Clinical Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Complement Ther Clin Pract. 2019 May;35:48-52. doi: 10.1016/j.ctcp.2019.01.007. Epub 2019 Jan 16.
Scientific rigor is a known challenge to establish in heavily individualized practices of traditional medicine. A national research agency in Korea carried out a 12-year project to promote case reports among clinics of Korean Medicine (KM). This report aims at providing challenges, achievements, and thoughts for future endeavors.
We reviewed all the projects executed by the Korea Institute of Oriental Medicine between 2005 and 2017 promoting case reports in clinics of KM. The findings were categorized stage of project development, themes of project stage, achievement, and challenges.
The implemented studies include eleven prospective- and five retrospective - case series, and one comparative trial. The project stages are divided into four, initial (surveying and building a database on Korean acupuncture), transitional (educating Korean Medicine doctors on writing case reports and building a case report system), stagnation (partially attributable to IRB's considering case report projects as clinical trial) and resurrection (building a rigorous evidence base from local clinics). The major challenges included practitioners' in clinics feeling burdened by the rigor of documentation requirement, the limited options of usable objective measurement tools available at general KM, and IRB's categorizing case report projects as clinical trials hence imposing unrealistic compliance burden.
Promoting case reports in local clinics, while being warranted to remain as a crucial research method to build evidence based KM practice, requires supports from stakeholders including motivated clinicians of KM, extended use of diagnostic device available at KM practice, and insightful and flexible regulatory bodies' decision making.
在传统医学这种高度个体化的实践中，科学严谨性是一个已知的挑战。韩国的一个国家研究机构在韩国的中医诊所开展了一个为期 12 年的项目，以促进案例报告的发表。本报告旨在为未来的努力提供挑战、成就和思路。
我们回顾了 2005 年至 2017 年间韩国东医研究院开展的所有促进中医诊所案例报告的项目。研究结果按项目发展阶段、项目阶段主题、成就和挑战进行分类。
实施的研究包括 11 项前瞻性和 5 项回顾性病例系列研究，以及 1 项对照试验。项目阶段分为四个阶段，初始阶段（对韩国针灸进行调查并建立数据库）、过渡阶段（对中医医生进行撰写案例报告和建立案例报告系统的教育）、停滞阶段（部分归因于 IRB 将案例报告项目视为临床试验，从而增加了不切实际的合规负担）和复苏阶段（从当地诊所建立严格的证据基础）。主要挑战包括临床医生认为文件要求过于严格而感到负担过重，一般中医可用的客观测量工具选择有限，以及 IRB 将案例报告项目归类为临床试验，从而增加了不切实际的合规负担。
在当地诊所推广案例报告，虽然作为建立基于证据的中医实践的重要研究方法仍然是必要的，但需要利益相关者的支持，包括有动力的中医临床医生、在中医实践中广泛使用诊断设备，以及有洞察力和灵活的监管机构的决策。
