Construction of core outcome set for clinical research on traditional Chinese medicine treatment of simple obesity.
10.19540/j.cnki.cjcmm.20250307.501
- Author:
Tong-Tong WU
1
;
Yan YU
1
;
Qian HUANG
2
;
Xue-Yin CHEN
2
;
Fu-Ming-Xiang LIU
1
;
Li-Hong YANG
2
;
Chang-Cai XIE
2
;
Shao-Nan LIU
2
;
Yu CHEN
2
;
Xin-Feng GUO
2
Author Information
1. the Second School of Clinical Medicine, Guangzhou University of Chinese Medicine Guangzhou 510405, China.
2. the Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine Guangzhou 510120, China.
- Publication Type:English Abstract
- Keywords:
clinical research;
core outcome set;
simple obesity;
traditional Chinese medicine
- MeSH:
Humans;
Obesity/therapy*;
Medicine, Chinese Traditional;
Randomized Controlled Trials as Topic;
Treatment Outcome;
Drugs, Chinese Herbal/therapeutic use*
- From:
China Journal of Chinese Materia Medica
2025;50(12):3423-3430
- CountryChina
- Language:Chinese
-
Abstract:
Following the core outcome set standards for development(COS-STAD), this study aims to construct core outcome set(COS) for clinical research on traditional Chinese medicine(TCM) treatment of simple obesity. Firstly, a comprehensive review was conducted on the randomized controlled trial(RCT) and systematic review(SR) about TCM treatment of simple obesity that were published in Chinese and English databases to collect reported outcomes. Additional outcomes were obtained through semi-structured interviews with patients and open-ended questionnaire surveys for clinicians. All the collected outcomes were then merged and organized as an initial outcome pool, and then a preliminary list of outcomes was formed after discussion by the working group. Subsequently, two rounds of Delphi surveys were conducted with clinicians, methodology experts, and patients to score the importance of outcomes in the list. Finally, a consensus meeting was held to establish the COS for clinical research on TCM treatment of simple obesity. A total of 221 RCTs and 12 SRs were included, and after integration of supplementary outcomes, an initial outcome pool of 141 outcomes were formed. Following discussions in the steering advisory group meeting, a preliminary list of 33 outcomes was finalized, encompassing 9 domains. Through two rounds of Delphi surveys and a consensus meeting, the final COS for clinical research on TCM treatment of simple obesity was determined to include 8 outcomes: TCM symptom scores, body mass index(BMI), waist-hip ratio, waist circumference, visceral fat index, body fat rate, quality of life, and safety, which were classified into 4 domains: TCM-related outcomes, anthropometric measurements, quality of life, and safety. This study has preliminarily established a COS for clinical research on TCM treatment of simple obesity. It helps reduce the heterogeneity in the selection and reporting of outcomes in similar clinical studies, thereby improving the comparability of research results and the feasibility of meta-analysis and providing higher-level evidence support for clinical practice.
