Developing a Core Outcome Set for Herpes Zoster-Associated Neuralgia in Clinical Trials of Traditional Chinese Medicine: A Study Protocol

Context: Herpes zoster-associated neuralgia (ZAN), the most common symptom across all stages of herpes zoster, significantly impacts patients' quality of life and emotional well-being. Traditional Chinese Medicine (TCM) treatments have demonstrated unique efficacy in treating ZAN. However, non-standardized outcome reporting remains a significant challenge. Therefore, establishing a core outcome set (COS) is essential for standardizing TCM clinical research on ZAN. Objective: This study aims to develop a COS for future clinical trials of TCM for ZAN (COS-TCM-ZAN). Methods: This study determined the list of outcomes measures by systematically searching databases and clinical trial registeres. Subsequently, multiple stakeholder groups from various fields were selected to conduct two rounds of Delphi surveys to assess the importance of each outcome measure. Finally, we will hold a face-to-face consensus conference to approve the final COS-TCM-ZAN. Timeline: The study will start in April 2025, aiming to finalize the outcomes list by June 2025. Then having stakeholder screening, a Delphi survey (July-Dec 2025), and a consensus conference in early 2026. In line with the COS-STAR (Core Outcome Set-STAndards for Reporting) guidelines, the COS findings will be reported and exchanged at national and international conference. Conclusion: The standardized COS will enhance the identification of effective evaluation indicators for TCM treatment of ZAN, thereby enhancing the comparability and reproducibility in research and clinical practice for TCM in the field of ZAN treatment. Trial Registration: This COS has been prospectively registered in the COMET database (registration #3370, available at https://www.comet-initiative.org/studies/details/3370). Clinical trial number: not applicable.