基于量化评价的临床研究过程质量控制及其案例分析

发布时间：2018-04-05 22:02

  本文选题：临床研究　切入点：慢性胃炎　出处：《中医杂志》2017年19期

【摘要】：目的以临床研究中运用量化评价标准为例,探讨建立量化评价指标并应用于临床研究过程质量控制中的可行性及意义。方法建立慢性胃炎中医药防治临床研究质量控制量化评价指标,包括研究药物管理、随机化执行、数据记录、受试者依从性、受试者保护、实验室检测等临床研究关键环节,并将其应用于国家中医药管理局中医药行业科研专项"慢性胃炎中医药防治技术及规范的转化应用研究"中每个环节的质量评价,实现临床研究质量的管理。结果临床研究启动初期、启动中期和结题前的三次质量控制量化评价显示,启动初期"研究记录及时"标化分值最低,为0.6;研究中期"数据记录"和"研究用药的依从性"方面标化分值最低,均为0.8;结题前的评价仍然是研究记录的规范性和完整性方面表现欠缺,标化分值均为0.8。三次量化评价总分值分别为91.3、94.6、96.7,呈逐渐升高趋势,表明研究质量总体情况良好。结论在对影响研究质量的风险进行识别的基础上,建立临床研究质量控制与评价量化指标,并在研究过程中实施质量控制评价,有助于对研究课题质量及时进行管理,可有效促进研究质量的提升。
[Abstract]:Objective to study the feasibility and significance of establishing quantitative evaluation index and applying it to quality control in clinical research.Methods the quantitative evaluation indexes of quality control in the clinical study of prevention and treatment of chronic gastritis were established, including drug management, randomization execution, data recording, subject compliance, subject protection, laboratory test, and other key links of clinical research.It is applied to the quality evaluation of every link in the special scientific research project of Chinese medicine industry of the State Administration of traditional Chinese Medicine, "Research on the Prevention and treatment of chronic gastritis by traditional Chinese Medicine and its Standard Transformation and Application", so as to realize the quality management of clinical research.Results at the beginning of clinical study, the quantitative evaluation of three times of quality control showed that the standardized score of "research record in time" was the lowest in the early stage of the clinical study.The standardized scores of "data record" and "compliance of research drugs" were the lowest (0.8) in the middle period of the study, and the evaluation before the conclusion was still lack of standardization and integrity of the research record, the standardized score was 0.8.The total score of the third quantitative evaluation was 91.3 / 94.6 / 96.7, which showed a trend of increasing gradually, indicating that the overall quality of the study was good.Conclusion on the basis of identifying the risk that affects the quality of the research, the quantitative index of quality control and evaluation of clinical research is established, and the quality control evaluation is carried out in the course of the research, which is helpful to the management of the quality of the research subject in time.It can effectively promote the quality of research.
【作者单位】： 中国中医科学院西苑医院;北京中医药大学东方医院;
【基金】：国家中医药管理局中医药行业科研专项(201107006)
【分类号】：R24
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本文编号：1716646