在大型会议上讨论随机化癌症试验的参与者的指导
Elizabeth A Eisenhauer1, Omar Abdihamid2, Christopher M Booth1
1Queen's University, Kingston, ON, Canada.
概括
讨论癌症临床试验的人需要一个标准化的框架来批判性地评估研究设计,结果和患者的结果. 这确保了对改变实践的研究进行准确的解释和传播,以在全球范围内改善癌症护理.
科学领域:
- 在瘤学瘤学.
- 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.
背景情况:
- 大型癌症会议的讨论者批判性地评估随机临床试验 (RCT),以将新发现置于背景,评估概括性,并确定对患者有意义的结果.
- 缺乏标准化的批评方法可能会导致在试验设计和结果解释方面忽视关键的弱点.
- 常识瘤学 (CSO) 倡议旨在改善证据生成和报告,以便患者平等地获得有意义的癌症治疗结果.
研究的目的:
- 为评估可能改变实践的随机临床试验 (RCT) 的讨论者提供一个结构化的框架.
- 促进在主要癌症会议上提出的RCT的平衡和高质量的检查.
- 加强对不同受众的试验结果的有效和客观沟通.
主要方法:
- 公民社会组织RCT工作组确定了批评RCT的关键要素.
- 评估包括研究设计 (问题,人群,对照组,失明,终点),研究结果 (交付,交叉,审查,分析,PRO,不良事件) 和结论 (价值,概括性,比标准护理有意义的好处).
主要成果:
- 已经制定了一份全面的检查清单,其中包括讨论演示文稿的元素.
- 该框架指导研究设计的评估,结果的解释以及试验发现的临床意义.
- 结构化方法旨在确保对RCT进行彻底和客观的评估.
结论:
- 实施这种标准化的方法将提高RCT讨论的质量.
- 它使讨论参与者能够提供更准确的背景,评估可概括性,并评估结果对患者的意义.
- 该倡议支持民间组织的愿景,即确保患者接受癌症治疗,从而显著改善结果.
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