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Study Designs 2015 Regular
Study Designs 2015 Regular
Kennedy Muthoka,
JKUAT
Study design: Definition
A study design is a specific plan or
protocol for conducting the study,
which allows the investigator to
translate the conceptual hypothesis
into an operational one
Study Designs: Types
Qualitative
Quantitative
Experimental
Observational
Quantitative designs
Experimental - Interventional
OBSERVATIONAL
Here nature allowed to take its course
Changes and differences in one variable are
medicines.
Characteristics of place e.g.:
Case reports
- Considers single or grp of patients with similar
diagnoses
Limitations include;
- Based on experience of one person. Presence
of any risk factors may be co-incidental
- Frequently not large enough to permit
quantification of frequency of an exposure
- Interpretation limited for lack of appropriate
control grp
Ecological (Correlational)…:
true link
- May be confounded by several factors
Ecological (Correlational)….:
Alcohol Consumption
Ecological (Correlational)…:
Example:
- Investigators compared prevalence rates of
CHD among white farmers between;
It could be :
True that whites develop more CHD or
Blacks have higher rates of CHD but die at higher rates.
So X-sectional data can not distinguish between
the two
In most instances X-sectional data is used to
describe characteristic of individuals with disease
and formulate hypotheses, but not test them
Cross-sectional Studies (Summary)
DISEASE
FOLLOW UP
EXPOSURE
NO DISEASE
DISEASE
FOLLOW UP
NO EXPOSURE
NO DISEASE
Advantages
Prospective (Concurrent)
Retrospective (Historical, Non Concurrent)
lung cancer
Excess in mortality from lung cancer
was noted
Then another investigation done using
Non-exposed:
Group must be as similar to exposed as
CASES DISEASE
NOT EXPOSED
EXPOSED
NO
CONTROLS
DISEASE NOT EXPOSED
CASE-CONTROL STUDY DESIGN
Hospitalized Controls.
Captive pop. So its easy.
Disease
No exposure
•Population
Exposure
No Disease
Collect blood and No exposure
keep
Case - Control Studies (summary)
Characteristics: two source populations;
assumption that non-cases are representative of
the source population of cases
Merits: least expensive; least time-consuming;
suitable for study of rare diseases (especially
NCDs)
Limitations: not suitable for rare exposures;
liable to selection bias and recall bias; not
suitable for calculation of frequency measures
Effect measure: Odds Ratio
INTERVENTIONAL
STUDIES
CLINICAL TRIALS
Clinical Trials
Treatment
grp
Refere Study
nce Pop
Pop
Non treatment
grp
Basic form of Clinical Trial
Improved
Exposure
(Treatment Grp)
A
Not
Improved
Improved
No Exposure
(Non Treatment
Grp. Placebo)
B
Not Improved
Advantage of Clinical Trials
Preventive
Therapeutic (or Secondary prevention)