Coordination and Management of Multisite Complementary and Alternative Medicine (CAM) Therapies: Experience from a Multisite Reflexology Intervention Trial
Identifieur interne : 000103 ( Ncbi/Merge ); précédent : 000102; suivant : 000104Coordination and Management of Multisite Complementary and Alternative Medicine (CAM) Therapies: Experience from a Multisite Reflexology Intervention Trial
Auteurs : Mohammad H. Rahbar ; Gwen Wyatt ; Alla Sikorskii ; David Victorson ; Manouchehr Ardjomand-HessabiSource :
- Contemporary clinical trials [ 1551-7144 ] ; 2011.
Abstract
Multisite randomized clinical trials allow for increased research collaboration among investigators and expedite data collection efforts. As a result, government funding agencies typically look favorably upon this approach. As the field of complementary and alternative medicine (CAM) continues to evolve, so do increased calls for the use of more rigorous study design and trial methodologies, which can present challenges for investigators.
To describe the processes involved in the coordination and management of a multisite randomized clinical trial of a CAM intervention.
Key aspects related to the coordination and management of a multisite CAM randomized clinical trial are presented, including organizational and site selection considerations, recruitment concerns and issues related to data collection and randomization to treatment groups. Management and monitoring of data, as well as quality assurance procedures are described. Finally, a real world perspective is shared from a recently conducted multisite randomized clinical trial of reflexology for women diagnosed with advanced breast cancer.
The use of multiple sites in the conduct of CAM-based randomized clinical trials can provide an efficient, collaborative and robust approach to study coordination and data collection that maximizes efficiency and ensures the quality of results.
Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required.
Url:
DOI: 10.1016/j.cct.2011.05.015
PubMed: 21664296
PubMed Central: 3156393
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PMC:3156393Le document en format XML
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<author><name sortKey="Rahbar, Mohammad H" sort="Rahbar, Mohammad H" uniqKey="Rahbar M" first="Mohammad H." last="Rahbar">Mohammad H. Rahbar</name>
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<author><name sortKey="Wyatt, Gwen" sort="Wyatt, Gwen" uniqKey="Wyatt G" first="Gwen" last="Wyatt">Gwen Wyatt</name>
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<author><name sortKey="Sikorskii, Alla" sort="Sikorskii, Alla" uniqKey="Sikorskii A" first="Alla" last="Sikorskii">Alla Sikorskii</name>
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<author><name sortKey="Victorson, David" sort="Victorson, David" uniqKey="Victorson D" first="David" last="Victorson">David Victorson</name>
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<author><name sortKey="Ardjomand Hessabi, Manouchehr" sort="Ardjomand Hessabi, Manouchehr" uniqKey="Ardjomand Hessabi M" first="Manouchehr" last="Ardjomand-Hessabi">Manouchehr Ardjomand-Hessabi</name>
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<author><name sortKey="Victorson, David" sort="Victorson, David" uniqKey="Victorson D" first="David" last="Victorson">David Victorson</name>
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<author><name sortKey="Ardjomand Hessabi, Manouchehr" sort="Ardjomand Hessabi, Manouchehr" uniqKey="Ardjomand Hessabi M" first="Manouchehr" last="Ardjomand-Hessabi">Manouchehr Ardjomand-Hessabi</name>
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<series><title level="j">Contemporary clinical trials</title>
<idno type="ISSN">1551-7144</idno>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P1">Multisite randomized clinical trials allow for increased research collaboration among investigators and expedite data collection efforts. As a result, government funding agencies typically look favorably upon this approach. As the field of complementary and alternative medicine (CAM) continues to evolve, so do increased calls for the use of more rigorous study design and trial methodologies, which can present challenges for investigators.</p>
</sec>
<sec id="S2"><title>Purpose</title>
<p id="P2">To describe the processes involved in the coordination and management of a multisite randomized clinical trial of a CAM intervention.</p>
</sec>
<sec sec-type="methods" id="S3"><title>Methods</title>
<p id="P3">Key aspects related to the coordination and management of a multisite CAM randomized clinical trial are presented, including organizational and site selection considerations, recruitment concerns and issues related to data collection and randomization to treatment groups. Management and monitoring of data, as well as quality assurance procedures are described. Finally, a real world perspective is shared from a recently conducted multisite randomized clinical trial of reflexology for women diagnosed with advanced breast cancer.</p>
</sec>
<sec id="S4"><title>Results</title>
<p id="P4">The use of multiple sites in the conduct of CAM-based randomized clinical trials can provide an efficient, collaborative and robust approach to study coordination and data collection that maximizes efficiency and ensures the quality of results.</p>
</sec>
<sec id="S5"><title>Conclusions</title>
<p id="P5">Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article" xml:lang="en"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">101242342</journal-id>
<journal-id journal-id-type="pubmed-jr-id">32406</journal-id>
<journal-id journal-id-type="nlm-ta">Contemp Clin Trials</journal-id>
<journal-title-group><journal-title>Contemporary clinical trials</journal-title>
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<issn pub-type="ppub">1551-7144</issn>
<issn pub-type="epub">1559-2030</issn>
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<article-meta><article-id pub-id-type="pmid">21664296</article-id>
<article-id pub-id-type="pmc">3156393</article-id>
<article-id pub-id-type="doi">10.1016/j.cct.2011.05.015</article-id>
