临床试验设计和实施中的方法学考虑。
Methodological considerations in the design and implementation of clinical trials.
出版信息
Semin Oncol Nurs. 2014 Feb;30(1):74-9. doi: 10.1016/j.soncn.2013.12.011. Epub 2013 Dec 17.
Abstract
OBJECTIVES
To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials.
DATA SOURCES
Studies available at clinicaltrials.gov using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted.
CONCLUSION
The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself.
IMPLICATIONS FOR NURSING PRACTICE
Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on.
摘要
目的
回顾肿瘤护士主导的临床试验中的研究设计问题，特别关注合作组环境下开展的临床试验；强调统计学家在临床试验过程中的作用。
资料来源
在 clinicaltrials.gov 上，使用已在同行评审期刊上发表的实验设计，可获取相关研究；重点介绍合作组试验。
结论
临床试验是检验干预效果的主要手段。设计合理、有足够效力、目标清晰且可衡量的研究与干预本身同样重要。
对护理实践的意义
研究团队（包括统计学家）之间的协作对于开展设计合理的研究至关重要。为了获得最佳结果，协作是一个持续的过程，应尽早开始。
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