Uso da Análise dos Modos de Falha e seus Efeitos (FMEA) como ferramenta para mapear os riscos em um estudo clínico

Introduction: This study describes the application of the Failure Mode and Effects Analysis (FMEA) as a tool for risk management during clinical research to establish the treatment of patients simultaneously infected with HIV and tuberculosis. Objective: To demonstrate the importance of risk analysis associated with clinical trial protocols in safeguarding the participant and study data, and as a study’s quality standard. Method: Procedures demanded by the clinical protocol were detailed and then associated with failure modes based on the programmed visits of the participant to the study center. The failure modes were rated between 1 and 10 according to: Severity, Occurrence and Detectability, and the Risk Priority Number (RPN) was calculated by multiplying the three values. Results: In a panel of 25 procedures and 60 failure modes, 50% resulted in RPN > 120; six of which contained more than five failure modes. The highest risks were associated with the DOT strategy (RPN 294), blood collection (RPN 288), the Informed Consent Term (RPN 270) and participant data collection (RPN 240). Conclusions: The results demonstrate the importance of FMEA as a tool to assess risks in clinical studies, in line with the recommendations of international standardization organizations.Introdução: O presente estudo descreve a aplicação da ferramenta de gerenciamento de riscos Análise de Modo e Efeito de Falha (Failure Mode Effects Analysis – FMEA) a uma pesquisa clínica que estabelecerá um tratamento de indivíduos simultaneamente infectados por HIV e tuberculose. Objetivo: Demonstrar a importância da análise de riscos associada aos protocolos de estudos clínicos na salvaguarda do participante e dos dados do estudo, e como padrão de qualidade do estudo. Método: Os procedimentos demandados na execução do protocolo clínico e os potenciais modos de falha a eles associados foram estipulados com base na programação de visitas do participante ao centro do estudo. Os modos de falha foram valorados entre 1 e 10 de acordo com: Gravidade, Ocorrência e Detectabilidade, calculando-se o Número de Prioridade de Risco (NPR) pela multiplicação dos três valores. Resultados: Num painel de 25 procedimentos e 60 modos de falha, 50% resultaram em NPR > 120; seis deles contendo mais de cinco modos de falha. Os maiores riscos foram associados à estratégia DOT (NPR 294), à coleta de sangue (NPR 288), ao Termo de Consentimento Livre e Esclarecido (NPR 270) e a coletas de dados do participante (NPR 240). Conclusões: Os resultados demonstraram a importância da FMEA como instrumento de avaliação de riscos em estudos clínicos, alinhando-se com recomendações de órgãos normalizadores internacionais

Tuberculosis-HIV treatment with rifampicin or rifabutin: are the outcomes different?

BACKGROUND Rifamycins are a group of antibiotics mainly used in the treatment of tuberculosis (TB), however they interact with antiretroviral therapy (ART). Rifabutin allows more regimens options for concomitant imunodeficiency virus (HIV) treatment compared to rifampicin. OBJECTIVE Compare the outcomes of TB-HIV co-infected patients who used rifampicin or rifabutin. METHODS We analysed data from a prospective cohort study at National Institute of Infectious Diseases Evandro Chagas, Rio de Janeiro (RJ), Brazil. Patients who were treated for TB and HIV with rifampicin or rifabutin, from February 2011 to September 2016 were included. FINDINGS There were 130 TB-HIV patients, of whom 102 were treated with rifampicin and 28 with rifabutin. All patients in the rifabutin-treated group and 55% of the rifampicin-treated group patients were ART-experienced. Patients treated with rifampicin had similar abandon and cure rates, interruptions in treatment due to adverse reactions, immune reconstitution inflammatory syndrome and a similar mortality rate as those treated with rifabutin. However, rifampicin-treated patients had higher CD4 counts and more frequently undetectable HIV viral load by the end of treatment (67% versus 18%, p < 0.001) compared to rifabutin-treated patients, even when only ART-experienced patients were evaluated (66,6% versus 36,3%, p = 0.039). CONCLUSIONS Patients who used rifabutin had worst immune and virological control. This group had more ART-experienced patients. New and simpler regimens are needed for patients who do not respond to previous antiretroviral therapies

Perspectives of Patients, Doctors and Medical Students at a Public University Hospital in Rio de Janeiro Regarding Tuberculosis and Therapeutic Adherence

