Total

3
New drug – 20 80 100 Incidence in Relative Risk =
exposed exposed = 20/100 20%/10% = 2
= 20% (drug is 2 times more
Unexposed 10 90 100 Incidence in likely to cure than no
(control) unexposed = drug)
10/100 = 10%

Study 2 Disease No disease Total

New vaccine 20 80 100 Incidence in Relative Risk =
– exposed exposed = 20/100 20%/60% = 0.33
= 20% Protective effect
Unexposed 60 40 100 Incidence in = 1-RR = 0.67 or
(control) unexposed = 67%
60/100 = 60%
There is a 67% reduction in incidence of disease with the vaccine
as compared to the situation where no vaccine is used

Experiments/Trials – differences cf. with observational cohort studies

Experiments involve deliberate exposure for one group cf. with other group without
exposure
(Investigator can control type of exposure, amount, duration)
Experiments - can ensure that the two comparison groups are similar to each other in all
other aspects (except that one will receive the intervention) through randomised
allocation of exposure
Experiments/trials only possible when exposure is protective or therapeutic
In an experiment can blind the subjects as to whether they are getting the exposure or not

Randomized Controlled Trials (RCTs) –three methodological issues

1. Comparison/control groups
(standard of care –if exists; placebo/no treatment/different dose/other active treatment)
No conclusion of efficacy of treatment or causation of disease without a comparison
group

4
2. Random assignment (randomization) of subjects to intervention/control groups

3. Masking
(hide knowledge about who is getting what intervention, to avoid information bias)

Effectiveness of vaccines and drugs:

decreasing incidence of disease/adverse parameter or increasing incidence of cure

Disease No Disease
Exposed a c Incidence in exposed = a/a+c
Unexposed b d Incidence in unexposed = b/b+d

Results: If incidence of dis in exposed < incidence of dis in unexposed (RR < 1) -
protective
Conclusions:
Can we conclude that this exposure definitely protects from the disease?
Are we sure that there were no other factors that made the exposed group less prone for
disease or deaths? Were the two groups similar in all other aspects (e.g. age, BMI, social
class)
Solution: randomly divide one set of people into the two groups (randomisation),
so that at baseline the two groups are similar, and the only difference between them
during the study will be the exposure factor

Randomisation

With random allocation, each participant has a known probability of receiving

each intervention before it is assigned, but the assigned intervention is determined by a
chance process and cannot be predicted.

5
Select a set of eligible, consenting individuals

Randomly allocate exposure in the set of eligible individuals:

division into exposed and unexposed groups

6
Randomised allocation results in division into exposed and unexposed
groups who are similar (group characteristics) except for exposure, in
reasonably large trials- baseline table in results

Analysis: Relative Risk =incidence of disease in exposed (vaccine) / incidence in

unexposed

7
Non random allocation of participants into exposure groups for clinical trials
Selection by participants
Selection by investigators
Systematic allocation
Above methods not acceptable as they will introduce selection bias:
(Participants will be enrolled into exposure groups which are likely to lead to a specific
outcome)

Usefulness of randomisation
 Avoids selection bias
 Makes the treatment and control groups comparable to known and unknown risk
factors*/avoid systematic differences (avoid confounding)
 Satisfy requirements for certain statistical tests to be used in analysis
(randomization tests/permutation tests)
 Allows blinding of treatment

Classification of RCTs
1. Based on design
Parallel
Cross over
Factorial (combination of interventions)

Cross over trial:

Compares the same group of people as exposed and unexposed (everyone in the trial got
a chance to experience the intervention), a near perfect design, but not always feasible

8
2. Based on unit of randomization

Individual

Randomized Controlled Trials (RCTs

Cluster randomized trials:

Randomize clusters, later recruit individuals
-Community
-Family
-Clinic
Advantages: convenience/avoid treatment contamination

9
3. Based on centers
Single center
Multi-center

4. Based on masking:
a. Single blinding/masking

10
b. Double blinding/masking

c. Triple blinding

11
d. Open/unmasked trials

The multistage clinical trial process for drugs/vaccines

Phase I –Assessment of tolerance and adverse effects on a few healthy volunteers

Phase II –small scale studies assessing potential impact on patients -a few hundreds
(PROOF OF CONCEPT)
Phase III –Therapeutic efficacy studied among large numbers of patients (proof of
efficacy)-most RCTs
After Phase III –regulatory approval for marketing
Phase IV –post-marketing surveillance of approved drugs (rare side effects, unexpected
benefits –not captured in RCTs)

12
Summary
An RCT is the best statistically sound epidemiological research design to test the
efficacy of a new intervention (prevention or treatment)
Randomization of subjects into the various study arms ensures that study subjects
are not allotted interventions in a biased manner and that the two groups are comparable
A control group is needed to tell us if the experience of the intervention arm is
really different from the ‘unexposed’ or ‘control’ arm

References
Clinical trials. Design, conduct and analysis. Second edition. Curtis L. Meinert

Dona Schneider, David Lilienfeld. 2015. Foundations of Epidemiology.

