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Determination of the minimal important difference for the acute otitis media severity of symptom scale
Nader Shaikh1, Howard E Rockette, Alejandro Hoberman
1From the *Division of General Academic Pediatrics, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine; and †Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA.
Insights
This study estimates the minimal important difference (MID) for the Acute Otitis Media Severity of Symptom (AOM-SOS) scale. A 55% relative decrease in AOM-SOS scores indicates a meaningful improvement in young children with AOM.
Area of Science:
- Pediatrics
- Otolaryngology
- Clinical Trials
Background:
- The Acute Otitis Media Severity of Symptom (AOM-SOS) scale was previously developed to assess AOM symptoms in children.
- Estimating the minimal important difference (MID) is crucial for interpreting clinical significance of AOM-SOS score changes.
Purpose of the Study:
- To estimate the minimal important difference (MID) for the AOM-SOS scale in young children.
- To evaluate the MID's utility in analyzing clinical trial data for AOM treatment efficacy.
Main Methods:
- Children aged 6-24 months with AOM were analyzed from a placebo-controlled antibiotic efficacy trial.
- Changes in AOM-SOS scores were correlated with parental reports of symptom improvement over 24 hours.
- Mean absolute and relative score changes in children with minor improvement were used to estimate the MID.
Main Results:
- A 55% relative decrease in AOM-SOS score corresponded to a small degree of improvement reported by parents.
- The proportion of children showing a >55% AOM-SOS score decrease by Day 7 was 12.3% (antibiotic) vs. 23.8% (placebo).
- During Days 4-7, the proportions were 28% (antibiotic) vs. 40% (placebo), indicating a trend.
Conclusions:
- The MID for AOM-SOS score change in young children was estimated at a 55% relative decrease.
- The MID serves as a valuable metric for interpreting clinical trial outcomes in AOM research.
Background:
We previously developed and validated the acute otitis media severity of symptom (AOM-SOS) scale for rating symptoms of AOM in young children. In this report, we sought to estimate the minimal important difference (MID) for change in AOM-SOS scores.
Methods:
In a group of children 6-24 months of age with AOM enrolled in a recently reported placebo-controlled clinical trial of antibiotic efficacy, we compared changes in AOM-SOS scores with parental assessments of change over a 24-hour period. Mean absolute and mean relative change in scores in children reportedly exhibiting only a small degree of improvement were considered in arriving at an estimated MID. We then compared the proportions of children in the antibiotic and placebo groups, respectively, whose AOM-SOS scores changed more than the estimated MID at various time points after enrollment.
Results:
Data were available for 277 children. Children whose parents reported only a small degree of improvement 24 hours after enrollment had a mean decrease in AOM-SOS score of 3.8, or 55%, from baseline. We found the relative decrease more telling than the absolute decrease. The proportions of children in the antibiotic and placebo groups, respectively, whose AOM-SOS scores had decreased <55% on Day 7 were 12.3 and 23.8% (P=0.02), and during Days 4-7 were 28 and 40% (P=0.046).
Conclusions:
We estimated the MID for change in AOM-SOS scores in young children and described use of the MID as an added metric in interpreting results from a clinical trial of antibiotic efficacy.
