Performance, Acceptability, and Usability of Respiratory Rate Timers and Pulse Oximeters When Used by Frontline Health Workers to Detect Symptoms of Pneumonia in Sub-Saharan Africa and Southeast Asia: Protocol for a Two-Phase, Multisite, Mixed-Methods Trial

Abstract

BackgroundPneumonia is one of the leading causes of death in children aged under 5 years in both sub-Saharan Africa and Southeast Asia. The current diagnostic criterion for pneumonia is based on the increased respiratory rate (RR) in children with cough or difficulty breathing. Low oxygen saturation, measured using pulse oximeters, is indicative of severe pneumonia. Health workers often find it difficult to accurately count the number of breaths, and the current RR counting devices are often difficult to use or unavailable. Nonetheless, improved counting devices and low-cost pulse oximeters are now available on the market.ObjectiveThe objective of our study was to identify the most accurate, usable, and acceptable devices for the diagnosis of pneumonia symptoms by community health workers and first-level health facility workers or frontline health workers in resource-poor settings.MethodsThis was a multicenter, prospective, two-stage, observational study to assess the performance and usability or acceptability of 9 potential diagnostic devices when used to detect symptoms of pneumonia in the hands of frontline health workers. Notably, 188 possible devices were ranked and scored, tested for suitability in a laboratory, and 5 pulse oximeters and 4 RR timers were evaluated for usability and performance by frontline health workers in hospital, health facility, and community settings. The performance was evaluated against 2 references over 3 months in Cambodia, Ethiopia, South Sudan, and Uganda. Furthermore, acceptability and usability was subsequently evaluated using both qualitative and quantitative methodologies in routine practice, over 3 months, in the 4 countries.ResultsThis project was funded in 2014, and data collection has been completed. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018.ConclusionsThis is the first large-scale evaluation of tools to detect symptoms of pneumonia at the community level. In addition, selecting an appropriate reference standard against which the devices were measured was challenging given the lack of existing standards and differences of opinions among experts. The findings from this study will help create a standardized and validated protocol for future studies and support further comparative testing of diagnostic devices in these settings.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12615000348550; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367306&isReview=true (Archived by Website at http://www.webcitation.org/72OcvgBcf)International Registered Report Identifier (IRRID)RR1-10.2196/10191

Performance of five pulse oximeters to detect hypoxaemia as an indicator of severe illness in children under five by frontline health workers in low resource settings – A prospective, multicentre, single-blinded, trial in Cambodia, Ethiopia, South Sudan, and Uganda

“…A multi-centred, prospective, single-blinded, comparison of performance of devices to detect hypoxaemia in the hands of CHWs and FLHFWs was conducted in Cambodia, Ethiopia, South Sudan and Uganda. Detailed description of the methods are published elsehwere [19]. Study sites of district hospitals were selected in each of the four countries after confirming that they had CHWs who were actively delivering iCCM services.…”

“…The study was approved by ethical review boards in each study country at national or regional level -in The study protocol is published [19] and is registered with the Australia New Zealand Clinical Trials Registry (ANZCTR) (Ref: ACTRrn12615000348550). All participants and accompanying caregivers provided written consent before being enroled in the study.…”

Performance of Four Respiratory Rate Counters to Support Community Health Workers to Detect the Symptoms of Pneumonia in Children in Low Resource Settings: A Prospective, Multicentre, Hospital-Based, Single-Blinded, Comparative Trial

“…Baseline characteristics within each country and strata were summarised using appropriate descriptive statistics. The study protocol is published [33] and is registered with the Australia New Zealand Trials Registry (ANZCTR) (Ref: ACTRN12615000348550). A video detailing the study methods can be seen here (link to: https://www.malariaconsortium.org/resources/video-library/927/protocol-film-implementing-a-trial-to-evaluate-pneumonia-diagnostic-devices).…”

Stock-Outs of Essential Medicines Among Community Health Workers (CHWs) In Low- And Middle-Income Countries (LMICs): A Systematic Literature Review of The Extent, Reasons, And Consequences

“…CHWs continue to play critical roles in reaching communities with essential health services because of their social and geographical proximity to residents and the cost-effectiveness of their services (4)(5)(6). Delivery of Integrated Community Case Management (iCCM), for example, has been shown to reduce child deaths from malaria, pneumonia, and diarrhea by up to 60% (7)(8)(9)(10)(11)-but only if CHWs have access to essential supplies. Essential medicines consist of drugs with potential for safe treatment of priority conditions in a basic health-care system (12); CHWs are typically supplied by a primary health center to which they are linked.…”