Metodologi

Penelitian
Clarasintha Nindyatami
1406544772
Fakultas Farmasi

Outline

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1. Randomized controlled trials with one experimental
group and one control group
2 kelompok (treatment group dan control group) dan dipilih secara
random (independen sample) (Jekel, 2007)

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2.

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3.

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4.

For example, if 30% of the animals are

infected and the investigator wishes to
have a 95% chance of detecting that
infection, the number, n, of animals that
are need is:

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CALCULATING SAMPLE SIZE FOR
SINGLE-GROUP EXPERIMENTS
If the aim is to determine whether an event has
occurred (for example, whether a pathogen is
present in a colony of animals), the number of
animals that need to be tested or produced is
given by

= probability of committing a Type II error

(usually 0.10 or 0.05)
p = the proportion of the animals in the colony
that are not infected.

Thus nine animals should be examined to

have a 95% chance of detecting an
infection that has affected 30% of the
animals in the colony. If the prevalence of
infection is lowersay, 10%then

and about 30 animals would be needed.

More animals are needed if the
prevalence of the pathogen is low.

National Research Council (US) Committee on Guidelines for the Use of Animals in Neuroscience and Behavioral Research.
Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research. Washington (DC): National Academies
Press (US); 2003. A, Sample Size Determination. Available from: http://www.ncbi.nlm.nih.gov/books/NBK43321/

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CALCULATING SAMPLE SIZE FOR
Continuous variables concentration
of a substance in a body fluid or
CONTINUOUS
VARIABLES
blood flow rate. Although the statistical models may be complex, it is
often critical to detect the difference in the mean of a variable between
two groups if there is such a difference. In this case, a simple formula
derived from the formula for the t-test can be used to compute sample
size when power, significance level, size of difference in means (called the
effect), and variability or standard deviation of the population means are
specified:

where C is dependent on values chosen for

significance level () and power (1-)
s = standard deviation
d = difference to be detected

Suppose that a chemical that reduces

appetite is to be tested to learn whether
it alters the body weight of the rats. In
previous experiments, the mean body
weight of the rats used was 400g, with
a standard deviation of 23g. Assume
also that the scientist would like to be
able to detect a 20g reduction in body
weight between control and treated rats
with a power (1-) of 90% and a
significance level () of 5%. Then,

animals are needed in each

group or roughly 60 animals for
the whole study.

National Research Council (US) Committee on Guidelines for the Use of Animals in Neuroscience and Behavioral Research.
Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research. Washington (DC): National Academies
Press (US); 2003. A, Sample Size Determination. Available from: http://www.ncbi.nlm.nih.gov/books/NBK43321/

National Research Council (US) Committee on Guidelines for the Use of Animals in Neuroscience and Behavioral Research.
Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research. Washington (DC): National Academies
Press (US); 2003. A, Sample Size Determination. Available from: http://www.ncbi.nlm.nih.gov/books/NBK43321/

Menghitung jumlah sampel

CALCULATING SAMPLE SIZE FOR REPEAT
Estimates of required sample size depend on the variability of the population. The greater
STUDIES

the variability, the larger the required sample. One method of controlling for variability of a
continuous variable, such as blood flow, is to measure the variable before and after an
experimental intervention in a single animal, also called a paired study. In this case, instead
of using an estimate of the variability of the population mean, one estimates the variability
of the difference. The standard deviation of a difference in measurement in an individual is
lower because it does not include interindividual variability. Stated in other terms, each
animal is its own control. The number of animals needed to test a hypothesis will be
reduced because the effect of animal-to-animal variation on the measurement is eliminated.
Such an experiment is normally analyzed with a paired t-test. The following equation for n is
derived from the paired t-test equation:

a paired study is more powerful than a comparison of two

independent means, as occurs in sample size calculations of

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If the s, d and C cannot be determined Federers Formula
(t-1) (n-1) 15
t = number of treatment
n = number of sample

Metode pengolahan data meliputi

analisis statistic
Program : SPSS

Normality and homogeneity test

Quantitative and Qualitative test
Post hoc analysis

Metode pengolahan data meliputi

analisis statistik
Analisis pada studi eksperimen tergantung
kepada beberapa faktor :
skala pengukuran dari
variabel exposure
and variabel outcome
(kategorikal atau
kontinyu)
apakah distribusi dari
variabel yang diukur sesuai
dengan uji statistik yang
dipakai

apakah subjeksubjek dalam

penelitian di followup untuk waktu yang
sama sampai
outcome muncul

Analisis Univariat
Mendeskripsikan
karakteristik setiap variabel
penelitian
Jika data numerik, dicari
mean, median, dan standar
deviasi

Analisis Bivariat
Mencari korelasi antara
dua variabel
Misal, variabel umur dan
penyakit jantung

Analisis Multivariate
Lebih dari satu variabel independen, dan satu variabel dependen
Misal, pendidikan Ibu, pengetahuan Ibu, sosial ekonomi keluarga,
dan jumlah anak.

