报告内镜结肠直肠癌查质量随机对照试验:遵守建议和干预措施
Fouad Jaber1,2, Khalid Ahmed3, Osama Hamid4
1Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas.
Gastro hep advances
|September 23, 2024
概括
结肠直肠癌查试验显示良好遵守报告准则,但试验注册和同意表需要改进. 参与者对查方案的遵守率总体为69.8%.
科学领域:
- 临床试验 临床试验
- 胃肠病学 胃肠病学
- 公共卫生 公共卫生
背景情况:
- 标准协议项目:对干预试验的建议 (SPIRIT) 准则于2013年发布,以标准化随机对照试验 (RCT) 报告.
- 评估是否遵守SPIRIT指南对于临床研究的质量和透明度至关重要.
研究的目的:
- 评估对内镜结直肠癌 (CRC) 查的RCT中遵守SPIRIT报告准则.
- 在这些CRC查RCT中评估参与者遵守试验协议的程度.
主要方法:
- 在2023年9月之前,针对CRC查进行了灵活的半导体镜或结肠镜RCT的系统搜索.
- 分析了五个符合条件的RCT对51个SPIRIT项目的遵守情况,并以被选与被邀请的比例计算了参与者遵守情况.
主要成果:
- 遵守SPIRIT指南的比例在82.4%至92.2%之间,普遍不遵守试验注册 (第2b项).
- 报告知情同意材料 (32项) 和盲目化 (17a和b项) 的报告显示,遵守率分别低于20%和40%.
- 参与者对CRC查方案的整体遵守率为69.8%,但差异很大,其中一项试验显示了42%的遵守率.
结论:
- 内镜CRC查RCT通常很好地遵守SPIRIT报告准则.
- 建议在报告同意表格和综合试验注册数据方面进行改进.
- 参与者在RCT中遵守查协议是可以接受的,但需要注意优化.
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