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 | Â | Â | Â | 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 | Â | Â | Â | 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 | Â | Â | Â | Â |
   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 | Â | Â | Â | Â |
   Primary analysis | 2 | 5 |  |  |
   Secondary/sensitivity analysis | 5 | 5 |  |  |
Type of outcomes | Â | Â | Â | 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 |