Department of Biosurgery and Surgical Technology, Imperial College London, St Mary's Campus, QEQM Building Praed Street, London W2 1NY, UK.
Soc Sci Med. 2009 Dec;69(12):1767-76. doi: 10.1016/j.socscimed.2009.09.051. Epub 2009 Oct 23.
Large-scale national and multi-institutional patient safety improvement programmes are being developed in the health care systems of several countries to address problems in the reliability of care delivered to patients. Drawing upon popular collaborative improvement models, these campaigns are ambitious in their aims to improve patient safety in macro-level systems such as whole health care organisations. This article considers the methodological issues involved in conducting research and evaluation of these programmes. Several specific research challenges are outlined, which result from the complexity of longitudinal, multi-level intervention programmes and the variable, highly sociotechnical care systems, with which they interact. Organisational-level improvement programmes are often underspecified due to local variations in context and organisational readiness for improvement work. The result is variable implementation patterns and local adaptations. Programme effects span levels and other boundaries within a system, vary dynamically or are cumulative over time and are problematic to understand in terms of cause and effect, where concurrent external influences exist and the impact upon study endpoints may be mediated by a range of organisational and social factors. We outline the methodological approach to research in the United Kingdom Safer Patients Initiative, to exemplify how some of the challenges for research in this area can be met through a multi-method, longitudinal research design. Specifically, effective research designs must be sensitive to complex variation, through employing multiple qualitative and quantitative measures, collect data over time to understand change and utilise descriptive techniques to capture specific interactions between programme and context for implementation. When considering the long-term, sustained impact of an improvement programme, researchers must consider how to define and measure the capability for continuous safe and reliable care as a property of the whole care system. This requires a sociotechnical approach, rather than focusing upon one microsystem, disciplinary perspective or single level of the system.
大型国家和多机构患者安全改进计划正在几个国家的医疗保健系统中制定，以解决提供给患者的护理可靠性方面的问题。这些活动借鉴了流行的协作改进模式，其目标是雄心勃勃的，旨在改善宏观层面系统（如整个医疗保健组织）中的患者安全性。本文考虑了对这些计划进行研究和评估所涉及的方法问题。由于纵向、多层次干预计划的复杂性以及与之相互作用的变量、高度社会技术护理系统，出现了几个具体的研究挑战。由于背景和组织对改进工作的准备情况存在地方差异，组织层面的改进计划通常规定不明确。其结果是实施模式和本地调整具有变异性。计划效果跨越系统内的水平和其他边界，随时间动态变化或累积，并且由于存在并发的外部影响，以及对研究终点的影响可能受到一系列组织和社会因素的调节，因此在因果关系方面难以理解。我们概述了英国更安全患者倡议研究中的方法方法，以举例说明如何通过多方法、纵向研究设计来应对该领域研究的一些挑战。具体来说，有效的研究设计必须通过采用多种定性和定量措施，随着时间的推移收集数据以了解变化，并利用描述性技术来捕捉计划和实施背景之间的特定交互作用，从而对复杂的变化保持敏感。当考虑改进计划的长期、持续影响时，研究人员必须考虑如何定义和衡量整个护理系统作为持续安全和可靠护理能力的属性。这需要一种社会技术方法，而不是专注于一个微观系统、学科视角或系统的单个级别。
