Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity
Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity
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DOI：
10.1186/s13063-017-2189-8
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发表时间：
2017-11-17
期刊：
影响因子：
2.5
通讯作者：
Stewart, Duncan
中科院分区：
文献类型：
--
作者：
James, Karen;Quirk, Alan;Stewart, Duncan
背景：了解干预保真度是评估复杂干预措施的重要组成部分，因为保真度不仅影响试验结果的有效性，而且还因为保真度研究可用于识别成功实施的障碍和促进因素，从而提供可能影响干预措施进入临床实践的因素的重要信息。参与式观察方法在保真度研究中被认为是特别有价值的，但很少使用。本研究旨在利用这些方法在聚类随机对照试验中探讨在精神卫生病房实施复杂干预（Safewards）的质量。具体目标首先是描述实施干预的不同方式，其次是探索调节干预交付质量的背景因素，以便为“现实世界”的干预实施提供信息。方法：在英国16个精神卫生病房实施安全措施。我们使用经过参与观察训练的研究助理（RAs）记录干预交付质量的定性观察数据（n = 565项观察）。在试验结束时，与RAs进行了两个焦点小组，用于开发编码框架。采用专题分析对数据进行分析。结果：不同病房间的干预递送有很大差异。我们观察到对干预的修改既有保真度一致的，也有不一致的，可以增强或减弱干预效果。我们利用这些数据开发了一个类型学，描述了干预的不同方式。这种类型可以用作收集试验期间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因素、人际因素和个体因素以及患者对干预的反应。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有关干预交付质量的高质量观察数据，提供比单独依从性测量更完整的“保真度”图像。
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.