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The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework

机译：证据，背景和协助在实施试验中的作用：对PARIHS框架发展的影响

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Background The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework. Methods The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets. Results A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes. Conclusions This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation. Trial registration ISRCTN18046709 - Peri-operative Implementation Study Evaluation (PoISE).
机译：背景技术为在试验中进行更多更好的理论依据的过程评估提供了依据，以促进对干预工作原理的深刻理解。在本文中，我们对实施过程进行了解释，这是最早的一项在急性护理中进行的具有嵌入式过程评估的国家实施研究随机对照试验，以及对卫生服务研究实施促进行动（PARIHS）框架的拟议扩展。方法在一项旨在减少围手术期禁食时间的试验中，PARIHS框架被前瞻性地用于指导有关干预设计，数据收集和分析过程的决策。为了全面了解实施过程，不考虑干预措施的分配，在19家参与医院中收集了相同的数据。本文报告了从151名干预前后患者和患者的有针对性样本中收集的数据得出的结论。使用内容分析对数据集进行内部分析，然后对数据集进行分析。结果强有力且无争议的证据基础是改变实践的必要条件，但不是充分条件，因为个人员工和患者的反应（例如谨慎）会影响决策。实施环境充满挑战，个人和团队都受到专业问题，沟通挑战，权力以及对实践变更的权力和责任缺乏明确性的束缚。在流程与现有计划保持一致的站点上取得了进展。此外，主持人报告说他们参与了许多干预措施的实施活动，其中一些活动导致了实践的改变，但并未显着改善结果。结论本研究为反思PARIHS框架的全面性提供了机会。与PARIHS的基本租户一致，实施的多方面动态故事显而易见。但是，在框架内，目前尚不清楚个人在证据与情境之间相互作用中扮演的重要角色。我们建议成功地将证据付诸实践是一个计划好的过程，涉及个人，证据和环境之间的相互作用，以促进循证实践。该提案将增强PARIHS框架进行解释的潜力，并确保理论发展为实施提供依据和依据。试用注册ISRCTN18046709-围手术期实施研究评估（PoISE）。

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