title: Effectiveness Guidance Document (EGD) for acupuncture research - a consensus document for conducting trials.
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.
  
  
  CONCLUSIONS
  The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.
authors.affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, Berlin, Germany. claudia.witt@charite.de
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
authors.forename: Mikel
authors.initials: M
authors.lastname: Aickin
authors.forename: Trini
authors.initials: T
authors.lastname: Baca
authors.forename: Dan
authors.initials: D
authors.lastname: Cherkin
authors.forename: Mary N
authors.initials: MN
authors.lastname: Haan
authors.forename: Richard
authors.initials: R
authors.lastname: Hammerschlag
authors.forename: Jason Jishun
authors.initials: JJ
authors.lastname: Hao
authors.forename: George A
authors.initials: GA
authors.lastname: Kaplan
authors.forename: Lixing
authors.initials: L
authors.lastname: Lao
authors.forename: Terri
authors.initials: T
authors.lastname: McKay
authors.forename: Beverly
authors.initials: B
authors.lastname: Pierce
authors.forename: David
authors.initials: D
authors.lastname: Riley
authors.forename: Cheryl
authors.initials: C
authors.lastname: Ritenbaugh
authors.forename: Kevin
authors.initials: K
authors.lastname: Thorpe
authors.forename: Sean
authors.initials: S
authors.lastname: Tunis
authors.forename: Jed
authors.initials: J
authors.lastname: Weissberg
authors.forename: Brian M
authors.initials: BM
authors.lastname: Berman
mesh_terms: D015670:Acupuncture Therapy / Q000592:standards; D057186:Comparative Effectiveness Research; D032921:Consensus; D003657:Decision Making; D019317:Evidence-Based Medicine; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards