Table 2.
Factors associated with pediatric clinical trial reporting of participant/caregiver preferred language
| Trial Characteristics | Reported Language (N=181), n (%) |
Did Not Report Language (N=431), n (%) |
Adjusted Odds Ratio (95% CI) |
P value |
|---|---|---|---|---|
| Participant age group in article | ||||
| All pediatric age groups | 28 (15.4) | 63 (14.6) | 1.48 (0.71, 3.15) | 0.30 |
| Neonate (0-30 days) | 17 (9.4) | 98 (22.7) | Referent | |
| Infants and toddlers (31 days-3 years) | 36 (19.9) | 56 (13.0) | 2.32 (1.14, 4.81) | 0.02 |
| Pre-school and school age (4-12 years) | 36 (19.9) | 102 (23.7) | 0.86 (0.42, 1.78) | 0.68 |
| Adolescent (13-18 years) | 64 (35.4) | 112 (26.0) | 1.16 (0.58, 2.37) | 0.68 |
| Trial allocation | ||||
| Not randomized | 6 (3.3) | 32 (7.4) | Referent | |
| Randomized | 175 (96.7) | 399 (92.6) | 1.98 (0.80, 5.68) | 0.16 |
| Trial enrollment | ||||
| <100 | 45 (24.9) | 127 (29.5) | Referent | |
| 100-499 | 89 (49.2) | 195 (45.2) | 0.89 (0.55, 1.44) | 0.63 |
| ≥500 | 47 (25.9) | 109 (25.3) | 0.58 (0.33, 1.01) | 0.06 |
| Trial intervention | ||||
| Drug/biologic/dietary supplement | 37 (20.4) | 202 (46.9) | Referent | |
| Behavioral | 110 (60.8) | 134 (31.1) | 5.14 (3.15, 8.59) | <0.001 |
| Device/procedure | 11 (6.1) | 64 (14.8) | 1.02 (0.46, 2.11) | 0.97 |
| Screening/Referral or Health services | 23 (12.7) | 31 (7.2) | 4.87 (2.42, 9.85) | <0.001 |
| Funding source | ||||
| Public and Private | 36 (19.9) | 92 (21.3) | Referent | |
| Private | 30 (16.6) | 82 (19.0) | 1.02 (0.55, 1.88) | 0.95 |
| Public | 109 (60.2) | 233 (54.1) | 1.15 (0.71, 1.89) | 0.56 |
| None Reported | 6 (3.3) | 24 (5.6) | 1.06 (0.34, 3.01) | 0.91 |
Note: Boldface indicates statistical significance (P<0.05).