A novel digital health approach to improving global pediatric sepsis care in Bangladesh using wearable technology and machine learning.

Sepsis is the leading cause of child death globally with low- and middle-income countries (LMICs) bearing a disproportionate burden of pediatric sepsis deaths. Limited diagnostic and critical care capacity and health worker shortages contribute to delayed recognition of advanced sepsis (severe sepsis, septic shock, and/or multiple organ dysfunction) in LMICs. The aims of this study were to 1) assess the feasibility of a wearable device for physiologic monitoring of septic children in a LMIC setting and 2) develop machine learning models that utilize readily available wearable and clinical data to predict advanced sepsis in children. This was a prospective observational study of children with sepsis admitted to an intensive care unit in Dhaka, Bangladesh. A wireless, wearable device linked to a smartphone was used to collect continuous recordings of physiologic data for the duration of each patient's admission. The correlation between wearable device-collected vital signs (heart rate [HR], respiratory rate [RR], temperature [T]) and manually collected vital signs was assessed using Pearson's correlation coefficients and agreement was assessed using Bland-Altman plots. Clinical and laboratory data were used to calculate twice daily pediatric Sequential Organ Failure Assessment (pSOFA) scores. Ridge regression was used to develop three candidate models for advanced sepsis (pSOFA > 8) using combinations of clinical and wearable device data. In addition, the lead time between the models' detection of advanced sepsis and physicians' documentation was compared. 100 children were enrolled of whom 41% were female with a mean age of 15.4 (SD 29.6) months. In-hospital mortality rate was 24%. Patients were monitored for an average of 2.2 days, with > 99% data capture from the wearable device during this period. Pearson's r was 0.93 and 0.94 for HR and RR, respectively) with r = 0.72 for core T). Mean difference (limits of agreement) was 0.04 (-14.26, 14.34) for HR, 0.29 (-5.91, 6.48) for RR, and -0.0004 (-1.48, 1.47) for core T. Model B, which included two manually measured variables (mean arterial pressure and SpO2:FiO2) and wearable device data had excellent discrimination, with an area under the Receiver-Operating Curve (AUC) of 0.86. Model C, which consisted of only wearable device features, also performed well, with an AUC of 0.78. Model B was able to predict the development of advanced sepsis more than 2.5 hours earlier compared to clinical documentation. A wireless, wearable device was feasible for continuous, remote physiologic monitoring among children with sepsis in a LMIC setting. Additionally, machine-learning models using wearable device data could discriminate cases of advanced sepsis without any laboratory tests and minimal or no clinician inputs. Future research will develop this technology into a smartphone-based system which can serve as both a low-cost telemetry monitor and an early warning clinical alert system, providing the potential for high-quality critical care capacity for pediatric sepsis in resource-limited settings.