HCS: Case study, Context and Complex interventions (TRIPLE C) - development of guidance and publication standards to support case study-based research

在卫生服务和公共卫生实践中广泛采用了复杂的干预措施（如重新设计中风服务、城市更新规划）。如何开发、实施和评估复杂的干预措施仍然是研究人员的一个关键问题。为了应对这一挑战，传统的研究方法已经到了极限。人们越来越有兴趣发展研究方法，以支持改进卫生保健方面的发展和实施，并考虑到复杂干预措施的背景（社区、组织等）。案例研究被广泛认为提供了这样的方法，并且是理解环境对复杂干预的影响的重要资源。在卫生服务研究和社会科学领域已经存在大量关于案例研究的文献。这些文献是从不同的学科（如心理学、社会学、管理学）和研究传统（如定性或定量）发展而来的。尚未以一种能够支持改进保健和公共卫生领域复杂干预措施的制定和实施的方式对其进行研究。传统的系统文献综述方法试图整理符合预先规定的资格标准的所有证据，以回答特定的研究问题。这种方法适用于某些（通常是相当狭窄的）工作领域，但在审查不同的、跨学科的主题（如案例研究在评估复杂干预措施中的作用）时往往用处不大。因此，我们提出了一种元叙事回顾：换句话说，使用一种系统的、理论驱动的技术来指导对案例研究方法的广泛文献的回顾，并帮助我们理解这些方法是如何被不同的研究者群体不同地概念化和使用的。元叙事评论是一个持续的过程，涉及审稿人理解什么对目标受众最有用，从多个角度阐明主题，捕捉研究传统如何随着时间的推移而展开，检查来自不同研究传统的“冲突数据”，不断反思新发现，并从外部受众那里获得反馈，以指导进一步的反思和分析。我们将结合主要来源的数据，阐述案例研究传统的演变方式和原因，然后比较这些不同传统的研究结果，从多个角度构建复杂干预措施案例研究的丰富图景。在总结了相关文献后，我们将与一组多达30名案例研究专家进行在线调查（确保有一系列的观点、组织和地点）。我们的想法是与小组分享我们对文献的总结，激发反思，并（超过三轮在线讨论）努力在研究复杂干预措施时使用案例研究的指导草案上尽可能接近共识。然后，我们计划在多达五个研究小组中测试该指南草案，这些研究小组已经进行并发表了关于复杂干预措施的高度重视的案例研究，以及一组多达10名案例研究专家。通过这一迭代过程，我们将制定关于如何设计和开展卫生保健领域复杂干预措施案例研究的方法学指导，并发布基于案例研究的复杂干预措施研究标准。我们将免费提供这些信息。我们还计划围绕该领域的案例研究建立一个实践社区，将来自不同学科和传统的专家聚集在一起，为未来复杂系统级干预措施的发展、实施和评估提供信息。

Complex interventions (e.g. redesign of stroke services, urban regeneration programmes) are widely used in the health service and in public health practice. The issue of how one develops, implements and evaluates complex interventions remains a key one for researchers. Traditional research methods have been stretched to the limit in meeting this challenge. There has been growing interest in developing research methods that support improved development and implementation in health care, and in ways that account for the contexts (communities, organisations and so on) in which complex interventions are intended. Case study research is widely recognised as offering such methods, and as a vital resource for understanding the influence of context on complex interventions. A significant literature on case study research already exists in health services research and the social sciences. This literature has evolved out of different disciplines (e.g. psychology, sociology, management), and research traditions (e.g. qualitative or quantitative). It has yet to be interrogated in a way that can support improved development and implementation of complex interventions in health care and public health. Traditional approaches to systematic literature review attempt to collate all evidence that fits pre-specified eligibility criteria in order to answer a specific research question. Such approaches lend themselves to certain (often quite narrow) areas of work but tend to be far less helpful when reviewing diverse, cross-disciplinary topics like the role of case study research in evaluating complex interventions. We therefore propose a meta-narrative review: in other words, using a systematic, theory-driven technique to guide reviewing the wide-ranging literature on case study methods and help us to understand how such methods have been differently conceptualised and used by different groups of researchers. Meta-narrative review is an on-going process, involving the reviewer in understanding what will be most useful to the intended audience, illuminating the topic from multiple angles, capturing how research traditions have unfolded over time, examining 'conflicting data' from different research traditions, continually reflecting on emerging findings and gaining feedback from an external audience to guide further reflection and analysis. We will combine data from key sources to produce an account of how and why case study traditions have evolved, and then compare findings from these different traditions to build a rich picture of case study research on complex interventions from multiple perspectives.Having summarised the relevant literature, we will conduct an online survey with a group of up to 30 experts in case study research (ensuring a range of perspectives, organisations and locations). The idea will be to share our summary of the literature with the group, stimulate reflection and (over three rounds of online discussion) work towards getting as close as possible to consensus on draft guidance on the use of case study when researching complex interventions. We plan to then test this draft guidance with up to five teams of researchers who have conducted and published highly regarded case studies of complex interventions, as well as a group of up to 10 case study experts. Through this iterative process, we will develop methodological guidance on how to design and carry out case studies of complex interventions in health care, and publish standards for case study-based research on complex interventions. We will make these freely available. We also plan to build a community of practice around case study research in this field, bringing together experts from different disciplines and traditions to inform future development, implementation and evaluation of complex system-level interventions.