Neonatal jaundice detection in low-resource Mexican settings: possibilities and barriers for innovation with mobile health.

BACKGROUND: Neonatal jaundice is a common condition that can lead to brain damage and disabilities when severe cases go undetected. Low- and middle-income countries often lack accurate methods for detecting neonatal jaundice and rely on visual assessment, resulting in a higher incidence of adverse consequences. Picterus Jaundice Pro (Picterus JP), an easy-to-use and affordable smartphone-based screening device for the condition, has demonstrated higher accuracy than visual assessment in Norwegian, Philippine and Mexican newborns. This study aimed to identify the barriers and facilitators to implementing Picterus JP in public health services in low-income settings in Mexico by exploring the current process of neonatal jaundice detection and stakeholders' perspectives in that context. METHODS: Qualitative data collection techniques, including one focus group, 15 semi-structured interviews and four observations, were employed in urban and rural health facilities in Oaxaca, Mexico. The participants included medical doctors, nurses and health administrators. The data were analysed by thematic analysis guided by the Consolidated Framework for Implementation Research. RESULTS: The analysis yielded four main themes: (I) the current state of neonatal care and NNJ detection, (II) the needs and desires for enhancing NNJ detection, (III) the barriers and facilitators to implementing Picterus JP in the health system and (IV) HCWs' expectations of Picterus JP. The findings identify deficiencies in the current neonatal jaundice detection process and the participants' desire for a more accurate method. Picterus JP was perceived as easy to use, useful and compatible with the work routine, but barriers to adoption were identified, including internet deficiencies and costs. CONCLUSIONS: The introduction of Picterus JP as a supporting tool to screen for neonatal jaundice is promising but contextual barriers in the setting must be addressed for successful implementation. There is also an opportunity to optimise visual assessment to improve detection of neonatal jaundice.

Healthcare workers' perceptions about the use of mobile health technologies in public health facilities in Lagos, Nigeria.

Background: Mobile health has enormous potential in healthcare due to the increasing use of mobile phones in low- and middle-income countries; its effective deployment, uptake, and utilization may result in improved health outcomes, including a reduction in neonatal deaths. However, there is a suboptimal uptake of mobile health technologies among healthcare workers in low-resource settings like Nigeria, which are often context-specific. Objective: To investigate healthcare workers' perceptions of mobile health technologies in public health facilities in Lagos, Nigeria. Method: A qualitative study was conducted, and data were collected through six focus group discussions with 26 healthcare workers (doctors, nurses, and community health extension workers) from three public health facilities in Lagos, Nigeria. The collected data were analyzed using a thematic approach, where themes and subthemes were created. Results: Although the participants acknowledged that mobile health enhances patient-provider communication and saves time, they identified altering of healthcare workers' routine practices, information overload, power and network failure, skepticism, lack of trust, and concerns over diagnostic accuracy as potential barriers to its uptake. Conclusion: Addressing healthcare workers' perceptions of mobile health technologies may enhance the deployment and uptake of such solutions in Nigeria and similar low-resource settings. Developers and implementers of such can use them to create new or enhance existing mobile health solutions to better meet the needs and requirements of healthcare workers in low- to middle-income health settings, such as Lagos, Nigeria.

Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study.

BACKGROUND: Medical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable. OBJECTIVE: This study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings. METHODS: We used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server. RESULTS: Three iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%). CONCLUSIONS: Our smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.

Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels.

AIM: Neonatal jaundice is an important cause of morbidity and mortality, and identifying the condition remains a challenge. This study evaluated a novel method of estimating bilirubin levels from colour-calibrated smartphone images. METHODS: A cross-sectional prospective study was undertaken at two hospitals in Norway from February 2017 to March 2019, with standardised illumination at one hospital and non-standardised illumination at the other hospital. Healthy term-born infants with a normal birthweight were recruited up to 15 days of age. The main outcome measures were bilirubin estimates from digital images, plus total bilirubin in serum (TSB) and transcutaneous bilirubin (TcB). RESULTS: Bilirubin estimates were performed for 302 newborn infants, and 76 had severe jaundice. The correlation between the smartphone estimates and TSB was measured by Pearson's r and was .84 for the whole sample. The correlation between the image estimates and TcB was 0.81. There were no significant differences between the hospitals. Sensitivity was 100%, and specificity was 69% for identifying severe jaundice of more than 250 µmol/L. CONCLUSION: A smartphone-based tool that estimated bilirubin levels from digital images identified severe jaundice with high sensitivity and could provide a screening tool for neonatal jaundice.