在一项集群随机对照试验中干预措施的实施质量：一项具有保真度教训的定性观察研究。
Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity.
机构信息
Kingston University and St George's University of London, Joint Faculty of Health, Social Care and Education, Grosvenor Wing, Cranmer Terrace, London, SW17 ORE, UK.
Royal College of Psychiatrists, College Centre for Quality Improvement, 21 Prescot Street, London, E1 8BB, UK.
出版信息
Trials. 2017 Nov 17;18(1):548. doi: 10.1186/s13063-017-2189-8.
BACKGROUND
Understanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity not only affects the validity of trial findings, but also because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Participant observation methods have been identified as being particularly valuable in studies of fidelity, yet are rarely used. This study aimed to use these methods to explore the quality of implementation of a complex intervention (Safewards) on mental health wards during a cluster randomised controlled trial. Specific aims were firstly to describe the different ways in which the intervention was implemented, and secondly to explore the contextual factors moderating the quality of intervention delivery, in order to inform 'real world' implementation of the intervention.
METHODS
Safewards was implemented on 16 mental health wards in England. We used Research Assistants (RAs) trained in participant observation to record qualitative observational data on the quality of intervention delivery (n = 565 observations). At the end of the trial, two focus groups were conducted with RAs, which were used to develop the coding framework. Data were analysed using thematic analysis.
RESULTS
There was substantial variation in intervention delivery between wards. We observed modifications to the intervention which were both fidelity consistent and inconsistent, and could enhance or dilute the intervention effects. We used these data to develop a typology which describes the different ways in which the intervention was delivered. This typology could be used as a tool to collect qualitative observational data about fidelity during trials. Moderators of Safewards implementation included systemic, interpersonal, and individual factors and patient responses to the intervention.
CONCLUSIONS
Our study demonstrates how, with appropriate training in participant observation, RAs can collect high-quality observational data about the quality of intervention delivery during a trial, giving a more complete picture of 'fidelity' than measurements of adherence alone.
TRIAL REGISTRATION
ISRCTN registry; IRSCTN38001825 . Registered 29 August 2012.
背景
理解干预措施的保真度是评估复杂干预措施的重要组成部分，因为保真度不仅会影响试验结果的有效性，而且还因为对保真度的研究可以用于确定成功实施的障碍和促进因素，从而提供有关可能影响干预措施在临床实践中应用的因素的重要信息。参与者观察方法已被确定为保真度研究中特别有价值的方法，但很少使用。本研究旨在使用这些方法来探索一项复杂干预措施（Safewards）在一项集群随机对照试验中在精神科病房的实施质量。具体目标首先是描述干预措施实施的不同方式，其次是探索调节干预措施交付质量的背景因素，以便为干预措施的“现实世界”实施提供信息。
方法
Safewards 在英格兰的 16 个精神科病房实施。我们使用经过参与者观察培训的研究助理（RAs）记录干预措施交付质量的定性观察数据（n=565 次观察）。在试验结束时，对 RAs 进行了两次焦点小组讨论，这些讨论用于开发编码框架。使用主题分析对数据进行分析。
结果
病房之间的干预措施交付存在很大差异。我们观察到对干预措施的修改既符合保真度，也不一致，可以增强或削弱干预效果。我们使用这些数据开发了一种分类法，描述了干预措施交付的不同方式。这种分类法可以用作在试验中收集关于保真度的定性观察数据的工具。Safewards 实施的调节因素包括系统、人际和个体因素以及患者对干预措施的反应。
结论
我们的研究表明，通过适当的参与者观察培训，RAs 可以在试验期间收集高质量的干预措施交付观察数据，提供比仅测量依从性更完整的“保真度”画面。
试验注册
ISRCTN 注册表； IRSCTN38001825。于 2012 年 8 月 29 日注册。
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