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Reflections One Year into the 22 Center NIH-funded WRIST Study. A Primer on Conducting a Multicenter Clinical Trial

机译:一年后进入22个由美国国立卫生研究院资助的WRIST研究的反思。进行多中心临床试验入门

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摘要

The Wrist and Radius Surgery Trial (WRIST) study group is a collaboration of 22 hand surgery centers in the US, Canada, and Singapore to showcase the interest and capability of hand surgeons to conduct a multicenter clinical trial. The WRIST study group was formed in response to the seminal systematic review by Margaliot et al. and the Cochrane report that indicated marked deficiency in the quality of evidence in the distal radius fracture literature. Since the initial description of this fracture by Colles in 1814, over 2,000 studies have been published on this subject, yet high level studies based on the principles of evidence-based medicine are lacking. As we continue to embrace evidence-based medicine to raise the quality of research, the lessons learned during the organization and conduct of WRIST can serve as a template for others contemplating similar efforts. This paper will trace the course of WRIST by sharing the triumphs, and more importantly the struggles, faced in the first year of this study.
机译:手腕和半径外科手术试验(WRIST)研究小组是美国,加拿大和新加坡的22个手外科中心的合作,以展示手外科医师进行多中心临床试验的兴趣和能力。 WRIST研究小组是为回应Margaliot等人的开创性系统审查而成立的。 Cochrane报告指出radius骨远端骨折文献的证据质量明显不足。自1814年Colles首次对这种骨折进行描述以来,已针对该主题发表了2,000多项研究,但缺乏基于循证医学原理的高级研究。随着我们继续采用循证医学来提高研究质量,WRIST在组织和开展过程中吸取的教训可以作为其他人在考虑类似工作时的模板。本文将通过分享胜利,更重要的是,在本研究的第一年面临的斗争来追踪WRIST的过程。

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