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

• 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
• 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

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 创新、廉价的多模式数字听诊器能够同时自动发出肺音和 呼吸率分析，以及移动电话与电子健康(EHealth)DHIS2平台的互操作性 用于LMICs(R21期间)的实时LRI和抗生素监测，然后对多模式进行评估 数字听诊器和电子健康系统使用单独随机对照试验(R33期)。这个 下呼吸道感染肺炎是全球儿童死亡的主要感染性原因 在撒哈拉以南非洲，但适用于低收入者的适当、准确和用户友好的LRI诊断 中等收入国家(LMIC)严重匮乏。这会导致误诊和死亡，以及 不适当的抗生素使用，导致全球抗生素耐药率总体上升。 我们的目标是开发、验证和严格评估创新、廉价的多 能够同时自动分析肺音和呼吸频率的模式数字听诊器，以及 移动电话与电子健康(EHealth)DHIS2平台的互操作性，以实现实时LRI和抗生素 LMIC中的监控。我们假设多模式数字听诊器将满足预先指定的 性能基准及其在eHealth平台中的实施将解决关键的LRI 诊断实施结果。为了实现我们的总体项目目标，我们将建立在 我们在七个LMIC上进行了十年的多学科数字听诊器研发，我们的 以前使用以人为中心的设计(HCD)策略开发成功的LMIC脉搏血氧计设备， 和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， 绝大多数非严重的LRIS根本不需要抗生素。在两年的R21期间，我们将申请 以人为中心的设计方法开发多模式数字听诊器和eHealth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，范围为 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 DHIS2系统在各种设施(Khayelitsha医院和两个初级保健诊所)上运行，这些设施为 在南非开普敦的一个小镇，进行一项个人随机对照试验，以评估其正确性 LRI诊断“作为主要成果(目标2)，以及次要实施成果。 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 价格实惠、可持续互操作的LRI和抗生素使用具有高级诊断功能的eHealth系统 技术适用于LMICs，那里发生了大多数LRIS造成的儿科死亡。