Melloh Markus, Röder Christoph, Elfering Achim, Theis Jean-Claude, Müller Urs, Staub Lukas P, Aghayev Emin, Zweig Thomas, Barz Thomas, Kohlmann Thomas, Wieser Simon, Jüni Peter, Zwahlen Marcel
MEM Research Center for Orthopaedic Surgery, University of Berne, Stauffacherstrasse 78, 3014 Berne, Switzerland.
BMC Musculoskelet Disord. 2008 Jun 6;9:81. doi: 10.1186/1471-2474-9-81.
There is little evidence on differences across health care systems in choice and outcome of the treatment of chronic low back pain (CLBP) with spinal surgery and conservative treatment as the main options. At least six randomised controlled trials comparing these two options have been performed; they show conflicting results without clear-cut evidence for superior effectiveness of any of the evaluated interventions and could not address whether treatment effect varied across patient subgroups. Cost-utility analyses display inconsistent results when comparing surgical and conservative treatment of CLBP. Due to its higher feasibility, we chose to conduct a prospective observational cohort study.
This study aims to examine if1. Differences across health care systems result in different treatment outcomes of surgical and conservative treatment of CLBP2. Patient characteristics (work-related, psychological factors, etc.) and co-interventions (physiotherapy, cognitive behavioural therapy, return-to-work programs, etc.) modify the outcome of treatment for CLBP3. Cost-utility in terms of quality-adjusted life years differs between surgical and conservative treatment of CLBP. This study will recruit 1000 patients from orthopaedic spine units, rehabilitation centres, and pain clinics in Switzerland and New Zealand. Effectiveness will be measured by the Oswestry Disability Index (ODI) at baseline and after six months. The change in ODI will be the primary endpoint of this study. Multiple linear regression models will be used, with the change in ODI from baseline to six months as the dependent variable and the type of health care system, type of treatment, patient characteristics, and co-interventions as independent variables. Interactions will be incorporated between type of treatment and different co-interventions and patient characteristics. Cost-utility will be measured with an index based on EQol-5D in combination with cost data.
This study will provide evidence if differences across health care systems in the outcome of treatment of CLBP exist. It will classify patients with CLBP into different clinical subgroups and help to identify specific target groups who might benefit from specific surgical or conservative interventions. Furthermore, cost-utility differences will be identified for different groups of patients with CLBP. Main results of this study should be replicated in future studies on CLBP.
关于以脊柱手术和保守治疗为主要选择的慢性下腰痛（CLBP）治疗在不同医疗保健系统中的选择及治疗结果差异，几乎没有证据。至少已经进行了六项比较这两种选择的随机对照试验；它们显示出相互矛盾的结果，没有明确证据表明任何一种评估干预措施具有更优的有效性，并且无法解决治疗效果在不同患者亚组中是否存在差异的问题。在比较CLBP的手术治疗和保守治疗时，成本效益分析显示结果不一致。由于其更高的可行性，我们选择进行一项前瞻性观察队列研究。
本研究旨在检验：1. 不同医疗保健系统之间的差异是否会导致CLBP手术治疗和保守治疗产生不同的治疗结果；2. 患者特征（与工作相关的因素、心理因素等）和联合干预措施（物理治疗、认知行为疗法、重返工作项目等）是否会改变CLBP的治疗结果；3. CLBP手术治疗和保守治疗在质量调整生命年方面的成本效益是否存在差异。本研究将从瑞士和新西兰的骨科脊柱科室、康复中心和疼痛诊所招募1000名患者。将在基线和六个月后通过Oswestry功能障碍指数（ODI）来衡量有效性。ODI的变化将是本研究的主要终点。将使用多元线性回归模型，以从基线到六个月的ODI变化作为因变量，以医疗保健系统类型、治疗类型、患者特征和联合干预措施作为自变量。将纳入治疗类型与不同联合干预措施和患者特征之间的相互作用。将使用基于EQol - 5D结合成本数据的指数来衡量成本效益。
本研究将提供证据，证明在CLBP治疗结果方面不同医疗保健系统之间是否存在差异。它将把CLBP患者分类到不同的临床亚组中，并有助于识别可能从特定手术或保守干预措施中受益的特定目标群体。此外，将确定不同CLBP患者群体的成本效益差异。本研究的主要结果应在未来关于CLBP的研究中得到重复验证。