CONSORT guidelines

Penn State courses:

https://newonlinecourses.science.psu.edu/stat509/node/52/
https://www.cebm.net/wp-content/uploads/2014/06/CEBM-Levels-of-Evidence-
2.1.pdf

13
 COHORT STUDIES

Vinod Joseph AbrahamProfessor

Dept. of Community Health
Christian Medical College, Vellore

Types of Research Study Designs

What is a Cohort ?
A group of individuals that are all similar in some trait and move forward together as a
unit

Examples of different types of cohorts

•Birth cohort:
A group of people born during a particular period or year.
•Inception cohort:
All individuals assembled at a given point based on some factor. e.g.where they live or
work
•Exposure cohort:
Individuals assembled as a group based on some common exposure. e.g. smokers,
miners, etc

1
Features of Cohort Studies

•Cohorts are identified prior to the onset of the condition under study
•The study groups are observed over a period of time to determine the frequency of
disease
•The study proceeds from cause to effect Framework of a Cohort Study
•The investigator selects a group of exposed individuals and a group of non-exposed
individuals
•Follows up both groups
•Compare the incidence of disease in the 2 groups

Types of cohort study designs

Prospective Cohort Study

•Also known as concurrent, longitudinal or follow-up cohort study.
•Investigator identifies the original population at the beginning of the study and follows
them up in real time until the study ends at a pre-specified time.

Retrospective Cohort Study

•Also known as historical or non concurrent cohort study
•Investigator identifies a group of subjects with historical records of both exposure and
outcome available in the past.

Ambi-directional Cohort Study

•Elements of Prospective and Retrospective cohorts are combined
•The cohort is identified from past records and exposure is ascertained from the records
•The same cohort is followed up prospectively to assess occurrence of the outcome

2
When can a cohort study be done?

•There is evidence of association between the exposure and the disease

•Exposure is rare
•Attrition of the study population can be minimized
•Sufficient funds and time are available

The pros and cons of a Prospective - Cohort Study

•Pros:
–Good for rare exposures
–Can assess multiple outcomes
–Can generate incidence data
–Generally no ethical issues
•Cons:
–Bad for rare outcomes
–Subjects can change exposure status (smokers quit and non smokers start smoking)
–Takes time
–Relatively expensive
–Comparability of study groups
–Loss to follow-up
–Are all subjects really free of the outcome at the start of the study?

3
The pros and cons a Retrospective - Cohort Study

•Pros:
–Good for rare exposures
–Relatively short time to complete the study
–Relatively inexpensive
–Can assess multiple outcomes
–Can generate incidence data
–Generally no ethical issues
•Cons:
–Bad for rare outcomes
–Imperfect information in medical records
–Loss to follow up
–Comparability of study arms
–Subjects can change exposure status
–Are all subjects really free of the outcome at the start of the study?

Steps in a Cohort Study

•Selection of study subjects
•Obtaining data on exposure
•Selection of comparison groups
•Follow-up
•Analysis
Analysis

4
How to Interpret Relative Risk?

5
 Measurements in Mortality
Prof. Venkata Raghava Mohan
Community Health
Christian Medical College, Vellore
Why is Mortality important?
• Death is a unique and universal event, and as a final event, usually is clearly
defined.
• One of the indicators of health status of populations.
• Age at death and cause provide an instant depiction of health status.

Uses of mortality data

• Explaining trends and differentials in overall mortality
• Indicate priorities for health action, resource allocation.
• Designing intervention programmes.
• Monitoring public health programmes.
•

1
Causes of deaths according to income

2
Sources of Mortality data
• Civil registration system
• Sample Registration System (SRS)
• NFHS

Measurements – Rates and Ratios

I. Crude Death Rate
II. Specific Death Rates
III. Case Fatality Rate (Ratio)
IV. Proportional Mortality Rate (Ratio)
V. Survival Rate
VI. Adjusted or Standardised Rates

3
 I. Crude Death Rate
The crude death rate is the number of deaths in a population during a specified
time period divided by the population "at risk" of dying during that period.
By convention, the resulting fraction is applied to a standard-sized population of
1,000, thus making the crude death rate the number of deaths per 1,000 midyear
population.

• The midyear population of a block was 1,16,000 in the year 2018 and there were a
total of 753 deaths in 2018.
• Calculate the CDR

• CDR summarises two factors:

• Population composition
• Age specific death rates

CDR/1000 myp
Country A 15.2
Country B 9.9

4
CDR – country wise

II. Specific death rates

A. Sex specific
B. Age specific
C. Cause specific
D. Income, religion…
• Permit comparisons across groups within the same population

II A. Sex specific death rates

Total number of deaths of a particular sex X 1000
Total myp of the same sex
• CDR = 7.5 / 1000 myp
• CDR - males = 9.5/1000 myp
• CDR – females = 6.7/1000 myp

5
 II B. Age specific death rates (ASDR)

Why ASDRs?
• Can compare mortality at different ages
• Can compare mortality in the same age groups over time and/or between
geographic locations
• Can be used to calculate life tables (life-expectancy)
Age specific death rates per 1000 population

CDR/1000
Less than 1 1 to 4 5 to 7 8 to 44 45 to 64 65 and above
myp

Country A
15.2 13.5 0.6 0.4 1.5 10.7 59.7
Country B
19.9 22.6 1 0.5 3.6 18.8 61.1

6
 II C. Cause specific death rate
• Number of deaths attributable to a particular cause ‘c’ divided by population at
risk , usually expressed in deaths per 100,000

7
• The cause specific death rate per 100,000 for tuberculosis in South Africa in 1993
was:

Cause specific death rates for TB in Philippines, Mexico and Sweden were 36.7,
5.1, and 0.4 respectively
(UN Demographic year book, 1997)

8
Trend in CSDR in a rural block

III. Case Fatality Rate (Ratio)

 Killing power of any disease
 a case fatality rate (CFR)—or case fatality risk, case fatality ratio or just
fatality rate—is the proportion of deaths within a designated population of
"cases“.

