Department of Clinical Pharmacology, Odense University Hospital, J. B. Winsløws Vej 19, 2, 5000 Odense C, Denmark.
Department of Clinical Pharmacology, Odense University Hospital, J. B. Winsløws Vej 19, 2, 5000 Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark; Novo Nordisk, Vandtårnsvej 108, 2860, Søborg, Denmark.
Public Health. 2023 Mar;216:27-29. doi: 10.1016/j.puhe.2023.01.004. Epub 2023 Feb 8.
We aimed to investigate the quality of evidence and the expected added clinical value of treatments recommended by the Danish Medicines Council (DMC).
This was an observational study.
The DMC prepares reports on drugs considered for possible new standard treatments in Danish hospitals. These reports evaluate the available evidence on efficacy and safety. The quality of evidence is systematically rated by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria, and estimates of added clinical value are presented. The recommendations take into account expected economic implications of new treatments. The publicly available reports up until December 29, 2021, were downloaded from the DMC Web page. Reports on drugs marked "recommended" were included. Data on quality of evidence, expected clinical value, and economic implications were imputed in a Microsoft Excel spreadsheet.
Seventy-nine reports were included in the analysis. In 79% of these, the quality of evidence was rated low (24%) or very low (55%), whereas no recommendations were based on evidence rated as high quality. Three (5%) of recommended treatments were expected to add large clinical value.
Most recommendations by the DMC are based on evidence formally rated as low or very low quality by GRADE, and no recommendations were based on evidence rated as high quality. The added clinical value of the treatments was often not documented and rarely large. Continued attention to improve the clinical evidence behind national recommendations is necessary.
我们旨在研究丹麦药品理事会（DMC）推荐的治疗方法的证据质量和预期的附加临床价值。
这是一项观察性研究。
DMC 编写关于考虑在丹麦医院采用新标准治疗的药物报告。这些报告评估了疗效和安全性方面的现有证据。证据质量通过推荐评估、制定和评估（GRADE）标准进行系统评估，并提出了附加临床价值的估计。建议考虑了新治疗方法的预期经济影响。截至 2021 年 12 月 29 日，从 DMC 网页上下载了公开的报告。纳入了标记为“推荐”的药物报告。在 Microsoft Excel 电子表格中推断了有关证据质量、预期临床价值和经济影响的数据。
分析中纳入了 79 份报告。其中 79%的报告证据质量被评为低（24%）或极低（55%），而没有建议基于高质量证据。三种（5%）推荐的治疗方法预计会增加大量的临床价值。
DMC 的大多数建议都是基于 GRADE 正式评为低或极低质量的证据，没有建议是基于评为高质量的证据。治疗方法的附加临床价值通常未记录，且很少是大的。需要持续关注改善国家建议背后的临床证据。
