The Development of Core Outcome Set for Premature Ovarian Insufficiency Treated with Traditional Chinese Medicine
10.13288/j.11-2166/r.2024.13.006
- VernacularTitle:中医药治疗早发性卵巢功能不全核心指标集的构建
- Author:
Xue CAO
1
;
Changhe YU
2
;
Xiangran MENG
1
;
Yuning QIN
1
;
Yanke AI
1
;
Jia LIU
1
Author Information
1. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing， 100700
2. Dongzhimen Hospital， Beijing University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
premature ovarian insufficiency;
core outcome set;
traditional Chinese medicine therapy;
clinical efficacy evaluation
- From:Journal of Traditional Chinese Medicine
2024;65(13):1334-1339
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo construct the core outcome set （COS） for premature ovarian insufficiency （POI） treated with traditional chinese medicine （TCM）， thereby standardizing the effect evaluation system of POI clinical researches. MethodsDatabases including PubMed， EMbase， Cochrane Library， Web of Science， CNKI， Wanfang， VIP， SinoMed from January 2017 to December 31， 2021， and Chinese Clinical Trials Registry （ChiCTR）， ClinicalTrials.gov were searched to collect the outcomes used in clinical studies of POI. Supplemented with the patients preferred outcomes through semi-structured interviews， the outcome pool was then constructed. Finally through the Delphi survey and consensus conference， the COS for POI was obtained. ResultsA total of 554 clinical researches and 14 registered clinical research protocols were included. A semi-structured interview was conducted within 20 patients. A total of 77 outcomes were included in the pool after consolidation. After two rounds of Delphi surveys， 20 outcomes were initially included. The COS， which was finalized through expert consensus conference， consists of 8 outcomes in 3 domains， which were ovarian reserve function （follicle stimulating hormone， estradiol， anti-Mullerian hormone， sinus follicle count）， menstruation-related indicators （menstrual symptoms condition） and fertility indicators （pregnancy rate， live birth rate and the numbers of retrieved oocytes）. Through expert discussion， the corresponding measurement methods as well as the measurement time points of the COS were determined. ConclusionThis study formed COS for clinical studies of TCM in the treatment of POI， by practicing the general method of developing COS， and exploring the key points of developing COS with TCM features.
