Jansen Yvonne J F M, Bal Roland, Bruijnzeels Marc, Foets Marleen, Frenken Rianne, de Bont Antoinette
Institute of Health Policy and Management, Erasmus MC Rotterdam, Rotterdam, The Netherlands.
BMC Health Serv Res. 2006 Dec 13;6:160. doi: 10.1186/1472-6963-6-160.
The aim of this paper is to show how researchers balance between scientific rigour and localisation in conducting pragmatic trial research. Our case is the Quattro Study, a pragmatic trial on the effectiveness of multidisciplinary patient care teams used in primary health care centres in deprived neighbourhoods of two major cities in the Netherlands for intensified secondary prevention of cardiovascular diseases.
For this study an ethnographic design was used. We observed and interviewed the researchers and the practice nurses. All gathered research documents, transcribed observations and interviews were analysed thematically.
Conducting a pragmatic trial is a continuous balancing act between meeting methodological demands and implementing a complex intervention in routine primary health care. As an effect, the research design had to be adjusted pragmatically several times and the intervention that was meant to be tailor-made became a rather stringent procedure.
A pragmatic trial research is a dynamic process that, in order to be able to assess the validity and reliability of any effects of interventions must also have a continuous process of methodological and practical reflection. Ethnographic analysis, as we show, is therefore of complementary value.
本文旨在展示研究人员在进行务实试验研究时如何在科学严谨性和本土化之间取得平衡。我们的案例是四重奏研究，这是一项关于多学科患者护理团队有效性的务实试验，该团队在荷兰两个主要城市贫困社区的初级卫生保健中心用于强化心血管疾病的二级预防。
本研究采用了人种志设计。我们观察并采访了研究人员和执业护士。对所有收集到的研究文件、转录的观察资料和访谈进行了主题分析。
进行务实试验是在满足方法学要求和在常规初级卫生保健中实施复杂干预之间不断进行的平衡行为。结果，研究设计不得不多次进行务实调整，原本旨在量身定制的干预措施变成了一个相当严格的程序。
务实试验研究是一个动态过程，为了能够评估干预措施任何效果的有效性和可靠性，还必须有一个持续的方法学和实践反思过程。因此，正如我们所展示的，人种志分析具有补充价值。
