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# 3/3/2016

Variabel dalam
Penelitian
Miftahul Mushlih, M.Sc.

Mendapatkan suatu jawaban dari
sebuah permasalahan

## atau dengan kata lain

menjawab sebuah HIPOTESIS

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Jenis Variabel
V. Suatu Variabel yang di
Bebas control oleh peneliti

Variabel yang
Hasilnya berasal dari V.
V. Bebas Terikat

## V. Variabel yang harus di

Kontrol kendalikan supaya tidak
mempengaruhi V. Bebas

Contoh
Seorang peneliti ingin mengetahui pegaruh pupuk terhadap beberapa
jenis varieties padi yaitu varieties raja lele dan varieties tawon,
kosentrasi yang digunakan adalah 10 ppm, 20 ppm, 30 ppm, 40 ppm,
dari penelitian tersebut tentukan
A. jenis data (para metric/ non parametric)
B. V. Bebas
C. V. Kontrol
D. V. terikat

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Sample Size
Miftahul Mushlih, M.Sc

## Sample size determination:

Studies Comparing Two Group Means
To compute sample size for continuous variables, it is necessary to obtain an
estimate of the population standard deviation of the variable (s) and the
magnitude of the difference (d) the investigator wishes to detect, often
called the effect.
Sample size is given by

## where s is the standard deviation, d is the difference to be detected, and C is

a constant dependent on the value of and selected. C is 10.51 and 2C
would be 21

## Ralph B. Dell, Steve Holleran, R Ramakhakrishnan, Sample sice determination, 2002

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Contoh
Seorang peneliti ingin mengetahui perbedaan penghasilan masyarakat
lubuk buaya dengan kota tengah . . ..

Sd
X1-x2

Paired Studies
Paired studies compare values before and after an intervention in the
same animal. In this case, data are analyzed by a paired t test, and the
sample size is computed by

## Ralph B. Dell, Steve Holleran, R Ramakhakrishnan, Sample sice determination, 2002

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Federer Formula
If the s, d and C cannot be determined Federers
Formula

(t-1) (r-1) 15
t = number of treatment
r = number of sample (repeat)

## Federer WT. Experimental design, theory and application, 1967.

(t-1) (r-1) 15
(3-1)(r-1) 15

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contoh
Penelitian
Pengaruh pemberian ekstrak tapak dara terhadap pertumbuhan
sel-sel kanker payudara
Perlakuan
1. 0 mg/kg bb mencit
2. 10 mg/ kg bb mencit
3. 30 mg/ kg bb mencit
4. 50 mg/ kg bb mencit
Berapa ulangan minimal ulangan pada penelitian tersebut?

## Hukum Roscoe (1975)

Roscoe (1975), memberikan beberapa panduan untuk
menentukan
ukuran sampel yaitu :
Ukuran sampel lebih dari 30 dan kurang dari 500 adalah tepat
untuk kebanyakan penelitian.
Jika sampel dipecah ke dalam sub-sampel (pria/wanita,
junior/senior, dsb), ukuran sampel minimum 30 untuk tiap
Dalam penelitian mutivariate (termasuk analisis regresi
berganda), ukuran sampel sebaiknya 10 kali lebih besar dari
jumlah variabel dalam penelitian.
Untuk penelitian eksperimental sederhana dengan control
eskperimen yang ketat, penelitian yang sukses adalah mungkin
dengan ukuran sampel kecil antara 10 sampai dengan 20 buah.

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## Krejcie, R. & Morgan D. (1970).

Sample size determination for
most practical situations
Source: Krejcie, R. & Morgan D. (1970). Determining
Sample Size for Research Activities, Educational and X2NP(1 P)
Psychological Measurement, 30, 607-610. S (n) =
Where:
d2(N-1)+x2P(1-P)
N = Population Size s =ukuran sampel yang diperlukan
S = Sample Size N = ukuran populasi yang dikenalpasti
P = perkadaran populasi diandaikan 0.5 kerana
magnitud ini akan menghasilkan ukuran sampel
yang maksimum.
d = darjah ketepatan yang maksimum (0.05)
x2 = nilai khi square, db 1 yaitu 3.841 (note: bisa
berubah sesuai dengan uji yang digunakan)

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## Krejcie, R. & Morgan D.

