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      Impact of the GeneXpert ® MTB/RIF rapid molecular test on tuberculosis detection: temporal trends and vulnerable territories* Translated title: Impacto do teste rápido molecular GeneXpert ® MTB/RIF na detecção da tuberculose: tendências temporais e territórios vulneráveis Translated title: Impacto de la prueba rápida molecular GeneXpert ® MTB/RIF en la detección de tuberculosis: tendencias temporales y territorios vulnerables

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          Abstract

          Objective:

          to assess the impact of the GeneXpert ® MTB/RIF rapid molecular test on tuberculosis detection, to analyze the temporal trend of the event and to identify vulnerable territories in a Brazilian municipality.

          Method:

          an ecological study carried out in Ribeirão Preto, São Paulo, Brazil, a municipality considered a priority in tuberculosis control due to the high number of cases. To classify the temporal trend, the Prais-Winsten method and the Interrupted Time Series were used to identify changes in the disease incidence. Kernel intensity analysis was applied to identify vulnerable areas.

          Results:

          the temporal trend of tuberculosis decreased by 18.1%/year and by 6.9%/year for children under 15 years old. The North District decreased by 6.67%/year and the East District increased by 17.5%/year in the incidence of tuberculosis. Resistant tuberculosis, after the implementation of the Rapid Molecular Test, increased by 0.6% per year. The South and West Districts showed a higher density of cases, with a range from 45 to 79 tuberculosis cases per square kilometer (km 2).

          Conclusion:

          although resistant tuberculosis is not a problem in the scenario, the study showed an increase in its incidence, which puts it on alert. The use of spatial analysis enabled the identification of priority areas, putting them in evidence for health surveillance actions.

          Translated abstract

          Objetivo:

          avaliar o impacto do teste rápido molecular GeneXpert ® MTB/RIF na detecção da tuberculose, analisar a tendência temporal do evento e identificar territórios vulneráveis em município brasileiro.

          Método:

          estudo ecológico realizado em Ribeirão Preto, São Paulo, Brasil, município considerado prioritário no controle da tuberculose devido ao elevado número de casos. Para classificar a tendência temporal foi utilizado o método de Prais-Winsten e a Série Temporal Interrompida para identificar mudanças na incidência da doença. Aplicou-se a análise de intensidade de Kernel para a identificação de áreas vulneráveis.

          Resultados:

          a tendência temporal da tuberculose apresentou decréscimo de 18,1%/ano e de 6,9%/ano em menores de 15 anos. O Distrito Norte apresentou decréscimo de 6,67%/ano e o Distrito Leste crescimento de 17,5%/ano, na incidência de tuberculose. A tuberculose resistente, após a implementação do teste rápido molecular, apresentou aumento de 0,6% por ano. Os Distritos Sul e Oeste apresentaram maior densidade de casos, com variação de 45 a 79 casos de tuberculose por quilômetro quadrado (km 2).

          Conclusão:

          apesar da tuberculose resistente não ser um problema no cenário, o estudo evidenciou um crescimento na sua incidência, o que o coloca em estado de alerta. O uso da análise espacial possibilitou a identificação das áreas prioritárias, colocando-as em evidência para ações de vigilância em saúde.

          Translated abstract

          Objetivo:

          evaluar el impacto de la prueba rápida molecular GeneXpert ® MTB/RIF en la detección de tuberculosis, analizar la tendencia temporal del evento e identificar territorios vulnerables en un municipio brasileño.

          Método:

          estudio ecológico realizado en Ribeirão Preto, São Paulo, Brasil, municipio considerado prioritario en el control de la tuberculosis por el elevado número de casos. Se utilizó el método de Prais-Winsten para clasificar la tendencia temporal y la técnica de Series de Tiempo Interrumpidas para identificar cambios en la incidencia de la enfermedad. Se aplicó un análisis de intensidad de Kernel para identificar áreas vulnerables.

          Resultados:

          la tendencia temporal de la tuberculosis disminuyó un 18,1%/año y un 6,9%/año en los menores de 15 años. La incidencia de tuberculosis disminuyó un 6,67%/año en el Distrito Norte y aumentó un 17,5%/año en el Distrito Este. La tuberculosis resistente, después de la implementación de la Prueba Molecular Rápida, aumentó un 0,6% anual. Los Distritos Sur y Oeste presentaron una mayor densidad de casos, con un rango de 45 a 79 casos de tuberculosis por kilómetros cuadrados (km 2).

          Conclusión:

          aunque la tuberculosis resistente no representa un problema en el escenario, el estudio mostró un aumento en la incidencia, lo que genera una señal de alerta. El uso del análisis espacial permitió identificar áreas prioritarias, para que puedan llevarse a cabo acciones de vigilancia en salud.

