Data Manager in a Bone Marrow Transplant Team in Brazil: Training, Certifications, International Connections and Dissemination

Abstract

Introduction Regular analysis of demographic, clinical and outcome data is indispensable for ensuring and maintaining quality in a hematopoietic stem cell transplant (HSCT) center. For this, data needs to be extracted accurately. Organization accreditations such as FACT (Foundation for the Accreditation of Cellular Therapy) require submission of data to the US (CIBMTR) or the European (EBMT) Registries correctly. Due to discrepancies found between medical charts data and the data submitted to CIBMTR in the first FACT accreditation cycle (2012), our HSCT center decided to hire a dedicated data manager. Objective We describe here the training and performance of the data manager in the process of collecting and transferring HSCT data to national and international registries. Methods The professional hired as data manager received internal and external training. Externally, she attended national and international congresses and visited the CIBMTR (2016). Internally, she first received training by the clinical team about the forms to be filled in. Together with the HSCT multi-professional team, they evaluated the data collection process and defined which data should appear in the medical records. Appropriate outcomes were defined for data analysis based on literature searches, the FACT requirements and the need of the clinical staff, and the data manager was trained in data analysis using R. The clinical team together with data manager developed templates appropriate for the clinical follow-up of patients, such as the Dentistry to collect data on mucositis. The quality nurse developed a regular internal auditing system. Results One of the results was the reduction of three hours in filling out the forms (TED 2400). From the structuring, organization and updating of the database, it was possible to obtain relevant indicators on survival and cumulative incidence of acute and chronic graft versus host disease, transplant-related mortality and disease relapse. These are used by the HSCT team in clinical rounds and in critical analyses of the program performance. In re-accreditations (2015 and 2018) after hiring and training, no non-compliance was identified in item B9, related to the insertion and submission of transplant data. In 2017, the clinical team designed, with the data manager, an ethically-approved multicenter study until 2027, about on transplant-related outcomes, currently with 19 centers in Brazil that sending data to CIBMTR. Conclusion Training of the data manager at our HSCT center (a profession not official in Brazil) allowed the development of strategies and tools that resulted in greater accuracy in data collection and analysis, and FACT-compliant.