Using a smartphone app to record and assess coughs for respiratory illnesses in children in the organized chaos of emergency room settings was never going to be easy. But when the results of a double-blind clinical study to evaluate efficacy at three sites earlier this year had to be thrown out because of poor data, ResApp was forced back to the drawing board.
CEO Tony Keating and his team developed a revised clinical trial design that sought to provide clearer instructions for data collectors, particularly with an eye to getting the best recording possible. So far, ResApp has received institutional review board approval for its Smartcough-C-2 study from Massachusetts General Hospital and Texas Medical Center. The company is just waiting on Cleveland Clinic. Once it has that IRB, recruitment will begin by emergency room and urgent care doctors for 1,000 patients aged 29 days old to 12 years old who present with signs or symptoms of respiratory disease to ER and urgent care doctors at one of the three participating sites.
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Keating shared some of the lessons learned from the first trial in a Skype interview from Brisbane, Australia.
“I don’t think anyone has really tried to do this before,” Keating observed. “It is definitely a challenging environment…We have learned a lot of lessons.”
The co-primary endpoints for the study are positive and negative percent agreement with clinical diagnosis for pneumonia, lower respiratory tract disease, viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease and croup, according to a company news release. The clinical diagnosis will be made by an independent, centralized clinical adjudication committee using all available clinical data, including radiology and microbiology.
The app is designed to distinguish between asthma, pneumonia, pediatric reactive airways disease, croup, and upper respiratory tract infection. The study will evaluate its effectiveness in ER and urgent care settings.
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One of the biggest problems with the previous study was that when the patient was instructed to cough, someone else frequently coughed in the background, making it impossible for the app to distinguish the patient from a family member or another member of the care team. Data collectors were instructed to re-record patients when someone else starts coughing.
Emergency rooms are frequently a hive of activity so that added to the complexity of isolating the sound of a patient’s cough. Although separate rooms could be used for these patients, someone would frequently turn on the TV as they waited for the child to be assessed, making it impossible for the app to record a cough clearly. So TVs need to be off before cough recording begins.
Keating was thrilled with the principal investigators at the sites who have been able to turn around a restart of the study in four months.
“It was very key to us to develop a strong relationship with ER doctors because they are the gateway to the patients. At the beginning of the shift, data collectors would go to them and get them to understand what we need. Getting them to understand why the trial is important and the potential of the technology…really made a difference.”
If the trials go according to plan this time, Keating said it will resubmit an application for FDA clearance.
Photo: flytosky11, Getty Images
