Table 2.
Non-consenters N=62 | Consenters N=58 | P value§ | |
---|---|---|---|
Parent/child characteristics |
Number (%)
|
||
Child too young to express opinion (45)* | 58 (93.5) | 55 (94.8) | 1.00 |
Child vulnerable (58) | 3 (4.8) | 6 (10.3) | 0.312 |
Decision making style (47) | |||
Self/family | 31 (50) | 32 (55) | 0.571 |
Shared with MD | 31 (50) | 26 (45) | |
Mean score (SD)
|
|||
Trust in research (20,22,24) - Total score (3–15) | 11.26 (1.88) | 12.83 (1.55) | <0.001 |
External influences |
Number (%)
|
||
Talked to other person (44a) | 59 (95.2) | 52 (89.7) | 0.312 |
This person helped a lot to make your decision (44b) | 40 (67.8) | 33 (63.5) | 0.236 |
Family or friends who participated in research (4) | 19 (30.6) | 14 (24.1) | 0.425 |
Parent’s understanding - Total score (1–5) |
Mean score (SD)
|
||
Equipoise (26) | 3.71 (0.80) | 3.88 (0.73) | 0.338 |
Randomization (27) | 3.98 (0.76) | 4.38 (0.62) | 0.004 |
Patient Blinding (28) | 3.94 (0.85) | 4.4 (0.82) | 0.001 |
Investigators blinding (29†) | 2.90 (1.11) | 3.28 (1.40) | 0.090 |
Voluntary participation (21) | 4.45 (0.67) | 4.60 (0.53) | 0.196 |
Right to withdraw (30) | 3.87 (0.74) | 4.48 (0.71) | <0.001 |
Risk level of the study (16) | 4.05 (0.69) | 4.29 (0.75) | 0.020 |
Parent’s perceptions | |||
Consent document characteristics (7,8,9) - Total score (3–15) | 13.2 (1.86) | 12.3 (2.80) | 0.304 |
Consent environment (12,13,14†,18†) - Total score (4–20) | 16.44 (2.63) | 17.00 (2.64) | 0.188 |
Researcher characteristics (15, 17, 19, 23) - Total score (4–20) | 17.33 (1.89) | 18.33 (1.90) | 0.003 |
Risk of the study (32) – Total score (0–10) | 6.05 (2.28) | 3.14 (1.75) | <0.001 |
Benefit to my child (33) – Total score (0–10) | 3.65 (2.10) | 7.31 (1.98) | <0.001 |
Benefit to others (34) – Total score (0–10) | 6.48 (2.35) | 8.48 (1.49) | <0.001 |
Importance of study (35) – Total score (0–10) | 6.77 (1.96) | 9.05 (1.18) | <0.001 |
Study may interfere with standard care (39†) – Total score (0–10) | 5.27 (3.45) | 2.72 (2.78) | <0.001 |
Study may enhance standard care (31) – Total score (1–5) | 2.50 (0.90) | 4.36 (0.72) | <0.001 |
Decision making | |||
Altruism† (25) – Total score (1–5) | 2.73 (0.81) | 4.10 (0.74) | <0.001 |
Acceptance of blinding (38) – Total score (0–10) | 7.68 (2.94) | 5.19 (2.89) | <0.001 |
Uncertainty (36,37) – Total score (0–20) | 13.32 (4.31) | 9.88 (5.62) | <0.001 |
Number indicate survey question;
Influence of benefit to other children on decision to participate;
Chi square, Fisher’s exact test, or Mann-Whitney
Coding was reversed for items 14, 18, 29 and 39 for analysis and presentation of results