Table 8.
Characteristics of Randomized Clinical Trials by Presence of Avoidable Design Flaws
| Characteristic | Absence of design flaw, No. (%) | Presence of design flaw, No. (%) | Total, No. (%) | P |
|---|---|---|---|---|
| Time of registration | ||||
| 2003–2013.06 | 15 (55.56) | 66 (73.33) | 81 (69.23) | 0.079 |
| 2013.06–2023 | 12 (44.44) | 24 (26.67) | 36 (30.77) | |
| Primary purpose | ||||
| Treatment | 25 (92.59) | 74 (82.22) | 99 (84.62) | 0.505 |
| Other | 2 (7.41) | 15 (16.67) | 17 (14.53) | |
| Prevent | 0 (0.00) | 1 (1.11) | 1 (0.85) | |
| Intervention | ||||
| Pharmacological | 19 (70.37) | 63 (70.00) | 82 (70.09) | 0.971 |
| Nonpharmacological | 8 (29.63) | 27 (30.00) | 35 (29.91) | |
| Intervention model | ||||
| Crossover | 2 (7.41) | 17 (18.89) | 19 (16.24) | 0.108 |
| Parallel | 24 (88.89) | 73 (81.11) | 97 (82.91) | |
| Factorial | 1 (3.70) | 0 (0.00) | 1 (0.85) | |
| Arm | ||||
| 2 | 21 (77.78) | 73 (81.11) | 94 (80.34) | 0.671 |
| 3 | 4 (14.81) | 14 (15.56) | 18 (15.38) | |
| ≥4 | 2 (7.41) | 3 (3.33) | 5 (4.27) | |
| Blinding | ||||
| None or open label | 3 (11.11) | 31 (34.44) | 34 (29.06) | 0.025* |
| Single | 2 (7.41) | 10 (11.11) | 12 (10.26) | |
| Double or more | 22 (81.48) | 49 (54.44) | 71 (60.68) | |
| Funder type | ||||
| None or departmental | 16 (59.26) | 46 (51.11) | 62 (52.99) | 0.457 |
| Industry or other external | 11 (40.74) | 44 (48.89) | 55 (47.01) | |
| Recruitment | ||||
| Single center | 11 (40.74) | 35 (38.89) | 46 (39.32) | 0.674 |
| Multicenter | 14 (51.85) | 54 (60.00) | 68 (58.12) | |
| Missing | 2 (7.41) | 1 (1.11) | 3 (2.56) | |
| No. of participants | ||||
| <350 | 17 (62.96) | 64 (71.11) | 81 (69.23) | 0.421 |
| ≥350 | 10 (37.04) | 26 (28.89) | 36 (30.77) | |
| PI region | ||||
| Nonhigh SDI | 8 (29.63) | 17 (18.89) | 25 (21.37) | 0.232 |
| High SDI | 19 (70.37) | 73 (81.11) | 92 (78.63) | |
| PI region | ||||
| <90 | 21 (77.78) | 79 (87.78) | 100 (85.47) | 0.218 |
| ≥90 | 6 (22.22) | 11 (12.22) | 17 (14.53) | |
| PI region | ||||
| High income | 21 (77.78) | 75 (83.33) | 96 (82.05) | 0.570 |
| Nonhigh income | 6 (22.22) | 15 (16.67) | 21 (17.95) | |
| PI region | ||||
| North America | 8 (29.63) | 34 (37.78) | 42 (35.90) | 0.693 |
| Europe | 8 (29.63) | 21 (23.33) | 29 (24.79) | |
| Other | 11 (40.74) | 35 (38.89) | 46 (39.32) | |
P < 0.05