May Carl R, Mair Frances S, Dowrick Christopher F, Finch Tracy L
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
BMC Fam Pract. 2007 Jul 24;8:42. doi: 10.1186/1471-2296-8-42.
The Normalization Process Model is a conceptual tool intended to assist in understanding the factors that affect implementation processes in clinical trials and other evaluations of complex interventions. It focuses on the ways that the implementation of complex interventions is shaped by problems of workability and integration.
In this paper the model is applied to two different complex trials: (i) the delivery of problem solving therapies for psychosocial distress, and (ii) the delivery of nurse-led clinics for heart failure treatment in primary care.
Application of the model shows how process evaluations need to focus on more than the immediate contexts in which trial outcomes are generated. Problems relating to intervention workability and integration also need to be understood. The model may be used effectively to explain the implementation process in trials of complex interventions.
The model invites evaluators to attend equally to considering how a complex intervention interacts with existing patterns of service organization, professional practice, and professional-patient interaction. The justification for this may be found in the abundance of reports of clinical effectiveness for interventions that have little hope of being implemented in real healthcare settings.
规范化过程模型是一种概念工具,旨在帮助理解影响临床试验及其他复杂干预评估中实施过程的因素。它关注复杂干预实施过程中因可操作性和整合性问题而形成的方式。
本文将该模型应用于两项不同的复杂试验:(i)针对心理社会困扰提供问题解决疗法,以及(ii)在初级保健中提供由护士主导的心力衰竭治疗诊所服务。
该模型的应用表明,过程评估需要关注的不仅仅是产生试验结果的直接背景。与干预可操作性和整合性相关的问题也需要理解。该模型可有效地用于解释复杂干预试验中的实施过程。
该模型促使评估者同样关注思考复杂干预如何与现有的服务组织模式、专业实践以及专业人员与患者的互动模式相互作用。这样做的理由可从大量关于临床有效性的报告中找到,这些干预措施在实际医疗环境中几乎没有实施的希望。