一项针对研究和医疗保健决策的真实世界数据源的国家评估分析和专家采访研究
Veronika Mikl1,2, Dejan Baltic1,3, Thomas Czypionka4
1Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria.
Scientific reports
|April 28, 2024
概括
奥地利的真实世界数据 (RWD) 源面临着数据孤岛和标准化不足等挑战. 国家健康数据战略对于改善基于RWD的研究和支持监管决策至关重要.
科学领域:
- 医疗信息学 医疗信息学
- 数据科学数据科学数据科学
- 公共卫生政策 公共卫生政策
背景情况:
- 现实世界数据 (RWD) 为医疗保健研究,开发和政策提供了宝贵的见解.
- 全球监管机构鼓励将现实世界证据 (RWE) 纳入决策,但挑战仍然存在.
- 奥地利有立法努力,允许RWD的二次使用.
研究的目的:
- 评估奥地利的RWD来源是否适合产生RWE.
- 确定阻碍奥地利有效使用RWD的挑战.
- 为制定国家健康数据战略提供信息.
主要方法:
- 使用多边查询方法来评估73个RWD来源.
- 根据已确立的RWD标准对来源进行了交叉检查.
- 与RWD来源代表进行了直接采访.
主要成果:
- 确定了重大挑战,包括数据孤岛,不一致的标准化和治理问题.
- 该研究对104个评估的RWD来源中的73个提供了概述.
- 调查结果强调需要改善数据可访问性和互操作性.
结论:
- 国家卫生数据战略和治理框架是必不可少的.
- 这些框架应指导研究人员和政策制定者,以提高RWD的利用率.
- 改进的基于RWD的研究可以支持监管决策,并为健康数据政策提供信息.
关键词:
数据质量数据质量数据质量数据质量标准 数据质量标准数据质量建议数据质量建议公平的数据原则.在 GPMed 中.制药医疗公司的公司.卫生数据战略 卫生数据战略使用健康数据使用健康数据在医疗保健决策过程中.制药研究 制药研究医疗保健中RWD的质量标准现实世界的数据数据.现实世界的证据.健康数据的二次使用更多相关视频
相关概念视频
Data Collection I
6.2K
Data collection gathers information needed to make accurate judgments about a patient's present condition. During a health history interview, subjective data is collected from the patient, their caregivers, or family members, and objective data is collected through observations and physical assessment. Patients are the primary source of subjective data. Thus information gathered from patients through interviews, observations, and physical examination is primary data. Secondary sources of...
6.2K
Health Information Technology and Healthcare Information System
834
Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
834
Purpose of Health Records I
1.2K
The vital purpose of health records is to provide a complete and accurate account of a patient's medical history, including communication, diagnostic and therapeutic orders, care planning, research, and quality review.
Here's a breakdown of how health records serve these purposes:
Here's a breakdown of how health records serve these purposes:
1.2K
Study Designs in Epidemiology
215
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
215
Data Validation
5.0K
Data validation is an essential part of a comprehensive assessment. Validation is confirming or verifying and opening the door to gathering more assessment data as it clarifies vague or unclear data. The process of checking and verifying the collected information is called data validation. The primary purpose of data validation is to ensure data is as free from error, bias, and misinterpretation as possible.
Nursing assessment guides are generally based on holistic models rather than medical...
Nursing assessment guides are generally based on holistic models rather than medical...
5.0K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
125
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
125


