|
Ethic committee study approval
|
9 (69.2)
|
23 (82.1)
|
33 (84.6)
|
.470b
|
65 (81.2)
|
|
Details about ethic committee
|
6 (46.2)
|
13 (46.4)
|
22 (56.4)
|
.667c
|
41 (51.2)
|
|
Consent
|
11 (84.6)
|
26 (92.9)
|
37 (94.9)
|
.443b
|
74 (92.5)
|
|
Details about the consent process
|
4 (30.8)
|
16 (57.1)
|
22 (56.4)
|
.245b
|
42 (52.5)
|
|
Assessment of reduced cognitive competence
|
3 (23.1)
|
18 (64.3)
|
20 (51.3)
|
.049b
|
41 (51.2)
|
|
Incentives or compensation, and details
|
0 (0.0)
|
0 (0.0)
|
3 (7.7)
|
.278b
|
3 (3.8)
|
|
Funders and details
|
10 (76.9)
|
20 (71.4)
|
26 (66.7)
|
.848b
|
56 (70.0)
|
|
Potential conflicts of interest
|
3 (23.1)
|
8 (28.6)
|
30 (76.9)
|
<.001b
|
41 (51.2)
|
|
Statement about sample size estimates
|
5 (38.5)
|
8 (28.6)
|
17 (43.6)
|
.455c
|
30 (37.5)
|
|
Performing of power calculations
|
5 (38.5)
|
7 (25.0)
|
15 (38.5)
|
.478c
|
27 (33.8)
|
|
Appropriateness of comparators
|
10 (76.9)
|
24 (85.7)
|
34 (87.2)
|
.638b
|
68 (85.0)
|
|
Matching of comparators
|
11 (84.6)
|
19 (67.9)
|
30 (76.9)
|
.509b
|
60 (75.0)
|
|
Potential harm for participants
|
1 (7.7)
|
6 (21.4)
|
10 (25.6)
|
.470b
|
17 (21.2)
|
|
Reporting presence/absence of adverse events
|
4 (30.8)
|
7 (25.0)
|
20 (51.3)
|
.081b
|
31 (38.8)
|
|
Accordance with the Helsinki declaration.
|
0 (0.0)
|
3 (10.7)
|
6 (15.4)
|
.403b
|
9 (11.2)
|
|
Number of ethics-related issues reporteda
|
7.5 (1.6)
|
8.5 (2.3)
|
9.9 (2.9)
|
.009d
|
9.0 (2.6)
|
