TY - JOUR
T1 - Longitudinal consent-related abilities among research participants with schizophrenia
T2 - Results from the CATIE study
AU - Stroup, T. Scott
AU - Appelbaum, Paul S.
AU - Gu, Hongbin
AU - Hays, Spencer
AU - Swartz, Marvin S.
AU - Keefe, Richard S.E.
AU - Kim, Scott Y.
AU - Manschreck, Theo C.
AU - Boshes, Roger A.
AU - McEvoy, Joseph Patrick
AU - Lieberman, Jeffrey A.
N1 - Funding Information:
This article was based on results from the Clinical Antipsychotic Trials of Intervention Effectiveness project, supported with Federal funds from the National Institute of Mental Health under contract NO1 MH90001 . AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Forest Pharmaceuticals, Inc., Janssen Pharmaceutica Products, L.P., Eli Lilly and Company, Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., and Zenith Goldline Pharmaceuticals, Inc., provided medications for the studies.
Funding Information:
This project was supported by NIH Research Grant # 1K23 MH67002-01A1 funded by the National Institute of Mental Health and the Office of the Director, Office of Behavioral and Social Research (OD/OBSSR) , and by the National Association of Research in Schizophrenia and Affective Disorders (NARSAD) .
PY - 2011/8
Y1 - 2011/8
N2 - Objective: Research participants must have adequate consent-related abilities to provide informed consent at the time of study enrollment. We sought to determine if research participants with schizophrenia maintain adequate consent-related abilities during a longitudinal study. If participants lose abilities during a trial they may not be able to judge and protect their interests. If reduced abilities are common or can be predicted, special protections can be targeted appropriately. Method: We examined longitudinal consent-related abilities of participants in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study using the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) at protocol-specified times over 18. months. Results: Of 1158 research participants in this analysis, most (n = 650, 56%) had a stable pattern of MacCAT-CR Understanding scores, 235 (20%) improved substantially with no evidence of decline, 273 (24%) had at least one assessment with substantial worsening. During the course of the trial, 43 (4%) fell below the initial threshold for adequate capacity, which was predicted by lower Understanding scores, more severe positive symptoms, and poorer neurocognitive functioning at baseline, and by increases in negative symptoms and deteriorating global status. Conclusions: Most participants in this long-term study had stable or improved consent-related abilities, but almost one-fourth experienced substantial worsening and 4% of participants fell below the study's capacity threshold for enrollment. Clinical investigators should monitor with special care individuals with marginal capacity or higher levels of psychotic symptoms at study entry and those who exhibit clinical worsening during a study.
AB - Objective: Research participants must have adequate consent-related abilities to provide informed consent at the time of study enrollment. We sought to determine if research participants with schizophrenia maintain adequate consent-related abilities during a longitudinal study. If participants lose abilities during a trial they may not be able to judge and protect their interests. If reduced abilities are common or can be predicted, special protections can be targeted appropriately. Method: We examined longitudinal consent-related abilities of participants in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study using the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) at protocol-specified times over 18. months. Results: Of 1158 research participants in this analysis, most (n = 650, 56%) had a stable pattern of MacCAT-CR Understanding scores, 235 (20%) improved substantially with no evidence of decline, 273 (24%) had at least one assessment with substantial worsening. During the course of the trial, 43 (4%) fell below the initial threshold for adequate capacity, which was predicted by lower Understanding scores, more severe positive symptoms, and poorer neurocognitive functioning at baseline, and by increases in negative symptoms and deteriorating global status. Conclusions: Most participants in this long-term study had stable or improved consent-related abilities, but almost one-fourth experienced substantial worsening and 4% of participants fell below the study's capacity threshold for enrollment. Clinical investigators should monitor with special care individuals with marginal capacity or higher levels of psychotic symptoms at study entry and those who exhibit clinical worsening during a study.
KW - Decision-making capacity
KW - Schizophrenia
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U2 - 10.1016/j.schres.2011.04.012
DO - 10.1016/j.schres.2011.04.012
M3 - Article
C2 - 21561740
AN - SCOPUS:79960315812
SN - 0920-9964
VL - 130
SP - 47
EP - 52
JO - Schizophrenia Research
JF - Schizophrenia Research
IS - 1-3
ER -
