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开发用于辅助诊断脊髓损伤后感染的风险评分:一项回顾性队列研究方案

Development of a Risk Score to Aid With the Diagnosis of Infections After Spinal Cord Injury: Protocol for a Retrospective Cohort Study.

作者信息

Skelton Felicia, Grigoryan Larissa, Pan Joann, Collazo Ashley, Trautner Barbara

机构信息

Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey VA Medical Center, Houston, TX, United States.

H. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, United States.

出版信息

JMIR Res Protoc. 2025 May 8;14:e52610. doi: 10.2196/52610.

Abstract

BACKGROUND

Patients with spinal cord injury (SCI) who develop urinary tract infection (UTI) present differently than the non-SCI population. UTIs can cause loss of quality of life and even lead to life-threatening complications including urosepsis. Challenges in SCI management include distinguishing symptomatic UTI from asymptomatic bacteriuria (ASB), which occurs often in patients with SCI, and the lack of standardization in UTI diagnosis in SCI.

OBJECTIVE

This study aims to set the foundation for the development of a risk score to improve diagnostic accuracy of UTI after SCI.

METHODS

This study will use data from the Veterans Health Administration Corporate Data Warehouse from national outpatient clinics. It will use 2 approaches: (1) a case-control study comparing frequency-matched healthy SCI cases (n=2000) with healthy non-SCI controls (n=2000) to establish a physiologic baseline for vital sign and lab measurements after SCI and (2) a retrospective cohort study of patients with SCI (n=400) to determine the positive predictive value of the baseline vital signs and lab measurements found in step 1, from which a threshold for clinically meaningful UTI after SCI will be established.

RESULTS

The study was funded in May 2023, and initial data extraction started in early 2024 and is expected to be completed in 2026. Data extraction, analysis, and results for aim 1 were completed as of manuscript submission. For aim 1, we hypothesize that SCI will be associated with lower temperature, heart rate, and systolic blood pressure when compared with non-SCI controls. SCI will also be associated with higher baseline levels of pyuria and peripheral white blood cells when compared with non-SCI controls. Data extraction for aim 2 will begin in year 1, and analysis and results will be completed in year 2. For aim 2, we hypothesize that pyuria, heart rate, and temperature measurements will have a high positive predictive value for clinically meaningful UTI.

CONCLUSIONS

Once complete, this study will be the basis for our future work developing a risk score to aid with the diagnosis of UTI after SCI and prevent antibiotic overuse in patients with SCI.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52610.

摘要

背景

脊髓损伤(SCI)患者发生尿路感染(UTI)的表现与非SCI人群不同。UTI会导致生活质量下降,甚至引发包括尿脓毒症在内的危及生命的并发症。SCI管理面临的挑战包括区分有症状的UTI和无症状菌尿(ASB),后者在SCI患者中经常出现,以及SCI中UTI诊断缺乏标准化。

目的

本研究旨在为开发风险评分奠定基础,以提高SCI后UTI的诊断准确性。

方法

本研究将使用退伍军人健康管理局企业数据仓库中来自全国门诊诊所的数据。将采用两种方法:(1)一项病例对照研究,比较频率匹配的健康SCI病例(n = 2000)与健康非SCI对照(n = 2000),以建立SCI后生命体征和实验室测量的生理基线;(2)一项对SCI患者(n = 400)的回顾性队列研究,以确定在第1步中发现的基线生命体征和实验室测量的阳性预测值,据此建立SCI后具有临床意义的UTI阈值。

结果

该研究于2023年5月获得资助,初始数据提取于2024年初开始,预计2026年完成。截至稿件提交时,目标1的数据提取、分析和结果已完成。对于目标1,我们假设与非SCI对照相比,SCI将与较低的体温、心率和收缩压相关。与非SCI对照相比,SCI还将与较高的脓尿和外周白细胞基线水平相关。目标2的数据提取将于第1年开始,分析和结果将于第2年完成。对于目标2,我们假设脓尿、心率和体温测量对具有临床意义的UTI具有较高的阳性预测值。

结论

本研究一旦完成,将成为我们未来开发风险评分的工作基础,以帮助诊断SCI后UTI并防止SCI患者过度使用抗生素。

国际注册报告标识符(IRRID):DERR1-10.2196/52610。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7416/12099271/f61827602f1a/resprot_v14i1e52610_fig1.jpg

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