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Experimental Epidemiology - 3

Epidemiology

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29 views25 pages

Experimental Epidemiology - 3

Epidemiology

Uploaded by

JIAEN
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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PRINCIPLES OF

EPIDEMIOLOGY

Dr Shilpa Gunjal
COH 1 Module Coordinator
[email protected]
Content

• Experimental study

• Types of Experimental designs.

• Types of Randomized controlled clinical trial.

• Steps in conducting experimental study.

• Advantages and disadvantages of experimental


epidemiology.
EXPERIMENTAL
EPIDEMIOLOGY
“In modern usage experimental epidemiology is
often equated with Randomized Controlled Trials”

Experimental studies involve some action, intervention,


or manipulation such as:

1. Deliberate application or withdrawal of suspected


causative agent.

2. Changing one variable of the causative chain in


experimental group but not in the control group.
FEATURES OF EXPERIMENTAL EPIDEMIOLOGY

1. The experiment is observed and the outcome is compared


between experimental and control groups to statistically
deduce the association between independent and
dependent variables.
2. Experimental research allows causal effects to be tested.
3. It can be of predictive values where the expected results
of certain interventions can be predicted precisely.
4. Experimenter should identify independent and dependent
variable at an early stage .

Independent variable is that which we are testing and


dependent variable is the outcome.
Aims of Experimental Studies

1. To provide “Scientific Proof” of aetiological


(risk) factors which may permit the modification
or control of those diseases.

2. To provide a method of measuring the


effectiveness and efficiency of health services
for the prevention, control and treatment of
disease and improve the health of the
community.
CLASSIFICATION OF EXPERIMENTS

1. ANIMAL EXPERIMENTS
2. HUMAN EXPERIMENTS
PURPOSES OF ANIMAL STUDIES

Animal studies are done for the following purposes


a) Experimental reproduction of human disease in
animals to confirm aetiological hypothesis.
b) To test the efficacy of various therapeutic and
preventive measures such as vaccines and drugs.
c) To study the natural history of disease.

Animal experiments are done on carefully bred animals


in controlled environments.
ADVANTAGES

1. Animals are bred in laboratories and manipulated


easily according to wishes of the experimenter.

2. They multiply rapidly and enable experimenter to


carry out certain experiments which are not
possible in human beings.
LIMITATIONS

1. All human diseases cannot be reproduced in


animals.

2. Results of animal studies cannot be extrapolated


to human beings.
HUMAN EXPERIMENTS
1. They are done on humans and very much needed to investigate
disease etiology.

2. They are also done to evaluate the preventive and therapeutic


measures.
Eg. James Lind (1747) – Study done on Sailors to reveal the
association of lemons, oranges in diet on scurvy among a
group of Sailors.
Edward Jenner’s (1796) experimental work with Cowpox to
develop vaccine against Small pox.

3.Human studies should be carefully designed because they


involve logistic and ethical implications
CLASSIFICATION OF EXPERIMENTAL
STUDIES

They are broadly divided into two types


1. Randomized Controlled Trials
2. Non Randomized Trials
RANDOMIZED CONTROLLED TRIALS

RCT is considered as the gold standard in


epidemiology and perhaps the most
concrete evidence for establishing
association.
STEPS IN RCT DESIGN
1. Drawing up a protocol
2. Selecting reference and experimental
Populations
3. Randomization
4. Manipulation or Intervention
5. Follow-up
6. Assessment of outcome
DESIGN OF A RANDOMIZED CONTROLLED TRIAL

Select suitable population


(Reference or Target Population)

Select suitable sample


(Experimental or study population)

Those not eligible


Make necessary exclusions

RANDOMIZE

Experimental group Control Group Those who do not


wish to give consent
Manipulation & Follow up

Assessment
The protocol
• A strict protocol is the basic requisite
• It specifies
– Aims & objectives of the study
– Questions to be answered
– Criteria for study and control groups
– Sample size,
– Standardization of working procedures and schedules
– … till the evaluation of the outcomes
• It aims at preventing bias and reducing the sources of error
• Preliminary or pilot studies before setting the protocol
Selecting reference & experimental populations

• Reference or target population

• Experimental or study population

– Consent

– Representative of the reference population

– Satisfy selection criteria


Randomization
• A statistical procedure by which the study participants are
allocated in to groups- usually called study and control
groups.

• Every individual gets an equal chance of being allocated in


to either group or any of the trial groups.

• Eliminates selection bias and allows comparability.


• Manipulation
– Experimental group is exposed to the procedure under
test, strictly according to the pre-determined protocol.

• Follow up
– Examination of experimental & control groups at
defined intervals of time
– Examinations should be done in a standard manner, with
equal intensity, under the same circumstances & in the
same timeframe
– Duration of the trial …
– Attrition
Assessment

• In terms of
– Positive results
– Negative results
• Statistical analysis
STUDY DESIGNS IN RCT’S

1. Concurrent Parallel Study


2. Cross-over type of Study
CONCURRENT PARALLEL STUDY DESIGN

Random Assignment Exposed to specific Observation


Treatment Compare
Patients Outcome
Unexposed to
specific treatment

Time
CROSS-OVER TYPE OF STUDY DESIGN
Random Assignment Observation
Exposed to
specific Compare
Patients Treatment Outcome
Exposed and
Unexposed to Unexposed
specific treatment to treatment

Time
TYPES OF RCT’S

1. CLINICAL TRIALS
2. PREVENTIVE TRIALS
3. RISK FACTOR TRIALS
4. CESSATION EXPERIMENT
5. TRIAL OF ETIOLOGICAL FACTORS
6. EVALUATION OF HEALTH SERVICES
REFERENCES
1. K. Park. Park’s Text book of Preventive and Social Medicine, 22nd edition

2. Leon Gordis. Epidemiology 4th edition.

3. R. Beaglehole, R. Bonita, T. Kjellstrom. Basic Epidemiology. World Health

Organization, Geneva .

4. Health research methodology: A guide for training in research methods, 2nd

edition. World Health Organization, Geneva.

5. Brian Mc Mahon, Thomas F. Pugh, Little. Epidemiology- Principles and

methods. Brown and Co. Boston.

6. Kenneth J. Rothman, Sander Greenland. Modern epidemiology, 2nd edition.

Lippincott Williams & Wilkins.


THANK YOU

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