Sanders James O, Newton Peter O, Browne Richard H, Herring Anthony J
Department of Orthopaedics, University of Rochester, Rochester, NY 14642, USA.
J Pediatr Orthop. 2012 Sep;32 Suppl 2:S153-7. doi: 10.1097/BPO.0b013e31825199e5.
In this manuscript we will present several evidence-based medicine concepts and tools that can be helpful to the clinician seeking answers to clinical questions. The clinical scenario used to demonstrate these concepts is one of the substantial current controversy in pediatric orthopaedics, that is the efficacy of bracing in adolescent idiopathic scoliosis. We hope to provide some important information about how to search and interpret the current literature on bracing but also to discuss the concepts related to "surrogate outcomes" and the "number needed to treat," which we believe are increasingly important in this era of evidence-based medicine.
We performed a structured literature review of scoliosis bracing and also a separate analysis of the number needed to treat (NNT) for preventing surgery in adolescent idiopathic scoliosis.
Bracing for idiopathic scoliosis significantly reduces the rate of curve progression more than 6 degrees. However, the applicability of the 6-degree surrogate outcome compared with a more important outcome such as progression to surgery is doubtful. Bracing may decrease the risk of progression to surgery although the confidence intervals are large. The NNT for routine scoliosis bracing is about 9 patients for each surgery prevented. The NNT for patients highly compliant with bracing is about 4. We caution that these NNTs are derived from nonrandomized cohorts, and the true values from quality randomized controlled studies may be substantially different. There is no evidence for any particular brace over another although rigid bracing seems better than SpineCor bracing from 1 small randomized controlled study.
Systematic reviews support bracing's ability to prevent curve progression of 6 degrees but not for preventing surgery. Analysis of a patient cohort does support bracing's ability to prevent surgery with NNT of 9 for all patients and 4 for highly compliant patients.
Systematic review-therapeutic level 2. Cohort analysis-therapeutic level 2.
在本论文中,我们将介绍几种循证医学的概念和工具,这些对寻求临床问题答案的临床医生可能会有所帮助。用于阐述这些概念的临床案例是目前小儿骨科领域一个重大的争议点,即青少年特发性脊柱侧弯支具治疗的疗效。我们希望提供一些关于如何检索和解读当前支具治疗文献的重要信息,同时讨论与“替代结局”和“需治疗人数”相关的概念,我们认为在这个循证医学时代,这些概念变得越来越重要。
我们对脊柱侧弯支具治疗进行了结构化文献综述,并单独分析了青少年特发性脊柱侧弯预防手术的需治疗人数(NNT)。
特发性脊柱侧弯支具治疗能显著降低侧弯进展超过6度的发生率。然而,与手术进展等更重要的结局相比,6度替代结局的适用性值得怀疑。支具治疗可能会降低进展至手术的风险,尽管置信区间较大。常规脊柱侧弯支具治疗的NNT约为每预防一例手术需治疗9名患者。高度依从支具治疗的患者NNT约为4。我们提醒,这些NNT值来自非随机队列,高质量随机对照研究的真实值可能会有很大不同。尽管一项小型随机对照研究表明刚性支具似乎比SpineCor支具更好,但没有证据表明某种支具优于其他支具。
系统评价支持支具预防侧弯进展超过6度的能力,但不支持预防手术的能力。对患者队列的分析确实支持支具预防手术的能力,所有患者的NNT为9,高度依从患者的NNT为4。
系统评价——治疗性2级。队列分析——治疗性2级。