Beemster Timo T, van Velzen Judith M, van Bennekom Coen A M, Frings-Dresen Monique H W, Reneman Michiel F
Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of Research and Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.
Trials. 2015 Jul 28;16:317. doi: 10.1186/s13063-015-0861-4.
Although vocational rehabilitation is a widely advocated intervention for workers on sick leave due to subacute or chronic nonspecific musculoskeletal pain, the optimal dosage of effective and cost-effective vocational rehabilitation remains unknown. The objective of this paper is to describe the design of a non-inferiority trial evaluating the effectiveness and cost-effectiveness of 40-h multidisciplinary vocational rehabilitation compared with 100-h multidisciplinary vocational rehabilitation on work participation for workers on sick leave due to subacute or chronic musculoskeletal pain.
METHODS/DESIGN: A non-inferiority study design will be applied. The study population consists of workers who are on part-time or full-time sick leave due to subacute or chronic nonspecific musculoskeletal pain. Two multidisciplinary vocational rehabilitation programs following the bio-psychosocial approach will be evaluated in this study: 40-h vocational rehabilitation and 100-h vocational rehabilitation, both delivered over a maximum of 15 weeks. The 100-h vocational rehabilitation comprises five modules: work participation coordination, graded activity, cognitive behavioral therapy, group education, and relaxation. The 40-h vocational rehabilitation comprises work participation coordination and a well-reasoned choice from the other four modules. Four rehabilitation centers will participate in this study, each delivering both interventions. Patients will be randomized into one of the interventions, stratified for the duration of sick leave (<6 weeks or ≥ 6 weeks) and type of sick leave (part-time or full-time). The primary outcome is work participation, measured by self-reported sick leave days, and will be assessed at baseline, mid-term, discharge, and at 2, 4, 6, 8, 10, and 12 months follow-up. Secondary outcomes are work ability, disability, quality of life, and physical functioning and will be assessed at baseline, discharge, and at 6 and 12 months follow-up. Cost outcomes are absenteeism, presenteeism, healthcare usage, and travelling costs. Cost-effectiveness will be evaluated from the societal and employer perspectives.
The results obtained from this study will be useful for vocational rehabilitation practice and will provide stakeholders with relevant insights into two versions of vocational rehabilitation.
Dutch Trial Register identifier: NTR4362 (registered 17 March 2014).
尽管职业康复是一种广泛倡导的针对因亚急性或慢性非特异性肌肉骨骼疼痛而休病假的工人的干预措施，但有效且具有成本效益的职业康复的最佳剂量仍不清楚。本文的目的是描述一项非劣效性试验的设计，该试验评估了40小时多学科职业康复与100小时多学科职业康复相比，对因亚急性或慢性肌肉骨骼疼痛而休病假的工人的工作参与度的有效性和成本效益。
方法/设计：将采用非劣效性研究设计。研究人群包括因亚急性或慢性非特异性肌肉骨骼疼痛而休兼职或全职病假的工人。本研究将评估两个遵循生物心理社会方法的多学科职业康复计划：40小时职业康复和100小时职业康复，两者最多在15周内完成。100小时的职业康复包括五个模块：工作参与协调、分级活动、认知行为疗法、团体教育和放松。40小时的职业康复包括工作参与协调以及从其他四个模块中合理选择的一个模块。四个康复中心将参与本研究，每个中心都提供这两种干预措施。患者将被随机分配到其中一种干预措施中，根据病假时长（<6周或≥6周）和病假类型（兼职或全职）进行分层。主要结局是工作参与度，通过自我报告的病假天数来衡量，并将在基线、中期、出院时以及随访的2、4、6、8、10和12个月时进行评估。次要结局包括工作能力、残疾、生活质量和身体功能，并将在基线、出院时以及随访的6和12个月时进行评估。成本结局包括旷工、出勤主义、医疗保健使用和交通成本。将从社会和雇主的角度评估成本效益。
本研究获得的结果将对职业康复实践有用，并将为利益相关者提供有关两种职业康复版本的相关见解。
荷兰试验注册标识符：NTR4362（2014年3月17日注册）。
