提高研究者依从性,提升针灸临床研究质量--关于针灸医生和针灸研究者角色冲突思考

Improving the researchers' compliance and the quality of clinical study on acupuncture and moxibustion:thoughts on the role conflict between doctors and researchers

一项高质量临床随机对照研究顺利完成需要许多环节协同与协作,其中作为对临床研究质量和研究中受试者安全与权益负责的研究者的依从程度高低在一定程度上影响研究最终结果与质量。围绕研究者依从性这一焦点,认为研究者依从性提高对临床研究证据的提升具有重要意义,指出目前常见的研究者低依从性表现,如不按照研究方案规定执行各项操作(如纳入患者不符合标准、不按规定的顺序入组病例等)、不按相关标准操作规程采集与收集数据、不重视保存原始文件而随意修改数据、汇报不良事件不及时等,并从临床研究监察者角度对研究者这些低依从性表现的原因进行了分析并提出了一些解决方案。

The coordination and collaboration of many links are required to achieve the successful development of a high-quality clinical randomized controlled trial,in which,the compliance of the researchers affects the ultimate results and quality of the study since it is responsible for the safety and benefits of subjects in the trials and study quality.Focusing on the researchers＇ compliance,it is believed that the improvements in the researchers＇ compliance are very significant in the implementation of study scheme.At present,commonly,the researchers are of the low compliance,manifest as failure to obey the study scheme（such as inclusive criteria,enrollment sequence）,failure to obey the rules of operation and data collection,failure to store the original documents but to modify the data,failure to report timely adverse events,etc.In view of clinical research monitors,the reasons on the low compliance are analyzed and the solutions are proposed.