Epidemiology is the basic science of preventive and social medicine.

Epidemiology is defined
as ‘the study of the occurrence and distribution of health related events ,states and processes
in specified populations ,including the study of the determenants influencing such
processes,and the application of this knowledge to control relevant health problem.’

The primary concern of the epidemiologist is to study diseases occurrence in people, who
during the course of their lives are exposed to numerous factors and circumstances ,some of
which may have a role in disease etiology.

Epidemiological studies can be classified as observational studies and experimental studies.

Observational studies are two types-

i.Descriptive study

ii.Analytical study

Analytical Epidemiology :Second major type of epidemiology.Focus on individual within

population.Objective is not to formulate hypothesis but to test hypothesis.Analytical study
comprise two distinc types of study-

a.Case control study

b. Cohort study

a.Case control study : It is often called “retrospective studies”are a common first approach to
test causal hypothesis.The case control method has three distinct features:

 Both exposure and outcome have occurred before the start of the study.
 The study proceeds backwards from effect to cause.
 It uses a control or comparism group to support or refute an inference.

Basic steps:There are four basic steps in concluding a case control study:
1. Selection of cases and controls
2. Matching
3. Measurement of exposure
4. Analysis and interpretation
Selection of cases:

a.Definition of a case:The prior definition of what constitutes a” case” is crucial is to case

control study.It involves two speci fication-
  Diagnostic criteria:The diagnostic criteria of the disease and the stages of disease
if any to be included in the study must be specified before the study is
undertaken.
 Eligibility criteria:The second criterion is that of eligibility.A criterion customarily
employed is the requirement that new ly diagnosed cases within a specified
period of time are eligible than old cases.
b.Sources of cases: The cases may be drawn from

 Hospitals
 General population
Selections of controls: The controls must be free from the disease under study.They
must be as similar to the cases as possible ,except for the absence of disease under
study.
Sources of controls:The sources from which controls may be selected include hospitals,
relatives neighbours,and general population.

Matching: Matching is defined as a process by which we select controls in such away that they
are similar to the cases with regard to certain patient selected variables (eg.age) which are
known to influence the outcome of disease and which ,if not adequately matched for
comparability,could distort or confound the results.

Confounding Factor:It is defined as one which is associated both with exposure and disease
and is distributed unequally in study and control groups.More specifically “confounding factor”
is one that,although associated with “exposure”under investigation,is itself,independently of
any such association,a”risk factor “for disease.

Eg.In the study of the role of alcohol in the aetiology of oesophageal cancer,smoking
is a confounding factor because –

I. It is associated with consumption of alcohol

II. It is an independent risk factor for oesophageal cancer

In this condition,the effect of alcohol consumption can be determined only if the influence of
smoking is neutralised by matching.

Measurement of exposure:Definition and criteria about exposure(or variables which may be of

aetiological importance)are just as important as those used to define cases and controls.

This may be obtained by-

I. Interviews
 II. Questionnaries

III. Studying past records of cases such as hospital records,employment records.

IV. Clinical or laboratory examination

Analysis:The final step is analysis,to find out

I. Exposure rates among cases and controls to suspected factor

II. Estimation of disease risk associated with exposure(odds ratio)

I.Exposure Rates:

Example of a case control study of tobaco chewing and oral cancer-

Cases Controls Total

(With oral cancer) (Without oral cancer)

Tobaco chewer 33(a) 55(b) 88 (a+b)

Non chewer 2(c) 27(d) 29(c+d)

Total 35(a+c) 82(b+d) n=a+b+c+d

Exposure rates

 Cases=a/(a+c)=33/35=94.2%

 Controls=b/(b+d)=55/82=67.0%

II.Estimation of risk:

Relative risk=Incidence among exposed/incidence among non-exposed

a c
(a+b) (c+d)

Odd Ratio=(a/b )/(c/d)=ad/bc

33*27/55*2=8.1
It measure the strength of association between risk factor and outcome.
Bias in case control studies:Many varieties of bias may arise in epidemiological studies.some of
these are-
 Bias due to confouding
 Memory or recall bias
 Selection bias-The cases and controls may not be representative of cases and controls in
the general population.
 Berkesonian bias-The bias arises because of the different rate of admission to hospitals
for people with different diseases.
 Interviewer’s bias

