The 6 D’s of Health

Outcomes
 Death
 A bad outcome if Untimely

 Disease  A set of Symptoms, Signs and Lab

results
 Discomfort
 Symptoms such as pain, nausea and
itching
 Disability
 Impaired ability to go about usual
activities
 Dissatisfaction
 Emotional reaction to disease and its
 Destitution care

 Financial Cost of Illness

 Clinical Questions
 AbnormalityIs the patient sick or well
 Frequency How often does disease occur
 Diagnosis How accurate are the diagnostic tests
 Cause What conditions lead to disease
 Risk What factors are associated with the disease
 Prognosis What are the consequences of disease
 Treatment How does treatment change the course
 Prevention Does an intervention prevent disease
Does an early detection improve the course
 Cost How much will care cost
Non Interventional Studies
(Observational)

Interventional Studies
(Experimental)
 Epidemiological Studies
Descriptive Studies
Describes Disease occurrence in a population
 Incidence
 Prevalence
 Survivial

Analytic Studies
To determine etiology of disease
 Cohort
 Case Control
 Cross Sectional
 EPIDEMIOLOICAL METHODS

OBSERVATIONAL STUDIES EXPERIMENTAL STUDIES

(NON INTERVENTIONAL) (INTERVENTIONAL)

Descriptive Analytical
studies Studies
Randomized
Controlled Trials

Cross Sectional Case Control

Field trials

Longitudnal Cohort
Community Trials
Descriptive Analytic
•Case report
•Case series
•Survey Observational Experimental
•Cross sectional •Randomized
•Case-control controlled trials
•Cohort studies

Strength of evidence for causality between a risk factor and outcome

 Epidemiological sequence
 Observation – data collection

 Counting cases and events

 Relating cases and events to population at risk

 Making comparison

 Developing hypothesis

 Testing of hypothesis by analytical studies

 Making scientific inferences

 Conducting experimental studies

 Interventions/Evaluation
FIRST THING’S FIRST…..!!!!

1. DESCRIPTIVE STUDY
 Definition
It involves the systematic collection and
presentation of data to give a clear picture of
a particular situation.

Descriptive can be carried out on small or

large scales in community
 Concerns
Descriptive study is concerned with the
following questions:
a. When is the disease occurring (Time)
b. Where it is occurring (Place)
c. Who is getting the disease (Person)

T.P.P
 Procedures
 Defining the population to be studied
 Defining the disease under study
 Describing the disease by
 Time
 Place
 Person
 Measurement of the disease
 Cross Sectional Study
 Logitudinal Study
 Comparing with known indices
 Formulation of an etiological hypothesis
1. Defining the
population
Descriptive studies are investigations of
populations, not individuals. The first step is to
define the “population base” not only in terms
of
total number
composition in terms of age
Sex
Occupation
cultural characters
similar information needed for the study.
Characters of a “defined
population”
The whole population in a geographic area, or more
often a representative sample taken from it.
It can be a specially selected group such as age and
sex groups, occupational groups, hospital patients,
school children, small communities as well as wider
groupings – wherever a group of people can be fairly
accurately counted.
Needs to be large enough so that age, sex and other
specific rates are meaningful.
Characters of a “defined
population”
The community chosen should be stable.
It should be clear who does and who does
not belong to the population.
The population should not be overtly
different from other communities in the
region.
A health facility should be close enough to
provide relatively easy access for patients
requiring medical services.
Characters of a “defined
population”
The concept of ‘defined population’ (or
population at risk) is crucial in epidemiological
studies.
It provides the denominator for calculating
rates which are essential to measure the
frequency of disease and study its distribution
and determinants.
Epidemiologists therefore have been labeled
as men in search of a denominator.
2. Defining the disease under
study
Once the population to be studied is
defined or specified, one must then define
the disease or condition being
investigated.
Here the needs of the clinician and
epidemiologist may diverge.
 The Clinician Vs
Epidemiologist
The clinician may not need a precise definition of
disease (e.g. migraine) for immediate patient
care. If the diagnosis is wrong, he can revise it
subsequently.

