Background
Methods and results
Theoretical Issues
The mixed-effects model
Group effect variance
Two-way ANOVA
One-way ANOVA
Source | DF | SS | E(MS) |
---|---|---|---|
Group | 2 - 1 | ||
Residual |
N - 2 | ||
Total |
N - 1 |
The Design Effect
Simulation study
ICC = 0.01 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
N subjects | 100 | 200 | 500 | |||||||||
N centers | 5 | 10 | 20 | 5 | 10 | 20 | 50 | 5 | 10 | 20 | 50 | 100 |
S1 Deff
| 0.9969 | 0.9938 | 0.9921 | 0.9966 | 0.9936 | 0.9922 | 0.9911 | 0.9965 | 0.9933 | 0.9919 | 0.9913 | 0.9908 |
rdiff
| 0.0065 | 0.0032 | 0.0016 | 0.0065 | 0.0032 | 0.0016 | 0.0006 | 0.0065 | 0.0032 | 0.0016 | 0.0006 | 0.0003 |
S2 Deff
| 0.9972 | 0.9949 | 0.9928 | 0.9972 | 0.9956 | 0.9938 | 0.9917 | 0.9980 | 0.9989 | 0.9956 | 0.9931 | 0.9918 |
rdiff
| 0.0065 | 0.0032 | 0.0014 | 0.0065 | 0.0032 | 0.0016 | 0.0005 | 0.0065 | 0.0033 | 0.0016 | 0.0006 | 0.0003 |
S3 Deff
| 1.0102 | 1.0306 | 1.0147 | 1.0217 | 1.0622 | 1.0431 | 1.0132 | 1.0575 | 1.1788 | 1.1143 | 1.0487 | 1.0204 |
rdiff
| 0.0066 | 0.0035 | 0.0016 | 0.0066 | 0.0036 | 0.0018 | 0.0006 | 0.0066 | 0.0036 | 0.0019 | 0.0007 | 0.0003 |
S4 Deff
| 1.1038 | 1.0323 | 1.0285 | 1.2026 | 1.0538 | 1.0604 | 1.0184 | 1.4788 | 1.1290 | 1.1588 | 1.0559 | 1.0186 |
rdiff
| 0.0077 | 0.0051 | 0.0027 | 0.0077 | 0.0052 | 0.0030 | 0.0011 | 0.0077 | 0.0053 | 0.0030 | 0.0013 | 0.0006 |
ICC = 0.10 | ||||||||||||
N subjects | 100 | 200 | 500 | |||||||||
N centers | 5 | 10 | 20 | 5 | 10 | 20 | 50 | 5 | 10 | 20 | 50 | 100 |
S1 Deff
| 0.9655 | 0.9356 | 0.9197 | 0.9642 | 0.9337 | 0.9209 | 0.9105 | 0.9631 | 0.9313 | 0.9177 | 0.9124 | 0.9076 |
rdiff
| 0.0643 | 0.0318 | 0.0155 | 0.0649 | 0.0320 | 0.0160 | 0.0061 | 0.0649 | 0.0324 | 0.0161 | 0.0063 | 0.0031 |
S2 Deff
| 0.9709 | 0.9469 | 0.9269 | 0.9696 | 0.9547 | 0.9359 | 0.9171 | 0.9793 | 0.9827 | 0.9549 | 0.9300 | 0.9174 |
rdiff
| 0.0656 | 0.0318 | 0.0142 | 0.0648 | 0.0323 | 0.0157 | 0.0053 | 0.0651 | 0.0325 | 0.0161 | 0.0063 | 0.0028 |
S3 Deff
| 1.1101 | 1.3018 | 1.1721 | 1.2095 | 1.6471 | 1.4256 | 1.1337 | 1.6662 | 2.7175 | 2.1685 | 1.4965 | 1.2049 |
rdiff
| 0.0654 | 0.0349 | 0.0166 | 0.0659 | 0.0354 | 0.0182 | 0.0063 | 0.0662 | 0.0358 | 0.0185 | 0.0074 | 0.0034 |
S4 Deff
| 2.0718 | 1.3360 | 1.2725 | 3.1669 | 1.5750 | 1.6252 | 1.1934 | 6.2708 | 2.5759 | 2.5886 | 1.5687 | 1.2017 |
rdiff
| 0.0768 | 0.0507 | 0.0272 | 0.0770 | 0.0517 | 0.0299 | 0.0110 | 0.0771 | 0.0513 | 0.0299 | 0.0126 | 0.0059 |
Some specific designs
Stratified Multicenter Individually Randomized Trial
Matched Pair Design
Cluster Randomized Trial and Expertise-based Randomized Trial
Multicenter Observational Study
Example
Group distribution among centers | Quite homogeneous | Heterogeneous | Cluster design | ||||||
---|---|---|---|---|---|---|---|---|---|
Group size per center
|
m
1j
|
m
2j
| %* |
m
1j
|
m
2j
| %* |
m
1j
|
m
2j
| %* |
Center 1 (n = 57) | 16 | 41 |
28
| 11 | 46 |
19
| 0 | 57 |
0
|
Center 2 (n = 38) | 10 | 28 |
26
| 24 | 14 |
63
| 38 | 0 |
100
|
Center 3 (n = 44) | 11 | 33 |
25
| 7 | 37 |
16
| 0 | 44 |
0
|
Center 4 (n = 15) | 3 | 12 |
20
| 1 | 14 |
7
| 0 | 15 |
0
|
Center 5 (n = 41) | 9 | 32 |
22
| 8 | 33 |
20
| 0 | 41 |
0
|
Center 6 (n = 19) | 5 | 14 |
26
| 10 | 9 |
53
| 19 | 0 |
100
|
Center 7 (n = 37) | 8 | 29 |
22
| 9 | 28 |
24
| 0 | 37 |
0
|
Center 8 (n = 52) | 12 | 40 |
23
| 4 | 48 |
8
| 0 | 52 |
0
|
Center 9 (n = 12) | 3 | 9 |
25
| 1 | 11 |
8
| 0 | 12 |
0
|
Center 10 (n = 28) | 8 | 20 |
29
| 10 | 18 |
36
| 28 | 0 |
100
|
S
| 0.14 | 5.79 | 33.77 | ||||||
Deff
(
ρ
= 0.10)
|
0.91
|
1.48
|
4.28
|