Automated Respiratory Rate Counter to Assess Children for Symptoms of Pneumonia: Protocol for Cross-Sectional Usability and Acceptability Studies in Ethiopia and Nepal

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 Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn.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: Manually counting a child’s respiratory rate (RR) for 60 seconds using an acute respiratory infection (ARI) timer is the World Health Organization (WHO) recommended method for detecting fast breathing as a sign of pneumonia. However, counting RR is challenging and the misclassification of an observed rate is common, often leading to inappropriate treatment. To address this gap, the Acute Respiratory Infection Diagnostic Aid (ARIDA) project was initiated to respond to a call for better pneumonia diagnostic aids and aims to identify and assess automated RR counters for classifying fast breathing pneumonia, for use by frontline health workers in resource-limited community settings and health facilities. The Children’s Respiration Monitor (ChARM), developed by Philips, and the Rad-G, developed by Masimo, are the ARIDA devices being tested to understand usability for Community Health Workers (CHWs), measured as adherence to required WHO case management guidelines and device manufacturer instructions for use on children under five (U5) with cough and/or difficult breathing and whether the devices are acceptable to CHWs and First-Level Health Facility Workers (FLHFWs) and caregivers in the Southern Nations, Nationalities, and Peoples' Region (SNNPR), Ethiopia and in the Karnali region in Nepal. Objective: In this study, we aim to understand the usability of a new automated RR device for CHWs/HEWs/FCHVs and its acceptability to community health workers, first-level health facility workers (Ethiopia only) and caregivers. Methods: This is a prospective, cross-sectional study with a mixed methods design. CHWs and FLHFWs were trained on how to use both devices and provided refresher training on integrated community case management (iCCM) or integrated management of childhood illness (IMCI) in Ethiopia and community based integrated management of newborn and childhood illness (CB-IMNCI) in Nepal. Immediately after training, CHWs were observed using ARIDA on two children (observation 1). Routine pneumonia case management consultations for U5 children and the device used for these consultations between the first and second consultations were recorded by CHWs in their patient log books. CHWs were observed a second time after two months (observation 2), again using ARIDA on two children. Semi-structured interviews were also conducted with CHWs, FLHFWs and caregivers. The proportion of under-five child consultations where CHWs using an ARIDA adhered to required WHO case management guidelines and device manufacturer instructions for use after two months will be calculated. Secondary outcomes include the mean time taken to complete the consultation, the proportion of times a CHWs used an ARIDA during routine use, and the association between CHW experience and training in relation to adherence results. Qualitative data from semi-structured interviews will be analysed using a thematic framework approach. Results: The ARIDA project was funded in November 2015 and data collection was conducted between April and December 2018. Data analysis is currently underway and the first results are expected to be submitted for publication in 2019. Conclusions: This is the first time the usability and acceptability of these automated RR counters in these settings have been evaluated. Outcomes will be relevant for policymakers and are important for future research into of these classes of devices for the management of children with suspected pneumonia.