Pharmacoepidemiology research: delivering evidence about drug safety and effectiveness in mental health

Pharmacoepidemiology research: delivering evidence about drug safety and effectiveness in mental health
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DOI:
10.1016/s2215-0366(19)30298-6
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发表时间:
2020-04-01
期刊:
影响因子:
64.3
通讯作者:
Woelbert, Eva
Woelbert, Eva
中科院分区:
医学1区
文献类型:
--
作者:
Davis, Katrina A. S.;Farooq, Saeed;Woelbert, Eva

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需要进行研究,为精神障碍患者的药物治疗提供证据基础。丰富的数字数据促进了药物流行病学,特别是对现实世界药物有效性的观察性研究。药物流行病学研究的优点是可获得大量患者样本,并且覆盖了未充分研究的自然条件下的亚群。这类研究也比随机对照试验更便宜、更快捷,这意味着有关仿制药、停药(开处方)和长期结果的问题更有可能得到解决。药物流行病学方法也可以扩展到药物警戒和帮助开发现有药物的新用途。观察性药物流行病学研究的缺点来自治疗选择的非随机性质,导致适应症混淆。管理这一缺陷的潜在方法包括积极的对照组、个体内设计和倾向评分。许多更严格的药物流行病学研究已经通过三角化的多种分析方法得到加强,以提高对推断因果关系的信心。随着数据资源和分析技术的发展,令人鼓舞的是,指南开始包括来自可靠的观察性药物流行病学研究和随机对照试验的证据。指南作者和参与药物流行病学的研究人员之间的合作可以帮助研究人员回答对决策者很重要的问题,并确保结果被纳入证据基础。统计和数据科学技术的进一步发展,以及公众参与和能力建设(数据资源和研究人员基础),将是充分利用未来机会的必要条件。
Research that provides an evidence base for the pharmacotherapy of people with mental disorders is needed. The abundance of digital data has facilitated pharmacoepidemiology and, in particular, observational research on the effectiveness of real-world medication. Advantages of pharmacoepidemiological research are the availability of large patient samples, and coverage of under-researched subpopulations in their naturalistic conditions. Such research is also cheaper and quicker to do than randomised controlled trials, meaning that issues regarding generic medication, stopping medication (deprescribing), and long-term outcomes are more likely to be addressed. Pharmacoepidemiological methods can also be extended to pharmacovigilance and to aid the development of new purposes for existing drugs. Drawbacks of observational pharmacoepidemiological studies come from the non-randomised nature of treatment selection, leading to confounding by indication. Potential methods for managing this drawback include active comparison groups, within-individual designs, and propensity scoring. Many of the more rigorous pharmacoepidemiology studies have been strengthened through multiple analytical approaches triangulated to improve confidence in inferred causal relationships. With developments in data resources and analytical techniques, it is encouraging that guidelines are beginning to include evidence from robust observational pharmacoepidemiological studies alongside randomised controlled trials. Collaboration between guideline writers and researchers involved in pharmacoepidemiology could help researchers to answer the questions that are important to policy makers and ensure that results are integrated into the evidence base. Further development of statistical and data science techniques, alongside public engagement and capacity building (data resources and researcher base), will be necessary to take full advantage of future opportunities.