背景:不良事件(AE)通常在临床研究中使用医学规范活动词典(MedDRA)报告,药物安全监测的国际标准。然而,MedDRA的技术语言使得患者和临床医生分享理解并因此就医疗干预做出共同决策具有挑战性.在这个项目中,有抑郁症和抗抑郁治疗经验的人与临床医生和研究人员合作,共同设计了与抗抑郁药相关的AEs在线词典,考虑到它的易用性和对现实世界设置的适用性。
方法:通过预定义的文献检索,我们从抗抑郁药治疗抑郁症的随机对照试验中发现了MedDRA编码的AE.与McPin基金会合作,与现场经验咨询小组(LEAP)和一个独立焦点小组(FG)进行了四个共同设计研讨会,以制作用户友好的AE术语翻译。翻译的指导原则是与McPin/LEAP成员共同设计的,并在临床规范(CC,或非技术术语来代表特定的AE概念)。使用框架方法对FG结果进行主题分析。
结果:从搜索确定的522项试验开始,736个MedDRA编码的AE术语被翻译成187个CC,哪些平衡了被确定为对LEAP和FG重要的关键因素(即,广度,特异性,概括性,患者的可理解性和可接受性)。与LEAP的合作表明,用户友好的AE语言应旨在减轻污名,承认语言中的多个理解层次,并平衡对语义准确性和用户友好性的需求。在这些原则的指导下,在线AE词典是共同设计并免费提供的(https://thesymptomglossary.com)。LEAP和FG认为数字工具是一种资源,可以通过促进准确,通过共同的决策过程,有意义地表达对潜在危害的偏好。
结论:这本词典是围绕抑郁症抗抑郁药的AEs用英语开发的,但它可以适应不同的语言和文化背景,也可以成为其他干预措施和疾病的模型(即,精神分裂症中的抗精神病药)。共同设计的数字资源可以通过帮助提供基于证据的潜在益处和危害的个性化信息来改善患者体验,偏好敏感的方式。
BACKGROUND: Adverse events (AEs) are commonly reported in clinical studies using the Medical Dictionary for Regulatory Activities (MedDRA), an international standard for drug safety monitoring. However, the technical language of MedDRA makes it challenging for patients and clinicians to share understanding and therefore to make shared decisions about medical interventions. In this project, people with lived experience of depression and antidepressant treatment worked with clinicians and researchers to co-design an online dictionary of AEs associated with
antidepressants, taking into account its ease of use and applicability to real-world settings.
METHODS: Through a pre-defined literature search, we identified MedDRA-coded AEs from randomised controlled trials of
antidepressants used in the treatment of depression. In collaboration with the McPin Foundation, four co-design workshops with a lived experience advisory panel (LEAP) and one independent focus group (FG) were conducted to produce user-friendly translations of AE terms. Guiding principles for translation were co-designed with McPin/LEAP members and defined before the finalisation of Clinical Codes (CCs, or non-technical terms to represent specific AE concepts). FG results were thematically analysed using the Framework Method.
RESULTS: Starting from 522 trials identified by the search, 736 MedDRA-coded AE terms were translated into 187 CCs, which balanced key factors identified as important to the LEAP and FG (namely, breadth, specificity, generalisability, patient-understandability and acceptability). Work with the LEAP showed that a user-friendly language of AEs should aim to mitigate stigma, acknowledge the multiple levels of comprehension in \'lay\' language and balance the need for semantic accuracy with user-friendliness. Guided by these principles, an online dictionary of AEs was co-designed and made freely available ( https://thesymptomglossary.com ). The digital tool was perceived by the LEAP and FG as a resource which could feasibly improve antidepressant treatment by facilitating the accurate, meaningful expression of preferences about potential harms through a shared decision-making process.
CONCLUSIONS: This dictionary was developed in English around AEs from
antidepressants in depression but it can be adapted to different languages and cultural contexts, and can also become a model for other interventions and disorders (i.e., antipsychotics in schizophrenia). Co-designed digital resources may improve the patient experience by helping to deliver personalised information on potential benefits and harms in an evidence-based, preference-sensitive way.