The epidemiologist, whose main concern is to

obtain an accurate estimate of disease in a
population, needs a definition that is both precise
and valid to enable him (or observers working in
field conditions) to identify those who have the
disease from those who do not.
The diagnostic method for use in
epidemiological studies must be acceptable to
the population to be studied, and applicable to
their use in large populations.
3. Describing the disease
The primary objective of descriptive
epidemiology is to describe the occurrence
and distribution of disease (or health-related
events or characteristics within populations)
by time, place and person, and identifying
those characteristics associated with presence
or absence of disease in individuals.
Characteristics frequently
examined in descriptive studies
Time Place Person
Year, season Climatic zones Age Birth order
Month, week Country region Sex Family size
Day, hours of Urban/rural Marital status Height
onset, Local community Occupation Weight
duration Towns Social status Blood pressure
Cities Education Blood cholesterol
Institutions Personal habits
Time distribution
The pattern of disease may be described by
the time of its occurrence, i.e., by week,
month, year, the day of the week, hour of
onset, etc. It raises questions whether the
disease is seasonal in occurrence; whether it
shows periodic increase or decrease; or
whether it follows a consistent time trend.
 Time trends or fluctuations in
disease occurrence.

I. Short-term fluctuations
II. Periodic fluctuations, and
III. Long- term or secular trends
 Endemic, Epidemic and
occurrence) of a
Pandemic
Endemic - The habitual presence (or usual
disease within a given
geographic area
Epidemic - The occurrence of an infectious disease
clearly in excess of normal expectancy, and
generated from a common or propagated
source
Pandemic - A worldwide epidemic affecting an
exceptionally
Number high proportion of the
global
of Cases population
of “Endemic”
Disease

“Epidemic”

Time
 Three major types of epidemics may be
distinguished.

a) Common source
• Single exposure or “point source” epidemics.
• Continuous or multiple exposure epidemics.
a) Propagated epidemics.
• Person-to-person
• Arthropod vector
• Animal reservoir
a) Slow (modern) epidemics
PLACE DISTRIBUTION
(geographical comparisons)
Studies of the geography of disease (or
geographical pathology) is one of the
important dimensions of descriptive
epidemiology.
By studying the distribution of disease in
different populations we gain perspective on
the fascinating differences (or variations) in
disease patterns not only between countries,
but also within countries.
Geographic patterns provide an important
source of clues about the causes of the
disease.
The range of geographic studies include those
concerned with local variations.
At a broader level, international comparisons
may examine mortality in relation to socio-
economic factors, dietary differences and the
differences in culture and behaviour.
 These variations may be
classified as:

a) International variations
b) National variations
c) Rural-urban differences
d) Local distributions
International variations
Descriptive studies by place have shown that
the pattern of disease is not the same
everywhere.
There is a marked difference between the
incidence of each cancer in different parts of
the world.
Gastric Carcinoma is more common in Japan
while Esophageal is more common in Iran and
Afghanistan
Cancers of the oral cavity and uterine cervix
are exceedingly common in India as compared
to industrialized countries.
An international study of breast cancer
showed that rates differ widely from country
to country with the lowest prevalence in Japan
and the highest in the western countries.
There are marked international differences in
the occurrence of cardiovascular diseases.
These variations have stimulated
epidemiologists to search for cause-effect
relationships between the environmental
factors and disease. The aim is to identify
factors which are crucial in the cause and
prevention of disease.
National variations
It is obvious that variations in disease
occurrence must also exist within countries or
national boundaries.
For example the distribution of endemic
goitre, fluorosis, guinea-worm disease,
malaria, nutritional deficiency diseases have
all shown variations in their distribution in
Pakistan, with some parts of the country more
affected and others less affected or not
affected at all.
Such situations exist in every country. One of
the functions of descriptive epidemiology is to
provide data regarding the type of disease
problems and their magnitude in terms of
incidence, prevalence and mortality rates.
Such information is needed to demarcate the
affected areas and for providing appropriate
health care services.
Rural-urban variations
Urban Predominance Rural Predominance
Chronic bronchitis • skin Infections

