EPIDEMIOLOGICAL METHODS

PRESENTED BY :-
Mayank Aggarwal
MDS 1st year
Content
 Introduction
 Definition
 Aims of Epidemiology
 Principles of Epidemiology
 Use of Epidemiology
 Tools of Measurement
 Epidemiological Methods
◦ Observational
◦ Experimental
 Reference
 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 protection and
- Health services research.
•The results of epidemiological studies are also used by other
scientists, including health economists , health policy analysts,
and health services managers.
Definition
“The study of the distribution and
determinants of health-related states or
events in specified populations, and the
application of this study to the prevention
and control of health problems” .

As defined by John M. Last (1988)

AIMS OF EPIDEMIOLOGY
1.To describe the distribution and magnitude of health and
disease problems in human population.
2.To identify etiological factors (risk factors) in the
pathogenesis of disease.
3.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
services.
(Acc. to International Epidemiological Association)
PRINCIPLES OF EPIDEMIOLOGY
The Four important principle of epidemiology are :-
 Exact Observation ( strict, vigorous, accurate, precise)
 Correct Interpretation ( free from error)
 Rational Explanation ( Intelligent, sensible, reasonable )
 Scientific Construction ( by expert knowledge & technical
skill)
USE OF EPIDEMIOLOGY
 It is used in Community diagnosis.
 It can tell us about Rise and Fall of disease.
 It help in Planning & Evaluation of a health program.
 It ( Modern analytical epidemiology ) enables us to predict
an individual’s chance/risk for developing the disease.
 It enables us to classify and identify the clinical syndrome.
 It ( Analytical epidemiology ) help us in searching the
cause/risk factors related to the disease.
 It also help in completing the natural history of disease.
TOOLS OF MEASUREMENTS

The most commonly used tools for

epidemiological studies are
Rates
Ratios
Proportions
Numerator and Denominator
Rates
A “Rate” measures the occurrence of some specific event in
a population during given time period.
 A rate comprises of following element :- Numerator,
Denominator, Time specification & Multiplier.
 The rate is expressed in per 1000 or some other round figure
(10000, 10000) selected according convince or convention
to avoid fraction.
 Example :-
Rate
Various category of the rates are the following :-
 Crude rate :- These are the actual observed rate these are
unstandardized rates. For example :- Death rate & Birth rate.
 Specific rate :- These are actual observed rate due to specific
causes (e.g., Corona), or occurring in specific groups ( e.g.,
age-sex group) or during specific time periods (e.g., annual,
monthly, weekly rates)
 Standardized rate :- These are obtained by direct or indirect
method of standardization or adjustment .
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
A proportion is a ratio which indicates the relation in the
magnitude of a part of the whole.
 The numerator is always included in the denominator .
 Proportion is usually expressed as the percentage.
Basic Measurements In Epidemiology
 The basic requirement of epidemiology is a definition of
what is to be measured and what criteria or standard are
using for measuring it.
 The most commonly used measurement in epidemiology
are:

 Measurement of Mortality
 Measurement of Morbidity
Measurement of Mortality
 Mortality is the condition of being mortal, or susceptible to
death.
 As a major component of population change , mortality is
an integral part of demography and many epidemiological
studies begin with the mortality data.
 The level of mortality in a region or of a subpopulation is
also used as a public health indicator.

 There are various way of mortality.

a) Crude Death Rate : It is the simplest measure of mortality.

b) Specific Death Rate : A specific death rate measures the

number of deaths among people in a category per 1000 people
in that category in a given year.
c) Case Fatality Rate : It represents the killing power of a
disease. This is usually used in cases of acute infection.

d) Proportional Mortality case : It is defined as “ the number of

deaths due to particular cause per 100 or 1000 total death” this
rates are used when population data are not available.
e) Standardized Rates : It is defined as “ the overall rates
adjusted for the effects of differences in population
composition”. This is done in cases where we want to
compare death rates of two population, with different
age of composition. The standardization can be done by
direct and indirect standardization.
f) Infant Mortality Rates : The number of deaths among
infants under one year of age per 1000 live births. For a
cohort based measure, the rate includes the death under
one year of age per 1000 live births.
Measurements Of Morbidity
WHO has defined ‘Morbidity’ as “ any departure, subjective ,
or objective, from a state of physiological well-being”.

According to the WHO expert committee on the health

statistics , morbidity can be measured based on three units,
such as,
 Person who were ill.
 The illnesses or diseases these persons experienced.
 The duration of these illnesses or diseases.
USES OF MORBIDITY DATA
1. They are used to describe the extent and nature of the
disease in the community and thus assist in the
establishment of priorities.
2. They are useful in providing more comprehensive and
more accurate and clinically relevant information on
patient characteristics that can be obtained from mortality
data and are therefore essential for basic research.
3. They play as a starting point for etiological studies and
thus play a crucial role in disease prevention.
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 a specified
population, while.

 prevalence is the number of existing cases (old+new) in a

defined population at a given point in time.
Incidence
The number of new cases of a specific disease occurring in a
defined population during specified period of time.
Incidence
Special Incidence Rate
Attack rate :- It is used only when the population is
exposed to a risk for a limited period of time as in case of
an epidemic.

