Washington University in St. Louis School of Medicine; St. Louis, MO.
University of Virginia; Charlottesville, VA.
Spine (Phila Pa 1976). 2018 Jun 1;43(11):747-753. doi: 10.1097/BRS.0000000000002479.
This is an analysis of a prospective 2-year study on nonoperative patients enrolled in the Adult Symptomatic Lumbar Scoliosis (ASLS) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) trial.
The purpose was to evaluate the impact of serious adverse events (SAEs) on patient-reported outcomes (PROs) in nonoperative management of ASLS as measured by Scoliosis Research Society-22 (SRS-22), Oswestry Disability Index (ODI), and Short Form-12 (SF-12) at 2-year follow-up.
Little is known about PROs in the nonoperative management of ASLS or the prevalence and impact of SAEs on PROs.
The ASLS trial dataset was analyzed to identify adult lumbar scoliosis patients electively choosing or randomly assigned to nonoperative treatment with minimum 2-year follow-up. Patient data were collected prospectively from 2010 to 2015 as part of NIAMS R01-AR055176-01A2 "A Multi-Centered Prospective Study of Quality of Life in Adult Scoliosis." SAEs were defined as life-threatening medical events, new significant or permanent disability, new or prolonged hospitalization, or death.
One hundred five nonoperative patients were studied to 2-year follow-up. Twenty-seven patients (25.7%) had 42 SAEs; 15 (14.3%) had a SAE during the first year. The SAE group had higher body mass index (29.4 vs. 25.2; P = 0.008) and reported worse SRS-22 Function scores than the non-SAE group at baseline (3.3 vs. 3.6; P = 0.024). At 2-year follow-up, SAE patients experienced less improvement (change) in SRS-22 Self-Image (-0.07 vs. 0.26; P = 0.018) and Mental Health domains (-0.19 vs. 0.25; P = 0.002) than non-SAE patients and had lower SRS-22 Function, Self-Image, Subscore, and SF-12 Mental and Physical component scores (MCS/PCS). Fewer SAE patients reached minimal clinically important difference (MCID) threshold in SRS-22 Mental Health (14.8% vs. 43.6%; P = 0.01).
A high percentage (25.7%) of ASLS patients managed nonoperatively experienced SAEs. Those patients who sustained a SAE had less improvement in reported outcomes.
这是一项对参加成人症状性腰椎侧凸（ASLS）国家关节炎和肌肉骨骼及皮肤病研究所（NIAMS）试验的非手术患者进行的为期 2 年的前瞻性研究的分析。
目的是评估在 ASLS 的非手术管理中，严重不良事件（SAE）对患者报告的结果（PRO）的影响，PRO 由 Scoliosis Research Society-22（SRS-22）、Oswestry 残疾指数（ODI）和简短形式-12（SF-12）在 2 年随访时进行测量。
对于 ASLS 的非手术管理中的 PRO 或 SAE 对 PRO 的发生率和影响知之甚少。
对 ASLS 试验数据集进行分析，以确定选择或随机分配接受非手术治疗的成人腰椎侧凸患者，随访时间至少为 2 年。从 2010 年到 2015 年，患者数据作为 NIAMS R01-AR055176-01A2“成人脊柱侧凸生活质量的多中心前瞻性研究”的一部分进行前瞻性收集。SAE 定义为危及生命的医疗事件、新的重大或永久性残疾、新的或延长的住院时间或死亡。
对 105 名接受非手术治疗并随访至 2 年的患者进行了研究。27 名患者（25.7%）发生 42 例 SAE；15 例（14.3%）在第一年发生 SAE。SAE 组的体重指数（29.4 比 25.2；P=0.008）和基线 SRS-22 功能评分（3.3 比 3.6；P=0.024）均高于非 SAE 组。在 2 年随访时，SAE 患者在 SRS-22 自我形象（-0.07 比 0.26；P=0.018）和心理健康领域（-0.19 比 0.25；P=0.002）的改善（变化）较小，且 SRS-22 功能、自我形象、子评分和 SF-12 心理健康和生理成分评分（MCS/PCS）较低。较少的 SAE 患者达到了最小临床重要差异（MCID）阈值，在 SRS-22 心理健康方面（14.8%比 43.6%；P=0.01）。
接受非手术治疗的 ASLS 患者中，有相当高比例（25.7%）发生 SAE。那些发生 SAE 的患者报告的结果改善较少。
2 级。
