Читать книгу Blood and Marrow Transplantation Long Term Management - Группа авторов - Страница 27

CIBMTR has been collecting longitudinal patient outcome data for over 45 years. The complexity and volume of data collected has increased with time, as the field has progressed. In the US, reporting of all allogeneic transplants is mandatory to meet the requirements of the Stem Cell Therapeutic Outcomes Database (SCTOD) contract (which CIBMTR holds) for the Health Resources and Services Administration (HRSA)‐sponsored C.W. Bill Young Cell Transplantation Program (CWBYCTP). This contract requires CIBMTR to produce an annual center‐specific survival analysis evaluating the one‐year survival rates among US centers. All patients participate at the “essential” level of data collection, which includes details related to patient, disease and transplant characteristics which impact transplant outcomes. A subset of patients who consent to research (approximately 25% of the registry) have more comprehensive data collected, which includes details of pretransplant disease course and therapy, as well as additional outcomes data such as infections and organ‐specific late effects. Data are collected for as long as the patient is followed clinically (lifelong if applicable).

Data quality is an essential aspect of the registry and multiple steps are in place to enhance this. These include: upfront data validations, automated cross‐form data validations, in‐system data queries, automated data quality checks performed by a dedicated data quality team and, finally, direct review by medical and scientific staff of individual data elements at the time of data analyses. In addition, CIBMTR has a routine system to ensure the completeness of form submission on a calendar basis, and an audit team who perform comprehensive on‐site data audits for participating sites every four years. There are ongoing challenges related to the burden of data entry at the transplant centers and laboratories, as well as challenges related to the need to regularly update the data variables collected on the forms to reflect changing transplant practice.