Nurse Researcher Quantitative research

Fundamentals of
estimating sample size
Cite this article as: Malone HE, Nicholl H, Coyne I (2016) Fundamentals of estimating sample size.
Nurse Researcher. 23, 5, 21-25.

Date of submission: June 1 2015. Date of acceptance: August 27 2015.

Correspondence
helenmalone3@gmail.com
Helen Evelyn Malone PhD, MSc,
RNT, SCM, SRN is a research
fellow at the School of
Nursing & Midwifery
Honor Nicholl PhD, BSc,
RCN is assistant professor
(nursing) at the School of
Nursing & Midwifery
Imelda Coyne PhD, MA,
BSc(Hons), Dip N, RSCN, RGN,
RNT, FEANS is head of children’s
nursing and research
All at Trinity College Dublin,
Republic of Ireland
Peer review
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Abstract
Background Estimating sample size is an integral
requirement in the planning stages of quantitative
studies. However, although abundant literature is
available that describes techniques for calculating
sample size, many are in-depth and have varying
degrees of complexity.
Aim To provide an overview of four basic parameters
that underpin the determination of sample size and to
explain sample-size estimation for three study designs
common in nursing research.
Discussion Researchers can estimate basic
sample size if they have a comprehension of
four parameters, such as significance level, power,
effect size, and standard deviation (for continuous
data) or event rate (for dichotomous data). In this
paper, these parameters are applied to determine
sample size for the following well-established study
designs: a comparison of two independent means,
the paired mean study design and a comparison
of two proportions.
Conclusion An informed choice of parameter values
to input into estimates of sample size enables the
researcher to derive the minimum sample size required
with sufficient power to detect a meaningful effect.
An understanding of the parameters provides the
foundation from which to generalise to more complex
size estimates. It also enables more informed entry of
required parameters into sample size software.
Implications for practice Underpinning the concept
of evidence-based practice in nursing and midwifery
is the application of findings that are statistically
sound. Researchers with a good understanding
of parameters, such as significance level, power,
effect size, standard deviation and event rate,
are enabled to calculate an informed sample size
estimation and to report more clearly the rationale
for applying any particular parameter value in sample
size determination.
Keywords effect size, power, quantitative research,
sample size, significance level, standard deviation

Introduction a sample size may be considered unethical, wasteful

‘WHAT SAMPLE size do I require?’ is a question
frequently asked by novice researchers
(Kelly et al 2010). It is unnecessary to recruit the
entire population to a study: a sufficiently large
representative subset or sample can provide
information concerning that population to whatever
degree of accuracy is required (Daly et al 1991).
Nevertheless, a balance is needed between
using too few or too many subjects in the sample
(Kelly et al 2010). Too small a sample size will have
insufficient power to statistically detect a true
difference, so important differences between study
groups may be declared statistically insignificant
(Daly et al 1991, Karlsson et al 2003). Too large
of resources and can affect a study’s feasibility.
Additionally, funding agencies, ethics committees
and journal editors increasingly expect sample size
to be justified.
Defining sample size
A sample size is appropriate if it enables the
researcher to make an unequivocal judgement that
a statistical result is correct to a chosen degree
of error (‘type I error’) and has sufficient power
(‘1-type II error’) to detect a specified meaningful
effect. The sample size determination in this paper
is based on power calculations and is suitable
for testing hypotheses.

