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Open Access Methodology

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

Claudia M Witt12*, Mikel Aickin3, Daniel Cherkin4, Chun Tao Che5, Charles Elder6, Andrew Flower7, Richard Hammerschlag8, Jian-Ping Liu9, Lixing Lao10, Steve Phurrough11, Cheryl Ritenbaugh3, Lee Hullender Rubin8, Rosa Schnyer12, Peter M Wayne13, Shelly Rafferty Withers14, Bian Zhao-Xiang15, Jeanette Young16, Brian M Berman142 and Collaborators

Author Affiliations

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

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Trials 2014, 15:169  doi:10.1186/1745-6215-15-169

Published: 13 May 2014

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.

Keywords:
Comparative effectiveness research; Effectiveness guidance document; Chinese medicine research