Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.

BACKGROUND: Medical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context. METHODS: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting. FINDINGS: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023). CONCLUSIONS: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

A scoping review of research on policies to address child undernutrition in the Millennium Development Goals era.

OBJECTIVE: The breadth of research on the impact of nutrition-specific policies to address child undernutrition is not well documented. This review maps the evidence base and identifies gaps on such policies. DESIGN: We systematically searched Medline, Embase, PAIS Index for public policy, Scopus and Web of Science databases to identify eligible studies. Key study characteristics, including research design, type of policy, time span of policy before impact assessment, child age at outcome assessment and types of outcomes assessed, were abstracted in duplicate. SETTING: Low-, middle- and high-income countries. PARTICIPANTS: Studies were eligible for inclusion if they aimed to assess the impact of population-level nutrition-specific policies on undernutrition among children under 10 years of age. RESULTS: Of the 5646 abstracts screened, eighty-three studies were included. A range of policies to address child undernutrition were evaluated; the majority were related to micronutrient fortification. Most studies were observational, reported on mandatory regional or sub-national polices, were conducted in high-income countries and evaluated policies within 1 year of implementation. A narrow set of health outcomes were evaluated, most commonly iodine deficiency disorders and neural tube defects. CONCLUSIONS: Nutrition policies were commonly associated with improved child nutritional status and health. However, this evidence is primarily based on limited settings and on a limited number of outcomes. Further research is needed to assess the longer-term impact of a broader range of nutrition policies on child health, particularly in low- and middle-income countries.

The development and implementation of an oxygen treatment solution for health facilities in low and middle-income countries.

BACKGROUND: Oxygen reduces mortality from severe pneumonia and is a vital part of case management, but achieving reliable access to oxygen is challenging in low and middle-income country (LMIC) settings. We developed and field tested two oxygen supply solutions suitable for the realities of LMIC health facilities. METHODS: A Health Needs Assessment identified a technology gap preventing reliable oxygen supplies in Gambian hospitals. We used simultaneous engineering to develop two solutions: a Mains-Power Storage (Mains-PS) system consisting of an oxygen concentrator and batteries connected to mains power, and a Solar-Power Storage (Solar-PS) system (with batteries charged by photovoltaic panels) and evaluated them in health facilities in The Gambia and Fiji to assess reliability, usability and costs. RESULTS: The Mains-PS system delivered the specified ≥85% (±3%) oxygen concentration in 100% of 1-2 weekly measurements over 12 months, which was available to 100% of hypoxaemic patients, and 100% of users rated ease-of-use as at least 'good' (90% very good or excellent). The Solar-PS system delivered ≥85% ± 3%) oxygen concentration in 100% of 1-2 weekly measurements, was available to 100% of patients needing oxygen, and 100% of users rated ease-of-use at least very good.Costs for the systems (in US dollars) were: PS$9519, Solar-PS standard version $20 718. The of oxygen for a standardised 30-bed health facility using 1.7 million litres of oxygen per year was: for cylinders 3.2 cents (c)/L in The Gambia and 6.8 c/L in Fiji, for the PS system 1.2 c/L in both countries, and for the Solar-PS system 1.5 c/L in both countries. CONCLUSIONS: The oxygen systems developed and tested delivered high-quality, reliable, cost-efficient oxygen in LMIC contexts, and were easy to operate. Reliable oxygen supplies are achievable in LMIC health facilities like those in The Gambia and Fiji.

Maternal and Fetal Outcomes With Early Neuraxial Engagement in Obese Parturients.

Research indicates the combination of obesity and pregnancy is correlated with increased morbidity, mortality, and healthcare costs. The clinical inquiry of this study was: Does early neuraxial placement in obese parturients decrease the rate of cesarean delivery, decrease use of general anesthesia, and improve fetal Apgar scores? A retrospective analysis of 212 obese parturients with neuraxial anesthesia based on cervical dilation at time of placement and low-intervention delivery was conducted to evaluate the impact of early neuraxial intervention. The study site was a university-affiliated women and children's hospital in the US Midwest. Appropriate statistical analysis tests were performed to compare maternal and fetal outcomes of early, late, and no neuraxial anesthesia. Maternal outcomes included type of delivery, surgical anesthesia, and complications associated with the delivery. Fetal outcomes were Apgar scores and umbilical artery pH. Results of the retrospective analysis showed that early neuraxial placement was associated with a higher incidence of cesarean deliveries, successful conversion of laboring epidural to surgical epidural, avoidance of general anesthesia, potential loss of airway, and death. No significant differences were noted in Apgar scores based on neuraxial anesthesia timing. Further research regarding the risks and benefits of early neuraxial anesthesia in obese parturients is recommended.

