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Representativeness of a Large Multicenter Observational Cohort of Tuberculosis Patients: The Example of RePORT Brazil

24 Pages Posted: 5 Oct 2020

See all articles by María B. Arriaga

María B. Arriaga

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative; Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Inflamação e Biomarcadores

Gustavo Amorim

Vanderbilt University - Division of Infectious Diseases

Artur T. L. Queiroz

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative

Moreno M. S. Rodrigues

Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Análise e Visualização de Dados

Mariana Araújo-Pereira

Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Inflamação e Biomarcadores; Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative

Betania M. F. Nogueira

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative

Alexandra Brito Souza

Universidade do Estado do Amazonas - Programa de Pós-Graduação em Medicina Tropical

Michael S. Rocha

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative

Aline Benjamin

Oswaldo Cruz Foundation (FIOCRUZ) - Evandro Chagas National Institute of Infectious Diseases (INI)

Adriana S. R. Moreira

Universidade Federal do Rio de Janeiro (UFRJ) - Programa Acadêmico de Tuberculose

Jamile G. de Oliveira

Secretaria Municipal de Saúde do Rio de Janeiro (Clínica da Família Rinaldo Delamare); City Department of Health of Rio de Janeiro

Marina C. Figueiredo

Vanderbilt University - Division of Infectious Diseases

Megan M. Turner

Vanderbilt University - Division of Infectious Diseases

Kleydson Alves

Ministério da Saúde - National Tuberculosis Control Program

Betina Durovni

Universidade do Estado do Rio de Janeiro (UERJ) - Programa Acadêmico de Tuberculose

José R. Lapa-e-Silva

affiliation not provided to SSRN

Afranio L. Kritski

Universidade Federal do Rio de Janeiro (UFRJ) - Programa Acadêmico de Tuberculose

Solange Cavalcante

Oswaldo Cruz Foundation (FIOCRUZ) - Evandro Chagas National Institute of Infectious Diseases (INI)

Valeria C. Rolla

Oswaldo Cruz Foundation (FIOCRUZ) - Evandro Chagas National Institute of Infectious Diseases (INI)

Marcelo Cordeiro-Santos

Universidade do Estado do Amazonas - Programa de Pós-Graduação em Medicina Tropical

Timothy R. Sterling

Vanderbilt University - Division of Infectious Diseases

Bruno B. Andrade

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative; Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Inflamação e Biomarcadores

RePORT Brazil Consortium

Independent

More...

Abstract

Background: 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.

Interpretations: 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.

Funding Statement: Fundação José Silveira and Ministério da Saúde, Brazil and the National Institutes of Allergy and Infectious Diseases.

Declaration of Interests: All authors: none reported.

Ethics Approval Statement: All clinical investigations were conducted according to the principles of the Declaration of Helsinki. The RePORT-Brazil protocol, informed consent, and study documents were approved by the institutional review boards at each study site and at Vanderbilt University Medical Center. Participation in RePORT Brazil was voluntary, and written informed consent was obtained from all such participants. For the data extracted from SINAN, the anonymity of study subjects was preserved, and all data were de-identified.

Keywords: tuberculosis, cohort study, sample representativeness, epidemiology, treatment outcome

Suggested Citation

Arriaga, María B. and Amorim, Gustavo and Queiroz, Artur T. L. and Rodrigues, Moreno M. S. and Araújo-Pereira, Mariana and Nogueira, Betania M. F. and Souza, Alexandra Brito and Rocha, Michael S. and Benjamin, Aline and Moreira, Adriana S. R. and de Oliveira, Jamile G. and Figueiredo, Marina C. and Turner, Megan M. and Alves, Kleydson and Durovni, Betina and Lapa-e-Silva, José R. and Kritski, Afranio L. and Cavalcante, Solange and Rolla, Valeria C. and Cordeiro-Santos, Marcelo and Sterling, Timothy R. and Andrade, Bruno B. and Consortium, RePORT Brazil, Representativeness of a Large Multicenter Observational Cohort of Tuberculosis Patients: The Example of RePORT Brazil. Available at SSRN: https://ssrn.com/abstract=3700958 or http://dx.doi.org/10.2139/ssrn.3700958

María B. Arriaga

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative ( email )

Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Inflamação e Biomarcadores ( email )

Salvador
Brazil

Gustavo Amorim

Vanderbilt University - Division of Infectious Diseases

United States

Artur T. L. Queiroz

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative ( email )

Salvador
Brazil

Moreno M. S. Rodrigues

Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Análise e Visualização de Dados ( email )

Rio de Janeiro
Brazil

Mariana Araújo-Pereira

Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Inflamação e Biomarcadores ( email )

Salvador
Brazil

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative ( email )

Betania M. F. Nogueira

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative ( email )

Salvador
Brazil

Alexandra Brito Souza

Universidade do Estado do Amazonas - Programa de Pós-Graduação em Medicina Tropical ( email )

Avenida Djalma Batista, 3578
Manaus, 69050-010
Brazil

Michael S. Rocha

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative ( email )

Salvador
Brazil

Aline Benjamin

Oswaldo Cruz Foundation (FIOCRUZ) - Evandro Chagas National Institute of Infectious Diseases (INI) ( email )

Av. Brasil 4365
Rio de Janeiro, 21040-360
Brazil

Adriana S. R. Moreira

Universidade Federal do Rio de Janeiro (UFRJ) - Programa Acadêmico de Tuberculose

Av; Pasteur, 250
terreo - Bairro Maracana
Rio de Janeiro, Rio de Janeiro 23890000
Brazil

Jamile G. De Oliveira

Secretaria Municipal de Saúde do Rio de Janeiro (Clínica da Família Rinaldo Delamare) ( email )

City Department of Health of Rio de Janeiro ( email )

Marina C. Figueiredo

Vanderbilt University - Division of Infectious Diseases

United States

Megan M. Turner

Vanderbilt University - Division of Infectious Diseases

United States

Kleydson Alves

Ministério da Saúde - National Tuberculosis Control Program ( email )

Betina Durovni

Universidade do Estado do Rio de Janeiro (UERJ) - Programa Acadêmico de Tuberculose ( email )

Rua Tonelero, 380 apt. 804
Copacabana, 22030-000
Brazil

José R. Lapa-e-Silva

affiliation not provided to SSRN

Afranio L. Kritski

Universidade Federal do Rio de Janeiro (UFRJ) - Programa Acadêmico de Tuberculose ( email )

Rua Tonelero, 380 apt. 804
Copacabana, 22030-000
Brazil

Solange Cavalcante

Oswaldo Cruz Foundation (FIOCRUZ) - Evandro Chagas National Institute of Infectious Diseases (INI) ( email )

Av. Brasil 4365
Rio de Janeiro, 21040-360
Brazil

Valeria C. Rolla

Oswaldo Cruz Foundation (FIOCRUZ) - Evandro Chagas National Institute of Infectious Diseases (INI) ( email )

Av. Brasil 4365
Rio de Janeiro, 21040-360
Brazil

Marcelo Cordeiro-Santos

Universidade do Estado do Amazonas - Programa de Pós-Graduação em Medicina Tropical ( email )

Avenida Djalma Batista, 3578
Manaus, 69050-010
Brazil

Timothy R. Sterling

Vanderbilt University - Division of Infectious Diseases ( email )

United States

Bruno B. Andrade (Contact Author)

Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative ( email )

Oswaldo Cruz Foundation (FIOCRUZ) - Laboratório de Inflamação e Biomarcadores ( email )

Salvador
Brazil