Accidents • zoonotic diseases

lung cancer • soil-transmitted

helminths
cardio-vascular
• Death rates, especially
disease
infant and maternal
mental illness
mortality rates, are
drug dependence higher for rural than
are urban areas.
Causes of Rural/Urban
Variations
Population density
Social class
Deficiencies in medical care
Levels of sanitation
Education
Environmental factors.
The epidemiologist seeks to define groups which
are at higher risk for particular diseases, and
provides guidelines to the health administrator
for their prevention and control.
Local distributions
Inner and outer city variations in disease frequency
are well known.
These variations are best studied with the aid of ‘spot
maps’ or ‘shaded maps’.
These maps show at a glance area of high or low
frequency, the boundaries and patterns of disease
distribution.
For example if the map shows “clustering” of cases, it
may suggest a common source of infection or a
common risk factor shared by all the cases. It was by
such a study (spot map of fatal cases),
Geographic spot map showing areas of high and low density
Rate per lakh population

Bimodality of Hodgkin’s disease distribution

John Snow of England in his classic
investigation of cholera epidemic in 1854 in
the Golden Square district of London was able
to focus attention on the common water pump
in Broad street as the source of infection.
Based on his descriptive findings. Snow was
able to hypothesize that cholera was a water-
borne disease, long before the birth of
bacteriology.
Migration studies
Large scale migration of human populations
from one country to another provides a
unique opportunity to evaluate the role of the
possible genetic and environmental factors in
the occurrence of disease in a population.
Migrant studies have shown that men of
Japanese ancestry living in USA experience a
higher rate of coronary hear disease than do
the Japanese in Japan
Person distribution
This means describing the distribution of a
disease in the community with reference to
the host characters of the persons affected,
such as age, sex, occupation, marital status,
social class, behavior, and such other factors.
Age
Age of an individual is strongly related to
the disease. Certain diseases occur more
frequently in certain age group.
Ex: Measles and Diphtheria among pre
school children, Cancer in the middle age,
Atherosclerosis among elderly.
 But there are certain disease like Hodgkin’s
disease and Leukemia, which has increased
incidence in two age groups.
Ex: Hodgkin’s disease is more between 15 to
35 years and between 70 to 90 years. Such
a tendency of a disease to show two
separate peaks, is called “Bimodality
phenomenon.”
Sex
Certain diseases are more common among
men. Ex: Lung cancer, coronary heart disease
and some are more common among women.
Ex. Diabetes, obesity, myxoedema, ect. Such a
difference may be because of either genetic
constitution or cultural and behavioral factors
like smoking drinking alcohol, etc.
Marital Status
This often becomes a risk factor. Cancer
cervix is rare in nuns compared to married
women. Similarly mortality rates are high
among unmarried than among married
persons. This is because married people
lead a secured and protected life.
Occupation
many diseases are related to occupation.
Persons working in particular occupations
are exposed to particular types of risks.
Ex: Tetanus, Ankylostomiasis are common
among agriculturist workers, Respiratory
dusty diseases (pneumoconiosis) are
common among industrial workers,
accidents among drivers, etc
Social Class
Diseases like Hypertension, diabetes, coronary
artery diseases are common among people of
higher socio-economic class
Diseases like Malnutrition, Rheumatic heart
disease and communicable diseases are common
among people of lower socio-economic class.
Thus social factors like poverty, illiteracy,
ignorance, poor standard of living, overcrowding,
etc play a very important role in the development
of the diseases in the community. Since the social
classifications vary from one country to another
country, it is difficult to compare the results.
Behavior
Human life-style or behavior such as
smoking, alcholism, over eating, multiple
sexual partnership, drug-abuse, etc
influence the development of the disease.
Thus study of these risk factors help the
epidemiologist to formulate an etiological
hypothesis.
Stress
Stress increases the susceptibility of an
individual to the disease and often
exacerbates the symptoms.
Migration
Movement of the people from rural to urban
areas has resulted in the spread of diseases
from one place to another. Migration of the
people is a challenge for the prevention and
control of the disease.
Measurement of Disease
a. Cross Sectional Study

b. Longitudinal Study
Cross sectional studies

Based on a single examination of

a cross section of population at
one point in time, results of
which can be projected on the
whole population provided the
sampling has been done
correctly.
 Uses
a. More useful in chronic diseases

b. To find more about disease rather than its

etiology
 Characteristics
 Physical characteristics of people, material
and environment

 Socio-economic characteristics e.g., age,

education , marital status, number of children
and income

 Behavior of people like knowledge, attitude

and beliefs (KAP)

