Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A Stepped-Wedge Cluster-Randomized Trial

Durovni, Betina; Saraceni, Valéria; Hof, Susan van den; Trajman, Anete; Cordeiro-Santos, Marcelo; Cavalcante, Solange; Menezes, Alexandre; Cobelens, Frank

doi:10.1371/journal.pmed.1001766

Cited by 117 publications

(162 citation statements)

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“…O cenário de referência da análise de impacto orçamentário foi o ano de 2013, considerado aqui como o ano inicial de aquisição dos equipamentos pelo PNCT a partir da incorporação do Xpert MTB/RIF na rede de serviços de saúde de dois municípios (Rio de Janeiro e Manaus, Amazonas) em um estudo piloto de implantação 11 . Naquele ano, a baciloscopia era o teste de rotina.…”

Section: Cenário De Referênciaunclassified

“…Utilizaram-se como parâmetros para os cálculos do impacto orçamentário os critérios do PNCT para a seleção dos municípios: (i) municípios que notificaram mais de 200 casos novos de TB em 2011 e que tinham um laboratório com estrutura física e de biossegurança equivalente à necessária para a realização da baciloscopia; (ii) capitais estaduais que não notificaram mais de 200 casos novos em 2011, mas que são referência para o diagnóstico e tratamento da TB nos seus estados; (iii) municípios onde há presídios ou com população indígena que notificaram pelo menos 50 casos em 2011, critério utilizado pela alta taxa de TB-MDR nos presídios e pela dificuldade do diagnóstico nas populações indígenas; e (iv) Laboratórios Centrais de Saúde Pública, que são coordenadores da rede estadual de laborató-rios e responsáveis pelos treinamentos e controle de qualidade dos exames realizados. Ademais, a nova tecnologia gera um incremento da taxa de notificação de TB em 15% (IC95%: -6%; 37%) que foi incluída no modelo 11 .…”

Section: Cenário De Referênciaunclassified

“…Estudos sugerem que o Xpert MTB/RIF é custo-efetivo em diferentes cenários 11,12,13,14,15 . Também no Brasil, um país de média renda, o teste para uma amostra de escarro se mostrou mais custo-efetivo 15 do que a baciloscopia de duas amostras diagnós-ticas na perspectiva do SUS.…”

Section: Introductionunclassified

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Impacto orçamentário da incorporação do GeneXpert MTB/RIF para o diagnóstico da tuberculose pulmonar na perspectiva do Sistema Único de Saúde, Brasil, 2013-2017

et al. 2017

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Resumo: O objetivo do estudo foi estimar o impacto orçamentário do GeneXpert MTB/RIF para o diagnóstico da tuberculose sob a perspectiva do Programa Nacional de Controle da Tuberculose, valendo-se de um modelo estático apoiado no método epidemiológico entre 2013 e 2017. Comparou-se um teste Xpert MTB/RIF com duas baciloscopias diagnósticas. Utilizaram-se dados epidemiológicos, populacionais, de custos, a taxa de câmbio e bases de dados do Sistema Único de Saúde. Foi realizada análise de sensibilidade por cenários. A incorporação do GeneXpert MTB/RIF demandaria um montante de R$ 147 milhões em cinco anos e representaria um impacto de 23% a 26% nos dois primeiros anos, e de cerca de 11% entre 2015 e 2017. Os resultados podem apoiar os gestores brasileiros e dos países latino-americanos no planejamento e gestão na sua decisão de incorporação da tecnologia.

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Impacto orçamentário da incorporação do GeneXpert MTB/RIF para o diagnóstico da tuberculose pulmonar na perspectiva do Sistema Único de Saúde, Brasil, 2013-2017

et al. 2017

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“…These data would enable us to evaluate the incremental number of transmissions that a novel test might be able to avert, relative to the existing standard of care. A series of recent high-quality studies suggests that, when patients present with symptoms that are highly suggestive of TB in upper-middle income settings (for example, South Africa and Brazil), the probability of empirical diagnosis is reasonably high [8][9][10][11] -but that a large number of people may be presenting to care with a cough without TB ever being considered 8 . Such studies are crucial to understand the likely diagnostic gaps for TB, but unfortunately, very few such analyses have been performed in settings with fewer resources (for example, most of sub-Saharan Africa 73,74 and Southeast Asia) where empirical diagnosis rates (and the capacity to implement novel diagnostic tests) may be much lower.…”

Section: S65mentioning

confidence: 99%

“…Nevertheless, the link between improved diagnostic sensitivity and better TB detection remains uncertain. Studies [8][9][10][11] in different settings have found little or no change in the number of pulmonary TB diagnoses or deaths when comparing sputum smear microscopy and Xpert MTB/RIF, a more sensitive molecular test 12 . This result may reflect high levels of empirical treatment among people who test negative [13][14][15] .…”

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Understanding the incremental value of novel diagnostic tests for tuberculosis

