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奥氮平治疗青少年神经性厌食症的可行性试验(OPEN):临床医生的观点

A feasibility trial of olanzapine for young people with Anorexia Nervosa (OPEN): clinicians' perspectives.

作者信息

Kellermann Vanessa, Sengun Filiz Ece, Said Olena, Bentley Jessica, Khor Joel W T, Simic Mima, Nicholls Dasha, Treasure Janet, Schmidt Ulrike, Himmerich Hubertus, Lawrence Vanessa

机构信息

Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK.

出版信息

J Eat Disord. 2024 Sep 27;12(1):146. doi: 10.1186/s40337-024-01106-9.

Abstract

BACKGROUND

The OPEN feasibility trial testing olanzapine in anorexia nervosa (AN) in young people (YP) was not successful due to poor recruitment. This study aims to understand clinicians' views and experiences of using olanzapine in AN and the challenges in implementing the trial in National Health Service (NHS) clinical settings.

METHODS

We conducted qualitative interviews with eating disorders (ED) clinicians involved with the study (n = 11). Framework analysis was applied to qualitative data to identify barriers and facilitators to recruitment and study implementation. A web-based semi-structured Qualtrics survey was administered to ED clinicians (n = 24). Findings from the survey were used to corroborate and expand on the information derived from qualitative interviews.

RESULTS

Qualitative analysis identified four main themes: (1) Acknowledging Service User (SU) / Family Concerns, (2) Prioritising person-centred care, (3) Limited Service Capacity and (4) Study eligibility criteria. Subthemes are outlined accordingly. Clinicians appeared confident addressing SU concerns around olanzapine in clinical discussions, but timing was critical, and olanzapine was considered one aspect of treatment that needed to align with their holistic approach. Service pressures restricted opportunities for recruitment and the ability to offer regular review. At the same time, some YP were ineligible for the trial, as they were already taking olanzapine, or needed to be prescribed it more promptly than the study procedures allowed. Survey findings underlined confidence in prescribing and informing on olanzapine, the various possible benefits of olanzapine besides weight gain, and the importance of therapeutic alliances and informed consent. Both data sets highlight the need for further evidence on long-term safety, side effects and efficacy of olanzapine use for AN. Where clinical service capacity is at a premium, research implementation is not prioritised, particularly in intensive clinical settings.

CONCLUSIONS

Findings provide first-hand insight into individual and systemic challenges with research implementation in the NHS, which need to be considered when designing future clinical research studies. We emphasise a person-centred approach when discussing olanzapine to consider a holistic recovery from AN beyond weight-gain as an isolated outcome for improvement.

摘要

背景

在年轻人中开展的奥氮平治疗神经性厌食症(AN)的开放可行性试验因招募不佳而未成功。本研究旨在了解临床医生在AN中使用奥氮平的观点和经验,以及在国民保健服务(NHS)临床环境中开展该试验所面临的挑战。

方法

我们对参与该研究的饮食失调(ED)临床医生进行了定性访谈(n = 11)。对定性数据应用框架分析,以确定招募和研究实施的障碍及促进因素。对ED临床医生进行了基于网络的半结构化Qualtrics调查(n = 24)。调查结果用于证实和扩展从定性访谈中获得的信息。

结果

定性分析确定了四个主要主题:(1)认识到服务使用者(SU)/家庭的担忧,(2)将以患者为中心的护理放在首位,(3)服务能力有限,(4)研究纳入标准。相应地概述了子主题。临床医生在临床讨论中似乎有信心解决SU对奥氮平的担忧,但时机很关键,且奥氮平被视为治疗的一个方面,需要与他们整体方法保持一致。服务压力限制了招募机会和定期复查的能力。同时,一些年轻人不符合试验条件,因为他们已经在服用奥氮平,或者需要比研究程序允许的更迅速地开具奥氮平。调查结果强调了在开具奥氮平和提供相关信息方面的信心、奥氮平除体重增加外的各种可能益处,以及治疗联盟和知情同意书的重要性。两个数据集都强调需要关于奥氮平用于AN的长期安全性、副作用和疗效的进一步证据。在临床服务能力至关重要的情况下,研究实施未被优先考虑,尤其是在高强度临床环境中时。

结论

研究结果提供了对NHS中研究实施的个体和系统性挑战的第一手见解,在设计未来临床研究时需要考虑这些挑战。我们强调在讨论奥氮平时采用以患者为中心的方法,以考虑从AN全面康复而非仅将体重增加作为改善的孤立结果。

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