<div><p>Introduction</p><p>The World Health Organization (WHO) identifies 8.7 million new cases of tuberculosis (TB) annually around the world. The unfavorable outcomes of TB treatment prevent the achievement of the WHO’s cure target.</p><p>Goal</p><p>To evaluate existing intersections in the conceptions relative to the knowledge of TB, the experience of the illness and the treatment.</p><p>Methods</p><p>Doctors, medical students and patients were selected from a public university in Rio de Janeiro, Brazil, from 2011 to 2013. The data were obtained by semi-structured individual and focus group interviews, participant observation and a field journal. The inclusion of patients was interrupted due to saturation, and the inclusion of doctors and medical students stopped due to exhaustion. The theoretical background included symbolic Interactionism, and the analysis used rounded Theory. The analysis prioritized the actions/interactions axis.</p><p>Results</p><p>Twenty-three patients with pulmonary TB, seven doctors and 15 medical students were included. In the interviews, themes such as stigma, self-segregation, and difficulties in assistance emerged, in addition to defense mechanisms such as denial, rationalization, isolation and other mental mechanisms, including guilt, accountability and concealment of the disease. Aspects related to the assistance strategy, the social support network, bonding with the healthcare staff and the doctor-patient relationship were highlighted as adherence enablers. Doctors and students recommended an expansion of the theoretical and practical instruction on TB during medical students’ education. The existence of health programs and policies was mentioned as a potential enabler of adherence.</p><p>Conclusion</p><p>The main concepts identified were the stigma, self-segregation, guilt, responsibility, concealment and emotional repercussions. In relation to the facilitation of therapeutic adherence, the concepts identified were the bonds with healthcare staff, the doctor-patient relationship, assistance and educational health strategies.</p></div

Cutaneous tuberculosis and HIV infection at a referral centre in Rio de Janeiro, Brazil

Submitted by Janaína Nascimento ([email protected]) on 2019-01-18T11:27:28Z No. of bitstreams: 1 ve_Mann_Danielle_etal_INI_2018.pdf: 732770 bytes, checksum: d49f7837eb1215a120fa05c9da699184 (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-01-18T13:24:32Z (GMT) No. of bitstreams: 1 ve_Mann_Danielle_etal_INI_2018.pdf: 732770 bytes, checksum: d49f7837eb1215a120fa05c9da699184 (MD5)Made available in DSpace on 2019-01-18T13:24:32Z (GMT). No. of bitstreams: 1 ve_Mann_Danielle_etal_INI_2018.pdf: 732770 bytes, checksum: d49f7837eb1215a120fa05c9da699184 (MD5) Previous issue date: 2018Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Dermatologia Infecciosa. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Micobacterioses. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Micobacterioses. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Dermatologia Infecciosa. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Micobacterioses. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Micobacterioses. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Dermatologia Infecciosa. Rio de Janeiro, RJ, Brasil.BACKGROUND: Cutaneous tuberculosis (CTB) is a rare extrapulmonary form of tuberculosis (TB). Despite the increase in the number of cases of TB and HIV, few cases of CTB have been reported. OBJECTIVE To describe CTB cases among patients with HIV infection from a cohort with tuberculosis. METHODS We describe a series of 15 CTB and HIV cases, based on secondary data from 2000 to 2016. Diagnosis was based on isolation of Mycobacterium tuberculosis in culture or clinical response to anti-tuberculous treatment associated with positive smear or histopathologic findings from affected skin or an adjacent lymph node. FINDINGS; Scrofuloderma was present in 12 (80%) patients and solitary gumma in three (20%) patients. One case of scrofuloderma was associated with papulonecrotic tuberculid. Seven (46.6%) patients had pulmonary TB. Diagnosis was based on culture in nine patients (60%). The median CD4 cell count was 262 cells/µL. All patients were cured at the end of treatment (median time 6 months). Three patients presented with immune reconstitution inflammatory syndrome. CONCLUSIONS: In this study, CTB associated with HIV infection presented as localised forms or in association with pulmonary TB. In patients with HIV who have subacute and chronic skin lesions, CTB should be considered in differential diagnosis, which may represent a good opportunity for early diagnosis of active TB

No association of IFNG+874T/A SNP and NOS2A-954G/C SNP variants with nitric oxide radical serum levels or susceptibility to tuberculosis in a Brazilian population subset

Submitted by Repositório Arca ([email protected]) on 2019-04-24T17:15:36Z No. of bitstreams: 1 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-09-27T14:41:49Z (GMT) No. of bitstreams: 2 ve_Leandro_Ana_etal_INI_2013.pdf: 613537 bytes, checksum: 2da9ad57c3a06a3e5d8a98f3a6e52fba (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5)Made available in DSpace on 2019-09-27T14:41:49Z (GMT). No. of bitstreams: 2 ve_Leandro_Ana_etal_INI_2013.pdf: 613537 bytes, checksum: 2da9ad57c3a06a3e5d8a98f3a6e52fba (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2013Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Imunologia e Imunogenética em Doenças Infecciosas. Rio de Janeiro, RJ, Brasil / Texas Biomedical Research Institute. Department of Genetics and Southwest National Primate Research Center. San Antonio, TX, USA.Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Imunologia e Imunogenética em Doenças Infecciosas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Imunologia e Imunogenética em Doenças Infecciosas. Rio de Janeiro, RJ, Brasil.Texas Biomedical Research Institute. Department of Genetics and Southwest National Primate Research Center. San Antonio, TX, USA.Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Imunologia e Imunogenética em Doenças Infecciosas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Imunologia e Imunogenética em Doenças Infecciosas. Rio de Janeiro, RJ, Brasil.Tuberculosis (TB) is one of the most common infectious diseases in the world. Mycobacterium tuberculosis infection leads to pulmonary active disease in approximately 5–10% of exposed individuals. Both bacteria- and host-related characteristics influence latent infection and disease. Host genetic predisposition to develop TB may involve multiple genes and their polymorphisms. It was reported previously that interferon gamma (IFN-) and nitric oxide synthase 2 (NOS2) are expressed on alveolar macrophages from TB patients and are responsible for bacilli control; thus, we aimed this study at genotyping single nucleotide polymorphisms IFNG+874T/A SNP and NOS2A-954G/C SNP to estimate their role on TB susceptibility and determine whether these polymorphisms influence serum nitrite and NO− production. This case-control study enrolled 172 TB patients and 179 Thealthy controls. Neither polymorphism was associated with susceptibility to TB. NOS2A-954G/C SNP was not associated with serum levels of nitrite and NO−. These results indicate that variants of IFNG+874T/A SNP and NOS2A-954G/C SNP do not influence TB susceptibility or the secretion of nitric oxide radicals in the study population

