Testing decision-making competency of schizophrenia
participants in clinical trials. A meta-analysis and meta-regression
Authors: Sorin Hostiuc1(sorin.hostiuc@umfcd.ro), Mugurel Constantin Rusu1, Ionuț Negoi1, Eduard Drima2 1. Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, 2. University of Medicine and Pharmacy, Galați, Romania Aim. The primary purpose of this study is to evaluate the degree of impairment of decision-making capacity in schizophrenia patients compared to non-mentally-ill controls, as determined by the MacCAT-CR instrument. Materials and Methods. We analyzed the results obtained from three databases: ISI Web of Science, Pubmed, and Scopus. Each database was scrutinized using the following keywords: “MacCAT-CR + schizophrenia”, “decision-making capacity + schizophrenia”, and “informed consent + schizophrenia.” Results Testing decision-making competency of schizophrenia participants in clinical trials. A meta-analysis and meta-regression
By running a meta-regression using mean age for the
schizophrenia group as a covariate, we found a slight decrease in understanding with growing age, but the result was not statistically significant (B=-1.51, Z=-1.75, p=0.08).. By running a meta-regression using mean age for the schizophrenia group as a covariate, we found a significant decrease in appreciation with growing age (B=1.07, Z=-2.78, p=0.005). Increasing the percentage of men between the comparison and the control group (B=-0.87, Z=-10.30, p<0.001), and increasing the inpatient rate (B=-0.71 Z=-5.65, p<0.001) also significantly decreased DMC in schizophrenia subjects. By running a meta-regression using mean age for the schizophrenia group as covariate we found a slight decrease in reasoning with increasing age, but the result was not statistically significant B=-1.30, Z=-1.72, p=0.21). The parameter was significantly affected when the difference in the percentage of men in cases versus control group increased (B=-1.00, Z=-5.15, p<0.001), and when the proportion of inpatients increased (B=-0.77, Z=-2.36, p=0.01). By running a meta-regression using mean age for the schizophrenia group as covariate we found a slight decrease in the aptitude to express a choice with increasing age, but the result was not statistically significant (B=-1.10, Z=-1.66, p=0.10). This parameter was significantly affected when the differential between men percentage in cases and control group increased (B=-0.53, Z=-3.67, p=0.0002), and when the proportion Conclusions of inpatients increased (B=-0.08, Z=-2.23, p=0.02). Even if schizophrenia patients have a significantly decreased DMC Candilis, P. J., K. E. Fletcher, C. M. Geppert, C. W. Lidz, and P. S. Appelbaum. "A Direct Comparison of Research Decision-Making Capacity: Schizophrenia/ compared to non-mentally-ill controls, they should be considered as competent unless very severe alterations are identified during the clinical Schizoaffective, Medically Ill, and Non-Ill Subjects." Schizophr Res 99, no. 1-3 (Feb 2008): 350-8. Carpenter, W. T., Jr., J. M. Gold, A. C. Lahti, C. A. Queern, R. R. Conley, J. J. Bartko, J. Kovnick, and P. S. Appelbaum. "Decisional Capacity for Informed Consent in Schizophrenia Research." Arch Gen Psychiatry 57, no. 6 (Jun 2000): 533-8.
examination. Age, men gender and the percentage of inpatients tend to
Harmell, A. L., B. W. Palmer, and D. V. Jeste. "Preliminary Study of a Web-Based Tool for Enhancing the Informed Consent Process in Schizophrenia Research." Schizophr Res 141, no. 2-3 (Nov 2012): 247-50. Jeste, D. V., B. W. Palmer, S. Golshan, L. T. Eyler, L. B. Dunn, T. Meeks, D. Glorioso, et al. "Multimedia Consent for Research in People with Schizophrenia
increase the differential of decision-making incompetence compared to
and Normal Subjects: A Randomized Controlled Trial." Schizophr Bull 35, no. 4 (Jul 2009): 719-29. Kim, S. Y., P. S. Appelbaum, J. Swan, T. S. Stroup, J. P. McEvoy, D. C. Goff, D. V. Jeste, et al. "Determining When Impairment Constitutes Incapacity for Informed Consent in Schizophrenia Research." Br J Psychiatry 191 (Jul 2007): 38-43.
non-mentally-ill subjects in various dimensions of the decision-making
Kovnick, J. A., P. S. Appelbaum, S. K. Hoge, and R. A. Leadbetter. "Competence to Consent to Research among Long-Stay Inpatients with Chronic Schizophrenia." Psychiatr Serv 54, no. 9 (Sep 2003): 1247-52. Moser, D. J., R. L. Reese, C. T. Hey, S. K. Schultz, S. Arndt, L. J. Beglinger, K. M. Duff, and N. C. Andreasen. "Using a Brief Intervention to Improve Decisional
competence as analyzed by the MacCAT-CR scale.
Capacity in Schizophrenia Research." Schizophr Bull 32, no. 1 (Jan 2006): 116-20. Moser, D. J., S. K. Schultz, S. Arndt, M. L. Benjamin, F. W. Fleming, C. S. Brems, J. S. Paulsen, P. S. Appelbaum, and N. C. Andreasen. "Capacity to Provide Informed Consent for Participation in Schizophrenia and Hiv Research." Am J Psychiatry 159, no. 7 (Jul 2002): 1201-7. Palmer, B. W., L. B. Dunn, P. S. Appelbaum, S. Mudaliar, L. Thal, R. Henry, S. Golshan, and D. V. Jeste. "Assessment of Capacity to Consent to Research among Older Persons with Schizophrenia, Alzheimer Disease, or Diabetes Mellitus: Comparison of a 3-Item Questionnaire with a Comprehensive Standardized Capacity Instrument." Arch Gen Psychiatry 62, no. 7 (Jul 2005): 726-33. Palmer, B. W., L. B. Dunn, C. A. Depp, L. T. Eyler, and D. V. Jeste. "Decisional Capacity to Consent to Research among Patients with Bipolar Disorder: Comparison with Schizophrenia Patients and Healthy Subjects." J Clin Psychiatry 68, no. 5 (May 2007): 689-96.