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Journal of Chinese Integrative Medicine ›› 2007, Vol. 5 ›› Issue (5): 497-501.doi: 10.3736/jcim20070503

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Clinical outcome assessment and the effect measure

Hong-wei Zhang, Jian-ping Liu, Xia Wan, Yan-ke Ai   

  1. Evidence-based Chinese Medicine Center, Beijing University of Chinese Medicine, Beijing 100029, China
  • Online:2007-09-20 Published:2007-09-15

Effect of clinical intervention on human body is multistage and multifaceted, involving physiology, psychology, social function and the surrounding resources, etc. Therefore, the range of clinical outcome assessment includes patient, his or her family and care giver. The evaluation of clinical intervention mainly focuses on its effectiveness, safety and health economics. Effects of clinical interventions are measured by comparisons of the outcome of intervention and control groups. Different effect measures come from different comparisons.

Key words: clinical trials, treatment outcome, outcome assessment

CLC Number: 

  • R-44

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组别 结局事件 无结局事件 合计
试验组 a b a+b
对照组 c d c+d
[1] Gray M, 唐金陵.循证医学-循证医疗卫生决策(第1版)[M]. 北京: 北京大学医学出版社, 2004,( 第1版):167-237
Gray M, Tang JL. Evidence-based decision making in health care(1st ed)[M]. Beijing: Peking University Medical Press, 2004,( 1st ed):167-237
[2] 郭新峰, 赖世隆, 梁伟雄 . 中医药临床疗效评价中结局指标的选择与应用[J]. 广州中医药大学学报, 2002,19(4):251-255
doi: 10.3969/j.issn.1007-3213.2002.04.002
Guo XF, Lai SL, Liang WX . Choice and application of the outcome indexes for clinical effectiveness assessment of traditional Chinese medicine[J]. Guangzhou Zhong Yi Yao Da Xue Xue Bao, 2002,19(4):251-255
[3] 谭燕, 刘鸣 . 抗高血压治疗二级预防国际大型临床试验的回顾[J]. 中国现代神经疾病杂志, 2005,5(6):377-380
Tan Y, Liu M . Review of large scale international clinical trials on secondary prevention of antihypertensive treatment[J]. Zhongguo Xian Dai Shen Jing Ji Bing Za Zhi, 2005,5(6):377-380
[4] 郭新峰, 朱泉, 赖世隆 . 替代指标和中间指标及其在中医药疗效评价研究中应用价值的思考[J]. 中国中西医结合杂志, 2005,25(7):585-590
Guo XF, Zhu Q, Lai SL . Thinking on surrogate outcomes, intermediary outcomes and their application in TCM clinical efficacy evaluation[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2005,25(7):585-590
[5] Ellenberg S, 刘淑红, 李海欣, 等.替代终点:一个值得讨论的热点问题[J]. 药物流行病学杂志, 2002,11(4):207-208
Ellenberg S, Liu SH, Li HX , et al. Surrogate endpoints: a hot topic worthy of more discussion[J]. Yao Wu Liu Xing Bing Xue Za Zhi, 2002,11(4):207-208
[6] 国家中医药管理局. 中华人民共和国中医药行业标准--中医病证诊断疗效标准(第1版)[M]. 南京: 南京大学出版社, 1994,( 第1版):6
State Administration of Traditional Chinese Medicine. Traditional Chinese medicine profession criterion for People's Republic of China--Standard for diagnosis and therapeutic effectiveness evaluation of traditional Chinese medicine syndromes(1st ed)[M]. Nanjing: Nanjing University Press, 1994,( 1st ed):6
[7] 赵利, 刘凤斌, 梁国辉 , 等. 中华生存质量量表的信度和效度[J]. 中国临床康复, 2006,10(8):1-3
Zhao L, Liu FB, Liang GH , et al. Reliability and validity of Chinese Quality of Life Instrument[J]. Zhongguo Lin Chuang Kang Fu, 2006,10(8):1-3
[8] 王家良 . 临床流行病学--临床科研设计、衡量与评价(第2版)[M]. 上海: 上海科学技术出版社, 2001,( 第2版):345-357
Wang JL . Clinical epidemiology--Clinical research design, measurement and evaluation(2nd ed)[M]. Shanghai: Shanghai Scientific and Techincal Publishers, 2001,( 2nd ed):345-357
[9] 刘建平 . 临床试验效应的表达--指标及其意义.[J] 中国中西医结合杂志, 2004,24(8):677-680
Liu JP . Effect measure of clinical trial--Item and significance[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2004,24(8):677-680
[10] Cochrane Handbook for Systematic Reviews of Interventions 4.2.5. [2005-05][ 2005-05].
[11] Moher D, Schultz KF, Altman D . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. JAMA, 2001,285(15):1987-1991
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