| |
Yes |
No |
Not reported or unclear |
| Reporting of research objectives |
| Specific hypothesis |
4 |
10 |
13 |
| Statistical significance and clinical relevance |
|
|
| Multiple domains |
17 |
10 |
0 |
| If yes, was statistical correction used? |
0 |
3 |
14 |
| Repeated assessments |
24 |
3 |
0 |
| If yes, was a statistical technique used that allowed the inclusion of repeated assessment points, or was a statistical correction used? |
16 |
7 |
1 |
| Reporting of descriptive data |
17 |
10 |
0 |
| Primary statistical method |
|
|
|
| Linear mixed models |
7 |
NA |
NA |
| Wilcoxon rank-sum test or t-test |
6 |
NA |
NA |
| ANOVA or linear regression |
2 |
NA |
NA |
| Time to event |
2 |
NA |
NA |
| Repeated measures ANOVA |
2 |
NA |
NA |
| Proportion of patients or responder analysis |
1 |
NA |
NA |
| Others |
3 |
NA |
NA |
| Unreported or unclear |
4 |
NA |
NA |
| Reporting of clinical relevance |
6 |
21 |
0 |
| Change of X points from baseline |
4 |
NA |
NA |
| X points difference between arms |
1 |
NA |
NA |
| Change of X points from baseline and X points difference between arms |
1 |
NA |
NA |
| Baseline assessment |
|
|
|
| Assessed baseline |
24 |
2 |
1 |
| Compared baseline scores between treatments |
7 |
17 |
0 |
| Included baseline as a covariate |
12 |
11 |
1 |
| Assessing the prevalence and handling of missing data |
|
| Intention-to-treat population |
5 |
18 |
4 |
| Baseline compliance rates for each treatment arm |
16 |
11 |
NA |
| Follow-up compliance rates for each treatment arm |
20 |
7 |
NA |
| Strategy to handle missing data |
16 |
11 |
NA |
