Table 3. Complete informed consent comprehension percentages by study and age group. .
Informed consent element | Intervention group | Control group | P value |
Nature of procedure (Subscore = 4) | Parent (P): 97 %--------------Youth (Y): 86 % Child (C): 79 %Adolescent (A): 94 % | P: 98 %--------------Y: 55 % C: Child 44 %A: Adolescent 63 % | 1---------0.003 |
Benefits of procedure | P: 100 %--------------Y: 76 % C: 53 %A, 100 % | P: 98 %--------------Y: 83 % C: Child 69 %A: Adolescent 92 % | 1----------0.58 |
Risks of procedures (Subscore = 3) | P: 92 %--------------Y: 84 % C: 68 %A, 100 % | P: 48 %--------------Y: 15 % C: Child 0 %A: Adolescent 25 % | < 0.0001----------- < 0.0001 |
Alternatives to procedure | P: 72 %--------------Y: 24 % C: 5 %A, 44 % | P: 43 %--------------Y: 15 % C: 6 %A: 21 % | 0.01---------0.39 |
Complete informed consent comprehension1 (%) | P: 69 %--------------Y: 22 % C: 0 %A: 44 % | P: 25 %--------------Y: 8 % C: 0 %A: 13 % | 0.0002---------0.11 |
Percentages presented reflect the % of the study group that completely understood the informed consent element. Youth = Child (7 – 12 years) and Adolescent (13 – 17 years).
Complete informed consent comprehension meant that the participant understood all key IC elements (nature of the procedure, benefits of the procedure, risks of the procedure, AND alternatives to the procedure).