Treating Acute Otitis Media in Young Children

What Constitutes Success?

Jack L. Paradise, MD; Alejandro Hoberman, MD; Howard E. Rockette, PhD; Nader Shaikh, MD, MPH

Disclosures

Pediatr Infect Dis J. 2013;32(7):745-747. 

In This Article

Protocol-Defined Outcomes

Resolution of Infection

We categorized children as having experienced clinical failure at the day 4–5 visit if otoscopic signs of infection had worsened, and at the day 10–12 visit if otoscopic evidence of infection (ie, TM bulging) persisted.

Abatement of Symptoms

To rate symptoms, we used the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale,[3,4] comprising 7 discrete, parent-reported symptoms: ear tugging or rubbing, crying, irritability, difficulty sleeping, diminished activity, diminished appetite and fever. Parents were to rate each of these symptoms at specified intervals, in comparison with the child's usual state, as "none," "a little" or "a lot," with corresponding scores of 0, 1 and 2. Summing the scores thus gave an AOM-SOS score at each evaluation within a range of 0 to 14. We considered that symptom abatement comprised 2 main components: time to resolution of symptoms and symptom burden over time, and we measured each of these components in 2 ways, giving a total of 4 discrete measures.

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