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PRESENTED BY GROUP ( 2 )

Cross – sectional studies:

• It is the simplest form of an observational


study.
• It is based on a single examination of a
cross – section of population at one
point in time (known as prevalence
study).
• Cross sectional studies are more useful
for chronic than shortlived diseases.

PRESENTED BY GROUP ( 2 )
• The cross-sectional studies provide very
little information about the natural history
of disease.
• .Advantages: easy & inexpensive.
• Cross sectional studies are used to GEN-
ERATE HYPOTHESIS.

PRESENTED BY GROUP ( 2 )
ANALYTICAL EPIDEMIOLOGY

• Analytical studies are observational studies where the object of in-


terest is not to formulate, but to test hypotheses & to determine
whether there is an association between a factor or characteristic
and the development of a disease,.
• Although individuals are evaluated in analytical studies, the infer-
ence is not to individuals, but to the population from which they are
selected.

• Two types of analytical studies :


A- Case Control Study.
B- Cohort Study.

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ANALYTICAL EPIDEMIOLOGY
CASE CONTROL STUDY
Factor(s) Individuals with Cases
Present Particular Disease
Or
Absent Individuals without Controls

Particular Disease

COHORT STUDY
Individuals Exposed
Presence or
to Particular Fctors

Individuals Unexposed Absence of


to Particular Fctors Particular
disease

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CASE CONTROL STUDY
• Case Control (Retrospective) studies have 3 features:
• A) Both exposure & outcome (disease) have occured before the
start of the study.
• B) The study proceeds backwards from effect to cause;
• C) It uses a control or comparison group to support or refute an in-
ference.

• Cases & controls must be compareable with respect to


known ”confounding factors” such as age, sex, occupa-
tion, social status, etc.

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PRESENTED BY GROUP ( 2 )
Framework of a case control study

Suspected or Cases Controls


Risk Factors ( Disease Present ) ( Disease Absent )

Present a b

Absent c d

a+c b+d

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BASIC STEPS

• There are four basic steps in conducting a


Case Control Study:

• (1) Selection of Cases & Controls.


• (2) Matching.
• (3) Measurement of Exposure.
• (4) Analysis & Interpretation.

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SELECTION OF CASES

( A ) Definition of a case: It involves two specifications:


(i) Diagnostic criteria & stage of disease (ex. Cancer).
(ii) Eligibility criteriais the requirement that only newly
diagnosed (incident) cases within specified period.
( B ) Source of cases:
(i) Hospitals; cases admitted during a specified period.
(ii) General Population; cases within a defined ge-
ografic area during a specified period of time & should
be fairly representative of all cases in the community.

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SELECTION OF CONTROS

• The controls must be as similar to the


cases as possible, except for the ab-
sence of the disease under study.
• Sources of Controls:
(i) Hospital Controls.
(ii) Relatives.
(iii) Neighbourhood Controls.
(iv) General Population.

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MATCHING
• Matching is defined as the process by which we select
controls in such a way that they are similar to cases with
regards to certain selected variables (e.g. Age) which are
known to influence the outcome of disease & which, if
not adequately matched for comparability, could distort
or confound the results.
• A ”confounding factor” is defined as one which is associ-
ated both with exposre and disease, and is distributed
unequally in study & control groups.

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MEASUREMENT OF EXPOSURE

• Information about exposure may be obtained by


interviews, by questionnaires,or by studing past
records of cases such as hospital records, em-
ployment records,etc.

• The most important factor to be considered to


test associations is the question of bias or sys-
tematic error which must be ruled out.

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ANALYSIS

• The final step is analysis, to find out:


(a) Exposure rates among cases and controls to
suspected factor.
(b) Estimation of disease risk associated with ex-
posure ( Odds ratio)

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Bias in case control Studies

• Bias is any systematic error in the determination of


the association between the exposure and disease.

• It reflects some type of non- comparability between


the study and control groups.

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Varieties of bias

1/Bias due to confounding – an important source of bias – can be re-


moved by matching in case control studies.

2/ Memory or recall bias – cases may have different recall of past events
than control.

3/ Selection bias – there may be systematic differences in characters be-


tween cases and controls-best controlled by its prevention.

4/ Berkesonian bias – different rates of admissions to hospital.

5/ Interviewers bias – if the hypothesis and cases are known by the inter-
viewer – can be eleminated by double – blinding ( planned trial in which
neither the doctor nor the participant is aware of the group allocation and
treatment received).
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Advantages of case control
studies
1. Relatively easy to carry out.

2. Rapid and inexpensive ( compared with cohort studies).

3. Require comparatively few subjects.

4. Suitable to investigate rare diseases or diseases about which little is


known.

5. No risk to subjects.

6. Allow the study of several different aetiological factors .

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Advantages cont.

7/ No attrition problems, because case control studies do not


require follow- up of individuals into the future.

8/ Risk factors can be identified. Rational prevention and con-


trol programmes can be established.

9/ Ethical problems minimal.

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Disadvantages
1. Problems of bias relies on memory or past records, the accuracy of
which may be uncertain; validation of information obtained is diffi-
cult or sometimes impossible.

2. Selection of an appropriate control group may be difficult.

3. We can not 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 con-


trols.

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Example of case control studies
1. Cigarette smoking and lung cancer.

2. Maternal smoking and congenital malformation.

3. Radiation and leukaemia.

4. Oral contraceptive use and hepatocellular adenoma.

5. Herpes simplex and Bell palsy.

6. Induced abortion and spontaneous abortion.

7. Physical activity and coronary death.

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Cohort study

• Prospective study .
• Longitudinal study .
• Incidences study .
• Forward – looking .

