Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials
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
BMC Complementary and Alternative Medicine 2012, 12:148 doi:10.1186/1472-6882-12-148Published: 6 September 2012
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.
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.
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.
The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.