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FUSE-ML:用于退行性疾病腰椎融合术后中期结局的临床预测模型的开发和外部验证。

FUSE-ML: development and external validation of a clinical prediction model for mid-term outcomes after lumbar spinal fusion for degenerative disease.

机构信息

Machine Intelligence in Clinical Neuroscience (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, University of Zurich, Frauenklinikstrasse 10, 8091, Zurich, Switzerland.

Amsterdam UMC, Neurosurgery, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

出版信息

Eur Spine J. 2022 Oct;31(10):2629-2638. doi: 10.1007/s00586-022-07135-9. Epub 2022 Feb 21.

Abstract

BACKGROUND

Indications and outcomes in lumbar spinal fusion for degenerative disease are notoriously heterogenous. Selected subsets of patients show remarkable benefit. However, their objective identification is often difficult. Decision-making may be improved with reliable prediction of long-term outcomes for each individual patient, improving patient selection and avoiding ineffective procedures.

METHODS

Clinical prediction models for long-term functional impairment [Oswestry Disability Index (ODI) or Core Outcome Measures Index (COMI)], back pain, and leg pain after lumbar fusion for degenerative disease were developed. Achievement of the minimum clinically important difference at 12 months postoperatively was defined as a reduction from baseline of at least 15 points for ODI, 2.2 points for COMI, or 2 points for pain severity.

RESULTS

Models were developed and integrated into a web-app ( https://neurosurgery.shinyapps.io/fuseml/ ) based on a multinational cohort [N = 817; 42.7% male; mean (SD) age: 61.19 (12.36) years]. At external validation [N = 298; 35.6% male; mean (SD) age: 59.73 (12.64) years], areas under the curves for functional impairment [0.67, 95% confidence interval (CI): 0.59-0.74], back pain (0.72, 95%CI: 0.64-0.79), and leg pain (0.64, 95%CI: 0.54-0.73) demonstrated moderate ability to identify patients who are likely to benefit from surgery. Models demonstrated fair calibration of the predicted probabilities.

CONCLUSIONS

Outcomes after lumbar spinal fusion for degenerative disease remain difficult to predict. Although assistive clinical prediction models can help in quantifying potential benefits of surgery and the externally validated FUSE-ML tool may aid in individualized risk-benefit estimation, truly impacting clinical practice in the era of "personalized medicine" necessitates more robust tools in this patient population.

摘要

背景

退行性疾病腰椎融合术的适应证和疗效差异很大。一些特定的患者亚组显示出显著的获益。然而,这些患者的识别往往很困难。如果能够对每位患者的长期疗效进行可靠预测,改善决策,提高患者选择的准确性并避免无效的手术,可能会有所帮助。

方法

本研究旨在建立退行性疾病腰椎融合术后长期功能障碍(Oswestry 功能障碍指数(ODI)或核心结局测量指标(COMI))、腰痛和腿痛的临床预测模型。术后 12 个月达到最小临床重要差异定义为 ODI 至少降低 15 分,COMI 至少降低 2.2 分,疼痛严重程度至少降低 2 分。

结果

基于多中心队列(N=817;男性占 42.7%;平均年龄 61.19±12.36 岁)建立并整合到一个网络应用程序(https://neurosurgery.shinyapps.io/fuseml/)中。在外部验证队列(N=298;男性占 35.6%;平均年龄 59.73±12.64 岁)中,功能障碍(0.67,95%置信区间:0.59-0.74)、腰痛(0.72,95%置信区间:0.64-0.79)和腿痛(0.64,95%置信区间:0.54-0.73)的曲线下面积表明,这些模型具有中等识别术后获益患者的能力。模型预测概率的校准效果中等。

结论

退行性疾病腰椎融合术后的疗效仍然难以预测。尽管辅助临床预测模型有助于量化手术的潜在获益,且外部验证的 FUSE-ML 工具可能有助于进行个体化的风险效益评估,但在“个体化医学”时代,真正对临床实践产生影响,还需要在该患者人群中开发更强大的工具。

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