Infectious disease CFR

Varicella (chickenpox), adults 0.02%

Influenza A, typical pandemics < 0.1%

Malaria ~ 0.3%
Severe acute respiratory syndrome 11%
(SARS)
Cholera 1 to 2.24%
Covid-19 1-2%
AIDS/HIV infection 80–90%
Rabies ~ 99%

IV. Proportional mortality rate (Ratio)

Of all the deaths, what proportion of deaths are due to a particular cause?

9
Global, regional, and national causes of child mortality in 2008: a systematic
analysis. The Lancet. DOI:https://doi.org/10.1016/S0140-6736 (10)60549-1

10
11
V. Survival rate
 Proportion of survivors in a group followed up over a specified time
interval.
 Describing prognosis in certain diseases.
 Serves as a yardstick for assessing standards of therapy.

12
 VI. Adjusted or standardised rates
 We want to compare death rates of two cities, with different age structures
 CDR will not work – incorrect measure
 Adjust for age - Age standardisation
Standardisation
• Direct
• Indirect

Direct standardisation
• To estimate standardised mortality rate (SMR) for Vellore city
• We need a “Standard population”
• We also need population and ASMR of Vellore city.
• Standard population is one whose age and sex distribution is known (WHO,
GOI..)
• Apply to this standard population, the age specific mortality rates of Vellore city
• We get expected number of deaths in the standard population.
• Add them to get total expected deaths.
Divide this by the standard population to get the SMR.

13
Vellore city details

Age In Years Population Of Vellore Deaths

0 4000 60

1-4 4500 20

5-14 4000 12
15-19 5000 15

20-24 4000 16

25-34 8000 25
35-44 9000 48

45-64 15000 250

Total 53500 446

India population - Census 2001 (Standard pop)

Age group Population

0-4 110,447,164

5-9 128,316,790

10 - 14 124,846,858

15- 19 100,215,890

20 - 24 89,764,132

25 - 44 284,008,819

45 - 64 139,166,661

All Ages

Source : C2 and C14 Table, India, Census of India

2001.

14
 Apply ASMR to std pop

Age group Population ASMR Vlr /1000

0-4 11,04,47,164 15.0

05-09 12,83,16,790 4.4

10-14 12,48,46,858 3.0

15- 19 10,02,15,890 3.0

20 - 24 8,97,64,132 4.0

25 - 44 28,40,08,819 3.1

45 - 64 13,91,66,661 5.3

All Ages 97,67,66,314 16.7

SMR = (total expected deaths)/total std pop *1000 = 5.01 / 1000 myp
CDR = 8.3 / 1000 myp

Indirect standardisation

• The indirect method of standardisation is commonly used when age-specific rates

are unavailable.
• For example if we did not know the age specific mortality rates for country B.
• In this method, instead of taking one population structure as standard and
applying sets of rates to it to estimate expected events, a set of rates from a
standard population (country A) is applied to each of the populations being
compared to calculate standardized mortality ratios (SMR).

Special mortality indicators

• Infant Mortality Rate (IMR)
• Infant mortality is the death of young children under the age of 1 year.
• This death toll is measured by the infant mortality rate (IMR), which is the
number of deaths of children under one year of age per 1000 live births.
15
 IMR – 2013

Perinatal mortality rate (PMR)

• The number of perinatal deaths per 1000 total births
• A perinatal death is a fetal death (stillbirth) or an early neonatal death.
• The perinatal mortality rate is calculated as:
• (# of perinatal deaths / total # of births (still births + live births)) x 1000
• A stillbirth is the death of a fetus weighing 500g or more, or of 28 -weeks
gestation or more if weight is unavailable.
• An early neonatal death (END) is the death of a live newborn in the first 7 days
(i.e., 0-6 days) of life.

16
International Death Certificate

Further reading
• https://www.who.int/whosis/whostat/EN_WHS09_Table2.pdf
• http://conflict.lshtm.ac.uk/page_95.htm#Mortality_Why_measure_
mortality
• https://www.lung.org/assets/documents/research/tb-trend-
report.pdf
• Park’s Textbook of Preventive and Social Medicine

17
 INFECTIOUS DISEASE
EPIDEMIOLOGY
Shantidani Minz
Professor Community Medicine
CMC Vellore

What does an infection mean to us today?

NIPAH
COVID
Hand washing
RO
Dengue
Mosquitoes
Vaccination
(Upper and Upper Middle Class Indians)

1
GLOBAL TB INCIDENT CASES: COUNTRIES WITH AT LEAST 100,000
INCIDENT CASES

2
 INDIAN INFECTIOUS DISEASE BURDEN

DEATH DUE TO TB
https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-
tuberculosis-report-2022/tb-disease-burden/2-2-tb-mortality
https://www.macrotrends.net/countries/WLD/world/death-rate

What happened to death rate in 2020 and 2021 in India?

