Development and implementation of a pediatric AI multi-modal digital stethoscope and respiratory surveillance system in South Africa

项目概要： 这是美国国立卫生研究院R21/R33奖的提交材料，旨在开发和验证 创新的、廉价的多模式数字听诊器，能够同时自动肺音， 呼吸频率分析，以及移动的电话与电子健康（eHealth）DHIS 2平台的互操作性 用于LMIC的实时LRI和抗生素监测（R21期），然后评估多模式 数字听诊器和电子健康系统，使用单独随机对照试验（R33期）。的 下呼吸道感染（LRI）肺炎是全球儿童死亡的主要传染性原因 在撒哈拉以南非洲，适当、准确和用户友好的LRI诊断适合低收入人群， 中等收入国家（LMICs）则严重缺乏。这导致误诊和死亡，以及 抗生素使用不当导致全球抗生素耐药性总体上升。 我们的目标是开发，验证和严格评估一个创新的，廉价的多功能， 能够同时进行自动肺音和呼吸率分析的模态数字听诊器，以及 移动的电话与电子健康（eHealth）DHIS 2平台的互操作性，用于实时LRI和抗生素 在中低收入国家进行监视。我们假设多模态数字听诊器将满足预先规定的 绩效基准及其在电子健康平台内的实施将解决关键的LRI问题 诊断实施结果。为了实现我们的整体项目目标，我们将建立在近一个 我们在七个LMICs进行了十年的多学科数字听诊器研究和开发，我们的 先前使用以人为中心的设计（HCD）策略的成功的LMIC脉搏血氧计设备开发， 我们最近在马拉维进行的抗生素治疗随机对照试验的证据表明， 绝大多数非严重LRI根本不需要抗生素。在两年的R21期间，我们将申请 以人为本的设计方法来开发多模态数字听诊器和电子健康系统（Aim 1）。该设备将在声音实验室进行验证，并在各种临床环境中进行现场测试， 南非开普敦的一名医生。然后，我们将实施多模态数字听诊器， DHIS 2系统在各种设施（Khayelitsha医院和两个初级保健诊所），服务于大型 在南非开普敦的一个小镇，并进行一个单独的随机对照试验，以评估“正确的 LRI诊断作为主要结局（目标2），以及次要实施结局。 成功完成本申请中描述的研究可能会导致更广泛的规模扩大， 经济实惠、可持续的可互操作LRI和抗生素使用电子健康系统，具有先进的诊断功能 LRIs的儿童死亡率最高的地方。

PROJECT SUMMARY: This is a submission for a National Institutes of Health R21/R33 award aiming to develop and validate an innovative, inexpensive multi-modal digital stethoscope capable of simultaneous automated lung sound and respiratory rate analysis, and mobile phone interoperability with an electronic health (eHealth) DHIS2 platform for real-time LRI and antibiotic surveillance in LMICs (R21 period), and then evaluation of the multi-modal digital stethoscope and eHealth system using an individually randomized controlled trial (R33 period). The lower respiratory infection (LRI) pneumonia is the leading infectious cause of death among children globally and in sub-Saharan Africa, but appropriate, accurate and user-friendly LRI diagnostics suitable for low-income and middle-income countries (LMICs) are severely lacking. This results in misdiagnosis and death, as well as inappropriate antibiotic use that contribute to overall rising antibiotic resistance rates globally. We aim to develop, validate, and rigorously evaluate the implementation of an innovative, inexpensive multi- modal digital stethoscope capable of simultaneous automated lung sound and respiratory rate analysis, and mobile phone interoperability with an electronic health (eHealth) DHIS2 platform for real-time LRI and antibiotic surveillance in LMICs. We hypothesize that a multi-modal digital stethoscope will meet pre-specified performance benchmarks and its implementation within an eHealth platform will address key LRI diagnosis implementation outcomes. To accomplish our overall project goal we will build upon nearly a decade of our multi-disciplinary digital stethoscope research and development across seven LMICs, our previous successful LMIC pulse oximeter device development using a human centered design (HCD) strategy, and evidence from our recent randomized controlled trial of antibiotic treatment in Malawi that suggested the vast majority of non-severe LRIs did not require antibiotics at all. During the two-year R21 period we will apply the human centered design approach to develop a multi-modal digital stethoscope and eHealth system (Aim 1). The device will be validated in a sound laboratory and field tested in various clinical settings with a range of practitioners in Cape Town, South Africa. We will then implement the multimodal digital stethoscope and DHIS2 system at a variety of facilities (Khayelitsha Hospital, and two primary care clinics) that serve a large township in Cape Town, South Africa and conduct an individual randomized controlled trial to evaluate `correct LRI diagnosis' as the primary outcome (Aim 2), as well as secondary implementation outcomes. Successful completion of the research described in this application could lead to broader scale-up of an affordable, sustainable interoperable LRI and antibiotic use eHealth system with advanced diagnostic technology contextually appropriate for LMICs, where most pediatric deaths from LRIs occur.