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The 21st Century Cures Act: can the regulatory framework survive the “cures”?
(Cadernos de Saúde Pública, 2015) Osorio-de-Castro, Claudia Garcia Serpa; Caetano, Rosângela; Pepe, Vera Lúcia Edais
In 1963, Edward Lorenz proposed a theory, which has now entered into lore, that the ripples in the air produced by the fluttering of a butterfly’s wings may cause a hurricane on the other side of the planet. In July 2015, the House of Representatives of the United States Congress approved an act that considerably alters the USA’s regulatory framework. The act, known as the 21st Century Cures Act (“ an act to accelerate the discovery, development, and delivery of 21st Century cures, and for other purposes ” 1) is now to be examined by the Senate. Both the Democratic and Republican parties worked jointly to pass this legislation.
A incorporação do nusinersena no Sistema Único de Saúde: uma reflexão crítica sobre a institucionalização da avaliação de tecnologias em saúde no Brasil
(Cadernos de Saúde Pública, 2019) Caetano, Rosângela; Hauegen, Renata Curi; Osorio-de-Castro, Claudia Garcia Serpa
Em abril de 2019, foi assinada a portaria de incorporação do medicamento nusinersena no Sistema Único de Saúde (SUS). É o medicamento mais caro já incorporado ao SUS, para uso no tratamento de atrofia muscular espinhal 5q tipo I. A incorporação é referida como um marco na tomada de decisão sobre novas tecnologias no SUS, a ser viabilizada por meio de acordo de partilha de risco. O trabalho discute o processo de incorporação do nusinersena, desta- cando aspectos contextuais, temporais e técnicos, além de possíveis consequên- cias para a institucionalização da avaliação de tecnologias em saúde (ATS) no SUS. Seguiu método exploratório, com revisão de informações públicas pro- duzidas pela Comissão de Incorporação de Tecnologias no SUS (CONITEC) e busca em bancos de dados governamentais de preços e compras. Foi produ- zida linha temporal descrevendo os pontos-chave do processo de incorporação. Houve dois pedidos de incorporação do medicamento. O primeiro, submeti- do pela Secretaria de Ciência, Tecnologia e Insumos Estratégicos (SCTIE) do Ministério da Saúde, negado por unanimidade, em novembro de 2018. Se- guiu-se o pedido do Secretário da SCTIE à Advocacia-Geral da União (AGU), para que pudesse decidir de forma contrária à recomendação do plenário da CONITEC. A AGU recomendou uma nova submissão, feita pela empresa produtora e aprovada por unanimidade, em março de 2019. Não houve acrés- cimo de novas evidências ou redução de preço que justificassem a mudança de decisão. Não foram identificados os elementos constituintes do acordo de partilha de risco. São sinalizados problemas de transparência e accountabi- lity, bem como riscos ao processo de institucionalização da ATS que vinha em curso no SUS.
A novel risk score for predicting new-onset atrial fibrillation in subjects with chronic chagas heart disease
(Heart Rhythm, 2010) Barbosa, Paulo R.; Tura, Bernardo R.; Barbosa-Filho, José; Kantharia, Bharat K.
Introduction: Atrial fibrillation affects about 20% of subjects with chronic Chagas disease (CCD) and heralds poor prognosis. This study prospectively investigated echocardiographic and electrocardiographic parameters aiming at creating a risk score for new-onset AF (NOAF) in CCD and to compare its performance to Rassi score. Methods: Clinically stable outpatients with CCD (34 to 74 y.o, 38 males) staged according to Los Andes (Class I: N=28; II: N=48; III: N=24) were enrolled. Patients were assessed by 12-lead ECG, 24h ambulatory ECG and 1D/2D echocardiogram. NOAF lasting >24h was tracked at three to six-month intervals. Results: During a follow-up of (mean±SEM) 91.2 ± 3.2 months, 18 developed NOAF (incidence: 30.2 ± 2.6 /year), and 20 died (rate: 26.4 ± 1.4 /year). Relative risk of NOAF for cardiac death was 3.6 (p=0.001). In multivariate Cox proportional hazard model, PVC>3,000/24h (p=0.02), LAD>3.3cm (p=0.001), and PAP>30mmHg (p=0.004) were independent predictors for NOAF (Table inset). A prognostic score for NOAF was developed by calculating weighted points proportional to beta coefficient in Cox model (table inset). ROC analysis of novel score showed optimal cut-off value at 2 (Figure A). KM curves of novel score for NOAF is presented in Figure B (proportional hazard test: rho=0.1; p=0.6). In 1,000 bootstraps, ROC c-statistic of novel score was significantly superior to Rassi score (Figure C). Conclusions: In CCD, high grade PVC, LAD>3.3cm and PAP>30mmHg are independent predictors for NOAF. Novel risk score improves NOAF predictive accuracy in this population.