Secondary Attack Rate :- It is defined as the number of

exposed person developing the disease within the range of
incubation
Prevalence
 The term prevalence used to indicate all current cases
( Both old & new) existing in a given population at a given
point in time , or over a period of time.
 Last has given a broader definition :- the total number of
all individuals who have an attribute or disease at a
particular time divided by the population at the risk of
having the attribute or disease at this point in time or
midway through the period.
 Prevalence rate is really a ratio.
Type of Prevalence
Point Prevalence :- It is defined as the number of all
current cases of a disease at one point of time in relation to
defined population.

Period Prevalence :- It is defined as the number of all

current cases of a disease existing during a defined period
of time.
Relation between Incidence & Prevalence
Prevalence = Incidence x Mean duration of disease
P=IxD
Example – if,
I= 10 cases per 1000 per year.
D = 5 years.
P = 10 x 5
50 cases per 1000 population.
Epidemiological Methods
Observational Studies
 Observational studies allow nature to take its course.
 The investigator measures but does not intervene.

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.
Descriptive Epidemiologic Studies
 A simple description of the health status of a community.
 Based on routinely available data or data obtained in special
surveys.
 is often the first step in an epidemiological investigation.

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.
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. This definition
helps epidemiologist in identifying and measuring the
disease in a given population with a degree of accuracy.

 Thisalso help in identifying the people with the disease

who don’t have a disease.

 ‘Case definition’ should be adhered throughout the study

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

Short term fluctuation Periodic Fluctuation Long term fluctuation

A. Common Source epidemic A. Seasonal Trend A. Secular Trend
1. Single exposure or point source B. Cyclic Trend
2. Continuous or multiple source
B. Propagated Epidemic
1. Person to Person
2. Arthropod vector
3. Animal reservoir
C. Slow or Modern Epidemic
Short term fluctuation
 Common Source epidemic- Single exposure or point source
– e.g. Food poisoning
 Continuous or multiple source – contaminated water-
Cholera
 Propagated Epidemic- Hepatitis A, Polio epidemic

Periodic Fluctuation
 Seasonal Trend – measles, varicella, URTI, malaria etc.
 Cyclic Trend – measles in pre vaccination era appeared in
major peaks every 2-3 years and rubella in every 6-9 years
Long term fluctuation- Secular Trend –progressive increase or
decrease over a long period of time. CHD, Diabetes showed
an upward trend during past 50 years
Place distribution
Presence of disease varies in different geographical
areas depended upon the environmental condition
and genetic variation of the host.
a. International variation – Ca Cx and Ca oral cavity
in India, Ca breast in western countries.
b. National variation – malaria, endemic goitre,
flurosis
c. Rural urban variation –urban- lung Ca, CVDs,
mental illnesses, chr. Bronchitis. Rural- skin
diseases, zoonosis, soil transmitted disease
d. Local distribution – endemic goitre, yellow fever
Person distribution
Age : Childhood – measles, Upper respiratory illness,
Pneumonia etc.
Middle Age :- Cancer, Accident, Occupational diseases,
Peptic ulcer
Old Age :- Atherosclerosis, Cancer, Cardiovascular diseases,
Hypertension, Chronic Degenerative diseases.
Bio Modality – Hodgkin's disease
Sex : Some diseases are common in females and some common
in males. In males - lung cancer
In females Breast, Ovarian, Cervical cancer
Marital Status : Cancer cervix more common in early marriage,
multiple sex partner.
Occupation : sedentary occupation more of cardiovascular risk,
diabetes, obesity.
Occupational hazards like skin cancer and allergy in dye
industry, Bronchitis and lung disease in dusty trades .
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

1) Cross sectional studies-

 Prevalence can be obtained.
 t is based on a single examination of a cross section of population at
one point in time.
 More useful for chronic diseases

