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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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| Published in: | Schizophrenia research 2011-08, Vol.130 (1), p.34-39 |
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| creator | Barnett, Paul G Scott, Jennifer Y Rosenheck, Robert A |
| description | 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. |
| doi_str_mv | 10.1016/j.schres.2011.03.033 |
| format | article |
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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.]]></description><identifier>ISSN: 0920-9964</identifier><identifier>EISSN: 1573-2509</identifier><identifier>DOI: 10.1016/j.schres.2011.03.033</identifier><identifier>PMID: 21514794</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>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</subject><ispartof>Schizophrenia research, 2011-08, Vol.130 (1), p.34-39</ispartof><rights>2011</rights><rights>2015 INIST-CNRS</rights><rights>Published by Elsevier B.V.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c492t-55352d30507b88ce419c69d86069eb29e639240ed7583d5a65b5e7d0902551463</citedby><cites>FETCH-LOGICAL-c492t-55352d30507b88ce419c69d86069eb29e639240ed7583d5a65b5e7d0902551463</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24412121$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21514794$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Barnett, Paul G</creatorcontrib><creatorcontrib>Scott, Jennifer Y</creatorcontrib><creatorcontrib>Rosenheck, Robert A</creatorcontrib><creatorcontrib>for the CSP 555 Study Group</creatorcontrib><creatorcontrib>CSP 555 Study Group</creatorcontrib><title>How do clinical trial participants compare to other patients with schizophrenia?</title><title>Schizophrenia research</title><addtitle>Schizophr Res</addtitle><description><![CDATA[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.]]></description><subject>Adherence</subject><subject>Adult</subject><subject>Adult and adolescent clinical studies</subject><subject>Anti-psychotic medication</subject><subject>Antipsychotic Agents - economics</subject><subject>Antipsychotic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Clinical Trials as Topic - economics</subject><subject>Clinical Trials as Topic - methods</subject><subject>Cohort Studies</subject><subject>Cost</subject><subject>Costs and Cost Analysis</subject><subject>Female</subject><subject>Hospitalization</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multivariate Analysis</subject><subject>Patient Compliance - psychology</subject><subject>Patient Compliance - statistics & numerical data</subject><subject>Psychiatry</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology. Psychiatry</subject><subject>Psychoses</subject><subject>Risperidone - economics</subject><subject>Risperidone - therapeutic use</subject><subject>Schizophrenia</subject><subject>Schizophrenia - drug therapy</subject><subject>Schizophrenia - economics</subject><subject>Schizophrenic Psychology</subject><subject>United States</subject><subject>United States Department of Veterans Affairs</subject><issn>0920-9964</issn><issn>1573-2509</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNqFkd9rFDEQx4Mo9lr9D0T2RXza6-TX7uZFKaW1QkFBfQ657ByXc2-zJjlL-9d3lrsq-CIZEkK-M_PNZxh7w2HJgTfn22X2m4R5KYDzJUgK-YwtuG5lLTSY52wBRkBtTKNO2GnOWwDgGtqX7ERwzVVr1IJ9vYl3VR8rP4QxeDdUJQXaJ5dK8GFyY8mVjzu6Y1ViFcsGE72WgPPLXSibimyEhziRlzG4j6_Yi7UbMr4-nmfsx_XV98ub-vbLp8-XF7e1V0aUWmupRS-B_Ky6zqPixjem7xpoDK6EwUYaoQD7Vney167RK41tDwaEJu-NPGPvD3WnFH_tMRe7C9njMLgR4z7brmv1_F1OSnVQ-hRzTri2Uwo7l-4tBzujtFt7QGlnlBYkhaS0t8cG-9UO-z9JT-xI8O4ocJnIrZMbfch_dUpxQYt0Hw46JBy_AybqRvg89iGhL7aP4X9O_i3wNK2feI95G_dpJNSW2yws2G_z2Oepc04D77iQjxPbp2c</recordid><startdate>20110801</startdate><enddate>20110801</enddate><creator>Barnett, Paul G</creator><creator>Scott, Jennifer Y</creator><creator>Rosenheck, Robert A</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20110801</creationdate><title>How do clinical trial participants compare to other patients with schizophrenia?</title><author>Barnett, Paul G ; Scott, Jennifer Y ; Rosenheck, Robert A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c492t-55352d30507b88ce419c69d86069eb29e639240ed7583d5a65b5e7d0902551463</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adherence</topic><topic>Adult</topic><topic>Adult and adolescent clinical studies</topic><topic>Anti-psychotic medication</topic><topic>Antipsychotic Agents - economics</topic><topic>Antipsychotic Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Clinical Trials as Topic - economics</topic><topic>Clinical Trials as Topic - methods</topic><topic>Cohort Studies</topic><topic>Cost</topic><topic>Costs and Cost Analysis</topic><topic>Female</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multivariate Analysis</topic><topic>Patient Compliance - psychology</topic><topic>Patient Compliance - statistics & numerical data</topic><topic>Psychiatry</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology. Psychiatry</topic><topic>Psychoses</topic><topic>Risperidone - economics</topic><topic>Risperidone - therapeutic use</topic><topic>Schizophrenia</topic><topic>Schizophrenia - drug therapy</topic><topic>Schizophrenia - economics</topic><topic>Schizophrenic Psychology</topic><topic>United States</topic><topic>United States Department of Veterans Affairs</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Barnett, Paul G</creatorcontrib><creatorcontrib>Scott, Jennifer Y</creatorcontrib><creatorcontrib>Rosenheck, Robert A</creatorcontrib><creatorcontrib>for the CSP 555 Study Group</creatorcontrib><creatorcontrib>CSP 555 Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Schizophrenia research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Barnett, Paul G</au><au>Scott, Jennifer Y</au><au>Rosenheck, Robert A</au><aucorp>for the CSP 555 Study Group</aucorp><aucorp>CSP 555 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>How do clinical trial participants compare to other patients with schizophrenia?</atitle><jtitle>Schizophrenia research</jtitle><addtitle>Schizophr Res</addtitle><date>2011-08-01</date><risdate>2011</risdate><volume>130</volume><issue>1</issue><spage>34</spage><epage>39</epage><pages>34-39</pages><issn>0920-9964</issn><eissn>1573-2509</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-News-2</notes><notes>ObjectType-Feature-3</notes><notes>content type line 23</notes><abstract><![CDATA[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.]]></abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>21514794</pmid><doi>10.1016/j.schres.2011.03.033</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| 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 |
| title | How do clinical trial participants compare to other patients with schizophrenia? |
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