 Events that occur in population

 Advantages of CSS
 May study several outcomes

 Control over selection of subjects

 Control over measurements

 Relatively short duration

 First step for cohort study

 Yields prevalence
 Disadvantages of CSS
Does not establish cause/effect ratio

Potential bias in measuring exposure

Potential survival bias

Not feasible for rare disease

Does not yield incidence

 Longitudinal Study

Based on multiple observations in

the same population over a prolong
period of time.
 Uses of Longitudinal Study

Natural History of Disease

Identifying Risk factors

Finding out incidence rate

Cross Sectional Vs
Longitudinal
Making Comparison with Known
Indices
The observations are compared with different
groups. This helps to fine out the etiological
factors and also helps to identify the “Risk”
group, so that preventive measures can be
adopted
Formulation of Etiological
Hypothesis
Specify
The population
The specific cause being studied
The expected outcome of the disease
Cause and effect relationship
Dose-response relationship.
 Uses
 Provides data regarding
 The magnitude of the disease load

 The types of disease problem in the

community in term of morbidity and mortality
rate and ratio

 Provides “clues” to the disease etiology

 Helps in
 Formulation of etiological hypothesis

 Helps in planning, implementation and

evaluation of health services/programmes
COMPARATIVE or ANALYTICAL
STUDY

An ANALYTICAL STUDY attempts to

establish causes or risk factors for
certain problems. This is done by
comparing two or more groups,
some of which have or develop the
problem and some of which have
not.
 Analytic Epidemiology
 Second major type of epidemiological studies

 Subject of interest is individual within the

population

 The objective is to test hypothesis

 The study determines whether or not a

statistical association exists between a
disease and suspected factor

 Strength of association, if it exists

 CASE CONTROL STUDY

In a CASE-CONTROL STUDY, the

investigator compares one group
among whom a problem is (e.g.,
malnutrition) with another group,
called a control or comparison
group, where the problem is absent
to find out what factors have
contributed to the problem.
CASE CONTROL STUDY
Often called retrospective study

First approach to test causal

hypothesis
 Properties
Both exposed and outcome (Disease) have
occurred before the start of study

The study proceeds backward from effect

to cause

It uses a control or comparison group to

support or refute an inference
 Case Control VS Cohort Study
CASE CONTROL STUDY
Factors
Disease
 Present
 Present (Cases)

 Absent
 Absent (Controls)

COHORT STUDY
Risk Factors
Disease
 Exposed
 Present on Followup

 Unexposed
 Absent on Followup

TIME LINE
 Method
 Selection of cases and Controls

 Matching

 Measurement of Exposure

 Analysis and Interpretation

 Exposure Rates

 Estimation of Risk (Relative Risk & Odds

Ratio)
Selection of Case and
Controls
Selection of Case
Cases can be selected from a variety of
sources including hospital patients, private
clinics or general population. Many
communities maintain registries of patients
with certain disease, such as cancer and these
registries serve as valuable sources of cases.
 The entire case series or a random sample of
it is selected for study.
• General population:
In a population-based case control study, all
cases of the study disease occurring within a
defined geographic area during a specified
period of time are ascertained, often through
a survey, a disease registry or hospital
network.
Case Definition
Appropriate ‘case definition’ should be made.
“Diagnostic criteria” for case selection should
be clearly specified.

Eligibility Criteria
It is considered that for better study results
incident cases (newly diagnosed cases) are
more eligible than old cases in an advanced
stage of disease.
Selection of controls
Controls must be free from the disease under
study.

