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Selecting Study Design

STUDY DESIGN a. SampleSizec,d
IN Study design
Objective (Hypothesis orEstimates)
One Populationor two population.
EPIDEMIOLOGY Power andAlfa

b. Measurementand interpretation the associatione,f,g

Crosssectional
PrevalenceRatio / PR
PrevalenceOdds Ratio / POR
CaseControl
OddsRatio/OR
Kohort
RelativeRisk/RR
c. Bias, Confounding,and Interaction
Liberty, Iche A
d. Analysis Statistic : scala-numeric/category
Epidemiology and Biostatistic Department
Medical Faculty of Sriwijaya University

DEFINING EPIDEMIOLOGY STUDY DESIGN

DESCRIPTIVE STUDIES ANALYTICSTUDIES

(design to desribe occurrence of (design to examine etiology and

The study of the distribution disease by time, place, and person) causal association)
and determinants of health
Experimental Observasional
related states and events in CaseReport (Intervension (Without
Study) Intervension)
populations, and the
application of this study to CaseSeries
ClinicalTrial Ecologycal Study
control health problems.
Surveilance Community Cross Sectional
Trial
Descriptive Analyses of
routinely, collected Case Control
John M Last data, registeries,
mortality, etc
Dictionary of Epidemiology Cohort

Hybrid Design
(Case cross over, nested case
control, Before-after study)

Planning a Study

Magnitude Therapy - Facility

Selecting Research Topica I.1 : Meta-Analisis/ Systematic Review
dari RCT
Objective: Feasible Measurable - Benefit and Impact
Problem solved with studya
Association/ Comparable / Correlate Independent I-2 : Large Randomized Controlled Trial
Dependent Variable. One or two sided (RCT)
Formulate theHypothesisb
II.1 : Controlled Trial withoutRandomization
LiteraturReviewa

Conseptual Frame II-2 : Cohort, Case Control Study

Selecting StudyDesign
III-1 : Cross Sectional

AnalysisData
III-2 : Case Series, Case Report
Descriptive/Analitic. Statistic JUST TOOLS.

Significant : Clinic andStatistic

IV : ExpertOpinion

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Timeframe of Studies Contoh:

Prospective Study - looks forward, looks to Kasus diare di Kecamatan Seberang Ulu I, Kota
the future, examines future events, follows a Palembang tahun 2016.
condition, concern or disease into the future Prevalensi BBLR (Bayi Berat Lahir Rendah) di
(looking forward) RSMH Palembang tahun 2016.
Insidensi penyakit DBD di Kabupaten Ogan
time Komering Ilir tahun 2016.
Gambaran klinis dan laboratorium penderita PJK di
Study begins here RSMH Palembang tahun 2016.

PERTUSSIS (WHOOPING COUGH)

Timeframe of Studies INCIDENCE BY AGE GROUP,
UNITED STATES, 1989
Retrospective Study - to look back,
50
looks back in time to study events that
40
have already occurred
REPORTED CASES

100.000 POP

30

(looking back)
20

10
PER

0
time
< 1 TH 1-4 T H 5-9 T H 10-14 T H 15-19 T H 2 0 +T H
AG E G RO UP ( Y EARS)
Study begins here

EPIDEMIOLOGI DESKRIPTIF Case Report

Case reports are simply reports of events
Hanya ada 1 kelompok studi. observed in single patients.
Mengukur insidensi atau prevalensi
Case reports are useful for raising
Menggambarkan distribusi penyakit menurut variabel
tempat, orang dan waktu.
hypotheses, to be tested with more rigorous
study designs.
Tidak ada kesimpulan tentang hubungan antara
exposure dan outcome. Example: Case report about a young woman
Informasi yang diperoleh dapat mengarahkan suatu who was taking oral contraceptives and who
exposure dengan outcome tertentu Untuk uji suffered a pulmonary embolism.
hipotesis.
Penyajian dilakukan dengan grafik, tabel, spot-map, dsb.

