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. 2025 Apr 28;26(1):134.
doi: 10.1186/s12875-025-02821-1.

A core outcome set for acute otitis media (COS-AOM) for primary and community care studies

Esther T van der Werf  1   2 , Rachel Perry  3 , Thomas Ostermann  4 , Henrik Szőke  5 , Alyson L Huntley  6
Affiliations

A core outcome set for acute otitis media (COS-AOM) for primary and community care studies

Esther T van der Werf et al. BMC Prim Care. .

Abstract

Background and objective: Outcome heterogeneity reported in Acute Otitis Media (AOM) research hinders evidence accumulation. Identification of a Core Outcome Set (COS) to report on in future studies in AOM is warranted.

Methods: Phase 1: Candidate outcomes identification by reviewing previously reported outcomes in systematic reviews of AOM. Phase 2: In a Parent and Public Involvement (PPI) meeting candidate outcomes were discussed on their importance, presence, and absence. Phase 3: The clinical perspective of health professionals and pharmacists was anonymously gained through a ranking task. Phase 4: An International Steering Committee (ISC) discussed the ranked outcomes and advised on the final COS.

Results: 51 candidate outcomes were identified from 3 reviews and summarised to 20 overarching outcomes in Phase 1. Eight parents participated in the PPI meeting. 28 participants (11 GPs, 11 Traditional Complementary and Integrative medicine (TCIM) Professionals, 6 Pharmacists) ranked the 20 outcome cards. Moderate agreement in ranking was reached within all 3 medical groups, with pharmacists showing the highest agreement (0.540) and the TCIM professionals the lowest (0.421). Correlation coefficients between the groups show a sufficiently high agreement (P < 0.01). The ICS confirmed the final COS-AOM including 8 acute outcomes and 2 mid-long-term outcomes. Agreement for each outcome was reached with 100%.

Conclusion: The proposed COS defines a minimum set of outcomes to be measured and reported in primary care and community studies on AOM, including TCIM clinical trials, to enhance evidence-based knowledge. Future research should focus on validating commonly used measurement tools for these outcomes and enhancing findings' generalisability beyond the UK, Europe and primary care settings.

Keywords: Acute otitis media (AOM); Core outcome set (COS); Randomised controlled trial (RCT); Traditional complementary and integrative medicine (TCIM).

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Conflict of interest statement

Declarations. Ethics approval and consent to participate, consent for publication: Due to the nature of the study, no ethical approval was requested. Consent to participate or and publication is not applicable. Competing interests: The authors declare no competing interests. Clinical trial number: Not applicable

Figures

Fig. 1
Fig. 1
Summary of the COS-AOM process
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