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3个月的模型或观察到的3个月或6个月患者报告的结局指标能否准确预测腰椎减压术后12个月的残疾和疼痛情况?

Can 3-month models or observed 3- or 6-month patient-reported outcome measures accurately predict 12-month disability and pain after lumbar decompressive surgery?

作者信息

Geere Jonathan H, Hunter Paul R, Cook Andrew J, Rai Amarjit S

机构信息

Physiotherapy Department, Spire Norwich Hospital, Old Watton Road, Colney, Norwich, NR4 7TD, UK.

Norwich Medical School, University of East Anglia, Norwich, UK.

出版信息

Arch Orthop Trauma Surg. 2025 Apr 24;145(1):260. doi: 10.1007/s00402-025-05877-x.

DOI:10.1007/s00402-025-05877-x
PMID:40274675
Abstract

INTRODUCTION

Most lumbar decompressive surgery patients experience symptom improvement to 3 months, after which about 13% experience a clinically relevant deterioration. Patient-reported outcome measures (PROMs) are accepted as indicators of clinical outcome, but the earliest timepoint when PROMs stabilise is unknown and few studies have assessed risk factors for symptom deterioration. This study aimed to identify risk factors for symptom deterioration and identify whether 3-month models or observed 3- or 6-month outcomes accurately predict 12-month disability and pain.

METHODS

The development cohort included 1096 prospectively collected discectomy or laminectomy cases with or without single-level fusion from 01/01/2008-31/12/2020 at a single centre. Three-month models were developed using baseline clinical variables and 3-month PROM. The primary 12-month outcome was the Oswestry Disability Index (ODI), and secondary outcomes were back and leg pain. Validation was on 364 cases from 01/01/2021-31/12/2022. Predictive accuracy was evaluated by interclass correlation coefficient (ICC) and by area-under-the-curve (AUC) to classify to a minimal clinically important difference (MCID). MCID concordance rates for observed 3-month and 6-month with 12-month PROM were calculated.

RESULTS

Three-month predictors of 12-month disability and pain were condition duration, smoking, diabetes, rheumatic disorder, lower limb arthroplasty, mobility aided, underweight (BMI < 18.5 kg/m), and 3-month PROM. ODI model and observed 3-month ODI had equivalent ICC and AUC values. Observed 3-month ODI ICC was 0.71 [95% confidence intervals (CI) 0.68-0.74] and AUC was 0.83 [95%CI 0.80-0.86]. Observed 6-month ODI ICC was 0.82 [95%CI 0.79-0.85] and AUC was 0.92 [95%CI 0.89-0.95]. MCID concordance for 3-month ODI was 84% and 6-month ODI was 91%.

CONCLUSION

Symptom deterioration after 3 months is linked to baseline factors. This study demonstrates that 6-month PROM accurately predict individual patient 12-month disability and pain after 1-2 level discectomy or laminectomy. Fusion surgery requires a minimum 12-month PROM follow-up.

摘要

引言

大多数接受腰椎减压手术的患者在术后3个月症状会有所改善,此后约13%的患者会出现临床上相关的病情恶化。患者报告的结局指标(PROMs)被公认为临床结局的指标,但PROMs稳定的最早时间点尚不清楚,且很少有研究评估症状恶化的危险因素。本研究旨在确定症状恶化的危险因素,并确定3个月模型或观察到的3个月或6个月结局能否准确预测12个月时的残疾和疼痛情况。

方法

开发队列包括2008年1月1日至2020年12月31日在单一中心前瞻性收集的1096例接受椎间盘切除术或椎板切除术的病例,其中部分病例进行了单节段融合手术。使用基线临床变量和3个月时的PROMs建立3个月模型。12个月的主要结局指标是Oswestry功能障碍指数(ODI),次要结局指标是腰背痛和腿痛。在2021年1月1日至2022年12月31日的364例病例上进行验证。通过组内相关系数(ICC)和曲线下面积(AUC)评估预测准确性,以分类至最小临床重要差异(MCID)。计算观察到的3个月和6个月时的PROM与12个月时的PROM的MCID一致性率。

结果

12个月时残疾和疼痛的3个月预测因素包括病程、吸烟、糖尿病、风湿性疾病、下肢关节置换术、使用辅助行动工具、体重过轻(BMI<18.5kg/m²)以及3个月时的PROMs。ODI模型和观察到的3个月时的ODI具有相同的ICC和AUC值。观察到的3个月时的ODI的ICC为0.71[95%置信区间(CI)0.68 - 0.74],AUC为0.83[95%CI 0.80 - 0.86]。观察到的6个月时的ODI的ICC为0.82[95%CI 0.79 - 0.85],AUC为0.92[95%CI 0.89 - 0.95]。3个月时的ODI的MCID一致性为84%,6个月时的ODI的MCID一致性为91%。

结论

3个月后症状恶化与基线因素有关。本研究表明,6个月时的PROMs能够准确预测1 - 2节段椎间盘切除术或椎板切除术后个体患者12个月时的残疾和疼痛情况。融合手术需要至少12个月的PROMs随访。

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本文引用的文献

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Measuring clinically relevant improvement after lumbar spine surgery: is it time for something new?测量腰椎手术后临床相关的改善:是否需要新的方法?
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Adding 3-month patient data improves prognostic models of 12-month disability, pain, and satisfaction after specific lumbar spine surgical procedures: development and validation of a prediction model.添加 3 个月患者数据可改善特定腰椎手术治疗后 12 个月残疾、疼痛和满意度的预后模型:预测模型的开发和验证。
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ISSLS prize in clinical science 2020: the reliability and interpretability of score change in lumbar spine research.2020 年国际脊柱侧凸研究学会临床科学奖:腰椎研究中评分变化的可靠性和可解释性。
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Patient-reported outcomes unbiased by length of follow-up after lumbar degenerative spine surgery: Do we need 2 years of follow-up?腰椎退行性脊柱手术后随访时间长短不影响患者报告的结局:我们是否需要 2 年的随访?
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