To develop a Core Outcome Set (COS) specifically for clinical trials of Traditional Chinese Medicine (TCM) in the treatment of pharyngitis.
Approach:
Phase 1: Conduct a systematic review to capture all previously reported outcomes in pharyngitis research.
Phase 2: Utilize qualitative research with semi-structured interviews to identify critical outcomes from patients and clinicians.
Phase 3: Engage a multidisciplinary panel in a two-round Delphi survey to rate the importance of identified outcomes.
Phase 4: Hold a face-to-face consensus meeting using the modified Nominal Group Technique (NGT) to finalize COS items.
Key Findings:
Pharyngitis significantly impairs health-related quality of life and places a strain on healthcare resources.
Current conventional therapies have suboptimal efficacy in preventing recurrence and improving long-term outcomes.
Traditional Chinese Medicine (TCM) shows potential in managing pharyngitis but suffers from heterogeneity in outcome measures across studies.
Interpretation:
The establishment of a COS aims to standardize outcome reporting in TCM clinical trials for pharyngitis, enhancing research integrity and patient care.
Limitations:
Existing studies often rely on poorly defined composite endpoints and ad hoc symptom scales.
Heterogeneity in outcome measures complicates cross-study comparisons and evidence synthesis.
Conclusion:
The COS will facilitate high-quality guideline development and improve the standard of patient care in TCM for pharyngitis.
