No. of clusters randomised (N = 86)
|
4–10
|
2
|
2
|
77 (121)
|
44
|
7–922
|
25–74
|
11–20
|
11
|
13
| | | | |
21–50
|
40
|
47
| | | | |
51–100
|
21
|
24
| | | | |
101–200
|
5
|
6
| | | | |
> 200
|
7
|
8
| | | | |
No. of clusters analysed (N = 86)
|
0–10
|
2
|
2
|
76 (118)
|
43
|
7–864
|
25–69
|
11–20
|
12
|
14
| | | | |
21–50
|
40
|
47
| | | | |
51–100
|
21
|
24
| | | | |
101–200
|
4
|
5
| | | | |
> 200
|
7
|
8
| | | | |
No. of subjects recruited (N = 84b)
|
≤ 300
|
7
|
8
|
15,348 (48315)
|
1184
|
141–265,434
|
597–3653
|
301–600
|
14
|
17
| | | | |
601–900
|
11
|
13
| | | | |
901–1200
|
9
|
11
| | | | |
1201–1500
|
9
|
11
| | | | |
1501–1800
|
3
|
4
| | | | |
> 1800
|
29
|
34
| | | | |
Not reported
|
2
|
2
| | | | |
No. of subject analysed (N = 84b)
|
≤ 300
|
15
|
18
|
14,367 (48419)
|
870
|
42–264,325
|
441–2356
|
301–600
|
15
|
18
| | | | |
601–900
|
13
|
15
| | | | |
901–1200
|
5
|
6
| | | | |
1201–1500
|
5
|
6
| | | | |
1501–1800
|
2
|
2
| | | | |
> 1800
|
25
|
30
| | | | |
Not reported
|
4
|
5
| | | | |
Planned ICC for sample size (N = 86)
|
0.00–0.02
|
18
|
21
|
0.065 (0.082)
|
0.05
|
0.0002–0.5
|
0.0258–0.0700
|
> 0.02–0.05
|
33
|
38
| | | | |
> 0.05–0.08
|
9
|
11
| | | | |
> 0.08–0.11
|
8
|
9
| | | | |
> 0.11–0.14
|
2
|
2
| | | | |
> 0.14
|
6
|
7
| | | | |
Not reported
|
10
|
12
| | | | |
Planned design effect (N = 86)
|
0.00–2.99
|
47
|
55
|
4.5 (8.90)
|
1.96
|
1.03–70.5
|
1.384–4.600
|
3.00–5.99
|
12
|
14
| | | | |
6.00–8.99
|
10
|
12
| | | | |
9.00–11.99
|
1
|
1
| | | | |
≥ 12
|
3
|
3
| | | | |
Not reported
|
13
|
15
| | | | |
Observed ICC of analysed primary outcome (N = 100)
|
− 0.02 to 0.02
|
35
|
35
|
0.06 (0.12)
|
0.02
|
-0.02 to 0.63
|
0.0010–0.0600
|
> 0.02–0.07
|
9
|
9
| | | | |
> 0.07–0.12
|
3
|
3
| | | | |
> 0.12–0.17
|
6
|
6
| | | | |
> 0.17–0.22
|
2
|
2
| | | | |
> 0.22
|
3
|
3
| | | | |
Not reported
|
42
|
42
| | | | |