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制定澳大利亚“零儿童癌症”(Zero)计划实施和评估策略:研究方案。

Development of an implementation and evaluation strategy for the Australian 'Zero Childhood Cancer' (Zero) Program: a study protocol.

机构信息

Centre for Healthcare Resilience and Implementation Science, Australian Institute of Health Innovation, Macquarie University, North Ryde, New South Wales, Australia

Centre for Healthcare Resilience and Implementation Science, Australian Institute of Health Innovation, Macquarie University, North Ryde, New South Wales, Australia.

出版信息

BMJ Open. 2020 Jun 23;10(6):e034522. doi: 10.1136/bmjopen-2019-034522.

DOI:10.1136/bmjopen-2019-034522
PMID:32580982
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7312332/
Abstract

INTRODUCTION

Effective implementation of a research Program requires an actionable plan to guide execution. To assess the actionability and success of that plan, both scientific and implementation elements must be taken into account. The aim of this study is to assess the 'Zero Childhood Cancer Personalised Medicine Program' (the Zero Program), an Australian first-ever and most comprehensive personalised medicine programme for children with high-risk or relapsed cancer, in terms of its structure, process and implementational effect.

METHODS AND ANALYSIS

We will assess Program delivery mechanisms. The development of the implementation and evaluation strategy will concentrate on the work of the Zero Program as a complex whole. This includes the structure of collaborative links across stakeholder groups involved in Program development and delivery, changes to collaborative relationships over time and the impact of group working on Program outcomes. We are applying a mixed-methods design including: a rapid ethnography (observations of stakeholder interactions and informal conversations), Program professionals' completion of a rapid health implementation proforma and a social network analysis. Formative evaluations of the implementation science effects, applying feedback techniques, for example, Formative Evaluation Feedback Loops and the Zero Program professionals' feedback, will determine where Program tailoring may be needed. A repeat of the social network analysis downstream will examine network changes over time, followed by an expert panel using the expert recommendations for implementing change to assess the integration of implementation strategies into the Program structure. A summative evaluation of the Program will bring the research elements together, leading to comprehensive data triangulation and determining the sustainability and implementational effects of Program delivery.

ETHICS AND DISSEMINATION

Ethical approval for this study has been granted by Hunter New England Research Ethics Committee, New South Wales, Australia (approval ref: 2019/ETH12025). Knowledge translation will be achieved through publications, reports and conference presentations to healthcare professionals, patients, families and researchers.

TRIAL REGISTRATION

NCT03336931; Pre-results.

摘要

简介

有效的研究计划实施需要一个可操作的计划来指导执行。为了评估该计划的可操作性和成功与否,必须同时考虑科学和实施要素。本研究旨在评估“零儿童癌症个体化医学计划”(零计划),这是澳大利亚首个也是最全面的针对高危或复发癌症儿童的个体化医学计划,从其结构、过程和实施效果方面进行评估。

方法和分析

我们将评估计划的交付机制。实施和评估策略的制定将集中在零计划作为一个整体的工作上。这包括参与计划开发和实施的利益相关者群体之间协作关系的结构、随着时间的推移协作关系的变化以及群体工作对计划结果的影响。我们正在采用混合方法设计,包括:快速民族志(观察利益相关者的互动和非正式对话)、计划专业人员快速完成健康实施简表以及社会网络分析。实施科学效果的形成性评估,应用反馈技术,例如形成性评估反馈循环和零计划专业人员的反馈,将确定需要对计划进行定制的地方。下游重复进行社会网络分析,以检查随时间的网络变化,然后由专家小组使用实施变革的专家建议来评估实施策略整合到计划结构中的情况。对计划的总结性评估将汇集研究内容,导致综合数据三角测量,并确定计划交付的可持续性和实施效果。

伦理和传播

这项研究已获得澳大利亚新南威尔士州亨特新英格兰研究伦理委员会的伦理批准(批准文号:2019/ETH12025)。知识转化将通过向医疗保健专业人员、患者、家属和研究人员发表出版物、报告和会议演讲来实现。

试验注册

NCT03336931;预结果。

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