1

SAMPLE SIZE CALCULATION

Learning Objectives:
At the end of this session, learners should be able
to:
1. Explain the concept/importance of sample
size,
2. Explain and apply the concept of hypothesis
testing,
3. Apply sample size formulas for descriptive
and analytic studies,
4. Identify the requirements for sample size
calculation ,
5. Apply OPEN EPI/EPIINFO for sample size
calculation for cross-sectional, cohort, case-
control and experimental studies.
How many subjects are to be included in the
sample?
- SAMPLE SIZE CALCULATION
- Why calculate?
o for planning purposes
o for power of the study (low
power it will have little chance of
giving a statistically significant
difference).
o meaningful results (small sample -
the study will have failed to
establish that the intervention has
no appreciable effect).
How do we calculate sample size?
Using formulas
Using tables of sample sizes
Using statistical calculators
(StatCalc of EpiInfo, Open EPI)
Sample size calculation
- Things to know:
o type of the study: descriptive or
analytic?
o proportions or means? usual
values?
o amount of deviation from the true
value? Clinically important
difference?
o confidence level? power?
o one-tailed or two-tailed hypotheses
Hypotheses testing
The first thing to do when given a claim is to write
the claim mathematically (if possible), and decide
whether the given claim is the null or alternative
hypothesis.
If the given claim contains equality, or a statement
of no change from the given or accepted condition,
then it is the null hypothesis, otherwise, if it
represents change, it is the alternative hypothesis.
- hypothesis -- a statement about the
population
- null hypothesis (Ho) -- equality
- alternative hypothesis (Ha) --
o two-tailed -- not equal
o one-tailed -- one is greater than the
other
- Possible states of nature (Based on H
0
)
o Patient is alive (H
0
true - H
1
false )
o Patient is dead (H
0
false - H
1
true)
- Possible decisions (Based on H
0
) /
conclusions (Based on claim )
Subject: COMMED
Topic: Sample Size Calculation
Lecturer: Dr. Frias
Date of Lecture: August 26, 2011
Transcriptionist: Jobell
Editor: Pinay
Pages: 8

S
Y

2
0
1
1
-
2
0
1
2


2
o Reject H
0
/ "Sufficient evidence to
say patient is dead"
o Fail to Reject H
0
/ "Insufficient
evidence to say patient is dead"
- There are four possibilities that can occur
based on the two possible states of nature
and the two decisions which we can make.
- Statisticians will never accept the null
hypothesis, we will fail to reject. In other
words, we'll say that it isn't, or that we
don't have enough evidence to say that it
isn't, but we'll never say that it is, because
someone else might come along with
another sample which shows that it isn't
and we don't want to be wrong.
Hypotheses testing - Statistically speaking:

Hypotheses testing Were you right?

Hypotheses testing



Hypotheses testing
Since Type I is the more serious error
(usually), that is the one we concentrate on.
We usually pick alpha to be very small (0.05,
0.01). Note: alpha is not a Type I error.
Alpha is the probability of committing a
Type I error. Likewise beta is the probability
of committing a Type II error.
Conclusions
Conclusions are sentence answers which
include whether there is enough evidence
or not (based on the decision), the level of
significance, and whether the original claim
is supported or rejected.
Conclusions are based on the original claim,
which may be the null or alternative
hypotheses. The decisions are always based
on the null hypothesis.
Hypotheses testing Conclusions

Definitions
Null Hypothesis ( H
0
)
Statement of zero or no change.

3
If the original claim includes
equality (<=, =, or >=), it is the null
hypothesis.
If the original claim does not
include equality (<, not equal, >)
then the null hypothesis is the
complement of the original claim.
The null hypothesis always includes
the equal sign. The decision is
based on the null hypothesis.
Alternative Hypothesis ( H
1
or H
a
)
Statement which is true if the null
hypothesis is false.
The type of test (left, right, or two-
tail) is based on the alternative
hypothesis.
One-Tailed (Sided) Test

Two-Tailed (Sided) Test

Type I error
Rejecting the null hypothesis when
it is true (saying false when true).
Usually the more serious error.
Type II error
Failing to reject the null hypothesis
when it is false (saying true when
false).
alpha (a) - probability of committing Type I
error
1- a - the confidence level
beta (b) - probability of committing Type II
error
1- b - power of the study; ability to detect a true
difference
Significance level ( alpha )
The probability of rejecting the null
hypothesis when it is true. alpha =
0.05 and alpha = 0.01 are common.
If no level of significance is given,
use alpha = 0.05.
The level of significance is the
complement of the level of
confidence in estimation.
Confidence level, Power
Usual Values:
a = 0.05,
1- a (confidence level) = .95
b = 0.20,
1- b (power) = 0.80
The easiest ways to increase power are to:
increase sample size
increase desired difference (or
effect size)
decrease significance level desired
e.g. 10%
Decision
A statement based upon the null
hypothesis.
It is either "reject the null
hypothesis" or "fail to reject the
null hypothesis".
We will never accept the null
hypothesis.
Conclusion
A statement which indicates the
level of evidence (sufficient or
insufficient),
at what level of significance,
and whether the original claim is
rejected (null) or supported
(alternative).


