|
Clinical change
|
Caset 1
|
Case 2
|
Case 3
|
|---|
| |
SDD1
|
N1
|
SDD2
|
N2
|
SDD3
|
N3
|
|---|
|
λ (0.063)
|
0.078
|
26
|
0.117
|
56
|
0.156
|
98
|
|
ECV (0.038)
|
0.048
|
27
|
0.072
|
58
|
0.096
|
102
|
- Sample size need to detect a clinical meaning change of ECV and λ with 80% of power and an alpha error of 0.05. Sample size is derived from the inter-study SDD as described by Altman [33] and Marchin [32]. Note that for studies comparing active vs. placebo, these sample size numbers need to be doubled. Case 1: the inter-study SDD1 in HF group was estimated 2.8 fold greater than the intra-study SDD; Case 2, the inter-study SDD2 was estimated 1.5 times more than SDD1; Case3, the inter-study SDD3 was estimated 2 times more than SDD1.
