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确定自动呼吸频率计数器与检测儿童肺炎症状参考标准之间的一致性:埃塞俄比亚一项横断面研究方案

Determining the Agreement Between an Automated Respiratory Rate Counter and a Reference Standard for Detecting Symptoms of Pneumonia in Children: Protocol for a Cross-Sectional Study in Ethiopia.

作者信息

Ward Charlotte, Baker Kevin, Marks Sarah, Getachew Dawit, Habte Tedila, McWhorter Cindy, Labarre Paul, Howard-Brand Jonathan, Miller Nathan P, Tarekegn Hayalnesh, Deribessa Solomie Jebessa, Petzold Max, Kallander Karin

机构信息

Malaria Consortium, London, United Kingdom.

Department of Public Health Sciences, Karolinska Institutet, Solnavägen, Sweden.

出版信息

JMIR Res Protoc. 2020 Apr 2;9(4):e16531. doi: 10.2196/16531.

DOI:10.2196/16531
PMID:32238340
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7163412/
Abstract

BACKGROUND

Acute respiratory infections (ARIs), primarily pneumonia, are the leading infectious cause of under-5 mortality worldwide. Manually counting respiratory rate (RR) for 60 seconds using an ARI timer is commonly practiced by community health workers to detect fast breathing, an important sign of pneumonia. However, correctly counting breaths manually and classifying the RR is challenging, often leading to inappropriate treatment. A potential solution is to introduce RR counters, which count and classify RR automatically.

OBJECTIVE

This study aims to determine how the RR count of an Automated Respiratory Infection Diagnostic Aid (ARIDA) agrees with the count of an expert panel of pediatricians counting RR by reviewing a video of the child's chest for 60 seconds (reference standard), for children aged younger than 5 years with cough and/or difficult breathing.

METHODS

A cross-sectional study aiming to enroll 290 children aged 0 to 59 months presenting to pediatric in- and outpatient departments at a teaching hospital in Addis Ababa, Ethiopia, was conducted. Enrollment occurred between April and May 2017. Once enrolled, children participated in at least one of three types of RR evaluations: (1) agreement-measure the RR count of an ARIDA in comparison with the reference standard, (2) consistency-measure the agreement between two ARIDA devices strapped to one child, and (3) RR fluctuation-measure RR count variability over time after ARIDA attachment as measured by a manual count. The agreement and consistency of expert clinicians (ECs) counting RR for the same child with the Mark 2 ARI timer for 60 seconds was also measured in comparison with the reference standard.

RESULTS

Primary outcomes were (1) mean difference between the ARIDA and reference standard RR count (agreement) and (2) mean difference between RR counts obtained by two ARIDA devices started simultaneously (consistency).

CONCLUSIONS

Study strengths included the design allowing for comparison between both ARIDA and the EC with the reference standard RR count. A limitation is that exactly the same set of breaths were not compared between ARIDA and the reference standard since ARIDA can take longer than 60 seconds to count RR. Also, manual RR counting, even when aided by a video of the child's chest movements, is subject to human error and can result in low interrater reliability. Further work is needed to reach global consensus on the most appropriate reference standard and an acceptable level of agreement to provide ministries of health with evidence to make an informed decision on whether to scale up new automated RR counters.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03067558; https://clinicaltrials.gov/ct2/show/NCT03067558.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/16531.

摘要

背景

急性呼吸道感染(ARIs),主要是肺炎,是全球五岁以下儿童死亡的主要感染原因。社区卫生工作者通常使用急性呼吸道感染计时器手动计数呼吸频率(RR)60秒,以检测呼吸急促,这是肺炎的一个重要体征。然而,手动正确计数呼吸并对RR进行分类具有挑战性,常常导致不适当的治疗。一个潜在的解决方案是引入RR计数器,它可以自动计数和分类RR。

目的

本研究旨在通过查看儿童胸部视频60秒(参考标准),确定自动呼吸道感染诊断辅助设备(ARIDA)的RR计数与儿科医生专家小组计数RR的一致性,研究对象为年龄小于5岁且有咳嗽和/或呼吸困难的儿童。

方法

进行了一项横断面研究,旨在招募290名年龄在0至59个月之间、前往埃塞俄比亚亚的斯亚贝巴一家教学医院儿科门诊和住院部就诊的儿童。招募工作于2017年4月至5月期间进行。一旦入选,儿童至少参与三种类型的RR评估中的一种:(1)一致性——将ARIDA的RR计数与参考标准进行比较;(2)一致性——测量绑在一个儿童身上的两个ARIDA设备之间的一致性;(3)RR波动——测量ARIDA附着后随时间的RR计数变异性,通过手动计数测量。还测量了专家临床医生(ECs)使用Mark 2 ARI计时器为同一儿童计数RR 60秒与参考标准的一致性和一致性。

结果

主要结果为:(1)ARIDA与参考标准RR计数之间的平均差异(一致性);(2)两个同时启动的ARIDA设备获得的RR计数之间的平均差异(一致性)。

结论

研究的优势包括该设计允许将ARIDA和EC与参考标准RR计数进行比较。一个局限性是,由于ARIDA计数RR可能需要超过60秒,因此ARIDA与参考标准之间没有比较完全相同的一组呼吸。此外,即使借助儿童胸部运动视频进行手动RR计数,也容易出现人为误差,可能导致评分者间信度较低。需要进一步开展工作,就最合适的参考标准和可接受的一致性水平达成全球共识,以便为各国卫生部提供证据,使其能够就是否扩大新型自动RR计数器的使用做出明智决策。

试验注册

ClinicalTrials.gov NCT03067558;https://clinicaltrials.gov/ct2/show/NCT03067558。

国际注册报告识别码(IRRID):RR1-10.2196/16531。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd38/7163412/9be99a9e80a2/resprot_v9i4e16531_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd38/7163412/9be99a9e80a2/resprot_v9i4e16531_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd38/7163412/9be99a9e80a2/resprot_v9i4e16531_fig1.jpg

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