BASIC CONCEPTS

& PRINCIPLES OF
EPIDEMIOLOGY

Dr Earnest Njih Tabah, MD, MPH, PhD

Course tutor
Dr Earnest Njih Tabah, MD, MPH, PhD
Doctorate Degree in Medicine in 2001 from FMBS, UY1
Master of Public Health in 2007 from The Joseph H. and Belle R. Braun
School of Public Health and Community Medicine, Hebrew University
Hadassah, Jerusalem, Israel
PhD in Epidemiology in 2018 from the Swiss Tropical and Public Health
Institute, University of Basel, Switzerland.
Permanent Secretary, in the National Yaws, Leishmaniasis, Leprosy and
Buruli ulcer Control Programme, Ministry of Public Health, Yaounde
Cameroon
 Introduction
 Epidemiology is the basic science of
Preventive and Social Medicine.
 Epidemiology is scientific discipline of
public health to study diseases in the
community to acquire knowledge for health
care of the society (prevention, control
and treatment).
Epidemiological principles and methods are applied in –
 Clinical research,
 Disease prevention,
 Health promotion,
 Health prevention and
 Health service reseach

The results of epidemiological studies are also used by

•
other scientists, including health economists, health policy
analysts, and health services managers.
MODERN EPIDEMIOLOGY
 Infectious disease Epidemiology.
 Chronic disease Epidemiology.
 Clinical Epidemiology.
 Genetic Epidemiology.
 Occupational Epidemiology.
 Cancer Epidemiology.
 Neuro-Epidemilogy.
 Definition of epidemiology
« The study of the distribution and
déterminants of health-related states or
events in specified populations, and the
application of this study to the prevention
and control of the health problem »
John M. Last, 1988
 Definition of epidemiology
The word "epidemiology" is derived from the Greek words: epi "upon” Demos "people” and logos
"study". This broad definition of epidemiology can be further elaborated as follows:

Term explanation
Study includes: surveillance, observation, hypothesis testing, analytic research and
experiments
Distribution refers to analysis of: Times, persons, places and classes of people affected
Determinants include factors that Influence health: biological, chemical, physical, social, cultural,
economic,, genetic and behavioral.
Health-related refer to: diseases, causes of death, behaviors such as use of tobacco positive health
states & events states, reactions to preventive regimes and provision and use of health services.
Specified Include those with identifiable characteristics such as occupational groups
populations
Application to the aims of public health - to promote, protect, and restore health
prevention &
control
Ultimate Aim of Epidemiology is:

• 1. To eliminate or reduce the health

problems of community.

• 2. To promote the health and well-

being of society as a whole.
Aims & Objectives of Epidemiology
 To describe the distribution and magnitude
of health and disease problems in human
population.

.
 To identify etiological factors (risk factors)
in the pathogenesis of disease.
 To provide data essential to the planning,
implementation and evaluation of services
for the prevention, control and treatment of
disease and setting priorities among those
(Acc. to International Epidemiological Association)
services
Distribution
Distribution of disease occurs in a PATTERN.
 PATTERN- Time, Place, Person .
 PATTERN – h e l p s i n :
 Formulating Hypothesis for
Causative/Risk factor –Etiological
Hypothesis.
Déterminants
 Identifying the causes and risk factors
for diseases.
 Testing the Hypothesis – (Biostatistics)

 This is Analytical Epidemiology

 Scope of Epidemiology

• 1. Causation of the disease.

• 2. Natural history of the disease.

• 3. Health status of the population.

• 4. Evaluation of Interventions.
1. Causation of the disease.
Most of diseases are caused by interaction
between
 genetic and environmental factors. (Diabetes )
 Personal behaviors affect this interplay.
Epidemiology is used to study their influence
and the effects of preventive interventions
through health promotion
Causation of the disease
Genetic
factors

Good
Ill health
health

Environmental
factors (including
behaviors)
 2. Natural history of the
disease is also concerned with the course and
• Epidemiology
outcome (natural history ) of diseases in individuals
and groups
Recovery

Subclinic
Good Clinical
al
health changes
changes

Death
 3. Health status of the population
 Epidemiology is often used to describe the health
status of population.

