Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document
1 Institute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Switzerland
2 Center for Integrative Medicine, University of Maryland, School of Medicine, Baltimore, MD, USA
3 Department of Family and Community Medicine, University of Arizona, Tucson, AZ, USA
4 Group Health Research Institute, Seattle, WA, USA
5 Department of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago, Chicago, IL, USA
6 Kaiser Permanente Northwest, Center for Health Research, Portland, OR, USA
7 Complementary and Integrated Medicine Research Unit, Department of Primary Care, University of Southampton, Southampton, UK
8 Research Department, Oregon College of Oriental Medicine, Portland, Oregon, USA
9 Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
10 Complementary Medicine Program and Integrative Medicine, University of Maryland Medical Center, Baltimore, MD, USA
11 Centers for Medicare and Medicaid Services, Baltimore, Maryland, USA
12 School of Nursing, The University of Texas at Austin, Austin, TX, USA
13 Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
14 The Institute for Integrative Health, Baltimore, MD, USA
15 School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, China
16 Patient stakeholder, New York, NY 10001, USA
Trials 2014, 15:169 doi:10.1186/1745-6215-15-169Published: 13 May 2014
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.
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.
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.
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.