Objective: To develop a comprehensive framework for selecting outcomes in evaluating the clinical efficacy of Chinese herbal injections and to scientifically select outcomes for the clinical randomized controlled trial (RCT) of Tan-Re-Qing injection intervening AECOPD.
Methods: A comprehensive literature review and consensus methods, including focus groups and Delphi surveys, were utilized.
Results: Literature analysis identified 513 publications, encompassing regulatory guidance, guidelines, expert consensus, and RCTs. Initial dimensions include clinical efficacy, safety, and health economics. Primary outcomes should align with study objectives. Recommended evaluation domains include death, treatment outcome, future impact, quality of life, and safety. Commonly recommended outcomes comprise mortality, arterial blood gases, CAT, exacerbation frequency, adverse events, and lung function. Network meta-analysis identified specific therapeutic efficacy markers (white blood cell count, IL-6, IL-8). Quality of life assessment recommended SF-12, EQ-5D, or CAT. Emphasis on AECOPD frequency and lung function was noted. Delphi survey yielded 41 outcomes across various domains for evaluating Tan-Re-Qing in AECOPD.
Conclusion: The findings contribute to developing a robust and reliable trial design for Tan-Re-Qing injection in AECOPD. The methodology employed in this study ensures a systematic and comprehensive approach to the selection of outcomes for the clinical evaluation of future studies in this field.
Keywords: AECOPD; Chinese herbal injection; Outcomes selection; clinical evaluation; methodology.