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Open Access Highly Accessed Correspondence

Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials

Claudia M Witt12*, Mikel Aickin3, Trini Baca4, Dan Cherkin5, Mary N Haan6, Richard Hammerschlag7, Jason Jishun Hao8, George A Kaplan9, Lixing Lao2, Terri McKay4, Beverly Pierce10, David Riley11, Cheryl Ritenbaugh3, Kevin Thorpe12, Sean Tunis13, Jed Weissberg14, Brian M Berman2 and Collaborators

Author affiliations

1 Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, Berlin, Germany

2 Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA

3 Department of Family and Community Medicine, University of Arizona, Tucson, USA

4 Patient stakeholder

5 Group Health Center for Health Studies, Seattle, USA

6 Department of Epidemiology and Biostatistics, University of California, San Francisco, USA

7 Research Department, Oregon College of Oriental Medicine, Portland, Oregon, USA

8 International Academy of Scalp Acupuncture, Southwest Acupuncture College, Santa Fe, USA

9 Center for Social Epidemiology and Population Health, University of Michigan, Ann Arbor, USA

10 The Institute for Integrative Health, Community programs, Baltimore, USA

11 Integrative Medicine, University of New Mexico Medical School, Albuquerque, USA

12 Dalla Lana School of Public Health, University of Toronto, Toronto, Canada

13 Center for Medical Technology Policy, Baltimore, Maryland, USA

14 Kaiser Foundation Health Plan and Hospitals, Hospitals, Quality and Care Delivery Excellence, Oakland, USA

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Citation and License

BMC Complementary and Alternative Medicine 2012, 12:148  doi:10.1186/1472-6882-12-148

Published: 6 September 2012

Abstract

Background

There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making.

Methods

Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved.

Results

Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.

Conclusion

The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.

Keywords:
Comparative effectiveness research; Effectiveness guidance document; Acupuncture