Epidemiological

Investigations
Dr. Rabaa Mahmoud
Dr. Amjad Hussain
 Objectives
• By the End of This Lecture the Students Should Be to:

I. Understand different types of epidemiological studies

II. Illustrate how to estimate odd ratio and incidence rate

III. Compare between different types of epidemiological

studies

IV. Realize the importance of randomized control trials (RCT)

V. Identify different factors affecting validity of RCT

2
Scientific method of epidemiology
1) Formulation of the hypothesis
2) Design the investigation
3) Selection of the sample
4) Conducting of investigation
5) Analysis of the data
6) Drawing the conclusion
7) Publishing of the results
 Types of Epidemiological Studies

A. Experimental B. Non-Experimental
studies studies

I. Randomized
a. Descriptive
control trial
1-Cross sectional
2-Case series

II. Community b. Analytical

trial 1-Cohort
2-Case control 4
I. Non-Experimental
studies

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 (1) Descriptive Studies (Who? What? Where? When?)

• First phase of epidemiological investigation

• Study of the occurrence and distribution of disease
• The study describe the disease in the terms of time, place, and
person (PPT), :

Time
place
person
 Procedures in descriptive studies

• 1. Defining the population to be studied

• 2. Defining the disease under study.
• 3. Describing the disease by time, place, person.
• 4. Measurement of the disease.
• 5. Comparing with known indices.
• 6. Formulation of an etiological hypothesis
1. Defining the population to be studied

Age, gender, cultural

Define population by character ……

1.The whole population

in selected area

2. Specially selected
group according to age
or ……..
The study population can be
2. Defining the disease under study.

The precise and valid definition

Operational definition

To differentiate between diseased and

non diseased
3. Describing the disease by time, place, person

place

Person

PPT = person, place, time

 A. Time distribution
the onset and the duration of the disease

Disease by
time

Short time
fluctuation Periodic Long term
fluctuation fluctuation
( epidemic)

Continuous
Single exposure Seasonal trend Cyclic trend
exposure
 International
variation

B. Place Rural –
National Urban
variation distribution differences

Local distribution
 C. Person distribution

Age Gender Ethnicity Social class

 4. Measurement of the disease

Measure
the
disease

Morbidity Mortality
rate rate

Prevalence Incidence
study study
 5. Comparing with known indices.
• 1. The comparison should be made with
different populations.

• 2. Helping us to known the possible risk factors

related to the disease
(formulating the hypothesis)
 6. Formulation of an etiological hypothesis

• We assume the possible risk (etiological) factors.

• It can be accepted or rejected
 Cross-Sectional Studies (prevalence studies)

1. It is based on single examination of a cross – section

of the population at one point of time

2. It provides snapshot of the population at a certain

point of time.

3. Both exposure and disease outcomes are

determined simultaneously.
Advantages of Cross-Sectional Studies :-
Simple , economic and less time consuming

Good for identifying prevalence of common outcomes.

Dis-Advantages of Cross-Sectional Studies :-

Cannot determine whether exposure preceded disease (time
sequence)
Little information about the natural history of the disease and rate of
incidence
 Uses of descriptive epidemiology
1. Provides data regarding the magnitude of the disease in the
community

2. Provides a clue to disease etiology

3. Provides data for planning , organizing, evaluating preventive

and curative services

4. Contributing to research
2. Analytical epidemiology (test the etiological hypothesis)

Analytical
studies

Case
Cohort
control
study
study
A. Case-Control (Retrospective study)

It is the first step to test causal hypothesis

Have the following features

1 Exposure and disease preceed the study

The study proceed from the effect to the

2 cause

3 Use a control group

Framework of a case control study
Control Case Risk Factors
( disease absent) ( disease present)

b a Present

d c Absent

b+d a+c total

 Basic steps in case control study

1. Selection of cases and controls

 Definition of cases
 Source of cases
 Selection of controls
 Source of the controls
2. Matching
Group matching
Matching by pair
3. Measurement of Exposure
4. Analysis and interpretation
Estimation of the risk (Odd Ratio)
 example A case control study of betel chewing and oral
cancer
Controls ( without oral Cases ( with oral cancer) Risk factor (betel
cancer (NO) (Yes) chewing)
48 (b) 21 (a) Betel chewers
(exposed)
30 (d) 4 (c) Non betel chewers
( non exposed)