Advantages:-
1. Relatively easy to carry out.
2. Rapid and inexpensive.
3. Require comperatively few subjects.
4. Particularly suitable to investigate rare diseases or diseases about which little
is known.
5. No risk to subjects.
6. Allows the study of several different aetiological factor.
7. Risk factor can be identified .
8. No attrition problem because no follow up require in future.
9. Ethical problem minimal.
Disadvantage:-
1. Problems of bias relies on memory or past records,the accuracy of which may
be uncertain.
2. Selection of appropriate control group may be difficult.
3. We cannot measure incidence,and can only estimate the relative risk.
4. Do not distinguish between causes and associated factors.
5. Not suited to the evaluation of therapy or prophylaxis of disease.
6. Another major concern is the representativeness of cases and controls.
study,incid
Cohort study:-It is another type of analytical study which is also known as prospective
study,longitudinal ence study and forward looking study.The distinguishing features of cohort
studies are-
 The cohort are idntified prior to the apperance of the disease under investigation
 The study groups,so defined,are observed over a period of time to determine the
frequency of disease among them
 The study proceed forward from cause to effect
 Concept of cohort:-In epidemiology,the term “cohort”is defined as a group of people who
share a common characteristic or experience within a defined time period
(eg.age,occupation exposure to drug or vaccine,pregnancy etc).Thus a group of people born
on the same day or in the same period of time(usually a year) form a birth cohort.
Indication of cohort study:-
 When there is good evidence of an association between exposure and disease ,as
derived from clinical observations and supported by descriptive and case control
studies
 When exposure is rare but the incidence of disease high among exposed e.g.special
exposure groups like those in industries,exposure to x-ray etc.
 When attrition of study population can be minimized,e.g.follow up is easy,cohort is
stable ,cooperative and easily accessible and
 when sample funds are avaible
Types of cohort studies:-
1. Prospective cohort studies
2. Retrospective cohot studies
3. Combination of retrospective and prospective cohort studies

Prospective cohort studies:-It is one in which the outcome has not yet occurred at the
time the investigation begins.Most pros pective studies begin in the present and continue into
future.For e.g.the long term effects of exposure to uranium miners and acomparism group of
individuals not exposed to uranium mining and by assessing subsequent development of lung
cancer in both the groups.The principal finding was that the uranium miners had an excess
frequency of lung cancer compare to non-miners.Since the disease had not yet occured when
the study was under taken,this was a prospective cohort design.

Retrospective cohot studies:-It is one in which outcomes have all occurred before the start of
investigation. The investigator goes back in time some times 10-30 years,to select his study
groups from existing records of past employment,medical or other records and traces them
forward through time,from a past date fixed on the records,usually up to the present.It is also
known as historical cohort study ,prospective study in retospective and non-concurrent
prospective study.
e.g.In 1978- a cohort of 17080 babies born between January 1,1969 and December 31,1975 at a
Boston hospital were investigated of the effects of electronic foetal monitoring during
labour.The outcome measured was the neonatal death.The study showed that the neonatal
death rate was1.7 times higher in unmonitored infants.
Combination of retrospective and prospective cohort studies:-In this type of study,both the
retrospective and prospective elements are combined.The cohort is identified from the past
records,and is assessed of date for the outcome.Same cohort is followed up prospectively into
future for further assessment of outcome.
Elements of a cohort study:-
1. Selection of study subjects
2. Obtaining data on exposure
3. Selection of comparism groups
4. Follow-up
5. Analysis
1.Selection of study subjects:-The subjects of a cohort study are usually assembled in one of
two ways-
a) General population:-When the exposure or cause of death is fairly
frequent in the population,cohorts may be assembled from the general
population,residing in well-defined geographical,political and
administrative areas.

