EXPERIMENTAL EPIDIOMOLOGY

Experimental or intervention studies are studies carried out under direct control of investigator.

The Aims of experimental studies are:

(a) To provide scientific proof of ethological (or risk) factors which may permit the
modification or control of those diseases
(b) To provide 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.

Experimental studies may be conducted in the animals or human beings.

Experimental studies are of two types:

1. Randomized controlled trails(those involving process of random allocation0
2. Non- randomized or non-experimental trails(those departing from strict randomization
for practical purposes, but in such manner that non-randomization does not seriously
affect the basis of conclusions)

In modern usage, experimental epidemiology is often equated with Randomized Controlled

Trials.

Randomized Controlled Trails (RCT)

The basic steps in concluding RCT include the following:

1. Drawing up protocol
2. Selecting reference and experimental populations
3. Randomization
4. Manipulation or intervention
5. Follow Up
6. Assessment of outcome

1. Drawing Up Protocol:
The protocol specifies the aims and objectives of the study, criteria for the selection of
study and control groups, size of the sample, the procedures for allocation of subjects into
the study and control groups, treatments to be applied, standardization of working
procedures and schedules , up to the stage of evaluation of outcome of the study.
 2. Selecting reference and experimental populations:

(a) Reference or target population: It is the population to which the findings of

the trail, if found successful, is expected to be applicable. A reference
population may be as broad as mankind or it may be geographically limited
or limited to persons specific age, sex or social groups.
(b) Experimental or study population: The study population is derived from the
reference population. It is the actual population that participates in the
experimental study, Ideally it should be randomly chosen from the reference
population, so that it has same characteristics as the reference population.

When an experimental population has been defined its members are invited in the study.

The participants or volunteers must fulfill the following three criteria:

A. They must give informed consent that is they must agree to participate in the trail after
having been fully informed about the purpose, procedures and possible dangers of the
trail.
B. They should be representative of the population to which they belong.
C. They should be qualifies or eligible for the trail. In other words, the participants must be
fully susceptible to the disease under study.

3. Randomization:

Randomization is statistical procedure by which the participants are alloated into

groups usually called study & control groups, to receive or not to receive an
experimental preventive or therapeutic procedure or intervention. Randomization is
an attempt to eliminate bias and allows comparability. By random allocation, every
individual gets an equal chance of being allocated into either group. Randomization
is best done using a table of random numbers.

4. Manipulation:

Having formed the study and control groups, the next step is to intervene or
manipulate the study (Experimental) group by deliberate application or withdrawal
or reduction of the suspected casual factor as laid down in the protocol.
5. Follow -Up:

This involves examination of the experimental and control group subjects at defined
intervals of time, in a standard manner under the same given circumstances till final
assessment of the outcome. Some losses to follow-up are inevitable due to factors
such as death, migration and loss of interest. This is known as attrition.