EPIDEMIOLOGY

IMPORTANT TERMS IN INFECTIOUS DISEASE EPIDEMIOLOGY

Agent
Pathogenesis - capacity of a microbe to cause disease in a susceptible host
Virulence - severity or harmfulness
Contagious - ability to pass from one host to another

Host
Susceptibility
Exposure

3
Agent -Host interaction
Transmission - direct or indirect, fomite, waterborne, airborne
Vectors - living organism passing on an infectious agent to from an infected
animal or human to another host

Environment - supporting factors for Agent-Host interaction, vector breeding, vector-

host interaction

INCUBATION PERIOD AND WHY IT IS IMPORTANT

EPIDEMICS

www.researchgate.net/figure/Epidemic-curves-for-A-point-source-exposure-and-B-
propagated-transmission_fig1_319603090/download
4
EPIDEMIOLOGY AND INFECTIOUS DISEASES

EPIDEMIOLOGY OF MALARIA
Distribution - where
Who
When/how much

5
DETERMINANTS OF MALARIA IN TANZANIA

https://ars.els-cdn.com/content/image/1-s2.0-S0001706X15000042-fx1.jpg

AGE DISTRIBUTION
COVID STUDY – DATA FROM DRIVE THROUGH TESTING CENTRES

https://assets.cureus.com/uploads/original_article/pdf/65555/20210922-5324-
1peiqp6.pdf

6
HEALTH SYSTEM DETERMINANTS OF TUBERCULOSIS MORTALITY IN
SOUTH AFRICA: A CAUSAL LOOP MODEL

https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06398-0
https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06398-
0/figures/2

7
HEALTH SEEKING FORTB SYMPTOMS – VELLORE DISTRICT STUDY

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191591

THE ENVIRONMENT

Direct And Indirect

Visible And Invisible
Micro And Macro
Natural And Manmade
Nature And System

THE VECTOR

Linked to environment
Influenced by human activity - vector-
human interface
Role of Development
Lifestyle
Biological change - resistance

8
WHAT IS DIFFERENT (NON-COMMUNICABLE DISEASES)

No agent but risk factors

No vector
Host factors - very important
Environment - different but important role

SUMMARISING
Epidemiology for Infectious Diseases leads to the understanding ofThe disease
process
Prevention for individual and the community
Reducing the burden by preventing disease and death

Helps in
Planning strategies and programs
Policy making

9
 Biostatistics and Epidemiology
Cross sectional and ecological studies

1.Descriptive

-Frequency of occurrence of a condition

-Patterns of occurrence according to person, place, time
-Who? Where? When?

2.Analytic

-to specify in more detail the possible causes

-to identify factors associated with the condition
-To study the relationships between diseases (outcomes) and putative causes (exposures)

Study designs and corresponding questions

•Ecological: What explains differences between groups?

•Case series: How common is this finding in a disease?
•Cross sectional: How common is the disease or condition?
•Case-control: What factors are associated with having a disease?

1
•Cohort: How many people gets the disease?
What factors predict development of the disease?
•Randomized trial: Does the outcome change if we change something?

Descriptive studies

•KAP (knowledge, attitudes, and practices) study:

–KAP studies are descriptive

–help to build up a better understanding of the behavior of the population
–If we attempt to relate the level of knowledge/ attitude/ practice to any disease
or health outcome, it becomes analytical

Cross sectional studies

•Measures the prevalence of health outcome (proportion of people with a particular
condition)
or
•measures the prevalence of determinants of health (risk factors associated with health
outcome/ exposure)
or
•both in a population at a same point in time or over a short period in a given population
.
Repeated cross sectional studies in the same samples can give incidence.
•Can infer a relationship or correlation but are not always sufficient to determine a direct
cause. As a result, these studies often pave the way for further investigations to explore
etiology.
•The temporal relationship between exposure and disease cannot be determined

2
Can be either descriptive (only description of samples being studied) or analytical
(comparing the prevalence between samples with exposure and without exposure)
•Eg:
•Prevalence of chronic obstructive airway disease (COPD) among women from an urban
area
•Prevalence of COPD women with and without second-hand smoke

Descriptive cross sectional studies

•Proportion of the study population with particular condition of interest.

•Called as ‘Prevalent study’

•Two types of measuring prevalence:

–Point prevalence –no .of samples with the disease at the time of
measuring . Eg: do you currently have asthma?

–Period prevalence –No. of samples with disease during a specified period of

time. Eg: Did you have asthma in the last 6 months?

Snap shot of a population

3
Analytical cross sectional studies
Divide the study samples based on the

•Presence of the exposure (risk factor) or not

•Disease or not

Attempts to make any relationship between the presence of the risk factor and the
disease

4
Cross-sectional studies

Case control studies

Cohort studies
Outcome/disease

5
 Experimental studies
Outcome

How to design a cross sectional study

Cross sectional studies –methods

•Choose the problem, analyze and justify the need

•Review the literature:

–What information about the study is already known

–what is not known and what is the gap

–what methodology was used in the previous studies and the limitations

•Frame objectives:
–what are we going to find in this study

–Specific and measureable objectives

Cross sectional studies –Methodology

•Study population:

–Study area
–Target population -inclusion criteria & any exclusion criteria
–Sampling frame –census list, telephone users …
–Sample size
–Sample population –sampling

•Measurement tool:

–Which variables are needed to answer the objectives

–Method of collection –physical measurement, questionnaire, records…….
–Work plan -how and who collects the data, training and standardization, time frame

6
•Ethical and research committee clearance -consent
•Data entry, cleaning
•Analysis and interpretation & publication plan
•Resources needed –sponsors, internally funded

Prevalence of domestic violence in tribal areas of Vellore district

Researcher:

Objective:

To estimate the prevalence of domestic violence among married women in the
age group of 18-45 years residing in the tribal area
Factors associated with domestic violence

Time period:

Target population:

married women in the age group of 18-45, permanent residents of the tribal area

Description of the study area:

This tribal area has 6 panchayats, total population 60000, road accessibility is
only for 50% Villages

Prevalence of domestic violence

Sampling frame:
-No accurate data on households or population is available
Sample design:
2 stage sampling

1ststage –few panchayats

2ndstage -house to house or every …th house

Sample size:
4pq/d*d
Study tool: questionnaire
Mode of administration:
face-to-face interviews
Data entry –epidata
Analysis: SPSS or ….

