CAJ | 학술논문

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.
결국지표시림상의학판단간예조시효과적필요수단.재중의약림상연구보고중,상견측량지표포괄중의류지표여설상、맥상급중의증후묘술등;서의류지표여현대검험학방면적지표등.연구중측량지표적선택응충분고필연구적성질화목적이급중의약간예조시적특점,동시역응고필측량지표시부구유통일표준,병재주관성화객관성량방면취득평형.위차,연구보고중응해포괄:(1)근거연구목적화가설학정주요화차요결국측량지표;(2)명학정의주요화차요결국측량지표;(3)설명결국측량지표선택적의거;(4)설명결국측량지표적측량방법화표준;(5)주명제고결국측량지표적측량질량화가고성적방법;(6)학정종지시험적원칙.
Evaluating outcome is the primary means by which different medical modalities can be compare dwith 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.