Danon-Hersch Nadia, Samartzis Dino, Wietlisbach Vincent, Porchet François, Vader John-Paul
From the *Institute of Social and Preventive Medicine (IUMSP), University of Lausanne, Lausanne, Switzerland; †Department of Orthopaedics and Traumatology, University of Hong Kong, Hong Kong SAR, China; and ‡Neurosurgical Department, Schulthess-Clinic, Zürich, Switzerland.
Spine (Phila Pa 1976). 2010 Mar 15;35(6):672-83. doi: 10.1097/BRS.0b013e3181b71a79.
Prospective, controlled, observational outcome study using clinical, radiographic, and patient/physician-based questionnaire data, with patient outcomes at 12 months follow-up.
To validate appropriateness criteria for low back surgery.
Most surgical treatment failures are attributed to poor patient selection, but no widely accepted consensus exists on detailed indications for appropriate surgery.
Appropriateness criteria for low back surgery have been developed by a multispecialty panel using the RAND appropriateness method. Based on panel criteria, a prospective study compared outcomes of patients appropriately and inappropriately treated at a single institution with 12 months follow-up assessment. Included were patients with low back pain and/or sciatica referred to the neurosurgical department. Information about symptoms, neurologic signs, the health-related quality of life (SF-36), disability status (Roland-Morris), and pain intensity (VAS) was assessed at baseline, at 6 months, and at 12 months follow-up. The appropriateness criteria were administered prospectively to each clinical situation and outside of the clinical setting, with the surgeon and patients blinded to the results of the panel decision. The patients were further stratified into 2 groups: appropriate treatment group (ATG) and inappropriate treatment group (ITG).
Overall, 398 patients completed all forms at 12 months. Treatment was considered appropriate for 365 participants and inappropriate for 33 participants. The mean improvement in the SF-36 physical component score at 12 months was significantly higher in the ATG (mean: 12.3 points) than in the ITG (mean: 6.8 points) (P = 0.01), as well as the mean improvement in the SF-36 mental component score (ATG mean: 5.0 points; ITG mean: -0.5 points) (P = 0.02). Improvement was also significantly higher in the ATG for the mean VAS back pain (ATG mean: 2.3 points; ITG mean: 0.8 points; P = 0.02) and Roland-Morris disability score (ATG mean: 7.7 points; ITG mean: 4.2 points; P = 0.004). The ATG also had a higher improvement in mean VAS for sciatica (4.0 points) than the ITG (2.8 points), but the difference was not significant (P = 0.08). The SF-36 General Health score declined in both groups after 12 months, however, the decline was worse in the ITG (mean decline: 8.2 points) than in the ATG (mean decline: 1.2 points) (P = 0.04). Overall, in comparison to ITG patients, ATG patients had significantly higher improvement at 12 months, both statistically and clinically.
In comparison to previously reported literature, our study is the first to assess the utility of appropriateness criteria for low back surgery at 1-year follow-up with multiple outcome dimensions. Our results confirm the hypothesis that application of appropriateness criteria can significantly improve patient outcomes.
前瞻性、对照、观察性结局研究,使用临床、影像学以及基于患者/医生的问卷数据,并对患者进行12个月的随访以获取结局数据。
验证腰椎手术的适宜性标准。
大多数手术治疗失败归因于患者选择不当,但对于合适手术的详细指征尚无广泛认可的共识。
一个多专业小组采用兰德适宜性方法制定了腰椎手术的适宜性标准。基于小组标准,一项前瞻性研究比较了在单一机构接受适当和不适当治疗的患者的结局,并进行了12个月的随访评估。纳入的患者为因腰痛和/或坐骨神经痛转诊至神经外科的患者。在基线、6个月和12个月随访时评估了有关症状、神经体征、健康相关生活质量(SF-36)、残疾状况(罗兰-莫里斯量表)和疼痛强度(视觉模拟评分法)的信息。前瞻性地将适宜性标准应用于每种临床情况以及临床环境之外,外科医生和患者对小组决策结果不知情。患者进一步分为两组:适当治疗组(ATG)和不适当治疗组(ITG)。
总体而言,398例患者在12个月时完成了所有表格。365名参与者的治疗被认为是适当的,33名参与者的治疗被认为是不适当的。12个月时,ATG患者的SF-36身体成分评分的平均改善(平均:12.3分)显著高于ITG患者(平均:6.8分)(P = 0.01),SF-36心理成分评分的平均改善也是如此(ATG平均:5.0分;ITG平均:-0.5分)(P = 0.02)。ATG患者的平均视觉模拟评分法背痛改善也显著更高(ATG平均:2.3分;ITG平均:0.8分;P = 0.02)以及罗兰-莫里斯残疾评分(ATG平均:7.7分;ITG平均:4.2分;P = 0.004)。ATG患者坐骨神经痛的平均视觉模拟评分法改善(4.0分)也高于ITG患者(2.8分),但差异不显著(P = 0.08)。两组患者的SF-36总体健康评分在12个月后均下降,然而,ITG患者的下降情况(平均下降:8.2分)比ATG患者更严重(平均下降:1.2分)(P = 0.04)。总体而言,与ITG患者相比,ATG患者在12个月时的改善在统计学和临床上均显著更高。
与先前报道的文献相比,我们的研究是首个在1年随访时通过多个结局维度评估腰椎手术适宜性标准效用的研究。我们的结果证实了应用适宜性标准可显著改善患者结局这一假设。