[Development of core outcome set for efficacy evaluation of traditional Chinese medicine treatment of early-stage respiratory virus infection with external cold and internal heat syndrome].
This study constructed a core outcome set(COS) for traditional Chinese medicine(TCM) treatment of early-stage external cold and internal heat syndrome in respiratory viral infections, aiming to provide a reference for selecting outcomes in related clinical studies. A literature review was conducted to collect outcomes related to the early-stage external cold and internal heat syndrome in respiratory viral infections under TCM treatment from randomized controlled trials, systematic reviews, guidelines, and registered clinical trial protocols. Supplementary searches were performed in high-impact journals for systematic reviews on conventional medicine treatments for respiratory viral infections, as well as on the official websites of the Center for Drug Evaluation of the National Medical Products Administration and the US Food and Drug Administration, to develop the initial outcome pool. Two rounds of the Delphi surveys using a 9-point Likert scale were conducted to evaluate the importance of outcomes. The final outcomes were determined through a face-to-face expert consensus meeting. A total of 31 clinical studies, five systematic reviews, two guidelines, five registered clinical trial protocols, and eight new drug evaluation guidelines were included. After standardizing and sorting the outcomes, a pool of 34 outcomes was established. After two rounds of Delphi surveys, 17 outcomes were initially included. After the expert consensus meeting, 10 core outcome indicators were finally determined, including rate of progression to severe cases, time to major symptom improvement, time to resolution of all symptoms, dosage of antipyretic and analgesic medications, incidence of adverse events, time to viral clearance, mortality rate, quality of life, length of hospital stay, and time to normalization of body temperature.