b)Special groups:-These may be special groups or exposure groups that can readily
be studied-
 Select groups-These may be professional groups(e.g.doctors
,nurses,lawyers)obstetric population,government employees etc.These groups are
usually a homogeneous population.
 Exposure groups-If the exposure is rare,a more economical procedure is to select a
cohort of persons known to have experienced the exposure.A readily accessible
sorce of these groups are the workers in industries and those employed in high
risk situation (e.g.radiologists exposed to x-rays)
2.Obtaining data on exposure:-Information about exposure may be obtained directly from the-
a) Cohort members-Through personal interviews or mailed questionnaires.
b) Review of records-Certain kind of information e.g. dose of radiation,kinds of surgery etc
can be obtained from only medical records.
c) Medical examination or special tests-Some types of information can be obtained only by
medical examination or special tests.
d) Environmental surveys-This is the best source for obtaining information on exposure
levels of the suspected factor in the environment where the cohort live or worked.
3.Selection of comparison groups:-There are many ways of assembling comparism groups:
a) Internal comparison-In some cohort studies,no outside comparism group is
required.The comparism groups are in built.That is single cohort enters the study,and
its member may,on the basis of information obtained,be classified into several
comparism groups according to the degrees or levels of exposure to risk
(e.g.smoking ,blood pressure)before the dvelopmet of the disease in question.
 b) External comparisons-When information on degree of exposure is not available,it is
necessary to put up an external control,to evaluate the experience of the exposed
group,e.g.,smokers and non smokers.
c) Comparison with general populaton rates-If none is available,the mortality
experience of the exposed group is compared with the mortality experience of the
general population in the same geographic area as the exposed people ,e.g.comparison
of frequency of lung cancer among uranium mine workers with lung cancer mortality in
the general population where the miners resided.
4.Follow up-One of the problems in cohort studies is the regular follow up of all the
participants.The procedures required comprise:
a) Periodic medical examination of each member of the cohort
b) Reviewing physician and hospital records
c) Routine surveillance of death records and
d) Mailed questionnaires,telephone calls,periodic home
5.Analysis-The data are analysed in terms of-
a) Incidence rates
b) Estimation of risk

(a)Incidence rates:-
Contingency table applied to hypothetical cigarette smoking and lung cancer example
Cigarette smoking Developed Did not develop Total
lung cancer lung cancer
Yes 70 6930 7000
(a) (b) (a+b)
No 3 2997 3000
(c) (d) (c+d)

Incidence rates

(a) among smokers =70/7000=10 per 1000

(b)among non smokers=3/3000=1 per 1000

(b)Estimation risk

Having calculated the incidence rates,the next step is to estimate the risk of outcome(e.g.
disease or death ) in the exposed or non- exposed cohorts.This is done in the terms of two well
known indices :

(i)relative risk (ii)attributable risk

RR Incidence of disease or death among exposed

Incidence or disease or death among non exposed

In our hypothetical example RR of lung cancer =10/1=10

Attibutable risk is often often expressed as a percent.This is given by the formula

Incidence of disease rate among exposed-incidence of disease rate among non exposed

Incidence rate among exposed

Attributable risk in our example would be:

10 – 1 100 =90%

10

Advantages :-

 Incidence can be calculated

 Several possible outcome related to exposure can be studied simultaneously

 Cohort studies provide a direct estimate of relative risk

 Dose -response ratios can be calculated

 Since comparison groups are formed before disease develops certain forms of bias
can be minimised

Disadvantage:-

 Cohort studies involve a large number of pupils

 It takes a long time to complete the studies and obtain result

 Certain administrative problems ,such as loss of experience staff,loss of funding

,and extensive record keeping are inevitable

 It is not unusual to lose a substanial proportion of original cohort

 Selection of comparison groups which are representative of the exposed and un-
exposed segments of the population is a limiting factor
  There may be changes in the standard methods or diagonastic criteria of the
disease over prolonged follow-up.

 Cohort studies are expensive.

 The study itself may alter people’s behaviour

 With any cohort study we are faced with ethical problems of varying importance.

 In a cohort study,practical considerations dictate that we must concentrate on a

limited number or factors possibly related to disease outcome.

Main differences between case control and cohort studies:-

Case control study Cohort study

1.proceeds from “effect to cause” Proceed from cause to effect

2.Starts with the disease Starts with people exposed to risk factor or
suspected cause
3.Test whether the suspected cause occur
more frequently in those with the disease than Tests wheather disease occurs more frequently
among those without the disease. in those exposed,than in those not similarly
exposed.
4.Usually the first approach to the testing of a
hypothesis,but also useful for exploratory Reserved for testing of precisely formulated
studies. hypothesis

5.Involves fewer number of subjects Involves larger number of subjects

6.Yields relatively quick results Long follow up period often needed,involving

delayed results.

Inappropriate when the disease or exposure

7.Suitable for the study of rare disease
under investigation is rare
8.Generally yields only estimate of RR
Yields incidence rates, RR as well as AR
9.Cannot yieldinformation about diseases
Can yield information about more than one
other than that selected for study
disease outcome
10.Relatively inexpensive
Expensive
 Experimental epidemiology:-Experimental studies also called ‘intervention studies’.In this
study,some action or intervention is involved such as deliberate application or withdrawl of the
suspected cause in the experimental group and no change in the control group. Later the
outcome is compared in both groups.

The aim isto provide ‘scientific proof’ of the etiological factors andto evaluate the health
services.

