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.

中文翻译：

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焦虑症治疗抵抗的定义：基于德尔菲法的共识指南

焦虑症是非常普遍且通常持续存在的精神障碍，具有相当大的治疗抵抗率，需要创新治疗干预措施的监管临床试验。然而，目前尚缺乏为此类试验提供信息的难治性焦虑症（TR-AD）的明确定义。我们使用基于德尔菲法的共识方法为成人 TR-AD 提供国际商定的、一致的和临床有用的操作标准。根据国际指南和现有的系统综述对当前知识状况进行总结，对 TR-AD 相关方面的 29 项调查问卷的自由文本回复进行调查，并召开在线共识会议，由 36 名专家组成的小组多学科国际专家和利益相关者在三轮调查中对书面陈述进行了匿名投票。共识被定义为≥75% 的专家组同意某项声明。专家组就 TR-AD 的定义达成了 14 条建议，提供了药物和/或心理治疗耐药性的详细操作标准，以及潜在的分期模型。专家组还进一步评估了流行病学亚组、合并症和传记因素、TR-AD 与“难以治疗”焦虑症的术语、患有这些疾病的人的偏好和态度以及未来的研究方向。这种基于 Delphi 方法的关于 TR-AD 操作标准的共识预计将作为系统、一致和实用的临床指南，以帮助设计未来的机制研究并促进出于监管目的的临床试验。这项努力最终可能会为焦虑症患者开发出更有效的循证阶梯式护理治疗算法。