Childhood pneumonia and other respiratory illnesses are a lingering plague in many developing nations. Though incidences of pneumonia have decreased overall, the disease is the leading infectious cause of death in children globally, affecting one in six childhood deaths. Pneumonia claimed the lives of 921,000 children younger than 5 in 2015, according to the most recent data published in The Lancet Global Health.

While these statistics are sobering, progress is within reach. Building simple digital instruments to measure and improve pediatric respiratory health could potentially save many lives. However, many well-intentioned tools don’t work properly or aren’t sufficiently fit for purpose to be feasible for data collection among this target.  

ObvioHealth has conducted a meta review of the current state of the pediatric respiratory field. This research provides insights into where and how to make progress toward better measurement of symptomology, with the goal of early intervention and better clinical research to develop treatments and reduce childhood mortality.

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Challenges in Detecting and Diagnosing Childhood Pneumonia

Limited resources make timely pneumonia diagnosis a “much greater challenge” in low- and middle-income countries, researchers note in The Lancet’s eClinicalMedicine.  

A key resource challenge is reliance on community health workers (CHWs) to provide primary healthcare. CHWs are not always fully trained in detecting pneumonia, which can make it more difficult for them to accurately identify the signs and symptoms of the disease. Additionally, community-based workers may find it challenging to stay current on, and effectively deploy, medical best practices, especially when these protocols are open to interpretation.  

For instance, the World Health Organization (WHO) recommends using respiratory rate to help diagnose pneumonia. However, respiratory rate (RR) measurement can take many forms. In a systematic review of tools, researchers summarize 19 ways to measure RR, from manual breath count to humidity sensors, digital stethoscopes, and barometric pressure sensors. Some methods even capture the respiratory system’s effects on cardiovascular physiology using tools such as pulse oximetry systems.

In low-resource settings, healthcare workers don’t have access to these tools, so they must diagnose pneumonia using “subjective clinical signs and symptoms” derived from WHO guidelines. Although manual breath count is the most common way to measure RR, it poses challenges for accuracy and reliability. Measuring a child’s RR through visual observation “requires focused concentration and can be challenging in a child who may be moving, crying, or breathing rapidly,” according to the systematic review. “Inaccurate or imprecise measurements can stem from factors including poor visibility of the start or end of a breath, an irritable or moving child, or difficulty counting or remembering the count.”

Vulnerability to human error can compromise the effectiveness of these methods:

• In two Ugandan studies, CHWs correctly diagnosed and treated only 40% of childhood pneumonia cases by counting respiratory rate.  
• A clinical study assessing four non-contact manual RR counters found that none performed well, which researchers attribute partly to poor usability. Commentary on the study notes that these methods “still rely on the CHW to count the RR or to tap the screen of a phone, and both CHW-based methods are prone to error and lead to overdiagnosis and/or underdiagnosis and inappropriate treatment.”

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The Current State of Diagnostic Solutions for Childhood Pneumonia  

Medical manufacturers have launched an array of wearable digital devices that could contribute to improving diagnosis for respiratory illnesses such as pneumonia, including:

• Pulse oximetry devices
• Contactless portable respiratory rate monitors (CPRM) 
• Sensors to detect breathing-related chest wall motion
• Clip-on devices that track breathing, movement, and sleeping position in babies
• Mobile, or mHealth, devices that track respiratory rate using smartphones

However, these devices lack adequate clinical trials, and the existing trials lack representative participant pools that include underserved pediatric populations. Research in The Lancet’s eClinical Medicine notes that these tools have not been validated in low- to middle-income countries. Many of the existing trials were conducted on relatively affluent children, who have better access to digital health tools than their counterparts in developing countries. The limited available information on clinical outcomes points to a significant need for portable, affordable, user-centric devices.

A lack of standardization also limits the effectiveness of RR measurement tools:

• Researchers developed a contactless portable respiratory rate monitor (CPRM) to address the “inherent variability in respiratory rate measurements between observers.” While they successfully measured RR with the CPRM, they noted that the tool in its present form “does not appear accurate enough to be used in clinical practice.”
• In an article titled “Measurement of respiratory rate by multiple raters in a clinical setting is unreliable: a cross-sectional simulation study,” researchers state: “A rigorous evaluation of accuracy is necessary to validate any technology before widespread use as a diagnostic tool. Although all studies in this review included an assessment of accuracy, there was wide variation in reference standard selection and statistical methods of comparison. This variation precluded the ability to compare devices head-to-head and complicated attempts to develop standard criteria or a cutoff for determining accuracy.”
• Researchers note in Breathe: “The vast majority of wearable devices have not been characterized in terms of reliability, measurement accuracy, safety and efficacy. Patients and users have to navigate through thousands of iOS and Android health and fitness mobile applications connected to wearable devices and determine by themselves the effectiveness and usefulness of these apps and devices. An extremely low number of wearable devices have a CE, FDA or any other mark of conformity.”

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Future Opportunities in Digital Diagnostic Solutions for Childhood Pneumonia

Surveying the current state of research and care delivery, we’ve identified significant gaps in the technology and methodology leveraged to diagnose pediatric respiratory illness in remote communities. These gaps include difficulty in measuring respiratory rate and the lack of standardized, clinically validated devices to support accurate, timely diagnosis.

Writing in Breathe, researchers conclude that “there is undoubtedly the need for clinical evaluation of most wearable devices” through a systematic process to collect and assess clinical data that verifies a device’s safety, performance, and clinical benefits.  

This situation leaves considerable opportunity for the medical device industry. ObvioHealth is exploring creative ways to combine signals from multiple devices in our mission to advance data collection in our upcoming trials.