TY - JOUR
T1 - The CERTAIN registry: A novel, web-based registry and research platform for pediatric renal transplantation in Europe
AU - Plotnicki, L.
AU - Kohl, C. D.
AU - Höcker, B.
AU - Krupka, K.
AU - Rahmel, A.
AU - Pape, L.
AU - Hoyer, P.
AU - Marks, S. D.
AU - Webb, N. J A
AU - Söylemezoglu, O.
AU - Topaloglu, R.
AU - Szabo, A. J.
AU - Seeman, T.
AU - Marlies Cornelissen, E. A.
AU - Knops, N.
AU - Grenda, R.
AU - Tönshoff, B.
PY - 2013/5
Y1 - 2013/5
N2 - Background: The results of pediatric renal transplantation have improved markedly in the last decade. However, a number of relevant clinical problems remain, such as organ damage caused by chronic rejection, long-term toxicity of immunosuppressive therapy, difficulty in developing tolerance-inducing protocols, secondary cardiovascular comorbidity, post-transplantation lymphoproliferative disease, suboptimal longitudinal growth, quality of life, adherence to immunosuppressive medication, and structured transition programs to adult care. These unmet clinical needs require intense collaborative and interdisciplinary clinical research. We recently founded the Cooperative European Paediatric Renal TransplAnt INitiative (CERTAIN; www.certain-registry. eu) as a research network and platform built on a novel, web-based registry. Results: The registry's dataset provides essential information on generic kidney transplantation-related topics and also captures pediatric-specific topics, such as growth, physical and psychosocial development, and adherence. Due to its flexibility the system can be used as follows: (1) as a registry capturing a minimal or an extended dataset; (2) as a center and/or country-specific transplantation database; or (3) as a patient-specific electronic transplantation chart. The data can be exported directly from the CERTAIN web application into statistical software packages for scientific analyses. The rights regarding data ownership, evaluation, and publications are regulated in the registry's rules of procedure. Data quality is ensured by automatic software validation and a manual data review process. To avoid redundant data entry, CERTAIN has established interfaces for data change with Eurotransplant, the Collaborative Transplant Study (CTS), and the registry of the European Society of Pediatric Nephrology (ESPN) and European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) (ESPN/ERA-EDTA registry). CERTAIN fulfils all regulatory and ethical requirements of the European Union and Germany, in particular, regarding patients' data privacy and security. Conclusion: Using modern information technology, the recently established multinational CERTAIN Registry fills a gap in Europe for collaborative 5research and quality assurance in the field of pediatric renal transplantation. © 2013 Elsevier Inc. All rights reserved.
AB - Background: The results of pediatric renal transplantation have improved markedly in the last decade. However, a number of relevant clinical problems remain, such as organ damage caused by chronic rejection, long-term toxicity of immunosuppressive therapy, difficulty in developing tolerance-inducing protocols, secondary cardiovascular comorbidity, post-transplantation lymphoproliferative disease, suboptimal longitudinal growth, quality of life, adherence to immunosuppressive medication, and structured transition programs to adult care. These unmet clinical needs require intense collaborative and interdisciplinary clinical research. We recently founded the Cooperative European Paediatric Renal TransplAnt INitiative (CERTAIN; www.certain-registry. eu) as a research network and platform built on a novel, web-based registry. Results: The registry's dataset provides essential information on generic kidney transplantation-related topics and also captures pediatric-specific topics, such as growth, physical and psychosocial development, and adherence. Due to its flexibility the system can be used as follows: (1) as a registry capturing a minimal or an extended dataset; (2) as a center and/or country-specific transplantation database; or (3) as a patient-specific electronic transplantation chart. The data can be exported directly from the CERTAIN web application into statistical software packages for scientific analyses. The rights regarding data ownership, evaluation, and publications are regulated in the registry's rules of procedure. Data quality is ensured by automatic software validation and a manual data review process. To avoid redundant data entry, CERTAIN has established interfaces for data change with Eurotransplant, the Collaborative Transplant Study (CTS), and the registry of the European Society of Pediatric Nephrology (ESPN) and European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) (ESPN/ERA-EDTA registry). CERTAIN fulfils all regulatory and ethical requirements of the European Union and Germany, in particular, regarding patients' data privacy and security. Conclusion: Using modern information technology, the recently established multinational CERTAIN Registry fills a gap in Europe for collaborative 5research and quality assurance in the field of pediatric renal transplantation. © 2013 Elsevier Inc. All rights reserved.
U2 - 10.1016/j.transproceed.2013.01.007
DO - 10.1016/j.transproceed.2013.01.007
M3 - Article
SN - 0041-1345
VL - 45
SP - 1414
EP - 1417
JO - Transplantation proceedings
JF - Transplantation proceedings
IS - 4
ER -