Richter-Sundberg Linda, Nyström Monica Elisabeth, Krakau Ingvar, Sandahl Christer
1PhD Student,Department of Public Health and Clinical Medicine,Unit for Epidemiology and Global Health,Umeå University,Umeå,Sweden.
3Senior Lecturer,Department of Learning,Informatics,Management and Ethics,Medical Management Center,Karolinska Institutet,Stockholm,Sweden.
Prim Health Care Res Dev. 2015 Apr;16(2):188-200. doi: 10.1017/S1463423614000243. Epub 2014 Jun 27.
The aim of this study is to investigate factors contributing to the failure of a randomized clinical trial designed to implement and test clinical practice guidelines for the treatment of depression in primary health care (PHC).
Although the occurrence of depression is increasing globally, many patients with depression do not receive optimal treatment. Clinical practice guidelines for the treatment of depression, which aim to establish evidence-based clinical practice in health care, are often underused and in need of operationalization in and adaptation to clinical praxis. This study explores a failed clinical trial designed to implement and test treatment of depression in PHC in Sweden.
Qualitative case study methodology was used. Semi-structured interviews were conducted with eight participants from the clinical trial researcher group and 11 health care professionals at five PHC units. Additionally, archival data (ie, documents, email correspondence, reports on the clinical trial) from the years 2007-2010 were analysed.
The study identified barriers to the implementation of the clinical trial in the project characteristics, the medical professionals, the patients, and the social network, as well as in the organizational, economic and political context. The project increased staff workload and created tension as the PHC culture and the research activities clashed (eg, because of the systematic use of questionnaires and changes in scheduling and planning of patient visits). Furthermore, there was a perception that the PHC units' management did not sufficiently support the project and that the project lacked basic incentives for reaching a sustainable resolution. Despite efforts by the project managers to enhance and support implementation of the innovation, they were unable to overcome these barriers. The study illustrates the complexity and barriers of performing clinical trials in the PHC.
本研究旨在调查导致一项随机临床试验失败的因素，该试验旨在实施和测试初级卫生保健（PHC）中抑郁症治疗的临床实践指南。
尽管全球抑郁症的发病率在上升，但许多抑郁症患者并未得到最佳治疗。旨在在医疗保健中建立循证临床实践的抑郁症治疗临床实践指南，常常未得到充分利用，需要在临床实践中进行实施和调整。本研究探讨了一项在瑞典初级卫生保健中实施和测试抑郁症治疗的失败临床试验。
采用定性案例研究方法。对来自临床试验研究组的8名参与者和5个初级卫生保健单位的11名医疗保健专业人员进行了半结构化访谈。此外，还分析了2007 - 2010年的档案数据（即文件、电子邮件通信、临床试验报告）。
该研究确定了在项目特征、医疗专业人员、患者和社交网络以及组织、经济和政治背景等方面存在的阻碍临床试验实施的因素。该项目增加了工作人员的工作量，并因初级卫生保健文化与研究活动发生冲突（例如，由于系统使用问卷以及患者就诊安排和计划的变化）而产生了紧张关系。此外，有人认为初级卫生保健单位的管理层对该项目支持不足，且该项目缺乏实现可持续解决方案的基本激励措施。尽管项目经理努力加强和支持创新的实施，但他们无法克服这些障碍。该研究说明了在初级卫生保健中开展临床试验的复杂性和障碍。
