SBIR-STTR Award

An automated system to differentiate Kawasaki disease from febrile illness with real life clinical datasets in New York City
Award last edited on: 2/26/2023

Sponsored Program
STTR
Awarding Agency
NIH : NCATS
Total Award Amount
$345,852
Award Phase
1
Solicitation Topic Code
350
Principal Investigator
James Schilling

Company Information

HBI Solutions Inc

3000 El Camino Real Bldg 4 Suite 200
Palo Alto, CA 94306
   (650) 285-2404
   info@hbisolutions.com
   www.hbisolutions.com

Research Institution

Stanford University

Phase I

Contract Number: 1R41TR004351-01
Start Date: 9/1/2022    Completed: 8/31/2023
Phase I year
2022
Phase I Amount
$345,852
Kawasaki disease (KD) is the most common cause of acquired heart disease in children. Treatment with intravenous immunoglobulin (IVIG) reduces the incidence of coronary aneuryms and risk of long-term cardiovascular complications. IVIG is recommended to be given within 10 days of illness; however only 4.7% receive the correct diagnosis at the first medical visit. Timely and accurately diagnosis of KD is critical, yet there isn't a gold standard diagnostic test. A challenge of diagnosis is that the clinical signs of KD overlap those of other pediatric febrile illnesses. We previously applied statistical learning using clinical and laboratory test variables to differentiate KD from febrile illnesses and validated the algorithm in five children's hospitals in the US. Results showed its potential of being a computer-assist tool of decision making at point of care in the settings where echocardiography would not be readily available. Before translation and commercialization, the algorithm needs to be validated in a large, diverse population and integrated into a patient surveillance platform as a real-time screening tool for healthcare providers to use. In this project, we propose three specific aims to address the central hypothesis that a KD screening tool incorporating our previously identified and newly found patient-level variables in the electronic health record (EHR) can differentiate KD from clinically similar febrile illnesses in an ethnically diverse pediatric population in New York City (NYC). We will collaborate with Healthix, the nation's largest public health information exchange (HIE) with data of over 16 million patients from NYC. In Aim 1, we will set up a pediatric EHR warehouse of patients with KD and other febrile illnesses from Healthix NYC data sources. In Aim 2, we will identify features that are differentially expressed between patients with KD and patients with other febrile illnesses, and develop an improved algorithm to differentiate KD from other febrile illnesses. Finally, we will integrate the algorithm into the HBI Spotlight Solutions. The Spotlight Solutions include a healthcare surveillance platform with high-capacity data infrastructure and risk engines to offer AI solutions to providers. We expect ultimately an HIE-based pediatric KD assessment system will be ready to alert HIE participating providers for timely evaluation, treatment and follow up for the long-term cardiovascular sequelae in NYC and other communities.

Public Health Relevance Statement:
Accomplishing the proposed project shall contribute to addressing the problem of delayed diagnosis of Kawasaki disease (KD). This rapid, low-cost KD screening system is expected to assist clinical decision-making and enable timely evaluation and actionable treatment for patients' better health outcomes in medical facilities. The results will also add to the knowledge of clinical patterns associated with patients of different racial and ethnic groups.

Project Terms:

Phase II

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