2) Longitudinal studies-
 Incidence can be obtained.
 The observations are repeated in the same population over a
prolonged period of time by means of follow up examination.
 Longitudinal is more useful, but it is time consuming.
5. Comparing with known indices.
 Basic epidemiological approach –
1. making comparisons.
2. Asking questions.
 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.
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-
1. Statistical association. (between disease and suspected
factor)
2. 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
 Selection of controls
 Selection of cases
– Crucial step in case-control
– Define the cases studies
 Diagnostic criteria – Controls must be
 Eligibility criteria  Free from the disease under study
 Be similar to the cases except for
– Sources of cases
the absence of the disease under
 Hospitals
study
 General population
-Sources of controls
 Hospitals
 Relatives
 Neighbourhood controls
 General population
2.Matching
 Should be done to ensure comparability between cases and
controls
 Defined “ as process by which we select controls in such a
way that they are similar to the cases with regard to certain
pertinent variables which known to influence the outcome
of the diseases and which, if not adequately matched for
comparability, could distort or confound the results ”.
CONFOUNDING FACTORS:
 Defined as “one which is associated with the exposure and
the disease and is distributed unequally in the study and
control group”.
 E.g.: Smoking and alcohol in throat cancer, Age in oral
cancer
3. Measurement of exposure.
Definition and criteria about exposure are just as important as
those used to define cases and controls.
This may be obtained by :
 Interviews
 Questionnaires
 Studying past record of cases such as hospital records,
employment records etc.
 Clinical or laboratory examination.

 Bias should be avoided while measuring the exposure by

blinding the investigator
4. Analysis and interpretation
Involves two steps
1.Exposure rates among cases and controls to suspected factor
2.Estimation of disease risk associated with exposure (odds
ratio)

Exposure rates:
 Direct estimation of exposure rates to a suspected factor
in disease and non disease groups.
Exposure Rate
CASES CONTROLS TOTAL
(Lung Cancer) (Without Lung
Cancer)

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

Non-Smoker 2 (c) 27 (d) 30 (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%.
ESTIMATION OF THE DISEASE RISK
 Relative risk or risk ratio – ratio between the incidence of
disease among exposed persons and incidence among non-
exposed.

 However, because the incidence of disease is unknown, the

relative risk can not be calculated.
Odds ratio/ Cross product ratio is strength of association
between risk factor and outcome.
 Odd ratio is closely related to risk ratio
 Derivation of odds ratio is based on 3 assumptions

– Disease under investigation is a rare one

– Cases are representative of those with disease
– Controls are representative of those without 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.
Cohort Study
 Usually undertaken to obtain additional evidence to refute
or support the existence of an association between
suspected cause and disease
 Cohort is group of people with similar characteristics.
 also called follow-up or incidence studies or prospective
studies or longitudinal studies.
 Begin with a group of people who are free of disease.
 Whole cohort is followed up to see the effect of exposure
Study design of a cohort study
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
 Group that can be readily studied
 GENERAL POPULATION:

◦ If cause of death fairly frequent in population

◦ If population very large - Appropriate sample taken
 SPECIAL GROUP:

Select groups:
◦ Professional group
◦ Government employees
◦ Volunteers
E.g.: radiologists, workers in industries
OBTAINING DATA ON EXPOSURE
COHORT MEMBERS
 Interviews/ questionnaires

REVIEW OF RECORDS:
 Medical records – H/O surgery etc

MEDICAL EXAMINATION/ SPECIAL TESTS:

 E.g.: blood pressure, ECG etc

ENVIRONMENTAL SURVEYS:
 To determine levels of exposure factor in environment
where cohort lived
 Information about exposure should be collected that will
allow classification of cohort members:
 Whether or not they have been exposed to suspected factor
 According to level or degree of exposure
 Demographic variables that may affect frequency of disease
under investigation
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 records.
4. 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 TOTAL
LUNG CANCER DEVELOPED
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.
Relative Risk (Risk ratio)

 Relativerisk is the ratio of the incidence of disease among

exposed and incidence among non-exposed.
RR of Lung cancer = 10/1 = 10

 Itis 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.
 Example – 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/I.R. in total population X 100
 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.
Comparison Between Descriptive & Analytic Epidemiology
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 and risk
factor which may allow modification of occurrence of
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. Non-Randomized Control 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
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
 Randomization is a statistical procedure by which the
participants are allocated into groups usually called "study"
and "control" groups, to receive or not to receive an
experimental preventive or therapeutic procedure,
manoeuvre or intervention.
 Randomization is the "heart" of a control trial.
 It will give the greatest confidence that the groups are
comparable so that "like can be compared with like".
 In other words, by random allocation, every individual gets
an equal chance of being allocated into either group or any
of the trial groups
 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
study the difference of risk factor. So only option is
Matching
Manipulation or Intervention
 Manipulate the study (experimental) group by the
deliberate application or withdrawal or reduction of the
suspected causal factor.