 Knowledge of the disease burden in populations is

essential for health authorities
.
 To use limited resources to the best possible effect by
identifying priority health programmes for
prevention and care.
3. Health status of the population
 4. Evaluation of Interventions

 To evaluate the effectiveness and efficiency of

health services

 This means determining things such as –

 Impact of Contraceptive use on Population
Control.
 the efficiency of sanitation measures to control
diarrheal diseases and
 the impact of reducing lead additives in petrol.
4. Evaluation of  Treatment
interventions  Medical care

Good Ill
health health
 Health promotion
 Preventive measures
 Public Health
Services
APPLICATIONS OF
EPIDEMIOLOGY
Applications of epidemiology in public
health
1. Preventing disease and promoting health.
2. Community health assessment (Community
Diagnosis) and priority setting.
3. Improving diagnosis, treatment and prognosis of
clinical diseases.
4. Evaluating health interventions and programmes
 Epidemiology and public health
 Public health, refers to collective actions to
improve population health.
 Epidemiology, one of the tools for improving
public health, is used in several ways.
 Epidemiology & Clinical Medicine
1. In Clinical Medicine the unit of study is a ‘case’,
but in the Epidemiology the unit of study is ‘defined
population’ or ‘population at risk’
 Physician is concerned with the disease in the
individual patient, whereas Epidemiologist is
concern with the disease pattern in entire
population
 So, the Epidemiology is concern with the both Sick
& Healthy
2. In Clinical Medicine, the physician seeks to make a
diagnosis for which he derives prognosis and prescribes
specific treatment.
 The Epidemiologist is confronted with the relevant data
derived from the particular epidemiological study.
(Community Diagnosis)
 He seek to identify the source of infection, mode of
transmission, and an etiological factor to determine
the future trends, prevention and control measure.

3. In Clinical Medicine patient comes to the Doctor.

 Epidemiologist, goes to the community to find out the
disease pattern and suspected causal factors in the
question
EPIDEMIOLOGICAL
APPROACH
Epidemiological approach

1.Asking questions.
2.Making comparisons
 1. Asking questions
Related to health events Related to health action
1. What can be done to reduce
1. What is the event? (Problem)
2. What is magnitude? 2. the problem?
3. Where did happen? 3. How can be prevented in

4. When did happen?

future?
4. What action should be taken
5. Who are affected?
by community?
6. Why did it happen?
5. What resources required?
6. How activities to be organized?
7. What difficulties may arise?

Epidemiology is “a means of learning by asking questions

and getting answers that lead to further questions”
The questions can be referred to as:

1. Case definition: - (what)

2. Person - (who)
3. Place - (where)
4. Time - (when)
5. Cause - (why)
 2.Making Comparisons

 To find out the differences in the AGENT,

HOST and ENVIRONMENT conditions
between two groups.

 Weighs, balances and contrasts give clues

to ETIOLOGICAL HYPOTHESIS
 BASIC
MEASUREMENTS IN
EPIDEMIOLOGY
Defining health and disease
•Definition:

“Health is a state of complete physical,

mental and social well-being and not
merely the absence of disease or infirmity.”

(WHO, 1948)
 This definition – criticized because of the
difficulty in defining and measuring well-being
– remains an ideal.

 The World Health Assembly resolved in 1977

that all people should attain a level of health
permitting them to lead socially and
economically productive lives by the year 2000.
(Health for All by 2000)
• Practical definitions of health and disease are
needed in epidemiology, which concentrates on
aspects of health that are easily measurable and
amenable to improvement

• Definitions of health states used by

epidemiologists
tend to be simple, for example,
“ disease present” or “ disease absent”
 There is often no clear distinction between
normal and abnormal.
 Specially, for normally distributed continuous
variables that may be associated with several
diseases.

