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

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Acute respiratory infections (ARIs), primarily pneumonia, are the leading infectious cause of under-five 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 paediatricians counting RR by reviewing a video of the child’s chest for 60 seconds (reference standard), for children under five years of age with cough and/or difficult breathing. Methods: A cross-sectional study aiming to enrol 290 children 0-59 months presenting to paediatric in- and out-patient departments at a teaching hospital in Addis Ababa, Ethiopia was conducted. Enrolment occurred between April and May 2017. Once enrolled, children participated in at least one of three types of RR evaluations: 1) agreement – to measure the RR count of ARIDA in comparison to the reference standard, 2) consistency – to measure the agreement between two ARIDA devices strapped to one child and 3) RR fluctuation – to 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 (MK2) ARI timer for 60 seconds was also measured in comparison to the reference standard. Results: Primary outcomes were 1) mean difference between 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 inter-rater 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. Clinical Trial: www.clinicaltrials.gov, identifier NCT03067558