Operations research in global health: a scoping review with a focus on the themes of health equity and impact.

BACKGROUND: Operations research (OR) is a discipline that uses advanced analytical methods (e.g. simulation, optimisation, decision analysis) to better understand complex systems and aid in decision-making. Herein, we present a scoping review of the use of OR to analyse issues in global health, with an emphasis on health equity and research impact. A systematic search of five databases was designed to identify relevant published literature. A global overview of 1099 studies highlights the geographic distribution of OR and common OR methods used. From this collection of literature, a narrative description of the use of OR across four main application areas of global health - health systems and operations, clinical medicine, public health and health innovation - is also presented. The theme of health equity is then explored in detail through a subset of 44 studies. Health equity is a critical element of global health that cuts across all four application areas, and is an issue particularly amenable to analysis through OR. Finally, we present seven select cases of OR analyses that have been implemented or have influenced decision-making in global health policy or practice. Based on these cases, we identify three key drivers for success in bridging the gap between OR and global health policy, namely international collaboration with stakeholders, use of contextually appropriate data, and varied communication outlets for research findings. Such cases, however, represent a very small proportion of the literature found. CONCLUSION: Poor availability of representative and quality data, and a lack of collaboration between those who develop OR models and stakeholders in the contexts where OR analyses are intended to serve, were found to be common challenges for effective OR modelling in global health.

Estimating oxygen needs for childhood pneumonia in developing country health systems: a new model for expecting the unexpected.

BACKGROUND: Planning for the reliable and cost-effective supply of a health service commodity such as medical oxygen requires an understanding of the dynamic need or 'demand' for the commodity over time. In developing country health systems, however, collecting longitudinal clinical data for forecasting purposes is very difficult. Furthermore, approaches to estimating demand for supplies based on annual averages can underestimate demand some of the time by missing temporal variability. METHODS: A discrete event simulation model was developed to estimate variable demand for a health service commodity using the important example of medical oxygen for childhood pneumonia. The model is based on five key factors affecting oxygen demand: annual pneumonia admission rate, hypoxaemia prevalence, degree of seasonality, treatment duration, and oxygen flow rate. These parameters were varied over a wide range of values to generate simulation results for different settings. Total oxygen volume, peak patient load, and hours spent above average-based demand estimates were computed for both low and high seasons. FINDINGS: Oxygen demand estimates based on annual average values of demand factors can often severely underestimate actual demand. For scenarios with high hypoxaemia prevalence and degree of seasonality, demand can exceed average levels up to 68% of the time. Even for typical scenarios, demand may exceed three times the average level for several hours per day. Peak patient load is sensitive to hypoxaemia prevalence, whereas time spent at such peak loads is strongly influenced by degree of seasonality. CONCLUSION: A theoretical study is presented whereby a simulation approach to estimating oxygen demand is used to better capture temporal variability compared to standard average-based approaches. This approach provides better grounds for health service planning, including decision-making around technologies for oxygen delivery. Beyond oxygen, this approach is widely applicable to other areas of resource and technology planning in developing country health systems.

Continuous multiorgan variability analysis to track severity of organ failure in critically ill patients.

