Table 1.
Trial Characteristics
| Characteristic | N (% of total) | N (% of total with the characteristic) | |
|---|---|---|---|
|
| |||
| Total (N = 294) | Reported a DSMB in the manuscript | DSMB identified via any method* | |
|
| |||
| Journal | |||
| Annals of Internal Medicine | 8 (3) | 1/8 (13) | 4/8 (50) |
| BMJ | 13 (4) | 7/13 (54) | 8/13 (62) |
| JAMA | 71 (24) | 49/71 (69) | 62/71 (87) |
| JAMA Internal Medicine | 10 (3) | 0/10 (0) | 6/10 (60) |
| Lancet | 69 (23) | 41/69 (59) | 50/69 (72) |
| New England Journal of Medicine | 123 (42) | 77/123 (63) | 107/123 (87) |
|
| |||
| Sponsor | |||
| Industry | 169 (57) | 98/169 (58) | 136/169 (80) |
| Other | 125 (43) | 77/125 (62) | 101/125 (81) |
|
| |||
| Intervention type | |||
| Non-invasive pharmacologic | 103 (35) | 65/103 (63) | 84/103 (82) |
| Invasive pharmacologic | 50 (17) | 33/50 (66) | 42/50 (84) |
| Surgical | 11 (4) | 8/11 (73) | 10/11 (91) |
| Invasive device | 12 (4) | 5/12 (42) | 10/12 (83) |
| Non-invasive device | 6 (2) | 3/6 (50) | 3/6 (50) |
| Radiologic | 4 (1) | 3/4 (75) | 4/4 (100) |
| Biologic | 19 (6) | 11/19 (58) | 16/19 (84) |
| Psychological/Behavioral | 12 (4) | 6/12 (50) | 10/12 (83) |
| Physical therapy | 5 (2) | 3/5 (60) | 3/5 (60) |
| Dietary | 6 (2) | 4/6 (67) | 5/6 (83) |
| Other | 66 (22) | 34/66 (52) | 50/66 (76) |
|
| |||
| Number of sites | |||
| Multi-site | 263 (90) | 165/263 (63) | 219/263 (83) |
| Single-site | 27 (9) | 9/27 (33) | 16/27 (59) |
| Unclear | 4 (1) | 1/4 (25) | 2/4 (50) |
|
| |||
| Longest follow-up duration | |||
| < 3 months | 47 (16) | 27/47 (57) | 31/47 (66) |
| 3 months – 1 year | 127 (43) | 68/127 (54) | 96/127 (76) |
| >1 year – 5 years | 98 (33) | 68/98 (69) | 92/98 (94) |
| >5 years | 22 (7) | 12/22 (55) | 18/22 (82) |
|
| |||
| Number randomized | |||
| <100 | 12 (4) | 8/12 (67) | 9/12 (75) |
| 100–499 | 134 (46) | 72/134 (54) | 102/134 (76) |
| 500–999 | 70 (24) | 41/70 (59) | 59/70 (84) |
| >=1000 | 78 (27) | 54/78 (69) | 67/78 (86) |
|
| |||
| Blinding | |||
| Double-blind | 129 (44) | 78/129 (60) | 105/129 (81) |
| Patient and/or assessor blinded only | 99 (34) | 56/99 (57) | 77/99 (78) |
| None reported | 66 (22) | 41/66 (62) | 55/66 (83) |
|
| |||
| Vulnerable participant population | |||
| Yes | 68 (23) | 48/68 (71) | 55/68 (81) |
| Children | 43 (15) | 28/43 (65) | 32/43 (74) |
| Pregnant women | 9 (3) | 7/9 (78) | 8/9 (89) |
| Cognitively impaired | 15 (5) | 13/15 (87) | 14/15 (93) |
| Pregnant women and children | 1 (0.3) | — | 1/1 (100) |
| No | 226 (77) | 175/226 (77) | 182/226 (81) |
|
| |||
| Trial stopped earlier than planned | |||
| Yes | 58 (20) | 50/58 (86) | 54/58 (93) |
| No | 236 (80) | 125/236 (53) | 183/236 (78) |
Sponsor “other”: Studies that received no funding or donation of study treatment from industry; other sources included government agency, academic institution/departmental funds, or professional foundation
Intervention type “other”: multiple intervention types, induced hypothermia, different care protocols, care coordination
*
DMC/DSMB searched for on registries (e.g., clinicaltrials.gov), published protocols, and personal correspondence; 7 articles remained with no data pertaining to whether a DSMB was present.