Table 1.
Characteristics of Heart Failure RCTs Published in High‐Impact Journals From 2000 to 2020, Stratified According to Inclusion of PROs (N=417)
| Clinical trial characteristic | No. (%) of RCTs with PROs (n=226) | No. (%) of RCTs without PROs (n=191) | No. (%) of total RCTs (N=417) |
|---|---|---|---|
| Trial size | |||
| Small (≤50) | 52 (23.0) | 82 (42.9) | 134 (32.1) |
| Medium (51–250) | 88 (38.9) | 52 (27.2) | 140 (33.6) |
| Large (>250) | 86 (38.1) | 57 (29.8) | 143 (34.3) |
| Primary outcome results | |||
| Positive | 134 (59.3) | 139 (72.8) | 273 (65.5) |
| Neutral | 92 (40.7) | 52 (27.2) | 144 (34.5) |
| Unit of randomization | |||
| Individual | 223 (98.7) | 190 (99.5) | 413 (99.0) |
| Cluster | 3 (1.3) | 1 (0.5) | 4 (1.0) |
| Type of consent | |||
| Informed consent | 226 (100.0) | 191 (100.0) | 417 (100.0) |
| Region of coordinating center | |||
| Europe | 111 (49.1) | 109 (57.0) | 220 (52.8) |
| North America | 94 (41.6) | 63 (33.0) | 157 (37.6) |
| Asia | 4 (1.8) | 13 (6.8) | 17 (4.1) |
| Australia | 6 (2.7) | 3 (1.6) | 9 (2.2) |
| South America | 11 (4.9) | 3 (1.6) | 14 (3.4) |
| Recruitment | |||
| Inpatient | 54 (23.9) | 45 (23.6) | 99 (23.7) |
| Ambulatory | 172 (76.1) | 146 (76.4) | 318 (76.3) |
| Type of intervention | |||
| Health service | 41 (18.1) | 14 (7.3) | 55 (13.2) |
| Exercise/rehabilitation | 19 (8.4) | 10 (5.2) | 29 (7.0) |
| Pharmaceutical | 117 (51.8) | 156 (81.7) | 273 (65.5) |
| Device | 41 (18.1) | 9 (4.7) | 50 (12.0) |
| Surgery/procedure | 8 (3.5) | 2 (1.0) | 10 (2.4) |
| Scope of trial | |||
| National | 154 (68.1) | 143 (74.9) | 297 (71.2) |
| International | 72 (31.9) | 48 (25.1) | 120 (28.8) |
| Type of funding | |||
| Industry* | 123 (54.4) | 99 (51.8) | 222 (53.2) |
| Public | 103 (45.6) | 92 (48.2) | 195 (46.8) |
| No. of centers | |||
| Multicenter | 152 (67.3) | 92 (48.2) | 244 (58.5) |
| Single center | 74 (32.7) | 99 (51.8) | 173 (41.5) |
| Gender* of the lead author | |||
| Man | 189 (83.6) | 162 (84.8) | 351 (84.2) |
| Woman | 37 (16.4) | 29 (15.2) | 66 (15.8) |
| Gender* of the senior author | |||
| Man | 201 (88.9) | 170 (89.0) | 371 (89.0) |
| Woman | 25 (11.1) | 21 (11.0) | 46 (11.0) |
| Year of publication | |||
| 2000–2003 | 46 (20.4) | 77 (40.3) | 123 (29.5) |
| 2004–2007 | 51 (22.6) | 55 (28.8) | 106 (25.4) |
| 2008–2011 | 31 (13.7) | 17 (8.9) | 48 (11.5) |
| 2012–2015 | 40 (17.7) | 13 (6.8) | 53 (12.7) |
| 2016–2020 | 58 (25.7) | 29 (15.2) | 87 (20.9) |
| Trial registration | |||
| Yes | 125 (55.3) | 54 (28.3) | 179 (42.9) |
PRO indicates patient‐reported outcome; and RCT, randomized controlled trial.
*
We classified trials that received partial or full industry funding as industry‐funded trials. Gender was obtained from online resources.