Bakker Ingrid M, Terluin Berend, van Marwijk Harm W J, Gundy Chad M, Smit Johannes H, van Mechelen Willem, Stalman Wim A B
EMGO Institute, VU University Medical Centre Amsterdam, The Netherlands.
BMC Public Health. 2006 May 4;6:124. doi: 10.1186/1471-2458-6-124.
The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS), as well as to ascertain the study complies with the requirements for a cluster randomised controlled trial (RCT). The potential adverse consequences of sick leave due to Stress-related Mental Disorders (SMDs) are extensive, but often not recognised. Since most people having SMDs with sick leave consult their general practitioner (GP) at an early stage, a tailored intervention given by GPs is justified. We provide a detailed description of the MISS; that is more accurate assessment, education, advice and monitoring to treat SMDs in patients on sick leave. Our hypothesis is that the MISS will be more effective compared to the usual care, in reducing days of sick leave of these patients.
The design is a pragmatic RCT. Randomisation is at the level of GPs. They received the MISS-training versus no training, in order to compare the MISS vs. usual care at patient level. Enrollment of patients took place after screening in the source population, that comprised 20-60 year old primary care attendees. Inclusion criteria were: moderately elevated distress levels, having a paid job and sick leave for no longer than three months. There is a one year follow up. The primary outcome measure is lasting full return to work. Reduction of SMD- symptoms is one of the secondary outcome measures. Forty-six GPs and 433 patients agreed to participate.
In our study design, attention is given to the practical application of the requirements for a pragmatic trial. The results of this cluster RCT will add to the evidence about treatment options in general practice for SMDs in patients on sick leave, and might contribute to a new and appropriate guideline. These results will be available at the end of 2006.
本文的主要目的是描述针对病假患者应激相关精神障碍的全科最小干预措施（MISS）的背景和设计，以及确定该研究是否符合整群随机对照试验（RCT）的要求。因应激相关精神障碍（SMD）导致病假的潜在不良后果广泛，但往往未被认识到。由于大多数患有SMD且正在休病假的人会在早期咨询他们的全科医生（GP），因此由全科医生提供量身定制的干预措施是合理的。我们详细描述了MISS；即对休病假的患者进行更准确的评估、教育、建议和监测以治疗SMD。我们的假设是，与常规护理相比，MISS在减少这些患者的病假天数方面将更有效。
该设计为实用RCT。随机化在全科医生层面进行。他们接受MISS培训与不接受培训，以便在患者层面比较MISS与常规护理。患者在源人群筛查后入组，源人群包括20至60岁的初级保健就诊者。纳入标准为：痛苦水平中度升高、有带薪工作且病假不超过三个月。有一年的随访期。主要结局指标是持续完全恢复工作。SMD症状的减轻是次要结局指标之一。46名全科医生和433名患者同意参与。
在我们的研究设计中，关注了实用试验要求的实际应用。这项整群RCT的结果将增加关于全科医疗中治疗休病假的SMD患者的治疗选择的证据，并可能有助于制定新的适当指南。这些结果将于2006年底公布。
Zotero 插件