PURPOSE: The purpose of this study is to evaluate the utility of using continuous heart rate variability (HRV) and respiratory rate variability (RRV) monitoring for (a) tracking daily organ dysfunction in critically ill patients and (b) identifying patterns of variability changes during onset of shock and resolution of respiratory failure. MATERIALS AND METHODS: Thirty-three critically ill patients experiencing respiratory and/or cardiac failure underwent continuous recording of their electrocardiogram and capnogram (CO2) waveforms from admission or intubation until discharge (maximum 14 days). HRV and RRV were computed in 5-minute overlapping windows, using Continuous Individualized Multi-organ Variability Analysis software. Multiple organ dysfunction scores were recorded daily. HRV and RRV trajectories were characterized during onset of shock and resolution of respiratory failure. RESULTS: Both HRV and RRV decreased with increasing severity of multiple organ dysfunction scores for a variety of variability metrics. A decline in several measures of HRV and no decline in RRV were observed before onset of shock (n=6). In contrast, during resolution of respiratory failure, an increase in RRV was observed in patients who successfully passed extubation (n=12), with no change in RRV in those who subsequently failed extubation (n=2). CONCLUSIONS: There is an association between reduced HRV and RRV and increasing organ dysfunction in critically ill patients. The significance of observing trends of decreasing HRV (with onset of shock) and increasing RRV (with resolution of respiratory failure) merits further investigation.

NASN position statement: Sexual orientation and gender identity/expression (sexual minority students): school nurse practice.

It is the position of the National Association of School Nurses that all students, regardless of their sexual orientation or the sexual orientation of their parents and family members, are entitled to a safe school environment and equal opportunities for a high level of academic achievement and school participation/involvement. Sexual minority persons are those who identify themselves as gay, lesbian, or bisexual (LGB) or are unsure of their sexual orientation, or those who have had sexual contact with persons of the same sex or both sexes (Kann et al., 2011). Sexual minority is thought to be a more inclusive and neutral term. For the purposes of this statement, the term sexual minority will be used in lieu of LGBTQ (lesbian, gay, bisexual, transgender, or questioning).

Do health and education agencies in the United States share responsibility for academic achievement and health? A review of 25 years of evidence about the relationship of adolescents' academic achievement and health behaviors.

PURPOSE: The United States Centers for Disease Control and Prevention monitors health-risk behaviors of adolescents in United States, which include (1) violence; (2) tobacco use; (3) alcohol and other drug use; (4) sexual behaviors contributing to unintended pregnancy and sexually transmitted diseases; (5) inadequate physical activity; and (6) unhealthy dietary behaviors. We reviewed original research published in peer-reviewed journals between 1985 and 2010 to synthesize evidence about the association of adolescent health-risk behaviors and academic achievement. METHODS: Using predetermined selection criteria, 122 articles were included that used at least one variable for health-risk behaviors and also for academic achievement. RESULTS: For all six health-risk behaviors, 96.6% of the studies reported statistically significant inverse relationships between health-risk behaviors and academic achievement. CONCLUSIONS: With this persuasive evidence about the interrelationship of health-risk behaviors and academic achievement, it is imperative that leaders in education and health act together to make wise investments in our nation's school-age youth that will benefit the entire population. A unified system that addresses both health behavior and academic achievement would have reciprocal and synergistic effects on the health and academic achievement not only of children and adolescents, but also of adults in the United States.

Impact of sedation and organ failure on continuous heart and respiratory rate variability monitoring in critically ill patients: a pilot study.