Correction: Nutritional Supplementation Is a Necessary Complement to Dietary Counseling among Tuberculosis and Tuberculosis-HIV Patients.

The Brazilian Ministry of Health and the World Health Organization recommend dietary counseling for patients with malnutrition during tuberculosis treatment. Patients under tuberculosis therapy (infected and not infected with HIV) were followed-up to evaluate the effectiveness of dietary counseling.describe the nutritional status of patients with tuberculosis.an observational follow-up study over a 180-day period of tuberculosis therapy in adults was conducted. Subjects were assessed for body composition (using BMI, TSF and MUAC parameters), serum biomarkers and offered dietary counseling. The data obtained at each visit (D15, D30, D60, D90, D120, D150, and D180) were analyzed, showing trajectories over time and central tendencies each time.at baseline, the mean age was 41.1 (± 13.4) years; they were predominantly male, with income lower than a local minimum wage and at least six years of schooling. Patients showed predominantly pulmonary tuberculosis. At baseline, all patients suffered from malnutrition. The overall energy malnutrition prevalence was of 70.6%. Anemia at baseline was observed in both groups (63.2%), however, it was significantly more pronounced in the HIV+. At the end, energy malnutrition was reduced to 57.1% (42.9% of HIV- and 71.4% of the HIV+). Micronutrients malnutrition was evident in 71.4% of the HIV- patients and 85.7% of HIV+ patients at the end of tuberculosis therapy. Using BMI (≤ 18.5 kg/m2cutoff) as an index of malnutrition, it was detected in 23.9% of the HIV- and 27.3% of the HIV+ patients at baseline, with no evident improvement over time; using TSF (≤ 11.4mm as cutoff) or MUAC (≤ 28.5cm as cutoff), malnutrition was detected in 70.1% and 85.3% of all patients, respectively. Nevertheless, combining all biomarkers, at the end of follow-up, all patients suffered from malnutrition.Although with a limited number of patients, the evidence does not support that dietary counseling is effective to recover from malnutrition in our population

Anemia in tuberculosis cases: A biomarker of severity?

IntroductionAnemia is a common condition at tuberculosis diagnosis, and there is evidence that its prevalence is higher in patients with tuberculosis than in those infected with Mycobacterium tuberculosis and healthy controls. Information about anemia during tuberculosis diagnosis is still scarce in the Brazilian population. The aim of this study was to describe the prevalence of anemia in patients with tuberculosis cared for at a referral center and its association with clinical forms of tuberculosis and other characteristics of these patients.Materials and methodsThis was a retrospective cross-sectional study of tuberculosis patients diagnosed from January 2015 to December 2018 at the Clinical Research Laboratory on Mycobacteria (LAPCLIN-TB) of Evandro Chagas National Institute of Infectious Diseases (INI)/Oswaldo Cruz Foundation (Fiocruz). A database of an ongoing cohort study underway at this service since 2000 provided the baseline information on tuberculosis cases extracted from a visit template. Exploratory and logistic regression analyses were performed to verify associations between anemia and demographic characteristics, socioeconomic status, clinical conditions, and laboratory results.ResultsOf the 328 cases reviewed, 70 were excluded, with258 retained. The prevalence of anemia was 61.2% (27.5% mild, 27.5% moderate and 6.2% severe). Among patients with anemia, 60.8% had normochromic normocytic anemia, and 27.8% showed hypochromic microcytic anemia. In logistic regression analysis, anemia was associated with a history of weight loss >10%, hospitalizations, coinfection with HIV, increased platelet count and microcytosis. Anemia was more frequent in the most severe clinical forms, such as meningeal and disseminated tuberculosis.ConclusionsAnemia was highly prevalent in tuberculosis patients at diagnosis, predominantly as normochromic normocytic anemia and in mild and moderate forms. It was associated with baseline characteristics and conditions indicative of severe disease, suggesting that anemia could be a biomarker of tuberculosis severity