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You are on page 1of 43

DETERMINATION

BY

DR ZUBAIR K.O.

DEPT OF MEDICAL MICROBIOLOGY.NHA

MBBS(IL),SR II

1

OUTLINE

• Our take home…………….

• What is sample size?

• What is sample size determination?

• How large a sample do I need?

• What are the methods of determining it?

• What are the factors that affect it?

• Mind my language

• How do you determine it?

• How do you use it?

• A final word………………..

2

OUR TAKE HOME

At the end of this presentation, we should be able to;

Determine sample size.

Understand factors that may affect sample size

Use sample size in our research or study.

3

WHAT IS SAMPLE SIZE?

This is the sub-population to be studied in order to make an

inference to a reference population(A broader population to

which the findings from a study are to be generalized)

In census, the sample size is equal to the population size.

However, in research, because of time constraint and budget, a

representative sample are normally used.

The larger the sample size the more accurate the findings from a

study.

4

Availability of resources sets the upper limit of the sample

size.

While the required accuracy sets the lower limit of sample

size

Therefore, an optimum sample size is an essential

component of any research.

5

6

WHAT IS SAMPLE SIZE DETERMINATION

Sample size determination is the mathematical estimation of

the number of subjects/units to be included in a study.

When a representative sample is taken from a population,

the finding are generalized to the population.

Optimum sample size determination is required for the

following reasons:

4. To allow for appropriate analysis

5. To provide the desired level of accuracy

6. To allow validity of significance test.

7

HOW LARGE A SAMPLE DO I NEED?

If the sample is too small:

2. Even a well conducted study may fail to answer it research

question

3. It may fail to detect important effect or associations

4. It may associate this effect or association imprecisely

8

CONVERSELY

If the sample size is too large:

2. The study will be difficult and costly

3. Time constraint

4. Available cases e.g rare disease.

5. Loss of accuracy.

commencement of a study.

9

MIND MY LANGUAGE

Random error Type I(a) error

Systematic error (bias) Type II (b) error

Precision (reliability) Power (1-b)

Accuracy (Validity) Effect size

Null hypothesis Design effect

Alternative hypothesis

10

Random error: error that occur by chance. Sources are sample

variability, subject to subject differences & measurement errors.

It can be reduce by averaging, increase sample size, repeating the

experiment.

Systematic error: deviations not due to chance alone. Several

factors, e.g patient selection criteria may contribute. It can be

reduce by good study design and conduct of the experiment.

Precision: the degree to which a variable has the same value

when measured several times. It is a function of random error.

Accuracy: the degree to which a variable actually represent the

true value. It is function of systematic error.

11

12

Null hypothesis: It state that there is no difference among

groups or no association between the predictor & the

outcome variable. This hypothesis need to be tested.

If the alternative hypothesis cannot be tested directly, it is

accepted by exclusion if the test of significance rejects the

null hypothesis. There are two types; one tail(one-sided) or

two tailed(two-sided)

13

Type I(a) error: It occurs if an investigator rejects a null

hypothesis that is actually true in the population. The

probability of making (a) error is called as level of

significance & considered as 0.05(5%). It is specified as Za

in sample size computing. Za is a value from standard

normal distribution ≡ a. Sample size is inversely

proportional to type I error.

Type II(b) error: it occur if the investigator fails to reject a

null hypothesis that is actually false in the population. It is

specify in terms of Zb in sample size computing. Zb is a

value from standard normal distribution ≡b

14

Power(1-b): This is the probability that the test will correctly

identify a significant difference, effect or association in the

sample should one exist in the population. Sample size is directly

proportional to the power of the study. The larger the sample

size, the study will have greater power to detect significance

difference, effect or association.

two variables in a population. It is the magnitude of the effect

under the alternative hypothesis. The bigger the size of the effect

in the population, the easier it will be to find.

15

Design effect: Geographic clustering is generally used to

make the study easier & cheaper to perform.

