SBIR-STTR Award

The overall goal of the proposed research and technology transfer effort is to develop a low-cost, point-of-care, mobile device-based technology for automated identification of Still's murmur, the most common innocent (benign and harmless) heart murmur of childhood. This novel technology could reduce the current rate of over a million children unnecessarily referred to pediatric cardiologists by general physicians each year in the United States. Investigators from Auscultech Dx, a startup company, and Children's National Medical Center will collaborate to begin converting the academic, patent-pending research into a commercial product through this STTR initiative. The three specific aims of the project are to (1) refine and test thoroughly the algorithm for identifying Still's murmur, (2) improve and test smartphone stethoscope, and (3) integrate hardware and software components to develop a fully integrated prototype. These aims will lead to the development of a fully integrated prototype that records and discriminates pediatric heart murmurs in this Phase I feasibility study. In Phase II, we will continue with prototype improvements and conduct a clinical trial with general physicians, and pursue regulatory and marketing approvals. The successful completion of this feasibility study in Phase I and subsequent clinical testing in Phase II will result in a validated device for identifying Still's murmur in an office setting. Significant reduction in the number of unnecessary referrals will save the healthcare system hundreds of millions of dollars annually; allow pediatric cardiologists to focus on patients with serious conditions; and save children and families from the unnecessary anxiety, inconvenience, and expense of seeing a cardiologist.

Public Health Relevance Statement:
PROJECT NARRATIVE Over a million children are referred to pediatric cardiologists by general physicians for the evaluation of Still's murmur, a normal and harmless heart murmur. This project will develop a novel mobile technology for automated recognition of this murmur and reducing the current rate of such unnecessary referrals.

Project Terms:
Algorithms; analog; Anxiety; Archives; base; Benign; Cellular Phone; Characteristics; Child; Childhood; Clinical; clinical Diagnosis; Clinical Trials; Computer software; computerized; Congenital Heart Defects; Consultations; cost; design; Development; Devices; Diagnosis; digital; Electronics; Emotional; Evaluation; Family; Feasibility Studies; Goals; handheld mobile device; Healthcare; Healthcare Systems; Hearing; Heart; Heart Diseases; Heart murmur; Heart Sounds; improved; Incidence; Institution; Lead; Legal patent; Marketing; Medical center; meetings; Methods; mobile computing; new technology; novel; Patients; Pattern; pediatric cardiologist; pediatrician; Performance; Phase; Physicians; point of care; Population; Primary Care Physician; prototype; Records; Research; research clinical testing; Research Personnel; Resources; signal processing; Small Business Technology Transfer Research; Stethoscopes; Technology; Technology Transfer; Testing; United States; wasting

The overall goal of the proposed research and technology transfer effort is to develop a low-cost, point-of-care, mobile device-based technology for automated identification of Still's murmur, the most common innocent (benign and harmless) heart murmur of childhood. This novel technology could reduce the current rate of over half a million children unnecessarily referred to pediatric cardiologists by primary care providers each year in the United States. In Phase I, AusculTech Dx and Children's National Medical Center developed a machine-learning algorithm capable of identifying Still's murmur with high accuracy (90% sensitivity, 99% specificity). To enable digital recording, essential for computerized murmur analysis, we also developed a digital stethoscope that connects to a smartphone and is equivalent in performance to a commercial stethoscope. Our envisioned product, called StethAid, is a combination of this novel digital stethoscope and a smartphone application (app). Having successfully met the Phase I performance milestones, we now propose to fully develop StethAid and conduct a multicenter trial through the following three specific aims: (1) develop and test a clinical-grade digital stethoscope, (2) develop fully feature software app, (3) conduct a multicenter trial of automated Still's murmur identification. For the multicenter trial, we have expanded our collaboration to include Boston Children's Hospital and Walter Reed National Military Medical Center. Our deliverable for Phase II is a technology platform validated by leading pediatric cardiologists that is ready for seeking regulatory approvals, deployment at PCP offices, and commercialization. As a decision support system, StethAid could empower PCPs to identify Still's murmur accurately and thus reduce the huge number of unnecessary specialist referrals. This should save the healthcare system hundreds of millions of dollars annually, allow pediatric cardiologists to focus on patients with serious conditions, and protect healthy children and their families from the unnecessary anxiety, inconvenience, and expense of seeing a pediatric cardiologist.

Public Health Relevance Statement:
PROJECT NARRATIVE Over half a million children are referred unnecessarily to pediatric cardiologists by general physicians for the evaluation of Still's murmur, a normal and harmless heart murmur. This project will develop and clinically validate a novel mobile technology for automated recognition of this murmur in order to reduce the current rate of such unnecessary referrals and associated costs and inconvenience.

Project Terms:
Algorithms; Anxiety; Apple; base; Benign; Bluetooth; Boston; care providers; Cellular Phone; Characteristics; Child; Childhood; Classification; classification algorithm; Clinical; cloud based; Collaborations; commercialization; Computer software; computerized; Congenital Heart Defects; Consultations; cost; Data; Decision Support Systems; design; Devices; Diagnosis; digital; Emotional; Evaluation; Exhibits; Family; Future; Goals; handheld mobile device; Healthcare; Healthcare Systems; Hearing; Heart Diseases; Heart murmur; Heart Sounds; improved; Incidence; Legal patent; Libraries; machine learning algorithm; Medical center; Military Personnel; mobile computing; Modeling; Multicenter Trials; new technology; novel; off-patent; Patients; Pattern; pediatric cardiologist; Pediatric Hospitals; Performance; performance tests; Phase; Physicians; point of care; Population; prototype; Research; Resources; Sample Size; Small Business Technology Transfer Research; smartphone Application; sound; Specialist; Specificity; Stethoscopes; Technology; Technology Transfer; Testing; tool; Training; United States; Validation; wasting; web interface; Wireless Technology; Work