在对直肠癌治疗的随机对照试验中报告的结果:对CORRECT倡议的范围审查
Richard Garfinkle1, Saba Balvardi2, Heather Carmichael3
1Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, QC, Canada.
概括
本次对直肠癌随机对照试验 (RCT) 的综述确定了53个结局术语. 虽然在41.6%的试验中使用了患者报告结果指标 (PROM),但初级结果报告仍然高度可变.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 基于证据的医学基于证据的医学.
背景情况:
- 结直肠癌研究依赖于随机对照试验 (RCT) 来评估治疗方法.
- 标准化结果报告对于比较治疗疗效至关重要.
- 患者报告的结果指标 (PROM) 为患者体验提供了宝贵的见解.
研究的目的:
- 系统地审查直肠癌RCT中报告的结果.
- 创建一个全面的研究结果列表.
- 分析结果报告的趋势,重点关注PROM.
主要方法:
- 对2000年以后发表的RCT进行系统的文献搜索.
- 包括评估非转移性直肠癌局部或全身疗法的试验.
- 将所有报告结果提取和分类为标准化术语和OMERACT核心领域.
主要成果:
- 包括89个RCT,分为新辅助,手术和辅助试验.
- 在各种健康领域确定了53个标准化结果术语.
- 患者报告的结果指标 (PROMs),主要是与健康有关的生活质量,在41.6%的试验中使用.
- 在不同类型的研究中观察到主要结果的变化;报告中没有发现随着时间的推移或作者专业的显著趋势.
结论:
- 建立了对直肠癌RCT研究结果的全面列表.
- 在直肠癌试验中的结果报告是多样化的.
- 进一步标准化可能会提高试验结果的可比性和解释性.
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