纸尿裤作为养老院居民尿液标本有前景的采集方法：一项非劣效性研究。

Diapers as Promising Alternative Collection Method for Urine Specimens in Nursing Home Residents: A Noninferiority Study.

机构信息

Department of Medical Microbiology, Amsterdam UMC, University of Amsterdam, Amsterdam Infection & Immunity Institute, Amsterdam, The Netherlands.

Department of Clinical Chemistry, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

J Am Med Dir Assoc. 2021 Jun;22(6):1222-1227.e1. doi: 10.1016/j.jamda.2020.10.003. Epub 2020 Dec 7.

DOI:10.1016/j.jamda.2020.10.003

PMID:33303395

Abstract

OBJECTIVE

There is unmet need for an easy, noninvasive urine collection method to diagnose urinary tract infections (UTIs) in nursing home residents suffering from urinary incontinence or cognitive impairments. UTIs are highly prevalent in nursing home residents, and urine specimen collection can be difficult. The objective of this study was to assess if urine specimens collected from super-absorbing incontinence pads (adult diapers) are a reliable collection method for UTI diagnosis.

DESIGN

This was a paired noninferiority laboratory study, in which pairing refers to UTI diagnostics performed directly using clinical urine specimens (reference specimen) and indirectly using urine extracted from diapers (diaper specimen).

SETTING AND PARTICIPANTS

In this study, remnants of 250 clinical urine specimens were used to assess noninferiority in diagnosing UTIs, based on a 1-sided type I error of 2.5%, a power of 90%, and a noninferiority margin of 15%.

METHODS

Urine specimens were poured on super-absorbing disposable adult diapers and extracted after 3 hours, to use for dipstick urinalysis and bacterial culture. UTIs were defined as presence of leukocytes and a positive bacterial culture. Noninferiority was assessed by calculating a Wald-type test statistic.

RESULTS

Noninferiority was established for diagnosing UTIs in diaper specimens, and for each of its components (dipstick leukocyte detection and bacterial culture positivity). Positive bacterial cultures were found in 72 (29.0%) diaper specimens compared with 65 (26.2%) reference specimens (difference -2.8%, 97.5% CI -7.1% to 1.5%). Leukocytes were present in 162 (64.8%) diaper specimens, compared with 175 (70.0%) reference specimens (difference -5.7%, 97.5% CI: -10.6% to -0.7%).

CONCLUSION AND IMPLICATIONS

Our results on diagnosing UTIs, by dipstick analysis and bacterial cultures, using super-absorbing adult diapers are promising. Before translation into clinical practice, further studies are needed to evaluate the risk of bacterial contamination by wearing adult diapers, possibly resulting in overdiagnosis of UTI.

摘要

目的

对于患有尿失禁或认知障碍的护理院居民，需要一种简单、非侵入性的尿液采集方法来诊断尿路感染（UTI），但目前这种方法尚未满足需求。UTI 在护理院居民中非常普遍，而且尿液标本采集可能很困难。本研究的目的是评估是否可以使用超强吸收失禁垫（成人纸尿裤）收集的尿液标本作为诊断 UTI 的可靠采集方法。

设计

这是一项配对非劣效性实验室研究，配对是指直接使用临床尿液标本（参考标本）和间接使用从尿布中提取的尿液标本（尿布标本）进行 UTI 诊断。

地点和参与者

在这项研究中，使用 250 份临床尿液标本的残余物来评估基于单侧 2.5%的Ⅰ类错误、90%的功效和 15%的非劣效性边界的诊断 UTI 的非劣效性。

方法

将尿液标本倒入超强吸收一次性成人纸尿裤中，3 小时后提取，用于尿试纸分析和细菌培养。UTI 的定义为白细胞阳性和细菌培养阳性。非劣效性通过计算 Wald 型检验统计量来评估。

结果

在尿布标本中诊断 UTI 及其各个组成部分（尿试纸白细胞检测和细菌培养阳性）方面，均确立了非劣效性。与 65 份参考标本相比，72 份（29.0%）尿布标本中发现了阳性细菌培养（差值-2.8%，97.5%CI-7.1%至 1.5%）。162 份（64.8%）尿布标本中存在白细胞，而 175 份（70.0%）参考标本中存在白细胞（差值-5.7%，97.5%CI：-10.6%至-0.7%）。