Criterion | Item no. | No. (%) of trials in which the item was clearly reported | P value | ||
---|---|---|---|---|---|
 |  | All (n = 6994) | Before 2010 (n = 4133) | After 2010 (n = 2861) |  |
Title and abstract | 1a | 56 (0.80) | 23 (0.56) | 33 (1.15) | 0.006 |
 | 1b | 5852 (83.67) | 3505 (84.81) | 2347 (82.03) | 0.002 |
Background and objectives | 2a | 2028 (29.00) | 1021 (24.71) | 1007 (35.20) | <0.001 |
 | 2b | 410 (5.86) | 263 (6.36) | 147 (5.14) | 0.032 |
Trial design | 3a | 277 (3.96) | 184 (4.45) | 93 (3.25) | 0.011 |
Participants | 4a | 3925 (56.12) | 2058 (49.79) | 1867 (65.26) | <0.001 |
 | 4b | 4938 (70.60) | 2664 (64.46) | 2274 (79.48) | <0.001 |
Interventions | 5 | 5699 (81.48) | 3342 (80.86) | 2357 (82.38) | 0.107 |
Outcomes | 6a | 6176 (88.30) | 3626 (87.73) | 2550 (89.13) | 0.074 |
Sample size | 7a | 20 (0.29) | 8 (0.19) | 12 (0.42) | 0.082 |
Sequence generation | 8a | 1137 (16.26) | 569 (13.77) | 568 (19.85) | <0.001 |
 | 8b | 117 (1.67) | 78 (1.89) | 39 (1.36) | 0.093 |
Allocation concealment mechanism | 9 | 48 (0.69) | 30 (0.73) | 18 (0.63) | 0.63 |
Implementation | 10 | 36 (0.51) | 31 (0.75) | 5 (0.17) | 0.001 |
Blinding | 11a | 268 (3.83) | 197 (4.77) | 71 (2.48) | <0.001 |
 | 11b | 8 (0.11) | 5 (0.12) | 3 (0.10) | 1.000 |
Statistical methods | 12a | 4686 (67.00) | 2604 (63.00) | 2082 (72.77) | <0.001 |
Flow diagram | 13a | 20 (0.29) | 11 (0.27) | 9 (0.31) | 0.709 |
 | 13b | 246 (3.52) | 141 (3.41) | 105 (3.67) | 0.564 |
Recruitment | 14a | 5198 (74.32) | 2899 (70.14) | 2299 (80.36) | <0.001 |
Baseline data | 15 | 445 (6.36) | 232 (5.61) | 213 (7.44) | 0.002 |
Numbers analyzed | 16 | 127 (1.82) | 80 (1.94) | 47 (1.64) | 0.367 |
Outcomes and estimation | 17a | 89 (1.27) | 58 (1.40) | 31 (1.08) | 0.241 |
 | 17b | 21 (0.30) | 8 (0.19) | 13 (0.45) | 0.050 |
Harms | 19 | 1830 (26.17) | 1096 (26.52) | 734 (25.66) | 0.42 |
Limitations | 20 | 572 (8.18) | 356 (8.61) | 216 (7.55) | 0.11 |
Generalizability | 21 | 187 (2.67) | 115 (2.78) | 72 (2.52) | 0.498 |
Interpretation | 22 | 6473 (92.55) | 3806 (92.09) | 2667 (93.22) | 0.077 |
Registration | 23 | 1 (0.01) | 0 (0) | 1 (0.03) | 0.853 |
Protocol | 24 | 1 (0.01) | 0 (0) | 1 (0.03) | 0.853 |
Funding | 25 | 413 (5.91) | 270 (6.53) | 143 (5.00) | 0.007 |