Sources of Control
Hospital controls
Relatives
Neighborhood
General population
Number of Controls
If the study group is large one control may be
identified for each case. For small study
groups (<50) as many as 2,3 or even 4
controls may be selected for each case.
Matching
Process of selecting controls so that they are
similar to the case in characteristic such as
age, race, sex, socioeconomic status and
occupation.
Matching is done to ensure comparability
between cases and controls. In other words
matching is done to eliminate
“confounding factors”.
Confounding Factor
This factor although associated with exposure
under investigation is an independent risk
factor for the disease in itself.
Examples:
1. In the study of role of alcohol in the aetiology of
oesophageal cancer, smoking is a confounding
factor because it is associated with alcohol
consumption and smoking is an independent risk
factor for oesophageal cancer.
2. Age could also be a confounding variable. If
women taking oral contraceptives were younger
than those in the comparison group, they would
be at lower risk of breast cancer since this disease
is common with increasing age.
Type of Matching
Matching may be of two types:
• Group matching
• Individual matching
Group Matching (frequency
matching):
Controls are selected in such a manner that the proportion of
controls with a certain characteristic is identical to the proportion
of cases with the same characteristic. Thus, if 25% of the cases
are married, the controls will be selected so that 25% of that
group is also married.
Individual Matching (matched
pairs):
For each case selected for the study, a
control is selected who is similar to the
case in terms of the specific variable or
variables of concern, for example, if the
first case enrolled in a study is a 45-
year-old white female, control also will
be a 45-year-old white female.
Measuring Exposure
Interviews on exposure is measured by
using questionnaires, past records
(hospital, employment etc). This should
be done in a precise manner for both
cases and controls.
Estimating Risk
Odd ratio: it is the ratio of the odds that a case
was exposed to the risk factor to the odds that a
control was exposed to the risk factor.
Odds ratio is a cross product ratio.
Formula
Exposed with disease x unexposed without disease
=
Exposed without disease x unexposed with disease

Odds ratio: a b = ad
C d bc
 Significance: OR provides a reasonably
good estimate or relative risk provided
that the:
• Incidence of disease is low (as in chronic
disease).
• Cases and controls are representative.
the odds ratio is similar to relative risk as
both demonstrate the strength of the
association between the risk factors and
the disease (but in different ways). Odds
ratio is also referred at time as
“estimated relative risk”.
Inference
OR = 1: Risk factor not related to the
disease.
OR < 1: Risk factor is a actually protective
factor against the disease.
OR > 1: Risk factor positively associated
with the disease.
 Odds Ratio (OR)
 Measure of the strength of the association between risk
factor and outcome.

 The derivation of the Odds Ratio is based on three

assumptions:

- the disease being investigated must be relatively rare

- the cases must be representative of those with the

disease

- the controls must be representative of those without

disease
Analysis
Relative risk (RR) Attributable risk
Ie (AR)
RR = ----- Ie-Io
Io AR = -------- X100
Ie

• Whereas
Ie : Incidence among exposed
Io : Incidence among non
exposed
 Relative Risk (RR)
Ratio of incidence of the disease (or

death) among exposed and the incidence

among non-exposed.

It is a direct measure (or index) of the

“strength” of the association between

suspected cause and effect

Role of relative risk in case-control
studies

Incidence rates cannot be obtained from

a typical case control study from which
relative risk can be calculated since
there is no appropriate denominator or
population at risk. In general relative
risk can be exactly determined only
from a cohort study.
 Oral contraceptives and
Thromboembolic disease
Period: 1968 – 1969
Cases: Women admitted in hospitals with
venous thrombosis or pulmonary
embolism without medical causes.
Controls: Women admitted to the same
hospital with other disease matched for
age, marital status and party.
Conclusion: Users of oral contraceptives
were 6 times likely as nonusers to
develop thromboembolic disease.
Thalidomide Tragedy
Study Period: 1958 – 1961
Cases: 46 mothers who delivered deformed
babies.
Controls: 300 mothers who delivered normal
babies.
conclusion: 41 out of 46 mothers had
thalidomide during their early pregnancy.
Bias in epidemiological
studies
These are systematic errors occurring in
epidemiological studies. About 35 different
types of biases exists. The important bias
are:
1) Selection bias
2) Information bias (Recall bias)
3) Interviewer’s bias
4) Confounding bias
Selection bias:
This is due to systematic difference between the
characteristics of the people selected for the study
and the characteristics of those who are not.
For example
In a clinical trial for evaluating new drugs for
treatment of myocardial infarction, if older
people are excluded from the group getting the
new drugs, this will lead to a selection bias
(because older people have poorer prognosis
and they are intentionally not included in study
group).The bias will result in the new drug
having higher survival rate.
Information bias (recall
bias)
Individual with a disease tend to report
past events more accurately than those
without a disease leading to recall bias.
Interviewer’s bias
If the interviewer tends to probe for
answers more while interviewing cases
as compared to interviewing controls,
this will lead to information bias.
Confounding bias
While studying association between exposure
and outcome (disease) confounding can occur
when another exposure exists in the study
population and is associated with both the
disease and the exposure being studied. For
example, if an association is found to exist
between coffee drinking and coronary heart
disease, then this association may not be a true
association due to confounding.
The confounding factor here could be
cigarette smoking, people who drink coffee
are more likely to smoke than people who do
not drink coffee. It is well known that
smoking is associated with CHD. It is thus
possible that the relationship between coffee
and CHD is actually the reflection of strong
association between smoking and CHD.
Smoking here confounds the observed
association between coffee drinking and
CHD.
Berkson bias
This bias occurs due to different
admission rates in hospitals. Each
hospital will have an independent
admission policy and therefore certain
disease may be given more priority in
that hospital. This type of bias is
commonly taken into account in case-
control studies.
2 x 2 Contingency Table for Cases and Controls

