Abstract
The Japanese phrase Tokutei Shikkan refers to intractable diseases that result from unidentifiable causes and that are very difficult to treat, as there no treatment procedures have been established. Typically, the treatment of these diseases requires long-term care and medicines, which causes great financial and mental stress on the patient's family, so these treatments are subsidized at public expense. Given the lack of statistical information on these rare diseases, The Specified Disease Treatment Research Program was established in 1972, and 56 intractable diseases are currently included as Tokutei Shikkan. The program has been very successful, and many clinical research groups have gained new insight into intractable diseases. Unfortunately, no cross-sectional studies of these diseases have been conducted due to semantic differences among clinical research forms, which are designed mainly to apply for administrative funds and which contain little clinical information. We redesigned the forms as openEHR-based templates and mapped specific clinical notations for intractable diseases onto the archetypes in CKM (Clinical Knowledge Manager). The openEHR project is a current reference implementation of ISO/CEN 13606. We are now trying to bridge the gaps between international standards and criteria and those unique to Japan. This paper shows how we mapped the clinical information on intractable diseases onto the archetypes and how we implemented a clinical research form entry system that is coordinated with electronic medical records.
