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Clinical trial assessing the use of optical coherence tomography in decision making for children presenting with
Joseph E Kerschner1, Roger A Daley1, Roxanne Link1
1Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, WI, USA.
Insights
Optical coherence tomography (OCT) improved diagnosis and treatment for children with suspected acute otitis media (AOM). OCT enhanced clinical decisions, particularly for middle ear effusion (MEE) cases not initially diagnosed as AOM.
Area of Science:
- Otolaryngology
- Medical Imaging
- Pediatric Primary Care
Background:
- Acute otitis media (AOM) is a common childhood illness.
- Accurate diagnosis of AOM can be challenging in primary care settings.
- Pneumatic otoscopy (PO) is the standard diagnostic tool, but its effectiveness can be limited.
Purpose of the Study:
- To evaluate the utility of optical coherence tomography (OCT) in assisting primary care providers (PCPs) with AOM diagnosis and treatment.
- To determine if OCT improves diagnostic accuracy and clinical decision-making in pediatric patients presenting with ear symptoms.
Main Methods:
- A clinical trial involving 75 children aged 1-7 years presenting with ear pain or suspected ear infection.
- Initial diagnosis and treatment plan based on history, physical exam, and PO.
- OCT imaging performed subsequently, with reassessment of diagnosis and treatment plan.
Main Results:
- The diagnosis and/or treatment plan changed for 15.3% of patients after OCT use compared to PO alone.
- OCT had the greatest impact in patients with middle ear effusion (MEE) without AOM, altering the diagnosis/treatment in 36% of cases.
- OCT provided enhanced visualization of the tympanic membrane and middle ear structures.
Conclusions:
- Optical coherence tomography (OCT) serves as a valuable adjunct for PCPs in diagnosing middle ear conditions.
- OCT enhances visualization, leading to improved clinical decision-making, especially for ambiguous cases like MEE without AOM.
Objective:
To identify the ability of optical coherence tomography (OCT) to assist in the diagnosis and treatment of patients presenting to a primary care provider with signs and symptoms suggesting acute otitis media (AOM).
Design-Setting-Participants:
An NIH-funded clinical trial was conducted and enrolled 75 children between 1 and under 7 years of age. Children presented with complaints of ear pain or suspected ear infection from their caregiver history to primary care clinics associated with an academic children's hospital. These patients upon presentation were eligible to enroll in the trial. Following a complete history and physical exam, including pneumatic otoscopy (PO), patients were provided with a diagnosis and treatment plan. Diagnoses included: AOM, middle ear effusion without AOM, or no evidence of otitis media with a clear middle ear space. Following this, OCT was performed, and the diagnosis and treatment plan was reassessed using this data.
Results:
The diagnosis and/or treatment plan changed for 15.3 % of patients following the use of OCT compared with the initial use of PO. The greatest influence was seen in the patient group with MEE without AOM, with 36 % (5/14) of these patients having their diagnosis and/or treatment plan changed after OCT was employed.
Conclusions:
OCT provides an additional adjunct for primary care providers to enhance visualization of the tympanic membrane and middle ear space. This data, in our clinical trial, resulted in enhanced clinical decision making, in particular for patients with MEE who were not diagnosed with AOM on PO.
Trial Registration Information:
Coherent Optical Detection of Middle Ear Disease (OCTII).
Clinicaltrials:
gov ID number: NCT05353569.
