TY - JOUR
T1 - Effectiveness guidance document (EGD) for Chinese medicine trials
T2 - A consensus document
AU - Witt, Claudia M.
AU - Aickin, Mikel
AU - Cherkin, Daniel
AU - Che, Chun T.
AU - Elder, Charles
AU - Flower, Andrew
AU - Hammerschlag, Richard
AU - Liu, Jian Ping
AU - Lao, Lixing
AU - Phurrough, Steve
AU - Ritenbaugh, Cheryl
AU - Rubin, Lee H.
AU - Schnyer, Rosa
AU - Wayne, Peter M.
AU - Withers, Shelly R.
AU - Zhao-Xiang, Bian
AU - Young, Jeanette
AU - Berman, Brian M.
AU - Bensoussan, Alan
AU - Brinkhaus, Benno
AU - Cardini, Francesco
AU - Chen, Kevin
AU - Lewith, George
AU - Linde, Klaus
AU - MacPherson, Hugh
AU - Nahin, Richard L.
AU - Weissberg, Jed
N1 - Funding Information:
The workshop was funded by The Institute for Integrative Health (TIIH), Baltimore MD, USA, a non-profit organization. Brian Berman is the president of TIIH, which supported Claudia Witt with a travel grant for the submitted work.
PY - 2014/5/13
Y1 - 2014/5/13
N2 - 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.
AB - 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.
KW - Chinese medicine research
KW - Comparative effectiveness research
KW - Effectiveness guidance document
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U2 - 10.1186/1745-6215-15-169
DO - 10.1186/1745-6215-15-169
M3 - Article
C2 - 24885146
AN - SCOPUS:84902104006
SN - 1745-6215
VL - 15
JO - Trials
JF - Trials
IS - 1
M1 - 169
ER -