Establishment and exploration of a quality monitoring indicator system for Investigator-Initiated ophthalmology clinical research in China
10.3760/cma.j.cn113565-20241213-00326
- VernacularTitle:研究者发起的眼科临床研究质量监管指标体系的建立与探索
- Author:
Jiangyi LIU
1
;
Cong YE
;
Ayong YU
;
Jian ZHANG
;
Yuanbo LIANG
;
Jia QU
Author Information
1. 温州医科大学附属眼视光医院 国家眼耳鼻喉疾病（眼部疾病）临床医学研究中心 325027
- Publication Type:Journal Article
- Keywords:
Ophthalmology;
Quality evaluation;
Investigator-Initiated Trials;
Evaluation indicators;
Delphi method
- From:
Chinese Journal of Medical Science Research Management
2025;38(4):298-305
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop an evaluation index system for the quality management process of investigator-initiated trials(IITs) in ophthalmology, providing a scientific tool and reference for improving clinical research quality and standardized management.Methods:Key quality management elements of ophthalmology IITs were identified through a literature review and experts interviews. A three-round Delphi consultation was conducted with experts from 16 provinces and municipalities in China who specialize in ophthalmic clinical research management. The importance of each index was scored, and weighting calculations were performed. Based on ranking and feasibility, a validated quality index system for ophthalmology IITs was established.Results:A three-tier index system was developed, comprising three first-level indicators (structure, process, and outcome), 15 secondary indicators, and 44 tertiary indicators. The expert authority coefficient was 0.87, and the response rates for the three Delphi rounds were 100%, 92.58%, and 100%, respectively. Among the first-level indicators, the highest weight was assigned to ″Structure″ (0.443 2). The top three secondary indicators were ″Data analysis report″ (0.098 3), ″Study protocol execution and data archiving″ (0.096 0), and ″Research team″ (0.094 1). At the tertiary level, the highest-ranked indicators were ″Data cleaning, verification, and database locking″ (0.049 2), ″Archiving and preservation of research data″ (0.048 8), and ″Execution of statistical analysis as planned″ (0.048 4).Conclusions:The ophthalmology IIT process quality evaluation index system developed in this study is scientifically grounded and will provides a valuable reference for standardizing quality management and further empirical research in ophthalmology IITs.
