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

doi:10.12114/j.issn.1007-9572.2020.00.633

Abstract

Abstract: 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.

Key words: Clinical trials, Telephone follow-up, Follow-up rate, Methodology, Data management

摘要： 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。

关键词: 临床试验, 电话随访, 随访率, 方法学, 数据管理

WANG Tianyuan,SUN Xing,HU Jing, et al. Reflections on Methodological Approaches to Telephone Follow-ups in Clinical Trials of Traditional Chinese Medicine　[J]. Chinese General Practice, 2021, 24(2): 248-252. DOI: 10.12114/j.issn.1007-9572.2020.00.633.
王天园,孙星,胡晶等. 中医药临床试验中电话随访的方法学应对与思考[J]. 中国全科医学, 2021, 24(2): 248-252. DOI: 10.12114/j.issn.1007-9572.2020.00.633.

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