7
Target population

•The target populationis the total group of individuals from which the sample might be
drawn.
•Eg: Adolescents in Vellore District

•A sample is the group of people who take part in the investigation

Frame population / Sampling frame

•Is the set of target population members that has a chance to be selected into the sample

•Inclusion criteria

•Exclusion criteria

•Sampling frame –listing of all units (people) in the target population

•Eg: list from data base/ census / telephone users

Sample population

•A fraction of the target population -selected as a sample form whom measurements will
be done (sample will be a small fraction of the target population)
•Respondents –those successfully measured
•The results from this sample population are used to make inferences on the
characteristics of the population
•The sample selected should be representative of the population.

8
 Biostatistics and Epidemiology
Case Control Studies
Dr. Divya Muliyil, MD
21 October 2023
Contents

During this session we will have a brief overview of what case controls studies are, the
steps we follow while designing and carrying out the case control study, biases that can
creep in during the design stage and while collecting data, how to analyze the data
collected and important features to keep in mind as we draw inferences from the
analysis.
Introduction and overview of case control study designs

Such information is always from an observation study

1
Hierarchy of evidence

The strongest evidence is that generated from Systematic reviews, metanalysis and
cohort studies. Why is it that the evidence generated from a case control study is
considered slightly inferior? This is something that we will understand by the end of this
session.

What is a case control study?

• In this study design we begin with the outcome, i.e. occurrence of disease
• We choose people with and without the condition we are studying (randomly)
• Measure exposure to various possible risk factors among those with the disease
(cases) and those without the disease (controls)
• Compare the odds of exposure to a risk factor among cases and odds of exposure
to the risk factor among the controls.

A quick recap of cohort studies

2
Disadvantages of a cohort study
• If the disease is very rare the study will have to include a very large number of
people
• Participants will have to be followed up for many years
• Very time consuming and requires a lot of resources

Why and when do we choose this study design?

• How would we answer this research question “Does low dose ionizing radiation
increase the occurrence of malignant tumors in humans?”
• Are there ethical issues in a cohort studies? (watching and estimating risk factors)
• How long would it take to complete a study with this design?
• During this period of time are there going to be other changes in the world
that can affect the outcomes of the study?
• Is it the best use of resources – material, personnel, and time?
There are 2 types of study designs that you have come across – observational and
experimental. In the experimental designs the investigator will choose and control the
level of exposure to a certain factor and then study the outcomes. In an observational
study the investigator simply measures if a participant has been exposed or not to
certain factors

3
Steps involved in a case control study

a. The research objective

 Usually, a case control study is used to study multiple risk factors
 Is used to study rare diseases
 “To study the factors associated malnutrition among children under years of
age in rural India”
 “To study the factors associated with pneumonia in under 5 children”

b. Sampling

Matching
• Individual – can be matched case by case e.g. on age and gender
• Frequency – overall equal no. of cases and controls with certain variables

c. Ascertainment of the exposure

Have an objective definition of an exposure
E.g.: “Use of alcohol”
Refine further : “ current user/ never used/ used in the past”
Refine further : “ no. of drinks per week”
OR a standardized score such as AUDIT/ CAGE questionnaire

Is maternal education associated with malnutrition among under 5 children?

4
Bias: Selection and information Bias

What is bias?
Any systematic error in an epidemiological study that results in an incorrect estimate of
the true effect of an exposure on the outcome of interest.

Source of bias
• Selection bias
• Information bias
• Recall bias
• Confounding

Selection bias – in selection of controls

Source of controls : hospital based / population based
Sampling technique : Ideally random
Main principle : They should be from the same population from which the cases emerge
So, if cases are people in the armed forces the controls should also be from the armed
forces because their occupational hazard is so unique.

Selection bias (through poor selection of controls)

• Research question 1: Are NSAIDS associated (increase risk) with colorectal
cancers?

5
 • Cases : Colorectal cancer patients admitted to hospital
• Controls : Patients admitted to the hospital with arthritis
• Non representativeness: Controls probably have high degrees of exposure to
NSAIDS
• Selection bias results in a reduction in the estimate of the effect (OR)

Ex 1: Selection of controls
• On a case control study related to heart attacks which population would be best
as controls
• A. Patients attending a COPD clinic?
• B. Patient attending a dermatology clinic?
• And why?
• Which hospital-based control would work better

Ex 2: Selection of controls
In a study on risk factors for oral cancer.
1. Patients admitted in the CCU with acute cardiac events
2. Relative of the patient who is disease free
3. A patient from the same part of the country attending the dental OPD for
other reasons

Selection bias – selection of cases

• Selecting cases who are more likely to be exposed
• The identification of individual subjects into the study based on exposure
• This may occur in the presence of surveillance systems
• For example, if there is a registry of people using OCPs and they are routinely
screened for DVTs  if they become the source population for cases there will be
an unusually high rate of exposure
• Survivors are more likely o be selected as cases (choosing prevalent cases vs
incident cases)

Matching controls and cases

• Cases and controls may be matched on important factors such as age and sex
• This is mainly done to reduce confounding