78 (b+d) 25 (a+c) Total

Exposure rate among cases = a / (a+ c)

Exposure rate among controls = b / (b + d)
 Estimation of the risk
Odd Ratio: It measure the strength of association between risk
factors and outcome
Odds ratio (OR) = ad / cb
 = (21x 30) / (4x48) =
The betel shows risk of having oral cancer 3.2 times more than that
of non betel chewers
 Interpretation of Odds Ratio

• OR > 1: Increased odds of exposure among those with outcome

• OR < 1: Decreased odds, or protective effects, among those with

outcome

• OR = 1: No association between exposure and outcome

Advantages
1. Easy to carry out
2. Rapid and inexpensive
3. Few subjects are required
4. Rare disease can be studied
5. No risk to subjects
6. Allow study several etiological factors
7. Risk factors can be identified
8. No attrition problem
9. Ethical problems are minimal
Disadvantages
1. Incomplete information

2. Bias - selection bias, recall bias, information bias, non

response bias, analysis bias, misclassification bias, confounding

3. Problem in identifying control group and matching variables

4. Yields only odds ratio

5. Temporal relationship not clear (time sequence between exposure

& disease)
 B. Cohort studies (Prospective)

 It is also called (longitudinal, incidence, forward and looking

study).
 Cohort a group of people who share a common
characteristic or experience within a defined time period.
 Cohort study (prospective study)
Have the following features

1 Cohorts are identified before the appearance of the

diseases

Study groups are observed over a period of time

2 to determine the frequency of the disease among
them

The study proceed forward from the cause to the

3 effect
 Indications
1. when there is a good evidence of an association between
exposure and disease, supported by descriptive and case
control studies.

2. when the exposure is rare but the incidence of disease is

high among the exposed.

3. when attrition of the study population can be minimized.

4. when ample funds are available

 Types of cohort
studies

Prospective Retrospective
Combination
(Current) )Historical(
Framework of a cohort study

Total Diseases Cohort

No yes

a+b b a Exposed to the putative etiologic

factor

c+d d c Not Exposed to the putative

etiologic factor
 Steps of cohort study
1. Selection of study subjects
 General population
 Special groups

2. Obtaining data on exposure

3. Selection of comparison group
4. Follow up
5. Analysis
 Incidence rate
 Estimation of the risk
Example: A cohort study of betel chewing and
oral cancer
Total Diseases Betel chewer s

No yes

7000 (a + b) 6930 (b) 70 (a) Exposed (yes)

3000 (c + d) 2997(d) 3 (c) Not Exposed (no)

Incidence rate among exposed (betel chewer) =

a/a+b = 70/ 7000 = 10 per 1000
Incidence rate among non exposed (non betel
chewer) = c/c+d = 3/ 3000 = 1 per 1000
 Estimation of the risk
• Relative risk (RR)

Incidence of disease among exposed

RR =
Incidence of disease among non exposed

If the RR > 1 positive association

 Relative Risk
• Ratio of the incidence rates between two groups
• Can only be calculated from prospective studies
(cohort studies)
• Interpretation
• RR > 1: Increased risk of outcome among “exposed”
group
• RR < 1: Decreased risk, or protective effects, among
“exposed” group
• RR = 1: No association between exposure and outcome
 Advantages

1. Suitable for rare as well as common exposure.

2. Exposure data are often more accurate.

3. Less information bias.

4. Examines multiple effects of a single exposure.

5. Can elucidate temporal relationship between exposure and disease.

6. Allows direct measurement of incidence of disease in the exposed and non-

exposed groups.
 Disadvantages

1. Large number of study subjects.

2. Extensive records keeping needed (retrospective).

3. Attrition problem among study population.

4. Selection of groups is a limiting factor.

5. Diagnostic criteria can be changed over prolonged follow

up.

