Table 3 Data analysis and missing data
Trials with flow diagrams (240) | Trials without flow diagrams (330) | p value | |
|---|---|---|---|
Strategy for primary analysis | n (%) | n (%) | |
Intention-to-treat | 81 (34%) | 23 (7%) | < 0.0001 |
Modified intention-to-treat | 3 (1%) | 4 (1%) | 1 |
Per-protocol | 15 (6%) | 1 (0%) | < 0.0001 |
Not mentioned | 141 (59%) | 302 (92%) | < 0.0001 |
Handling of missing outcome data | |||
Not mentioned | 207 (86%) | 309 (94%) | 0.001 |
Excluded from analysis | 15 (6%) | 14 (4%) | 0.27 |
Imputed | 14 (6%) | 3 (1%) | 0.0007 |
Last observation carried forward | 4 (2%) | 4 (1%) | 0.32 |
Reasons for post-randomisation exclusions | |||
Non-adherence to the protocola | 90 (35%) | 106 (32%) | N/A |
None excluded | 81 (32%) | 43 (13%) | N/A |
Withdrawal of consent incl. dropouts/attrition | 79 (31%) | 38 (12%) | N/A |
Did not receive intervention | 51 (20%) | 26 (8%) | N/A |
Intractable pain/non-protocolled analgesicsb | 34 (13%) | 44 (13%) | N/A |
Wrongful inclusion | 25 (10%) | 12 (4%) | N/A |
No outcome data | 24 (9%) | 19 (6%) | N/A |
Group size too small to analyse | 1 (0%) | 0 (0%) | N/A |
Not mentioned | 0 (0%) | 147 (45%) | N/A |