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STUDY DESIGN

Siswanto
Department of Public Health
Faculty of Medicine
University of Brawijaya
OVERVIEW STUDY DESIGNS
The difference between interventional
(experimental) study and observational study
An interventional or experimental study is 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 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
Observational studies : descriptive (without
control group), analytic (with control group ) :
cross-sectional, case-control study and cohort
study.
RESEARCH DESIGN
OBSERVATIONAL STUDIES
(NO CONTROL OVER EXPOSURE)
NO COMPARISON GROUP
THE RESEARCH
INTERVENTIONAL STUDIES
(INVESTIGATOR DETERMINE WHO EXPOSED
OR NOT EXPOSED)
ANALYTIC
CASE REVIEW
SURVEILLANCE
SURVEY
CROS SEC
TIONAL
STUDY

CASE CONTROL
STUDY
COHORT
STUDY
DESCRIPTIVE
COMPARISON
GROUP
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
DESCRIPTIVE STUDIES
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

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
ANALYSES 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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Comparison of the incidence of tuberculosis among migrants who moved from high
to low risk countries with the incidence in the general population of the
adopted country
ANALYSES 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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ANALYSES 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
Toll-like receptor 2 genotypes and clinical types of
tuberculosis (TB) disease (Ogus et al., 2004)
Type of TB Subjects Genotype
n(%)
AA GA GG
Pulmonary 129 (85.4) 11 12 106
Lymphadenitis 8 (5.3) 2 1 5
Pleural 10 (6.6) 10
Pulmonary and
Lymphadenitis 2 (1.3) 1 1
Bone 1 (0.7) 1
Renal 1 (0.7) 1
A: adenine; G: guanine

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
W ------ Both Case and Control exposed
X-------- Case exposed but control unexposed
Y-------- Case unexposed but control exposed
Z-------- Both case and control unexposed
W and Z Concordant pairs
X and Y discordant pairs
Odds Ratio = X/Y
Control
Exposed
Control
Unexposed
Total
Case Exposed W X W+X
Case Unexposed

Total
Y

W+Y

Z

X+Z
Y+Z

W+X+Y+Z
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)


Table.5 Distribution of the TLR2 polymorphism and
odds ratios in the study and control groups (Ogus et
al., 2004)
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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

Background:
Breastfeeding is the basis for appropriate nutrition for infants
and is strongly supported by the Ministry of Health in China.
However, there are differences in infant feeding practices in
different areas of the country. The aim of this study was to
compare the infant feeding practices and the prevalence of
determinants of initiation and continuing to breastfeed until
six months of age in city, suburb and rural areas in Zhejiang
Province, PRC.

Methods:
A longitudinal cohort study of infant feeding practices was
undertaken in city, suburban and rural areas in 2004/2005.
Mothers were recruited and interviewed before discharge
from hospitals. A total of 1520 mothers were recruited
into the study. Follow-up interviews were administered at
1, 3 and 6 months after birth to obtain details of infant
feeding practices.
Results:
Any breastfeeding' rates were high before discharge at all three
locations, 96.5% in city, 96.8% in suburb and 97.4% in the rural area.
The 'exclusive breastfeeding' rates in the city, suburban and rural
areas before discharge were 38.0%, 63.4% and 61.0% respectively. By
sixth months the 'any breastfeeding' rates had declined to 62.8%,
76.9% and 83.6% and the 'exclusive breastfeeding rates had fallen to
0.2%, 0.5% and 7.2% in city, suburb and rural areas respectively. There
were
differences in feeding practices between the three locations, including
the use of prelacteal feeds and the introduction of supplementary
feeds.
Daftar pustaka
Ann Bowling and Shah Ebrahim. (2005). Handbook of Health
research methods. Investigation, Measurement and analysis.
England. Open University Press.
Norman Vetter and Ian Mathews (2006) . Epidemiology and
Public Health Medicine.
Raymond S, Stephen R. Daniels, W. Dana Flanders (2005).
Medical Epidemiology.
Mark Elwood (1998). Critical Appraisal of Epidemiological Studies
and Clinical trials. Second Edition. Oxford University Press
Robert H. Fletcher, Suzanne W. Fletcher and Edward H. Wagner.
Clinical Epidemiology. The Essentials. Second Edition.
Diederick E. Grobbee and Arno W. Hoes (2009). Clinical
Epidemiology. Principles, Methods, and Application for Clinical
Research.

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GOOD LUCK !

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