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

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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
2R42HL131081-02
Application #
9680749
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Evans, Frank
Project Start
2016-09-06
Project End
2021-03-31
Budget Start
2019-04-01
Budget End
2020-03-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Auscultech Dx, LLC
Department
Type
DUNS #
079727453
City
Dayton
State
MD
Country
United States
Zip Code
21036