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 Nurse
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Four parameters that underpin power
The significance level For testing hypotheses,
the significance level ‘α’ (alpha) cuts off the area
under the sampling distribution curve that divides
a significant from a non-significant result:
if a statistical test’s result has a p-value less
than α, then the statistical test is deemed to be
significant. For a significance of 5%, for example,
α=0.05 and if p<0.05, the result is deemed
significant. This α is the same α that is entered
into sample size software or formulae.
The ‘alpha error’ or ‘type I error’ is the risk of
accepting that a treatment is effective when it is not
(Karlsson et al 2003). More formally, it is rejecting
the null hypothesis Ho when Ho is true (Sakpal
2010). A p<0.05 means that if the experiment was
repeated 100 times, a type I error is likely to occur
five times (5% of times). Similarly, p<0.01 means
that if the experiment was repeated 100 times,
a type I error is likely to occur only once. While α is
likely to be set at 0.05 (Karlsson et al 2003, O’Hara
2008), the researcher can choose a lower risk of
a type I error using an α of 0.01. Such changes to
the chosen significance level affect the calculated
sample size. For example, if it is deemed acceptable
to change the conventional significance level of 5%
to 10%, the calculated sample size decreases.
Power of the test ‘Power’ is the probability of a true
positive effect (Kelly et al 2010) and can be defined
as the probability that a statistical test will produce
a significant result, given that a true difference
actually exists (Houle et al 2005). The probability
of a statistical test failing to detect a true difference
is called ‘β’ (beta) and the power is (1-β).
If a treatment effect is present but the test does
not find it, that is a ‘beta error’ – also known as
a ‘type II error’ or ‘false negative’. More formally,
it is accepting Ho when the alternative hypothesis
H1 is true (Sakpal 2010).
The choice of beta and therefore power depends
on the degree of certainty of detecting a real
difference or effect (‘a true positive’) that the
researcher requires. A beta β of 0.1 (10%) to 0.2 (20%)
is usually tolerated (Cohen 1987), giving a power
of 0.8 (80%) or 0.9 (90%) (Kelly et al 2010).
Table 1 Choosing the alpha value and the corresponding z value for a chosen
significance level for a one or a two-tail test
Significance Alpha (α) zα for a one-tail test zα for a two-tail test
5% 0.05 1.64 1.96
1% 0.01 2.33 2.58
Source: Colton (1974), Machin et al (2009)
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It is notable, using sample size tables from
Machin et al (2009), that at a significance level of
5%, sample sizes for means or proportions increase
by approximately 33% when the effect size and
standard deviation are held constant and the
power parameter is changed from 80% to 90%.
The effect size
Defining effect size for the comparison of means
When comparing two means, absolute effect size is
defined as |µ1-µ2| where μ1 and μ2 are the population
means. The standardised effect size – that is the
effect size measured in units of standard deviation
– is the absolute effect size divided by the relevant
standard deviation, σ, or |µ1- µ2|/σ (Machin et al
2009), where σ is the square root of the variance
of the populations (Petrie and Sabin 2010).
The Cohen (1987) operational definitions of the
standardised effect size for means are: 0.20 for
a small effect size, 0.50 for a moderate size and
0.80 for a large.
Defining effect size for the comparison of
proportions When comparing proportions (event
rates), absolute effect size is defined as |π1-π2|
where π1 and π2 are the anticipated population
proportions in the two groups to be compared
(Machin et al 2009). Authors generally report the
absolute effect size – for example, a difference in
absolute effect sizes of 15% was deemed clinically
important in Adam et al’s (2005) study of three-year,
leg amputation-free survival values, with 65% (π2)
in one group and 50% (π1) in the other.
Clinically meaningful effect size To calculate
sample size, a researcher needs to anticipate what
effect size to use. This should be the clinically
important difference (Kelly et al 2010) that the
treatment should make to justify a change in
practice (Gogtay 2010). For example, an intervention
that reduces maternal mortality by 1% could be
considered clinically important, but an intervention
that reduces the incidence of neonatal physiological
jaundice by 10% might be considered of lesser
clinical important in practice (Devane et al 2004).
Anticipated effect size and the primary outcome
A study’s principal endpoint of interest is its main
outcome (Kelly et al 2010). Sample size is calculated
using the anticipated effect size for the designated
primary outcome; where several outcomes are
equally important, the sample size is calculated
for all endpoints of interest and the largest
sample size is then used to conduct the study
(Machin et al 2009).
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If a researcher is over-optimistic and decides on
an anticipated effect size that is too large relative
to the true but unknown effect size, the resultant
sample size will be too small (Machin et al 2009).
Consequently, the study will be underpowered and
a true effect could be missed. In contrast, if the
researcher is pessimistic and sets the effect size too
low, the sample size can be prohibitively large and
may affect the study’s feasibility.
In practice, there can be a range of opinions
among clinicians on the minimum effect size
of clinical importance. These opinions can be
considered with the aim of balancing the detection
of a clinically meaningful effect size with the
feasibility of the study. A small adjustment to the
effect size can result in large changes to the calculated
sample size. For example, Mires et al (2001) estimated
a sample size of 2,552 to detect a 3% absolute
effect size. However, using the same significance
level and power, the estimated sample size
reduced to 1,704 subjects when the effect size was
increased to 4%.
The standard deviation or event rate For
continuous data, variability is measured by the
standard deviation, σ (Colton 1974). This is the
variation or spread associated with data, and can
be conceptualised as an average of deviations
from the mean µ.
Estimates for σ are difficult to obtain, but the
researcher can estimate it by undertaking a pilot
study (Kelly et al 2010), an internal pilot study
(Daly et al 1991, Machin et al 2009) or using the
σ reported by similar studies (Gogtay 2010).
For continuous data, the relevant standard deviation
can be entered directly into sample size software.
For discrete data (‘dichotomous data’), variability
depends on the proportion of subjects with the
outcome of interest (Kelly et al 2010). Thus, for the
comparison of two proportions, sample size is
calculated using the input of the two proportions
of interest: the control proportion (baseline
event rate) can be obtained from published
literature, while the treatment proportion (event
rate) is derived once the effect size is chosen.
The sample size calculation is informed by the
variation in the population and the effect size
by knowledge of the two proportions of interest.
Three sample size calculations
In the following three formulae, the significance level
is entered into the formula as a zα value. Similarly,
the power is entered into the formula as a zβ value.
A z-value or ‘standardised normal deviate’ (Petrie and
Sabin 2010) is a measure of the distance from the
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Quantitative research
Table 2  Choosing the power and the corresponding z value for a one- or a two-tail test
Power Beta β zβ
80% 20% 0.842
90% 10% 1.282
NB Power always cuts off only one tail
Source: Colton 1974, Machin et al 2009
mean in units of standard deviation (Castle 1977).
It is a standardised value used to cut off a particular
area in the normal distribution (Daly et al 1991).
Z-values do not need to be calculated, but can simply
be looked up in tables of the normal distribution
contained in most statistics books (Colton 1974,
Machin et al 2009). The zα values for one- and two-tail
tests are given in Table 1. The zβ values for powers
are given in Table 2. These values are sufficient
for most studies.
Design 1: A comparison of two independent means
(continuous data) This type of design can be applied
when randomising participants into an intervention
and a control group for a clinical trial. An appropriate
test would be the independent t-test (Colton 1974,
Petrie and Sabin 2010). The sample size calculated
gives the number in each arm of the study.
For example: A researcher is planning
a randomised controlled trial (RCT) to test the
effectiveness of a new pharmaceutical drug to
alter systolic blood pressure by a predetermined
effect size of 5mmHg for a group of subjects whose
blood pressure values have σ=10mmHg. For a two-tail
significance test, with 80% power
and 5% level of significance, how many subjects
does the study require? Assume that the data
sampled are normally distributed, there is equal
variance for both compared groups and there
are equal numbers in each group. The answer is
given in Figure 1.
Figure 1 Sample size formula for the comparison
of two independent means
2
⎡(zα+ zβ)σ ⎤
n=2
⎣ ES ⎦
 
