Kelly Michael P, Lenke Lawrence G, Godzik Jakub, Pellise Ferran, Shaffrey Christopher I, Smith Justin S, Lewis Stephen J, Ames Christopher P, Carreon Leah Y, Fehlings Michael G, Schwab Frank, Shimer Adam L
Department of Orthopedic Surgery, Washington University, Saint Louis, Missouri.
Department of Orthopedic Surgery, Columbia College of Physicians and Surgeons, New York, New York.
J Neurosurg Spine. 2017 Jul;27(1):68-73. doi: 10.3171/2016.12.SPINE161068. Epub 2017 May 5.
OBJECTIVE The authors conducted a study to compare neurological deficit rates associated with complex adult spinal deformity (ASD) surgery when recorded in retrospective and prospective studies. Retrospective studies may underreport neurological deficits due to selection, detection, and recall biases. Prospective studies are expensive and more difficult to perform, but they likely provide more accurate estimates of new neurological deficit rates. METHODS New neurological deficits were recorded in a prospective study of complex ASD surgeries (pSR1) with a defined outcomes measure (decrement in American Spinal Injury Association lower-extremity motor score) for neurological deficits. Using identical inclusion criteria and a subset of participating surgeons, a retrospective study was created (rSR1) and neurological deficit rates were collected. Continuous variables were compared with the Student t-test, with correction for multiple comparisons. Neurological deficit rates were compared using the Mantel-Haenszel method for standardized risks. Statistical significance for the primary outcome measure was p < 0.05. RESULTS Overall, 272 patients were enrolled in pSR1 and 207 patients were enrolled in rSR1. Inclusion criteria, defining complex spinal deformities, and exclusion criteria were identical. Sagittal Cobb measurements were higher in pSR1, although sagittal alignment was similar. Preoperative neurological deficit rates were similar in the groups. Three-column osteotomies were more common in pSR1, particularly vertebral column resection. New neurological deficits were more common in pSR1 (pSR1 17.3% [95% CI 12.6-22.2] and rSR1 9.0% [95% CI 5.0-13.0]; p = 0.01). The majority of deficits in both studies were at the nerve root level, and the distribution of level of injury was similar. CONCLUSIONS New neurological deficit rates were nearly twice as high in the prospective study than the retrospective study with identical inclusion criteria. These findings validate concerns regarding retrospective cohort studies and confirm the need for and value of carefully designed prospective, observational cohort studies in ASD.
目的 作者开展了一项研究，以比较在回顾性研究和前瞻性研究中记录的与复杂成人脊柱畸形（ASD）手术相关的神经功能缺损发生率。回顾性研究可能因选择、检测和回忆偏倚而少报神经功能缺损情况。前瞻性研究成本高昂且实施难度更大，但它们可能会更准确地估计新的神经功能缺损发生率。方法 在一项针对复杂ASD手术的前瞻性研究（pSR1）中记录新的神经功能缺损情况，该研究采用明确的结局指标（美国脊髓损伤协会下肢运动评分下降）来评估神经功能缺损。利用相同的纳入标准和部分参与手术的外科医生，开展了一项回顾性研究（rSR1）并收集神经功能缺损发生率。连续变量采用Student t检验进行比较，并对多重比较进行校正。使用Mantel-Haenszel方法对标准化风险的神经功能缺损发生率进行比较。主要结局指标的统计学显著性为p < 0.05。结果 总体而言，pSR1纳入了272例患者，rSR1纳入了207例患者。纳入标准、复杂脊柱畸形的定义及排除标准均相同。pSR1中的矢状面Cobb角测量值更高，尽管矢状面排列相似。两组术前神经功能缺损发生率相似。三柱截骨术在pSR1中更为常见，尤其是脊柱椎体切除术。新的神经功能缺损在pSR1中更为常见（pSR1为17.3% [95% CI 12.6 - 22.2]，rSR1为9.0% [95% CI 5.0 - 13.0]；p = 0.01）。两项研究中的大多数缺损均发生在神经根水平，且损伤水平的分布相似。结论 在纳入标准相同的情况下，前瞻性研究中的新神经功能缺损发生率几乎是回顾性研究的两倍。这些发现证实了对回顾性队列研究的担忧，并证实了精心设计的前瞻性观察性队列研究在ASD中的必要性和价值。