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          Interrupted time series regression for the evaluation of public health interventions: a tutorial

          Abstract Interrupted time series (ITS) analysis is a valuable study design for evaluating the effectiveness of population-level health interventions that have been implemented at a clearly defined point in time. It is increasingly being used to evaluate the effectiveness of interventions ranging from clinical therapy to national public health legislation. Whereas the design shares many properties of regression-based approaches in other epidemiological studies, there are a range of unique features of time series data that require additional methodological considerations. In this tutorial we use a worked example to demonstrate a robust approach to ITS analysis using segmented regression. We begin by describing the design and considering when ITS is an appropriate design choice. We then discuss the essential, yet often omitted, step of proposing the impact model a priori. Subsequently, we demonstrate the approach to statistical analysis including the main segmented regression model. Finally we describe the main methodological issues associated with ITS analysis: over-dispersion of time series data, autocorrelation, adjusting for seasonal trends and controlling for time-varying confounders, and we also outline some of the more complex design adaptations that can be used to strengthen the basic ITS design.
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            Using time series analysis in epidemiological studies

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              Diagnostic Accuracy of GeneXpert MTB/RIF Assay in Comparison to Conventional Drug Susceptibility Testing Method for the Diagnosis of Multidrug-Resistant Tuberculosis

              Xpert MTB/RIF assay is regarded as a great achievement of modern medicine for the rapid diagnosis of multidrug-resistant tuberculosis (MDR-TB). The main purpose of this study was to determine the performance of Xpert MTB/RIF assay compared to conventional drug susceptibility testing (DST) method for the diagnosis of MDR-TB. A comparative cross sectional study was carried out at German-Nepal Tuberculosis Project, Kathmandu, Nepal, from April 2014 to September 2014. A total of 88 culture positive clinical samples (83 pulmonary and 5 extra-pulmonary) received during the study period were analyzed for detection of multidrug-resistant tuberculosis by both GeneXpert MTB/RIF assay and conventional DST method. McNemar chi square test was used to compare the performance of Xpert with that of DST method. A p-value of less than 0.05 was considered as statistically significant. Of total 88 culture positive samples, one was reported as invalid while 2 were found to contain nontuberculous Mycobacteria (NTM). Among remaining 85 Mycobacterium tuberculosis culture positive samples, 69 were found to be MDR-TB positive by both methods. The overall sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GeneXpert MTB/RIF assay were found to be 98.6%, 100%, 100% and 93.8% respectively. Statistically, there was no significant difference between the diagnostic performance of Xpert and conventional DST method for detection of MDR-TB. GeneXpert MTB/RIF assay was found to be highly sensitive, specific and comparable to gold standard conventional DST method for the diagnosis of MDR-TB.
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                Author and article information

                Journal
                Rev Lat Am Enfermagem
                Rev Lat Am Enfermagem
                rlae
                Revista Latino-Americana de Enfermagem
                Escola de Enfermagem de Ribeirão Preto / Universidade de São Paulo
                0104-1169
                1518-8345
                19 July 2021
                2021
                : 29
                : e3441
                Affiliations
                [1 ]Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.
                [2 ]Scholarship holder at the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), Brazil.
                [3 ]Scholarship holder at the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brazil.
                [4 ]Scholarship holder at the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES), Brazil.
                Author notes
                Corresponding author: Thaís Zamboni Berra. E-mail: thaiszamboni@ 123456live.com

                Associate Editor: Maria Lúcia do Carmo Cruz Robazzi

                Authors’ contribution:

                Study concept and design: Thaís Zamboni Berra, Ricardo Alexandre Arcêncio. Obtaining data: Thaís Zamboni Berra, Ricardo Alexandre Arcêncio. Data analysis and interpretation: Thaís Zamboni Berra, Alexandre Tadashi Inomata Bruce, Yan Mathias Alves, Antônio Carlos Vieira Ramos, Clóvis Luciano Giacomet, Ricardo Alexandre Arcêncio. Statistical analysis: Thaís Zamboni Berra, Ricardo Alexandre Arcêncio. Obtaining financing: Thaís Zamboni Berra, Ricardo Alexandre Arcêncio. Drafting the manuscript: Thaís Zamboni Berra, Alexandre Tadashi Inomata Bruce, Yan Mathias Alves, Antônio Carlos Vieira Ramos, Clóvis Luciano Giacomet, Ricardo Alexandre Arcêncio. Critical review of the manuscript as to its relevant intellectual content: Thaís Zamboni Berra, Alexandre Tadashi Inomata Bruce, Yan Mathias Alves, Antônio Carlos Vieira Ramos, Clóvis Luciano Giacomet, Ricardo Alexandre Arcêncio. All authors approved the final version of the text.

                Conflict of interest: the authors have declared that there is no conflict of interest.

                Author information
                http://orcid.org/0000-0002-4163-8719
                http://orcid.org/0000-0002-7008-8023
                http://orcid.org/0000-0002-5596-0047
                http://orcid.org/0000-0002-7862-1355
                http://orcid.org/0000-0002-5473-9666
                http://orcid.org/0000-0003-4792-8714
                Article
                00357
                10.1590/1518.8345.4412.3441
                8294793
                34287540
                cb4f3b61-9e11-4d02-82b2-086b900c9163
                Copyright © 2021 Revista Latino-Americana de Enfermagem

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 April 2020
                : 27 September 2020
                Categories
                Original Article

                tuberculosis,mycobacterium tuberculosis,diagnosis,incidence,time series studies,spatial analysis,tuberculose,diagnóstico,incidência,estudos de série temporal,análise espacial,diagnostico,incidencia,estudios de series temporales,análisis espacial

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