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FEATURES OF COHORT STUDY

• The distinguishing feature of cohort


study are : -
• The cohort are identified prior to the appearance
of disease under investigation
• The study group , so defined , are observed
over the period of time to determine the fre-
quency of the disease among them .
• The study proceeds forward from cause to ef-
fect .

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CONCEPT OF COHORT

• Concept of cohort :-

• In epidemiology , the terms “ cohort “ is de-


fined a group of people who shared a
common characteristic or experience
within defined time period .

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INDICATORS FOR COHORT
• Indicators for cohort study : -
• when there is a good evidence of an as-
sociation between exposure & disease .
• when exposure is rare , but the incidence
of disease is high among exposed .
• When attrition of study population can be
minimized .
• When ample fund are available .

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FRAMEWORK

• Frame work of cohort study : -

DISEASE
DISEASE
cohort Yes No Total

Exposure A B A+B

Non- exposure C D C+ D

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GENERAL CONSIDERATIONS

1- Cohort must be free from the disease under


study .
2- In so far as the knowledge of the disease per-
mits , both the groups should be equally sus-
ceptible to the disease under study. .
3- Both the groups should be comparable in re-
spect of all possible variable , which may in-
fluence the frequency of the disease .
4.The diagnostic & eligibility criteria of the disease
must be defined before hand .

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TYPES OF COHORT STUDY

• Types of cohort study : -


1. Prospective cohort studies .
2. Retrospective cohort studies .
3. Combination of Retrospective &
Prospective cohort studies .

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Elements of cohort study

• Elements of cohort study :-


1. Selection of study subject .
2. Obtaining data on exposure .
3. Selection of comparison groups .
4. Follow – up .
5. Analysis .

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ANALYSIS

Analysis; The data are analysed in term of:

(a) Incidence rate of outcome among ex-


posed & nonexposed.
(b) Estimation of Risk.

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INCIDENCE RATES
• IR can be determined directly
in those exposed & not ex- Cigarette Developed Didnot
Smoking Lung Develop Total
posed; Cancer Lung
• Example: Cancer

Incidence rate among smokers


= 70 = 10 per 1000
Yes 70 6930 7000
7000 (a) (b) a+b
Among Nonsmokers
= 3 = 1 per 1000
3000
No 3 2997 3000
(c) (d) C+d
Statistical Significance.= P < 0.001

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ESTIMATION OF RISK

(A) RELATIVE RISK (RR) ( Risk Ratio ): is the ratio of the incidence
of the disease (or death) among exposed & the incidence among
non-exposed.
(B) RR = Incidence of the disease(or death) among ex-
posed
(C) Incidence of the disease(or death) among non-ex-
posed

(D) RR of lung cancer = 10 = 10


(E) 1
• It implies that Smokers are 10 times at greater risk of developing
Lung Cancer than Non-Smokers.

• It is often useful to consider the 95 per cent Confidence Interval of


a relative risk since it provides an indication of the likely & maxi-
mum levels of risk.
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ESTIMATION OF RISK

• (B) Attributable Risk (AR)(Risk difference);


is the difference between the incidence rate of the dis-
ease( or death) between an exposed & non-exposed
group & often expressed as per cent.
AR= Incidence of the disease rate among exposed
minus- Incidence of the disease rate among non-exposed X
100
Incidence rate among exposed

AR in our example= 10 - 1 X 100 = 90%


10

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ESTIMATION OF RISK

• Population Attributable Risk; is the incidence of


the disease (or death) in the total population minus the
incidence of the disease ( or death) among those who
were not exposed to the suspected causal factor.
• It is useful in that it provides an estimate of the amount
by which the disease could be reduced in that population
if the suspected factor was eliminated or modified.

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Lung Cancer death rates among smokers & non-smokers:
UK physicians

Deaths per 100,000 person - years


Heavy smokers 224 Exposed to suspected factor (a)

Non- smokers 10 Non-exposed to suspected causal


factor(b)
Total Population 74 (c)
Individual RR a/b = 224/10 =22.40
Population AR (c-b)/c = 86 per cent
One might expect that 86 per cent of deaths from Lung Cancer could be
avoided if the risk factor of Smoking were eliminated.

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Relative Risk versus Attributable Risk

• Relative Risk is a better index than Attributable


Risk for assessing the aetiological role of a fac-
tor in a disease; The larger the Relative Risk, the
stronger the association between cause & effect.
• Attributable Risk gives a better idea than does
Relative Risk of the impact of successful preven-
tive or public health programme might have in
reducing the problem.

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ADVANTAGES OF COHORT STUDIES

• (A) Incidence can be calculated.


• (B) Several outcomes related to exposure can be studied
simultaneously Ex. Smoking & (Lung Cancer) & (Chronic
heart disease) & (Peptic Ulcer).
• (C) Provide a direct estimate of ralative risk.
• (D) Dose-response ratios can also be calculated.

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DISADVANTAGES OF COHORT STUDIES

• (a) Invlove a large number of people.


• (b) It takes a long time to complete the study.
• (c) Administrative problems ,ex. Loss of experienced
staff, Loss of Funding.
• (d) Loss of substantial proportion of the original cohort-
they may migrate or lose interest.
• (e) Changes in the standard methods or diagnostic cri-
teria over prolonged follow-up.
• (f) Expensive.
• (g) May alter people`s behavior.
• (h)Ethical problems

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Differences between Case Control & Cohort
Study

Scan2.pdf

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