Characteristics of arthroplasty trials by journal type and year of publication. Values are n (%)
| Characteristic | Journal Type | Publication Year | ||||
|---|---|---|---|---|---|---|
| Orthopedics/surgery Journal, n = 125 | Anesthesia, n = 34 | Internal Medicine, n = 27 | Other/Rehab, n = 10 | 1997, n = 67 | 2006, n = 129 | |
| Randomization | ||||||
| Generation of allocation sequence | p = 0.146 | p = 0.155 | ||||
| Adequate | 49 (39) | 21 (62) | 11 (41) | 4 (40) | 23 (34) | 62 (48) |
| Inadequate | 13 (10) | 0 (0) | 0 (0) | 0 (0) | 3 (5) | 10 (8) |
| Not reported | 61 (49) | 13 (38) | 16 (59) | 6 (60) | 40 (60) | 56 (43) |
| Allocation concealment | p = 0.586 | p = 0.008 | ||||
| Adequate | 42 (34) | 17 (50) | 13 (48) | 4 (40) | 16 (24) | 60 (47) |
| Inadequate | 4 (3) | 1 (3) | 1 (4) | 0 (0) | 2 (3) | 4 (3) |
| Not reported | 79 (62) | 16 (47) | 13 (48) | 6 (60) | 49 (73) | 65 (50) |
| Intervention reproducible | p = 0.774 | p = 0.999 | ||||
| Adequate | 120 (96) | 34 (100) | 26 (96) | 10 (100) | 65 (97) | 125 (97) |
| Inadequate | 5 (4) | 0 (0) | 1 (4) | 0 (0) | 2 (3) | 4 (3) |
| CONSORT diagram reported | p < 0.001 | p = 0.008 | ||||
| Adequate | 3 (3) | 7 (21) | 8 (30) | 2 (20) | 1 (3) | 19 (15) |
| Not reported | 122 (97) | 27 (79) | 19 (70) | 8 (80) | 66 (97) | 110 (85) |
| Control intervention | p < 0.001 | p = 0.196 | ||||
| Placebo | 11 (9) | 12 (35) | 10 (37) | 3 (30) | 15 (22) | 21 (16) |
| No placebo | 114 (91) | 22 (65) | 17 (63) | 7 (70) | 52 (78) | 108 (84) |
| Influence of care provider skill | p = 0.766 | p = 0.432 | ||||
| Yes | 2 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (2) |
| No | 123 (98) | 34 (100) | 27 (100) | 10 (100) | 67 (100) | 127 (98) |
| Potential similar placebo effect | p = 0.054 | p < 0.001 | ||||
| Adequate | 75 (60) | 28 (82) | 18 (67) | 4 (40) | 30 (45) | 95 (74) |
| Inadequate | 8 (6) | 2 (6) | 1 (4) | 1 (10) | 6 (9) | 6 (5) |
| Not reported* | 42 (34) | 4 (12) | 8 (30) | 5 (50) | 31 (46) | 28 (22) |
| Blinding | ||||||
| Patients | p = 0.008 | p = 0.769 | ||||
| Adequate | 26 (21) | 17 (50) | 14 (52) | 3 (30) | 23 (34) | 37 (29) |
| Inadequate | 4 (3) | 3 (9) | 1 (4) | 0 (0) | 2 (3) | 6 (5) |
| Not reported* | 95 (76) | 14 (41) | 12 (44) | 7 (70) | 42 (63) | 86 (67) |
| Care providers | p < 0.001 | p = 0.017 | ||||
| Adequate | 9 (7) | 13 (38) | 9 (33) | 2 (20) | 16 (24) | 17 (13) |
| Inadequate | 84 (67) | 15 (44) | 5 (19) | 2 (20) | 27 (40) | 79 (61) |
| Not reported | 32 (26) | 6 (18) | 13 (48) | 6 (60) | 24 (36) | 33 (26) |
| Outcome assessors | p = 0.168 | p < 0.001 | ||||
| Adequate | 50 (40) | 18 (53) | 17 (63) | 4 (40) | 32 (48) | 57 (44) |
| Inadequate | 8 (6) | 4 (12) | 0 (0) | 1 (10) | 4 (6) | 9 (7) |
| Not reported | 67 (54) | 12 (35) | 10 (37) | 5 (50) | 31 (46) | 63 (49) |
| Were Adverse Events Reported | p = 0.980 | p = 0.487 | ||||
| Adequate | 70 (56) | 21 (62) | 15 (56) | 5 (50) | 35 (52) | 76 (59) |
| Inadequate | 54 (43) | 13 (38) | 12 (44) | 5 (50) | 32 (48) | 52 (40) |
| Not reported | 1 (1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1) |
| Sample size justification/power reported | p = 0.110 | p = 0.013 | ||||
| Adequate | 37 (30) | 17 (50) | 12 (44) | 4 (40) | 16 (24) | 54 (42) |
| Not reported | 88 (70) | 17 (50) | 15 (56) | 6 (60) | 51 (76) | 75 (58) |
| Statistical Analysis | p = 0.061 | p = 0.935 | ||||
| Described as ITT or modified ITT | 8 (6) | 4 (12) | 6 (22) | 2 (20) | 7 (10) | 13 (10) |
| Not described as ITT or modified ITT | 117 (94) | 30 (88) | 21 (78) | 8 (80) | 60 (90) | 116 (90) |
| Lost to followup < 20 | p = 0.129 | p = 0.435 | ||||
| Adequate | 63 (50) | 19 (56) | 13 (48) | 4 (40) | 30 (45) | 69 (54) |
| Inadequate | 10 (8) | 2 (6) | 7 (26) | 1 (10) | 4 (6) | 16 (12) |
| Not reported | 52 (42) | 13 (38) | 7 (26) | 5 (50) | 33 (49) | 44 (34) |
↵* Combination of not reported and not applicable. CONSORT: Consolidated Standards of Reporting Trials10; ITT: intention to treat.