6
Measuring risk factors / exposures

Information bias
• Clear criteria for measuring each exposure factor
• Best of the interviewer is not aware if the participant is a case / control (Blinded)
• Information bias: when the interviewer has some information that skews the way
in which exposures are measured for cases and controls
• Cases are questioned in greater depth

Recall bias
• People remember things differently
• People who have had adverse health outcomes are more likely to remember
certain exposures
• For example, women with adverse obstetric or perinatal outcomes will remember
or would have spent more time reflecting on what could have possibly gone
wrong and may remember more than women who have moved on

Analysis
Odds ratio
• Measures strength of the association
• Relationship of disease and exposure in a target population
• If the lifetime probability of developing breast cancer is 1/14 then the odds of
developing cancer is 1/13
• In rare diseases the probability of disease is identical to that of the odds of disease.
• So, in rare diseases Odds ratio is same as the relative risk
• Can be estimated in a case control or a cohort study

7
Calculating exposure odds ratio

Odds of exposure among cases = 688/21 = 32.7 , odds of exposure among controls =
609/41 = 14.8
Odds ratio = 2.2

Calculating disease odds ratio

Odds of exposure among cases = 688/21 = 32.7 , odds of exposure among controls =
609/41 = 14.8
Odds ratio = 2.2
Exposure odds ratio = disease odds ratio

Interpreting the odds ratio

8
Odds ratio
• Measures the strength of association
• Relationship of disease and exposure in a target population
• If the lifetime probability of developing breast cancer is 1/14 then the odds of
developing cancer is 1/13
• In rare diseases the probability of disease is identical to that of the odds of disease.
• So, in rare diseases Odds ratio is numerically same as the relative risk

For example
100,000 doctors who have never smoked and another 100,000 doctors who smoked more
than 25 cigarettes a day were followed up for a period of 20 years.
At the end of the study period, it was found that among the non smokers 7 people had
died and among the smokers 227 people had died

Death rate among nonsmoking doctors = 7/100,000

Death rate among the doctors who smoked >=25 cigarettes a day = 227/100,000
Relative risk of death among smokers compared to nonsmokers = 227/7 = 32.43

Odds of death among smokers = 227/99773

Odds of death among nonsmokers = 7/99993
Odds ratio = ( 227/99773) /(7/99993) = 32.5

Odds ratio in a matched study

• When cases and controls are matched for an important confounder, the analysis
should be carried out retaining the matching
• Each pair of cases and controls are examined for exposure status

9
Exercise
In a study to measure the effect of socioeconomic status on the risk of low birth weight,
the following methodology was adopted.
All deliveries resulting in low birth weight at CHAD hospital from 1 January to 31 July
1993 were selected
For each case the next normal birth weight delivery of the same parity was chosen as a
control. Socio economic status of the family was assessed using a scale which score type
of house, land ownership, education of parents and occupation. The median score was
used as a cut off to classify high and low SES.

The results

Odds ratio = ad/bc = 90*60/60*30 = 3

Dose response

OR1 = a1d/b1c = 80*30/30*10 = 8,

Odds of babies from low SES families being LBW was 8 times that of those from high
SES families

OR2 = a2d/b2c = 30*30/60*10 = 1.5,

Odds of babies from middle SES families being LBW was 1.5 times that of those from
high SES families

Since cases and controls were matched for parity

Ideally a matched pair analysis should be done

10
OR = b/c = 40/10=4
Conditional logistic regression

Confounding

• Effect of an extraneous variable that wholly or partially accounts for the apparent
effect of the study exposure or that masks an underlying true association.
• Conditions to satisfy
• - it is a risk factor for the study disease
• - it is associated with the study exposure
• - but is not a consequence of exposure ( it is not on the causal path)
• Can be managed through stratified analysis or a logistic regression

Confounding – example

Strengths of the case control study design

• Useful to study rare diseases and especially diseases with a long period of latency
• Less time consuming
• Less expensive
• Can study multiple exposures at the same time

Limitations of the Case control design

• Multiple sources of bias
• Does not examine temporal relationships
• Not suitable for rate exposures

11
Summary
• They are less time consuming and require less resources than a cohort study
• Starting point , outcome has already occurred, and we measure the rate of
exposure among cases and controls
• Choice of controls is important, and they should be at the same risk of the disease
as the general population from which the cases emerged
• Multiple risk factors for a certain disease can be studied at the same time
• Exposure odds ratio is the same as disease odds ratio
• Stratifying and logistic regression can be used to handle confounders

Sample size calculation

Sample size for a Case control study

• N= 2 pq (Za + Zb)² / (P cases - P controls)²

P= p cases + p controls
2
P cases = P1
P controls = P0

12
 P cases = P control (OR)/ P cases (OR-1)+1
(OR
P cases = 0.236x2.25/ 0.236(2.25-1)+1
0.236(2.25
P cases = 0.41
N= 2pq (Za+Zb)²/
)²/ (P cases - P controls)²
N= 2*0.375*0.675*7.84/ (0.41
(0.41-0.236) ² = 120

Unequal cases and controls

C= no of controls/no of cases
First calculate n using usual formula
Then
• New sample size for no of cases = n (C + 1)/2 C
• New no of controls = New case sample size X C

13
Example
Objective: To determine whether patients with carcinoma of the lung differed materially
from other persons in respect of their smoking habits ?

