设计实用性试验——我们能从经验教训中学到什么？
Designing pragmatic trials-what can we learn from lessons learned?
作者信息
Groenwold Rolf H H, Dekkers Olaf M
机构信息
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Utrecht 3584 CG, The Netherlands.
Department of Clinical Endocrinology and Metabolism, Leiden University Medical Centre, Albinusdreef 2, Leiden 2333 ZA, The Netherlands; Department of Clinical Epidemiology, Leiden University Medical Centre, Albinusdreef 2, Leiden 2333 ZA, The Netherlands; Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45, Aarhus DK-8200, Denmark.
出版信息
J Clin Epidemiol. 2017 Oct;90:3-5. doi: 10.1016/j.jclinepi.2017.06.006. Epub 2017 Jun 16.
Pragmatic trials aim to inform clinical decision making by measuring the effect of a treatment in clinical practice. The purpose of the PRECIS-2 tool is to support in designing a truly pragmatic trial. We comment on a study by Forbes et al., who assessed the applicability of the PRECIS-2 tool. The tool will prove particularly useful when implemented in the process of trial design. However, it is yet unclear how e.g., possible dependencies between PRECIS domains, or conducting a pragmatic trial within an existing data registry (e.g., electronic health records) affect the applicability of the tool.
实用性试验旨在通过衡量一种治疗方法在临床实践中的效果来为临床决策提供依据。PRECIS-2工具的目的是支持设计真正的实用性试验。我们对福布斯等人的一项研究进行评论，他们评估了PRECIS-2工具的适用性。该工具在试验设计过程中实施时将证明特别有用。然而，目前尚不清楚例如PRECIS各领域之间可能的相互依存关系，或在现有数据登记系统（如电子健康记录）内进行实用性试验如何影响该工具的适用性。
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