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用于减少抗菌药物耐药性的尿路感染即时检测:一项系统评价和概念性经济模型

Point-of-care tests for urinary tract infections to reduce antimicrobial resistance: a systematic review and conceptual economic model.

作者信息

Tomlinson Eve, Ward Mary, Cooper Chris, James Rachel, Stokes Christina, Begum Samina, Watson Jessica, Hay Alastair D, Jones Hayley E, Thom Howard, Whiting Penny

机构信息

Bristol TAG, Population Health Sciences, Bristol Medical School, Bristol, UK.

Patient representative, UK.

出版信息

Health Technol Assess. 2024 Nov;28(77):1-109. doi: 10.3310/PTMV8524.

Abstract

BACKGROUND

Urinary tract infections are diagnosed by general practitioners based on symptoms, dipstick tests in some and laboratory urine culture. Patients may be given inappropriate antibiotics. Point-of-care tests can diagnose urinary tract infection in near-patient settings quicker than standard culture. Some can identify the causative pathogen or antimicrobial sensitivity.

OBJECTIVE

To assess whether point-of-care tests for people with suspected urinary tract infection have the potential to be clinically effective and cost-effective to the NHS.

DESIGN

Systematic review and conceptual economic model.

RESULTS

Two randomised controlled trials evaluated Flexicult Human (one against standard care; one against ID Flexicult). One trial found no evidence of a difference between groups in concordant antibiotic use (odds ratio 0.84, 95% confidence interval 0.58 to 1.20), and the other found no difference in appropriate antibiotic prescribing (odds ratio 1.44, 95% confidence interval 1.03 to 1.99). Compared with standard care, Flexicult was associated with reduced antibiotic prescribing at initial consultation (odds ratio 0.56, 95% confidence interval 0.35 to 0.88). No difference was found for other outcomes. Sixteen studies reported test accuracy data. Most were rated as being at unclear or high risk of bias. We identified data on three rapid tests (results < 40 minutes). Lodestar DX ( = 1) had good sensitivity (86%, 95% confidence interval 74% to 99%) and specificity (88%, 95% confidence interval 83% to 94%) for detecting Uriscreen ( = 4) had modest summary sensitivity (74%, 95% confidence interval 59% to 84%) and specificity (64%, 95% confidence interval 41% to 82%). UTRiPLEX ( = 1) had poor sensitivity (21%) and good specificity (94%). Twelve studies evaluated culture-based tests (results 24 hours). Laboratory-based studies found Dipstreak ( = 2) and Uricult ( = 1) to be highly accurate, but there were limitations with these studies. Uricult Trio ( = 3) had more modest summary sensitivity (73%, 95% confidence interval 63% to 82%) and specificity (70%, 95% confidence interval 52% to 84%). Summary sensitivity for Flexicult Human ( = 4) and ID Flexicult ( = 2) was 79% (95% confidence interval 72% to 85%) and 89% (95% confidence interval 84% to 93%). Summary specificity was 67% (95% confidence interval 30% to 90%) and 70% (95% confidence interval 52% to 84%). Caution is needed in interpreting findings because of heterogeneity and limited data. Five studies evaluated technical performance (Flexicult Human, = 3; Uricult Trio, = 2). Limited data suggested that they are easier to use and interpret than standard culture. A conceptual economic model estimated the cost-effectiveness of point-of-care tests for urinary tract infection diagnosis, pathogen identification and antimicrobial sensitivity testing. Sensitivity and specificity of tests were informed by the clinical effectiveness review. Studies identified by the review were screened for evidence on treatment efficacy, costs and utility data; only two studies provided relevant evidence. A pragmatic search identified eight cost-effectiveness studies that provided further evidence. A decision tree comparing point-of-care tests in a mixed population (Lodestar DX vs. Flexicult Human) and in women with uncomplicated urinary tract infection (Lodestar DX vs. Flexicult Human vs. ID Flexicult) was implemented. The available input data were too limited for the results to be meaningful.

