Vanessa Kellermann, Ece Sengun Filiz, Olena Said, Jessica Bentley, Joel W T Khor, Mima Simic, Dasha Nicholls, Janet Treasure, Ulrike Schmidt, Hubertus Himmerich, Vanessa Lawrence
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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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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. 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引用次数: 0
摘要
背景:OPEN可行性试验测试了奥氮平在青少年厌食症(AN)中的应用,但由于招募情况不佳而未能成功。本研究旨在了解临床医生对使用奥氮平治疗厌食症的看法和经验,以及在国民健康服务(NHS)临床环境中实施该试验所面临的挑战:我们对参与研究的进食障碍(ED)临床医生(n = 11)进行了定性访谈。对定性数据进行了框架分析,以确定招募和研究实施的障碍和促进因素。对 ED 临床医生(24 人)进行了基于网络的半结构式 Qualtrics 调查。调查结果用于证实和扩展从定性访谈中获得的信息:定性分析确定了四大主题:(1) 承认服务使用者 (SU) / 家属的关切;(2) 优先考虑以人为本的护理;(3) 有限的服务能力;(4) 研究资格标准。次主题概述如下。临床医生似乎有信心在临床讨论中解决奥氮平引起的 SU 关切,但时机至关重要,而且奥氮平被认为是治疗的一个方面,需要与他们的整体方法保持一致。服务压力限制了招募的机会和提供定期复查的能力。同时,一些青年患者不符合试验条件,因为他们已经在服用奥氮平,或者需要比研究程序允许的时间更快地开出奥氮平处方。调查结果强调了对奥氮平处方和告知的信心、奥氮平除体重增加外可能带来的各种益处,以及治疗联盟和知情同意的重要性。这两组数据都强调,需要进一步证实奥氮平治疗自闭症的长期安全性、副作用和疗效。在临床服务能力有限的情况下,研究的实施并没有得到优先考虑,尤其是在密集的临床环境中:研究结果为我们提供了第一手资料,帮助我们了解国家医疗服务体系在实施研究时面临的个人和系统性挑战,在设计未来的临床研究时需要考虑到这些挑战。我们强调,在讨论奥氮平时,应采取以人为本的方法,从整体上考虑自闭症的康复,而不是将体重增加作为单独的改善结果。
A feasibility trial of olanzapine for young people with Anorexia Nervosa (OPEN): clinicians' perspectives.
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.
期刊介绍:
Journal of Eating Disorders is the first open access, peer-reviewed journal publishing leading research in the science and clinical practice of eating disorders. It disseminates research that provides answers to the important issues and key challenges in the field of eating disorders and to facilitate translation of evidence into practice.
The journal publishes research on all aspects of eating disorders namely their epidemiology, nature, determinants, neurobiology, prevention, treatment and outcomes. The scope includes, but is not limited to anorexia nervosa, bulimia nervosa, binge eating disorder and other eating disorders. Related areas such as important co-morbidities, obesity, body image, appetite, food and eating are also included. Articles about research methodology and assessment are welcomed where they advance the field of eating disorders.