 Examples:
 Cut-off point for Blood Pressure – HTN
 Cut-off point for Haemoglobine – Anaemia
 Normal range of Blood cholesterol.
BLOOD CHOLESTEROL (mg%) FREQUENCY

125 - 135 5

135-145 22

145-155 25

155-165 130

165-175 140

175-185 260

185-195 274

195-205 282

205-215 268

215-225 270

225-235 135

235-245 135

245-255 24

255-265 24

265-275 8

TOTAL 2000
MEASURING DISEASE
FREQUENCY
 Incidence and Prevalence

• These are fundamentally different ways of

measuring disease frequency.

• The incidence of disease represents the rate of

occurrence of new cases arising in a given period in
sapecified population, while

• prevalence is the number of existing cases

(old+
new) in a defined population at a given point in time.
 Incidence
• “Number of new cases occurring in
defined
population during specified period of time”

• Incidence = Number of new cases during

given period / Population at risk x 1000
 Prevalence
• Prevalence is total no of existing cases ( old +
new)
in a defined population at a particular point in time or
specified period.

• Prevalence = Total no of cases at given point of time

/ Estimated population at time x 100
 Relation between Incidence & Prevalence

Prevalence = Incidence x Mean duration of d/se.

P = I x D

Example – if,
I= 10 cases per 1000 per year.
D = 5 years.

P = 10 x 5
50 cases per 1000 population.
• 1. Point Prevalence

Prevalence for given point of time.

• 2. Period Prevalence

Prevalence for specified period.

Relation between Incidence & Prevalence
 :

January February March

What is the period prevalence during February? 6/20 30%

What is the point prevalence on the 28th 1/20 5%
February?
What is the incidence in February 4/18 22.2%
Factors influencing the prevalence
 TOOLS OF
MEASUREMENTS
 Numerator and Denominator
• Numerator – Number of events in a
population
during specified time.
• Denominator -
1. Total population
- Mid-year population
- Population at risk
2. Total events
 Tools of Measurements
Basic tools are -

• 1. Rate

• 2. Ratio

• 3. Proportion

• Used for expression of disease magnitude.

 Rate
• A “Rate” measures the occurrence of some
specific event in a population during given
time period.
• Example –

Death Rate = total no of death in 1yr / Mid-year population

x 1000.
ELEMENTS –
Numerator, Denominator, time & multiplier
 Ratio
• Ratio measures the relationship of size of two
random quantities.

• Numerator is not component of denominator.

• Ratio = x / y
• Example-
- Sex – Ratio
-
Doctor Population Ratio.
 Proportion
• Proportion is ratio which
indicates the relation
in a magnitude of a part of whole.
• The Numerator is always part of Denominator.

• Usually expressed in percentage.

Scope of Measurements in Epidemiology
1. Measurement of mortality.
2. Measurement of morbidity.
3. Measurement of disability.
4. Measurement of natality.
5. Measurement of presence or absence of attributes.
6. Measurement of health care need.
7. Measurement of environmental & other risk factors.
8. Measurement of demographic variables.
EPIDEMIOLOGIC
RESEARCH
METHODS
 Epidemiological Studies

Observational
studies
Observational studies allow nature to take its course.

The investigator measures but does not intervene.

Experimental
• studies
Active involvement to change disease determinants.
• such as an exposure or a behaviour – or the progress of a disease through
treatment.

• are similar in design to experiments in other sciences.

 Observational Studies

1. Descriptive Study

• is often the first step in an epidemiological investigation.

• is limited to a description of the occurrence of a disease in a population.
• Formulation of Hypothesis.

2. Analytical Study

• analyze relationships between health status and other variables.

• Testing of Hypothesis.
Types of Epidemiologic study designs
Type of study Alternative name Unit of study
Observational studies
Descriptive studies
Analytical studies
Ecological Correlational Populations
Cross-sectional Prevalence lndividuals
Case-control Case- refe rence lndividuals
Cohort Follow-up lndividuals
Experimenta/ studies Intervention studies
Randomized controlled Clinical trials lndividuals
trials
Cluster randomized Groups
controlled trials
Field trials
Community trials Community intervention Healthy people
studies Communities
 Did investigator
assign exposures?
yes no
Experimental Study Observational Study

randomize allocation? comparison group?

yes no yes no
Non- Analytical Descriptive
Randomized Study Study
Randomized
Controlled Trial Controlled Trial
direction?