Cases Controls

Exposure + A B
Exposure - C D
Total Cases A+C B+D
Exposure Among Cases Exposure Among Controls
A/(A+C) B/(B+D)
Advantages of case control study
 Relatively easy to carry out
 Rapid and inexpensive
 Particularly suitable to investigate rare
diseases
 No risk to subject
 Reveals the study of several different
etiological factors
 Risk factors can be identified
 No follow up in the future
 Minimum ethical problems
 Disadvantages of case control
study

Problems of bias

Selection of appropriate case control group

may be difficult

Cannot measure incidence, only relative

risk is measured
 Randomized controlled
trials
Investigator controls the predictor variable
(intervention or treatment)
Major advantage over observational studies is
ability to demonstrate causality
Randomization controls unmeasured
confounding
Only for mature research questions
Population Treatment Dx No Dx

Sample Randomization

Control
Placebo Dx No Dx
 Steps in a randomized
controlled trial
1. Select participants
 high-risk for outcome (high incidence)
 Likely to benefit and not be harmed
 Likely to adhere
1. Measure baseline variables
2. Randomize
 Eliminates baseline confounding
 Types (simple, stratified, block)
 Steps in a randomized
controlled trial
4. Blinding the intervention
 As important as randomization
 Eliminates
 co intervention
 biased outcome ascertainment
 biased measurement of outcome

5. Follow subjects
 Adherence to protocol
 Lost to follow up
6. Measure outcome
 Clinically important measures
 Adverse events
 Analysis of randomized
controlled trial
Analyzed like cohort study with RR
Intention to treat analysis
Most conservative interpretation
Include all persons assigned to intervention
group (including those who did not get
treatment or dropped out)
Subgroup analysis
Groups identified pre-randomization
High Quality Randomized
Trials
Tamper-proof randomization
Blinding of participants, study
staff, lab staff, outcome
ascertainment and adjudication
Adherence to study intervention
and protocol
Complete follow-up
 What is Blinding?
Single
 Single blind
blind -- participants
participants are
are not
not aware
aware
of
of treatment
treatment group
group
Double
 Double blind
blind -- both
both participants
participants and
and
investigators
investigators unaware
unaware
Triple
 Triple blind
blind -- various
various meanings
meanings

 persons
persons who
who perform
perform tests
tests

outcome
outcome adjudicators
adjudicators

safety
safety monitoring
monitoring group
group
Why blind?: Co interventions
 Unintended effective interventions
 participants use other therapy or change behavior
 study staff, medical providers, family or friends
treat participants differently
 Nondifferential - decreases power
 Differential - causes bias
 Why
Why blind?:
blind?: Biased
Biased Outcome
Outcome
Ascertainment
Ascertainment oror adjudication
adjudication
If
 If group
group assignment
assignment is
is known
known

 participants
participants may
may report
report symptoms
symptoms or
or outcomes
outcomes
differently
differently

physicians
physicians oror investigators
investigators may
may elicit
elicit symptoms
symptoms or
or
outcomes
outcomes differently
differently

Study
Study staff
staff or
or adjudicators
adjudicators may
may classify
classify similar
similar
events
events differently
differently inin treatment
treatment groups
groups

