Bian Zhao-xiang, Moher David, Li You-ping, Wu Tai-xiang, Dagenais Simon, Cheng Chung-wah, Li Jing, Li Ting-qian
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Zhong Xi Yi Jie He Xue Bao. 2008 Aug;6(8):771-5. doi: 10.3736/jcim20080801.
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.
评估结果是比较不同医学模式有效性的主要手段。在中医领域，这种关注促使从业者寻找能够客观验证中医干预措施有效性的结果指标，尤其是在随机对照试验（RCT）的背景下。中医RCT中常用的疗效评估指标可分为两类：中医特有的指标，如舌象和脉象特征；西医特有的指标，如血液检查和X光检查结果。一些研究同时纳入了这两类指标。在试验设计过程中，有必要考虑选择疗效评估指标的依据、目的和研究方法、客观指标与主观指标的平衡、疗效评估的标准化以及标准化的疗效指标。我们建议按照以下格式报告中医RCT的疗效评估：1）根据试验目的和假设确定主要和次要结局；2）明确界定主要和次要结局；3）阐述选择的依据；4）介绍旨在使评估过程标准化的方法；5）介绍提高评估可靠性的方法；6）说明试验中的终止标准。