Case-Control
Cohort Study Study Cross-sectional
Study
OBSERVATIONAL -
EPIDEMIOLOGY
 Descriptive Epidemiologic Studies

• A simple description of the health status of a community.

• Based on routinely available data or data obtained in special
surveys.
• It is often the first step in an epidemiological investigation
 Procedure in Descriptive Studies
1. Defining population to be studied.
2. Defining disease under study.
3. Describing disease by
• Time
• Place
• Person
4. Measurement of disease.
5. Comparing with known indices.
6. Formulation of etiological hypothesis.
1. Defining population to be studied.
• It is a ‘Population study’ not of an individual.

• Defining population by total number and

composition (age, sex, occupation etc. )
• Defined population- can ‘whole population’ or ‘a
representative sample’.
• It provides ‘denominator’ for calculating rates and
frequency.
2. Defining disease under study.
• Operational Definition - of disease is essential
for measuring the disease in defined population.

• ‘Case definition’ should be adhered to throughout

the study.
 3. Describing disease
• Describing the disease frequency and distribution in terms
of Time, Place and Person.

TIME: Year, month, week, season, duration.

PLACE: Country, region, climatic zone, urban/ rural,
community, Cities, towns.
PERSON: Age, Sex, marital status, occupation,
education,
socioeconomic status.
 4. Measurement of disease.
• To obtain the clear picture of ‘disease load’ in the
population.
• In terms of Mortality, Morbidity and Disability.
• Morbidity has two aspects –
 Incidence – Longitudinal Studies
 Prevalence - Cross-sectional studies.
 5. Comparing with known indices.
 Basic epidemiological approach –
 Asking questions.
 Making comparisons.

 Making comparison with known indices in population.

 By making comparisons - clues about

 disease etiology and
 high risk population.
6. Formulation of etiological hypothesis.
 A hypothesis is supposition arrived at observation or reflection.
 Hypothesis should specify –
1. Population.
2. Specific cause – risk factors/exposures.
3. Outcome – disease/disability.
4. Dose-response relationship.
5. Time response relationship.
Hypothesis should be formulated in a manner that it can be tested with
above parameters
 • Hypothesis- “Cigarette smoking causes lung cancer”

• Improved- “Smoking 30-40 Cigarette /day for 20 years of

causes lung cancer in 10% of smokers.”

TESTING OF HYPOTHESIS

‘Hypothesis’ can be accepted or rejected by using the

techniques of Analytical Epidemiology
Example - Descriptive study
Uses of Descriptive Epidemiology

1. Provide data of magnitude of problem- disease load.

2. Provide clues for etiology.

3. Provide background data for planning, organizing and

evaluating the preventive and curative services

4. Contributes to research.
 ANALYTICAL
EPIDEMIOLOGY
 Analytical Studies
 Analyzing relationships between health status and other variables.
 The objective is testing the hypothesis.
 Subject of interest is individual, but inference applied to population
TYPES
1. Case-control studies. (Case reference studies)
2. Cohort studies. (Follow-up studies)
 By analytical studies, we can determine:
 Statistical association. (between disease and suspected factor)
 Strength of association.
 Case-control studies
 It is first approach to testing causal hypothesis, especially for rare
disease.

 Three features-

1. Both exposure and outcome (disease) has occurred.

2. Study proceeds backwards from effect to cause.

3. It uses a control group to support or refuse a inference.

Design of a case-control study
 Basic steps in Case-control study

1. Selection of cases and controls.

2. Matching.

3. Measurement of exposure.

4. Analysis and interpretation.

 1. Selection of cases and controls

• CASES
- Case definition – (Diagnostic criteria and Eligibility criteria.)
- Source of Cases – (Hospital or General population)

•CONTROLS
-Free from the disease under study.
-Similar to the cases in all other
-aspects.
Source-Relative, Neighbourhood, General population
Hospital,
 2. Matching.