<article-id pub-id-type="manuscript">NIHMS301022</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
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</article-categories>
<title-group><article-title>Coordination and Management of Multisite Complementary and Alternative Medicine (CAM) Therapies: Experience from a Multisite Reflexology Intervention Trial</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Rahbar</surname>
<given-names>Mohammad H.</given-names>
</name>
<degrees>PhD</degrees>
<aff id="A1">Professor of Epidemiology and Biostatistics, The University of Texas School of Public Health at Houston and Biostatistics/Epidemiology/Research Design Core, Center for Clinical and Translational Sciences, The University of Texas Health Science Center at Houston, Houston, TX</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Wyatt</surname>
<given-names>Gwen</given-names>
</name>
<degrees>PhD, RN</degrees>
<aff id="A2">Professor, College of Nursing, Michigan State University, East Lansing, MI</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Sikorskii</surname>
<given-names>Alla</given-names>
</name>
<degrees>PhD</degrees>
<aff id="A3">Assistant Professor, Department of Statistics and Probability, Michigan State University, East Lansing, MI</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Victorson</surname>
<given-names>David</given-names>
</name>
<degrees>PhD</degrees>
<aff id="A4">Research Assistant Professor, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Ardjomand-Hessabi</surname>
<given-names>Manouchehr</given-names>
</name>
<degrees>MD, MPH</degrees>
<aff id="A5">Research Assistant, Biostatistics/Epidemiology/Research Design Core, Center for Clinical and Translational Sciences, The University of Texas Health Science Center at Houston, Houston, TX</aff>
</contrib>
</contrib-group>
<author-notes><corresp id="FN1">Corresponding Author: Mohammad H. Rahbar, PhD, The University of Texas Health Science Center, Biostatistics/Epidemiology/Research Design component of Center for Clinical and Translational Sciences, 6410 Fannin Street, UT Professional Building Suite 1100.05, <email>Mohammad.H.Rahbar@uth.tmc.edu</email>
, phone: (713)500-7901, fax: (713)500-0766</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>19</day>
<month>7</month>
<year>2011</year>
</pub-date>
<pub-date pub-type="epub"><day>2</day>
<month>6</month>
<year>2011</year>
</pub-date>
<pub-date pub-type="ppub"><month>9</month>
<year>2011</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>1</day>
<month>9</month>
<year>2012</year>
</pub-date>
<volume>32</volume>
<issue>5</issue>
<fpage>620</fpage>
<lpage>629</lpage>
<abstract><sec id="S1"><title>Background</title>
<p id="P1">Multisite randomized clinical trials allow for increased research collaboration among investigators and expedite data collection efforts. As a result, government funding agencies typically look favorably upon this approach. As the field of complementary and alternative medicine (CAM) continues to evolve, so do increased calls for the use of more rigorous study design and trial methodologies, which can present challenges for investigators.</p>
</sec>
<sec id="S2"><title>Purpose</title>
<p id="P2">To describe the processes involved in the coordination and management of a multisite randomized clinical trial of a CAM intervention.</p>
</sec>
<sec sec-type="methods" id="S3"><title>Methods</title>
<p id="P3">Key aspects related to the coordination and management of a multisite CAM randomized clinical trial are presented, including organizational and site selection considerations, recruitment concerns and issues related to data collection and randomization to treatment groups. Management and monitoring of data, as well as quality assurance procedures are described. Finally, a real world perspective is shared from a recently conducted multisite randomized clinical trial of reflexology for women diagnosed with advanced breast cancer.</p>
</sec>
<sec id="S4"><title>Results</title>
<p id="P4">The use of multiple sites in the conduct of CAM-based randomized clinical trials can provide an efficient, collaborative and robust approach to study coordination and data collection that maximizes efficiency and ensures the quality of results.</p>
</sec>
<sec id="S5"><title>Conclusions</title>
<p id="P5">Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required.</p>
</sec>
</abstract>
<kwd-group><kwd>Multisite randomized clinical trials</kwd>
<kwd>Complementary and Alternative Medicine</kwd>
<kwd>Reflexology</kwd>
<kwd>Data coordination and management</kwd>
<kwd>Quality assurance</kwd>
<kwd>CONSORT</kwd>
</kwd-group>
<funding-group><award-group><funding-source country="United States">National Center for Research Resources : NCRR</funding-source>
<award-id>UL1 RR024148-05 || RR</award-id>
</award-group>
<award-group><funding-source country="United States">National Center for Research Resources : NCRR</funding-source>
<award-id>UL1 RR024148-04 || RR</award-id>
</award-group>
<award-group><funding-source country="United States">National Center for Research Resources : NCRR</funding-source>
<award-id>UL1 RR024148-03 || RR</award-id>
</award-group>
<award-group><funding-source country="United States">National Cancer Institute : NCI</funding-source>
<award-id>R01 CA104883-04 || CA</award-id>
</award-group>
</funding-group>
</article-meta>
</front>
</pmc>
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<tree><noCountry><name sortKey="Ardjomand Hessabi, Manouchehr" sort="Ardjomand Hessabi, Manouchehr" uniqKey="Ardjomand Hessabi M" first="Manouchehr" last="Ardjomand-Hessabi">Manouchehr Ardjomand-Hessabi</name>
<name sortKey="Rahbar, Mohammad H" sort="Rahbar, Mohammad H" uniqKey="Rahbar M" first="Mohammad H." last="Rahbar">Mohammad H. Rahbar</name>
<name sortKey="Sikorskii, Alla" sort="Sikorskii, Alla" uniqKey="Sikorskii A" first="Alla" last="Sikorskii">Alla Sikorskii</name>
<name sortKey="Victorson, David" sort="Victorson, David" uniqKey="Victorson D" first="David" last="Victorson">David Victorson</name>
<name sortKey="Wyatt, Gwen" sort="Wyatt, Gwen" uniqKey="Wyatt G" first="Gwen" last="Wyatt">Gwen Wyatt</name>
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