(1970) Table

Perumusan berdasarkan
proporsi
Keterangan:
n = Jumlah sampel minimal
N = ukuran populasi
t = tingkat kepercayaan (digunakan 0,95 sehingga nilai t
= 1,96)
d = taraf kekeliruan (digunakan 0,05)
p = proporsi dari karakteristik tertentu (golongan)
q= 1 p
1 = Bilangan Konstan

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Contoh

Berdasarkan proporsi
Secara kuantitaf besarnya sampel dapat ditentukan dengan
menggunakan rumus
matematika sebagai berikut:
1. Meneliti harga mean:

## 2. Meneliti harga proporsi:

Keterangan:
d : Penyimpangan yang ditoleransi
: harga standar normal
a : varian populasi.

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Preclinical Animal
Study

Preclinical study/preclinical
trial
Preclinical trial - a laboratory test of a new drug or a new medical
device, usually done on animal subjects, to see if the hoped-for
treatment really works and if it is safe to test on humans.

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## Pre-Clinical Trials and Clinical Trials are the

processes by which scientists test drugs and
devices to see if they are SAFE and EFFECTIVE.

Experimental study
In vitro and in vivo
Animal models

Pharmacodynamic study

Toxicological study

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PHARMACODYNAMIC STUDIES

Effects / Efficacy
Mechanism of action

TOXICOLOGICAL STUDIES

Safety
Spectrum

Pharmacodynamic study
In vitro : tissue, cell culture, blood
. component, etc
In vivo : whole animal

## Disease model : inflammatory, dislipidemi,

sepsis, Ca/ malignancy, etc
Source of methode (literature) : Guidelines,
journal

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Methodology of
pharmacodynamic study
ANIMALS :
Rodent or non-rodent (may depend on desired effect)
Healthy or diseased-animal model
Sex : male and/or female
Number : adequate for statistical analysis

Toxicological studies
IN VIVO TOXICOLOGICAL STUDIES
A. GENERAL TESTS
SHORT TERM
Acute Toxicity Test (LD50)
LONG TERM:
Sub Acute Test
Sub Chronic Test
Chronic Test
B. LOCAL TOXICITY TEST
Dermatological Preparation
C. SPECIAL TOXICITY TESTS
Mutagenicity Test
Carcinogenicity Test
Reproductive and Development Toxicity Test

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Animal models
Animal models are, at the best, analogous
to human condition but no theory can be
provided or refused by analogy. The truth is
the evidence in animals can be a powerful
device in support of virtually theory.

## Why are animals necessary in research?

1. Diseases process in human and animals have
similarities
2. Cell systems contain or manipulate only a part
of the organ system.
3. Computer models lack the complexities of living
entity .

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(Tokyo 2004)

## BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH

- Medical research involving human subjects must
conform to generally accepted scientific principles,
be based on a thorough knowledge of the scientific
literature, other relevant sources of information, and
on adequate laboratory and, where appropriate,
animal experimentation.
- Appropriate caution must be exercised in the conduct
of research which may effect the environment, and
the welfare of animals used for research must be
respected

## R eplacement Alternatifve methode

lower class of animal model

R eduction
correct model
genetic homogenity
use healthy animal

R efinement
caring
treatment
non-invasive methode
pain, stress, distress minimization

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## The council believes that the welfare of an animal ...

should be considered with reference to Five
Freedoms.
Freedom from hunger and thirst
Freedom from discomfort
Freedom from pain, injury and disease
Freedom to express normal behaviour
Freedom from fear and distress
(Farm Animal Welfare Council UK, 1993)

ever possible

## Enrichment devices for Nesting materials

rodents: Igloo, nest etc.

Human interactions

Enrichment
Devices for NHP

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