Table 3.
Routine Consent, % Capable (N = 29) | Multimedia Consent, % Capable (N = 31) | Relative “Risk” of Capabilitya | 95% Confidence Interval | Fisher Exact Test/P Value | |
Healthy Comparison Subjects | |||||
CATIE criterion | |||||
Trial 1 | 100 | 100 | 1.000 | N/A | N/A |
Trial 2 | 100 | 100 | 1.000 | N/A | N/A |
Trial 3 | 100 | 100 | 1.000 | N/A | N/A |
UBACC criterion | 86 | 94 | 1.085 | 0.94, 1.32 | 0.417 |
Capacity determination by psychiatrist based on MacCAT-CRb | |||||
Trial 1 | 90 | 100 | 1.115 | 0.107 | |
Trial 3 | 97 | 100 | 1.036 | 0.483 | |
Schizophrenia patients | |||||
CATIE criterion | |||||
Trial 1 | 59 | 81 | 1.365 | 1.09, 1.75 | 0.012 |
Trial 2 | 77 | 92 | 1.190 | 1.03, 1.40 | 0.028 |
Trial 3 | 77 | 94 | 1.211 | 1.05, 1.42 | 0.012 |
UBACC criterion | 47 | 76 | 1.614 | 1.22, 2.22 | 0.001 |
Capacity determination by psychiatrist based on MacCAT-CRb | |||||
Trial 1 | 47 | 66 | 1.408 | 1.04, 1.97 | 0.034 |
Trial 3 | 70 | 89 | 1.273 | 1.06, 1.55 | 0.010 |
Note: MacCAT-CR, MacArthur Competence Assessment Tool for Clinical Research; UBACC, University of California, San Diego Brief Assessment of Capacity to Consent; CATIE, Clinical Antipsychotic Trials of Intervention Effetiveness; N/A, not applicable. Values in bold are the P values for those Fisher Exact tests that were statistically significant.
Relative “risk” = P (capable|multimedia)/P (capable|routine).
Clinical determination of capacity by an independent psychiatrist based on MacCAT-CR responses.