Intro to Med Lab Research
Lecture
SAMPLE SIZE DETERMINATION
1. WHEN IS IT APPROPRIATE TO DETERMINE
THE ADEQUATE SAMPLE SIZE FOR A GIVEN
STUDY?
a) When the study intends to collect data from
only a sub-set or a sample instead of the
whole population, and the intention is to
validly generalize the results based on the
sample, to the target population.
b) When a probability sampling design will
be used to select the sample.
c) When it is very important to derive precise
estimates of the variables/parameters
being studied, based on how the results will
be used.
2. GENERAL COMMENTS ABOUT SAMPLE SIZE
DETERMINATION
2.1 Sample size determination is a complicated
issue which needs a lot of:
a. statistical inputs, and
b. practical considerations.
2.2 The formula for sample size determination
differs according to:
a. type of study design,
b. type of sampling design,
c. type of variables being measured,
d. study objectives, and
e. number of groups being studied and compared
2.3 The following generalizations can be made
regarding the sample size requirements of a given
INTRO TO MED LAB RESEARCH (LEC) – MOD 6 l BY: LILIBETH MARTIN
Rolando Jr. V. Villamar
study:
a. longitudinal study designs require larger
samples than cross-sectional or case-control study
designs.
b. cluster sampling designs require larger
samples than simple random sampling of
elementary units.
c. the smaller the value of the parameter being
estimated, the larger the sample size needed
• rare conditions
• small difference
d. the more heterogeneous the variable is in the
population, the larger the sample size that is
necessary.
e. The more precise and the higher the
confidence level you wish to have for the resulting
estimates, the larger is the sample size needed.
3. INFORMATION NEEDED FOR SAMPLE SIZE
DETERMINATION WHEN ESTIMATING A MEAN
OR A PROPORTION
a. the anticipated value of the parameter to be
estimated in the study (e.g., the prevalence of the
disease; the average/mean grade of students given
a particular intervention, etc.) Possible sources of
this value are:
i. previous studies or past records
ii. values derived from the pre-test or pilot phase of
the project
iii. an expert’s opinion or an educated guess
iv. conducting the study in two parts
b. the degree of precision required for the
resulting estimates (margin of error) – this can be
expressed either in absolute (ex., ±5%) or in
relative terms (ex., ±5% of the value of the resulting
estimate). The value of an “acceptable” margin of
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 Intro to Med Lab Research
Lecture
Rolando Jr. V. Villamar

error will depend on: d = the margin of error or maximum permissible

i. the magnitude/level of the parameter being error; a measure of the desired level of precision for
estimated the resulting estimates
ii. how the results of the study will be used
iii. available resources for the conduct of the study SAMPLE PROBLEM: DETERMINING THE
SAMPLE SIZE IN ORDER TO ESTIMATE A
c. the desired confidence level – standard levels PROPORTION
used are 90%, 95% and 99%, with 95% being the
most commonly used. In a project which aims to assess, among others,
the effectiveness of a post-disaster nutrition
d. the estimated degree of variability of the program to be implemented in Province X, one of
observations (variance or the standard deviation). the impact indicators to be used is the decrease in
the prevalence of malnutrition among pre-schoolers
in the province. In order to measure this indicator,
4. EXAMPLE OF SAMPLE SIZE it is planned to conduct a baseline a survey to
DETERMINATION: ESTIMATING A determine the prevalence of malnutrition among
PROPORTION USING SIMPLE RANDOM preschoolers in Province X at the start of the
SAMPLING program. A review of nutrition data in the province
revealed that the only background data available is
n = z2- PQ the result of a study done in the province 2 years
d2 ago, which indicates that the prevalence of
moderate and severe malnutrition among
preschoolers is 25%. If it is decided to select a
where:
random sample of preschoolers for the baseline
z = a value derived from the normal distribution
survey , how big should the sample size be if the
and is dependent on the desired confidence level
error rate is set to be within ±5%, with 95%
for the derivation of the estimate. The z-values
confidence?
corresponding to the standard confidence levels
used when deriving estimates in research studies Based on the information provided in the sample
are as follows: problem:
z = 1.96 (based on the desired confidence level of
Confidence level z-value
90% 1.645 95%)
95% 1.96 P = 0.25 (malnutrition prevalence based on a
99% 2.58 survey done 2 years ago)
Q = (1 – P) = (1 - 0.25) = 0.75
d = 0.05
where: Therefore, n = (1.96)2 (0.25)(0.75) = 288
P = anticipated value of the proportion to be (.05)2
estimated in the population
Q = 1 – P (the complement of P, where P + Q = 1)
INTRO TO MED LAB RESEARCH (LEC) – MOD 6 l BY: LILIBETH MARTIN 2
 Intro to Med Lab Research
Lecture
5. DEALING WITH COMMON ISSUES IN
SAMPLE SIZE DETERMINATION
a. When deciding on the sample size requirements
for a study with more than one objective
involving the estimation and/or testing of
several parameters and hypothesis, the sample
size requirement of each important parameter has
to be computed and considered.
b. When estimating a proportion whose value is
unknown, a common practice is to assume that
P=.50. The basis for this is the fact that the
variance of indicators which are in the form of
proportions have a maximum value when P=.50
and Q=0.50, and hence will ensure an adequate
sample size irrespective of the actual value of P.
c. When the sampling design used makes use of
cluster sampling instead of pure simple random
sampling, the sample size has to be corrected for
the design effect (deff) – i.e.,
INTRO TO MED LAB RESEARCH (LEC) – MOD 6 l BY: LILIBETH MARTIN
Rolando Jr. V. Villamar
n(cluster sampling) = n(simple random sampling) x deff
“Deff” is the factor by which the sample size for a
cluster sample has to be increased in order to
derive estimates with the same precision as a
simple random sample. In the area of health, it has
been shown for most health surveys, deff = 1.5 to
2.0, with deff=2.0 being a common value used.
d. In order to ensure that the required sample size
is reached, a correction factor for non-response
is usually applied at the time of sample size
determination. This avoids the need for looking for
“substitutes” during data collection which usually
introduces biases in sample selection. The non-
response rate varies depending on the survey
setting (ex., urban areas generally have high non-
response rated compared to rural areas; surveys
which ask for sensitive questions also have higher
non-response rates) but in general, an inflation
factor of 10% for non-response has been shown to
be adequate in most situations. Therefore, if for
example, the required sample size of a given
survey after applying the design effect is 800, then
the revised target sample size after applying for the
correction factor for non-response will be 800 + 80
= 880. Data collection activities should therefore be
planned for a sample size of 880
. e. There are instances when the computed
sample size is deemed too big relative to the
population size. (There are even instances when
the computed sample size is bigger than the
population size).This is when the finite population
correction (fpc) can be applied to determine the
final sample size to be considered. The sample size
formula after application of the fpc is:
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 Intro to Med Lab Research
Lecture
Rolando Jr. V. Villamar

nfpc = n0
1+(n0-1)/N

where
nfpc = computed sample size after application of
the finite population correction
n0 = initial sample size computed prior to
application of fpc
N = population size

INTRO TO MED LAB RESEARCH (LEC) – MOD 6 l BY: LILIBETH MARTIN 4