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

在南非开发和实施儿科人工智能多模态数字听诊器和呼吸监测系统

基本信息

批准号：
10740943
负责人：
Eric Douglass McCollum
金额：
$ 36.77万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-07 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10740943
关键词：
5 year old Accident and Emergency department Address Africa Africa South of the Sahara Algorithms Antibiotic Resistance Antibiotic Therapy Antibiotics Antimicrobial Resistance Auscultation Award Benchmarking Breathing Caregivers Caring Cause of Death Cellular Phone Cessation of life Chest Child Childhood Clinic Clinical Community Health Country Crackles Development Device or Instrument Development Devices Diagnosis Diagnostic Disease Enrollment Etiology Evaluation Exclusion FDA approved Goals Guidelines Health Health Personnel Hospitals Impact evaluation Income Individual Interdisciplinary Study Interobserver Variability Intervention Interview Laboratories Language Learning Low income Lower Respiratory Tract Infection Lung Malawi Manuals Maps Methods Monitor Morphologic artifacts Noise Outcome Performance Physicians Physiologic pulse Pneumonia Population Process Questionnaires Randomized, Controlled Trials Research Resistance to infection Resources Respiratory Disease Respiratory Sounds Risk Rural Community South Africa South African Specific qualifier value Specificity Standardization Stethoscopes System Time Training United States National Institutes of Health Viral Bronchiolitis Wheezing adjudication behavior change behavioral construct diagnostic accuracy diagnostic algorithm diagnostic technologies digital eHealth electronic health system experience field study fighting human centered design implementation evaluation implementation outcomes improved improved outcome innovation interoperability low and middle-income countries mortality multidisciplinary multimodality pediatrician primary care clinic primary outcome process evaluation prospective randomized trial repository research and development respiratory scale up sound sound frequency stem success theories tool transmission process user-friendly

项目摘要

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.

项目摘要：这是美国国立卫生研究院R21/R33奖的提交，旨在开发和验证具有创新的，廉价的多模式数字听诊器，能够同时自动化肺部声音和呼吸率分析和电子健康（EHEALTH）DHIS2平台的手机互操作性在LMIC（R21时期）中进行实时LRI和抗生素监测，然后评估多模式使用单独随机对照试验（R33时期）的数字听诊器和eHealth系统。这下呼吸道感染（LRI）肺炎是全球儿童的主要感染原因在撒哈拉以南非洲，但适当，准确且用户友好的LRI诊断诊断适合低收入和中等收入国家（LMIC）严重缺乏。这导致误诊和死亡以及不适当的抗生素使用会导致全球抗生素耐药率总体上升。我们旨在开发，验证和严格评估创新，廉价的多种多样的实施模态数字听诊器，能够同时自动化肺部声音和呼吸率分析，并且带有电子健康（EHEATH）DHIS2实时LRI和抗生素平台的手机互操作性 LMIC的监视。我们假设多模式数字听诊器将符合预先指定的性能基准及其在eHealth平台中的实施将解决关键LRI 诊断实施结果。为了实现我们的整体项目目标，我们将基于几乎我们七个LMIC的多学科数字听诊器研发的十年，我们使用人类中心设计（HCD）策略，以前成功的LMIC脉搏血氧仪装置开发以及我们最近在马拉维抗生素治疗的随机对照试验的证据，这表明绝大多数非重生LRI根本不需要抗生素。在两年的R21期间，我们将申请人类以人为中心的设计方法来开发多模式数字听诊器和eHealth系统（AIM 1）。该设备将在具有各种临床环境中测试的声音实验室和现场进行验证南非开普敦的从业者。然后，我们将实施多模式数字听诊器和多种设施的DHIS2系统（Khayelitsha医院和两个初级保健诊所），可为大型服务南非开普敦的乡镇，并进行单独的随机对照试验，以评估“正确 LRI诊断为主要结果（AIM 2）以及次要实施结果。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负担得起，可持续的可互操作LRI和抗生素使用EHealth系统具有先进的诊断技术上适合LMIC的技术，大多数LRI的儿科死亡发生。