Protocol for developing a core outcome set for traditional Chinese medicine in the treatment of pharyngitis

Pharyngitis, a prevalent upper respiratory tract disorder, significantly impairs patients' health-related quality of life due to persistent symptoms such as sore throat and dryness. In particular, the recurrent and lingering nature of chronic cases places a substantial strain on both the healthcare system and society. Although conventional therapies dominated by anti-infective and anti-inflammatory agents are widely employed, their efficacy in curbing recurrence and enhancing long-term prognosis remains suboptimal. Conversely, Traditional Chinese Medicine (TCM) has demonstrated potential advantages in modulating the local inflammatory microenvironment and regulating systemic function, leading to a rapid proliferation of related randomized controlled trials (RCTs). Nevertheless, existing clinical evidence is plagued by significant heterogeneity in the selection and reporting of outcome measures. A substantial number of studies excessively rely on ill-defined composite endpoints, such as the "total effective rate," or utilize ad hoc symptom scales lacking validation for reliability and validity, thereby precluding high-quality quantitative assessment. Such non-standardized and fragmented evaluation criteria severely impede cross-study evidence synthesis and comparison, consequently restricting the formulation of high-level evidence-based clinical guidelines.

The primary objective of this protocol is to develop a Core Outcome Set (COS) specifically tailored for clinical trials of Traditional Chinese Medicine (TCM) in the treatment of pharyngitis. This process will strictly adhere to the international standards established by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative, employing a systematic methodological framework that integrates diverse stakeholder perspectives.

The development process will unfold in four distinct phases. First, a systematic review will be conducted to comprehensively capture all previously reported outcomes in pharyngitis research, thereby establishing an initial item pool. Second, qualitative research comprising semi-structured interviews will be utilized to uncover outcomes deemed critical by patients and frontline clinicians that may have been overlooked in existing literature. Third, a multidisciplinary panel-including TCM and Western medicine practitioners, pharmacologists, methodologists, and patient representatives-will participate in a two-round Delphi survey to anonymously rate the importance of these outcomes. Finally, a face-to-face consensus meeting employing the modified Nominal Group Technique (NGT) will be convened to vote on and ratify the final COS items, along with their definitions and recommended measurement instruments.

The establishment of this COS is expected to standardize outcome reporting in clinical trials regarding TCM for pharyngitis. By mitigating selective reporting bias and facilitating evidence synthesis, this COS will support high-quality guideline development, ultimately enhancing both research integrity and the standard of patient care.

https://www.comet-initiative.org/Studies/Details/2601, identifier 2601.