McGirt Matthew J, Bydon Mohamad, Archer Kristin R, Devin Clinton J, Chotai Silky, Parker Scott L, Nian Hui, Harrell Frank E, Speroff Theodore, Dittus Robert S, Philips Sharon E, Shaffrey Christopher I, Foley Kevin T, Asher Anthony L
Department of Neurological Surgery, Carolina Neurosurgery and Spine Associates, and Neurological Institute, Carolinas Healthcare System, Charlotte, North Carolina.
Department of Neurological Surgery, Mayo Clinic, Rochester, Minnesota.
J Neurosurg Spine. 2017 Oct;27(4):357-369. doi: 10.3171/2016.11.SPINE16526. Epub 2017 May 12.
OBJECTIVE Quality and outcomes registry platforms lie at the center of many emerging evidence-driven reform models. Specifically, clinical registry data are progressively informing health care decision-making. In this analysis, the authors used data from a national prospective outcomes registry (the Quality Outcomes Database) to develop a predictive model for 12-month postoperative pain, disability, and quality of life (QOL) in patients undergoing elective lumbar spine surgery. METHODS Included in this analysis were 7618 patients who had completed 12 months of follow-up. The authors prospectively assessed baseline and 12-month patient-reported outcomes (PROs) via telephone interviews. The PROs assessed were those ascertained using the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for back pain (BP) and leg pain (LP). Variables analyzed for the predictive model included age, gender, body mass index, race, education level, history of prior surgery, smoking status, comorbid conditions, American Society of Anesthesiologists (ASA) score, symptom duration, indication for surgery, number of levels surgically treated, history of fusion surgery, surgical approach, receipt of workers' compensation, liability insurance, insurance status, and ambulatory ability. To create a predictive model, each 12-month PRO was treated as an ordinal dependent variable and a separate proportional-odds ordinal logistic regression model was fitted for each PRO. RESULTS There was a significant improvement in all PROs (p < 0.0001) at 12 months following lumbar spine surgery. The most important predictors of overall disability, QOL, and pain outcomes following lumbar spine surgery were employment status, baseline NRS-BP scores, psychological distress, baseline ODI scores, level of education, workers' compensation status, symptom duration, race, baseline NRS-LP scores, ASA score, age, predominant symptom, smoking status, and insurance status. The prediction discrimination of the 4 separate novel predictive models was good, with a c-index of 0.69 for ODI, 0.69 for EQ-5D, 0.67 for NRS-BP, and 0.64 for NRS-LP (i.e., good concordance between predicted outcomes and observed outcomes). CONCLUSIONS This study found that preoperative patient-specific factors derived from a prospective national outcomes registry significantly influence PRO measures of treatment effectiveness at 12 months after lumbar surgery. Novel predictive models constructed with these data hold the potential to improve surgical effectiveness and the overall value of spine surgery by optimizing patient selection and identifying important modifiable factors before a surgery even takes place. Furthermore, these models can advance patient-focused care when used as shared decision-making tools during preoperative patient counseling.
目的 质量与结局登记平台处于许多新兴的循证改革模式的核心。具体而言,临床登记数据正逐渐为医疗决策提供信息。在本分析中,作者使用来自一个全国前瞻性结局登记库(质量结局数据库)的数据,为接受择期腰椎手术的患者建立了一个预测模型,以预测术后12个月的疼痛、残疾和生活质量(QOL)。方法 本分析纳入了7618例完成了12个月随访的患者。作者通过电话访谈前瞻性地评估了基线和12个月时患者报告的结局(PROs)。评估的PROs包括使用奥斯威斯利残疾指数(ODI)、EQ-5D以及背痛(BP)和腿痛(LP)的数字评定量表(NRS)所确定的指标。为预测模型分析的变量包括年龄、性别、体重指数、种族、教育水平、既往手术史、吸烟状况、合并症、美国麻醉医师协会(ASA)评分、症状持续时间、手术指征、手术治疗的节段数、融合手术史、手术入路、是否获得工伤赔偿、责任保险、保险状况以及活动能力。为创建预测模型,将每个12个月的PRO视为一个有序因变量,并为每个PRO拟合一个单独的比例优势有序逻辑回归模型。结果 腰椎手术后12个月时,所有PROs均有显著改善(p < 0.0001)。腰椎手术后总体残疾、QOL和疼痛结局的最重要预测因素是就业状况、基线NRS-BP评分、心理困扰、基线ODI评分、教育水平、工伤赔偿状况、症状持续时间、种族、基线NRS-LP评分、ASA评分、年龄、主要症状、吸烟状况和保险状况。4个单独的新型预测模型的预测辨别力良好,ODI的c指数为0.69,EQ-5D的为0.69,NRS-BP的为0.67,NRS-LP的为0.64(即预测结局与观察结局之间具有良好的一致性)。结论 本研究发现,来自全国前瞻性结局登记库的术前患者特异性因素显著影响腰椎手术后12个月时治疗效果的PRO测量指标。利用这些数据构建的新型预测模型有可能通过优化患者选择并在手术甚至尚未进行之前识别重要的可改变因素,来提高手术效果和脊柱手术的整体价值。此外,当这些模型在术前患者咨询期间用作共同决策工具时,可以推进以患者为中心的护理。