Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

Persistent Link:
http://hdl.handle.net/10150/610258
Title:
Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document
Author:
Witt, Claudia; Aickin, Mikel; Cherkin, Daniel; Che, Chun; Elder, Charles; Flower, Andrew; Hammerschlag, Richard; Liu, Jian-Ping; Lao, Lixing; Phurrough, Steve; Ritenbaugh, Cheryl; Rubin, Lee; Schnyer, Rosa; Wayne, Peter; Withers, Shelly; Zhao-Xiang, Bian; Young, Jeanette; Berman, Brian; Collaborators
Affiliation:
Institute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Switzerland; Center for Integrative Medicine, University of Maryland, School of Medicine, Baltimore, MD, USA; Department of Family and Community Medicine, University of Arizona, Tucson, AZ, USA; Group Health Research Institute, Seattle, WA, USA; Department of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago, Chicago, IL, USA; Kaiser Permanente Northwest, Center for Health Research, Portland, OR, USA; Complementary and Integrated Medicine Research Unit, Department of Primary Care, University of Southampton, Southampton, UK; Research Department, Oregon College of Oriental Medicine, Portland, Oregon, USA; Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Complementary Medicine Program and Integrative Medicine, University of Maryland Medical Center, Baltimore, MD, USA; Centers for Medicare and Medicaid Services, Baltimore, Maryland, USA; School of Nursing, The University of Texas at Austin, Austin, TX, USA; Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA; The Institute for Integrative Health, Baltimore, MD, USA; School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, China; Patient stakeholder, New York, NY 10001, USA
Issue Date:
2014
Publisher:
BioMed Central
Citation:
Witt et al. Trials 2014, 15:169 http://www.trialsjournal.com/content/15/1/169
Journal:
Trials
Rights:
© 2014 Witt et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)
Collection Information:
This item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.
Abstract:
BACKGROUND:There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.METHODS:The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.RESULTS:Recommendations were developed for "using available data" and "future clinical studies". The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.CONCLUSION:The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.
EISSN:
1745-6215
DOI:
10.1186/1745-6215-15-169
Keywords:
Comparative effectiveness research; Effectiveness guidance document; Chinese medicine research
Version:
Final published version
Additional Links:
http://www.trialsjournal.com/content/15/1/169

Full metadata record

DC FieldValue Language
dc.contributor.authorWitt, Claudiaen
dc.contributor.authorAickin, Mikelen
dc.contributor.authorCherkin, Danielen
dc.contributor.authorChe, Chunen
dc.contributor.authorElder, Charlesen
dc.contributor.authorFlower, Andrewen
dc.contributor.authorHammerschlag, Richarden
dc.contributor.authorLiu, Jian-Pingen
dc.contributor.authorLao, Lixingen
dc.contributor.authorPhurrough, Steveen
dc.contributor.authorRitenbaugh, Cherylen
dc.contributor.authorRubin, Leeen
dc.contributor.authorSchnyer, Rosaen
dc.contributor.authorWayne, Peteren
dc.contributor.authorWithers, Shellyen
dc.contributor.authorZhao-Xiang, Bianen
dc.contributor.authorYoung, Jeanetteen
dc.contributor.authorBerman, Brianen
dc.contributor.authorCollaboratorsen
dc.date.accessioned2016-05-20T09:02:25Z-
dc.date.available2016-05-20T09:02:25Z-
dc.date.issued2014en
dc.identifier.citationWitt et al. Trials 2014, 15:169 http://www.trialsjournal.com/content/15/1/169en
dc.identifier.doi10.1186/1745-6215-15-169en
dc.identifier.urihttp://hdl.handle.net/10150/610258-
dc.description.abstractBACKGROUND:There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.METHODS:The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.RESULTS:Recommendations were developed for "using available data" and "future clinical studies". The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.CONCLUSION:The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttp://www.trialsjournal.com/content/15/1/169en
dc.rights© 2014 Witt et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)en
dc.subjectComparative effectiveness researchen
dc.subjectEffectiveness guidance documenten
dc.subjectChinese medicine researchen
dc.titleEffectiveness guidance document (EGD) for Chinese medicine trials: a consensus documenten
dc.typeArticleen
dc.identifier.eissn1745-6215en
dc.contributor.departmentInstitute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Switzerlanden
dc.contributor.departmentCenter for Integrative Medicine, University of Maryland, School of Medicine, Baltimore, MD, USAen
dc.contributor.departmentDepartment of Family and Community Medicine, University of Arizona, Tucson, AZ, USAen
dc.contributor.departmentGroup Health Research Institute, Seattle, WA, USAen
dc.contributor.departmentDepartment of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago, Chicago, IL, USAen
dc.contributor.departmentKaiser Permanente Northwest, Center for Health Research, Portland, OR, USAen
dc.contributor.departmentComplementary and Integrated Medicine Research Unit, Department of Primary Care, University of Southampton, Southampton, UKen
dc.contributor.departmentResearch Department, Oregon College of Oriental Medicine, Portland, Oregon, USAen
dc.contributor.departmentCenter for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, Chinaen
dc.contributor.departmentComplementary Medicine Program and Integrative Medicine, University of Maryland Medical Center, Baltimore, MD, USAen
dc.contributor.departmentCenters for Medicare and Medicaid Services, Baltimore, Maryland, USAen
dc.contributor.departmentSchool of Nursing, The University of Texas at Austin, Austin, TX, USAen
dc.contributor.departmentOsher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USAen
dc.contributor.departmentThe Institute for Integrative Health, Baltimore, MD, USAen
dc.contributor.departmentSchool of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Chinaen
dc.contributor.departmentPatient stakeholder, New York, NY 10001, USAen
dc.identifier.journalTrialsen
dc.description.collectioninformationThis item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
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