Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine

Zhaoxiang Bian*, David Moher, You Ping Li., Tai Xiang Wu, Simon Dagenais, Chung Wah Cheng, Jing Li, Ting Qian Li

*Corresponding author for this work

Research output: Contribution to journalEditorial

22 Citations (Scopus)

Abstract

Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

结局指标是临床医学判断干预措施效果的必要手段。在中医药临床研究报告中,常见测量指标包括中医类指标如舌象、脉象及中医证候描述等;西医类指标如现代检验学方面的指标等。研究中测量指标的选择应充分考虑研究的性质和目的以及中医药干预措施的特点,同时亦应考虑测量指标是否具有统一标准,并在主观性和客观性两方面取得平衡。为此,研究报告中应该包括:(1)根据研究目的和假设确定主要和次要结局测量指标;(2)明确定义主要和次要结局测量指标;(3)说明结局测量指标选择的依据;(4)说明结局测量指标的测量方法和标准;(5)注明提高结局测量指标的测量质量和可靠性的方法;(6)确定终止试验的原则。 

Original languageEnglish
Pages (from-to)771-775
Number of pages5
Journal中西医结合学报
Volume6
Issue number8
DOIs
Publication statusPublished - 15 Aug 2008

Scopus Subject Areas

  • Complementary and alternative medicine

User-Defined Keywords

  • Chinese herbal drugs
  • Clinical research
  • Evidence-based medicine
  • Outcome measure
  • Randomized controlled trials
  • Traditional Chinese medicine
  • 中医学
  • 中药
  • 临床研究
  • 随机对照试验
  • 循证医学
  • 结果评价

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