STUDY DESIGN

Siswanto, MD, MSc.

Holipah, MD

RESEARCH DESIGN
THE RESEARCH
OBSERVATIONAL STUDY
(NO CONTROL OVER EXPOSURE)
DESCRIPTI
VE STUDY
COMPARISONS GROUP
NON COMPARRISONS
GROUP
INTERVENTIONAL STUDIES
(INVESTIGATOR DETERMINE WHO
EXPOSED OR NOT EXPOSED)

SURVEILLANCE SURVEY
CROS SEC
TIONAL
STUDY
CASE
CONTROL
STUDY
COHORT
STUDY
SCHEME FOR RESEARCH CYCLE
DESCRIPTIVE
STUDIES
MODEL BUILDING
FORMULATION OF
HYPOTHESIS
ANALYSIS OF RESULTS,
SUGGEST FURTHER-
DESCRIPTIVE AND NEW
HYPOTHESIS
ANALYTICAL STUDIES
- X - SECTIONAL
- CASE-CONTROL STUDY
- COHORT
- CLINICAL TRIALS
- FIELD TRIALS
EXPERIMENTAL STUDIES :
TEST HYPOTHESIS
THE EXPERIMENTAL STUDY
when the investigator test whether modifying or changing
something about study participant (risk factor) alter the
development of the outcome (disease)
The essence of an interventional study is that the
investigator has the power to randomly assign exposure in
a way that enhances the validity of a study (Investigator
determine who exposed or not exposed)

OBSERVATIONAL STUDY
Observational studies involve the investigator collecting data
on factors (exposures) associated with the occurrence of the
outcome of interest, without attempting to alter the exposure
status of participant (no control over exposure)

The investigator does not intervene or manipulate
the situation

Since the investigator does not control the circumstances of the
exposure, a simple comparison of exposed and not exposed will not
accurately reflect the effect of the exposure if those who are
exposed differ from those who are unexposed in other ways that are
related to the outcome

DESCRIPTIVE STUDY
Descriptive studies are used by public health specialist and health
provider for the surveillance of communicable disease or non-
communicable disease, to decide on the allocation of resources and
to plan prevention or health promotion programmes ( Grimes and
Schulz 2002)


Epidemiologist also undertake descriptive studies to
identify clues as to possible determinants of
diseases or risk factors and to formulate of
hypothesis


DESCRIPTIVE STUDY
The activities related to characterizing the distribution of diseases
(time, person and place) within population

Information is collected only on those individuals with a health
problem or a particular exposure. There is no comparison group.
Much useful information can be derived from these studies but no
definite analysis of cause-effect association can be made from these
information


ANALYSIS BY TIME
The frequency of diseases, health events or risk factors may increase,
decrease or stay constant over time


Disease rates change over time. Some of these changes occur
regularly and can be predicted



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ANALYSIS BY PLACE
We describe a health event by place to gain insight into the
geographical extent of the problem.

For place, we may use place of residence, birthplace, place of
employment, hospital unit, urban and rural etc, depending on which
may be related to the occurrence of the health event or disease


EXAMPLE
diseases that are passed from one person to
another spread more rapidly in urban areas
than in rural ones, because the greater
crowding in urban areas provides more
opportunities for susceptible people to come
into contact with some one who is infected.
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ANALYSIS BY PERSON
When we organize or analyze data by person there are several
person categories.


Inherent characteristics of people ( age, race, sex), acquired
characteristics ( immune, marital status), their activities ( occupation,
use of tobacco, drugs), the conditions under which they live
( socioeconomic, access to medical care)


Example : Sex
For some disease, this sex-related difference is
because of genetic, hormonal, anatomic, or
other inherent differences between the sexes.
Premenopausal women have a lower risk of
heart disease than man of the same age. This
difference is attributed to higher estrogen
level in women.
New smear-positive case notification by age
and sex (2005)
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Number of reported cases of tuberculosis by age in the United States 2002
CROSS-SECTIONAL STUDIES
A cross-sectional studies (prevalence study)
describes the frequency of particular attribute
such as a specific exposure , disease or other
health-related event in a defined population
or a sample of a population at a given point in
time
CROSS SECTIONAL STUDIES
The comparison is made between a group of
persons who has the disease and a group that does
not have the disease, but the characteristic and/ or
exposure of the two groups are observed in the
same time
D+ D- TOTAL
FR + A B A+B
FR - C D C+D
TOTAL A+C B+D A+B+C+D


CROSS-SECTIONAL-STUDY
TARGET POPULATION
STUDY SAMPLE
COMPARE
STUDIED CHARACTERISTIC STUDIED CHARACTERISTIC
D+ D-
SAMPLING
Study Process
1. Statement of the research question or
hypothesis.
2. Research variable identification :
Operational definition of risk factor (independent
variable) and disease ( dependent variable)
3. Assessment of risk factor and disease :
Interview, physical examination, laboratory test,
special procedures , medical record.

