职业医生对心理健康问题进行咨询对重返工作岗位影响的随机对照试验设计：CO-OP研究
Design of a randomized controlled trial on the effects of counseling of mental health problems by occupational physicians on return to work: the CO-OP-study.
作者信息
Rebergen David S, Bruinvels David J, van der Beek Allard J, van Mechelen Willem
机构信息
EMGO Institute, VU University Medical Centre, Department of Public and Occupational Health, Amsterdam, The Netherlands.
出版信息
BMC Public Health. 2007 Jul 26;7:183. doi: 10.1186/1471-2458-7-183.
BACKGROUND
Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.
METHODS/DESIGN: In a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.
DISCUSSION
In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN34887348.
背景
心理健康问题常常导致病假时间延长。在基层医疗中，针对这些患者的常规做法是建议其休息，在所有症状消失之前不要重返工作岗位。当症状持续存在时，这些患者通常会被转介到基层医疗和专科二级医疗的心理医生处。作为一种替代方法，人们一直在寻求激活荷兰基层医疗中的职业医生（OP）。2000年初，荷兰职业医生协会（NVAB）发布了一份关于职业医生对有心理健康问题员工的管理指南。该指南得到了员工、雇主和荷兰职业医生的积极反响。本文描述了一项研究的设计，旨在评估该指南与常规护理相比的效果。
方法/设计：在一项随机对照试验（RCT）中，干预组的受试者按照指南进行治疗。对照组接受常规护理，职业医生的参与度最低，且易于获得心理医生的帮助。受试者从荷兰的两个警察部门招募。该研究的主要结局是员工、雇主和职业医生的重返工作情况及治疗满意度。次要结局是与常规护理相比，干预措施的成本效益。此外，将预后指标作为潜在的混杂因素加以考虑。将通过基于该指南的绩效指标进行过程评估。
讨论
在这项务实的试验中，研究的是有效性而非效能。我们将评估在实际临床实践中可行的方法，而非在理想情况下。高质量试验的许多要求正在得到满足。这项研究的结果将有助于为因心理健康问题而休病假的员工提供职业健康实践中的治疗选择。此外，它们可能有助于制定新的、更合适的指南和逐步护理方案。结果将于2007年公布。
试验注册
当前受控试验ISRCTN34887348。
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