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评估慢性病随机对照试验中核心结果设置吸收率:截面分析
Alex Hagood1, Logan Patrick Corwin1, Jay S Modi1
1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Contemporary clinical trials communications
|September 12, 2024
概括
慢性病 (CKD) 核心结果集 (COS) 在临床试验中未得到充分利用. 即使在COS出版后,每年也只有不到40%的结果被测量,这凸显了需要改进采用.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 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:
- 慢性病 (CKD) 影响全球数百万人,需要标准化结果测量.
- 2019年,由国际健康结果和测量联盟建立了CKD的核心结果集 (COS).
- 评估在临床研究中采用这种COS对于患者护理至关重要.
研究的目的:
- 在临床试验中评估CKD核心结果集 (COS) 结果测量的频率.
- 为了比较2019年COS出版之前和之后的测量频率.
- 在CKD研究中发现结果测量的缺陷.
主要方法:
- 使用ClinicalTrials.gov.gov进行了III/IV期CKD临床试验的系统文献搜索.
- 数据提取包括研究特征,重点关注生存率,疾病负担,生活质量和治疗结果.
- 包括的研究被分析为测量COS领域.
主要成果:
- 大多数CKD核心成果集 (COS) 领域在出版前和出版后的试验中都没有得到充分的测量.
- 虽然测量频率在出版后增加,但即使在四年后,它仍然在每年40%以下.
- 在COS领域的完整测量中仍然存在重大缺陷.
结论:
- 在临床试验中对CKD核心结果集 (COS) 领域的综合测量存在重大差距.
- 建议更好地采用一致的结果措施,以使不断增长的CKD患者群体受益.
- 标准化结果测量对于推进CKD研究和患者管理至关重要.
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