Table 1 Descriptive data for interventional and observational trials listed in registries
From: Publication and non-publication of clinical trials in PTSD: an overview
Variable | Total | Interventional | Observational | |
|---|---|---|---|---|
|  |  | n = 438 | n = 380 | n = 58 |
Number enrolled, Mdn (IQR) | 70 (36; 133) | 62 (33; 120) | 209 (78; 500) | |
Duration of study (months), Mdn (IQR) | 29 (16; 45) | 31 (16; 47) | 26 (13; 36) | |
Gender, n (%) | ||||
| Â | Male only | 35 (8) | 30 (8) | 5 (9) |
| Â | Female only | 54 (12) | 49 (13) | 5 (9) |
| Â | Both | 348 (80) | 300 (79) | 48 (83) |
Age group | ||||
| Â | Adult | 383 (87) | 331 (87) | 52 (89) |
| Â | Child | 37 (8) | 33 (9) | 4 (6) |
| Â | Both | 18 (4) | 16 (4) | 2 (3) |
Any control condition used, n (%) (e.g. waitlist, placebo) | 354 (81) | 339 (89) | 15 (26) | |
Comparator used | 136 (31) | 127 (33) | 9 (16) | |
Randomisation, n (%) | Â | Â | Â | n/a |
| Â | Randomised | Â | 326 (86) | Â |
| Â | Non-randomised | Â | 21 (6) | Â |
| Â | Single group | Â | 28 (7) | Â |
| Â | Unclear | Â | 5 (1) | Â |
Blinding | Â | Â | Â | n/a |
| Â | Double blind | Â | 103 (27) | Â |
| Â | Single blind | Â | 108 (28) | Â |
| Â | Open label | Â | 132 (35) | Â |
| Â | Unclear | Â | 37 (10) | Â |
Intervention type, n (%) | Â | Â | Â | n/a |
| Â | Drug | Â | 85 (22) | Â |
| Â | Behavioural | Â | 247 (65) | Â |
| Â | Drug and behavioural | Â | 25 (7) | Â |
| Â | Procedure/device | Â | 23 (6) | Â |
Number of study arms, n (%) | Â | Â | Â | |
| Â | One | 73 (17) | 40 (11) | 33 (57) |
| Â | Two | 294 (67) | 278 (73) | 16 (28) |
| Â | Three to six | 71 (16) | 62 (16) | 9 (16) |
Actual vs planned enrolment, n (%) | ||||
| Â | More than planned | 71 (16) | 57 (15) | 14 (24) |
| Â | Less than planned | 171 (43) | 150 (37) | 21 (36) |
| Â | No difference | 187 (39) | 168 (44) | 19 (33) |
Status of main sponsor, n (%) | ||||
| Â | University | 176 (40) | 164 (43) | 12 (21) |
| Â | Hospital | 93 (21) | 76 (20) | 17 (29) |
| Â | Governmental organisation | 114 (26) | 90 (24) | 24 (41) |
| Â | Non-commercial (e.g. NGO) | 47 (11) | 44 (12) | 3 (5) |
| Â | Pharmaceutical/industry | 8 (2) | 6 (2) | 2 (3) |
Any secondary sponsors listed, n (%) | 209 (48) | 193 (51) | 16 (28) | |
Any sponsor university | 199 (45) | 183 (48) | 16 (28) | |
Any sponsor hospital | 106 (24) | 89 (23) | 17 (30) | |
Any sponsor governmental organisation | 231 (53) | 200 (53) | 31 (54) | |
Any sponsor non-commercial | 72 (17) | 67 (18) | 5 (9) | |
Any sponsor pharmaceutical/industry | 34 (8) | 29 (8) | 5 (9) | |
Contact email provided, n (%) | 188 (43) | 172 (45) | 16 (28) | |
Registered before 2006, n (%) | 97 (22) | 81 (21) | 16 (28) | |
Study registered before started, n (%) | 151 (35) | 127 (34) | 24 (42) | |
Study registered before completed, n (%) | 336 (80) | 291 (80) | 45 (79) | |