焦虑症是非常普遍的,通常是持续性的精神障碍,具有相当高的治疗耐药率,这需要创新治疗干预措施的监管临床试验。然而,目前尚缺乏明确定义治疗抗性焦虑症(TR-AD)作为此类试验的依据.我们使用基于德尔菲法的共识方法来提供国际公认的,成人TR-AD的一致和临床有用的操作标准。根据国际准则和现有的系统审查,总结了当前的知识状况,对关于TR-AD相关方面的29项问卷的自由文本答复的调查,和一个在线共识会议,一个由36名多学科国际专家和利益攸关方组成的小组在三轮调查中对书面声明进行了匿名投票。共识被定义为≥75%的小组同意一项声明。小组就TR-AD的定义达成了一套14项建议,提供药物和/或心理治疗抵抗的详细操作标准,以及潜在的分期模型。小组还评估了有关流行病学亚组的其他方面,合并症和传记因素,TR-AD与“难以治疗”的焦虑症,这些疾病患者的偏好和态度,以及未来的研究方向。这种基于德尔菲方法的TR-AD操作标准的共识预计将作为一个系统的,一致和实用的临床指南,以帮助设计未来的机械研究和促进临床试验的监管目的。这项努力最终可能导致为焦虑症患者开发更有效的基于证据的阶梯式护理治疗算法。
Anxiety disorders are very prevalent and often persistent mental disorders, with a considerable rate of treatment resistance which requires regulatory clinical trials of innovative therapeutic interventions. However, an explicit definition of treatment-resistant anxiety disorders (TR-AD) informing such trials is currently lacking. We used a Delphi method-based
consensus approach to provide internationally agreed, consistent and clinically useful operational criteria for TR-AD in adults. Following a summary of the current state of knowledge based on international
guidelines and an available systematic review, a survey of free-text responses to a 29-item questionnaire on relevant aspects of TR-AD, and an online consensus meeting, a panel of 36 multidisciplinary international experts and stakeholders voted anonymously on written statements in three survey rounds.
Consensus was defined as ≥75% of the panel agreeing with a statement. The panel agreed on a set of 14 recommendations for the definition of TR-AD, providing detailed operational criteria for resistance to pharmacological and/or psychotherapeutic treatment, as well as a potential staging model. The panel also evaluated further aspects regarding epidemiological subgroups, comorbidities and biographical factors, the terminology of TR-AD vs. \"difficult-to-treat\" anxiety disorders, preferences and attitudes of persons with these disorders, and future research directions. This Delphi method-based
consensus on operational criteria for TR-AD is expected to serve as a systematic, consistent and practical clinical
guideline to aid in designing future mechanistic studies and facilitate clinical trials for regulatory purposes. This effort could ultimately lead to the development of more effective evidence-based stepped-care treatment algorithms for patients with anxiety disorders.