Multimodal pulse oximeters to support the integrated management of childhood illnesses: A usability and diagnostic accuracy assessment from a multi-country hybrid type 2 study

Nearly 5 million children die each year of preventable causes, with pneumonia being a key contributor. The Integrated Management of Childhood Illnesses guidelines improve health care workers' diagnostic and management capabilities by relying mostly on clinical signs. Though there have been successes, challenges in the consistent application of IMCI and the accurate diagnosis of conditions like hypoxemia remain. Next generation pulse oximeters add functionality to stand alone pulse oximeters, like measurement of respiratory rate, temperature, and hemoglobin. While the TIMCI project sought to address gaps in the introduction of pulse oximetry in India, Kenya, Senegal, and Tanzania, research was also conducted to strengthen the market for multimodal pulse oximetry (PO) devices by filling evidence gaps around ideal product attributes and the validation of available and near to market photoplethysmography-derived clinical measurement tools (medical device and smartphone-based). A mixed-methods evaluation measured usability and diagnostic accuracy using multimodal PO devices among primary care providers in the four countries. Results showed good usability, minimal user errors, and high satisfaction and system usability scores across all devices. Additionally, across all age categories, device performance for hypoxemia, tachycardia, and fever exceeded 80% agreement; respiratory rate measurements exhibited greater variability in percent agreement between devices. A target product profile and an open-source data repository were developed to further advance device development and market alignment. This research provided data on the performance of various multimodal PO devices, considering different form factors and product attributes. Technological progress continues to expand opportunities for the collection of clinical measurements and data. Supporting providers with decision support and automated documentation tools ensures that the information generated is actionable and utilized, while an emphasis on integrated technologies is essential to maximize provider capabilities and improve the diagnosis and management of childhood illnesses in low- and middle-income countries.