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开展随机对照试验的障碍:从七叶树与下肢静脉溃疡试验(HAVLUT)中吸取的教训。

Barriers to conducting randomised controlled trials: lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT).

作者信息

Leach Matthew J

机构信息

University of South Australia, and Royal District Nursing Service, South Australia.

出版信息

Contemp Nurse. 2003 Aug;15(1-2):37-47. doi: 10.5172/conu.15.1-2.37.

DOI:10.5172/conu.15.1-2.37
PMID:14649507
Abstract

The RCT is considered the gold standard for testing a therapeutic intervention. However, the conduct of an RCT is not without numerous obstacles. As illustrated through the recent Horsechestnut and Venous Leg Ulcer Trial (HAVLUT), these barriers can be attributed to randomisation, recruitment, retention, blinding and sampling procedures, and to gate keeping. These obstacles, together with strategies to prevent and overcome them, are detailed throughout this article, and are aimed at ameliorating the future design and conduct of RCTs.

摘要

随机对照试验被视为测试治疗性干预措施的金标准。然而,开展随机对照试验并非没有诸多障碍。正如最近的七叶树与下肢静脉溃疡试验(HAVLUT)所表明的那样,这些障碍可归因于随机化、招募、保留、盲法和抽样程序,以及把关。本文详细阐述了这些障碍以及预防和克服它们的策略,旨在改进未来随机对照试验的设计和实施。

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