Surgical Outcomes Research Center, University of Washington, Seattle.
Department of Orthopaedic and Sports Medicine, University of Washington, Seattle.
JAMA Surg. 2018 Jul 1;153(7):634-642. doi: 10.1001/jamasurg.2018.0072.
Functional impairment and pain are common indications for the initiation of lumbar spine surgery, but information about expected improvement in these patient-reported outcome (PRO) domains is not readily available to most patients and clinicians considering this type of surgery.
To assess population-level PRO response after lumbar spine surgery, and develop/validate a prediction tool for PRO improvement.
DESIGN, SETTING, AND PARTICIPANTS: This statewide multicenter cohort was based at 15 Washington state hospitals representing approximately 75% of the state's spine fusion procedures. The Spine Surgical Care and Outcomes Assessment Program and the survey center at the Comparative Effectiveness Translational Network prospectively collected clinical and PRO data from adult candidates for lumbar surgery, preoperatively and postoperatively, between 2012 and 2016. Prediction models were derived for PRO improvement 1 year after lumbar fusion surgeries on a random sample of 85% of the data and were validated in the remaining 15%. Surgical candidates from 2012 through 2015 were included; follow-up surveying continued until December 31, 2016, and data analysis was completed from July 2016 to April 2017.
Functional improvement, defined as a reduction in Oswestry Disability Index score of 15 points or more; and back pain and leg pain improvement, defined a reduction in Numeric Rating Scale score of 2 points or more.
A total of 1965 adult lumbar surgical candidates (mean [SD] age, 61.3 [12.5] years; 944 [59.6%] female) completed baseline surveys before surgery and at least 1 postoperative follow-up survey within 3 years. Of these, 1583 (80.6%) underwent elective lumbar fusion procedures; 1223 (77.3%) had stenosis, and 1033 (65.3%) had spondylolisthesis. Twelve-month follow-up participation rates for each outcome were between 66% and 70%. Improvements were reported in function, back pain, and leg pain at 12 months by 306 of 528 surgical patients (58.0%), 616 of 899 patients (68.5%), and 355 of 464 patients (76.5%), respectively, whose baseline scores indicated moderate to severe symptoms. Among nonoperative patients, 35 (43.8%), 47 (53.4%), and 53 (63.9%) reported improvements in function, back pain, and leg pain, respectively. Demographic and clinical characteristics included in the final prediction models were age, sex, race, insurance status, American Society of Anesthesiologists score, smoking status, diagnoses, prior surgery, prescription opioid use, asthma, and baseline PRO scores. The models had good predictive performance in the validation cohort (concordance statistic, 0.66-0.79) and were incorporated into a patient-facing, web-based interactive tool (https://becertain.shinyapps.io/lumbar_fusion_calculator).
The PRO response prediction tool, informed by population-level data, explained most of the variability in pain reduction and functional improvement after surgery. Giving patients accurate information about their likelihood of outcomes may be a helpful component in surgery decision making.
功能障碍和疼痛是启动腰椎手术的常见指征,但大多数患者和考虑此类手术的临床医生并不了解这些患者报告的结果 (PRO) 领域的预期改善情况。
评估腰椎手术后的人群水平 PRO 反应,并开发/验证 PRO 改善的预测工具。
设计、地点和参与者:这项全州多中心队列研究基于华盛顿州的 15 家医院,这些医院代表了该州脊柱融合手术的约 75%。脊柱外科护理和结果评估计划以及比较效果转化网络的调查中心前瞻性地收集了 2012 年至 2016 年间成人腰椎手术候选者的临床和 PRO 数据,术前和术后均有。在随机抽取的 85%的数据中为腰椎融合手术后 1 年的 PRO 改善得出预测模型,并在其余 15%的数据中进行验证。纳入 2012 年至 2015 年的手术候选者;随访调查持续至 2016 年 12 月 31 日,数据分析于 2016 年 7 月至 2017 年 4 月完成。
功能改善,定义为 Oswestry 残疾指数评分降低 15 分或更多;以及腰背疼痛和腿痛改善,定义为数字评定量表评分降低 2 分或更多。
共有 1965 名成年腰椎手术候选者(平均[SD]年龄,61.3[12.5]岁;944[59.6%]女性)在手术前完成了基线调查,并在 3 年内至少完成了 1 次术后随访调查。其中,1583 名(80.6%)接受了选择性腰椎融合手术;1223 名(77.3%)患有狭窄,1033 名(65.3%)患有脊椎滑脱。每种结局的 12 个月随访参与率在 66%至 70%之间。在基线评分表明中度至重度症状的 528 名手术患者中有 306 名(58.0%)、899 名患者中有 616 名(68.5%)和 464 名患者中有 355 名(76.5%)报告在 12 个月时功能、腰背疼痛和腿痛得到改善。在非手术患者中,分别有 35 名(43.8%)、47 名(53.4%)和 53 名(63.9%)报告在功能、腰背疼痛和腿痛方面有所改善。最终预测模型中包含的人口统计学和临床特征包括年龄、性别、种族、保险状况、美国麻醉师协会评分、吸烟状况、诊断、既往手术、处方类阿片类药物使用、哮喘和基线 PRO 评分。该模型在验证队列中具有良好的预测性能(一致性统计量,0.66-0.79),并被纳入面向患者的基于网络的交互式工具(https://becertain.shinyapps.io/lumbar_fusion_calculator)。
基于人群水平数据的 PRO 反应预测工具解释了手术后疼痛减轻和功能改善的大部分变异性。为患者提供有关其结果可能性的准确信息可能是手术决策的一个有用组成部分。