Hassan Fthimnir M, Lenke Lawrence G, Berven Sigurd H, Kelly Michael P, Smith Justin S, Shaffrey Christopher I, Dahl Benny T, de Kleuver Marinus, Spruit Maarten, Pellise Ferran, Cheung Kenneth M C, Alanay Ahmet, Polly David W, Sembrano Jonathan, Matsuyama Yukihiro, Qiu Yong, Lewis Stephen J
Department of Orthopaedic Surgery, The Och Spine Hospital/Columbia University Irving Medical Center, New York, NY, USA.
Department of Orthopaedic Surgery, University of California San Francisco, San Francisco, CA, USA.
Global Spine J. 2024 Nov;14(8):2298-2310. doi: 10.1177/21925682231174182. Epub 2023 May 8.
Prospective, multicenter, international, observational study.
Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery.
Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively.
171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches.
In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID.
前瞻性、多中心、国际性观察性研究。
确定在接受初次重建手术的60岁及以上成人脊柱畸形(ASD)患者中,与患者报告结局测量指标(PROMs)达到最小临床重要差异(MCID)相关的独立预后因素。
招募年龄≥60岁、接受初次脊柱畸形手术且融合节段≥5个节段的患者参与本研究。采用三种方法评估MCID:(1)绝对变化:SRS - 22r总分增加0.5分/EQ - 5D指数增加0.18分;(2)相对变化:SRS - 22r总分/EQ - 5D指数增加15%;(3)基线结局有截断值的相对变化:分别类似于SRS - 22r/EQ - 5D基线评分≤3.2/0.7时的相对变化。
171例患者在基线和术后2年完成了SRS - 22r评估,170例患者完成了EQ - 5D评估。在SRS - 22r中达到MCID的患者,在方法(1)和(2)中,基线时自我报告的疼痛更多、健康状况更差。较低的基线PROMs((1) - 比值比:0.01[0.00 - 0.12];(2) - 比值比:0.00[0.00 - 0.07])和严重不良事件(AE)数量((1) - 比值比:0.48[0.28 - 0.82];(2) - 比值比:0.39[0.23 - 0.69])是唯一确定的危险因素。在EQ - 5D中达到MCID的患者,使用方法(1)和(2)时,基线时在疼痛和健康方面表现出与SRS - 22r类似的特征。较高的基线功能障碍指数(ODI)((1) - 比值比:1.05[1.02 - 1.07])和严重AE数量(比值比:0.58[0.38 - 0.89])被确定为预测变量。在SRS22r中达到MCID的患者,使用方法(3)时基线时健康状况更差。AE数量(比值比:0.44[0.25 - 0.77])和基线PROMs(比值比:0.01[0.00 - 0.22])是唯一确定的预测因素。在EQ - 5D中达到MCID的患者,使用方法(3)时经历的AE较少,因AE发生而采取的措施数量较少。因AE采取的措施数量(比值比:0.50[0.35 - 0.73])被发现是唯一的预测变量因素。使用上述任何一种方法均未确定手术、临床或影像学变量为危险因素。
在这个接受ASD初次重建手术的老年患者大型多中心前瞻性队列中,基线健康状况、AE及AE严重程度可预测是否达到MCID。未确定临床、放射学或手术参数为达到MCID的预后因素。