A breakthrough mobile phone technology that aids in early detection of COPD
突破性手机技术有助于早期发现慢性阻塞性肺病
基本信息
- 批准号:10760409
- 负责人:
- 金额:$ 29.94万
- 依托单位:
- 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:2023-09-15 至 2024-09-14
- 项目状态:已结题
- 来源:
- 关键词:AcousticsAddressAirAlgorithmsAreaAuscultationBloodCOVID detectionCOVID-19 detectionCardiopulmonaryCellsCellular PhoneChronic Obstructive Pulmonary DiseaseClassificationClinicalCodeDataDevelopmentDevicesDiagnosisDiagnosticDiseaseEFRACEarly DiagnosisEchocardiographyEconomicsEmergency MedicineEvaluationFailureFrequenciesFundingFutureGeographyGoalsGrantHealth Care CostsHeartHospitalsHumanImageInstitutional Review BoardsInternationalLegalLegal patentLogistic RegressionsLungLung CapacityMachine LearningMapsMedicineModelingObservational StudyOffice VisitsOrganOutcomePatient RecruitmentsPatientsPerformancePhasePhysical ExaminationPhysiciansPhysicsPopulationPrimary CarePrimary Care PhysicianProcessProtocols documentationProviderPublishingPulmonary Function Test/Forced Expiratory Volume 1PulmonologyRaceResearchResearch SupportRunningScheduleSensitivity and SpecificitySeriesShapesSideSiteSpecificitySpirometryStethoscopesTalentsTechnologyTelephoneTestingUniversitiesaccurate diagnosisaccurate diagnosticsartificial intelligence algorithmclinical practicecommercial launchcostdemographicsdiagnostic platformdiagnostic strategyhemodynamicshuman errorhuman studyimprovedimproved outcomeinfrastructure developmentinnovationinterestmembermicrophoneneural networknew technologynovelnovel strategiespower analysisrecruitremote gradingrespiratoryscreeningsuccesstechnology developmenttelehealthtext searching
项目摘要
Project Summary / Abstract
COPD is the fourth leading global killer, in part, because of the failure of frontline medicine to
detect the disease. Poor early detection leads to unfavorable outcomes and high healthcare
costs. Tele-stethoscope* or “TS” is novel technology that allows acoustic data captured from
ordinary mobile phones to perform robust analysis of hemodynamics and pneumodynamics.
TS is intended to be used in primary care particularly in Tele-health and before scheduled
physical examination. Its purpose is to alert primary care physicians to the need for physical
examination and possibly referral. In these situations, there are no other comparable testing
options.
TS has three important innovations. First, is a clinical use innovation which brings remote,
impromptu patient evaluation to anyone with a smartphone. Customer discovery has validated
both a workflow and reimbursement strategy consistent with commercial success. Further,
FDA guidance suggests viability of agency clearance. Second is TS’s novel approach to
making AI algorithms. TS uses acoustic data, captured by OEM phone microphones, into
rigorous, physics-based features that describe organ hemodynamics and pneumodynamics.
The features or independent variables are then used to create binary classification models
with logistic regression. By relying on physics, TS never has to use neural networks or
overfitting strategies that have raised concerns about data intensity, model stability, regulatory
transparency and unknown reliability. The third innovation is that, by relying on passive
acoustic data, TS classifies organ function by observing organ dynamics directly rather than
from forced air capacity. TS uses many ideas from physics that were not available until fairly
recently. By relying on dynamics, TS offers a novel approach to forced air that may eventually
be additive to our understanding of respiratory conditions even in PFT labs.
This will be the third large scale human study that demonstrates classification of cardio -
pulmonary functionality. It follows a published study on COVID detection as well as soon to
be published study on the ability of TS to reproduce echocardiogram estimates of ejection
fraction. Analysis of stethoscope recordings suggests that the COPD diagnostic will rely on
a combination of right heart side hemodynamics and low frequency lung pneumodynamics. A
significant body of research is presented which validates the use of mobile phones as an
auscultation device with the ability to detect and diagnosis COPD.
The Aim of this study is to develop, evaluate, and test an algorithm that allows ordinary mobile
phones to detect COPD. Our hypothesis is that TS technology can detect COPD by matching
phone acoustic recordings to diagnosis. Diagnosis will be determined by a physician after
considering gold standard testing. Performance of the models will be evaluated by using
common statistical approaches such as area under the receiver operating curve AUC,
sensitivity, specificity, accuracy. The research will have 3 milestones based on recruitment of
30, 60 and 100 patients respectively.
Our approach is based on recruitment from patients assigned to a hospital PFT lab so that
recordings and gold standard testing are done concurrently. Our team consists of a broad
range of talent including the inventor of TS, pulmonology expertise, the research director of
emergency medicine for the hospital running the tests, statistical expertise, and project
management.
* Tele-stethoscope or "TS" is patent pending technology developed by Fleming Scientific.
项目总结/摘要
COPD是全球第四大杀手,部分原因是一线药物未能
检测疾病。早期检测不佳导致不良结果和高医疗保健
成本远程听诊器 * 或“TS”是一种新颖的技术,
普通的移动的电话来执行血液动力学和气动力学的稳健分析。
TS旨在用于初级保健,特别是远程医疗和计划前
体检其目的是提醒初级保健医生需要进行身体检查,
检查和可能的转介。在这些情况下,没有其他可比较的测试
选项.
它有三个重要的创新。首先,是一种临床应用创新,
给任何一个有智能手机的人进行即兴的病人评估。客户发现已验证
工作流程和报销策略都与商业成功相一致。此外,本发明还
FDA指南表明机构许可的可行性。第二是TS的新方法,
做人工智能算法TS使用OEM电话麦克风捕获的声学数据,
描述器官血流动力学和血液动力学的严格的、基于物理学的特征。
然后使用特征或自变量来创建二元分类模型
Logistic回归。通过依赖物理学,TS永远不必使用神经网络或
过度拟合策略引发了对数据强度、模型稳定性、监管
透明度和未知的可靠性。第三个创新是,依靠被动
声学数据,TS通过直接观察器官动力学而不是
强制通风能力。TS使用了许多物理学上的想法,这些想法直到公平竞争时才出现。
最近通过依靠动力学,TS提供了一种新的强制通风方法,最终可能
有助于我们了解呼吸系统疾病,即使是在PFT实验室。
这将是第三次大规模的人类研究,证明心脏病的分类,
肺功能它遵循了一项关于COVID检测的已发表研究,
已发表的关于TS再现射血超声心动图估计值的能力的研究
分数听诊器记录的分析表明,COPD诊断将依赖于
右心侧血流动力学和低频肺血流动力学的组合。一
提出了一个重要的研究机构,它验证了使用移动的电话作为一种
具有检测和诊断COPD能力的听诊设备。
本研究的目的是开发,评估和测试一种算法,允许普通的移动的
手机检测COPD我们的假设是,TS技术可以通过匹配检测COPD
通过电话录音进行诊断诊断将由医生在
黄金标准测试模型的性能将通过使用
常用的统计方法如受试者工作曲线下面积AUC,
灵敏度、特异性、准确性。该研究将有3个里程碑,基于招募
分别为30、60和100例患者。
我们的方法是基于从分配到医院PFT实验室的患者中招募,
记录和金标准测试同时进行。我们的团队由广泛的
一系列的人才,包括TS的发明者,肺病学专业知识,
急诊医学的医院运行的测试,统计专业知识,和项目
管理
* 远程听诊器或“TS”是专利申请技术开发的弗莱明科学。
项目成果
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