The effect on the sample size depends on the number of

clusters & the variance between & within the cluster.

In practice, this is determined from previous studies and

is expressed as a constant called ‘design effect’ often

between 1.0 &2.0. The sample sizes for simple random

samples are multiplied by the design effect to obtain the

sample size for the cluster sample.

16

odds ratio is a measure of effect size, describing the

strength of association or non-independence between two

binary data values.

a disease) relative to exposure. Relative risk is a ratio of the

probability of the event occurring in the exposed group

versus a non-exposed group.

17

POWER ANALYSIS

When the estimated sample size can not be included in a

study, post-hoc power analysis should be carried out.

The probability of correctly rejecting the null hypothesis is

equal to 1 – b, which is called power. The power of a test

refers to its ability to detect what it is looking for.

the power of a test is our probability of finding what we are

looking for, given its size.

post-hoc power analysis is done after a study has been

carried out to help to explain the results if a study which did

not find any significant effects.

18

AT WHAT STAGE CAN SAMPLE SIZE BE

ADDRESSED?

2. Calculate the optimum sample size required during the

planning stage, while designing the study, using appropriate

approach & information on some parameters.

3. Or through post-hoc power analysis at the stage of

interpretation of the result.

19

APPROACH FOR ESTIMATING SAMPLE

SIZE/POWER ANALYSIS

Approaches for estimating sample size and performing power

analysis depend primarily on:

2. The study design &

3. The main outcome measure of the study

different study designs & different outcome measures.

20

1. THE STUDY DESIGN

There are many different approaches for calculating the sample

size for different study designs. Such as case control design,

cohort design, cross sectional studies, clinical trials,

diagnostic test studies etc.

Within each study design there could be more sub-designs and

the sample size calculation will vary accordingly.

Therefore, one must use the correct approach for computing the

sample size appropriate to the study design & its subtype.

21

2.PRIMARY OUTCOME MEASURE

1⁰ outcome measure is usually reflected in the 1⁰ research

question of the study & also depend on the study design.

For estimating the risk in control study, it will be the odds

ratio, while for cohort study it will be the relative ratio.

For case control study, it could be the difference in

means/proportions of exposure in case & controls,

crude/adjusted odds ratio etc.

Hence, while calculating sample size, one of these

1⁰outcome measures has to be specified b/c there are

distinct approach for calculating the sample size

22

statistical inference from the study

results

sample size for two approaches of drawing statistical inference

from the study result i.e

2. Estimation (Confidence interval approach)

3. Hypothesis testing(Test of significance approach)

A researcher needs to select the appropriate procedure for

computing the sample size & accordingly use the approach of

drawing a statistical inference subsequently.

23 value

ADDITIONAL PARAMETERS

Depending upon the approach chosen for calculating the sample

size, one also needs to specify some additional parameters such

as;

Hypothesis

Precision

Type I error

Type II error

Power

Effect size

Design effect

24

PROCEDURE FOR CALCULATING

SAMPLE SIZE.

There are four procedures that could be used for calculating sample

size:

2. Use of formulae

3. Ready made table

4. Nomograms

5. Computer software

25

USE OF FORMULAE FOR SAMPLE SIZE

CALCULATION & POWER ANALYSIS

There are many formulae for calculating sample size &

power in different situations for different study designs.

The appropriate sample size for population-based study is

determined largely by 3 factors

3. The estimated prevalence of the variable of interest.

4. The desired level of confidence.

5. The acceptable margin of error.

26

To calculate the minimum sample size required for accuracy, in

estimating proportions, the following decisions must be taken:

2. Decide on a reasonable estimate of key proportions (p) to be

measured in the study

3. Decide on the degree of accuracy (d) that is desired in the study.

~1%-5% or 0.01 and 0.05

4. Decide on the confidence level(Z) you want to use. Usually

95%≡1.96.

5. Determine the size (N) of the population that the sample is

supposed to represent.

6. Decide on the minimum differences you expect to find statistical

significance.