Therefore:
2
⎡(1.96 + 0.84)10 ⎤
n=2
⎣ 5 ⎦ = 63 in each group
      
The more precise estimate given by the G*Power
sample size software is 64 in each group.
(Colton 1974, Daly et al 1991)
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Figure 2 Sample size formula for the difference
of two dependent means: matched
paired design
2
np = ⎡(zα+ zβ)σd⎤ = Number of pairs
⎣ ES ⎦
Therefore: The answer is given in Figure 2.
2
⎡(1.96 + 0.84)10 ⎤
np = = 32 pairs
⎣ 5 ⎦
The more precise G*Power estimate is 34 pairs.
(Daly et al 1991)
Design 2: Paired design – comparison of
two dependent means (continuous data) A paired
design uses naturally matched pairs (‘matching
siblings’), artificial pairing (‘matching subjects for
important characteristics’) or self-pairing (Colton
1974). In self-pairing, participants act as their own
control and in matched pairs, two individuals
form a pair. Therefore, the total sample size is
doubled for matched pairs as compared to self-
pairing. The appropriate test is the paired t-test
(Colton 1974, Petrie and Sabin 2010). The sample
size calculated gives the number of pairs needed
for the study.
The relevant standard deviation is the ‘standard
deviation of difference’, σd – that is, the standard
deviation of the differences estimated from before
and after treatment. However, an estimate of σd
is difficult to obtain from published sources so
a preliminary estimate should be obtained at the
beginning of the study (Daly et al 1991) or through
a pilot study. For example, a researcher is
planning a study to test the efficacy of a new
Figure 3 Sample size formula for the difference of two independent proportions
For example:
2
⎡(zα+ zβ)⎤
n=2
⎣ π2– π1 ⎦ π(1–π)
 
