Core outcome set for Traditional Chinese Medicine treatment of adult allergic rhinitis: study protocol

Introduction Allergic rhinitis (AR) is a highly prevalent condition worldwide and imposes a substantial public health burden on adults. Although Traditional Chinese Medicine (TCM) therapies have shown potential therapeutic benefits in AR management, the lack of a standardised outcome evaluation framework limits evidence comparability and synthesis.

Current studies commonly exhibit inconsistent outcome selection, heterogeneous measurement instruments and unclear assessment time points, reducing the applicability of findings to evidence-based practice and guideline development. Moreover, existing AR-related core outcome set (COS) studies generally target a broad population, with limited focus on adults (aged 18 - 75 years) and insufficient involvement of patients and other stakeholders.

Therefore, this study aims to establish a standardised COS for clinical research in adult allergic rhinitis (COS-AR), with clearly defined outcomes, measurement instruments and recommended assessment time points. This COS-AR will provide a framework for outcome selection and measurement in clinical studies of TCM for adult AR.

Methods and analysis The development of COS-AR will be conducted in four sequential phases: (1) A comprehensive review of randomised controlled trials and clinical trial registry entries related to adult AR from major domestic and international databases published between 1 January 2019 and 31 August 2025 will be performed. This phase will involve the systematic categorisation of all reported outcomes, including their definitions, measurement instruments and assessment time points.

(2) An online survey will be administered to both clinicians and patients involved in AR management to identify outcomes considered most important by these stakeholders. (3) A modified Delphi process, consisting of two to three rounds of online surveys, will be conducted with over 100 key stakeholders to establish a COS.

(4) One or two online consensus meetings will be convened with a representative group of 20 - 30 key stakeholders to reach final consensus on the outcomes, their definitions, measurement instruments and recommended assessment time points to be included in the COS-AR. Ethics and dissemination All activities conducted in this study have received ethical approval from the Medical Ethics Committee of Zhejiang Hospital (Ethics Approval Number: 2023 (9K)-X4).

Written informed consent will be obtained from all participants prior to participation. The research findings will be disseminated through peer-reviewed publications and relevant academic and professional conferences.

Trial registration number China Clinical Trial Core Outcome Sets Research Centre (ChiCOS). Available at: https://www.chicos.org.cn/cos/1788748723768049665 (accessed 29 December 2025)