A public health approach to increase treatment of latent TB among household contacts in Brazil
(International Journal of Tuberculosis and Lung Disease, 2020) Bastos, M. L.; Oxlade, O.; Benedetti, A.; Fregonese, F.; Valiquette, C.; Lira, S. C. C.; Carvalho-Cordeiro, D.; Cavalcante, J. R.; Faerstein, E.; Trajman, A.
SETTING: Two consecutive trials were conducted to evaluate the effectiveness of a public health approach to identify and correct problems in the care cascade for household contacts (HHCs) of TB patients in three Brazilian high TB incidence cities. METHODS: In the first trial, 12 clinics underwent standardised evaluation using questionnaires admin- istered to TB patients, HHCs and healthcare workers, and analysis of the cascade of latent TB care among HHCs. Six clinics were then randomised to receive interventions to strengthen management of latent TB infection (LTBI), including in-service training pro- vided by nurses, work process organisation and additional clinic-specific solutions. In the second trial, a similar but streamlined evaluation was conducted in two clinics, who then received initial and subsequent intensive in-service training provided by a physician. RESULTS: In the evaluation phase of both trials, many HHCs were identified, but few started LTBI treatment. After the intervention, the number of HHCs initiating treatment per 100 active TB patients increased by 10 (95%CI 11 to 30) in the first trial, and by 44 (95%CI 26 to 61) in the second trial. DISCUSSION: A public health approach with standard- ised evaluation, local decisions for improvements, followed by intensive initial and in-service training appears promising for improved LTBI management.
A risk score based on spectral turbulence analysis of the signal averaged ECG for predicting cardiac death in subjects with chronic chagas heart disease
(Heart Rhythm, 2010) Barbosa, Paulo R.; Tura, Bernardo R.; Barbosa, Eduardo C.; Barbosa-Filho, José; Kantharia, Bharat K.
Introduction: Cardiac involvement is the main cause of death in chronic Chagas disease (CCD). This study prospectively investigated signal-averaged ECG (SAECG), 24h-ambulatory ECG and echocardiogram parameters in CCD aiming at developing a predictive score for death. Methods: Clinically stable outpatients with CCD (34 to 74 y.o, 38 males) staged according to Los Andes (Class I: N=28; II: N=48; III: N=24) were enrolled. Deaths were ascertained by review of medical records. SAECG was acquired on admission. Spectral turbulence analysis (STA) was carried out on XYZ leads after short-time Fourier transform mapping of ventricular activation, and applying intersegment spectral correlation technique. Results: During a follow-up of (mean±SEM) 95.3 ± 3.1 months, 20 patients died (rate: 26.4 ± 1.4/year). In multivariate Cox proportional hazard model, NSVT/24h (p=0.006), LVEF<50% (p<0.001), and positive STA (p=0.001) were independent predictors of death (Table inset). A prognostic score was developed by calculating weighted points proportional to beta coefficient in Cox model (Table inset). ROC analysis showed optimal cut-off value at 5 (Figure A). KM curves of novel score for deaths are presented in Figure B (proportional hazard test: rho=-0.5; p=0.06). In 1,000 bootstraps, ROC c-statistic of novel score was superior to Rassi score (Figure C). Conclusions: In CCD, NSVT, LVEF<50% and high SAECG spectral turbulence are independent predictors of death. A novel risk score improves predictive accuracy in this population.