Komputer
Editing
Coding
Memasukkan data
(Processing)
Pembersihan data
(cleaning)

What is statistics?
Data exploration and analysis
Inductive inference with probability
Quantification of uncertainty

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Example

We have data on the blood

pressure (BP) of 6 mice.
We are not interested in
these particular 6 mice.
Rather, we want to make
inferences about the BP of
all possible such mice.

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Sampling

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Several samples

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Distribution of
sample
average

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Confidence intervals
We observe the BP of 6 mice, with average = 103.6 and standard
deviation (SD) = 9.7.
We assume that BP in the underlying population follows a normal
(aka Gaussian) distribution.
On the basis of these data, we calculate a 95% confidence interval
(CI) for the underlying average BP:
103.6 10.2

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(93.4 to 113.8)

What is a CI?
The plausible values for the underlying population average BP,
given the data on the six mice.
In advance, there is a 95% chance of obtaining an interval that
contains the population average.

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100 CIs

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CI for difference

95% CI for treatment effect = 12.6 11.5

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Significance tests
Confidence interval:
The plausible values for the effect of salt water on
BP.
Test of statistical significance:
Answer the question, Does salt water have an
effect?
Null hypothesis (H0): Salt water has no effect on BP.
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Alt. hypothesis (Ha): Salt water does have an

Two possible
errors
Type I error (false positive)
Conclude that salt water has an effect on BP
when, in fact, it does not have an effect.
Type II error (false negative)
Fail to demonstrate the effect of salt water when
salt water really does have an effect on BP.

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Type I and II errors

The truth

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Conclusion

No effect

Has an effect

Reject H0

Type I error

Fail to reject H0

Type II error

Conducting the
test
Calculate a test statistic using the data.
(For example,
we could look at the difference between the average BP in the
treated and control groups; lets call this D.)
If this statistic, D, is large, the treatment appears to have some
effect.
How large is large?
We compare the observed statistic to its distribution if the
treatment had no effect.

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Significance level
We seek to control the rate of type I errors.
Significance level (usually denoted ) = chance you reject H0, if H0
is true; usually we take = 5%.
We reject H0 when |D| > C, for some C.
C is chosen so that, if H0 is true, the chance that

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|D| > C is .

If salt has no effect

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If salt has an effect

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P-values
A P-value is the probability of obtaining data as extreme as was
observed, if the null hypothesis were true (i.e., if the treatment has
no effect).
If your P-value is smaller than your chosen significance level (),
you reject the null hypothesis.
We seek to reject the null hypothesis (we seek to show that there is
a treatment effect), and so small P-values are good.

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Summary
Confidence interval
Plausible values for the true population average or
treatment effect, given the observed data.

Test of statistical significance

Use the observed data to answer a yes/no question, such
as Does the treatment have an effect?

P-value
Summarizes the result of the significance test.
Small P-value conclude that there is an effect.

Never cite a P-value without a confidence interval.

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Time table (jadwal kegiatan)

penelitian
Bulan

No
.
Kegiatan
1Meneliti literatur
Identifikasi dan
pembatasan
2 masalah
3Hipotesis
Rencana lengkap
4 dan operasional
Melaksanakan
5 eksperimen
Penentuan taraf
6 signifikansi
Mengolah data
dengan metode
7 statistika

6 7 8 9 10 11 12

An extremely
bad design

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Randomized

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A stratified design

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Referensi
oBroman, KW. [PPT]. Experimental design, basic statistics, and sample size
determination. http://www.biostat.jhsph.edu/~kbroman
oNational Research Council (US) Committee on Guidelines for the Use of Animals
in Neuroscience and Behavioral Research. Guidelines for the Care and Use of
Mammals in Neuroscience and Behavioral Research. Washington (DC): National
Academies Press (US); 2003. A, Sample Size Determination. Available from:
http://www.ncbi.nlm.nih.gov/books/NBK43321/
oSwarjana, IK. ( 2012). Metodologi Penelitian Kesehatan. Yogyakarta: Penerbit
Andi.