 This manipulation creates an independent variable whose

effect is then determined by measurement of the final out
come, which constitutes the dependent variable.
Follow-up
 This implies examination of the experimental and control
group subjects at defined intervals of time, in a standard
manner, with equal intensity, under the same given
circumstances, in the same time frame till final assessment
of outcome.
 ATTRITION - some losses to follow-up are inevitable due
to factors, such as death, migration and loss of interest.
 Every effort, should be made to minimise the losses to
follow-up.
Assessment
 The final step is assessment of the outcome of the trial in
terms of :
(a) Positive results : that is. benefits of the experimental
measure such as reduced incidence or severity of the
disease, cost to the health service or other appropriate
outcome in the study and control groups.
(b) Negative results : that is, severity and frequency of side-
effects and complications, if any, including death. Adverse
effects may be missed if they are not sought.
Types of Randomized Controlled Trials
1. Clinical Trials
2. Preventive Trial
3. Risk Factor Trials
4. Cessation Experiment
5. Trial of etiological agents
6. Evaluation of health services
1. Clinical Trial
- Concerned with evaluating therapeutic agent, mainly drugs.
2. Preventive Trials:
 Trial of primary preventive measures e.g.. Vaccines
 Analysis of preventive trials must result in clear statement
about benefits to community, risk involved and cost to
health.
3. Risk Factor Trials:
 Investigator intervenes to interrupt the usual sequence in
the development of disease for those individuals who have
risk factor for developing the disease
 Primary prevention of CHD using clofibrate to lower
serum cholesterol
4. Cessation Experiment:
 An attempt is made to evaluate the termination of a habit
which is considered to be causally related to disease.
 Cigarette smoking and lung cancer.

5. Trials of Etiological Agents:

 To confirm or refute an etiological hypothesis

6. Evaluation of Health Services:

 Domiciliary treatment of PTB was as effective as
 more costlier hospital or sanatorium treatment
Phases of clinical trials
 Phase – I Trial done on group of healthy individuals to
know safety, efficacy and the side effects
 Phase – II carried in diseased group to know safety and
efficacy done in multiple centres.
 Phase – III carried in thousands of people to study safety,
efficacy and whether fit for manufacturing. Determine the
effectiveness (overall benefit/risk-cost assessment) of new
therapies relative to standard therapy.
 Phase – IV Post-marketing study as the drug has already

been granted regulatory approval/license.

Non-Randomized Trials
UNCONTROLLED TRIALS
NATURAL EXPERIMENTS
BEFORE AND AFTER COMPARISONS
STUDIES
UNCONTROLLED TRIALS
 There is room for uncontrolled trials (i.e., trials with no
comparison group).
 Uncontrolled trials may be useful in evaluating whether a
specific therapy appears to have any value in a particular
disease, to determine an appropriate dose, to investigate
adverse reactions, etc.
For example – indirect epidemiological evidence that the
pap test is effective in reducing mortality from cervical
cancer.
Natural Experiment
 Where experimental studies are not possible in human populations, the
epidemiologist seeks to identify "natural circumstances" that mimic an
experiment.
For example,
1. In respect of cigarette smoking, people have separated themselves
"naturally" into two groups, smokers and non-smokers.
2. John Snow discovery - cholera – water borne disease
Before & After Comparison Studies
1.Before and after comparison studies without control These
studies centre round comparing the incidence of disease
before and after introduction of a preventive measure.
• The events which took place prior to the use of the new
treatment or preventive procedure are used as a standard
for comparison.
• The classic examples of "before and after comparison
studies" were the prevention of scurvy among sailors by
James Lind in 1750 by providing fresh fruit; studies on the
transmission of cholera by John Snow in 1854; and more
recently, prevention of polio by Salk and Sabin vaccines.
Before and after comparison studies with
control.
 In the absence of a control group, comparison between
observations before and after the use of a new treatment or
procedure may be misleading.
 In such situations, the epidemiologist tries to utilize a
"natural" control group i.e., the one provided by nature or
natural circumstances.
 If the preventive programme is to be applied to an entire
community, he would select another community as similar
as possible, particularly with respect to frequency and
characteristics of the disease to be prevented
IN THIS EXAMPLE, THE EXISTENCE OF A CONTROL
WITH
WHICH THE RESULTS IN VICTORIA COULD BE
COMPARED
STRENGTHENS THE CONCLUSION THAT THERE WAS
DEFINITE FALL IN THE NUMBER OF DEATHS AND
INJURIES IN OCCUPANTS OF CARS AFTER THE
INTRODUCTION OF
COMPULSORY SEAT-BELT LEGISLATION
Potential errors in epidemiological studies
(Bias)
 Bias may arise from the errors of assessment of outcome due to
human element.
 Bias due to confounding

• Selection bias:
 Prevalence and incidence bias (selective survival)
 Admission rate (Berksons/Berkesonian bias)

• Information bias: memory or recall bias

 telescopic bias
 interviewers bias

Confounding factor: One which is associated both with

exposure and disease; and is distributed unequally in study and
control groups
Blinding

Blinding is procedure to eliminate bias.

• Three 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
Reference
o Essentials of Public Health Dentistry, Soben Peter 5th
edition
o Park’s textbook of Preventive & social Medicine,
K.Park 25th edition
o Textbook of preventive & community dentistry, Joseph
John, 2nd edition.