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. 2025 Jan 24;111(3):2358–2375. doi: 10.1097/JS9.0000000000002227

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