A simple protocol for tuberculin skin test reading certification
(Cadernos de Saúde Pública, 2021) Gloria, Lara de Lima; Bastos, Mayara Lisboa; Santos Jr, Bráulio dos; Trajman, Anete
Although tuberculosis preventive therapy is one of the cornerstones for eliminating the disease, many barriers exist in the cascade of care for latent tuberculosis infection, including the need to certify healthcare professionals for reading tuberculin skin tests (TST). This paper proposes and evaluates a simple protocol for TST reading training. Primary care workers from different backgrounds received a 2-hour theoretical course, followed by a practical course on bleb reading. Blebs were obtained by injecting saline into sausages and then in volunteers. A certified trainer then evaluated the effectiveness of this protocol by analyzing the trainees' ability to read TST induration in clinical routine, blinded to each other's readings. Interobserver agreement was analyzed using the Bland-Altman test. The trainees' reading accuracy was calculated using two cut-off points - 5 and 10mm - and the effect of the number of readings was analyzed using a linear mixed model. Eleven healthcare workers read 53 saline blebs and 88 TST indurations, with high agreement for TST reading (0.07mm average bias). Sensitivity was 100% (94.6; 100.0) at 5mm cut-off and 87.3% (75.5; 94.7) at 10mm cut-off. The regression model found no effect of the number of readings [coefficient: -0.007 (-0.055; 0.040)]. A simple training protocol for reading TST with saline blebs simulations in sausages and volunteers was sufficient to achieve accurate TST induration readings, with no effect observed for the number of readings. Training with saline blebs injected into voluntary individuals is safer and easier than the traditional method.
A Systematic Review and a Meta-Analysis of the Yellow Fever Vaccine in the Elderly Population
(Vaccines, 2022) Abreu, Ariane de Jesus Lopes de; Cavalcante, João Roberto; Lagos, Letícia Wigg de Araújo; Caetano, Rosângela; Braga, José Ueleres
We conducted a systematic review and a meta-analysis to assess the risk of serious adverse events in the elderly after yellow fever vaccination compared to the non-elderly population. We searched multiple databases and grey literature, and we selected research without language and publication date restrictions. Studies were analyzed in a descriptive way and meta-analyzed and expressed in terms of prevalence ratio and risk ratio with a 95% confidence interval, depending on the degree of heterogeneity found. A total of 18 studies were included and 11 were meta-analyzed. The results obtained through the meta-analysis showed a risk of serious adverse events after yellow fever vaccination three times higher for the elderly when compared to the non-elderly popula- tion and five times higher for persons > 70 years. In relation to adverse event types, viscerotropic disease associated with the yellow fever vaccine had a risk that was six times higher when com- pared to the population < 60 years. The evidence found supports that the vaccine indication in individuals > 60 years of age should be based on a careful analysis of individual benefit-risk assess- ments. The results found suggest a higher risk of events for individuals > 70 years, especially for viscerotropic and neurotropic disease associated with YFV contraindicating the use of the YFV in this age group.
Abdominal aortic aneurysmatic Ssc shrinking is the new paradigm after endovascular treatment
(Clinics in Surgery, 2021-07) Espinosa, Gaudencio; Saad, Pedro; di Luccio, Giovanni; Vaz, Pedro Duarte; Baptista, Luiz; Magliano, Carlos
Objectives: Aneurysmal Sac (SAC) absorption after endovascular treatment (EVAR) of Abdominal Aortic Aneurysms (AAA) is related to a better prognosis but its long-term mandatory and predictive factors remain unclear. Our study aims to assess the impact of its total resorption on patient survival, as well as the factors that favor resorption. Methods: We followed a187 patients who underwent EVAR with a fully thrombosed SAC for 22 years in the postoperative control of Angio-CT. We established the significance of the factors for SAC resorption by logistic regression models, evaluating comorbidities, diameter, sex and age of the patient. We also compared the impact of absorption sac absorption with survival. Results: Diameter and age were significant for the resorption of the SAC together or even independently (p-value <0.001), the diameter (OR-0.29) showed a greater influence than age (OR= -0.063). The comorbidities studied and the sex of the patients was not statistically significant. Patients who had significant absorption (≥ 10 mm) had a survival rate of 12.72 ± 0.96 years, those with moderate absorption (5 mm to 9 mm) had of 8.34 ± 1.62 years and those without significant resorption or growth had 3.27 ± 0.48 years (p-value <0.001). Among patients with absorption of ≥ 5 mm in the first year, we found greater chances of total absorption (OR=4.72 p-value <0.001). Conclusion: Total sac resorption proved to be an important prognostic factor for patient survival after EVAR. The age of the patient and mainly the initial diameter of the sac were the factors significantly associated with the resorption of the sac.