4
How do we calculate sample size?
A.J. Dobsons formula (SIMPLE RANDOM SAMPLE)
descriptive studies
population proportion
population mean
analytic studies
comparing two proportions
comparing two means
Sample size for descriptive studies

1. Estimation of a population proportion


where
n = computed sample size
p = estimate of the proportion
A = the desired width of the confidence
interval
1- o = confidence level

A researcher wants to estimate the smoking
prevalence in high school students . What is the
sample size if it is expected that the smoking
prevalence is 15%, and a 95% confidence interval
will be used for an interval of 4% (11-19%)?




A researcher wants to estimate the mean serum
cholesterol level (mg/100ml) in a group of men.
How many men should be included if he wants to
be 90% confident that the estimate of the mean will
fall within 10mg/100ml of the true value and
standard deviation is estimated to be 40mg/100ml?

1. Hypothesis testing between two proportions


where
n = computed sample size
p1, p2 = estimate of the sample proportion
for each group
1- o = confidence level
1- | = power of the test

A new antibiotic is to be compared to a standard
drug with respect to cure rate of urinary tract
infection. The new drug will be considered better
) 1 (
) 100 (
2
o
A

= f
p p
n
) 1 (
) 100 (
2
o
A

= f
p p
n
) , (
) 2 1 (
) 2 100 ( 2 ) 1 100 ( 1
2
| o f
p p
p p p p
n

+
=

5
than the standard drug if it shows a 5% difference
from the cure rate of 80%. How many patients are
needed if the investigator wants 90% power and
95% confidence?




A new antibiotic is to be compared to a standard
drug with respect to cure rate of urinary tract
infection. The new drug will be considered better
than the standard drug if it shows a 5% difference
from the cure rate of 80%. How many patients are
needed if the investigator wants 90% power and
95% confidence?

2. Hypothesis testing between two means


where
n = computed sample size
s = estimate of the standard deviation of
the observations, assuming it is the same for each
group
A = the true difference between the means
1- o = confidence level
1- | = power

To determine whether an antihypertension therapy
can reduce the average blood pressure of some
group by 5 mmHg when the standard deviation is
10 mmHg, how many patients are needed for a two-
tailed test at the 5% significance level, and power of
90%?




To determine whether an antihypertension therapy
can reduce the average blood pressure of some
group by 5 mmHg when the standard deviation is
10 mmHg, how many patients are needed for a two-
tailed test at the 5% significance level, and power of
90%?


Sample size calculation using EPI-Info6
http://www.cdc.gov/epiinfo/Epi6/ei6.htm
- STATCALC program
) , (
) 2 1 (
) 2 100 ( 2 ) 1 100 ( 1
2
| o f
p p
p p p p
n

+
=
) , (
2
2
2
| o f
s
n
A
=
) , (
2
2
2
| o f
s
n
A
=

6

To compare two antianemia treatment groups in
terms of outcome of hemoglobin level. What is the
sample size needed if expected mean hgb level
after treatment for group A is 132.86 with standard
deviation of 15.34 and the mean hemoglobin level
for group B is 127.44 with sd of 18.23?


Sample size for analytic studies

Case Control Study
Research question: Is there an association between
receiving HRT and development of breast CA among
women in Dasmarinas, Cavite?

Odds of exposure among diseased = 175/75 = 2.3
Odds of exposure among non-diseased = 25/225 =
0.11
Odds Ratio = 21

Cohort Study
Research question: Is Hib vaccine associated with
the development of leukemia among children in
Dasmarinas, Cavite ?
Incidence of disease among exposed = 150/500 =
0.3
Incidence of disease among unexposed = 400/500 =
0.8
Relative Risk = 0.375

Calculate sample size: RCT
Example: Efficacy of flubendazole compared to
mebendazole in the treatment of trichiuriasis
among pediatric patients.
Objective: To compare resolution of trichiuriasis for
pediatric patients given flubendazole and those
given mebendazole.

7








General comments on estimation of sample size
Compute the sample size as early as
possible during the design phase, (to
estimate the resources required and the
feasibility of the study.
The rarer the condition being investigated,
the larger the sample size, all other things
being equal.
Complex data analysis generally requires
larger samples than simple analysis.
In general, longitudinal studies require a
larger sample size than case-control and
cross sectional studies.
The higher the level of accuracy and
precision desired for the resulting
estimates, the larger the sample size
necessary.
When more than 1 item or outcome are to
be studied, sample sizes are estimated
separately for each item. The final sample
size will be a compromise between the
largest n and the resources to conduct the
study.
Summary
Explained the concept/importance of
sample size,
Explained and applied the concept of
hypothesis testing,
Applied sample size formulas for descriptive
and analytic studies,
Identified the requirements for sample size
calculation ,
Introduced OPEN EPI/EPIINFO for
application in sample size calculation for

8
cross-sectional, cohort, case-control and
experimental studies.
Statistical inference allows us to generalize
sample results to the target population
sample size is based on the
research objectives/design
sample estimates, variability from
previous studies
power, level of confidence
operational constraints (time,
resources)
----------------END OF TRANX-----------------------
I will give up whole nations to save your life
because you are precious to me and because I love
you and gave you honor.
Isaiah 43:1-4