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用现实世界的数据来定义主要精神疾病治疗结果的建议
Elise Koch1, Sophie Smart2, Guðmundur Einarsson3
1Center for Precision Psychiatry, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
现实世界数据 (RWD) 提供了对精神病药物有效性的见解,但缺乏标准化的结果定义. 本次审查提出了RWD结果措施的标准,以改善精确精神病学和监管决策.
科学领域:
- 精神病学是一个精神病学.
- 药理学 药理学是指药理学的学科.
- 医疗信息学 医疗信息学
背景情况:
- 现实世界数据 (RWD) 越来越多地用于了解精神病药物的治疗有效性.
- 目前缺乏在治疗选择和结果评估中利用RWD的指导方针.
- 由于缺乏标准化的方法,在定义治疗结果方面存在很高的变化.
研究的目的:
- 审查和评估使用RWD的抗抑郁药,抗精神病药和情绪稳定剂治疗结果的现有定义.
- 提出标准化定义和方法来衡量精神病RWD的治疗结果.
- 增强RWD对精密精神病学和监管决策的实用性.
主要方法:
- 对使用RWD来定义主要精神药物药物类别治疗结果的研究进行系统文献综述.
- 报告结果定义的质量和一致性的评估.
- 根据数据可用性和验证需求,为标准化结果测量制定建议.
主要成果:
- 在研究中的治疗结果定义中发现了显著的异质性.
- 代理措施,如治疗延续,切换和多药,经常被使用,但需要验证.
- 提供了建议,以确定各种RWD场景的结果.
结论:
- 标准化和验证的治疗结果措施对于利用RWD在精神病学中至关重要.
- 实施这些标准可以推进精密精神病学,并为心理药物剂的监管过程提供信息.
- 使用多种数据源进行验证对于可靠的代理测量至关重要.
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