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.

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.

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.

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.