International journal of pediatric otorhinolaryngology · 2025
Clinical utility of an optical coherence tomography middle ear scope: Interim results of the modification of antibiotic treatment intervention in children (OTO-MATIC) pragmatic cluster randomized controlled trial (RCT).
СтатьяМногоцентровое исследованиеРандомизированное исследованиеPragmatic Clinical TrialНазвание и аннотация: Перевод пока не подготовлен
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Zambelli-Weiner April, Nathanson Brian H, Calcagno Frank, Ansley John, Vattana Karina, Burnette-Vick Bonnie
Аннотация
OBJECTIVES: To evaluate the impact of a novel Optical Coherence Tomography (OCT) otoscope on the number of antibiotic prescriptions written for pediatric patients presenting to a primary care office with ear-related complaints, compared to the Standard of Care (SOC), a traditional otoscope.
STUDY DESIGN: Planned interim analysis of the One Year OTO-MATIC Randomized Controlled Trial (RCT), multicenter, real-world effectiveness study. Pediatric patients presenting with ear-related complaints were seen by a provider previously randomized into the SOC or Intervention arm. The primary outcome was reduced antibiotic prescriptions (clinician rate and number of rounds per patient) for Intervention participants compared to the SOC participants. Secondary outcomes included changes in treatment recommendations at Baseline Visit (BV), including singular versus multimodal treatments, and referrals to an otolaryngologist, specifically.
RESULTS: At the time of the interim database lock, there were 248 participants enrolled across four sites and 16 providers who had completed the BV. Our results demonstrate that the OCT intervention reduced the odds of antibiotic prescribing by 50 % compared to the SOC (OR = 0.50, 95 % CI: 0.45-0.56). Additionally, providers in the Intervention group were significantly more likely to initiate a single therapeutic modality versus multiple, often disparate modalities (91.6 % vs. 73.8 %, p < 0.001, respectively).
CONCLUSIONS: Interim results suggest the OCT imaging technology (OtoSight, PhotoniCare) improves antibiotic stewardship with clinicians in the OCT arm having a reduced likelihood of prescribing antibiotics compared to the SOC arm. Overall, changes in provider prescribing patterns and therapeutic management of the patient are consistent with increased diagnostic certainty.
STUDY DESIGN: Planned interim analysis of the One Year OTO-MATIC Randomized Controlled Trial (RCT), multicenter, real-world effectiveness study. Pediatric patients presenting with ear-related complaints were seen by a provider previously randomized into the SOC or Intervention arm. The primary outcome was reduced antibiotic prescriptions (clinician rate and number of rounds per patient) for Intervention participants compared to the SOC participants. Secondary outcomes included changes in treatment recommendations at Baseline Visit (BV), including singular versus multimodal treatments, and referrals to an otolaryngologist, specifically.
RESULTS: At the time of the interim database lock, there were 248 participants enrolled across four sites and 16 providers who had completed the BV. Our results demonstrate that the OCT intervention reduced the odds of antibiotic prescribing by 50 % compared to the SOC (OR = 0.50, 95 % CI: 0.45-0.56). Additionally, providers in the Intervention group were significantly more likely to initiate a single therapeutic modality versus multiple, often disparate modalities (91.6 % vs. 73.8 %, p < 0.001, respectively).
CONCLUSIONS: Interim results suggest the OCT imaging technology (OtoSight, PhotoniCare) improves antibiotic stewardship with clinicians in the OCT arm having a reduced likelihood of prescribing antibiotics compared to the SOC arm. Overall, changes in provider prescribing patterns and therapeutic management of the patient are consistent with increased diagnostic certainty.