Summary Background Pneumonia is one of the leading causes of death in children under-five globally. The current diagnostic criteria for pneumonia are based on increased respiratory rate (RR) or chest in-drawing in children with cough and/or difficulty breathing. Accurately counting RR is difficult for community health workers (CHWs). Current RR counting devices are frequently inadequate or unavailable. This study analysed the performance of improved RR timers for detection of pneumonia symptoms in low-resource settings. Methods Four RR timers were evaluated on 454 children, aged from 0 to 59 months with cough and/or difficulty breathing, over three months, by CHWs in hospital settings in Cambodia, Ethiopia, South Sudan and Uganda. The devices were the Mark Two ARI timer (MK2 ARI), counting beads with ARI timer, Rrate Android phone and the Respirometer feature phone applications. Performance was evaluated for agreement with an automated RR reference standard (Masimo Root patient monitoring and connectivity platform with ISA CO 2 capnography). This study is registered with ANZCTR [ACTRN12615000348550]. Findings While most CHWs managed to achieve a RR count with the four devices, the agreement was low for all; the mean difference of RR measurements from the reference standard for the four devices ranged from 0.5 (95% C.I. − 2.2 to 1.2) for the respirometer to 5.5 (95% C.I. 3.2 to 7.8) for Rrate. Performance was consistently lower for young infants (0 to < 2 months) than for older children (2 to ≤ 59 months). Agreement of RR classification into fast and normal breathing was moderate across all four devices, with Cohen's Kappa statistics ranging from 0.41 (SE 0.04) to 0.49 (SE 0.05). Interpretation None of the four devices evaluated performed well based on agreement with the reference standard. The ARI timer currently recommended for use by CHWs should only be replaced by more expensive, equally performing, automated RR devices when aspects such as usability and duration of the device significantly improve the patient-provider experience. Funding [OPP1054367].
Aim Pneumonia is the leading infectious cause of death among children under five globally. Many pneumonia deaths result from inappropriate treatment due to misdiagnosis of signs and symptoms. This study aims to identify whether health extension workers (HEWs) in Ethiopia, using an automated multimodal device (Masimo Rad‐G), adhere to required guidelines while assessing and classifying under five children with cough or difficulty breathing and to understand device acceptability. Methods A cross‐sectional study was conducted in three districts of Southern Nations, Nationalities, and Peoples' Region, Ethiopia. Between September and December 2018, 133 HEWs were directly observed using Rad‐G while conducting 599 sick child consultations. Usability was measured as adherence to the World Health Organization requirements to assess fast breathing and device manufacturer instructions for use. Acceptability was assessed using semi‐structured interviews with HEWs, first‐level health facility workers and caregivers. Results Adherence using the Rad‐G routinely for 2 months was 85.3% (95% CI 80.2, 89.3). Health workers and caregivers stated a preference for Rad‐G. Users highlighted a number of device design issues. Conclusion While demonstrating high levels of acceptability and usability, the device modifications to consider include better probe fit, improved user interface with exclusive age categories and simplified classification outcomes.
Background: Low blood oxygen saturation (SpO 2 ), or hypoxaemia, is an indicator of severe illness in children. Pulse oximetry is a globally accepted, non-invasive method to identify hypoxaemia, but rarely available outside higher-level facilities in resource-constrained countries. This study aims to evaluate the performance of different types of pulse oximeters amongst frontline health workers in Cambodia, Ethiopia, South Sudan, and Uganda. Methods: Five pulse oximeters (POx) which passed laboratory testing, out of an initial 32 potential pulse oximeters, were evaluated by frontline health workers for performance, defined as agreement between the SpO 2 measurements of the test device and the reference standard. The study protocol is registered with the Australia New Zealand Clinical Trials Registry (Ref: ACTRrn12615000348550). Findings: Two finger-tip pulse oximeters (Contec and Devon), two handheld pulse oximeters (Lifebox and Utech), and one phone pulse oximeter (Masimo) passed the laboratory testing. They were evaluated for performance on 1,313 children under five years old by 207 frontline health workers between February and May 2015. Phone and handheld pulse oximeters had greater overall agreement with the reference standard (56%; 95% CI 0.52 -0.60 to 68%; 95% CI 0.65 -0.71) than the finger-tip POx (31%; 95% CI 0.26 to 0.36 and 47%; 95% CI 0.42 to 0.52). Fingertip POx performance was substantially lower in the 0À2 month olds; having just 17% and 25% agreement. The finger-tip devices more often underreported SpO 2 readings (mean difference -7.9%; 95%CI -8.6,-7.2 and -3.9%; 95%CI -4.4,-3.4), and therefore over diagnosed hypoxaemia in the children assessed. Interpretation: While the Masimo phone pulse oximeter performed best, all handheld POx with age-specific probes performed well in the hands of frontline health workers, further highlighting their suitability as a screening tool of severe illness. The poor performance of the fingertip POx suggests they should not be used in children under five by frontline health workers. It is essential that POx are performance tested on children in routine settings (in vivo), not only in laboratories or controlled settings (in vitro), before being introduced at scale.
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