ABSTRACT
Introduction: Low- and middle-income countries (LMICs) account for 99% of the global neonatal mortality. Limited access to advanced technology, such as bedside patient monitors contributes to disproportionately poor outcomes for critically ill newborns in LMICs. We designed a study to assess the feasibility, performance, and acceptability of a low-cost wireless wearable technology for continuous monitoring of sick newborns in resource-limited settings. Methods: This was a mixed-methods implementation study conducted between March and April 2021 at two health facilities in Western Kenya. Inclusion criteria for newborns monitored included: age 0 to 28 days, birthweight ≥2.0â kg, low-to-moderate severity of illness at admission and the guardian's willingness to provide informed consent. Medical staff who participated in monitoring the newborns were surveyed about their experience with the technology. We used descriptive statistics to summarize our quantitative findings and qualitative data was coded and analyzed as an iterative process to summarize quotes on user acceptability. Results: The results of the study demonstrated that adoption of neoGuard was feasible and acceptable in this setting. Medical staff described the technology as safe, user-friendly and efficient, after successfully monitoring 134 newborns. Despite the positive user experience, we did observe some notable technology performance issues such as a high percentage of missing vital signs data. Conclusion: The results of this study were critical in informing the iterative process of refining and validating an innovative vital signs monitor for patients in resource-limited settings. Further research and development are underway to optimize neoGuard's performance and to examine its clinical impact and cost effectiveness.
ABSTRACT
Objective: The purpose of this study was to evaluate the accuracy and reliability of neoGuard in comparison to a conventional bedside monitor on patients in a low-resource clinical setting. Design: This was a single-arm methods comparison study involving the use of a wearable vital signs monitor (neoGuardTM) versus a conventional bedside monitor (Edan iM8). Setting: The study was conducted at Jinja Regional Referral Hospital, a tertiary care hospital situated in Eastern Uganda. Participants: Thirty patients (10 male, 20 female) were enrolled from the adult recovery ward at JRRH. Participants were eligible for the study if they were at least 18 years of age, had 2 sets of normal vital sign measurements obtained 1â h apart, and were able and willing to provide informed consent. Main Outcome and Measures: The primary outcome measures were (i) bias (mean deviation) and (ii) limits of agreement [95% CI]. Bland-Altman plots were generated to illustrate the level of agreement between the neoGuardTM technology and the Edan iM8 monitor. Results: Bland-Altman analysis was performed for 24 participants; datasets from six participants were excluded due to missing or invalid measurements. Findings showed a moderate level of agreement for measurement of SpO2, PR, and RR, with >80% of subject means falling within the predefined acceptability limits. However, there was also notable variation in accuracy between subjects, with large standard deviations observed for measurement of all four parameters. While the level of agreement for measurement of temperature was low, this is partly explained by limitations in the comparison method.
ABSTRACT
The neoGuard™ technology is a wireless wearable vital signs monitor attached to a patient's forehead to continuously measure oxygen saturation, pulse rate, respiratory rate and temperature. Developed with feedback from more than 400 health workers, primarily in East Africa, the product has been designed to meet the unique constraints of low-resource settings. This perspective piece by the innovators of neoGuard™ and some of their key partners examines the complicated journey of taking a medical technology from concept through clinical validation and finally to market. By shedding light on some of the most critical steps and common challenges encountered along the pathway to commercialization, the authors hope that their experiences will provide some valuable insights to other aspiring innovators in this space.
