Diagnosis of two of the most common ear diseases in children may someday rely less on specialized medical equipment and more on widely used modern technology available to more providers and patients, particularly in resource-limited communities.
Investigators at the University of Washington recently published a study showing the feasibility of using smartphones to detect middle ear fluid in children with suspected acute otitis media and acute otitis media with effusion.
The study also included data from a clinical study of more than 98 patient ears testing the sensitivity and specificity of smartphone use in this setting, which demonstrated a diagnostic potential of smartphones comparable to and even better than the traditional diagnostic tools of pneumatic otoscopy or tympanometry.
“In the future, being able to perform diagnostic tests using technology that is readily available could increase the availability of healthcare in resource-limited regions and decrease the cost of healthcare if we can avoid emergency room visits and patients do some initial triage at home,” said study coauthor Sharat C. Raju, MD, a resident with the department of otolaryngology–head and neck surgery at the University of Washington in Seattle.
How It Works
With an array of sensors that includes microphones and speakers, smartphones have the technological components needed to assess tympanic membrane mobility to detect middle ear fluid. Using these two basic components of smartphones, the investigators improved on the technology by using machine learning methods to include additional data processing and signal processing systems to improve on the accuracy of older diagnostic techniques (pneumatic otoscopy or tympanometry).
“What happens is that the microphone [from the smartphone] picks up essentially the reflections of sound of the ear drum similar to tympanometry,” said Dr. Raju. Instead of calculating the angle of the wave form produced using the older data processing system used with tympanometry, which is very regimented and uses strict and fairly arbitrary cutoffs for what constitutes fluid and what does not, Dr. Raju said that the machine learning used with the smartphones informed what the different shapes of the curves meant based on real patients.
The investigators tested the system in two separate cohorts of patients, all of whom underwent otolaryngologic surgery. The first clinical study included patients aged 18 months to 17 years (n = 98 ears), and the second clinical study included children between nine and 18 months of age (n = 15 ears). Patients with existing tympanostomy tubes, those with tympanic membrane perforations, those who had undergone previous tympanoplasty, or those with comorbid middle ear diseases were not included in either cohort.
When used by trained clinicians, the study found an 85% sensitivity and 82% specificity with the use of this smartphone technology and augmented machine learning system.
“The nice thing about this study is that it was done primarily in surgical patients, specifically in children getting ear tubes,” said Dr. Raju, adding that they tested the smartphone technology in these patients because a definitive diagnosis of fluid behind the tympanic membrane can be made after surgical placement of ear tubes.
When they compared the smartphone technology system with the older medical equipment and systems used for diagnosis of tympanic membrane diseases, the investigators found significantly improved performance values with the smartphone technology using modern machine learning techniques.
High Diagnostic Performance Across Platforms and Practitioners
The study also found that the high sensitivity and specificity found with the smartphone technology were similar across various mobile platforms. The first clinical study included the use of both the iPhone 5s and Samsung Galaxy S6. Other mobile technologies tested in a subset of patients with similar performance outcomes included iPhone 6s and Galaxy S7.
The study also included assessment of performance when used by parents in the clinical setting. After a brief demonstration of how to use the technology by a trained clinician, parents of patients (n = 25 ears) using the technology achieved comparable results to those of the trained clinician.
Dr. Raju emphasized that the main role of this technology as he envisions it is to put it in the hands of providers and parents for whom the older, more costly technologies are not accessible or available. “I think pneumatic otoscopy or tympanometry still have critical roles in a physician office, but in places where providers don’t have access to those techniques or in situations where a patient at home can track fluid over time, this is where this technology comes in handy,” he said.
Going forward, he emphasized the need for additional testing at different sites and suggested also using the system in a fresh cohort of patients.