Development and implementation of pediatric mobile phone reflectance pulse oximeters and a hypoxemia surveillance system in South Africa

项目总结： 这是一份美国国立卫生研究院R21/R33奖项的申请书，旨在开发和验证 适合环境、价格低廉的基于移动电话的儿科反射式脉搏血氧仪，兼容 可互操作的低氧血症监测系统(R21期间)，然后评估现场执行情况 手机反射式脉搏血氧仪和低氧血症电子健康系统使用集群，随机 对照试验(R33期)。下呼吸道感染(LRIS)是导致死亡的主要传染病原因 在全球范围内，在低收入和中等收入国家(LMIC)的五岁以下儿童中。 低氧血症是一种低氧饱和度的血红蛋白，是LRI死亡风险升高的关键指标。脉搏血氧仪 是否是非侵入性测量外周血氧饱和度(SpO2)以识别 低氧血症，但在儿童LMICs中并不广泛使用，特别是在初级保健诊所 儿童优先获得照顾。尽管氧气可能是治疗低氧性心肌梗死的一种救命方法，但健康 LMIC中的系统没有完善的氧气系统来适当地匹配供需，以 使儿童受益最大。 我们的目标是开发、验证和严格评估创新、廉价的 基于移动电话的反射式脉搏血氧仪，嵌入电子健康DHIS2平台，用于实时- 儿童低氧血症的时间、诊断和监测。我们假设脉搏血氧仪 绩效将是有效的，其在DHIS2电子健康平台内的实施将解决关键问题 改进儿科的概念框架和变革理论构建中的实施终点 LMICs的下呼吸道感染死亡率。为了实现我们的总体项目目标，我们将在之前成功的儿科基础上再接再厉 脉搏血氧仪在撒哈拉以南非洲和南亚的开发工作使用创新的多学科 产品开发过程称为以人为本的设计。在为期两年的R21期间，我们将应用 基于手机的反射式脉搏血氧仪和eHealth的人性化设计 系统(目标1)。该装置将在气压式实验室中进行验证，并在各种临床试验中进行现场测试 与南非开普敦的一系列从业者建立联系。然后我们将实施脉搏血氧仪 和DHIS2系统在南非开普敦的一个大乡镇内进行分组，随机 将对照试验作为主要结果(目标2)以及次要结果来评估执行情况的忠实性 实施结果的可接受性和可行性。 成功完成本申请中描述的研究可能会导致更广泛的纵向扩展 经济实惠、可持续的可互操作低氧血症eHealth系统，配备先进但可访问的手机 技术适用于LMICs，大多数儿童死于低氧性LRIS的地方。

PROJECT SUMMARY: This is a submission for a National Institutes of Health R21/R33 award aiming to develop and validate a context-appropriate, inexpensive mobile phone-based pediatric reflectance pulse oximeter compatible with an interoperable hypoxemia surveillance system (R21 period), and then to evaluate the field implementation of a mobile phone reflectance pulse oximeter and hypoxemia eHealth system using a cluster, randomized controlled trial (R33 period). Lower respiratory infections (LRIs) are the leading infectious cause of death globally among children below five years of age in low-income and middle-income countries (LMICs). Hypoxemia, a low oxyhemoglobin saturation, is a key indicator of elevated LRI mortality risk. Pulse oximeters are devices that non-invasively measure the peripheral oxyhemoglobin saturation (SpO2) to identify hypoxemia, but are not widely available in LMICs for children, especially at primary healthcare clinics where children first access care. Although oxygen is potentially a life-saving treatment for hypoxemic LRIs, health systems in LMICs do not have well established oxygen systems to appropriately match supply with demand to optimally benefit children. We aim to develop, validate, and rigorously evaluate the implementation of an innovative, inexpensive mobile phone-based reflectance pulse oximeter, embedded within an electronic health DHIS2 platform for real- time hypoxemia diagnosis and surveillance of children in LMICs. We hypothesize that the pulse oximeter's performance will be valid and that its implementation within a DHIS2 electronic health platform will address key implementation endpoints in a conceptual framework and theory of change construct for improving pediatric LRI mortality in LMICs. To accomplish our overall project goal we will build upon our prior successful pediatric pulse oximeter development work in sub-Saharan Africa and South Asia using an innovative, multidisciplinary product development process called human centered design. During the two-year R21 period we will apply the human centered design approach to develop a mobile phone-based reflectance pulse oximeter and eHealth system (Aim 1). The device will be validated in a breath-down laboratory and field tested in various clinical settings with a range of practitioners in Cape Town, South Africa. We will then implement the pulse oximeter and DHIS2 system within a large township in Cape Town, South Africa and conduct a cluster, randomized controlled trial to evaluate implementation fidelity as the primary outcome (Aim 2), as well as secondary outcomes of implementation acceptability and feasibility. Successful completion of the research described in this application could lead to broader scale-up of an affordable, sustainable interoperable hypoxemia eHealth system with advanced but accessible mobile phone technology contextually appropriate for LMICs, where most pediatric deaths from hypoxemic LRIs occur.