Research Design

(Rancang Penelitian)

Siswanto, MD, MSc.

 RESEARCH DESIGN

THE RESEARCH

OBSERVATIONAL STUDIES
EXPERIMENTAL STUDIES
(NO CONTROL OVER EXPOSURE)
(INFESTIGATOR DETERMINE)
WHO EXPOSED OR NOT EXPOSED

NO COMPARISON GROUP COMPARISAN

GROUP

DESCRIPTIVE ANALYTIC

CASE SURVEILLANCE SURVEY CROS SEC CASE CON COHORT

REVIEW TIONAL TROL STUDY
STUDY STUDY
 SCHEME FOR RESEARCH CYCLE

DESCRIPTIVE
STUDIES

ANALYSIS OF RESULTS,
SUGGEST FURTHER- MODEL BUILDING
DESCRIPTIVE AND NEW FORMULATION
HYPOTHESIS OF HYPOTHESIS

TEST HYPOTHESIS

ANALYTICAL STUDIES EXPERIMENTAL STUDIES :

- X - SECTIONAL
- CASE-CONTROL STUDY - CLINICAL TRIALS
- COHORT - FIELD TRIALS
 5 CRITERIA CAUSAL
ASSOCIATION
1 TEMPORAL RELATIONSHIP --> means exposure to the
causal factor (risk factor) must precede development of
the disease (effect)
2 STRENGHT OF ASSOCIATION (RR> 4) --> Strength
refers to the size/magnitude of RR (not the p value or
degree of statistically significance which can be
increased by increasing the sample size).
3 CONSISTENCY (C) AND REPLICATION (R)
C--> means different studies resulted in the same
association
R--> means repetition of the same study resulted in the
same association.
4 SPECIFICITY/DOSE-RESPONSE RELATIONSHIP

Measures the degree to which one particular

exposure produces one specific disease.

5 COHERENCE WITH EXISTING KNOWLEDGE

(BIOLOGICAL PLAUSIBILITY)

Support for the causal of an association exist if a

causal interpretation is plausible in term of current
knowledge about the factor and the disease.
 THE SISTEMATIC THINKING OF
CAUSAL ASSOCIATION

Statistical absent Conclude the suspected

association factor is not implicated in
present etiology
present
Bias Conclude association is
artifactual (sporious)
absent

Apply 5 criteria
satisfied

Conclude
Association is causal

(Source : Morton and Hebel, 1980)

 PENELITIAN DESKRIPTIF
DEFINISI:
1 Penelitian yang bertujuan melakukan deskripsi
mengenai fenomena yang di-temukan baik yang
berupa faktor resiko, maupun efek
2 Penelitian yang memberi gambaran yang secermat
munkin mengenai individu, ke-adaan, gejala atau
kelompok tertentu
3 EPIDEMIOLOGI - Penelitian yang meng-
gambarkan distribusi masalah kesehatan pada
kelompok manusia menurut ciri-ciri tempat, waktu
dan orang.
CIRI-CIRI:
1 Tidak harus ada hipotesis (tidak menguji
hipotesis)
2 Tidak perlu kelompok pembanding
3 Tidak mencari penyebab terjadinya masalah
CONTOH:
Gambaran klinis dan laboratorium penderita
Nephrote syndroma
Distribusi umum penderita / anak dengan
penyakit PERTUSIS
SENSUS (memberikan gambaran penduduk
menurut distribusi tempat pendidikan, jenis
kelamin, penghasilan, pekerjaan dll)
 Contoh penelitian DESKRIPTIF yang sering
dilakukan di Kesehatan adalah Laporan
KASUS atau SERI KASUS
Laporan William Herberden th 1772 mengenai
sakit dada pada sejumlah kasus akhirnya
membuahkan penyakit ANGINA PERTORIS
Laporan pengaruh pengobatan atau tindakan
pada sejumlah KASUS yang berupa efek
samping kesembuhan dan Komplikasi
 PERTUSSIS (WHOOPING COUGH)
INCIDENCE BY AGE GROUP,
UNITED STATES, 1989
50
REPORTED CASES PER

40
100.000 POP

30

20

10

0
< 1 TH 1-4 TH 5-9 TH 10-14 TH 15-19 TH 20+TH
AGE GROUP (YEARS)
 PERTUSSIS (WHOOPING COUGH)
INCIDENCE BY AGE GROUP,
UNITED STATES, 1989
60
REPORTED CASES PER

50
100.000 POP

40
30
20
10
0
0-4 TH 5-9 TH 10-14 TH 15-19 TH 20+ TH
AGE GROUP (YEARS)
 PREVALENCE OF HAND/ WRIST
CUMULATIVE TRAUMA DISORDER BY SEX,
NEWSPAPER COMPANY A, 1990
16
14
12
% PREVALENCE

10
8
6
4
2
0
MALE FEMALE
SEX
 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
TOTAL POPULATION
SAMPLING

STUDIED POPULATION

D+ COMPARE D-

STUDIED STUDIED
CHARACTERISTIC CHARACTERISTIC
 LANGKAH-LANGKAH STUDI CROSS
SECTIONAL

1 Merumuskan Pertanyaan Penelitian dan

Hipotesis
Contoh :
Apakah ada hubungan antara vaksinasi BCG
dan terjadinya penyakit tuberkulosis pada
anak usia 0 - 12 th
2 Mengidentifikasi Variabel Penelitian
Difinisi operasional faktor resiko yang diteliti
/tidak diteliti, efek (kriteria diagnosis)
3 Menetapkan Subyek Penelitian
4 Melaksanakan Pengukuran faktor resiko dan efek
- Kuesioner, Catatan medik, uji laborato-
rium,pemeriksaan fisik
5 Menganalisis data
Rasio prevalens = A/(A+B):C/(C+D)
Statistik yang digunakan tergantung scala
variabel yang ada.
 ADVANTAGES
1 Quick and easy to perform

