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Experimental or intervention studies are studies carried out under direct control of investigator.
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:
When an experimental population has been defined its members are invited in the study.
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:
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.