Accuracy of ltrassonography in the diagnosis of hepatic steatosis and abdominal fat in adolescents: a systematic rewiew
(PARIPEX - Indian Journal of Research, 2018) Takey, Márcia; d'Abreu, Henrique César Chaves; Beker, Roseanne Szumsztajn B; Santos, Bráulio; Santos, Marisa da Silva; Kuschnir, Maria Cristina Caetano
INTRODUCTION: With the growing number of overweight adolescents, there was an increase in the prevalence of non-alcoholic fatty liver disease. MATERIAL AND METHOD: We performed a systematic review of the literature to identify and synthesize the available evidence on the ultrasonography accuracy in the diagnosis of hepatic steatosis and measurement of abdominal fat compared to computed tomography or magnetic resonance imaging in obese adolescents. Seven databases (MEDLINE, Cochrane Database of Systematic Reviews, SCOPUS, WEB of SCIENCE, EMBASE, LILACS and ADOLEC) were reviewed. RESULTS: three studies were included in a qualitative synthesis. CONCLUSIONS: Ultrasonography does not have the accuracy needed to classify the degree of steatosis. Magnetic resonance imaging would be considered a more useful and objective method than ultrasonography to discriminate differences in liver fat content and for monitoring of young patients with hepatic steatosis
Accuracy of positron emission tomography and positron emission tomography-CT in the detection of differentiated thyroid cancer recurrence with negative 131I whole-body scan results: A meta-analysis
(Head & Neck, 2016) Caetano, Rosângela; Bastos, Claudia Regina Garcia; Oliveira, Ione Ayala Gualandi de; Silva, Rondineli Mendes da; Fortes, Clarisse Pereira Dias Drumond; Pepe, Vera Lucia Edais; Reis, Lenice Gnocchi; Braga, Jose Ueleres
Background. The purpose of this review was to present a meta-analysis aimed to evaluate the accuracy of positron emission tomography (PET) and PET-CT for detecting recurrence of differentiated thyroid carcinoma (DTC) not identified by 131I whole-body scintigraphy. Methods. MEDLINE, EMBASE, LILACS, and Cochrane databases were searched for studies published between January 1985 and March 2012. Systematic methods were used to select and evaluate the quality of studies. Pooled sensitivity and specificity for conventional PET and PET- CT was estimated using random effects model. Results. Twenty studies were included in the systematic review; the data of 18 studies were used in the meta-analysis. The combined sensitivity and specificity for conventional PET were both found to be 84%; for PET- CT, they were 93% and 81%, respectively. The overall accuracies were 91% and 93%, respectively. Conclusion. 18Fluorodeoxyglucose (FDG)-PET and PET-CT are highly accurate diagnostics tools for DTC recurrence in patients who present a negative whole-body scintigraphy and could impact the clinical and ther- apeutic management of DTC. VC 2015 Wiley Periodicals, Inc. Head Neck 38: 316–327, 2016.
Accuracy of self-reported hypertension in Brazilian adolescents: Analysis of the Study of Cardiovascular Risk in Adolescents
(The Journal of Clinical Hypertension, 2018) Gonçalves, Vivian S. S.; Galvão, Taís F.; Silva, Marcus T.; Kuschnir, Maria C.; Dutra, Eliane S.; Carvalho, Kênia M. B.
Given the high prevalence of hypertension in adolescents, it is important to investi- gate alternatives for estimating the magnitude of the disease. Our objective was to investigate the accuracy of self-reported hypertension. The study assessed partici- pants of the Study of Cardiovascular Risk in Adolescents (ERICA). The following were calculated: sensitivity, specificity, positive predictive value (PPV), and negative pre- dictive value (NPV). The associations between inaccurate self-reporting and socio- economic factors were investigated. The accuracy of self-reported hypertension had a sensitivity of 7.5% (95% CI, 6.9-8.2), a specificity of 96.6% (95% CI, 96.5-96.7), a PPV of 18.9% (95% CI, 17.4-20.5), and a NPV of 90.8% (95% CI, 90.6-91.0). The prev- alence of inaccurate self-reported hypertension was smaller among girls (PR 0.68; 95% CI, 0.55-0.83) and younger boys (PR 0.68; 95% CI, 0.54-0.86) who were attend- ing private schools. The use of self-reported hypertension was not a good strategy for investigating the hypertension in adolescents.
