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Proportions: One and Two Groups

Two-Sample Proportions (Unpooled) Sample Size

Estimate the required sample size for each of two independent groups when comparing proportions with the two-sample unpooled Z-test. Enter the anticipated proportions, significance level, desired power, and test direction. The calculation uses the separate binomial variances of the two groups rather than a pooled variance.

Study Design Inputs

Specify the proportions expected under the alternative hypothesis.

Required Sample Size

Sample sizes are rounded up to whole participants so the requested power is not reduced by fractional enrollment.
Enter the study assumptions and click Calculate Sample Size.

Methodology

This calculator implements the large-sample normal-approximation formula for the equal-size two-sample Z-test of two independent proportions using the unpooled variance. In the unpooled approach, the variance contribution from Group 1 is calculated separately from the variance contribution from Group 2.

Unpooled sample-size formula

n = [(zα* + z1−β)² × {p1(1−p1) + p2(1−p2)}] / (p1 − p2

Here, n is the required sample size in each group, p1 and p2 are the anticipated population proportions, and z1−β is the standard-normal quantile corresponding to the desired power. For a two-sided test, zα* = z1−α/2; for a one-sided test, zα* = z1−α.

Why it is called unpooled

The unpooled test estimates the standard error from the two proportions separately:

σD,u = √[ p1(1−p1)/n + p2(1−p2)/n ]

This differs from the pooled approach, which uses a common proportion to estimate the variance. PASS documents the unpooled two-proportion Z-test using this separate-variance standard error and identifies Tests for Two Proportions — Z-Test (Unpooled) as one of its independent-two-proportion procedures.

Worked validation example

A published clinical study protocol reports a PASS calculation using the one-sided unpooled Z-test with Group 1 proportion p1 = 0.97, Group 2 proportion p2 = 0.85, significance level α = 0.025, and target power 0.80. The reported calculation gives approximately 85.36 subjects per group, which is rounded up to 86 per group, or 172 total.

z1−α = z0.975 ≈ 1.95996
z1−β = z0.80 ≈ 0.84162

n = [(1.95996 + 0.84162)² × {0.97(0.03) + 0.85(0.15)}] / (0.97 − 0.85)²

n ≈ 85.36 → 86 per group
Total N = 2 × 86 = 172

The calculator reproduces this validation result: 86 participants per group and 172 participants total.

Important interpretation

This is a normal-approximation planning calculation. It assumes two independent groups with equal sample sizes and uses the anticipated proportions under the alternative hypothesis. The calculation does not apply a continuity correction and does not inflate the result for dropout, loss to follow-up, or other study-design factors.

References

NCSS, LLC. (2024). PASS Sample Size Software: Tests for Two Proportions. NCSS documentation. The PASS procedure documents both pooled and unpooled versions of the two-proportion Z-test and describes the unpooled standard error as √[p₁(1−p₁)/n₁ + p₂(1−p₂)/n₂].

Fleiss, J. L., Tytun, A., & Ury, H. K. (1980). A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics, 36(2), 343–346. DOI: 10.2307/2529990.

The specific validation example is reported in a published study protocol that states it used PASS 15.0.12's “Z-Test with unpooled variance” and gives the corresponding formula and result of 86 participants per group.