4. Analysis of data
Prevalence ratio = A/(A+B):C/(C+D)


D+ D- TOTAL
FR + A B A+B
FR - C D C+D
TOTAL A+C B+D A+B+C+D


ADVANTAGES
1 Quick and easy to perform
2 Losses to follow up
3 Can be used to investigate many exposures
and outcomes


DISADVANTAGES
1 Difficult to interpret association in terms of
cause and effect (Problem with direction of
causality/reverse causality
2 Not suitable for the rare disease, since
sample size requirement will have to be
large
3 Not suitable for diseases of short duration



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CASE-CONTROL STUDY
THE STUDY MOVE BACKWARD FROM DISEASE (
EFFECT) TO RISK FACTOR (CAUSE).
PERSON WITH AND WITHOUT DISEASE ARE
IDENTIFIED AND THEN THE PRESENCE OR ABSENCE
OF PREVIOUS EXPOSURE TO THE RISK FACTOR IS
DETERMINED
scheme of case-control study
select cases
select appropriate
controls
obtain information about previous exposure
to proposed risk of factors each group
compare the frequency of exposure
between the two group
STUDY PROCESS
1 Selection of cases
. Clearly define case definition
. Should be incidence cases
. Representative of total cases.
2 Selection of controls
. Should be representative of the
population from which the cases come
. Be sure that the risk factor under study is not
also related to disease among control group



3. Sources of cases and controls
Cases : Hospital, Community,
Registration or surveillance system
Controls : Hospital, Community, relative of
cases, Neighbors
4. Assessment of exposure to risk factor
. Should be ascertain in the similar procedure between
cases and controls.
. Use record or documents as much as possible ( The goal
is to obtain as accurate information as possible about
each individuals exposure to the main risk factors)
. Clearly define exposure to risk factor





5. Try to minimize bias
. From selection of cases and controls :
Selection bias
. From data collection about risk factor
exposure : memory bias (information
bias)
. From data analysis : Confounding bias


Method of data analysis
Odds ratio : Odds of cases : odds of controls

A/(A+C) B/(B+D)
= :

C/(A+C) D/(B+D)
= A/C:B/D=AD/BC
D+ D-
FR + A B
FR - C D
ADVANTAGES
1 Efficient for the study of rare diseases
2 Efficient for the study of chronic disease (diseases
with a long latency)
3 Tend to require a smaller sample size than other
designs.
4 Less expensive than other designs
5 Many risk factors can be studied simultaneously
DISADVANTAGES
1. The temporal sequence between exposure
and outcome may be difficult to establish
(with come first : exposure or disease ?)
2. Obtaining valid information about past
exposures may be difficult ( recall bias)
3. Selection of an appropriate control group
may be difficult (selection bias)
4. Not suitable for investigating rare
exposures ( unless a large proportion of
cases are attributable to that exposure)


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The study move forward from risk
factor (cause) to disease (effect).
Population exposed and not exposed to a
risk factor are identified and then both
population were followed to determine
the frequencies of health problems.
COHORT STUDY

population
Risk factors +
Risk factors -
Disease +
Disease +
Disease -
Disease -
STUDY DESIGN OF COHORT
STUDY PROCESS
1 Selection of studied cohort
. Total population, divided by risk factor
exposure
. Special group who possessed certain
characteristics or exposure such as doctors
. Risk or exposure group, those who receives
risk factor such as industrial workers.
. From survey for special group : DM,
hypertension





2. Selection of comparison group or control
group without risk factor from
. General population
. Sample population without risk factor
3. Make sure that both exposure and non
exposure group do not have the disease of
interest before the study begins
4. Data collection
Risk factors : records, medical
examination, measures of the
environment, questionnaire
Problem : effect -
changes in exposure
Information on outcome/effect :
periodic/non periodic medical
examination, surveillance of death
certificate.
Problem : losses to follow-up

5.Method of data analysis
RELATIVE RISK = A/ (A+B) : C/ ( C+D )
D+ D-
FR + A B
FR - C D
ADVANTAGES
Direct calculation of relative risk
May yield information on the incidence of disease
Clear temporal relationship between exposure and
disease
Particularly efficient for study of rare exposure
Can examine multiple effect of a single exposure

Minimizes bias
Strongest observational design for establishing
cause and effect relationship
DISADVANTAGES
Time consuming
Often requires a large sample size
Expensive
Not efficient for the study of rare diseases
Lost to follow-up
Changes in exposure
Ethic
A cohort study of infant feeding practices in city,
suburban and rural areas in Zhejiang Province, PR
China
Liqian Qiu1,2, Yun Zhao2, Colin W Binns*2, Andy H Lee2 and Xing
Xie1
Address: 1Women's Hospital, School of Medicine, Zhejiang University, PR
China and 2School of Public Health, Curtin University, WA, Australia
Published: 3 March 2008
International Breastfeeding Journal 2008, 3:4

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GOOD LUCK !