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NOVEL STEPWISE APPROACH TO ASSESS REPRESENTATIVENESS OF A LARGE MULTICENTER OBSERVATIONAL COHORT OF TUBERCULOSIS PATIENTS: THE EXAMPLE OF REPORT BRAZIL
https://www.arca.fiocruz.br/handle/icict/61020
María B. Arriaga; Mariana Araújo-Pereira; Bruno B. Andrade. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Inflamação e Biomarcadores. Salvador, BA, Brazil.
Moreno M.S. Rodrigues. Fundação Oswaldo Cruz. Fiocruz Rondônia. Laboratório de Análise e Visualização de Dados. Porto Velho, RO, Brazil.
1Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil. 2Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil. 3Faculdade de Medicina, Universidade Federal da Bahia, Salvador, Brazil. 4Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA. 5Center of Data and Knowledge Integration for Health (CIDACS), Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil. 6Laboratório de Análise e Visualização de Dados, Fundação Oswaldo Cruz, Porto Velho, Brazil. 7Instituto Brasileiro para Investigação da Tuberculose, Fundação José Silveira, Salvador, Brazil. 8Fundação Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Brazil. 9 Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil. 10Instituto Nacional de Infectologia Evandro Chagas, Fiocruz, Rio de Janeiro, Brazil 11Programa Acadêmico de Tuberculose. Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. 12Secretaria Municipal de Saúde do Rio de Janeiro (Clínica da Família Rinaldo Delamare), Rocinha, Rio de Janeiro, Brazil. 13Ministério da Saúde, National Tuberculosis Control Program, Brasília, Brazil. 14Secretaria Municipal de Saúde do Rio de Janeiro, Rio de Janeiro, Brazil. 15Universidade Nilton Lins, Manaus, Brazil. 16Curso de Medicina, Universidade Salvador (UNIFACS), Laureate University, Salvador, Brazil. 17Curso de Medicina, Centro Universitário Faculdade de Tecnologia e Ciências (UniFTC), Salvador, Brazil. 18Programa de Pós-graduação em Ciências da Saúde, Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador, Bahia, Brazil.* T.R.S. and B.B.A. equally contributed to the work Corresponding author: Bruno B. Andrade, MD, PhD, Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Rua Waldemar Falcão, 121, Candeal, Salvador, Bahia 40296-710, Brazil. E-mail: bruno.andrade@fiocruz.br 40-word summary: We compared a multicenter tuberculosis cohort enrolled from three regions of Brazil with the Brazilian National Tuberculosis Program registry, using innovative statistical approaches. The cohort was representative of TB patients overall, facilitating generalizability of study outcomes.
Author
Arriaga Gutiérrez, María Belen
Amorim, Gustavo
Queiroz, Artur Trancoso Lopo de
Rodrigues, Moreno M. S.
Pereira, Mariana Araújo
Nogueira, Betania M. F.
Souza, Alexandra Brito
Rocha, Michael Santos
Benjamin, Aline
Moreira, Adriana S. R.
Oliveira, Jamile G. de
Figueiredo, Marina C.
Turner, Megan M.
Alves, Kleydson
Durovni, Betina
Silva, José R. Lapa e
Kritski, Afrânio L.
Cavalcante, Solange
Rolla, Valeria C.
Santos, Marcelo Cordeiro
Sterling, Timothy R.
Andrade, Bruno de Bezerril
Amorim, Gustavo
Queiroz, Artur Trancoso Lopo de
Rodrigues, Moreno M. S.
Pereira, Mariana Araújo
Nogueira, Betania M. F.
Souza, Alexandra Brito
Rocha, Michael Santos
Benjamin, Aline
Moreira, Adriana S. R.
Oliveira, Jamile G. de
Figueiredo, Marina C.
Turner, Megan M.
Alves, Kleydson
Durovni, Betina
Silva, José R. Lapa e
Kritski, Afrânio L.
Cavalcante, Solange
Rolla, Valeria C.
Santos, Marcelo Cordeiro
Sterling, Timothy R.
Andrade, Bruno de Bezerril
Affilliation
Múltipla ver em Notas.
