|
Jadad score (possible range of 0–5; higher scores indicate lower likelihood of bias)
|
0
|
2 (1.4%)
|
1 (1.1%)
|
|
1
|
26 (18.8%)
|
22 (23.9%)
|
|
2
|
44 (31.9%)
|
32 (34.8%)
|
|
3
|
66 (47.8%)
|
37 (40.2%)
|
|
Allocation sequence adequately generated
|
Low risk
|
75 (53.2%)
|
44 (47.3%)
|
|
High risk
|
3 (2.1%)
|
1 (1.1%)
|
|
Unclear
|
63 (44.7%)
|
48 (51.6%)
|
|
Allocation sequence adequately concealed
|
Low risk
|
30 (21.3%)
|
18 (19.3%)
|
|
High risk
|
3 (2.1%)
|
1 (1.1%)
|
|
Unclear
|
108 (76.6%)
|
74 (79.6%)
|
|
Randomisation after consent obtained
|
Low risk
|
116 (82.3%)
|
23 (24.7%)
|
|
High risk
|
6 (4.3%)
|
39 (41.9%)
|
|
Unclear / NA
|
19 (13.5%)
|
31 (33.3%)
|
|
Randomisation after baseline measures were completed
|
Low risk
|
56 (39.7%)
|
15 (16.1%)
|
|
High risk
|
14 (9.9%)
|
41 (44.1%)
|
|
Unclear
|
71 (50.4)
|
37 (39.8%)
|
|
Baseline outcome measurements similar across trial arms
|
Low risk
|
109 (77.3%)
|
70 (75.3%)
|
|
High risk
|
9 (6.4%)
|
11 (11.8%)
|
|
Unclear / NA
|
23 (16.3%)
|
12 (12.9%)
|
|
Baseline demographic characteristics similar across trial arms
|
Low risk
|
121 (85.8%)
|
69 (74.2%)
|
|
High risk
|
3 (2.1%)
|
18 (19.4%)
|
|
Unclear / NA
|
17 (12.1%)
|
6 (6.5%)
|
|
Knowledge of allocation adequately concealed
|
Low risk
|
0 (0%)
|
0 (0%)
|
|
High risk
|
141 (100%)
|
93 (100%)
|
|
Blinded outcome assessment
|
Low risk
|
63 (44.7%)
|
29 (31.2%)
|
|
High risk
|
8 (5.7%)
|
17 (18.3%)
|
|
Unclear / NA
|
70 (49.6%)
|
47 (50.5%)
|
|
Incomplete outcome data
|
Low risk
|
35 (24.8%)
|
22 (23.7%)
|
|
High risk
|
82 (58.2%)
|
57 (61.3)
|
|
Unclear / NA
|
24 (17.0%)
|
14 (15.1%)
|
|
Similar attrition between trial arms
|
Low risk
|
85 (60.3%)
|
51 (54.8%)
|
|
High risk
|
30 (21.3%)
|
25 (26.9%)
|
|
Unclear / NA
|
26 (18.4%)
|
17 (18.3%)
|
