Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine.
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.
Bian
Zhao-xiang
ZX
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. bzxiang@hkbu.edu.hk
Moher
David
D
Li
You-ping
YP
Wu
Tai-xiang
TX
Dagenais
Simon
S
Cheng
Chung-wah
CW
Li
Jing
J
Li
Ting-qian
TQ
D019317:Evidence-Based Medicine; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000592:standards*; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome