Evaluation of "subject advocate" procedures in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study.

Because the decision-making capacity of individuals with schizophrenia may fluctuate, additional protections for such persons who enroll in long-term research studies may be needed. For the NIMH-sponsored Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study, new procedures were developed to help ensure an objective assessment of a patient's continued participation in the study if decision-making capacity lapsed. Each research participant had a subject advocate who could recommend that the subject be withdrawn from the study if capacity lapsed and continued participation was not in the subject's best interest. The main goals of the procedures were to protect the interests of subjects and to prevent unnecessary dropouts. We surveyed research personnel regarding the effectiveness and implementation of the procedures. Responses were received from 73 personnel at 49 research sites, representing 70% of possible respondents and 91% of eligible sites. A majority of respondents were favorably disposed toward subject advocates, and though most reported that the procedures had no discernible effect on study recruitment, subject autonomy, or subject retention, for those who reported an impact, it was almost always positive. Some respondents reported that the procedures helped by engaging family members and promoting a positive view of schizophrenia research. A majority thought that similar arrangements would be useful in future longitudinal research studies. Nonspecific benefits included good public relations and engagement of family members. Improved training regarding the procedures may be needed to achieve specific goals of enhanced patient autonomy and retention in the study.