中医药临床试验中电话随访的方法学应对与思考

Reflections on Methodological Approaches to Telephone Follow-ups in Clinical Trials of Traditional Chinese Medicine

电话随访作为结局评价的一种,在中医药临床试验中十分重要。但随访结果质量偏低,存在随访信息不全、失访率高等问题。现探讨中医药临床试验中电话随访方法学的研究较少,本研究对中医药临床试验中电话随访中存在的问题进行探究,并提出方法学建议。在中医药临床试验中,结局评价十分重要,而结局评价的电话随访过程中存在诸多问题,需要标准化,需要建立方法学以规范流程。本研究聚焦电话随访流程的难点问题,通过中医药临床试验实际调研和总结归纳,从实际出发,提出中医药临床试验中电话随访的方法学建议:(1)合理中医药临床试验研究设计随访部分;(2)建立和完善随访岗位制度;(3)完善随访员培训后上岗机制;(4)提高患者对疾病与随访的认识;(5)优化随访机制。(6)聘请专业的随访团队进行定期规律的随访。未来可探索建立随访数据共享管理平台,全方位快速实现资源共享。

Outcome evaluation is very important for clinical trials of traditional Chinese medicine(TCM).As a way for obtaining outcome information,the process of telephone follow-up needs to be standardized using methodological approaches due to many problems.To address these problems,we put forward the following practical methodological approaches summarized from real investigation results of TCM clinical trials:(1)Rationally designing the telephone follow-up of a TCM clinical trial;(2)Developing and improving a telephone follow-up investigation responsibility system;(3)Improving the pre-job training system for a telephone follow-up investigator;(4)Improving patients'awareness of disease and follow-up;(5)Optimizing the follow-up mechanism;(6)Hiring a professional follow-up team for regular follow-up.We could probably explore and establish a follow-up data platform,sharing the resource rapidly and comprehensively in the future.