隨機對照實況試驗由于所納入的受試者和干預過程接近臨床實踐的真實狀況,其效應量接近或與臨床實踐真實情況相似,因此其療效效應量用于評估患者的療效較之辨析性研究更加準確。由于其特點是干預措施和過程可變,符合包括中醫藥和針灸在內的臨床治療特點,因而日益受到國內中醫藥界的極大興趣和關注。實際上,隨機對照實況試驗也適合于比較采用臨床路徑和不采用臨床路徑管理患者的效果。本文介紹了隨機對照實況試驗的原理和概念,并通過舉例說明其設計要點。
引用本文:
吳泰相,商洪才,卞兆祥. 隨機對照實況試驗的概念、設計和實施. 中國循證醫學雜志, 2009, 09(12): 1277-1280. doi: 10.7507/1672-2531.20090232
復制
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Merrick Z, Shaun T, Joel JG, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 2008, 337: a2390.
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Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis, 1967, 20(8): 637-648.
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Shaun T, Merrick Z. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials, 2009, 10: 37.
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- 1. Merrick Z, Shaun T, Joel JG, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 2008, 337: a2390.
- 2. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis, 1967, 20(8): 637-648.
- 3. Shaun T, Merrick Z. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials, 2009, 10: 37.