There are three types of experimental studies:

1. Clinical trial (or Randomized controlled Trial) with patients as the unit of study.

2. Field trial (or Community Intervention Studies) with healthy people as the unit of
study

3. Community trial with entire community as the unit of study.

Clinical trial (or Randomized controlled Trial):-It is so called because the patients who
constitute the unit of study are allocated into ‘study group’(experimental group) and’control
group’ at random ,depending upon whather they receive or do not receive the
intervention.Random allocation eliminates bias.

Aims: is to test efficiency of a new drug or a new drug regimen or a new therapeutic or surgical
procedure.

Basic steps:-In conducting a clinical trial are-

a) Drawing of a protocol

b) Selecting reference population( unit of study)

c) Randomization (allocation into experimental and control group)

d) Manipulation (intervention)

e) Follow up

f) Assessment of outcome

g) Reporting

Drawing of a protocol:-It means-

  Aim and objective of the study

 Criteria for the selection of the study group and control group

 Size of the sample

 Procedure for the allocation into study group and control group

 Intervention to be done

 The cooperation of the participants till the end of the study

Selection reference population-The study population is derived from the reference

population,on which the study is conducted.It is the population to which the findings of the
trial,if found successful,are expected to be applicable.

Randomization-It is a statistical procedure by which participants are allocatedinto groups

usually called ‘study’ and ‘cotrol’groups.It is done for elimination of ‘selection bias’.Three
common randomization scheme –Simple randomization,Stratified randomization,Clustered
randomization.

Objective-Everyone in the study has an equal probability of being offered each intervention.All
prognostic variables,known and unknown,have an equal distribution in the treatment groups in
the long run.

Manipulation-To manipulate the study group by the deliberate application or withdrawl or

reduction of the suspected causal factor or drug or treatment.

Follow up-This implies examination of the experimental and control groups.That defined
interval of time,in a standerd manner,with equal intensity,under the same given circumtances,in
the same time frame till final assessment of outcome.

Assessment-The final step is assessment of the outcome of the trials in terms of-positive
results- reduced incidence of severity of the disease,cost of health service and other
appropriate outcome.Negative result –severity and frequency of side effects and
complication.The incidence of positive/negative results is rigorously compared in both groups.

Reporting-A detail report of the trial is written and sent to a medical journal for publication.

Field trial:-This differ from clinical trial inthat’ healthy people’constitute the utit of study and
not the sick persons The trials are of the following types-

1. Preventive Trial-This involves trial of preventive measures in a study group of

individuals,e.g.trial of vaccine.
 2. Risk factor trial-this is the trial involves modification or elimination of the risk factor of
the disease. The risk factor trial may be single factor or multi factor tril,e.g.the major
risk factor of coronary disease are increased cholesterol level in the serum,smoking
habits,hypertention and sedentary habits.

Community Trial:-In this type of experimentalstudies,the unit of study is neither sick persons as
in clinical trial nor the healthy persons as in the field trial,but is the entire community.

Nonrandomized trials:-Since it is not always possible to resort to randomized controlled trial in

human beings due to ethical,administrative and other reasons,we can resort to other study
designs,such as non randomized trial.These nonrandomized trials are-

Uncontrolled trial-These are trial without controls,because necessity is not felt due to peculiar
nature of the outcome,e.g.in human rabies ,the mortality is 100%.If a new drug for human
rabies is invented,control group is not required.

Natural Experiments-In tese type ‘natural circumtances’such as earthquake,famine,floods etc

are identified as experiment,because such events cannot be artificially created for the sake of
the experiments.

Before and after comparison trials-In this type,the group receiving the intervention itself serves
as a control,e.g. use of seat-belt for prevention of death and injuries caused by motor vehicle
accidents.

References:-
1.Park K.Park ‘s Text book of Preventive and Social Medicine.25th ed.Pune:M/s Banarsidas
Bhanot;2019.P.70-95.

2.Basheer p Shebeer,Khan S Yaseen.A Concise Text Book of Advance Nursing Practice.2 nd

ed.Bangalore:Emmess Medical Publishers;2017.P.70-74.

3.Suryakanta AH.Community medicine With Recent Advances.5 th ed.New Delhi:Jaypee Brothers

Medical Publishers;2019.P.260-263.
 CONTENT
ON
ANALYTIC AND
EXPERIMENTAL
EPIDEMIOLOGY

SUBMITTED TO
SUBMITTED BY

DR.UMA ADHIKARI PIYALEE SAHA

SENIOR LECTURER M.SC NURSING 1 ST YEAR

CON,MCH CON,MCH