• Matching is process by we selecting controls in a

manner that they are similar to cases in all variables.

• Matching is essential for comparability and for

elimination of confounding bias.
 A Confounding factor is a factor which associated with
both exposure and disease and unequally distributed in the
study and control groups

Example- 1. Alcohol in esophageal cancer, smoking is confounding factor.

2. Age for steroid contraceptive are causative in Breast cancer.

 Matching procedure –
 Group matching (Strata matching).
 Pair matching.
 3. Measurement of exposure.
 Information of exposure of risk factor should be obtain in
the same manner for both cases and controls

 Information obtain by-

 Questionnaire.
 Interviews.
 Hospital records.
 Employment records.
 4. Analysis and interpretation

1. Exposure rates
Estimation of rates of exposure of suspected factor
among cases & controls.

2. Odds Ratio

risk associated with exposure among cases

&Estimation of disease controls.
 1. Exposure rates
CASES CONTROLS TOTAL
(Lung Cancer) (Without Lung Cancer)

SMOKERS 33 (a) 55 (b) 88 (a+b)

NON-SMOKERS 2 (c) 27 (d) 29 (c+d)
TOTAL 35 (a+c) 82 (b+d) N= a+b+c+d

Exposure rates-
a. Cases = a / (a+c) = 33/35 = 94.2%.
b. Controls = b/ (b+d) = 55/82 = 67%.
( p value is p<0.001 )

Whether the exposure is significantly associated to cause lung cancer.

TESTS OF SIGNIFICANCE (p value)
 2. Odds Ratio
(Cross-product
Ratio)
• It is estimation of risk of disease associated with exposure.
• It measures strength of association of risk factor and outcome(disease).

Odds Ratio = ad / bc

• Odds Ratio = 33 x 27 / 55 x 2 = 8.1

• Smokers have risk of developing lung cancer 8.1 times

higher than non-smoker.
• For the odds ratio to be a good approximation, the cases
and controls must be representative of the general population
with respect to exposure.

• However, because the incidence of disease is unknown,

the relative risk can not be calculated.
 Thalidomide Tragedy
A classic example of Case-control study
 A classic example of a case-control study was the discovery of the
relationship between thalidomide and limb defects in babies born
in the Federal Republic of Germany in 1959 and 1960.
 The study, done in 1961, compared affected children with normal
children.
 Of 46 mothers whose babies had malformations, 41 had been given
thalidomide between the fourth and ninth weeks of pregnancy,
whereas none of the 300 control mothers, whose children were
normal, had taken the drug during pregnancy.
 Accurate timing of the drug intake was crucial for determining relevant
exposure.
 Cohort Studies
• Cohort is group of people with similar characteristics.

• also called follow-up or incidence studies.

• Begin with a group of people who are free of disease.

• Whole cohort is followed up to see the effect of exposure.

Design of a COHORT
Study
Time

Direction of inquiry

D+
Exposed
D-
POPULATION
D+
Unexposed
D-
 Types of Cohort Studies
1. Prospective cohort studies. (Currents cohort study)

2. Retrospective cohort studies. (Historical cohort study)

3. Combination of retrospective and prospective cohort studies.

 Elements of Cohort studies

1. Selection of study subjects.

2. Obtaining data on exposure.
3. Selection of comparison group.
4. Follow-up.
5. Analysis.
 1. Selection of study subjects.
• General population or
• Special group (Doctors, Teachers,
Lawyers).

• Cohort should be selected from the group with special

exposure under study.
 2. Obtaining data on exposure.
1. Cohort members- questionnaire, interview.
2. Review of records.
3. Medical Examination or tests. Environmental
surveys.
4. Categorized according to exposure –
• Whether exposed or not exposed to special causal factor
• Degree of exposure.
 3. Selection of comparison group.

1. Internal comparison.
• Subjects are categorized in group according to degree of exposure &
mortality and morbidity compared.

2. External comparison.
• When degree of exposure not known.
• Control group with similar in other variable.

3. Comparison with general population.

• Comparison with the general population as exposed group.
 4. Follow-up.
• Regular follow-up of all participants.
• Measurement of variable depends upon outcome.

