Sample Size Calculation For Two Independent Groups: A Useful Rule of Thumb
Sample Size Calculation For Two Independent Groups: A Useful Rule of Thumb
Sample Size Calculation For Two Independent Groups: A Useful Rule of Thumb
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Sample Size Calculation for Two Independent Groups: A Useful Rule of Thumb
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Table 1. Sample size calculated using the Rule of Thumb (ROT) versus commercial software (PASS©).
Effect Size 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00
PASS© 393 176 100 64 45 33 26 21 17
n per Group
ROT 400 178 100 64 45 33 25 20 16
for a 2-sample test. This serves as a reminder that In approach (B) comparing time-averaged
comparing 2 groups requires 4 times the total differences, the sample size will be labelled
number of subjects as when comparing a single −
nμ(r , ρ). The standardised difference δ = Δ ∕ σ is a
mean to a known reference. meaningful effect size in the average response
between the 2 groups. For α = 0.05 and β = 0.20, the
2 Independent Samples with Repeated sample size nμ(r , ρ) can be obtained by multiplying
Measurements n in equation (1) by the factor [1 + ρ (r – 1)] ∕ r , i.e.
Extending the use of equation (1), suppose we
wish to determine n for 2 independent samples [1 + ρ (r – 1)]
nμ(r , ρ) = n • . (4)
for which r repeated measurements will be made r
on each subject over a period of time. Two analysis
approaches can be considered: (A) a comparison of Inspection of (4) indicates that low values of the
slopes of 2 linear trends; or (B) a comparison of time intra-class correlation ρ (the closer to 0 the better)
averaged differences. Within- and between-subject will reduce n for detecting an effect of size δ.
variance components are σw2 and σ b2, respectively, Spacing of measurement times is irrelevant.
with total variance σ 2 = σw2 + σ b2 . It is assumed
that each subject is measured at the same times Repeated measurement studies are likely to have
tj = ( j = 1, ..., r ) and s t2 = Σ j (tj – t̄)2 ∕ r is the missing follow-up visit data due to various reasons
within-subject variance of the tj. The only other (e.g. non-compliance). As a “hedge” against the
critical piece of information is an estimate of the potential for a substantial loss of power, the
intra-class correlation ρ = σ b2 ∕ σ 2 , the common proportion of patients anticipated to be lost
correlation between measurements taken on the to follow-up should be taken into account in
same subject, where 0 ≤ ρ ≤ 1. calculating sample size.