Novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients: The example of RePORT Brazil

Background: A major goal of tuberculosis (TB) epidemiological studies is to obtain results that can be generalized to the larger population with TB. The ability to extrapolate findings on the determinants of TB treatment outcomes is also important. Methods: We compared baseline clinical and demograp...

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Main Authors: María B. Arriaga, Gustavo Amorim, Artur T.L. Queiroz, Moreno M.S. Rodrigues, Mariana Araújo-Pereira, Betania M.F. Nogueira, Alexandra Brito Souza, Michael S. Rocha, Aline Benjamin, Adriana S.R. Moreira, Jamile G. de Oliveira, Marina C. Figueiredo, Megan M. Turner, Kleydson Alves, Betina Durovni, José R. Lapa-e-Silva, Afrânio L. Kritski, Solange Cavalcante, Valeria C. Rolla, Marcelo Cordeiro-Santos, Timothy R. Sterling, Bruno B. Andrade
Format: Article
Language:English
Published: Elsevier 2021-02-01
Series:International Journal of Infectious Diseases
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1201971220324528
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author María B. Arriaga
Gustavo Amorim
Artur T.L. Queiroz
Moreno M.S. Rodrigues
Mariana Araújo-Pereira
Betania M.F. Nogueira
Alexandra Brito Souza
Michael S. Rocha
Aline Benjamin
Adriana S.R. Moreira
Jamile G. de Oliveira
Marina C. Figueiredo
Megan M. Turner
Kleydson Alves
Betina Durovni
José R. Lapa-e-Silva
Afrânio L. Kritski
Solange Cavalcante
Valeria C. Rolla
Marcelo Cordeiro-Santos
Timothy R. Sterling
Bruno B. Andrade
author_facet María B. Arriaga
Gustavo Amorim
Artur T.L. Queiroz
Moreno M.S. Rodrigues
Mariana Araújo-Pereira
Betania M.F. Nogueira
Alexandra Brito Souza
Michael S. Rocha
Aline Benjamin
Adriana S.R. Moreira
Jamile G. de Oliveira
Marina C. Figueiredo
Megan M. Turner
Kleydson Alves
Betina Durovni
José R. Lapa-e-Silva
Afrânio L. Kritski
Solange Cavalcante
Valeria C. Rolla
Marcelo Cordeiro-Santos
Timothy R. Sterling
Bruno B. Andrade
author_sort María B. Arriaga
collection DOAJ
description Background: A major goal of tuberculosis (TB) epidemiological studies is to obtain results that can be generalized to the larger population with TB. The ability to extrapolate findings on the 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 in 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 the 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: A total of 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, the 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.
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spelling doaj.art-5d6e7985900b428ead391b9085d2d03d2022-12-21T19:58:50ZengElsevierInternational Journal of Infectious Diseases1201-97122021-02-01103110118Novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients: The example of RePORT BrazilMaría B. Arriaga0Gustavo Amorim1Artur T.L. Queiroz2Moreno M.S. Rodrigues3Mariana Araújo-Pereira4Betania M.F. Nogueira5Alexandra Brito Souza6Michael S. Rocha7Aline Benjamin8Adriana S.R. Moreira9Jamile G. de Oliveira10Marina C. Figueiredo11Megan M. Turner12Kleydson Alves13Betina Durovni14José R. Lapa-e-Silva15Afrânio L. Kritski16Solange Cavalcante17Valeria C. Rolla18Marcelo Cordeiro-Santos19Timothy R. Sterling20Bruno B. Andrade21Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil; Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Faculdade de Medicina, Universidade Federal da Bahia, Salvador, BrazilDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USAMultinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Center of Data and Knowledge Integration for Health (CIDACS), Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, BrazilLaboratório de Análise e Visualização de Dados, Fundação Oswaldo Cruz, Porto Velho, BrazilLaboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil; Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Faculdade de Medicina, Universidade Federal da Bahia, Salvador, BrazilMultinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Faculdade de Medicina, Universidade Federal da Bahia, Salvador, Brazil; Instituto Brasileiro para Investigação da Tuberculose, Fundação José Silveira, Salvador, Brazil; Curso de Medicina, Centro Universitário Faculdade de Tecnologia e Ciências (UniFTC), Salvador, Brazil; Programa de Pós-graduação em Ciências da Saúde, Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador, Bahia, BrazilFundação Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Brazil; Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, BrazilMultinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Instituto Brasileiro para Investigação da Tuberculose, Fundação José Silveira, Salvador, BrazilInstituto Nacional de Infectologia Evandro Chagas, Fiocruz, Rio de Janeiro, BrazilPrograma Acadêmico de Tuberculose, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilSecretaria Municipal de Saúde do Rio de Janeiro, BrazilDivision of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USADivision of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USAMinistério da Saúde, National Tuberculosis Control Program, Brasília, BrazilInstituto Nacional de Infectologia Evandro Chagas, Fiocruz, Rio de Janeiro, Brazil; Secretaria Municipal de Saúde do Rio de Janeiro, BrazilPrograma Acadêmico de Tuberculose, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilPrograma Acadêmico de Tuberculose, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilInstituto Nacional de Infectologia Evandro Chagas, Fiocruz, Rio de Janeiro, Brazil; Secretaria Municipal de Saúde do Rio de Janeiro, BrazilInstituto Nacional de Infectologia Evandro Chagas, Fiocruz, Rio de Janeiro, BrazilFundação Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Brazil; Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil; Universidade Nilton Lins, Manaus, BrazilDivision of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USALaboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil; Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Faculdade de Medicina, Universidade Federal da Bahia, Salvador, Brazil; Curso de Medicina, Centro Universitário Faculdade de Tecnologia e Ciências (UniFTC), Salvador, Brazil; Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA; Curso de Medicina, Universidade Salvador (UNIFACS), Laureate University, Salvador, Brazil; Corresponding author at: Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Rua Waldemar Falcão, 121, Candeal, Salvador, Bahia, 40296-710, Brazil.Background: A major goal of tuberculosis (TB) epidemiological studies is to obtain results that can be generalized to the larger population with TB. The ability to extrapolate findings on the 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 in 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 the 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: A total of 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, the 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.http://www.sciencedirect.com/science/article/pii/S1201971220324528TuberculosisCohort studySample representativenessEpidemiologyTreatment outcome
spellingShingle María B. Arriaga
Gustavo Amorim
Artur T.L. Queiroz
Moreno M.S. Rodrigues
Mariana Araújo-Pereira
Betania M.F. Nogueira
Alexandra Brito Souza
Michael S. Rocha
Aline Benjamin
Adriana S.R. Moreira
Jamile G. de Oliveira
Marina C. Figueiredo
Megan M. Turner
Kleydson Alves
Betina Durovni
José R. Lapa-e-Silva
Afrânio L. Kritski
Solange Cavalcante
Valeria C. Rolla
Marcelo Cordeiro-Santos
Timothy R. Sterling
Bruno B. Andrade
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
Tuberculosis
Cohort study
Sample representativeness
Epidemiology
Treatment outcome
title Novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients: The example of RePORT Brazil
title_full Novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients: The example of RePORT Brazil
title_fullStr Novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients: The example of RePORT Brazil
title_full_unstemmed Novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients: The example of RePORT Brazil
title_short Novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients: The example of RePORT Brazil
title_sort novel stepwise approach to assess representativeness of a large multicenter observational cohort of tuberculosis patients the example of report brazil
topic Tuberculosis
Cohort study
Sample representativeness
Epidemiology
Treatment outcome
url http://www.sciencedirect.com/science/article/pii/S1201971220324528
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