P. Holko, P. Kawalec
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引用次数: 0

摘要

使用国家卫生基金数据库作为真实世界证据的来源患者医疗记录和行政保健数据库是真实世界证据(RWE)的可能来源,即关于医疗产品潜在益处和风险的证据。RWE可以补充随机临床试验的证据。波兰国家卫生基金和卫生部收集的信息范围广泛,确保了数据的通用性,涵盖了在波兰接受治疗的几乎所有患者。除了行政数据(没有关于患者及其疾病的详细信息),某些患者群体的电子医疗记录可以从特殊程序(例如,kos - zawaov)或药物项目监测系统(SMPT)获得。NFZ数据库作为RWE的来源使用率低(只有37项研究),但可用性高。对来自行政数据库和SMPT的数据进行联合分析可以增加研究的可信度,但该研究仅限于在药物计划内治疗的患者。
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Wykorzystanie baz danych Narodowego Funduszu Zdrowia przy ocenie dowodów naukowych z praktyki klinicznej
The use of the National Health Fund databases as a source of real-world evidence Patient medical records and administrative healthcare databases are possible sources of real-world evidence (RWE), i.e., evidence on the potential benefits and risks of a medical product. RWE can complement the evidence from randomized clinical trials. The wide range of information collected by the National Health Fund (NFZ) and the Ministry of Health in Poland ensures the versatility of the data that cover almost all patients treated in Poland. In addition to administrative data (without detailed information about patients and their disease), electronic medical records of some patient groups can be obtained from special programs (e.g., KOS-Zawał) or the System of Monitoring Drug Programs (SMPT). Low usage (only 37 studies) but high usability of NFZ databases as a source of RWE were identified. Joint analysis of data from administrative databases and SMPT can increase the credibility of the study, but limits the study to only patients treated within the Drug Programs.
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