Methodology
Case design: Case control study
Study setting : 20 London hospitals were asked to notify all patients with carcinoma of
the lung/ stomach/colon/rectum
(admitting clerk, house- physician, cancer registrar or the radiotherapy department)

Defining cases
• Those with an admission diagnosis of cancer
• Once the house physician was sure that the person had a diagnosis of cancer
• Anyone on the cancer register
• Patients visiting the radiation therapy department for cancer care
• Exclusion criteria – people above the age of 75, unlikely to get a reliable history
from elderly people or if autopsy finally confirmed an alternative diagnosis.
• Could we refine this any further in today’s world

Sampling of cases
• From 20 hospitals of London
• All notified cases were eligible to participate
14
 • What are the pros and cons of this strategy of identifying cases only through
hospitals ?
• What are the various sources for identifying cases? Example – oral cancer,
pneumonia, malnutrition

Controls – definition and sampling

• For every case there was one control identified – within a 5-year age band, same
gender , admitted in the same hospital at the same time.
• When there was more than one suitable control the first one on the ward list
prepared by the ward sister was used.
• How do we confirm if a control is truly disease free?

Where can we ideally find controls ? Hospital based vs community based . This is the
most important step , is being disease free sufficient? Controls should be at a similar risk
of disease as the general population from which the cases emerged

Ascertaining a history of smoking

• A smoker was defined as a person who had smoked as much as one cigarette a
day for as long as one year. (any less was ignored)
• History of smoking pipes / cigarettes
• Have you ever smoked
• Duration : Age at which they started smoking, years / age at which they had
stopped smoking (if they had stopped), maximum no. of cigarettes they were in
the habit of smoking
• Degree of exposure : No. of cigarettes smoked and history of inhaling the smoke
• Pipes vs cigarette use

(a) if they had smoked at any period of their lives; (b) the ages at which they had started
and stopped; (c) the amount they were in the habit of smoking before the onset of XJPe
illness which had brought them into hospital; (d) the main changes in their smoking
history and the maximum they had ever been in the habit of smoking; (e) the varying
proportions smoked in pipes and cigarettes; and (f) whether or not they inhaled.

15
 Biostatistics and Epidemiology
Health system delivery structure India and NHP
Dr Dorothy Lall

Objectives
• To describe health care delivery in India
• Use a health system framework to understand structure of health care
organization
• To identify salient features of the national health policy
• To be aware of values, politics and power in policy and practice of health care
Health care delivery
• Part of health care system
• Purpose of health care delivery
• Who’s responsibility
Health care organization

1
Rural Health Care delivery

HS Frameworks
Many
• Descriptive
• Analytic
• Predictive
(Hsiao and Siadat 2008)

2
 WHO Health system framework

System approach to health

Van Olmen framework - Van Olmen etal 2012

3
Leadership/Governance
• the State (government organizations and agencies at central and sub-national
level);
• the health service providers (different public and private for and not for profit
clinical, para-medical and non-clinical health services providers; unions and other
professional associations; networks of care or of services);
• the citizen (population representatives, patients’ associations, CSOs/NGOs,
citizens associations protecting the poor, etc.) who become service users when
they interact with health service providers.

Models based on governance

• Public/ Private/ Mixed
• Centralized/ Decentralized
• Horizontal/Vertical

Strategies- Horizontal and vertical

• By horizontal delivery, services are delivered through public financed health
systems and are commonly referred as comprehensive primary care (WHO 1978).
• Vertical delivery of health services implies a selective targeting of specific
interventions not fully integrated in health systems (Banerji 1984; Rifkin and Walt
1986).
• Decentralization

Decentralization
To improve
• administrative and service delivery
• effectiveness, increase local participation and
• autonomy, redistribute power, and reduce ethnic and
• regional tensions;
Decentralization is also used as a
• means of increasing cost efficiency, giving local units
• greater control over resources and revenues, and
• increasing accountability
(Brinkerhoff and Leighton 2006)

4
Types of decentralization
• De-concentration: the transfer of authority and responsibility from the central
office to field offices of the same agency.
• Delegation: the transfer of authority and responsibility from central agencies to
organizations outside their direct control, for example, to semiautonomous
entities, NGOs, and regional or local governments.
• Devolution: the transfer of authority and responsibility from central government
agencies to lower level autonomous units of government through statutory or
constitutional measures.
• Privatization: sometimes considered a separate type of decentralization.

Financing - Who pays for health care?

PURCHASING ….
• TYPE OF PROVIDERS
• Depends on the services purchased
• Depends on the providers available
• REIMBURSEMENT MECHANISMS
• Salaries
• Fee for services
• Case based
• Capitation

Functions of health financing

5
COLLECTION
• SOURCE OF FUNDS
• Individual households through direct payments
• Individual households through taxes
• Individual households through premiums
• Companies
• Donors
• COLLECTION AGENCY
• Government
• Insurance companies
• Parastatal organisations
• Individuals

FINANCING MECHANISMS
• Direct payments
• Pre – payments
• Tax based financing mechanism
• Insurance based financing mechanism
• Medical savings account
• Donors (grants / loans)
EXAMPLES

COLLECTION POOLING PURCHASING

UK From taxes Government Private

Sri Lanka From taxes Government Public

Germany From premium Insurance company Private

(not for profit)

France From premium Insurance company Public

(not for profit)

USA From premium Insurance company Private

(for profit)

India OOP Nil Nil

6
Workforce

• Nurse led vs Doctor models- Africa

• Community health worker led services – Iran
• Team based models

Information system
• Surveillance models
• Proactive continuum of care models

Service delivery / medicines and technologies

• Primary, secondary , tertiary

• Rural/ Urban
• Digital platforms
• Home based care

Distinction

• Health System vs. Health Care delivery System

“A health system consists of all organizations, institutions, people and
actions whose primary intent is to promote, restore or maintain health.”
(WHO, 2007)

