Case study projects by a Korean national research agency: Past 12 years and future

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.