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Case Series Cross Sectional

Case series are collections of patients, all of A cross-sectional studies
whom have a single exposure with a similar Exposure and outcomes both measured at the same
time. Quantifies prevalence, risk.
diagnosis.
Examines the relationship between
Example, one might observe 100 consecutive
1) diseases/other health related characteristics and
women under the age of 50 who suffer from a
2) other variables of interest as they exist in a defined
pulmonary embolism, and note that 30 of them
population at one time.
had been taking oral contraceptives.

Cross-sectional studies
Ecological Studies
Analyses of secular trends An observational design that surveys
exposures and disease status at a single point
Examine trends in an exposure that in time (a cross-section of the population)
is a presumed cause and trends in
a disease that is a presumed effect
and test whether the trends
coincide.

time
Study only exists at this point in time

Cross-sectional Design
Ecologic Studies:
factor present
Breast Cancer Incidence by National Fat Intake
No Disease
factor absent
250 USA Study
Incidence per 100,000 p-

Switzerland population
200 factor present
Italy UK
150 Israel Sweden New Zealand Disease
France
factor absent
100 Yugoslavia
Romani Spain
50 Poland
a Hong Hungar
0 Kong y
y

500 Japan7 0 0 900 1100 1300 1500 1700

F a t i n t a k e ( k c a l / d) time
Study only exists at this point in time

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Prevalence ratio of disease in exposed and unexposed

Disease
Yes No Case-Control Studies
Cases: Disease
Yes a
a b Controls: No Disease
a +b
PR = c
c c +d
No d

So a/a+b and c/c+d = probabilities of disease and

PR is ratio of two probabilities

Uses of Cross-Sectional Studies factor present

Cases
Prevalence survey: The studies are commonly (disease)
Case-Control

factor absent
used to describe the burden of disease in the Study
community and its distribution.
Design

population
Describe population characteristics: They factor present Controls
are also commonly used to describe (no disease)
population characteristics, often in terms of factor absent
person (who?) and place (where?) present
To describe various age groups in the population in past
terms of food and nutrient intake and range of other
personal and lifestyle characteristics.

time
Study begins here

Case Control Odds ratio : Odds pada kasus : odds pada kontrol
A/(A+C) B/(B+D)
= : =A/C:B/D=AD/BC
Casecontrol studies are studies that compare C/(A+C) D/(B+D)
cases with a disease to controls without the D+ D-
disease, looking for differences in antecedent
exposures. E+ A B
As an example, one could select cases of young
women with venous thromboembolism and E- C D
compare them to controls without venous
thromboembolism, looking for differences in
antecedent oral contraceptive use.
OR = 1; Confident Interval (CI) menyentuh 1= tdak ada asosiasi
OR>1; Confident Interval (CI)>1 =faktor resiko
OR<1 ; Confident Interval (CI)<1=faktor protektif

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KASUS DAN KONTROL Prospective cohort study

KASUS Disease
Penetapan kriteria diagnosis. Exposure Study starts occurrence
Kriteria pemasukan (eligibility criteria eligibility
criteria) untuk seleksi individu ke dalam studi.
KONTROL time
Tidak mengalami penyakit yang diteliti/ mengalami
penyakit yg tidak ada hubungannya dengan
eksposure. Disease
Study starts Exposure occurrence
Comparable dengan kelompok kasus.

time

Cohort Studies Retrospective cohort studies

An observational design comparing individuals
with a known risk factor or exposure with
others without the risk factor or exposure. Disease
Exposure occurrence Study starts
Follow up over time, and looking for a
difference in the risk (incidence) of a disease
Data usually collected prospectively
For example, one could compare women of time
reproductive age who use oral contraceptives to
users of other contraceptive methods, looking for
the differences in the frequency of venous Case study
thromboembolism. Salmonella in Belfast