Problematic
 Problematic with
with “soft”
“soft” outcomes
outcomes

investigator
investigator judgement
judgement

participant
participant reported
reported symptoms,
symptoms, scales
scales
 COHORT STUDY
In a COHORT STUDY, a group of individuals
that is exposed to a risk factor (study group) is
compared with a group of individuals not
exposed to the risk factor (control group).
The researcher follows both groups over time

Compares the occurrence of the problem

related to the risk factor in the two groups

Determines whether a greater proportion of

those with the risk factor are indeed affected
CONCEPT OF COHORT

The term Cohort is defined as group

of people who share a common
characteristic or experience within a
defined time period e.g., age,
occupation, exposure of a drug or
vaccine, birth cohort and marriage
cohort etc.
Distinct features of cohort
study
The cohort are identified prior to the
appearance of disease under study.
The study groups so defined observed over a
period of time to determine the frequency of
the disease among them
The study proceeds forward from cost to
effect
2 x 2 Contingency Table for Cohort Study

Total
Disease + Disease -
Exposed
Risk Factor + A B A+B
Risk Factor - C D C+D

Incidence Among Exposed Incidence Among Unexposed

A/(A+B) B/(B+D)
 Elements of a cohort
study
Selection of the study group
Obtaining data on exposure
Selection of the comparison group
Follow up
Analysis
 Strengths of cohort
studies
Know that predictor variable was present before
outcome variable occurred (some evidence of
causality)

Directly measure incidence of a disease outcome

Can study multiple outcomes of a single

exposure (RR is measure of association)
 Weaknesses of cohort
studies
Expensive and inefficient for studying rare
outcomes
 HERS vs. WHI

Often need long follow-up period or a very large

population
 CARDIA

Loss to follow-up can affect validity of findings

 Framingham
 Selection of the study
group
General population
Selected group of population e.g.; doctors,
teachers, nurses, school children etc.
 Exposure Data
Personal interview
Mailed
questionnaire
Review of records
Medical examination
Environmental
survey
 Follow up
Periodic examination of each member of the
cohort
Reviewing physician and hospital record
Routine surveillance of death records
Mailed questionnaire
Telephone calls
Periodic home visit (on annual basis)
Follow up can be done through

• Online

Email
• Mail • Email
Interviews may be
conducted

Face-to-face

• Over the Telephone

Analysis
Relative Risk

Attributable Risk

Odds ratio
 Difference between BIAS and
CHANCE
BIAS
It is deviation of results, or inferences from the
truth or processes leading to such deviation. It
is a systematic error

CHANCE
It is a random error and may account for an
apparent association and make it appear real
when it is not (Type I or alpha error). It may
lead to an association being overlooked or
missed when it truly exists (Type II or Beta
error)
 Comparison
Case control Cohort
Retrospective Prospective/longitudin
Hospital based al
Quick Community based
Easy to conduct Time consuming
Small sample size Logistically difficult
Less expensive Large sample size
Rare diseases Very expensive
None Common disease
Incidence
 Case Control VS Cohort Study
CASE CONTROL STUDY
Factors
Disease
 Present
 Present (Cases)

 Absent
 Absent (Controls)

COHORT STUDY
Risk Factors
Disease
 Exposed
 Present on Followup

 Unexposed
 Absent on Followup

TIME LINE
INTERVENTIONAL STUDIES
 INTERVENTIONAL
STUDIES
In Intervention Studies the researcher
manipulates the situation and measures the
effects of this manipulation.

Usually (But not Always) 2 Groups are

compared, one in which the Intervention takes
place and the other group that remains
“Untouched”
 INTERVENTIONAL
STUDIES
The 2 categories of Intervention Studies are:

1. Experimental Studies

2. Quasi-Experimental Studies
 Experimental Studies
Individuals are randomly allocated to atleast 2
groups. One group is subject to Intervention
or Experiment while the other group is not.
Then the outcome of the intervention is
obtained by comparing the 2 groups
 Diagram of Experimental
Study
Study Population (Sampling)

Sample Population (Randomization)

Study Group
Control Group
(Experimental)
(Comparison)

1st Data Collection 1st Data Collection

(Before Intervention) (Same Time)

Intervention No Intervention

Last Data Collection Last Data Collection

(After Intervention) (Same Time)

