Table 1.
Comparison of reporting of design factors, statistical analysis and reporting of efficacy and safety outcomes across all three data sources
| Key information based on reporting of design aspects and statistical analysis, and reporting of efficacy and safety sections | CSR (N = 35) | Trial registry (N = 34) | Journal Publication(s) (N = 33) |
|---|---|---|---|
| Method and design | |||
| Randomisation | 30 (86%) | 0 (0%) | 21 (64%) |
| Allocation concealment | 28 (80%) | 1 (3%) | 11 (33%) |
| Blinding | 35 (100%) | 2 (6%) | 19 (58%) |
| Sample size calculation | 32 (91%) | 1 (3%) | 17 (52%) |
| Inclusion criteria specified | 35 (100%) | 32 (94%) | 32 (97%) |
| Definition of causality provided | 30 (86%) | 1 (3%) | 5 (15%) |
| Intervention and comparator | |||
| Intervention used | 35 (100%) | 30 (88%) | 33 (100%) |
| Dose and delivery | 35 (100%) | 10 (29%) | 27 (82%) |
| Placebo pill explained (i.e. visual detail) | 27 (77%) | 1 (3%) | 9 (27%) |
| Outcomes | |||
| Primary outcome specified | 35 (100%) | 30 (88%) | 25 (76%) |
| Secondary outcomes specified | 35 (100%) | 29 (85%) | 20 (61%) |
| HRQoL measured (i.e. SQLS or sleep quality) | 26 (74%) | 3 (9%) | 9 (27%) |
| Symptoms (depression or suicidality) | 34 (97%) | 1 (3%) | 5 (15%) |
| Safety | |||
| AEs | 35 (100%) | 10 (29%) | 29 (88%) |
| SAEs | 35 (100%) | 17 (49%) | 20 (61%) |
| Discontinuation due to AEs | 33 (94%) | 9 (26%) | 20 (61%) |
| Reason for withdrawal | 31 (89%) | 1 (3%) | 11 (33%) |
| Death | 35 (100%) | 9 (26%) | 29 (88%) |
| Reason for death | 35 (100%) | 33 (97%) | 30 (91%) |
CSR clinical study reports, HRQoL health-related quality of life, SQLS sleep quality of life survey, AEs adverse events, SAEs serious adverse events