背景:欧洲药品管理局将难治性抑郁症(TRD)定义为治疗后缺乏临床意义的改善,至少两种不同的抗抑郁药.个人,熟悉的,TRD的社会经济负担是巨大的。由于缺乏明确的指导方针,TRD方法在不同国家的巨大差异和新药物的可用性,以满足有效和快速行动的治疗策略的需要,了解意大利常规临床实践中关于TRD患者临床特征和治疗途径的共识非常重要,特别是考虑到最近有艾氯胺酮鼻喷雾剂。
方法:通过定制的基于网络的平台,对具有至少5年经验和在抑郁症领域的专业知识的意大利精神科医生进行了一份包含17项陈述的Delphi问卷(具有7分Likert量表的协议)。在第二轮中,医生被要求回答相同的陈述,考虑到每个问题的四分位数范围作为同事回答的索引。Stata16.1软件用于分析。
结果:60名小组成员,意大利领土的代表,在第一轮回答了问卷。对于8/17的陈述,超过75%的小组成员达成了一致意见,并达成了很高的共识,因为他们分配了相似的分数;对于4个陈述,小组成员分配了相似的分数,但在李克特量表的中间,显示与陈述的中度一致,而对于5份声明,协议中犹豫不决,声明中的共识较低。
结论:本德尔菲小组显示,在意大利,TRD患者的管理存在广泛的异质性,以及迫切需要专门批准用于TRD的标准化策略和治疗方法。关于添加锂和/或抗精神病药作为增强疗法的重要性以及同时需要长期维持治疗的重要性,获得了高度的共识和共识。对于将艾氯胺酮鼻喷雾剂确定为TRD患者的最佳选择以及在社区门诊环境中毫无困难地施用艾氯胺酮的可能性,同样达成了高度共识和协议。强调为患者提供适当的教育支持的好处。
BACKGROUND: Treatment-resistant depression (TRD) is defined by the European Medicines Agency as a lack of clinically meaningful improvement after treatment, with at least two different antidepressants. Individual, familiar, and socio-economic burden of TRD is huge. Given the lack of clear
guidelines, the large variability of TRD approaches across different countries and the availability of new medications to meet the need of effective and rapid acting therapeutic strategies, it is important to understand the
consensus regarding the clinical characteristics and treatment pathways of patients with TRD in Italian routine clinical practice, particularly in view of the recent availability of esketamine nasal spray.
METHODS: A Delphi questionnaire with 17 statements (with a 7 points Likert scale for agreement) was administered via a customized web-based platform to Italian psychiatrists with at least 5 years of experience and specific expertise in the field of depression. In the second-round physicians were asked to answer the same statements considering the interquartile range of each question as an index of their colleagues\' responses. Stata 16.1 software was used for the analyses.
RESULTS: Sixty panellists, representative of the Italian territory, answered the questionnaire at the first round. For 8/17 statements more than 75% of panellists reached agreement and a high
consensus as they assigned similar scores; for 4 statements the panellists assigned similar scores but in the middle of the Likert scale showing a moderate agreement with the statement, while for 5 statements there was indecision in the agreement and low
consensus with the statement.
CONCLUSIONS: This Delphi Panel showed that there is a wide heterogeneity in Italy in the management of TRD patients, and a compelling need of standardised strategies and treatments specifically approved for TRD. A high level of consensus and agreement was obtained about the importance of adding lithium and/or antipsychotics as augmentation therapies and in the meantime about the need for long-term maintenance therapy. A high level of
consensus and agreement was equally reached for the identification of esketamine nasal spray as the best option for TRD patients and for the possibility to administrate without difficulties esketamine in a community outpatient setting, highlighting the benefit of an appropriate educational support for patients.