Professional Documents
Culture Documents
Sample Size Determination: Janice Weinberg, SCD Professor of Biostatistics Boston University School of Public Health
Sample Size Determination: Janice Weinberg, SCD Professor of Biostatistics Boston University School of Public Health
Sample Size Determination: Janice Weinberg, SCD Professor of Biostatistics Boston University School of Public Health
Treatments Treatments
are equal differ
Decision (HO true) (HA true)
Based on Do Not O.K. Type II error
the Data Reject HO β
• increases? Power ↑
• decreases? Power ↓
• N increases? Power ↑
• variability increases? Power ↓
• POWER:
If a limited pool of subjects is available, what is the
likelihood of finding a statistically significant effect of
a given magnitude if one truly exists?
Before We Can Determine Sample Size We Need
To Answer The Following:
H 0: 1 = 2 vs. HA : 1 2
Some Basic Sample Size Formulas
1. level
2. level (1 – power)
3. Expected population proportions (p1, p2)
Some Basic Sample Size Formulas
1. level
2. level (1 – power)
3. Expected population difference (= |1 - 2|)
4. Expected population standard deviation (1 , 2)
The Standard Normal Distribution
N(0,1)
0 z1-
N(0,1) refers to standard normal (mean 0 and variance 1)
prob[N(0,1) > z1-/2 ] = /2 prob[N(0,1) > z1- ] =
Dichotomous Outcome (2 Independent Samples)
• Test H0: p1 = p2 vs. HA: p1 p2
• Assuming two-sided alternative and equal allocation
2
z1-/2 2 pq z1 p1q1 p2 q2
n per / group
n z1 / 2 2 pq
Power
p1q1 p2 q2
n per / group
2
1 2
2 z
1 / 2 z1
2
2
Continuous Outcome
(2 Independent Samples)
n
Power z1 / 2
12 22
• = 1 - 2 = 10 mg/dl
• 1= 2 = (50 mg/dl)
• z1-/2 = 1.96 z1- = 1.28
• n per group = 525
• Suppose 10% loss to follow-up expected,
adjust n = 525 / 0.9 = 584 per group
• These two basic formulas address common settings
but are often inappropriate
• Note: Only the basics of sample size are covered here. It’s
always a good idea to consult a statistician