Methodology for the selection and evaluation of outcomes for Chinese herbal injection in acute exacerbation of chronic obstructive pulmonary disease (AECOPD): a comprehensive study.

ABSTRACT:

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 recommen

SUBMITTER: Kong Z 

PROVIDER: S-EPMC11389646 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature