随机对照试验的外部有效性:"这项试验的结果适用于谁?"
1Stroke Prevention Research Unit, University Department of Clinical Neurology, Radcliffe Infirmary, Oxford OX2 6HE, UK. peter.rothwell@clneuro.ox.ac.uk
Lancet (London, England)
|January 11, 2005
概括
随机对照试验 (RCT) 的外部有效性或通用性对于有效的临床决策至关重要. 本次审查强调了对外部有效性的忽视,并提出了改善其在医学研究中的报告的建议.
科学领域:
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
- 医疗保健服务研究 医疗服务研究
背景情况:
- 治疗决策依赖于随机对照试验 (RCT) 和系统审查.
- 外部有效性 (通用性) 是将试验结果应用于真实世界的临床实践的关键.
- 临床医生认为一些试验的外部有效性很差,导致有效治疗的潜在使用不足.
研究的目的:
- 讨论临床试验中外部有效性的决定因素.
- 为临床医生提供一个检查清单,以评估外部有效性.
- 在RCT设计和报告中考虑外部有效性的改进建议.
主要方法:
- 关于RCT外部有效性决定因素的文献综述.
- 开发一个专注于临床医生的检查清单,以评估可概括性.
- 在试验出版物和系统审查中对外部有效性的当前报告实践的分析.
主要成果:
- 外部有效性经常被研究人员,行业和监管机构忽视.
- 在出版物中报告影响外部有效性的因素往往是不充分的.
- 临床医生可以独立判断试验结果的概括性.
结论:
- 改善报告和考虑外部有效性对于基于证据的实践至关重要.
- 结构化的方法和检查清单可以帮助临床医生评估治疗适用性.
- 更多地关注RCT的外部有效性,将提高研究结果在常规护理中的有用性.
关键词:
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