Baydaa Hameed Abdullah Definition A study design is a specific plan or protocol for conducting the study which allows the investigator to translate the conceptual hypothesis into operational one ID: 928579
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Slide1
Rerearch Design
Ass.Prof.Dr
.
Baydaa
Hameed Abdullah
Slide2Definition
A study design is a specific plan or protocol for conducting the study which allows the investigator to translate the conceptual hypothesis into operational one.
Study design is the plan
for
collection
of data to answer the
research
question.
Slide3What does
research design
do?
Helps take decisions about how to complete the entire research:
Validly
Objectively
Accurately
Economically
Slide4Functions of Research Design
1. The
identification and/ or development of procedures
and
logistical arrangements required to undertake a study
2. Ensuring that the procedures are adequate in quality to obtain valid, objective and accurate answers to the research questions.
Classifications of Study Designs
Three types of classifications
on the basis of:
The number of contacts with the study population
The reference period of the study
The nature of the investigation
Slide6Classifications of Study Design
Slide7Slide8r
Slide9Advantages of descriptive studies
They
use
already available
data.
They
are less expensive and less
time-
consuming.
They
describe
the
pattern
of
disease
occurrence.
They
formulate research
hypothesis.
Slide10Case reports
Researcher(physician) who see
unusal
preentation of a common desease and he describes the findings of this case,case
description may take any relevant description of the finding.
An unusual case may add to our Knowledge for example MI in very young person without ECG findings is unusual presentation of MI.
Slide11Case series(clinical series)
When a group of cases of the disease are reported, but in this study we can not:
*Study the aetiology of the disease
*
T
esting the hypothesis
* Have a control group
But in the study it can help in generating hypothesis
Example: vaginal cancer is very rare in young females if 10 cases were reported and studied it may help us to generate a hypothesis when we interrogated with
stilbestrol
taking during pregnancy among their mothers(this
canbe
done by further studies)
Discovery of AIDS was a case series
Many
clincal
studies are case series
Slide12Advantages of case reports or case series
Use available clinical
data
Detailed individual
data.
Add
to
our
knowledge.
Suggest need for
investigation (hypothesis
generation).
Slide13Disadvantages
of case report or
case series
1.
May reflect experience of
one
person or one
clinician.
2.
No
explicit(clear)
comparison group.
Ecological
Studies:
based on
studying
of a
group
of
people
not
individual as in
previous studies.
Correlation
data represent average
exposure level rather than
individual
level so we do
not
have each person
information
Ecological
studies
can
generate
a
hypothesis and need further confirmation
, it
provides
just initial
clues
to
causation
Example : as
meat consumption in
different
countries increases prevalence of
ca colon increases ,
Cigarette smoking increases ca lung prevalence increases as
well
Slide15Advantages
of Correlational
Study
They
describe
the
disease in the
entire
population in
relation to
the
factor
of
interest.
They
use
the
correlation
coefficient
(r)
to
measure the
association
between the two
variables
of
interest.
They
are easy
to do,
inexpensive and can be conducted
quickly.
They
represent
the first
step in
searchingfor
exposure-disease
relationship (generate
hypothesis)
They
use available
data (administrative
or other aggregate
data).
Slide16Disadvantages of correlational
study
Correlation data represent average exposure level rather than actual individual values. Data on exposure and data on outcome are collected
independently.
No
assurance
that
persons with exposure
(risk factor) of
interest are
the
same ones with outcome (disease)
of
interest.
Inability
to
link
exposure with the disease in particular
individual.
What
is
missing: relationship between exposure and outcome
at the
individual level
(incomplete
design)
Slide17Cross-Sectional
studies
(prevalence
studies or surveys)
Cross-sectional:
where
only
ONE
set of
observations is
collected
at a
certain point
in time, disregarding the length
of
time
of
the study
as
a whole
It is a study
of
a
group of
people
at
a
point
in time for the prevalence of a disease or an
attribute
in a well
defined
population
but
data is
collected at
individual levels.
In this study
the measurements of exposure and
effect are made at
the same time . In cross-sectional studies,
we are looking
for both exposure and
outcome
Slide18Study Design based on
no. of
contact with the population
Cross Sectional Studies:
One-shot or Status studies:
One time contact
Most commonly used design in social sciences
Obtain overall picture
Very
simple
design:
Decide what you want to find out about, identify the study population, select a sample and contact your respondents to find out the required information
Slide19Advantages
of cross
sectional
study
Provide generalization from
the
sample
to
the population.
They
are
short
term studies and
not expensive.
Provide good information
for the
health
problems and good
for
health planners
to
assess health care
needs.
Used
for
generating hypothesis to be
test in
further studies.5.
