Byrne Molly, Cupples Margaret E, Smith Susan M, Leathem Claire, Corrigan Mairead, Byrne Mary C, Murphy Andrew W
Department of Psychology, National University of Ireland, Galway, Ireland.
Am J Manag Care. 2006 May;12(5):261-6.
To apply the UK Medical Research Council (MRC) framework for development and evaluation of trials of complex interventions to a primary healthcare intervention to promote secondary prevention of coronary heart disease.
Case report of intervention development.
First, literature relating to secondary prevention and lifestyle change was reviewed. Second, a preliminary intervention was modeled, based on literature findings and focus group interviews with patients (n = 23) and staff (n = 29) from 4 general practices. Participants' experiences of and attitudes toward key intervention components were explored. Third, the preliminary intervention was pilot-tested in 4 general practices. After delivery of the pilot intervention, practitioners evaluated the training sessions, and qualitative data relating to experiences of the intervention were collected using semistructured interviews with staff (n = 10) and patient focus groups (n = 17).
Literature review identified 3 intervention components: a structured recall system, practitioner training, and patient information. Initial qualitative data identified variations in recall system design, training requirements (medication prescribing, facilitating behavior change), and information appropriate to the prospective study participants. Identifying detailed structures within intervention components clarified how the intervention could be tailored to individual practice, practitioner, and patient needs while preserving the theoretical functions of the components. Findings from the pilot phase informed further modeling of the intervention, reducing administrative time, increasing practical content of training, and omitting unhelpful patient information.
Application of the MRC framework helped to determine the feasibility and development of a complex intervention for primary care research.
将英国医学研究理事会（MRC）关于复杂干预试验的开发与评估框架应用于一项促进冠心病二级预防的初级医疗保健干预措施。
干预开发的病例报告。
首先，回顾与二级预防及生活方式改变相关的文献。其次，基于文献研究结果以及对来自4家全科诊所的患者（n = 23）和工作人员（n = 29）进行的焦点小组访谈，构建一个初步干预措施。探究了参与者对关键干预组成部分的体验和态度。第三，在4家全科诊所对初步干预措施进行试点测试。在实施试点干预后，从业者对培训课程进行了评估，并通过对工作人员（n = 10）和患者焦点小组（n = 17）进行半结构化访谈，收集了与干预体验相关的定性数据。
文献综述确定了3个干预组成部分：结构化召回系统、从业者培训和患者信息。初步定性数据确定了召回系统设计、培训要求（药物处方、促进行为改变）以及适合预期研究参与者的信息方面的差异。明确干预组成部分内的详细结构，阐明了如何在保持各组成部分理论功能的同时，根据个体诊所、从业者和患者的需求对干预措施进行调整。试点阶段的结果为干预措施的进一步建模提供了依据，减少了行政时间，增加了培训的实践内容，并省略了无用的患者信息。
MRC框架的应用有助于确定一项针对初级保健研究的复杂干预措施的可行性和开发。
