在细胞癌 (R-COS) 疗效试验和临床审计中制定核心结果集的协议
Steven MacLennan1, Lisa M Wintner2, Katharina Beyer3
1Academic Urology Unit, Institute of Applied Health Sciences University of Aberdeen Aberdeen UK.
BJUI compass
|August 28, 2023
概括
开发细胞癌 (RCC) 试验的核心结果集 (COS) 将标准化报告并改善局部,局部晚期和转移性疾病的证据. 这种标准化有助于临床决策和患者护理.
科学领域:
- 在瘤学瘤学.
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 细胞癌 (RCC) 研究中不一致的结果报告阻碍了证据综合和临床决策.
- 结果定义的变化使干预有效性的解释变得复杂.
- 需要一个标准化的核心成果集 (COS),以提高一致性并为临床实践提供信息.
研究的目的:
- 为细胞癌 (RCC) 临床试验开发三个不同的核心结果集 (COS).
- 该COS将解决RCC的局部,局部高级和转移性阶段.
- 提高RCC研究中的证据质量和可比性.
主要方法:
- 一种两阶段的方法,结合了系统的文献评论和患者访谈 (N≈30).
- 使用框架分析进行定性数据分析.
- 一个经过修改的eDelphi调查,包括患者和医疗保健专业人员 (每人50人),随后进行共识会议.
主要成果:
- 通过文献审查和患者的意见,识别潜在的相关结果.
- 通过eDelphi和面对面会议,就RCC试验的结果达成共识.
- 定义了对结果选择的"共识"和"共识"的标准.
结论:
- 开发的核心结果集 (COS) 将在RCC试验中标准化结果报告.
- 该倡议旨在减少异质性,并改善RCC的证据基础.
- 最终,R-COS将有利于临床实践指南和患者护理决策.
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