Year of publication |
2000 (n = 84)* |
2006 (n = 113)* |
% difference (95% CI) | P-value |
---|---|---|---|---|
Performed adjusted analysis on primary outcome† | 50 (90.9%) | 93 (93.9%) | 30.0 (-5.9 to 12.0) | 0.5 |
Reason for adjustment | 0.4 | |||
Imbalance in covariates | 9 (10.7%) | 12 (10.6%) | ||
Prognostic covariates | 6 (7.1%) | 15 (13.3%) | ||
Both | 0 | 3 (2.6%) | ||
Other reasons ‡ | 3 (3.6%) | 4 (3.5%) | ||
Not mentioned | 66 (78.6%) | 79 (69.9%) | ||
Choice of covariates | 0.5 | |||
All pre-specified | 5 (5.9%) | 8 (7.1%) | ||
All suggested by data | 12 (14.3%) | 20 (17.7%) | ||
Combination of pre-specified and post hoc | 0 | 3 (2.6%) | ||
Not mentioned | 67 (79.8%) | 82 (72.6%) | ||
Number of covariates adjusted for § | 0.02 || | |||
1 | 39 (46.4%) | 36 (31.8%) | ||
2 | 23 (27.4%) | 33 (29.2%) | ||
3-5 | 14 (16.7%) | 25 (22.1%) | ||
6-9 | 2 (2.4%) | 12 (10.6%) | ||
Not mentioned | 6 (7.1%) | 7 (6.2%) | ||
Covariate used for adjustment | ||||
Outcome assessed at baseline | 33/62 (53.2%) | 55/81 (67.9%) | 14.7 (-1.4 to 30.7) | 0.07 |
Centre/Country | 31/49 (63.3%) | 25/61 (41.0%) | -22.3 (-40.6 to -39.9) | 0.02 |
Assessed after randomisation | 9/78 (11.8%) | 9/107 (8.4%) | -3.1 (-12.0 to 5.7) | 0.5 |
All stratification factors were adjusted for | 11/25 (44.0%) | 20/46 (43.5%) | -0.5 (-24.7 to 23.6) | 1.0 |
Explicitly specified nature of analysis | ||||
Primary analysis | 2 | 5 | ||
Secondary/sensitivity analysis | 5 | 5 | ||
Type of outcomes | 0.8 | |||
Binary | 13 (15.5%) | 19 (16.8%) | ||
Continuous | 65 (77.4%) | 81 (71.7%) | ||
Ordinal | 1 (1.2%) | 3 (2.6%) | ||
Time-to-event | 5 (5.9%) | 10 (8.9%) | ||
Adjusted analysis method used was mentioned for specific outcome in the Method section | 62/78 ¶(79.5%) | 88/109 ¶ (80.7%) | 1.2 (-10.4 to 12.9) | 0.8 |