27

For population >10,000.

n=Z2pq/d2

Z=standard normal deviate; usually set at 1.96(or a~2), which correspond to

95% confidence level.

p=proportion in the target population estimated to have a particular

characteristics. If there is no reasonable estimate, use 50%(i.e 0.5)

q=1-p(proportion in the target population not having the particular

characteristics)

d= degree of accuracy required, usually set at 0.05 level( occasionally at 2.0)

28

E.g if the proportion of a target population with certain

characteristics is 0.50, Z statistics is 1.96 & we desire

accuracy at 0.05 level, then the sample size is

n=(1.962)(0.5)(0.5)/0.052

n=384.

29

If study population is < 10,000

nf=n/1+(n)/(N)

n= desired sample size, when the study population > 10,000

N= estimate of the population size

Example, if n were found to be 400 and if the population size were estimated at 1000,

then nf will be calculated as follows

nf= 400/1+400/1000

nf= 400/1.4

nf=286

30

SAMPLE SIZE FORMULA FOR COMPARISON OF GROUPS

proportion & can assume an equal number of cases(n1=n2=n’) in two sub-

samples, the formula for n’ is

n’=2z2pq/d2

with regards to women using contraception. If we expect p to be 40 & wish

to conclude that an observed difference of 0.10 or more is significant at the

0.05 level, the sample size will be:

n’= 2(1.96)2(0.4)(0.6)/0.12

=184

Thus, 184 experimental subject & another 184 control subjects are required.

31

USE OF READYMADE TABLE FOR SAMPLE

SIZE CALCULATION

How large a sample of patients should be followed up if an

investigator wishes to estimate the incidence rate of a disease to

within 10% of it’s true value with 95% confidence?

The table show that for e=0.10 & confidence level of 95%, a

sample size of 385 would be needed.

This table can be used to calculate the sample size making the

desired changes in the relative precision & confidence level .e.g

if the level of confidence is reduce to 90%, then the sample size

would be 271.

Such table that give ready made sample sizes are available for

different designs & situation

32

33

USE OF NOMOGRAM FOR SAMPLE SIZE

CALCULATION

needs to specify the study(group 1) & the control

group(group 2). It could be arbitrary or based on study

design; the nomogram will work either way.

The researcher should then decide the effect size that is

clinically important to detect. This should be expressed

in terms of % change in the response rate compared with

that of the control group.

34

E.g if 40% of patients treated with standard therapy are

cured and one wants to know whether a new drug can cure

50%, one is looking for a 25% increase in cure rate .

(50%-40%/40% = 25% )

35

36

USE OF COMPUTER SOFTWARE FOR SAMPLE

SIZE CALCULATION & POWER ANALYSIS

The following software can be used for calculating sample size

& power;

Epi-info

nQuerry

Power & precision

Sample

STATA

SPSS

37

Epi-info for sample size determination

In STATCALC:

1 Select SAMPLE SIZE & POWER.

2 Select POPULATION SURVEY.

3 Enter the size of population (e.g. 15 000).

4 Enter the expected frequency (an estimate of the true

prevalence, e.g.80% ± your minimum standard).

5 Enter the worst acceptable result (e.g. 75%) i.e the margin

of error is 5%

38

How to use sample size formulae

Steps:

1st Formulate a research question

2nd Select appropriate study design, primary outcome measure,

statistical significance.

3rd use the appropriate formula to calculate the sample size.

39

Finally

Sample size determination is one of the most essential

component of every research/study.

The larger the sample size, the higher the degree accuracy,

but this is limit by the availability of resources.

It can be determined using formulae, readymade table,

nomogram or computer software.

40

STILL CONFUSED………………………..

Call a statistician

•Sample selection

41 •Sample size determination

•Analysis of data

42

References

Research methodology, 2004, M.O. Araoye; sample size

determination, page 117

Research methodology, 2004,Zodpey SP ijvl.com

Wikipedia, sample size determination

43

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