Design and Methods of the Korean Organ Transplantation Registry.

BACKGROUND: Beneficial aspects of solid organ transplantation, which encompass survival benefit, improved quality of life, and cost efficacy, have been clearly demonstrated. However, regional and ethnic differences require further studies to identify prognostic factors and transplant outcomes against various backgrounds. After previous efforts of a nationwide, retrospective study on the kidney transplant outcomes in Korea, a new prospective-designed version of the Korean Organ Transplantation Registry (KOTRY) was launched in 2014.

METHODS: Cohorts of kidney, liver, heart, lung, and pancreas transplantation were developed. Data on demographics, comorbid conditions, laboratory tests, including tissue typing and panel reactive antibody tests, immunosuppressive regimen followed, concentration and dosage of immunosuppressants, allograft rejection type, infectious events, cardiovascular outcomes, malignancies, donor comorbidity, and outcomes of living donors are collected. Longitudinal data collection is based on a regular annual interval, and blood samples are collected before organ transplantation and again at 1 and 3 years posttransplantation. To enhance data quality, a predefined data verification system operates on a Web-based database, and transplant center users receive regular education about updates. Data are cleansed thrice a year, and feedback given to centers about outlier values and missing data. Annual auditing is conducted.

RESULTS: Currently, 59 centers are participating in KOTRY. The estimated annual enrollment is more than 2000 cases.

CONCLUSIONS: KOTRY, as a systematic Korean transplant cohort, is expected to provide important information on Asian organ transplantation. The processes used to establish KOTRY provide a good model for launching new nationwide transplant cohort studies.