How do clinical trial participants compare to other patients with schizophrenia?
Identifieur interne : 001566 ( Main/Corpus ); précédent : 001565; suivant : 001567How do clinical trial participants compare to other patients with schizophrenia?
Auteurs : Paul G. Barnett ; Jennifer Y. Scott ; Robert A. RosenheckSource :
- Schizophrenia research [ 1573-2509 ] ; 2011.
English descriptors
- KwdEn :
- Adult (MeSH), Antipsychotic Agents (economics), Antipsychotic Agents (therapeutic use), Clinical Trials as Topic (economics), Clinical Trials as Topic (methods), Cohort Studies (MeSH), Costs and Cost Analysis (MeSH), Female (MeSH), Hospitalization (MeSH), Humans (MeSH), Male (MeSH), Middle Aged (MeSH), Multivariate Analysis (MeSH), Patient Compliance (psychology), Patient Compliance (statistics & numerical data), Risperidone (economics), Risperidone (therapeutic use), Schizophrenia (drug therapy), Schizophrenia (economics), Schizophrenic Psychology (MeSH), United States (MeSH), United States Department of Veterans Affairs (MeSH).
- MESH :
- chemical , economics : Antipsychotic Agents, Risperidone.
- chemical , therapeutic use : Antipsychotic Agents, Risperidone.
- geographic : United States.
- drug therapy : Schizophrenia.
- economics : Clinical Trials as Topic, Schizophrenia.
- methods : Clinical Trials as Topic.
- psychology : Patient Compliance.
- statistics & numerical data : Patient Compliance.
- Adult, Cohort Studies, Costs and Cost Analysis, Female, Hospitalization, Humans, Male, Middle Aged, Multivariate Analysis, Schizophrenic Psychology, United States Department of Veterans Affairs.
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: 10.1016/j.schres.2011.03.033
PubMed: 21514794
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Rosenheck</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2011">2011</date><idno type="RBID">pubmed:21514794</idno><idno type="pmid">21514794</idno><idno type="doi">10.1016/j.schres.2011.03.033</idno><idno type="wicri:Area/Main/Corpus">001566</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001566</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">How do clinical trial participants compare to other patients with schizophrenia?</title><author><name sortKey="Barnett, Paul G" sort="Barnett, Paul G" uniqKey="Barnett P" first="Paul G" last="Barnett">Paul G. Barnett</name><affiliation><nlm:affiliation>Health Economics Resource Center, VA Cooperative Studies Program, VA Palo Alto Health Care System, 795 Willow Road (152), Menlo Park, CA 94025, USA. paul.barnett@va.gov</nlm:affiliation></affiliation></author><author><name sortKey="Scott, Jennifer Y" sort="Scott, Jennifer Y" uniqKey="Scott J" first="Jennifer Y" last="Scott">Jennifer Y. Scott</name></author><author><name sortKey="Rosenheck, Robert A" sort="Rosenheck, Robert A" uniqKey="Rosenheck R" first="Robert A" last="Rosenheck">Robert A. Rosenheck</name></author></analytic><series><title level="j">Schizophrenia research</title><idno type="eISSN">1573-2509</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>Antipsychotic Agents (economics)</term><term>Antipsychotic Agents (therapeutic use)</term><term>Clinical Trials as Topic (economics)</term><term>Clinical Trials as Topic (methods)</term><term>Cohort Studies (MeSH)</term><term>Costs and Cost Analysis (MeSH)</term><term>Female (MeSH)</term><term>Hospitalization (MeSH)</term><term>Humans (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Multivariate Analysis (MeSH)</term><term>Patient Compliance (psychology)</term><term>Patient Compliance (statistics & numerical data)</term><term>Risperidone (economics)</term><term>Risperidone (therapeutic use)</term><term>Schizophrenia (drug therapy)</term><term>Schizophrenia (economics)</term><term>Schizophrenic Psychology (MeSH)</term><term>United States (MeSH)</term><term>United States Department of Veterans Affairs (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="economics" xml:lang="en"><term>Antipsychotic Agents</term><term>Risperidone</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antipsychotic Agents</term><term>Risperidone</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Schizophrenia</term></keywords><keywords scheme="MESH" qualifier="economics" xml:lang="en"><term>Clinical Trials as Topic</term><term>Schizophrenia</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Patient Compliance</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Patient Compliance</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Cohort Studies</term><term>Costs and Cost Analysis</term><term>Female</term><term>Hospitalization</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Multivariate Analysis</term><term>Schizophrenic Psychology</term><term>United States Department of Veterans Affairs</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>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).</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>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.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21514794</PMID><DateCompleted><Year>2011</Year><Month>11</Month><Day>23</Day></DateCompleted><DateRevised><Year>2016</Year><Month>05</Month><Day>26</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1573-2509</ISSN><JournalIssue CitedMedium="Internet"><Volume>130</Volume><Issue>1-3</Issue><PubDate><Year>2011</Year><Month>Aug</Month></PubDate></JournalIssue><Title>Schizophrenia research</Title><ISOAbbreviation>Schizophr Res</ISOAbbreviation></Journal><ArticleTitle>How do clinical trial participants compare to other patients with schizophrenia?</ArticleTitle><Pagination><MedlinePgn>34-9</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.schres.2011.03.033</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="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.</AbstractText><AbstractText Label="METHODS" NlmCategory="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.</AbstractText><AbstractText Label="RESULTS" NlmCategory="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).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText><CopyrightInformation>Published by Elsevier B.V.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Barnett</LastName><ForeName>Paul G</ForeName><Initials>PG</Initials><AffiliationInfo><Affiliation>Health Economics Resource Center, VA Cooperative Studies Program, VA Palo Alto Health Care System, 795 Willow Road (152), Menlo Park, CA 94025, USA. paul.barnett@va.gov</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scott</LastName><ForeName>Jennifer Y</ForeName><Initials>JY</Initials></Author><Author 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