• Procedure-
1. Periodical medical examination.
2. Review of hospital records.
3. Routine surveillance and death
4. records.
Mailed questionnaire and phone calls.
 5. Analysis.
• Data are analyzed in terms of –

a. Incidence rates.
• Among exposed and non-exposed

b. Estimation of risk.
• Relative Risk.
• Attributable Risk.
 Incidence rates.
SMOKING DEVELOPED DID NOT DEVELOPED TOTAL
LUNG CANCER LUNG CANCER
YES 70 (a) 6930(b) 7000 (a+b)
NO 3(c) 2997 (d) 3000 (c+d)

• Incidence among smoker = 70/7000 = 10 per 1000.

• Incidence among non-smoker = 3/3000= 1per 1000.

Test of significance = p< 0.001

 Relative Risk (Risk ratio)
• Relative risk is the ratio of the incidence of disease among
exposed and incidence among non-exposed.

RR of Lung cancer = 10/1 = 10

• It is direct measure of strength of the association between

suspected cause and effect.

• It does not necessary implies the causal relationship.

 Attributable Risk
(Risk difference)
• AR is the difference in incidence rates of disease among exposed
and non- exposed group.

• AR= I.R. among exposed - I.R. among non-exposed

/Incidence among exposed x 100
Example - A.R.= 10-1/ 10 x 100 = 90 %

• AR is the proportion of disease due to particular risk factor exposure.

• Exm – 90% of lung cancers are due to smoking.

• That means- amount of disease eliminated if the suspected risk

factor is removed.
 Population Attributable Risk
Population A. R. = I.R. in total population – I.R. among non-exposed X
100
I.R. in total population

• Population Attributable Risk is useful concept as it give the magnitude of

disease that can be reduced from the population if the suspected risk factor is
eliminated or modified
 Case-control study Cohort study
1. From effect to cause. 1. From cause to effect.
2. Starts with disease. 2. Starts with people exposed to
risk factors.
3. Tests whether the suspected 3. Tests whether disease occur
factor associated more with more in those who exposed to
diseased. risk factor.
4. First approach to testing the 4. Reserved for precisely
hypothesis. formulated hypothesis.
5. fewer no of subjects. 5. Large no of subjects.
6. Suitable for rare disease. 6. Inappropriate when exposure
is rare.
7. Only estimates Odds ratio.
7. YeildS IR, RR, AR.
8. Relative inexpensive. 8. Expensive.
EXPERIMENTAL
EPIDEMIOLOGY
• Interventional or experimental study involves
attempting to change a variable in subjects under study..

• This could mean the elimination of a dietary factor thought

to cause allergy, or testing a new treatment on a selected group
of patients.

• The effects of an intervention are measured by comparing the

outcome in the experimental group with that in a control group.
 Objectives of Experimental Studies

1. To provide ‘scientific proof’ for etiology of disease risk

and which may allow modification of occurrence of
factor
disease.

2. To provide a method of measurement for effectiveness and

efficiency of therapeutic / preventive measure for disease.

3. To provide method to measurement for the efficiency health

services for prevention, control and treatment of disease.
 Types of Experimental Studies

1. Randomized Control Trials.

2. Field Trials & Community Trials.

 Randomized Control Trials
(RCT)
• RCT is a planned experiment designed to asses the efficacy
of an intervention in human beings by comparing the effect
of intervention in a study group to a control group.

• The allocation of subjects to study or control is determined

purely by chance (randomization).

• For new programme or new therapy RCT is best method of

evaluation.
 Basic Steps in RCT
1. Drawing-up a protocol.
2. Selecting reference and experimental population.
3. Randomization.
4. Manipulation or Intervention.
5. Follow-up.
6. Assessment of outcome.
 Design of RCT
TARGET POPULATION

SAMPLING

EXCLUSIONS

RANDOMIZATION

STUDY GROUP CONTROL GROUP

MANIPULATION AND FOLLOW-UP

ASSESSMENT
 The Protocol
• Study conducted under strict protocol.
• Protocol specifies –
• aim, objectives, criteria for selection of study and control
group, sample size, intervention applied, standardization
and schedule and responsibilities.

