1. 中国中医科学院西苑医院
2. 首都医科大学宣武医院
3. 北京中医药大学东直门医院
纸质出版:2021
移动端阅览
[1]杨洋,孙亚男,于长禾.冠心病中医临床疗效评价量表的测量学性能及研究方法学质量评价[J].中医杂志,2021,62(03):217-223.
YANG Yang, SUN Yanan, YU Changhe. The Measurement Property and Methodological Quality of Traditional Chinese Medicine Clinical Effectiveness Evaluation Scales for Coronary Heart Disease[J]. Journal of Traditional Chinese Medicine2021, 62(3): 217-223.
[1]杨洋,孙亚男,于长禾.冠心病中医临床疗效评价量表的测量学性能及研究方法学质量评价[J].中医杂志,2021,62(03):217-223. DOI: 10.13288/j.11-2166/r.2021.03.008.
YANG Yang, SUN Yanan, YU Changhe. The Measurement Property and Methodological Quality of Traditional Chinese Medicine Clinical Effectiveness Evaluation Scales for Coronary Heart Disease[J]. Journal of Traditional Chinese Medicine2021, 62(3): 217-223. DOI: 10.13288/j.11-2166/r.2021.03.008.
目的系统评价冠心病中医临床疗效评价量表的测量性能及相关研究的方法学质量。方法检索中国知网、万方、重庆维普、PubMed、Embase及OVID数据库
检索时间范围为建库至2019年11月1日。纳入测量冠心病中医临床疗效评价相关的工具及其测量学性能评价的文献
分别采用量表测量学性能评价标准和COSMIN清单对量表测量学性能、量表研究的方法学质量进行评价。结果纳入文献17篇
涉及14项研究共计8个量表
分别为冠心病稳定型心绞痛(痰瘀互结证)疗效评价证候计分表(TCMsys)、冠心病稳定型心绞痛(痰瘀互结证)自评量表(CHD-SF)、冠心病心绞痛血瘀证疗效评价量表(CHD-XY)、冠心病心纹痛中医证候疗效评价量表(CHD-TCM)、冠心病心绞痛患者报告临床结局疗效评价量表(CHD-PRO)、中医特色冠心病生存质量量表(CAD-QOL)、冠心病心绞痛(气虚血瘀证)症状疗效评分量表(CHD-QX)、冠心病中西医结合生存质量量表(CHD-QOL)。测量学性能方面
8个量表的理论框架和条目研发满足内容效度要求
且反应度评价均在一般及以上;除CHD-QOL外其余7个量表的内部一致性、效标效度、结构效度评价多为差或未提及;解释性评价5个量表未提及
可重复性中的一致性、天花板/地板效应评价8个量表均未提及。相关研究的方法学质量方面
量表总体研究方法学质量一般偏低
其中CHD-SF研究质量相对最好
其次是CHD-QOL。结论现有证据提示冠心病中医临床疗效评价量表的测量性能还不够全面、总体研究方法学质量偏低
其中CHD-QOL的性能评价及研究质量相对尚可
暂时推荐其作为以冠心病为目标人群的临床对照和纵向研究的测量工具。
Objective To systematically assess the measurement property and methodological quality of the traditional Chinese medicine(TCM) clinical effectiveness evaluation scales for coronary heart disease(CHD). Methods Databases including CNKI
Wanfang
VIP
PubMed
Embase and OVID were searched from the inception date till November 1 st
2019. Studies on TCM clinical effectiveness evaluation scales for CHD were included; the measurement property standards and the consensus-based standards for the selection of health measurement instruments(COSMIN) were used to evaluate the measurement performance and the methodological quality respectively. Results Eight scales involving 14 studies of 17 papers were included
which were TCM syndrome evaluation scale of phlegm and blood stasis syndrome in CHD with stable angina pectoris(TCMsys)
self-evaluation scale of CHD stable angina with the syndrome of phlegm and blood stasis(CHD-SF)
efficacy evaluation scale for CHD angina pectoris with syndrome of blood stasis(CHD-XY)
effectiveness evaluation scale of TCM pattens for CHD angina pectoris(CHD-TCM)
rating scale for patients reported outcomes of CHD angina(CHD-PRO)
quality of life scale with TCM characteristics for coronary artery disease(CAD)(CAD-QOL)
symptoms scale for evaluating efficacy of coronary angina pectoris with Qi deficiency and blood stagnation(CHD-QX)
quality of life scale of integration of TCM and western medicine for CHD(CHD-QOL). In terms of measurement property
the theoretical framework and the items development of eight scales meet the content validity requirements
and the responsiveness was at average level or above. The internal consistency
criterion validity
and construct validity were assessed as poor or not mentioned in all the scales except for CHD-QOL. Explanatory evaluation was not mentioned in five scales. Consistency and ceiling and floor effect of reproducibility evaluation were not mentioned in all scales. The methodological quality of the scale-related studies was generally poor
of which the quality of CHD-SF was the best
followed by CHD-QOL. Conclusion The measurement property of the current TCM clinical effectiveness evaluation scales for CHD is not comprehensive
and the overall methodological quality was poor. CHD-QOL is temporarily recommended as the measurement tool for clinical control studies and longitudinal researches on CHD
as its measurement property and methodological quality are relatively acceptable.
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