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相关概念视频

Data Reporting and Recording01:24

Data Reporting and Recording

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Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
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相关实验视频

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A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
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统一的数据质量指标在使用多发性硬化病注册表/数据源的长期安全研究中保持数据质量:来自CLARION研究的经验.

Jan Hillert1, Helmut Butzkueven2,3, Melinda Magyari4

  • 1Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.

Clinical epidemiology
|October 22, 2024
PubMed
概括

本研究使用数据质量指标 (DQI) 来评估多发性硬化症 (MS) 登记册数据的可靠性. 调查结果表明,DQI有效地跟踪监管决策的数据质量.

关键词:
克拉德里宾片 克拉德里宾片这就是fingolimod的意思.多发性硬化症多发性硬化症在安全方面,安全是安全的.

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科学领域:

  • 药物监督 药物监督 药物监督
  • 流行病学 流行病学
  • 数据科学数据科学数据科学

背景情况:

  • 基于注册表的研究对于在现实临床实践中评估多发性硬化症 (MS) 疾病修饰疗法 (DMT) 的长期安全性至关重要.
  • 数据质量在各个注册表中的变化对监管决策提出了挑战.
  • 该CLARION研究通过评估数据质量指标 (DQI) 在克拉迪宾片的非干预性安全性研究中解决了这一问题.

研究的目的:

  • 在CLARION研究中描述关键数据质量指标 (DQI) 的应用.
  • 随着时间的推移,评估来自成员国注册表/数据源的许可后安全数据的质量.
  • 确保数据适合监管决策,遵守EMA指南.

主要方法:

  • 根据EMA数据质量框架,定义了28个DQI与参与的MS注册表/数据源.
  • 评估数据质量的一致性,准确性,完整性和代表性.
  • 总结DQI总体和每个注册表/源到2022年11月1日.

主要成果:

  • 分析了来自14个国家的8个MS注册/数据源的5069名患者的数据.
  • 代表性DQI表明主要是女性队列 (72.0%) 患有复发性复发性MS (93.5%).
  • 一致性DQI显示,6.9%的患者在2年的随访期间缺乏记录的访问;3.8%的随访失去了. 记录MS发病日期和诊断的日期有所改善.

结论:

  • 在CLARION研究中应用28个DQI有效跟踪数据质量.
  • 这一过程确定了数据质量的决定因素,并确保了授权后安全数据的可靠性.
  • 该研究为有关多发性硬化治疗的监管决策提供了坚实的基础.