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评价腰椎退变性脊椎滑脱症手术决策的“适宜医疗标准”。一项对照、多中心、前瞻性观察研究。

Evaluation of "appropriate use criteria" for surgical decision-making in lumbar degenerative spondylolisthesis. A controlled, multicentre, prospective observational study.

机构信息

Spine Centre Division, Department of Teaching, Research and Development, Schulthess Klinik, Lengghalde 2, 8008, Zurich, Switzerland.

Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.

出版信息

Eur Spine J. 2024 May;33(5):1773-1785. doi: 10.1007/s00586-024-08157-1. Epub 2024 Feb 28.

Abstract

INTRODUCTION

Selecting patients with lumbar degenerative spondylolisthesis (LDS) for surgery is difficult. Appropriate use criteria (AUC) have been developed to clarify the indications for LDS surgery but have not been evaluated in controlled studies.

METHODS

This prospective, controlled, multicentre study involved 908 patients (561 surgical and 347 non-surgical controls; 69.5 ± 9.7y; 69% female), treated as per normal clinical practice. Their appropriateness for surgery was afterwards determined using the AUC. They completed the Core Outcome Measures Index (COMI) at baseline and 12 months' follow-up. Multiple regression adjusting for confounders evaluated the influence of appropriateness designation and treatment received on the 12-month COMI and achievement of MCIC (≥ 2.2-point-reduction).

RESULTS

As per convention, appropriate (A) and uncertain (U) groups were combined for comparison with the inappropriate (I) group. For the adjusted 12-month COMI, the benefit of surgery relative to non-surgical care was not significantly greater for the A/U than the I group (p = 0.189). There was, however, a greater treatment effect of surgery for those with higher baseline COMI (p = 0.035). The groups' adjusted probabilities of achieving MCIC were: 83% (A/U, receiving surgery), 71% (I, receiving surgery), 50% (A/U, receiving non-surgical care), and 32% (I, receiving non-surgical care).

CONCLUSIONS

A/U patients receiving surgery had the highest chances of achieving MCIC, but the AUC were not able to identify which patients had a greater treatment effect of surgery relative to non-surgical care. The identification of other characteristics that predict a greater treatment effect of surgery, in addition to baseline COMI, is required to improve decision-making.

摘要

简介

选择接受腰椎退行性滑脱(LDS)手术的患者较为困难。合适性使用标准(AUC)已经被制定出来以明确 LDS 手术的适应证,但这些标准尚未在对照研究中得到评估。

方法

本前瞻性、对照、多中心研究纳入了 908 名患者(561 名手术治疗患者和 347 名非手术治疗患者;年龄 69.5±9.7 岁;69%为女性),根据常规临床实践进行治疗。随后使用 AUC 来确定他们接受手术的合适性。他们在基线和 12 个月随访时完成了核心结局测量指标(COMI)。调整混杂因素的多元回归分析评估了合适性指定和所接受治疗对 12 个月 COMI 和达到 MCIC(≥2.2 分改善)的影响。

结果

根据惯例,将合适(A)和不确定(U)组与不合适(I)组进行合并,以与 I 组进行比较。对于调整后的 12 个月 COMI,与非手术治疗相比,A/U 组手术的获益并不显著大于 I 组(p=0.189)。然而,对于基线 COMI 较高的患者,手术的治疗效果更大(p=0.035)。各组达到 MCIC 的调整后概率分别为:83%(A/U,接受手术)、71%(I,接受手术)、50%(A/U,接受非手术治疗)和 32%(I,接受非手术治疗)。

结论

接受手术的 A/U 患者有最大的机会达到 MCIC,但 AUC 无法确定与非手术治疗相比,哪些患者手术的治疗效果更大。除了基线 COMI 外,还需要确定其他预测手术治疗效果更大的特征,以改善决策。

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