Abstract
A major goal of tuberculosis (TB) epidemiologic studies is to obtain results that can be generalized to the larger population with TB. The ability to extrapolate findings on determinants of TB treatment outcomes is also important. Methods: We compared baseline clinical and demographic characteristics and determinants of anti-TB treatment outcomes between persons enrolled into the Regional Prospective Observational Research in Tuberculosis (RePORT)-Brazil cohort between June 2015 and June 2019, and the registry of TB cases reported to the Brazilian National TB Program (Information System for Notifiable Diseases [SINAN]) during the same time period. Multivariable regression models adjusted for study site were performed using second-generation p-values, a novel statistical approach. Associations with unfavorable treatment outcomes were tested for both RePORT-Brazil and SINAN cohorts. Findings: 1,060 culture-confirmed TB patients were enrolled in RePORT-Brazil and 455,873 TB cases were reported to SINAN. Second-generation p-value analyses revealed that the cohorts were strikingly similar with regard to sex, age, use of antiretroviral therapy and positive initial smear sputum microscopy. However, diabetes, HIV infection and smoking were more frequently documented in RePORT-Brazil. Illicit drug use, presence of diabetes and history of prior TB were associated with unfavorable TB treatment outcomes; illicit drug use was associated with such outcomes in both cohorts. Conclusions: There were important similarities in demographic characteristics and determinants of clinical outcomes between the RePORT-Brazil cohort and the Brazilian National registry of TB cases.
Publisher
Elsevier
Later version
Citation
ARRIAGA GUTIÉRREZ, María Belen et al. Novel Stepwise Approach to Assess Representativeness of a Large Multicenter Observational Cohort of Tuberculosis Patients: The Example of RePORT Brazil. International Journal of Infectious Diseases, p. 1-28, 2020.DOI
10.1016/j.ijid.2020.11.140ISSN
1201-9712Notes
Aline Benjamin; Solange Cavalcante; Valeria C. Rolla. Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, RJ, Brazil.María B. Arriaga; Mariana Araújo-Pereira; Bruno B. Andrade. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Inflamação e Biomarcadores. Salvador, BA, Brazil.
Moreno M.S. Rodrigues. Fundação Oswaldo Cruz. Fiocruz Rondônia. Laboratório de Análise e Visualização de Dados. Porto Velho, RO, Brazil.
1Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil. 2Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil. 3Faculdade de Medicina, Universidade Federal da Bahia, Salvador, Brazil. 4Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA. 5Center of Data and Knowledge Integration for Health (CIDACS), Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil. 6Laboratório de Análise e Visualização de Dados, Fundação Oswaldo Cruz, Porto Velho, Brazil. 7Instituto Brasileiro para Investigação da Tuberculose, Fundação José Silveira, Salvador, Brazil. 8Fundação Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Brazil. 9 Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil. 10Instituto Nacional de Infectologia Evandro Chagas, Fiocruz, Rio de Janeiro, Brazil 11Programa Acadêmico de Tuberculose. Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. 12Secretaria Municipal de Saúde do Rio de Janeiro (Clínica da Família Rinaldo Delamare), Rocinha, Rio de Janeiro, Brazil. 13Ministério da Saúde, National Tuberculosis Control Program, Brasília, Brazil. 14Secretaria Municipal de Saúde do Rio de Janeiro, Rio de Janeiro, Brazil. 15Universidade Nilton Lins, Manaus, Brazil. 16Curso de Medicina, Universidade Salvador (UNIFACS), Laureate University, Salvador, Brazil. 17Curso de Medicina, Centro Universitário Faculdade de Tecnologia e Ciências (UniFTC), Salvador, Brazil. 18Programa de Pós-graduação em Ciências da Saúde, Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador, Bahia, Brazil.* T.R.S. and B.B.A. equally contributed to the work Corresponding author: Bruno B. Andrade, MD, PhD, Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Rua Waldemar Falcão, 121, Candeal, Salvador, Bahia 40296-710, Brazil. E-mail: bruno.andrade@fiocruz.br 40-word summary: We compared a multicenter tuberculosis cohort enrolled from three regions of Brazil with the Brazilian National Tuberculosis Program registry, using innovative statistical approaches. The cohort was representative of TB patients overall, facilitating generalizability of study outcomes.
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