How do clinical trial participants compare to other patients with schizophrenia?

Abstract Objective Patients with schizophrenia enrolled in a trial of long-acting injectable risperidone at multiple sites of the Veterans Health Administration (VHA). We considered if the trial participants were representative of the targeted group of high-utilization patients with poor adherence t...

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Bibliographic Details
Published in:Schizophrenia research 2011-08, Vol.130 (1), p.34-39
Main Authors: Barnett, Paul G, Scott, Jennifer Y, Rosenheck, Robert A
Format: Article
Language:English
Subjects:
Adherence
Adult
Adult and adolescent clinical studies
Anti-psychotic medication
Antipsychotic Agents - economics
Antipsychotic Agents - therapeutic use
Biological and medical sciences
Clinical Trials as Topic - economics
Clinical Trials as Topic - methods
Cohort Studies
Cost
Costs and Cost Analysis
Female
Hospitalization
Humans
Male
Medical sciences
Middle Aged
Multivariate Analysis
Patient Compliance - psychology
Patient Compliance - statistics & numerical data
Psychiatry
Psychology. Psychoanalysis. Psychiatry
Psychopathology. Psychiatry
Psychoses
Risperidone - economics
Risperidone - therapeutic use
Schizophrenia
Schizophrenia - drug therapy
Schizophrenia - economics
Schizophrenic Psychology
United States
United States Department of Veterans Affairs
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Summary:Abstract Objective Patients with schizophrenia enrolled in a trial of long-acting injectable risperidone at multiple sites of the Veterans Health Administration (VHA). We considered if the trial participants were representative of the targeted group of high-utilization patients with poor adherence to anti-psychotics. Methods Participants' characteristics, health services utilization, and cost in the year prior to randomization were compared to a randomly selected time-matched cohort of 10,000 other patients with schizophrenia who were not in the trial. Results There were few differences in the characteristics, utilization, or cost between trial participants and non-participants who met the key trial inclusion criterion of a history of psychiatric hospitalization in the prior 24 months. Trial participants were more likely to be African-American (45.5% vs. 35.1%, p < .001) and were less likely to have had a medical–surgical hospitalization in the study year (8.2% vs. 19.2% p < .001). Compared to non-participants who did not meet the inclusion criterion, trial participants were more likely to have a psychiatric condition in addition to schizophrenia (81.0% vs. 51.3%, p < .001), more likely to have a substance abuse disorder (46.3% vs. 13.9% p < .001), and less likely to be adherent with their anti-psychotic medication (21.3% vs. 37.9%, p < .001). They also incurred more than three times the annual cost ($42,563 vs. $12,270, p < .001). Conclusions Trial participants appeared to be representative of the 23.3% of VHA patients with schizophrenia who met the key trial inclusion criterion, suggesting that trial findings will be relevant to the broader group of high risk patients.
ISSN:0920-9964
1573-2509
DOI:10.1016/j.schres.2011.03.033