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失败试验的剖析 第 1 部分:对英国强化饮食失调服务机构中 DAISIES 试验实施情况的临床医生意见和经验的定性研究。

Autopsy of a failed trial part 1: A qualitative investigation of clinician's views on and experiences of the implementation of the DAISIES trial in UK-based intensive eating disorder services.

机构信息

Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.

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

出版信息

Eur Eat Disord Rev. 2023 Jul;31(4):489-504. doi: 10.1002/erv.2975. Epub 2023 Mar 23.

Abstract

OBJECTIVE

The DAISIES trial, comparing inpatient and stepped-care day patient treatment for adults with severe anorexia nervosa was prematurely terminated in March 2022 due to poor recruitment. This qualitative study seeks to understand the difficulties faced during the trial by investigating stakeholders' views on and experiences of its implementation.

METHOD

Semi-structured interview and focus group transcripts, and trial management and oversight group meeting minutes from May 2020-June 2022 were analysed using thematic analysis. Participants were 47 clinicians and co-investigators involved with the DAISIES trial. The Non-Adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework was applied to the interpretive themes to classify barriers and facilitators to implementation.

RESULTS

Five themes were identified: incompatible participation interests; changing standard practice; concerns around clinical management; systemic capacity and capability issues; and Covid-19 disrupting implementation. Applying the NASSS framework indicated the greatest implementation challenges to arise with the adopters (e.g. patients, clinicians), the organisational systems (e.g. service capacity), and the wider socio-political context (e.g. Covid-19 closing services).

CONCLUSIONS

Our findings emphasise the top-down impact of systemic-level research implementation challenges. The impact of the Covid-19 pandemic accentuated pre-existing organisational barriers to trial implementation within intensive eating disorder services, further limiting the capacity for research.

摘要

目的

DAISIES 试验比较了严重厌食症成年患者的住院和阶梯式日间治疗,由于招募情况不佳,该试验于 2022 年 3 月提前终止。本定性研究旨在通过调查利益相关者对试验实施的看法和经验,了解试验中面临的困难。

方法

使用主题分析方法对 2020 年 5 月至 2022 年 6 月的半结构式访谈和焦点小组记录以及试验管理和监督小组会议记录进行分析。参与者为 47 名参与 DAISIES 试验的临床医生和共同研究者。应用非采用、放弃、扩展、传播和可持续性(NASSS)框架对解释性主题进行分类,以确定实施的障碍和促进因素。

结果

确定了五个主题:参与利益不一致;改变标准实践;对临床管理的关注;系统能力和能力问题;以及新冠肺炎扰乱实施。应用 NASSS 框架表明,实施的最大挑战来自采用者(例如患者、临床医生)、组织系统(例如服务能力)和更广泛的社会政治背景(例如新冠肺炎关闭服务)。

结论

我们的研究结果强调了系统层面研究实施挑战的自上而下的影响。新冠肺炎大流行的影响加剧了强化饮食失调服务中试验实施的先前存在的组织障碍,进一步限制了研究的能力。

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本文引用的文献

1
Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial.
Eur Eat Disord Rev. 2024 May;32(3):476-489. doi: 10.1002/erv.3058. Epub 2023 Dec 18.

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