CONCLUSION AND FUTURE WORK

More research is required to determine whether point-of-care tests for urinary tract infection have the potential to be clinically effective and cost-effective to the NHS. Rapid tests such as Astrego PA-100 system and Lodestar DX appear promising, but data are very limited.

STUDY REGISTRATION

This study is registered as PROSPERO CRD42022383889.

FUNDING

This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135710) and is published in full in ; Vol. 28, No. 77. See the NIHR Funding and Awards website for further award information.

摘要

背景

全科医生根据症状、部分患者的试纸检测以及实验室尿液培养来诊断尿路感染。患者可能会被给予不恰当的抗生素。即时检验能够在患者身边的环境中比标准培养更快地诊断尿路感染。一些即时检验能够识别致病病原体或抗菌药敏情况。

目的

评估针对疑似尿路感染患者的即时检验对英国国民健康保险制度(NHS)而言是否具有临床有效性和成本效益。

设计

系统评价和概念性经济模型。

结果

两项随机对照试验评估了Flexicult Human(一项对比标准护理;一项对比ID Flexicult)。一项试验未发现两组在一致使用抗生素方面存在差异(优势比0.84,95%置信区间0.58至1.20),另一项试验未发现恰当开具抗生素方面存在差异(优势比1.44,95%置信区间1.03至1.99)。与标准护理相比,Flexicult在初次会诊时与减少抗生素开具相关(优势比0.56,95%置信区间0.35至0.88)。其他结局未发现差异。16项研究报告了检验准确性数据。大多数研究被评为存在不明确或高偏倚风险。我们确定了三项快速检验(结果<40分钟)的数据。Lodestar DX(=1)在检测时具有良好的敏感性(86%,95%置信区间74%至99%)和特异性(88%,95%置信区间83%至94%);Uriscreen(=4)具有中等的汇总敏感性(74%,95%置信区间59%至84%)和特异性(64%,95%置信区间41%至82%)。UTRiPLEX(=1)敏感性较差(21%)而特异性良好(94%)。12项研究评估了基于培养的检验(结果24小时)。基于实验室的研究发现Dipstreak(=2)和Uricult(=1)高度准确,但这些研究存在局限性。Uricult Trio(=3)具有更中等的汇总敏感性(73%,95%置信区间63%至82%)和特异性(70%,95%置信区间52%至84%)。Flexicult Human(=4)和ID Flexicult(=2)的汇总敏感性分别为79%(95%置信区间72%至85%)和89%(95%置信区间84%至93%)。汇总特异性分别为67%(95%置信区间30%至90%)和70%(95%置信区间52%至84%)。由于存在异质性和数据有限,在解释研究结果时需谨慎。5项研究评估了技术性能(Flexicult Human,=3;Uricult Trio,=2)。有限的数据表明它们比标准培养更易于使用和解释。一个概念性经济模型估计了用于尿路感染诊断、病原体鉴定和抗菌药敏检测的即时检验的成本效益。检验的敏感性和特异性通过临床有效性评价来确定。对该评价所确定的研究筛查治疗疗效、成本和效用数据方面的证据;仅有两项研究提供了相关证据。一项实用检索确定了八项成本效益研究,提供了进一步的证据。实施了一个决策树,比较了混合人群中(Lodestar DX与Flexicult Human)以及单纯性尿路感染女性中(Lodestar DX与Flexicult Human与ID Flexicult)的即时检验。现有的输入数据过于有限,以至于结果无意义。

结论与未来工作

需要更多研究来确定针对尿路感染的即时检验对NHS而言是否具有临床有效性和成本效益。诸如Astrego PA - 100系统和Lodestar DX等快速检验看起来有前景,但数据非常有限。

研究注册

本研究注册为PROSPERO CRD42022383889。

资助

本奖项由国家卫生与保健研究机构(NIHR)证据综合项目资助(NIHR奖项编号:NIHR135710),并全文发表于;第28卷,第77期。有关进一步的奖项信息,请参见NIHR资助与奖项网站。

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