OBJECTIVE: Our aim is to better characterize the impact of sedation and its interruption on continuously monitored heart rate variability and respiratory rate variability in critically ill patients. We aim to explore whether sedation reduces heart rate variability and respiratory rate variability in critically ill patients and whether the extent of reduction depends on degree of organ dysfunction. DESIGN: Prospective observational pilot study. SETTING: Intensive care unit in tertiary care teaching hospital. PATIENTS: Thirty-three critically ill adult patients experiencing respiratory and/or cardiac failure. INTERVENTIONS: Electrocardiogram and end-tidal capnography waveform capture were initiated from admission or intubation, respectively, and continued to intensive care unit discharge or a maximum of 14 d. MEASUREMENTS AND MAIN RESULTS: All patient days with a sedation interruption (defined as cessation of a continuous infusion of sedation agent) were identified. Mean heart rate variability and respiratory rate variability were computed over two periods: 4 hrs directly prior to the sedation interruption, and the duration of sedation interruption (median: 1 hr 45 mins, interquartile range: 4 hrs 15 mins or max 4 hrs). Severity of organ dysfunction was assessed through multiple organ dysfunction syndrome scores, and sedative agents were recorded for each sedation interruption. Multiple organ dysfunction syndrome levels were defined as low (0-2), medium (3-4), and high (> 4). Variability before and during sedation interruption was compared and analyzed across multiple organ dysfunction syndrome levels and sedative types. Our results suggest that both heart rate variability and respiratory rate variability increased during sedation interruption (p < 0.05 for coefficient of variation). Patients with low and medium multiple organ dysfunction syndrome experienced greater increase in heart rate variability during sedation interruption (p < 0.05 for coefficient of variation), compared to patients with high multiple organ dysfunction syndrome, who failed to mount a significant increase in heart rate variability when sedation was stopped. Similarly, sedation interruption led to increased respiratory rate variability for low multiple organ dysfunction syndrome patients (p < 0.05 for SD), but in contrast, a further deterioration in respiratory rate variability occurred in the high multiple organ dysfunction syndrome patients. All trends persisted when controlling for sedative agents. CONCLUSIONS: Interruption of sedation allows for uncovering a greater restoration of heart rate variability and respiratory rate variability in patients with low organ failure. The further reduction in respiratory variability during the elimination of sedation in patients with high multiple organ dysfunction syndrome suggests a differential response and benefit from sedation interruption, and merits further investigation. As reduced variability correlates with severity of illness, and need for sedation depends on organ failure, variability monitoring may offer a dynamic measure of a variable response to the benefit, timing, and duration of sedation interruption.

Feasibility of continuous multiorgan variability analysis in the intensive care unit.

PURPOSE: The aim of the study was to evaluate the feasibility of continuous heart and respiratory rate variability (HRV and RRV, respectively) monitoring in critically ill patients derived from electrocardiogram (ECG) and end-tidal capnography (etCO(2)) waveforms. METHODS: Thirty-four patients (age, 56.5 ± 15.9 years; Acute Physiology and Chronic Health Evaluation II score, 22.8 ± 6.7) underwent continuous recording of ECG and etCO(2) waveforms from intensive care unit admission and intubation to discharge or maximum of 14 days. Overlapping 5-minute windows were analyzed with a wide range of variability measures (time, frequency, entropy, and scale-invariant and nonlinear domains). Waveform data quality, presence of disconnections and arrhythmias, quality of beat and breath detection, and subsequent variability computations were evaluated. RESULTS: Patients were enrolled for 11.0 ± 3.6 days. The proportion of missing waveform data among all patients was (median [interquartile range, maximum]) 2.9% (1.3%-9.7%, 36.4%) for ECG and 3.1% (1.1%-11.4%, 84.5%) for etCO(2). Heart rate variability data loss (ie, proportion of windows removed) was 1.3% (1.0%-2.1%, 5.9%) due to disconnection, 0.6% (0.1%-3.9%, 39.5%) due to atrial fibrillation, and 6.6% (1.4%-17.9%, 89.0%) due to data cleaning. Respiratory rate variability data loss was 7.3% (2.9%-11.6%, 47.7%) due to disconnection (or apnea) and 5.5% (2.9%-8.4%, 56.4%) due to cleaning. Continuous individualized multiorgan variability analysis processing resulted in HRV and RRV computations for 81.2% ± 25.0% and 87.5% ± 11.9% of available ECG and etCO(2) waveform data, respectively. CONCLUSIONS: The quality of continuously recorded ECG and etCO(2) waveforms in critically ill patients is adequate for subsequent continuous variability monitoring in this pilot study. The clinical utility of continuous variability analysis merits further investigation.

A correlational study of the relationship between a coordinated school health program and school achievement: a case for school health.

The study was conducted to determine whether there is a relationship between the Coordinated School Health Program (CSHP) and student academic performance. Data were collected from schools and the community for three reports for 50 states and the District of Columbia (DC). The School Health Policies and Programs Survey (SHPPS), the National Assessment of Educational Progress (NAEP), and the U.S. Census 2000 Profile were used to study the relationships among three parameters: (a) The intervention called a CSHP: (b) Student achievement; and (c) Rate of poverty in each state. A stepwise regression analysis was conducted, controlling for poverty using state-level data. Components of a CSHP had statistically significant relationships with academic achievement. Students in states with policies promoting students' health demonstrated higher academic scores and higher rates of high school completion.