Indian Health care delivery

• Mixed and plural

• Governance structure
• Financing
• Health care delivery facilities- levels of care
• Work force

7
National Health Policy

• What is a policy
• Scope of national policy
• History- 1983, 2002 and 2017

Health policy 1983

• The Ministry of Health and Family Welfare, Govt. of India, evolved a National
Health Policy in 1983 till 2002.
• The policy lays stress on preventive, promotive, public health and rehabilitation
aspects of healthcare.
• The policy stresses the need of establishing comprehensive primary health care
services to reach the population in the remote area of the country.
• India had its first national health policy in 1983 i.e. 36 years after independence
• India had its first national health policy in 1983 i.e. 36 years after independence

Objectives of NHP 1983

i) A phased, time-bound programme for setting up a well-dispersed network of
comprehensive primary health care services, linked with extension and health education,
designed in the context of the ground reality that elementary health problems can be
resolved by the people themselves.
(ii) Intermediation through ‘Health volunteers’ having appropriate knowledge, simple
skills and requisite technologies;
(iii) Establishment of a well worked out referral system to ensure that patient load at the
higher levels of the hierarchy is not needlessly burdened by those who can be treated at
the decentralized level;
(iv) An integrated net-work of evenly spread speciality and super-speciality services;
encouragement of such facilities through private investments for patients who can pay,
so that the draw on the Government’s facilities is limited to those entitled to free use.

It was critical of the curative-oriented western model of health care

Emphasized a preventive, promotive and rehabilitative primary health care approach

8
Recommended a decentralized system of health care, the key features of which were low
cost, deprofessionalisation (use of volunteers and paramedics), & community
participation, expansion of the private curative sector which would help reduce the
government's burden. But by the end of 2000 century it was clear that the goals of health
for all by the year 2000 AD would not be achieved ......
The observed progress suggested that we may need some new and additional strategy or
new sizable intervention in achievement of an unacceptable health of the country.

NHP 2002
A revised health policy for achieving better health care and unmet goals has been
brought out by government of India- National Health Policy 2002.
According to this revised policy, government and health professionals are obligated to
render good health care to the society.
Optimizing the use of health service to a large group rather than a small group is a
foreseen event by the NHP 2002.
Inclusion of social policies adds to the credit of the revised NHP 2002

Key strategies
• Primary Health Care Approach
• Decentralized public health system
• Convergence of all health programme under single field umbrella
• Strengthening and extending public health services
• Enhanced contribution of private and NGO sector in health care delivery.
• Increase in public spending for health care.

NHP 2017
Objective-
Improve health status through concerted policy action in all sectors and expand
preventive, promotive, curative, palliative and rehabilitative services provided through
the public health sector with focus on quality. Progressively achieve Universal Health
Coverage
A. Assuring availability of free, comprehensive primary health care services, for all
aspects of reproductive, maternal, child and adolescent health and for the most prevalent
communicable, non-communicable and occupational diseases in the population. The
9
Policy also envisages optimum use of existing manpower and infrastructure as available
in the health sector and advocates collaboration with non -government sector on pro-
bono basis for delivery of health care services linked to a health card to enable every
family to have access to a doctor of their choice from amongst those volunteering their
services.
B. Ensuring improved access and affordability, of quality secondary and tertiary care
services through a combination of public hospitals and well measured strategic
purchasing of services in health care deficit areas, from private care providers, especially
the not-for profit providers
C. Achieving a significant reduction in out of pocket expenditure due to health care costs
and achieving reduction in proportion of households experiencing catastrophic health
expenditures and consequent impoverishment.

Policy thrusts
• Reinforcing trust in Public Health Care System
• Ensuring Adequate Investment
• Preventive and Promotive Health
• Align the growth of private health care sector with public health goals:

Organization of Public Health Care Delivery

• The policy proposes seven key policy shifts in organizing health care services
 In primary care – from selective care to assured comprehensive care with linkages
to referral hospitals
 In secondary and tertiary care – from an input oriented to an output based
strategic purchasing o In public hospitals – from user fees & cost recovery to
assured free drugs, diagnostic and emergency services to all
 In infrastructure and human resource development – from normative approach to
targeted approach to reach under-serviced areas

Organization of care
In urban health – from token interventions to on-scale assured interventions, to organize
Primary Health Care delivery and referral support for urban poor. Collaboration with
other sectors to address wider determinants of urban health is advocated.

10
 o In National Health Programmes–integration with health systems for programme
effectiveness and in turn contributing to strengthening of health systems for
efficiency.
o In AYUSH services – from stand-alone to a three dimensional mainstreaming

Free primary care provision by the public sector, supplemented by strategic purchase of
secondary care hospitalization and tertiary care services from both public and from non-
government sector to fill critical gaps would be the main strategy of assuring healthcare
services.

Policy Thrust- programs

1. The Swachh Bharat Abhiyan
2. Balanced, healthy diets and regular exercises.
3. Addressing tobacco, alcohol and substance abuse
4. Yatri Suraksha - preventing deaths due to rail and road traffic accidents
5. Nirbhaya Nari -action against gender violence
6. Reduced stress and improved safety in the workplace
7. Reducing indoor and outdoor air pollution

Implementation
• Ayushmann Bharat- 2 pillars
• Health and wellness centres
• National Health Insurance
• Digital India- ABDM ecosystem

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