Trial characteristics | PC-RCTs | ST-RCTs |
---|---|---|
N = 230 | N = 384 | |
Year of publication, median (IQR) | 2003 (1994–2010) | 2005 (1996–2011) |
Sample size, median (IQR) | 276 (146–561.5) | 139 (166–284.3) |
Number of centers, median (IQR) | 13 (3–40.5) | 1 (1–3) |
Medical fields | ||
Psychiatry/Addictology | 109 (47.4) | 184 (47.9) |
Pneumology | 15 (6.5) | 66 (17.2) |
Ear nose and throat | 12 (5.2) | 12 (3.1) |
Cardiology | 9 (3.9) | 15 (3.9) |
Dermatology | 6 (2.6) | 11 (2.9) |
Pediatrics | 11 (4.8) | 21 (5.5) |
Infectious diseases | 8 (3.5) | 4 (1.1) |
Others | 60 (26.1) | 71 (18.5) |
Intervention in experimental group, n (%) | ||
Pharmacological | 79 (34.3) | 171 (44.5) |
Non-pharmacological | 151 (65.7) | 213 (55.5) |
Intervention in control group, n (%) | ||
Active comparator | 35 (15.2) | 78 (20.3) |
Placebo | 29 (12.6) | 39 (10.2) |
No added intervention (i.e., usual care) | 115 (50.0) | 188 (49.0) |
Sham comparator | 2 (0.9) | 2 (0.5) |
Other | 49 (21.3) | 77 (20.0) |
Outcome objectivity, n (%) | ||
All-cause mortality | 3 (1.3) | 32 (8.3) |
Objectively assessed | 55 (23.9) | 48 (12.5) |
Objectively assessed but influenced by clinician or patient | 95 (41.3) | 170 (44.3) |
Subjectively assessed | 75 (32.6) | 132 (34.4) |
Unclear | 2 (0.9) | 2 (0.5) |
Cochrane Risk of Bias tool, n (%) | ||
Random sequence generation | ||
Low | 120 (57.4) | 197 (57.4) |
High | 11 (5.3) | 11 (3.2) |
Unclear | 78 (37.3) | 135 (39.4) |
Allocation concealment | ||
Low | 116 (50.4) | 165 (43.0) |
High | 21 (9.1) | 26 (6.8) |
Unclear | 93 (40.4) | 193 (50.3) |
Blinding of participants and personnel | ||
Low | 68 (45.6) | 74 (30.1) |
High | 33 (22.2) | 62 (25.2) |
Unclear | 48 (32,2) | 110 (44.7) |
Blinding of outcome assessors | ||
Low | 61 (62.9) | 83 (43.4) |
High | 14 (14.4) | 50 (26.2) |
Unclear | 22 (22.7) | 58 (30.4) |
Incomplete data outcome | ||
Low | 135 (64.3) | 215 (62.7) |
High | 34 (16.2) | 53 (15.4) |
Unclear | 41 (19.5) | 75 (21.9) |
Selective reporting | ||
Low | 85 (63.9) | 144 (58.5) |
High | 9 (6.8) | 23 (9.4) |
Unclear | 39 (29.3) | 79 (32.1) |