COMPARE
 Quasi-Experimental
Studies
In this at least one characteristic of a true
experiment is missing. This may be Either:

Missing of Randomization
Missing of separate Control group

This however always includes manipulation

of independent variable that serves as
intervention
Diagram of Quasi Experimental
Model
Study Group before Intervention Study Group After

COMPARE

Control Group Before Control Group After

THANK YOU
What is Incidence
No. of new cases of a disease or
health related event in a given
population in a given time
___________________________
X 1000
Total Population at risk in a given
time
What is Prevalence
No. of new as well as Old cases of a
disease or health related event in a
given population in a given time
___________________________

Total Population at risk in a given X 1000

time
What does Incidence
Signifies
It shows the RATE at which new diseases or
health problems occur in a population.
Prevalence shows the proportion of a
population at risk which is affected by a
disease at a specific point in time.
It is further of 2 types
Point Prevalence
Period prevalence.
 Case 1
Case 2

Case 3
Case 4
Total No of
Patients
Case 5 admitted
Case 6 during this 1
year = 100
Case 7

Case 8

Case 9

Case 10

1Jan,2004 28 Dec,2004
What is the prevalence of Hepatitis B on 1st
January 2004.
What is prevalence of Hepatitis B during the
year 2004.
Relation between Incidence and
Prevalence
Prevalence = Incidence x Duration of the
Disease
INCIDENCE

PREVALENCE

RECOVERY DEATH
Variations in Incidence and
Prevalence
Since Incidence depends on the occurrence of
new cases of a disease, a DECREASE in
Incidence may be due to
Enhanced Resistance to the disease
A change in Disease Etiology
An effective prevention program that reduces
exposure to a known risk factor for the disease.
A DECREASE in Prevalence may be due to
A decrease in Incidence
A shorter duration of the disease due to either
improved treatment methods leading to more
rapid recovery or an increase in virulence
leading to more rapid death.
Risk Factor and Causality
What is a Risk Factor

A condition, physical characteristic, or

behaviour that increases the probability that a
currently healthy individual will develop a
particular disease.
A Risk Factor may be a causal factor of the
disease in question or merely a marker for the
increased probability of disease.

E.g while poor antenatal acre and drug use

constitute causal factors for neonatal
mortality, socioeconomic status would be
considered a marker for neonatal mortality.
Risk Assessment
A number of epidemiological research designs
are used to evaluate the association between
a disease and a suspected risk factor.
Types of Epidemiological
Studies
Descriptive Studies
Also termed as Cross-sectional studies they
determine the disease frequency or prevalence
of a condition. Surveys are one example
Analytic Studies
Observational Studies
Experimental Studies
Analytical Studies
Observational
Case Control Studies
Cohort Studies
 Prospective Cohort Studies
 Retrospective Cohort Studies.
 Case control studies: Case-control studies
are those in which persons with a specified
condition (the cases) and pesons without the
condition (the controls) are selected for
study. The proportion of cases and controls
with certain characteristics or exposure is
then measured and compared. For example,
knowing that there are 10 school children
with purple spots in grade 3, a set of other
third grade children from the same school
but without purple spots would be identified
as controls, and analysis done to see what
different exposures the purple-spotted
children had than the non-spotted
Cohort studies: groups of individuals with some
common feature (age and geography, for
example) are identified for study over time to
learn about differing health and illness
experiences. For example, one might enroll in a
study all third graders in a school and follow
them until graduation, attempting to identify
the differences in experiences of those who
maintained a body weight close to
recommended and those who did not.
EXPERIMENTAL STUDIES
Quasi-Experimental Studies
True Experimental Studies
Randomization
Control Group
Excercise
In 1998 an outbreak of Cholera in a Peshawar Suburb shows the
following Data.

Cases presenting with People in the same

loose motions, vomiting area who didn’t have
of acute duration in the gastrointestinal
last 48 hours symptoms

Using community water 135 55

supply
Using own dugged 2 103
wells
  From 1960 to 1992, 35250 adults aged 20-25 years
were followed up for habits of smoking and were
assessed for presence of Bronchogenic Carcinoma with
following results.
CT Scan evidence of No evidence of ca Lung
Ca Lung

People who started and 435 20165

continued with Smoking

People who didn’t 10 14640

Smoke