UMST University of Medical Sciences & Technology
Graduate College
Medical and Health Studies Board
Diploma in Research Methodology & Biostatistics
Study design
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Study Design
(Intervention/manipulation)
Classification of Study Design
Yes No
Experimental Observational
Studies Studies
Features Availability of a
of true experiments control group
Yes No Yes No
Quasi Descriptive
Randomized Analytical
Experimental Studies
Control trials studies
Studies
Time of study
Longitudinal Point study
studies
Cohort Case-control Cross-sectional
study study studies
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Study Design
(Intervention/manipulation)
Classification of Study Design
Yes No
Experimental Observational
Studies Studies
Features Availability of a
of true experiments control group
Yes No Yes No
Quasi Descriptive
Randomized Analytical
Experimental Studies
Control trials studies
Studies
Time of study
Longitudinal Point study
studies
Cohort Case-control Cross-sectional
study study studies
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Experimental Studies
• Investigator can “control” the exposure
• Generally involves random assignment
to groups
• Clinical trials are the most well known
experimental design
• The ultimate step in testing causal
hypotheses
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Experimental Studies
• In an experiment, we are interested in
the consequences of some treatment
on some outcome.
• The subjects in the study who actually
receive the treatment of interest are
called the treatment group.
• The subjects in the study who receive
no treatment or a different treatment
are called the comparison group.
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Randomized Controlled Trials (RCTs)
• a design with subjects randomly assigned to
“treatment” and “comparison” groups
• provides most convincing evidence of
relationship between exposure and effect
• not possible to use RCTs to test effects of
exposures that are expected to be harmful,
for ethical reasons
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
RANDOMIZATION
outcome
Intervention
Experimental Design
no outcome
Study
population
outcome
Control
no outcome
baseline
future
time
Study begins here (baseline point)
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Randomized Controlled Trials (RCTs)
– the “gold standard” of research designs
– provides most convincing evidence of
relationship between exposure and effect
• trials of hormone replacement therapy in
menopausal women found no protection
for heart disease, contradicting findings of
prior observational studies
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Randomized Controlled Trials
• Disadvantages
–Very expensive
–Not appropriate to answer certain
types of questions
• it may be unethical, for
example, to assign persons to
certain treatment or
comparison groups
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Quasi-Experimental Studies
• a design in which one characteristic of a
true experiment is missing:
randomization or use of a separate
control group.
• Includes manipulation of an
independent variable which serves as
intervention
• Offers less tightness against bias
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
What is the Problem is this Study
• A researcher plans to study the impact of
health education on the level of participation
of a village in an immunization campaign.
• The researcher decides to select two villages.
One village (treatment group) will receives
sessions of health education and another
village (control group) will not receive health
education.
• Immunization campaign will be carried out in
both villages.
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
The Problem is a selection bias: villages was not
randomly assigned to groups
• A researcher plans to study the impact of
health education on the level of participation
of a village in an immunization campaign.
• The researcher decides to select two villages.
One village (treatment group) will receives
sessions of health education and another
village (control group) will not receive health
education.
• Immunization campaign will be carried out in
both villages.
Diploma in Research Methodology and Biostatistics – Dr. Mounkaila NOMA – mounkailanoma@gmail.com
Do you have any question?