Accuracy of Zika virus disease case definition during simultaneous Dengue and Chikungunya epidemics
(PLOS One, 2017) Braga, José Ueleres; Bressan, Clarisse; Dalvi, Ana Paula Razal; Calvet, Guilherme Amaral; Daumas, Regina Paiva; Rodrigues, Nadia; Wakimoto, Mayumi; Nogueira, Rita Maria Ribeiro; Nielsen-Saines, Karin; Brito, Carlos; Filippis, Ana Maria Bispo de; Brasil, Patrícia
Background Zika is a new disease in the American continent and its surveillance is of utmost importance, especially because of its ability to cause neurological manifestations as Guillain-Barre ́ syn- drome and serious congenital malformations through vertical transmission. The detection of suspected cases by the surveillance system depends on the case definition adopted. As the laboratory diagnosis of Zika infection still relies on the use of expensive and complex molec- ular techniques with low sensitivity due to a narrow window of detection, most suspected cases are not confirmed by laboratory tests, mainly reserved for pregnant women and new- borns. In this context, an accurate definition of a suspected Zika case is crucial in order for the surveillance system to gauge the magnitude of an epidemic. Methodology We evaluated the accuracy of various Zika case definitions in a scenario where Dengue and Chikungunya viruses co-circulate. Signs and symptoms that best discriminated PCR con- firmed Zika from other laboratory confirmed febrile or exanthematic diseases were identified to propose and test predictive models for Zika infection based on these clinical features. Results and discussion Our derived score prediction model had the best performance because it demonstrated the highest sensitivity and specificity, 866% and 783%, respectively. This Zika case definition also had the highest values for auROC (0903) and R2 (0417), and the lowest Brier score 0096. Conclusions In areas where multiple arboviruses circulate, the presence of rash with pruritus or conjuncti- val hyperemia, without any other general clinical manifestations such as fever, petechia or anorexia is the best Zika case definition.
Acesso ao diagnóstico da tuberculose em serviços de saúde do município de Vitória, ES, Brasil
(Ciência & Saúde Coletiva, 2014) Loureiro, Rafaela Borges; Villa, Tereza Cristina Scatena; Ruffino-Netto, Antônio; Peres, Renata Lyrio; Braga, José Ueleres; Zandonade, Eliana; Maciel, Ethel Leonor Noia
Objetivou-se avaliar a acessibilidade ao diagnóstico da tuberculose nos serviços de saúde em Vitória (ES). Estudo transversal realizado em 2009 com doentes de tuberculose, utilizando o instrumento Primary Care Assessment Tool. Análise estatística com Teste Qui-quadrado (p < 0,05). Em relação à porta de entrada, notou-se que o serviço de saúde mais procurado foi Atenção Básica (37,6%); a maioria dos diagnósticos ocorreu nas Unidades de Referência do Programa de Controle da Tuberculose (61,3%). Houve evidência de associação entre primeiro serviço de saúde procurado e fatores tempo de demora na obtenção de consulta neste (p = 0,0182), hipótese diagnóstica feita pelo primeiro serviço de saúde procurado (p = 0,0001), solicitação exame de escarro (p = 0,0003), solicitação exame de Raios-X (p = 0,0159), encaminhamento para Raios-X em outro serviço (p = 0,0001), diagnóstico pelo mesmo serviço de saúde (p = 0,0001), exames realizados no próprio serviço de saúde que diagnosticou tuberculose (p = 0,0018), proximidade do domicílio (p = 0,0001). Portanto, a identificação de lacunas importantes na acessibilidade ao diagnóstico de tuberculose parece estar relacionada às dificuldades operacionais de organização da atenção à saúde.
Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT)
(Circulation, 2011) ACT Investigators; Tura, Bernardo R; Santos Junior, Bráulio dos; Cramer, Helena
Background: It remains uncertain whether acetylcysteine prevents contrast-induced acute kidney injury. Methods and results: We randomly assigned 2308 patients undergoing an intravascular angiographic procedure with at least 1 risk factor for contrast-induced acute kidney injury (age >70 years, renal failure, diabetes mellitus, heart failure, or hypotension) to acetylcysteine 1200 mg or placebo. The study drugs were administered orally twice daily for 2 doses before and 2 doses after the procedure. The allocation was concealed (central Web-based randomization). All analysis followed the intention-to-treat principle. The incidence of contrast-induced acute kidney injury (primary end point) was 12.7% in the acetylcysteine group and 12.7% in the control group (relative risk, 1.00; 95% confidence interval, 0.81 to 1.25; P=0.97). A combined end point of mortality or need for dialysis at 30 days was also similar in both groups (2.2% and 2.3%, respectively; hazard ratio, 0.97; 95% confidence interval, 0.56 to 1.69; P=0.92). Consistent effects were observed in all subgroups analyzed, including those with renal impairment. Conclusions: In this large randomized trial, we found that acetylcysteine does not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in at-risk patients undergoing coronary and peripheral vascular angiography. Clinical trial registration: http://www.clinicaltrials.gov. Unique identifier: NCT00736866.
Active and latent tuberculosis in refugees and asylum seekers: a systematic review and meta-analysis
(BMC Public Health, 2020) Proença, Raquel; Souza, Fernanda Mattos; Bastos, Mayara Lisboa; Caetano, Rosângela; Braga, José Ueleres; Faerstein, Eduardo; Trajman, Anete
Background: In 2018, there were 70.8 million refugees, asylum seekers and persons displaced by wars and conflicts worldwide. Many of these individuals face a high risk for tuberculosis in their country of origin, which may be accentuated by adverse conditions endured during their journey. We summarised the prevalence of active and latent tuberculosis infection in refugees and asylum seekers through a systematic literature review and meta- analyses by country of origin and host continent. Methods: Articles published in Medline, EMBASE, Web of Science and LILACS from January 2000 to August 2017 were searched for, without language restriction. Two independent authors performed the study selection, data extraction and quality assessment. Random effect models were used to estimate average measures of active and latent tuberculosis prevalence. Sub-group meta-analyses were performed according to country of origin and host continent. Results: Sixty-seven out of 767 identified articles were included, of which 16 entered the meta-analyses. Average prevalence of active and latent tuberculosis was 1331 per 100 thousand inhabitants [95% confidence interval (CI) = 542–2384] and 37% (95% CI = 23–52%), respectively, both with high level of heterogeneity (variation in estimative attributable to heterogeneity [I2 ] = 98.2 and 99.8%). Prevalence varied more according to countries of origin than host continent. Ninety-one per cent of studies reported routine screening of recently arrived immigrants in the host country; two-thirds confirmed tuberculosis bacteriologically. Many studies failed to provide relevant information. Conclusion: Tuberculosis is a major health problem among refugees and asylum seekers and should be given special attention in any host continent. To protect this vulnerable population, ensuring access to healthcare for early detection for prevention and treatment of the disease is essential.
Acurácia do relacionamento probabilístico na avaliação da alta complexidade em cardiologia
(Revista de Saúde Pública, 2011) Migowski, Arn; Chaves, Rogério Brant Martins; Coeli, Cláudia Medina; Ribeiro, Antonio Luiz Pinho; Tura, Bernardo Rangel; Kuschnir, Maria Cristina Caetano; Azevedo, Vitor Manuel Pereira; Floriano, Daniel Brasil; Magalhães, Carlos Alberto Moreira; Pinheiro, Márcia Cristina Chagas Macedo; Xavier, Regina Maria de Aquino
OBJETIVO: Avaliar a viabilidade de estratégia de relacionamento probabilístico de bases de dados na identificação de óbitos de pacientes submetidos a procedimentos de alta complexidade em cardiologia. MÉTODOS: O custo de processamento foi estimado com base em 1.672 registros de pacientes submetidos à cirurgia de revascularização do miocárdio, relacionados com todos os registros de óbito no Brasil em 2005. A acurácia do relacionamento baseou-se em linkage probabilístico entre 99 registros de autorização de internação hospitalar de pacientes submetidos a cirurgias cardíacas em instituto de referência em cardiologia, com status vital conhecido, e todos os registros de óbito do estado do Rio de Janeiro em 2005. O linkage foi realizado em quatro etapas: padronização das bases, blocagem, pareamento e classificação dos pares. Utilizou-se a blocagem em cinco passos, com chaves de blocagem com combinação de variáveis como soundex do primeiro e último nome, sexo e ano de nascimento. As variáveis utilizadas no pareamento foram "nome completo", com a utilização da distância de Levenshtein, e "data de nascimento". RESULTADOS: O segundo e o quinto passos de blocagem tiveram os maiores números de pares formados e os maiores tempos de processamento para o pareamento. O quarto passo demandou menor custo de processamento. No estudo de acurácia, após os cinco passos de blocagem, a sensibilidade do linkage foi de 90,6% e a especificidade foi de 100%. CONCLUSÕES: A estratégia de relacionamento probabilístico utilizada apresenta boa acurácia e poderá ser utilizada em estudos sobre a efetividade dos procedimentos de alta complexidade e alto custo em cardiologia.
