Department of Neurosurgery, University of Virginia, Charlottesville, VA.
Department of Orthopedic Surgery, Washington University School of Medicine, St Louis, MO.
Spine (Phila Pa 1976). 2019 Sep 1;44(17):1211-1219. doi: 10.1097/BRS.0000000000003036.
Secondary analysis of prospective multicenter cohort.
To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).
Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.
The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.
Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).
Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.
前瞻性多中心队列的二次分析。
评估严重不良事件（SAE）对接受手术治疗的成人症状性腰椎侧凸（ASLS）患者的 2 年和 4 年患者报告结局测量（PROM）的影响。
ASLS 的手术治疗可以改善与健康相关的生活质量，但 SAE 发生率较高。这些 SAE 如何影响健康相关的生活质量尚不清楚。
ASLS 研究评估了手术与非手术 ASLS 治疗的效果，包括随机和观察性臂。患者年龄在 40 至 80 岁之间，ASLS 的定义为腰椎冠状 Cobb≥30°，Oswestry 残疾指数（ODI）≥20 或脊柱侧凸研究协会-22（SRS-22）在疼痛、功能和/或自我形象领域中≤4.0。使用结合了随机和观察队列的治疗分析，比较了手术患者中与 SAE 相关和不相关的患者以及非手术患者的 SRS-22 亚评分和 ODI。
共纳入 286 例患者，2 年和 4 年的随访率分别为 90%和 81%，尽管在数据提取时并非所有患者都有资格进行 4 年随访。在 173 例接受手术治疗的患者中，共报告了 97 例 SAE。最常见的是植入物失败/假关节（n=25）、近端交界性后凸/失败（n=10）和轻微运动缺陷（n=8）。在 2 年时，与无 SAE 的患者相比，有 SAE 的患者基于 SRS-22 的改善程度较低（0.52 对 0.79，P=0.004）和 ODI（-11.59 对-17.34，P=0.021）。在 4 年时，这两种情况均保持 SRS-22（0.51 对 0.86，P=0.001）和 ODI（-10.73 对-16.69，P=0.012）的改善程度。尽管存在这种影响，但与非手术患者相比，手术治疗后发生 SAE 的患者 PROM 的改善更大（P<0.001）。
接受手术治疗的 ASLS 患者在 2 年和 4 年的随访中，与无 SAE 的患者相比，PROM 的改善明显减少。无论 SAE 的发生与否，手术治疗的患者在 PROM 改善方面明显优于非手术治疗的患者。
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