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Development and preliminary evaluation of a parent-reported outcome instrument for clinical trials in acute otitis
Nader Shaikh1, Alejandro Hoberman, Jack L Paradise
1University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Division of General Academic Pediatrics, Pittsburgh, PA. nader.shaikh@chp.edu
Insights
A new parent-reported symptom scale, the Acute Otitis Media-Symptom Outcome Scale (AOM-SOS), effectively tracks early symptom changes in children with AOM. This tool aids in evaluating treatment effectiveness from a parent
Area of Science:
- Pediatrics
- Clinical Research
- Outcome Measurement
Background:
- Acute otitis media (AOM) is a common childhood illness, frequently treated with antibiotics.
- Current methods lack parent-reported tools to track early AOM symptom changes.
- Developing a parent-reported scale is crucial for AOM treatment trials.
Purpose of the Study:
- To develop and evaluate the Acute Otitis Media-Symptom Outcome Scale (AOM-SOS).
- To create a parent-reported outcome measure for AOM treatment studies.
Main Methods:
- Selected 7 symptoms for AOM-SOS based on parent input, expert interviews, and literature review.
- Administered AOM-SOS to children aged 6-25 months in primary care settings.
- Assessed scale's association with clinical AOM diagnosis and responsiveness to treatment.
Main Results:
- The AOM-SOS demonstrated significant association between each item and AOM diagnosis (P < 0.001).
- Mean AOM-SOS scores differed significantly between visits with and without AOM diagnosis (3.71 vs. 0.96, P < 0.001).
- The scale showed good internal reliability (Cronbach's alpha = 0.84) and responsiveness to treatment.
Conclusions:
- A short, parent-reported symptom scale (AOM-SOS) for children with AOM has been developed.
- Preliminary data support the AOM-SOS's performance in primary care.
- The AOM-SOS is a promising outcome measure for AOM treatment trials.
Background:
Acute otitis media (AOM) is the most common childhood diagnosis, leading to prescription of an antibiotic in the United States. Although antibiotics are used in children with AOM, in part, to shorten the duration of symptoms, no instruments have been developed to track early changes in symptoms from the parent's point of view. The goal of the present study was to develop and evaluate a parent-reported symptom scale for children with AOM (AOM-SOS) for use as an outcome measure in AOM treatment trials.
Methods:
From a pool of 28 potential symptoms, we selected 7 on the basis of parent questionnaire, expert interviews, and review of the literature for inclusion in the AOM-SOS. We administered the AOM-SOS to a primary-care sample of children aged 6-25 months enrolled in a study of nasopharyngeal bacterial colonization. Children were seen for well visits, illness visits, and AOM follow-up visits. At each visit, parents completed the AOM-SOS and their children were examined by trained otoscopists. As part of the evaluation of the AOM-SOS, we examined the association between each item on the questionnaire and the clinical diagnosis of AOM while adjusting for the presence of upper respiratory tract infection. To assess responsiveness, we examined the change in AOM-SOS scores in patients with AOM who were seen for follow-up within 3 weeks of diagnosis.
Results:
We evaluated 264 children (mean age, 12.5 months at entry) at a total of 642 visits. We diagnosed AOM at 24% of the visits. Each item on the questionnaire was significantly associated with the clinical diagnosis of AOM (P < 0.001 for each), before and after adjusting for the presence or absence of upper respiratory infection. The mean AOM-SOS score at visits when AOM was diagnosed was 3.71, compared with 0.96 at visits when AOM was not diagnosed (P < 0.001). Internal reliability of the scale as measured by Cronbach's alpha was 0.84. AOM-SOS scores in children with AOM who were otoscopically improved decreased by an average of 2.81 points (standardized response mean = 0.73).
Conclusions:
We have developed a short symptom scale for children with AOM. This study provides preliminary data on the performance of the AOM-SOS in a primary care sample of children.
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