Adogwa Owoicho, Elsamadicy Aladine A, Han Jing L, Cheng Joseph, Karikari Isaac, Bagley Carlos A
Division of Neurosurgery, Duke University Medical Center, Durham, North Carolina; and.
Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee.
J Neurosurg Spine. 2016 Dec;25(6):689-696. doi: 10.3171/2015.8.SPINE15476. Epub 2016 Jan 1.
OBJECTIVE With the recent passage of the Patient Protection and Affordable Care Act, there has been a dramatic shift toward critical analyses of quality and longitudinal assessment of subjective and objective outcomes after lumbar spine surgery. Accordingly, the emergence and routine use of real-world institutional registries have been vital to the longitudinal assessment of quality. However, prospectively obtaining longitudinal outcomes for patients at 24 months after spine surgery remains a challenge. The aim of this study was to assess if 12-month measures of treatment effectiveness accurately predict long-term outcomes (24 months). METHODS A nationwide, multiinstitutional, prospective spine outcomes registry was used for this study. Enrollment criteria included available demographic, surgical, and clinical outcomes data. All patients had prospectively collected outcomes measures and a minimum 2-year follow-up. Patient-reported outcomes instruments (Oswestry Disability Index [ODI], SF-36, and visual analog scale [VAS]-back pain/leg pain) were completed before surgery and then at 3, 6, 12, and 24 months after surgery. The Health Transition Index of the SF-36 was used to determine the 1- and 2-year minimum clinically important difference (MCID), and logistic regression modeling was performed to determine if achieving MCID at 1 year adequately predicted improvement and achievement of MCID at 24 months. RESULTS The study group included 969 patients: 300 patients underwent anterior lumbar interbody fusion (ALIF), 606 patients underwent transforaminal lumbar interbody fusion (TLIF), and 63 patients underwent lateral interbody fusion (LLIF). There was a significant correlation between the 12- and 24-month ODI (r = 0.82; p < 0.0001), SF-36 Physical Component Summary score (r = 0.89; p < 0.0001), VAS-back pain (r = 0.90; p < 0.0001), and VAS-leg pain (r = 0.85; p < 0.0001). For the ALIF cohort, patients achieving MCID thresholds for ODI at 12 months were 13-fold (p < 0.0001) more likely to achieve MCID at 24 months. Similarly, for the TLIF and LLIF cohorts, patients achieving MCID thresholds for ODI at 12 months were 13-fold and 14-fold (p < 0.0001) more likely to achieve MCID at 24 months. Outcome measures obtained at 12 months postoperatively are highly predictive of 24-month outcomes, independent of the surgical procedure. CONCLUSIONS In a multiinstitutional prospective study, patient-centered measures of surgical effectiveness obtained at 12 months adequately predict long-term (24-month) outcomes after lumbar spine surgery. Patients achieving MCID at 1 year were more likely to report meaningful and durable improvement at 24 months, suggesting that the 12-month time point is sufficient to identify effective versus ineffective patient care.
目的 随着《患者保护与平价医疗法案》的近期通过，在腰椎手术后，对于质量的批判性分析以及对主观和客观结果的纵向评估出现了巨大转变。因此，真实世界机构登记处的出现和常规使用对于质量的纵向评估至关重要。然而，前瞻性地获取脊柱手术后24个月患者的纵向结果仍然是一项挑战。本研究的目的是评估脊柱手术12个月时的治疗效果测量指标是否能准确预测长期结果（24个月）。方法 本研究使用了一个全国性、多机构的前瞻性脊柱结果登记处。纳入标准包括可用的人口统计学、手术和临床结果数据。所有患者均前瞻性地收集了结果测量指标，并进行了至少2年的随访。患者报告的结果工具（奥斯威斯利残疾指数[ODI]、SF-36和视觉模拟量表[VAS] - 背痛/腿痛）在手术前以及手术后3、6、12和24个月完成。使用SF-36的健康转变指数来确定1年和2年的最小临床重要差异（MCID），并进行逻辑回归建模以确定在1年时达到MCID是否能充分预测24个月时的改善情况和达到MCID的情况。结果 研究组包括969名患者：300名患者接受了前路腰椎椎间融合术（ALIF），606名患者接受了经椎间孔腰椎椎间融合术（TLIF），63名患者接受了外侧椎间融合术（LLIF）。12个月和24个月时的ODI（r = 0.82；p < 0.0001）、SF-36身体成分汇总得分（r = 0.89；p < 0.0001）、VAS-背痛（r = 0.90；p < 0.0001）和VAS-腿痛（r = 0.85；p < 0.0001）之间存在显著相关性。对于ALIF队列，在12个月时达到ODI的MCID阈值的患者在24个月时达到MCID的可能性高13倍（p < 0.0001）。同样，对于TLIF和LLIF队列，在12个月时达到ODI的MCID阈值的患者在24个月时达到MCID的可能性分别高13倍和14倍（p < 0.0001）。术后12个月获得的结果测量指标高度预测24个月的结果，与手术方式无关。结论 在一项多机构前瞻性研究中，腰椎手术后12个月获得的以患者为中心的手术效果测量指标能充分预测长期（24个月）结果。在1年时达到MCID的患者在24个月时更有可能报告有意义且持久的改善，这表明12个月的时间点足以确定有效的与无效的患者护理。