Therefore:
2
⎡(1.96+1.282) ⎤
  n= 2⎣ 0.15 ⎦ x 0.575 x 0.425 = 228 in each group
Where n = Number in each group
Where π1 and π2 are the proportions in each group
Where Effect size = |π2 – π1| = |0.65 – 0.50| = 0.15
Where π = (π1 + π2)/2 = 0.575 (Average of the two proportions)
Where (1 – π) = (1– 0.575) = 0.425
The more precise G*Power estimate is 227 in each group.
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pharmaceutical beta-blocker drug to alter heart
rate by a pre-determined effect size of five
beats/minute. The standard deviation of the
differences, σd, is ten beats/minute.
Using a two-tail test, 80% power and a 5%
significance level, how many subjects does the study
need? Assume the data are normally distributed.
(For the zα value for 5% Significance see Table 1).
(For the zβ value for 80% Power see Table 2).
Design 3: A comparison of two independent
proportions (categorical data) For this design,
appropriate tests are the z-test for the comparison
of two independent proportions (Colton 1974) or
the χ2 test (Petrie and Sabin 2010).
For example: a researcher wishes to detect
an effect size of 15% (absolute difference) in the
three-year, amputation-free survival rate between an
angioplasty group and a group undergoing bypass
surgery. The proportion in one group was assumed
to be 50%, in the other 65%.
Using a two-tail test, 5% significance level and
a power of 90%, how many subjects does the study
need? Assume that the groups have equal variance
and numbers. The answer is given in Figure 3.
The formula in Figure 3 assumes the normal
approximation to the binomial distribution. As such,
it can only be applied when the average of the two
proportions is not too small: (π1 + π2)/2>0.10
(Goodall et al 2009).
Anticipated drop-outs or losses to follow up If
a drop-out rate of r% is expected, the adjusted
sample size is obtained by multiplying the
unadjusted sample size by 100/(100–r)
(Petrie and Sabin 2010).
Allocation ratio In general, clinical trials allocate
equal numbers to both groups (Machin et al 2009).
However, other allocation ratios may be required.
For example, in placebo-controlled trials with very
ill patients, it may be unethical to assign equal
numbers to each group (Sakpal 2010). Additionally,
in case-control studies, where there are a limited
number of cases and controls are readily available,
it is acceptable to include more controls to increase
the power of the study (Machin et al 2009).
Sample size software assists with calculations
involving different allocation ratios. The sample size
derived in this paper for a 1:1 ratio can be adjusted
to give a different allocation ratio by applying the
following simple formula (where n is the number in
each arm with equal allocation and k is the required
allocation) (Sakpal 2010):
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 Quantitative research

Regardless of whether sample size is calculated

Arm (1) n1 = n (1+k)/2
Arm (2) n2 = n (1+k)/2k
N (total) = (n1 + n2)
A practical example of this formula can be
illustrated using the sample size estimation given in
this paper for the comparison of two Independent
means, with a 1:1 ratio gives a G*Power estimate of
64 in each arm (128 total). Then, for an allocation
ratio of 2:1 the required numbers in each arm to
maintain 80% power are (Sakpal 2010):
Arm (1) n1 = 64 (1+2)/2 = 96
Arm (2) n2 = 64 (1+2)/4 = 48
N (total) = (96 + 48) = 144
Sample size and study feasibility considerations
The estimated sample size may be too large,
rendering the study unfeasible. Sample size can
be reduced by decreasing the significance level
from 5% to 10%; changing power from 90% to 80%;
limiting the study to the primary outcome, if other
end-points require a larger sample size; applying
a paired design (‘reducing variability’); choosing
a continuous instead of a categorical variable;
or applying a one-sided significance test.
Conclusion
Sample-size software requires the input of the
parameters outlined in this paper. Familiarisation
with the formulae in this paper enables the
researcher to conceptualise what is happening
in the background when using such software.
using formulae or sample size software, carefully
estimated sample sizes are important. This is
because the research informing healthcare practice
needs to be based on evidence. Underpinning
the concept of evidence-based practice is
the application of research findings that are
statistically sound.
Four parameter values required for basic
estimation of sample size are: significance level,
power, effect size, and standard deviation (for
continuous data) or the event rate (for dichotomous
data). The conventional significance level is typically
5% and the conventional power is 80%. The effect
size is the clinically meaningful difference that can
justify a change in clinical practice. The standard
deviation is usually unknown and can be estimated
by undertaking a pilot study or using the standard
deviation reported for similar studies.
It is important for researchers to be aware that
the benefits of a properly calculated sample size
can be undermined by the presence of systematic
bias in the study design (Malone et al 2014).
When reporting study findings, researchers should
report their rationales for the choice of parameters
applied to calculate the sample size and whether any
adjustments were made to the calculations to take
account of attrition. Online archive
It is strongly recommended that a confidence
For related information, visit
interval should be reported for the effect size our online archive and search
observed (Noordzij et al 2011). Statistical guidance using the keywords
from a statistician is advised for study designs
that require more complex formulae than those Conflict of interest
presented in this paper. None declared

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