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

被引：23

作者：

Arriaga, Maria B. ^{[1
,2
,3
]}

Amorim, Gustavo ^{[4
]}

Queiroz, Artur T. L. ^{[2
,5
]}

Rodrigues, Moreno M. S. ^{[6
]}

Araujo-Pereira, Mariana ^{[1
,2
,3
]}

Nogueira, Betania M. F. ^{[2
,3
,7
,8
,9
]}

Souza, Alexandra Brito ^{[10
,11
]}

Rocha, Michael S. ^{[2
,7
]}

Benjamin, Aline ^{[12
]}

Moreira, Adriana S. R. ^{[13
]}

de Oliveira, Jamile G. ^{[14
]}

Figueiredo, Marina C. ^{[15
]}

Turner, Megan M. ^{[15
]}

Alves, Kleydson ^{[16
]}

Durovni, Betina ^{[14
]}

Lapa-e-Silva, Jose R. ^{[13
]}

Kritski, Afranio L. ^{[13
]}

Cavalcante, Solange ^{[12
,14
]}

Rolla, Valeria C. ^{[12
]}

Cordeiro-Santos, Marcelo ^{[10
,11
,17
]}

Sterling, Timothy R. ^{[15
]}

Andrade, Bruno B. ^{[1
,2
,3
,8
,15
,18
]}

机构：

[1] Fundacao Oswaldo Cruz, Inst Goncalo Moniz, Lab Inflamacao & Biomarcadores, Rua Waldemar Falcao 121, BR-40296710 Salvador, BA, Brazil

[2] Multinatl Org Network Sponsoring Translat & Epide, Salvador, BA, Brazil

[3] Univ Fed Bahia, Fac Med, Salvador, BA, Brazil

[4] Vanderbilt Univ, Dept Biostat, Med Ctr, Nashville, TN USA

[5] Fundacao Oswaldo Cruz, Inst Goncalo Moniz, Ctr Data & Knowledge Integrat Hlth CIDACS, Salvador, BA, Brazil

[6] Fundacao Oswaldo Cruz, Lab Anal & Visualizacao Dados, Porto Velho, Brazil

[7] Fundacao Jose Silveira, Inst Brasileiro Invest TB, Salvador, BA, Brazil

[8] Ctr Univ Fac Tecnol & Ciencias UniFTC, Curso Med, Salvador, BA, Brazil

[9] Univ Fed Bahia, Programa Posgrad Ciencias Saude, Fac Med Bahia, Salvador, BA, Brazil

[10] Fundacao Med Trop Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil

[11] Univ Estado Amazonas, Programa Posgrad Med Trop, Manaus, Amazonas, Brazil

[12] Fiocruz MS, Inst Nacl Infectol Evandro Chagas, Rio De Janeiro, Brazil

[13] Univ Fed Rio de Janeiro, Programa Acad TB, Fac Med, Rio De Janeiro, Brazil

[14] Secretaria Municipal Saude Rio de Janeiro, Rio De Janeiro, Brazil

[15] Vanderbilt Univ, Div Infect Dis, Dept Med, Sch Med, Nashville, TN USA

[16] Natl TB Control Program, Minist Saude, Brasilia, DF, Brazil

[17] Univ Nilton Lins, Manaus, Amazonas, Brazil

[18] Univ Salvador UNIFACS, Laureate Univ, Curso Med, Salvador, BA, Brazil

来源：

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES | 2021年 / 103卷

关键词：

Tuberculosis; Cohort study; Sample representativeness; Epidemiology; Treatment outcome;

D O I：

10.1016/j.ijid.2020.11.140

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

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. (c) 2020 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页码：110 / 118

页数：9

共 28 条

[1] Information bias in health research: definition, pitfalls, and adjustment methods [J].

Althubaiti, Alaa .

JOURNAL OF MULTIDISCIPLINARY HEALTHCARE, 2016, 9 :211-217

[2]

[Anonymous], 2014, REGISTRIES EVALUATIN

[3]

Baldez do Canto V., 2020, EPIDEMIOL SERV SAUDE, V29

[4] Second-generation p-values: Improved rigor, reproducibility, & transparency in statistical analyses [J].

Blume, Jeffrey D. ;

McGowan, Lucy D'Agostino ;

Dupont, William D. ;

Greevy, Robert A., Jr. .

PLOS ONE, 2018, 13 (03)

[5]

Brasil. Ministerio da Saude. Secretaria de Vigilancia em Sa?de, 2017, DEP VIG DOENC TRANSM

[6] Sex and age differences in Mycobacterium tuberculosis infection in Brazil [J].

Fernandes, P. ;

Ma, Y. ;

Gaeddert, M. ;

Tsacogianis, T. ;

Marques-Rodrigues, P. ;

Fregona, G. ;

Loomans, A. ;

Jones-Lopez, E. C. ;

Dietze, R. ;

Ellner, J. J. ;

White, L. F. ;

Hochberg, N. S. .

EPIDEMIOLOGY AND INFECTION, 2018, 146 (12) :1503-1510

[7] RePORT International: Advancing Tuberculosis Biomarker Research Through Global Collaboration [J].

Hamilton, Carol D. ;

Swaminathan, Soumya ;

Christopher, Devasahayam J. ;

Ellner, Jerrold ;

Gupta, Amita ;

Sterling, Timothy R. ;

Rolla, Valeria ;

Srinivasan, Sudha ;

Karyana, Muhammad ;

Siddiqui, Sophia ;

Stoszek, Sonia K. ;

Kim, Peter .

CLINICAL INFECTIOUS DISEASES, 2015, 61 :S155-S159

[8] Research electronic data capture (REDCap)-A metadata-driven methodology and workflow process for providing translational research informatics support [J].

Harris, Paul A. ;

Taylor, Robert ;

Thielke, Robert ;

Payne, Jonathon ;

Gonzalez, Nathaniel ;

Conde, Jose G. .

JOURNAL OF BIOMEDICAL INFORMATICS, 2009, 42 (02) :377-381

[9]

Hastie T., 2009, The Elements of Statistical Learning: Data Mining, Inference, and Prediction Springer Series in Statistics, P625, DOI DOI 10.1007/978-0-387-84858-717

[10] Multivariate analysis of the population representativeness of related clinical studies [J].

He, Zhe ;

Ryan, Patrick ;

Hoxha, Julia ;

Wang, Shuang ;

Carini, Simona ;

Sim, Ida ;

Weng, Chunhua .

JOURNAL OF BIOMEDICAL INFORMATICS, 2016, 60 :66-76

← 1 2 3 →