基于量化评价的临床研究结题质量评估体系的探索

Exploration of the quality egvaluation system for clinical research based on quantitative evaluation

目的临床研究中运用量化评价的标准评估建立量化评价指标并应用于临床研究结题质量控制中的可行性及意义。方法通过文献分析、头脑风暴和德尔菲专家咨询法,建立评估指标及相应的指标权重,运用雷达图进行数据分析。结果共建立5个一级指标和23个二级指标,从伦理要求、信息化、方案执行、质量控制、科研产出5个方面建立执行评估体系。结论该评估体系能够有效评估临床研究的完成质量,发现研究中质量管理的薄弱环节,是一种适合临床研究结题质量管理的方法。

Objective To evaluate the feasibility and significance of establishing quantitative evaluation indicators in the project closure quality control by quantitative evaluation criteria. Methods To establish the evaluation index and corresponding index weight according to literature analysis, brainstorming and Delphy's expert consultation methodologies, research data were analyzed by radar chart. Results A total of five first grade indicators and twenty-three second level indicators were established, and the implementation evaluation system was established from five aspects: ethical requirements, informatization, program implementation, quality control and scientific research output. Conclusions The evaluation system can effectively evaluate the quality of clinical research, identify the weak links of the study quality management. It is a suitable method for the quality management of clinical research problems.