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Collection of Survival and Clinical Data for Multicenter Clinical Trials Using the Qlikview App Provided By CIBMTR

Authors :
Afonso Celso Vigorito
Nelson Hamerschlak
Vergilio A.R. Colturato
Germison Silva Lopes
Anderson João Simioni
Fernando Barroso Duarte
Heliz Regina A. Neves
Marcos Paulo Colella
Roberto Luiz da Silva
Iracema Esteves
Victor Zecchin
Bruna Letícia da Silva Santos Geraldo
Vaneuza Araujo Moreira Funke
Cintia Monteiro
Samir Kanaan Nabhan
Carmem Bonfim
Larissa Codogno Guzelotto
Cinthya Corrêa da Silva
Source :
Biology of Blood and Marrow Transplantation. 25:S80
Publication Year :
2019
Publisher :
Elsevier BV, 2019.

Abstract

Introduction The Center for International Blood & Marrow Transplant Research (CIBMTR) presents a system that makes it easier to register standardized transplantation data, as well as a business intelligence tool for the devolution of data to the transplant centers, the Qlikview app, which allows data extraction. The software might be useful for the conduction of clinical trials. Objective To evaluate overall survival (OS) and clinical characteristics of patients (pts) undergoing hematopoietic stem cell transplantation (HSCT) in Brazil while testing the usefulness and efficacy of the Qlikview app. Methods Seven Brazilian transplantation centers were asked to enter the in the CIBMTR database using their passcodes and retrieve data from all the pts undergoing HSCT between 2008 (when the Data Back to Centers, DBtC, began) and 2018 using the Qlikview. The seven spreadsheets with the whole set of clinical and demographical data were unified and analyzed using the SPSS software. OS was calculated using Kaplan Meier curves and log rank test. Results In the study period, 3994 pts received transplants in the seven centers (1546 autologous and 2448 allogeneic transplants). The set of data analyzed represented approximately 21% of the transplants performed in Brazil in the period. Among the autologous HSCTs, 1346 (87%) pts were adults and 1514 (98%) had malignant diseases (750 multiple myelomas, 292 non-Hodgkin lymphomas and 262 Hodgkin lymphomas). Among allogeneic HSCTs, 1514 (62%) were adults, 1739 (71%) had malignant diseases (603 AML, 574 ALL and 263 pts with MDS/MPN). The allogeneic source of cells was the bone marrow in 1611 (66%), 685 (28%) peripheral blood and 152 (6%) umbilical cord blood. The two-year OS for the pts with malignant diseases undergoing autologous HSCT (1202) was 79% for adult pts (1055) and 68% for children (147), while for allogeneic transplants for malignant cases (1138) it was 55%, 45% and 38% respectively for pts receiving transplants from HLA matched related (777), unrelated (287) and related donors (74) but with some HLA incompatibility (p Conclusion The Qlikview app allowed the standardized collection and analysis of data from the selected transplant centers, which may be useful for countries, such as Brazil, where a national database is not available. However, some variables were lacking in the app and should be added to improve the analyses. The data analysis has shown that pts characteristics and survival in the seven Brazilian centers are similar to the international literature.

Details

ISSN :
10838791
Volume :
25
Database :
OpenAIRE
Journal :
Biology of Blood and Marrow Transplantation
Accession number :
edsair.doi...........686bc00e12e6ee20963d0213506f52cf
Full Text :
https://doi.org/10.1016/j.bbmt.2018.12.175