Arinaminpathy

Dowdy

2015

Nature

109

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Tuberculosis is a major source of global mortality caused by infection, partly because of a tremendous ongoing burden of undiagnosed disease. Improved diagnostic technology may play an increasingly crucial part in global efforts to end tuberculosis, but the ability of diagnostic tests to curb tuberculosis transmission is dependent on multiple factors, including the time taken by a patient to seek health care, the patient's symptoms, and the patterns of transmission before diagnosis. Novel diagnostic assays for tuberculosis have conventionally been evaluated on the basis of characteristics such as sensitivity and specificity, using assumptions that probably overestimate the impact of diagnostic tests on transmission. We argue for a shift in focus to the evaluation of such tests' incremental value, defining outcomes that reflect each test's purpose (for example, transmissions averted) and comparing systems with the test against those without, in terms of those outcomes. Incremental value can also be measured in units of outcome per incremental unit of resource (for example, money or human capacity). Using a novel, simplified model of tuberculosis transmission that addresses some of the limitations of earlier tuberculosis diagnostic models, we demonstrate that the incremental value of any novel test depends not just on its accuracy, but also on elements such as patient behaviour, tuberculosis natural history and health systems. By integrating these factors into a single unified framework, we advance an approach to the evaluation of new diagnostic tests for tuberculosis that considers the incremental value at the population level and demonstrates how additional data could inform more-effective implementation of tuberculosis diagnostic tests under various conditions

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Impact of the diagnostic test Xpert MTB/RIF on patient outcomes for tuberculosis

Haraka

Kakolwa

Schumacher

et al. 2021

Cochrane Database of Systematic Reviews

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Background The World Health Organization (WHO) recommends Xpert MTB/RIF in place of smear microscopy to diagnose tuberculosis (TB), and many countries have adopted it into their diagnostic algorithms. However, it is not clear whether the greater accuracy of the test translates into improved health outcomes. Objectives To assess the impact of Xpert MTB/RIF on patient outcomes in people being investigated for tuberculosis. Search methods We searched the following databases, without language restriction, from 2007 to 24 July 2020: Cochrane Infectious Disease Group (CIDG) Specialized Register; CENTRAL; MEDLINE OVID; Embase OVID; CINAHL EBSCO; LILACS BIREME; Science Citation Index Expanded (Web of Science), Social Sciences citation index (Web of Science), and Conference Proceedings Citation Index ‐ Social Science & Humanities (Web of Science). We also searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Pan African Clinical Trials Registry for ongoing trials. Selection criteria We included individual‐ and cluster‐randomized trials, and before‐after studies, in participants being investigated for tuberculosis. We analysed the randomized and non‐randomized studies separately. Data collection and analysis For each study, two review authors independently extracted data, using a piloted data extraction tool. We assessed the risk of bias using Cochrane and Effective Practice and Organisation of Care (EPOC) tools. We used random effects meta‐analysis to allow for heterogeneity between studies in setting and design. The certainty of the evidence in the randomized trials was assessed by GRADE. Main results We included 12 studies: eight were randomized controlled trials (RCTs), and four were before‐and‐after studies. Most included RCTs had a low risk of bias in most domains of the Cochrane 'Risk of bias' tool. There was inconclusive evidence of an effect of Xpert MTB/RIF on all‐cause mortality, both overall (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.75 to 1.05; 5 RCTs, 9932 participants, moderate‐certainty evidence), and restricted to studies with six‐month follow‐up (RR 0.98, 95% CI 0.78 to 1.22; 3 RCTs, 8143 participants; moderate‐certainty evidence). There was probably a reduction in mortality in participants known to be infected with HIV (odds ratio (OR) 0.80, 95% CI 0.67 to 0.96; 5 RCTs, 5855 participants; moderate‐certainty evidence). It is uncertain whether Xpert MTB/RIF has no or a modest effect on the proportion of participants starting tuberculosis treatment who had a successful treatment outcome (OR) 1.10, 95% CI 0.96 to 1.26; 3RCTs, 4802 participants; moderate‐certainty evidence). There was also inconclusive evidence of an effect on the proportion of participants who were treated for tuberculosis (RR 1.10, 95% CI 0.98 to 1.23; 5 RCTs, 8793 partic...

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Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A Stepped-Wedge Cluster-Randomized Trial

Cited by 117 publications

References 29 publications

Impacto orçamentário da incorporação do GeneXpert MTB/RIF para o diagnóstico da tuberculose pulmonar na perspectiva do Sistema Único de Saúde, Brasil, 2013-2017

Impacto orçamentário da incorporação do GeneXpert MTB/RIF para o diagnóstico da tuberculose pulmonar na perspectiva do Sistema Único de Saúde, Brasil, 2013-2017

Understanding the incremental value of novel diagnostic tests for tuberculosis

Impact of the diagnostic test Xpert MTB/RIF on patient outcomes for tuberculosis

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