• Pilot study –
• some time small preliminary study is conducted to find
out feasibility or operational efficiency.
 Reference and Experimental population
 Reference population (Target Population)
 Is the population in which the results of the study is applicable.
 A reference population may be – Human being, country, specific age,
sex, occupation etc.
 Experimental Population (Study Population)
 It is derived from the target population.
 Three criteria-
1. they must be representative of RP.
2. qualified for the study.
3. ready to give informed consents.
 Randomization
• It is statistical procedure to allocate participants in
groups – Study group and Control group.

• Randomization gives equal chance to participants to be

allocated in Study or Control group.

• Randomization is an attempt to eliminate ‘bias’ and allow

‘comparability’.
• Randomization eliminates ‘Selection Bias’.

• Matching is for only those variable which are known.

• Randomization is best done by the table of random

numbers.

• In Analytical study there is no randomization, we already

studied the difference of risk factor. So the only option is
Matching.
 Manipulation or Intervention

• Manipulation by application of therapy or reduction or

withdrawal of suspected causal factor in Study and control group

• This manipulation creates independent variable whose

effect is measured in final outcome.
 Follow-up
• Follow-up of both study and control group in
standard manner in definite time period.

• Duration of trial depends on the changes expected in

duration since study started.

• Some loss of subjects due to migration, death is k/as

Attrition.
 Assessment
• Final step is assessment of outcome in terms of
positive and negative results.

• The incidence of positive and negative results are

compared in both group- Study group and Control
group.
• Results are tested for statistical significance.
(p value)
 Potential errors in epidemiological studies
(Bias)

 Bias may arise from the errors of assessment of outcome

due to human element
 Three sources –
1. Bias on part of subject.

2. Observer bias.

3. Bias in evaluation.
 Blinding
• Blinding is procedure to eliminate bias.
• Thee types -

1. Single blind trial. Participant not aware of study.

2. Double blind trial. Examiner and participant both not aware.

3. Triple blind trial. Participant, examiner and person analyzing

the data not aware of the study.
 Field trials
• Field trials, in contrast to clinical trials, involve people
who are healthy but presumed to be at risk.

• Data collection takes place “in the field,” usually among

non-institutionalized people in the general population.

• Since the subjects are disease-free and the purpose is to

prevent diseases.
 Community Trials
• In this form of experiment, the treatment groups are
communities rather than individuals.

• This is particularly appropriate for diseases that are

influenced by social conditions, and for which
prevention efforts target group behaviour.

• Example –
• IDD and Iron deficiency Anaemia.
• Fortification of food.
 Ethical issues in Epidemiological Studies

1. Informed consent.
2. Confidentiality.
3. Respect for human
4. rights. Scientific
integrity.
ASSOCIATION AND
CAUSATION
 Descriptive studies-
• Identification of disease problem in community.
• Relating agent, host and environmental factor.
• Etiological hypothesis.

 Analytical and Experimental studies

• Tests the hypothesis derived from the descriptive studies.
• Accept or reject the association between the suspected
cause and disease.

• Epidemiologists are now proceed from demonstration of

statistical association to causal association.
• Association is defined as - the concurrence of two variables
more often than would be expected by chance.
• So association does not necessarily imply a causal
relationship.
• Correlation – is strength of association between two variable.
• Correlation coefficients ranges from - 1 to + 1.
• +1 = perfect linear positive relationship.
• -1 = perfect linear negative relationship.

• Causation implies association and correlation but

correlation and association do not necessarily imply
causation.
 TYPE OF ASSOCIATION
1. Spurious association.
Exp- IMR in home and institutional deliveries.

2. Indirect association.
Exp- Endemic goitre and
altitude

3. Direct or Causal association.

a. One to one causal association.
Exm- streptococcus-
b. tonsilitis.
Multi-factorial causation. Exm- CHD- multiple factors.
THANK YOU