Ações voltadas para o tabagismo: análise de sua implementação na Atenção Primária à Saúde
(Ciência & Saúde Coletiva, 2014) Portes, Leonardo Henriques; Campos, Estela Marcia Saraiva; Teixeira, Maria Teresa Bustamante; Caetano, Rosângela; Ribeiro, Luiz Cláudio
A pesquisa analisou a situação de imple- mentação das políticas voltadas para o controle do tabagismo em município de médio porte através da verificação das ações preconizadas pelo Progra- ma Nacional de Controle do Tabagismo (PNCT) desenvolvidas em Unidades de Atenção Primária à Saúde (UAPS). Foram entrevistados o coorde- nador municipal do PNCT e profissionais das 44 UAPS de Juiz de Fora (MG), entre maio e julho de 2011. Observou-se que as ações de tratamento e de promoção da saúde vêm sendo executadas, tendo destaque a capacitação de profissionais para im- plementação do tratamento nas UAPS. Em 40,9% das UAPS, há a oferta do tratamento para o fu- mante e, em 88,6%, as ações concentram-se em atividades de salas de espera, grupos e consultas individuais. Provavelmente não se restringem ao município a inadequada estruturação das unida- des, a alta rotatividade de trabalhadores, o grau variado de comprometimento dos profissionais em implementarem o atendimento e a carência de mecanismos que lhes permitam iniciar e dar con- tinuidade aos atendimentos em meio às demais atribuições que possuem. O grande desafio para o controle do tabagismo é realizar as ações interse- toriais e na atenção primária. Os resultados po- dem servir para a formulação de ações estratégicas de saúde em outras localidades do país.
Adesão às Listas de Medicamentos Essenciais por Médicos Brasileiros em Atuação no Sistema Único de Saúde
(Revista Brasileira de Educação Médica, 2014) Magarinos-Torres, Rachel; Esher, Ângela; Caetano, Rosângela; Pepe, Vera Lúcia Edais; Osorio-de-Castro, Claudia Garcia Serpa
Objetivo: Investigou-se a adesão de médicos brasileiros em atuação no SUS a listas de medicamentos essenciais (LME), buscando conhecer o papel das LME na prática prescritiva e identificar a aceitação e barreiras para sua uti- lização no Brasil. Métodos: O estudo, de âmbito nacional, entrevistou médicos da Atenção Primária e da hospita- lar de 30 unidades públicas de saúde de municípios com e sem LME definida. Na análise dos dados foram utilizadas técnicas da pesquisa qualitativa em saúde. As categorias finais de análise foram: (i) contato com diferentes LME; (ii) utilização das LME na prática clínica; (iii) percepção do conceito de medicamentos essenciais. Resultados: Foram ouvidos 58 médicos, sendo 11 do Nordeste e do Centro-Oeste e 12 do Sudeste, Norte e Sul. Apenas 17 dos 58 médicos entrevistados informaram contato anterior com uma LME, a maior parte referindo-se à lista municipal. Quando perguntados se utilizavam a Rename em sua prática clínica, todos os entrevistados responderam que não. Dentre os motivos citados, estão (i) a indisponibilidade dos medicamentos (da lista) no momento requerido; (ii) a falta de orientação necessária para o uso; (iii) a impressão de que a composição da lista é inadequada à demanda clínica. Conclusões: Os resultados das falas expõem desconhecimento e baixa adesão a LME. Ainda que tenham tido algum contato prévio com uma LME, esta não é valorizada como fonte de informações para a prescrição ba- seada em evidências.