Adapted
to chronic diseases
Slide20Slide21Disadvantages
1
.It
is di
f
fi
c
ult
to
s
e
pa
r
ate
cause
and
e
f
fe
ct
1-
because
measurement of exposure and disease are made at one point of
time
and
it is
impossible to
determined which
came first.
2-
Cases detected are prevalent cases (survivors)
leading to survival
bias cases cured or
died are not
detected.
Slide22Possible
measurement error;
not
suitable for
rare
conditions;
Non response and
this will
affect
the
representation
of
the
sample.
Not adapted
to
incidence measurement
6.Not adapted to
severe
/
acute
diseases
Slide23A
case control
study
Begins with the
selection
of
cases(diseases)
which
should represent
all
cases
from a
specified population.
The most difficult
task
is to select
controls
(people with no disease) the
controls
should
represent people who would have been
designated study
cases if they had developed the
diseases.
Slide24Case control
study
An
important
aspect of this
study
is the
determination
of the start
and duration
of
exposure,
the
exposure status is
usually
determined after
the development of
the disease (retrospective) and
usually
by direct questioning
of the
affected person. Exposure may be
determined by biochemical measurement, established recording
system.
Slide25Case control
study
Disease
Contro
l
s
Ex
p
o
s
ure
?
?
Retrospective
nature
Slide26Sources of
selection of cases
in
case
control study
Hospital-based
case
control study:
the cases
will
be identified from
the
hospital or other health care
facilities.
These are
common, relatively
easy
and
inexpensive.
Population-based case control
study:
It involves locating and
obtaining data from all affected
individuals or a random sample from population.
Slide27Selection
of
controls
in case
control study
It is
the
most
difficult
aspect of
Case
Control
Study (CCS), it
depends
on:
Characteristics and sources
of
cases.
Need to
obtain comparable
and
reliable information from cases and controls.
Practical
and economic
considerations.
Slide28The
control should be comparable
to
the
source
of the
population
of
cases.
Any
exclusion
or
restrictions
made in the
selection
of
cases should be applied equally
to
the controls and vice
versa
.
Slide29Advantages:
Suitable
for rare
diseases
.
Results can obtained
quickly.
Relatively
inexpensive and short term
study
Small sample
size
Available
data
No
ethical
problem
Slide30Disadvantages
of
case control
studies
Incidence or
absolute
risk cannot
be
determined directly
from a case
control
study.
Temporal
relationship exposure-disease
difficult to
establish
Difficulty
in
selection
the
control.
Case- control study rely
upon retrospective data which lead to recall
bias.
Because the data are collected after
Can not use to
establish prevalence
b
e
wh
ethe
r
(
ret
ros
pec
ti
vel
y) i
t
is d
iff
icu
lt
to correlation is causal or
not.
5.
Slide31Cohort Study:
(
follow up
study,
prospective ,
panel
study,
longitudinal,
incidence)
Follow
up
study
or
incidence study
Begin with a
group
of people (a
cohort) free
of
disease, who are
classified into subgroups according to exposure to
potential cause of disease, and the whole cohort is followed up to see how the subsequent development of new cases of the disease
differ between the groups
with and without exposure, cohort study
is a longitudinal study cohort study provides the best
information about the causation of disease
and the direct measurement of the risk of developing disease.
Slide32Cohort
study
Identify
group
of
Exposed subjects
Un exposed
subjects
Measure
incidence of
disease
Compare incidence between
exposed and unexposed
group
Slide33Population
Dis
e
a
s
ed
Exposed
Non-diseased
Diseased
Not exposed
Non
-
di
sease
d
T
ime
Direction of
inquiry
Figure shows cohort study
design
C
o
h
o
rt
Slide34Experimental Design
The researcher
introduces the intervention
that
is
assumed to be cause of change
and
waits until it has produced or has been
given sufficient
time to produce the change.
The independent variable can be
observed , introduced, controlled or manipulated
by the researcher.
Slide35An experimental study can be carried out in either a ‘
controlled’ or a ‘natural
’ environment.
Study population in a ‘controlled’ situation:
such as a
room
.
Study Population in a ‘natural’ situation,
population is in its
natural environment
Slide36Blind Studies
In a blind study, the study population does not know whether it is getting real or fake treatment or which treatment modality.
The main objective of blind study is to
isolate the
placebo effect
: the psychological effect
Usually applied to studies measuring the effectiveness of a drug or treatment.
Slide37Double- Blind Studies
Concept similar to that of a blind study
except that it also tries to
eliminate researcher bias
by concealing the identity of the experimental and placebo groups from the researcher.
Neither the researcher nor the study participants know who is receiving real and who is receiving fake treatment or which treatment model they are receiving.
Slide38THANK YOU