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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (8): 771-775.doi: 10.3736/jcim20080801

• Editorial •     Next Articles

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

Zhao-xiang Bian1(), David Moher2, You-ping Li3, Tai-xiang Wu3, Simon Dangenais4, Chung-wah Cheng1, Jing Li3, Ting-qian Li3   

  1. 1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
    2. Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    3. Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    4. Division of Orthopaedic Surgery and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  • Received:2008-05-05 Online:2008-08-20 Published:2008-08-15

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.

Key words: traditional Chinese medicine, Chinese herbal drugs, clinical research, randomized controlled trials, evidence-based medicine, outcome measure

CLC Number: 

  • R-3


论文部分和主题 项目 描述
6 根据研究目的和假设,明确定义主要和次要结局测量指标,解释其选择依据,并注明结局测量指标的测量方法(如评估人员的资历、怎样和何时进行等)和标准(如有否采用公认的金标准),及说明用于提高测量质量的方法(如多次重覆观察、评估人员培训等)。说明评估干预措施安全性的方法和终止试验的原则。
17 按照主要和次要结局测量指标顺序描述结果,对效应量及精确度进行描述(如95%可信区间)
20 针对研究假设对结果进行分析,阐述研究的潜在偏倚、不确定因素和导致多样性结果的风险,并根据研究目的和方向说明中药干预措施的疗效和安全性。
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