Adoecimentos raros e o diálogo associativo: ressignificações para experiências morais
(Ciência & Saúde Coletiva, 2019) Moreira, Martha Cristina Nunes; Nascimento, Marcos Antonio Ferreira do; Campos, Daniel de Souza; Albernaz, Lidianne; Costa, Ana Carolina Carioca da; Barros, Letícia Baptista de Paula; Horovitz, Dafne Dain Gandelman; Martins, Antilia Januária; Madureira, Adelino Furtado; Oliveira, Nicole Velloso de; Pinto, Márcia
Neste artigo, buscamos discutir a ex- periência de familiares de crianças e adolescentes com doenças raras como uma experiência moral. A experiência moral se caracteriza pelo sofrimento que é lido, coletivamente, como acontecimento ca- tastrófico, mobilizando recursos para significação e sentido que possibilitem reconstruções identi- tárias, valoração de novas trajetórias a partir de um diagnóstico raro, assim como a busca de pares. Nesse sentido, é fundamental a construção de re- lações de reconhecimento, alteridade e pertenci- mento. A partir de uma perspectiva interacionista simbólica, os resultados mostram dois núcleos: (1) o susto como surpresa diante do diagnóstico ines- perado, levando a busca de pares e promoção do reconhecimento social; (2) o custo envolvido com a trajetória de uma doença rara que implica um trabalho de care e a aquisição de capital associati- vo como possibilidade de fortalecimento e constru- ção de capital social de cuidado à saúde.
Adverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trials
(The Lancet: Infectious Diseases, 2020) Campbell, Jonathon R; Trajman, Anete; Cook, Victoria J; Johnston, James C; Adjobimey, Menonli; Ruslami, Rovina; Eisenbeis, Lisa; Fregonese, Federica; Valiquette, Chantal; Beneditti, Andrea; Menzies, Dick
Background An important problem limiting treatment of latent tuberculosis infection is the occurrence of adverse events with isoniazid. We combined populations from phase 2 and phase 3 open-label, randomised controlled trials, to establish risk factors for adverse events during latent tuberculosis infection treatment. Methods We did a post-hoc safety analysis based on data from two open-label, randomised controlled trials done in health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea. Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to rifampicin or isoniazid. Patients were centrally randomly assigned 1:1 to 4 months of daily 10 mg/kg rifampicin or 9 months of daily 5 mg/kg isoniazid. The primary outcome evaluated was adverse events (including grade 1–2 rash and all events of grade 3–5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug by a masked, independent,three-member adjudication panel (trial registration: NCT00170209; NCT00931736). Findings Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3). The safety populations for each group comprised 3205 individuals receiving isoniazid and 280 receiving rifampicin. Among those receiving isoniazid, 86 (2·7%) of 3205 had grade 1–2 rash or any grade 3–5 adverse events, more than the 50 (1·5%) of 3280 who had these events with rifampicin (risk difference –1·2%, 95% CI –1·9 to –0·5). Age was associated with adverse events in adults receiving isoniazid. Compared with individuals aged 18–34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1–3·0) for individuals aged 35–64 years and 3·0 (1·2–6·8) for individuals aged 65–90 years. With rifampicin, adverse events were associated with inconsistent medication adherence (adjusted OR 2·0, 1·1–3·6) and concomitant medication use (2·8, 1·5–5·2), but not age, with an adjusted OR of 1·1 (0·6–2·1) for individuals aged 35–64 years and 1·7 (0·5–4·7) for individuals aged 65–90 years. One treatment-related death occurred in the isoniazid group. Interpretation In patients without a contraindication, rifampicin is likely to be the safest latent tuberculosis infection treatment option. With more widespread use of rifampicin, rare, but serious adverse events might be seen. However, within these randomised trials, rifampicin was safer than isoniazid and adverse events were not associated with older age. Therefore, rifampicin should become a primary treatment option for latent tuberculosis infection based on its safety.

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