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一种新的用于治疗脊柱感染的评分系统概念,即脊柱感染治疗评估评分(SITE 评分):一项概念验证研究。

A novel scoring system concept for de novo spinal infection treatment, the Spinal Infection Treatment Evaluation Score (SITE Score): a proof-of-concept study.

机构信息

1Swedish Neuroscience Institute, Swedish Medical Center, Seattle.

2Seattle Science Foundation, Seattle, Washington; and.

出版信息

J Neurosurg Spine. 2022 Dec 9;38(3):396-404. doi: 10.3171/2022.11.SPINE22719. Print 2023 Mar 1.

Abstract

OBJECTIVE

De novo infections of the spine are an increasing healthcare problem. The decision for nonsurgical or surgical treatment is often made case by case on the basis of physician experience, specialty, or practice affiliation rather than evidence-based medicine. To create a more systematic foundation for surgical assessments of de novo spinal infections, the authors applied a formal validation process toward developing a spinal infection scoring system using principles gained from other spine severity scoring systems like the Spine Instability Neoplastic Score, Thoracolumbar Injury Classification and Severity Score, and AO Spine classification of thoracolumbar injuries. They utilized an expert panel and literature reviews to develop a severity scale called the "Spinal Infection Treatment Evaluation Score" (SITE Score).

METHODS

The authors conducted an evidence-based process of combining literature reviews, extracting key elements from previous scoring systems, and obtaining iterative expert panel input while following a formal Delphi process. The resulting basic SITE scoring system was tested on selected de novo spinal infection cases and serially refined by an international multidisciplinary expert panel. Intra- and interobserver reliabilities were calculated using the intraclass correlation coefficient (ICC) and Fleiss' and Cohen's kappa, respectively. A receiver operating characteristic analysis was performed for cutoff value analysis. The predictive validity was assessed through cross-tabulation analysis.

RESULTS

The conceptual SITE scoring system combines the key variables of neurological symptoms, infection location, radiological variables for instability and impingement of neural elements, pain, and patient comorbidities. Ten patients formed the first cohort of de novo spinal infections, which was used to validate the conceptual scoring system. A second cohort of 30 patients with de novo spinal infections, including the 10 patients from the first cohort, was utilized to validate the SITE Score. Mean scores of 6.73 ± 1.5 and 6.90 ± 3.61 were found in the first and second cohorts, respectively. The ICCs for the total score were 0.989 (95% CI 0.975-0.997, p < 0.01) in the first round of scoring system validation, 0.992 (95% CI 0.981-0.998, p < 0.01) in the second round, and 0.961 (95% CI 0.929-0.980, p < 0.01) in the third round. The mean intraobserver reliability was 0.851 ± 0.089 in the third validation round. The SITE Score yielded a sensitivity of 97.77% ± 3.87% and a specificity of 95.53% ± 3.87% in the last validation round for the panel treatment decision.

CONCLUSIONS

The SITE scoring concept showed statistically meaningful reliability parameters. Hopefully, this effort will provide a foundation for a future evidence-based decision aid for treating de novo spinal infections. The SITE Score showed promising inter- and intraobserver reliability. It could serve as a helpful tool to guide physicians' therapeutic decisions in managing de novo spinal infections and help in comparison studies to better understand disease severity and outcomes.

摘要

目的

脊柱新发感染是一个日益严重的医疗保健问题。非手术或手术治疗的决策通常是根据医生的经验、专业知识或实践关系来做出的,而不是基于循证医学。为了为脊柱新发感染的手术评估建立一个更系统的基础,作者应用了一种正式的验证过程,利用从其他脊柱严重程度评分系统(如脊柱不稳肿瘤评分、胸腰椎损伤分类和严重程度评分以及 AO 脊柱胸腰椎损伤分类)中获得的原则,开发了一种脊柱感染评分系统。他们利用专家小组和文献回顾,开发了一种称为“脊柱感染治疗评估评分”(SITE 评分)的严重程度评分系统。

方法

作者进行了循证过程,包括文献综述、从先前评分系统中提取关键要素,以及在遵循正式 Delphi 过程的同时获得迭代专家小组的投入。基本的 SITE 评分系统在选定的新发脊柱感染病例上进行了测试,并由国际多学科专家小组进行了连续改进。使用组内相关系数(ICC)和 Fleiss 和 Cohen 的kappa 分别计算了组内和组间的可靠性。进行了接受者操作特征分析以进行截断值分析。通过交叉表分析评估预测有效性。

结果

概念性 SITE 评分系统结合了神经症状、感染部位、不稳定和神经元素受压的影像学变量、疼痛和患者合并症等关键变量。10 名患者构成了新发脊柱感染的第一队列,用于验证概念性评分系统。第二个队列包括 30 名新发脊柱感染患者,包括第一队列中的 10 名患者,用于验证 SITE 评分。第一队列和第二队列的平均得分分别为 6.73±1.5 和 6.90±3.61。第一轮评分系统验证的总得分 ICC 为 0.989(95%CI 0.975-0.997,p<0.01),第二轮为 0.992(95%CI 0.981-0.998,p<0.01),第三轮为 0.961(95%CI 0.929-0.980,p<0.01)。第三轮验证的平均组内观察者可靠性为 0.851±0.089。SITE 评分在最后一轮验证中,面板治疗决策的敏感性为 97.77%±3.87%,特异性为 95.53%±3.87%。

结论

SITE 评分概念显示出具有统计学意义的可靠性参数。希望这一努力将为治疗新发脊柱感染的未来循证决策辅助工具提供基础。SITE 评分显示出良好的组间和组内观察者可靠性。它可以作为一种有用的工具,帮助医生在管理新发脊柱感染时做出治疗决策,并有助于比较研究,以更好地了解疾病严重程度和结果。

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