title: Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Switzerland. claudia.witt@uzh.ch.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
authors.forename: Mikel
authors.initials: M
authors.lastname: Aickin
authors.forename: Daniel
authors.initials: D
authors.lastname: Cherkin
authors.forename: Chun Tao
authors.initials: CT
authors.lastname: Che
authors.forename: Charles
authors.initials: C
authors.lastname: Elder
authors.forename: Andrew
authors.initials: A
authors.lastname: Flower
authors.forename: Richard
authors.initials: R
authors.lastname: Hammerschlag
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Liu
authors.forename: Lixing
authors.initials: L
authors.lastname: Lao
authors.forename: Steve
authors.initials: S
authors.lastname: Phurrough
authors.forename: Cheryl
authors.initials: C
authors.lastname: Ritenbaugh
authors.forename: Lee Hullender
authors.initials: LH
authors.lastname: Rubin
authors.forename: Rosa
authors.initials: R
authors.lastname: Schnyer
authors.forename: Peter M
authors.initials: PM
authors.lastname: Wayne
authors.forename: Shelly Rafferty
authors.initials: SR
authors.lastname: Withers
authors.forename: Bian
authors.initials: B
authors.lastname: Zhao-Xiang
authors.forename: Jeanette
authors.initials: J
authors.lastname: Young
authors.forename: Brian M
authors.initials: BM
authors.lastname: Berman
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D057186:Comparative Effectiveness Research / Q000592:standards*; D032921:Consensus; D003697:Delphi Technique; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000592:standards*; D012107:Research Design / Q000592:standards*