van der Werf Esther T, Perry Rachel, Ostermann Thomas, Szőke Henrik, Huntley Alyson L
Homeopathy Research Institute (HRI), London, UK.
Centre for Academic Primary Care, Bristol Medical School, Bristol, UK.
BMC Prim Care. 2025 Apr 28;26(1):134. doi: 10.1186/s12875-025-02821-1.
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.
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.
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%.
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.
急性中耳炎（AOM）研究中报告的结果异质性阻碍了证据积累。因此，有必要确定一个核心结局集（COS），以便在未来的AOM研究中进行报告。
第一阶段：通过回顾先前在AOM系统评价中报告的结局来确定候选结局。第二阶段：在一次家长和公众参与（PPI）会议上，讨论了候选结局的重要性、存在与否。第三阶段：通过排序任务匿名获取卫生专业人员和药剂师的临床观点。第四阶段：一个国际指导委员会（ISC）讨论了排序后的结局，并就最终的COS提供建议。
从3篇综述中确定了51个候选结局，并在第一阶段总结为20个总体结局。8名家长参加了PPI会议。28名参与者（11名全科医生、11名传统补充与整合医学（TCIM）专业人员、6名药剂师）对20张结局卡片进行了排序。所有3个医学组在排序上达成了中度一致，药剂师的一致性最高（0.540），TCIM专业人员的一致性最低（0.421）。各小组之间的相关系数显示出足够高的一致性（P < 0.01）。国际指导委员会确认了最终的AOM-COS，包括8个急性结局和2个中长期结局。每个结局的一致性均达到100%。
提议的COS定义了在AOM的初级保健和社区研究（包括TCIM临床试验）中要测量和报告的最小结局集，以增强基于证据的知识。未来的研究应侧重于验证这些结局常用的测量工具，并提高研究结果在英国、欧洲和初级保健环境之外的普遍性。
