Witt, Claudia MAickin, MikelCherkin, DanielChe, Chun TaoElder, CharlesFlower, AndrewHammerschlag, RichardLiu, Jian-PingLao, LixingPhurrough, SteveRitenbaugh, CherylRubin, Lee HullenderSchnyer, RosaWayne, PeterWithers, Shelly RaffertyZhao-Xiang, BianYoung, JeanetteBerman, Brian M2014-07-072014Witt, C. M., M. Aickin, D. Cherkin, C. T. Che, C. Elder, A. Flower, R. Hammerschlag, et al. 2014. “Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document.” Trials 15 (1): 169. doi:10.1186/1745-6215-15-169. http://dx.doi.org/10.1186/1745-6215-15-169.1745-6215http://nrs.harvard.edu/urn-3:HUL.InstRepos:12406815Background: 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.en-USComparative effectiveness researchEffectiveness guidance documentChinese medicine researchJournal Article2014-07-0710.1186/1745-6215-15-169