老年畸形手术前瞻性评估 (PEEDS) 研究中与患者报告结果改善相关的独立预后因素。

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS
ACS Applied Bio Materials Pub Date : 2024-11-01 Epub Date: 2023-05-08 DOI:10.1177/21925682231174182
Fthimnir M Hassan, Lawrence G Lenke, Sigurd H Berven, Michael P Kelly, Justin S Smith, Christopher I Shaffrey, Benny T Dahl, Marinus de Kleuver, Maarten Spruit, Ferran Pellise, Kenneth M C Cheung, Ahmet Alanay, David W Polly, Jonathan Sembrano, Yukihiro Matsuyama, Yong Qiu, Stephen J Lewis
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引用次数: 0

摘要

研究设计前瞻性、多中心、国际观察研究:在年龄≥60岁、接受初级重建手术的成人脊柱畸形(ASD)患者中,确定与患者报告结果指标(PROMs)达到最小临床重要差异(MCID)相关的独立预后因素:本研究招募了年龄≥60岁、接受初级脊柱畸形手术且融合程度≥5级的患者。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小总分/EQ-5D指数增加15%;(3)基线结果截止时的相对变化:分别与SRS-22r/EQ-5D基线分数≤3.2/0.7时的相对变化相似:171名患者完成了SRS-22r,170名患者在基线和术后2年完成了EQ-5D。在两种方法(1)和(2)中,SRS-22r 达到 MCID 的患者在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) - OR:.01 [.00-.12];(2) - OR:.00 [.00-.07])和严重不良事件 (AE) 的数量((1) - OR:.48 [.28-.82];(2) - OR:.39 [.23-.69])是唯一确定的风险因素。在 EQ-5D 中达到 MCID 的患者在基线疼痛和健康方面的特征与 SRS-22r 采用的方法(1)和(2)相似。较高的基线 ODI((1) - OR:1.05 [1.02-1.07])和严重 AE 数量(OR:.58 [.38-.89])被确定为预测变量。采用方法 (3) 在 SRS22r 中达到 MCID 的患者基线健康状况较差。AEs 数量(OR:.44 [.25-.77] )和基线 PROMs(OR:.01 [.00-.22] )是唯一确定的预测因素。在 EQ-5D 中达到 MCID 的患者发生的 AE 较少,因发生 AE 而采取的行动次数也较少。发现因 AEs 而采取的措施数量(OR:.50 [.35-.73])是唯一的预测变量因素。上述两种方法均未发现手术、临床或放射学变量是风险因素:结论:在这一大型多中心前瞻性队列中,对接受 ASD 初级重建手术的老年患者而言,基线健康状况、AEs 和 AEs 的严重程度是达到 MCID 的预测因素。没有发现任何临床、放射学或手术参数可作为达到 MCID 的预后因素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.

Study design: Prospective, multicenter, international, observational study.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
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