2 Straight forward data analysis

3 Loss to follow up
 DISADVANTAGES
1 Difficult to interprete association in terms
of cause and effect
2 Not suitable for the rare disease, since
sample size requirement will have to be
large.
 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
DESAIN STUDI CASE-CONTROL

TERPAPAR

TIDAK KASUS
TERPAPAR
POPULASI

TERPAPAR
KONTROL
TIDAK
TERPAPAR
 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. Assesment 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 or information bias
. From data analysis : Confounding bias
 Method of data analysis
Odds ratio : Odds pada kasus : odds pada kontrol

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

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

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
3 Tend to require a smaller sample size than
other designs.
4 Less expensive than other designs
 DISADVANTAGES
1 Risk of disease cannot be estimated directly
2 Not efficient for the study of rare exposures
3 More susceptible to selection bias
4 Information on exposure may be less
accurate than other design ( memory bias)
ODDS RATIO FOR SMOKERS AND NON
SMOKERS

DAILY AVERAGE LUNG CONTROLS O.R

CIGARETTES SMOKED CA

0 7 61 1.0
1-4 55 129 3.7
5-14 489 570 7.5
15-24 475 431 9.6
25-49 293 154 16.6
50 + 38 12 27.6

SUMBER : LILIENFELD
 COHORT STUDY

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.
 DESAIN STUDI COHORT

SAKIT

TERPAPAR
TIDAK
SAKIT

populasi SAKIT
TIDAK
TERPAPAR
TIDAK
SAKIT
 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 recieves
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 : loss 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
Particulary efficient for study of rare
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
 CLINICAL TRIALS
STUDY PROCESS
1. Statement of the research questions
Is intensive therapy, including more frequent insulin injection and blood glucose
monitoring superior to standard therapy for diabetes mellitus ?
 The parameter that is measured to answer the most
important question of the clinical trial is the
primary end point ( to assess treatment efficacy,
more than one end point can be measured)
. Quality of life
. Survival
. Complication
2. Sample size determination
Depend on :
. Research design
. Level acceptance
. Standard deviation
3. RANDOMIZATION
With randomization the determination of
treatment group assignment is based on
probability alone and is not influenced by
the physician or patient preference
 KELOMPOK
EFEK ?
PERLAKUAN

SUBYEK
PENELITIAN R

KELOMPOK EFEK ?
KONTROL

SKEMA DASAR DESAIN PARALEL

UNTUK UJI KLINIS DENGAN 2 KELOMPOK
 EFEK ?

KELOMPOK KELOMPOK
EFEK ?
PERLAKUAN PERLAKUAN

SUBYEK R

KELOMPOK
EFEK ? KELOMPOK
KONTROL
KONTROL

SKEMA DESAIN UJI KLINIS MENYILANG EFEK ?

( CROSS-OVER )
4. Blinded Fashion
Blinding means that the treatment
assignment is not known to certain persons.
Single blind study : the treatment assignment
is unknown to the patients or physician
Double blind study : the treatment assignment
is unknown either to the patients or to their
physicians.
5. Data collection ( see Cohort)
6. Method of data analysis ( see Cohort)
7. Ethical
 ADVANTAGES
Randomization tend to balance prognostic factors
across study group
Detailed information can be collected
Dose level can be predetermined by the
investigator
Blinding of participant can reduce distortion in
assessment of outcome
Assumptions of statistical tests tend to be met
 DISADVANTAGES
Subject exclusions may limit ability to
generalize finding to other patient ( validitas
externa)
Ethical concerns may arise
Subjects may not comply with treatment
assignment
Financial cost
1.Adanya randomisasi bias menurun, sebab
faktor perancau (confounding) agar tersebar
merata antar kelompok.
2. Kriteria inklusi, perlakuan dan outcome
telah ditentukan lebih dahulu.
3. Statistik lebih efektif ( pemilihan subyek
secara random)
1. Komplek dan mahal
2. Tidak representatif terhadap populasi
(validitas externa jelek)
3. Etika
4. Tidak praktis
 RANCANGAN PENELITIAN
EKSPERIMENTAL

I. PRE-EXPERIMENTAL DESIGN
1. The one - shot - case study
XO
2. The one - group pretest - posttest D.
O1 X O2
3. The static group comparison
X O1
- O2
II. TRUE EXPERIMENTAL DESIGN
1. Prestest - post-test with control group
Populasi O1 X O2
R
(Subyek)
O1 O2

2. The posttest - only control group

X O1

Populasi R

- O2
3. Randomized Solomon Four Group

O1 X O2

R O1 O2

X O2

O2
III. QUASI EXPERIMENTAL DESIGN
1. Time Series Design
O1 O2 O3 X O 4 O5 O6

2. Control Time Series Design

Kel Eks O1 O2 O3 X O 4 O5

Kel Kontrol O1 O2 O3 O 4 O5
3. Non Randomized Control Group Pretest-
Post Test Design
Kel Eks O1 X O 2

Kel Kontrol O1 O2