Dr SM Moslehuddin Ahmed

MBBS, MPH, MPhil, FMD

Professor
Dept of Community Medicine
U A M C
 Concept

It involves introducing a new variable or attempting to

change a variable in one or more groups of people.

Example

Elimination of a dietary factor thought to cause allergy

Testing a new drug/vaccine on selected groups of people
Health education about personal hygiene
Deworming of school children with a view to reduce
anaemia.
The effects of an intervention are measured by
comparing the out come in the experimental group
with that in a control group.

The investigator has complete control over the

subjects, as well as the intervention – Random
assignment.

i.e. the investigator enjoys the privilege of

assigning the exposure, can break the main problem
into subgroups to explore each separately
 Not always possible !!

Unethical as in studies inflicting pain or removing vital

organs (as in the Nazi studies in World War II)

Impractical (asking people to smoke or work in a coal

mine, etc.)

One community had its water supply fluoridated while a

similar community did not
 Types: Experimental Study

1. Randomized controlled trial

2. Field trial
3. Community trial
 Criteria

Randomization

Randomization is a process by which subjects are

assigned to control or experimental groups purely by
chance i.e. every person has equal chance of being
selected
Here random distribution of subjects to different
groups is done that is universally acceptable
Many of the systematic errors can be eliminated
 Manipulation

Investigator is able to manipulate the situation

Can select freely the cases & controls
Can select freely the intervening/experimental agent
e.g. drug, vaccine, placebo, health education

Control

Can select control at his own discretion e.g. persons

without the disease, friends, relatives, neighbours

Intervention
 Blindness
Blindness is a procedure of conducting a trial without any
possibilities of discretion practice of intellectual
discrimination
Single blind – the trial is so planned that the subjects are
unaware of the group they belong to
Double blind – both the investigator and subjects are
unaware of the group allocation and the treatment given
until the study is completed
Triple blind – goes one step further, where neither
the subjects or the investigator, nor the person
analyzing the data are aware of the allocations
RANDOMIZATION
outcome
Intervention
no outcome
Study
population
outcome
Control
no outcome
baseline
future

time
Study begins here (baseline point)
 Invitation

Participant Non-participant

Selection by defined criteria

Potential Participant Non participant

Study population
 Sample (randomization)

Study group (experimental) Study group (control)

First data collection First data collection

(before intervention) (same time as in study)

Intervention / Manipulation No Intervention / Manipulation

Last data collection Last data collection

(after intervention) (same time as in study group)

Compare
  Evaluation of Teaching Method
 Employee Skill Evaluation
 Administering Exams After The End of Semester

For example, consider 2 people randomly chosen to be the subject of

the social interaction research where one person is placed in a room
without human interaction for 1 year.

testing students' knowledge on different topics, coming up with better

teaching methods, and the implementation of other programs that will
use only lecture to aid student learning.