Soegaard Rikke, Bünger Cody E, Christiansen Terkel, Christensen Finn B
Spine Unit, Orthopaedic Research Laboratory, University Hospital of Aarhus, Norrebrogade 44, Building 1 A, 8000, Aarhus C, Denmark.
Eur Spine J. 2007 Nov;16(11):1822-31. doi: 10.1007/s00586-007-0378-y. Epub 2007 May 23.
Up to one third of patients undergoing lumbar spinal fusion show no improvement after the procedure and thus, despite evidence from RCTs, there might be a rationale for observational studies clarifying indications. Similarly, selection of the right patients for the right procedure could have significant impact on cost-effectiveness, which in some countries, in turn, affects whether procedures are to be available through the National Health Service. The aim of this study was to investigate determinants of cost-effectiveness in lumbar spinal fusion. An observational cohort study with 2-year follow-up was conducted: 695 patients who underwent lumbar spinal fusion from 1996 to 2002 were included and followed for 2 years. Patients had a localized segmental pathology and were diagnosed with MRI-verified isthmic spondylolisthesis (26%) or disc degeneration (74%). The surgical techniques were non-instrumented posterolateral fusion (14%), instrumented posterolateral fusion (54%), and circumferential fusion (32%). Societal costs and improvement in functional disability (Dallas Pain Questionnaire) were transformed into a net benefit measure. Classical linear regression of the net benefit was conducted using predictors of age, sex, diagnosis, duration of pain, smoking habits, occupational status, severity of disability, emotional distress, surgical technique, and number of levels fused. The main results were that two determinants were found to negatively influence net benefit: smoking and diagnosis, whereas two others were found to be positively associated with the net benefit: severe disability and emotional distress. In conclusion, predicting net benefit reverses the picture usually seen in studies predicting clinical outcomes, because the response variable is based on improvement over time rather than end-point measures alone. Smoking habits, diagnosis, pre-operative disability, and pre-operative emotional distress were found to be significantly associated with the net benefit of spinal fusion.
接受腰椎融合手术的患者中,高达三分之一的人术后并无改善。因此,尽管随机对照试验有相关证据,但进行观察性研究以明确适应症或许仍有其合理性。同样,为合适的患者选择合适的手术方式可能会对成本效益产生重大影响,而在某些国家,这反过来又会影响该手术是否能通过国民医疗服务体系获得。本研究的目的是调查腰椎融合手术成本效益的决定因素。我们进行了一项为期2年随访的观察性队列研究:纳入了1996年至2002年间接受腰椎融合手术的695名患者,并对其进行了2年的随访。患者患有局限性节段性病变,经磁共振成像(MRI)证实诊断为峡部裂型腰椎滑脱(26%)或椎间盘退变(74%)。手术技术包括非器械辅助后外侧融合术(14%)、器械辅助后外侧融合术(54%)和环形融合术(32%)。将社会成本和功能残疾改善情况(达拉斯疼痛问卷)转化为净效益指标。使用年龄、性别、诊断、疼痛持续时间、吸烟习惯、职业状况、残疾严重程度、情绪困扰、手术技术和融合节段数等预测因素对净效益进行经典线性回归分析。主要结果是发现有两个决定因素对净效益有负面影响:吸烟和诊断,而另外两个因素与净效益呈正相关:严重残疾和情绪困扰。总之,预测净效益扭转了通常在预测临床结果的研究中所看到的情况,因为反应变量是基于随时间的改善情况而非仅基于终点指标。研究发现吸烟习惯、诊断、术前残疾状况和术前情绪困扰与脊柱融合的净效益显著相关。