Timeframe of Studies
RR = A/ (A+B) : C/ ( C+D )
Prospective Study - looks forward,
looks to the future, examines future D+ D-
events, follows a condition, concern or
disease into the future E+ A B

E- C D

RR = 1; Confident Interval (CI) menyentuh 1 =tidak ada asosiasi

RR>1; Confident Interval (CI)>1 =faktor resiko
RR<1 ; Confident Interval (CI)<1=faktor protektif

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Isu dalam analisis Penelitian Eksperimental

Bias Tidak etis bila dilakukan untuk mengkaji
Losses to follow-up penyebab penyakit pada subjek manusia.
Misclassification of exposure Pada subjek manusia bertujuan untuk:
Nondifferential: a similar Preventif/Profilaktik
proportion of inaccuracy occurs Promotif
in each study group
Terapeutik
Differential

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 or control group.
KELOMPOK PERLAKUAN
Kelompok yang diberi intervensi yang
efektivitasnya, intervensi bisa tunggal
atau kombinasi
KELOMPOK PEMBANDING/KONTROL
Kelompok yang tidak diberi intervensi
yang diselidiki efektivitasnya, tetapi bukan
berarti berarti tanpa perlakuan

RANDOMIZATION outcome
Intervention Penelitian Eksperimental
no outcome
Experimental

Study Advantages:
disain terbaik untuk mengendalikan/ menyeimbangkan
population menyeimbangkan (balancing) confoundingvariables.
Design

outcome
Control Validitas internal internal tinggi.
mempunyai pembanding yang bersamaan waktu (concurrent
no outcome concurrent). Jadi intervensi intervensi luar tidak mempengaruhi
mempengaruhihasil akhir.
baseline Analisismudah.
future

Disadvantages:
expensive: time and money
time volunteer bias
ethically problematic at times
Study begins here (baseline point) Not appropriate to answer certain types of questions
(it may be e e n e ment or

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Experimental
Study Randomized Solomon Four Group Design
Controlled Uncontrolled
Trial Trial

Randomized
Control Trial Quasi Experimental
(RCT) Randomized trial without
control group
(Phase I/II
All Allocation done clinical trial)
participants using schemes,
have the number of
same chance medical record
of being
allocated
Non-randomized control-group
Non-Randomized
pretest-posttestdesign
Without any
underlying
random
process

EFEK ?
A. RANCANGANPRE-EXPERIMENTAL
1. The One-Shot Case Study
2. One Group Pretest-posttest Design KELOMPOK
KELOMPOK
3. The Static Group Comparison; Randomized Control EFEK ?
Group Only Design PERLAKUAN PERLAKUAN

B. RANCANGAN TRUE-EXPERIMENTAL
SUBYEK R
1. Randomized Control Group Pretest-posttest
Design
2. Randomized Solomon Four Group Design
3. FactorianDesign
KELOMPOK
EFEK ? KELOMPOK
KONTROL
KONTROL

SKEMA DESAIN UJI KLINIS MENYILANG

EFEK ?
( CROSS-OVER)

The One-Shot Case Study QUASI EXPERIMENTAL DESIGN

1. Time Series Design

O1 O2 O3 X O 4 O5 O6

2. Control Time Series Design

One GroupPretest-posttest Design Kel Eks O1 O2 O3 X O 4 O5

Kel Kontrol O1 O2 O3 O 4 O5

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Exercise
1. Select cases of young women with venous
thromboembolism and compare them to controls A. Case Series
without venous thromboembolism, looking for
differences in antecedent oral contraceptive use.
2. Observe 100 consecutive women under the age of
50 who suffer from a pulmonary embolism, and B. Cross Sectional
note that 30 of them had been taking oral
contraceptives.
3. One could compare women of reproductive age C. Case Control
who use oral contraceptives to users of other
contraceptive methods, looking for the
differences in the frequency of venous
thromboembolism. D. Cohort
4. Observe of risk factor of venous thromboembolism
among urban women at Palembang.