测量临床数据交换标准联盟 (CDISC) 的表达力研究数据表格模型 (SDTM) 美国烧伤协会烧伤护理质量计划注册表现实世界数据 (RWD)
Manju Bikkanuri1, Muayad Hamidi1, Meredith N Zozus1
1University of Texas Health Science Center at San Antonio TX USA.
Studies in health technology and informatics
|May 17, 2025
概括
临床数据交换标准联盟 (CDISC) 研究数据表格模型 (SDTM) 有效地代表了监管提交的注册表中的真实世界数据 (RWD). 这种映射支持在美国食品和药物管理局 (FDA) 的提交中使用注册表RWD.
科学领域:
- 监管科学 监管科学
- 医疗信息学 医疗信息学
- 数据标准 数据标准
背景情况:
- 美国"21世纪治疗法"促进了新型治疗方法的开发.
- 现实世界数据 (RWD) 越来越多地被美国食品和药物管理局 (FDA) 接受用于监管提交.
- 注册表是RWD的主要来源,但它们与监管数据标准的兼容性受到质疑.
研究的目的:
- 评估临床数据交换标准联盟 (CDISC) 研究数据表格模型 (SDTM) 的表达力,以表示注册表数据.
- 评估SDTM是否适合将注册表RWD纳入FDA提交的文件.
主要方法:
- 美国烧伤协会的烧伤护理质量计划 (BCQP) 注册表v4.1系统地映射到CDISC SDTM v3.3标准.
- 在SDTM框架内评估数据元素可表示性.
主要成果:
- 来自BCQP注册表的所有数据元素都可以使用SDTM标准进行表示.
- 93%的BCQP注册表数据直接映射到标准SDTM域.
- 剩余的7%的数据元素已成功地映射到SDTM补充资格.
结论:
- SDTM标准表现出强大的表达力,用于表示来自注册表的真实世界数据.
- SDTM 适用于注册数据的监管提交,支持RWD在治疗开发中的使用.
- 这一发现有助于将有价值的注册表数据整合到FDA监管流程中.
相关概念视频
01:14SBAR II: Application of SBAR
SBAR is an effective communication tool used by healthcare professionals to communicate patient information accurately. SBAR stands for Situation, Background, Assessment, and Recommendation. For a better understanding, an example is given below.
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
01:23Methods of Documentation V: CBE
Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
01:19Standards of Care II
Nurses bear specific legal responsibilities under several federal statutes, including: