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

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.