| 胡贵平,胡亚楠,詹思延.PRECIS研究进展[J].中华流行病学杂志,2016,37(3):439-442 |
| PRECIS研究进展 |
| Progress in research of pragmatic-explanatory continuum indicator summary |
| 收稿日期:2015-08-03 出版日期:2016-03-15 |
| DOI：10.3760/cma.j.issn.0254-6450.2016.03.031 |
| 中文关键词: 随机对照试验 PRECIS 实用性试验 解释性试验 |
| 英文关键词: Randomized controlled trial Pragmatic-explanatory continuum indicator summary Pragmatic/practical trial Explanatory trial |
| 基金项目:国家科技重大专项(2012ZX10005009-002) |
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| 中文摘要: |
| 随机对照试验(RCT)可分为评估效力的解释性试验和评估临床效果的实用性临床试验(PCT)。PCT反映了临床实际条件下的干预效应,具有一定的外推性,但其内部真实性相对较差。与此相反,解释性试验是在理想条件下进行,其内部真实性较好,而外推性较差。但在RCT实际设计中,PCT和解释性试验并不是截然分离的两个极端,有许多RCT同时兼有两种设计的属性。PRECIS通过评价RCT设计的解释和实用两方面,指导如何实行干预和试验设计,使RCT在内部和外部真实性之间达到平衡。目前国内对PRECIS介绍甚少,更未见应用的报道,基于此以下介绍PRECIS基本原理、特点及应用,以期为临床试验设计提供参考。 |
| 英文摘要: |
| Randomized controlled trial (RCT) can be designed as explanatory trial and pragmatic/practical trial (PCT) for clinical effect evaluation. The pragmatic/practical trial reflects the intervention effect under actual clinical condition, which has relatively good extrapolation, but its internal validity is relatively poor. In contrast, explanatory trials conducted under ideal conditions have better inner validity but inferior external validity. However, in the design of RCT, PCT and explanatory trials are not always opposite. Many RCTs have the properties of the two designs at the same time, Pragmatic-explanatory continuum indicator summary (PRECIS) can be used in the design of RCT for the balance between internal validity and external validity. There are few available reports about the application of PRECIS in China at present, so this paper summarizes the basic principles, characteristics of PRECIS and the application of PRECIS in order to provide reference for the clinical trial design in China. |
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