6. Study is expensive and time consuming (prospective).

Differences between case control and
cohort study ?????
 CASE CONTROL STUDY COHORT STUDY
1. Proceed from “effect to cause” 1. Proceeds from “cause to effect”
2. start with the disease 2. Start with people exposed to risk factor or
suspected cause
3. Test whether the suspected cause occurs 3. Test whether disease occurs more
more frequently in those with the disease frequently in those exposed than in those
than among those without the disease not similarly exposed.
4. Usually the first approach to the testing of 4. Reserved for testing of precisely formulated
a hypothesis , but also useful for hypothesis.
exploratory studies.
5. Involves larger number of subjects
5. Involve fewer numbers of subjects
6. Yields relatively quick results 6. Long follow – up period
7. Suitable for study of rare diseases 7. Inappropriate when the disease or
exposure under investigation is rare
8. Yield in incidence rate , RR.
8. Generally yield in OR.
9. Can yield information about more than one
9. cannot yield information about diseases disease outcome
other than that selected for study.
10.Relatively inexpensive 10. Expensive
II. Experimental
Epidemiology

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 Experimental epidemiology

Experimental epidemiology is often

equated with

Randomized control trial

It involve some actions as intervention,

manipulation ( application or withdrawal) or
change some variables in the causal chain
 AIMS
1. To provide “ scientific proof “ of etiological factors.

2. To provide a method of measuring the effectiveness and efficiency of

health services for prevention, control and treatment of disease and
improve the health of the community.
Types of experimental studies

Experimental
studies

Randomized
Community trial
control trial
 Steps of Randomized Control Trials

1. Randomization

2. Selection of reference and experimental populations

3. Manipulation or intervention

4. Blinding (Masking)

5. Follow – up ( periodic assessment)

6. Assessment of final outcome

1. Randomization

 The purpose of randomizations to insure

1. Comparability.
2. To avoid intrusion of conscious or sub-
conscious bias.
3. It gives validity.
 2. Select suitable population
Select the suitable sample
(experimental or study group)
Those not give Those not
consent eligible
Make necessary
exclusion

Randomize

Experimental Control
group
Manipulation and follow
up

Assessment
3. Manipulation

In this step the investigator intervenes or manipulates the

study group by application or withdrawal or
reduction of the suspected factor. The control
group may have a standard intervention, a placebo (an
inert substance that produces no effect) or no intervention at all.
4. Blinding (masking)

a. Single blind trial:

- Participant not aware

b. Double blind trial:

- Doctor nor participant aware

c. Triple blind trial:

- Participant, investigator nor person

analyzing the data are aware
5. Follow up
• At defined intervals of time, the both groups are assessed
for outcome of the intervention.

• A problem of follow up is attrition due to death or drop outs.

6. Assessment of outcome
• The outcome must be specified in advance and expressed
in term of positive results which are the benefits to the
subject.

• The negative or the severity and frequency of

side effects and complications also need to be stated.
 Types of control groups

1) Placebo
2) Passive control
3) Positive control
4) Historical control
 Factors affecting validity of clinical trials
1) Population
2) Comparability (randomization)
3) Adequate numbers (withdrawal)
4) Consistency in examination
5) Selection of diagnostic criteria
6) Duration of the trial
7) Compliance (reliability)
8) Determination of the effect (Blindness)
 Summary
• Steps for investigation of risk factors:

First
• Cross-Sectional study

Second
• Case-Control study

Third
• Cohort study

Fourth
• Randomized Control study
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 References
A Text-book of Public
Health Dentistry
Chapter 2 (13- 22)

56
 Quizzes
1. Incidence of any disease can be studied by:
a. Longitudinal study
b. Cross-sectional study
c. Retrospective study
d. None of the above

2. A 10 years long study commencing the use of fluorides and pit and
fissure sealants in control caries on same population group is an
example of:
e. Cross-sectional study
f. Retrospective study
g. Case-control study
h. Experimental study

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Thank You