Risk factors for adverse events of colorectal endoscopic submucosal dissection: a systematic review and meta-analysis.

Colorectal endoscopic submucosal dissection (ESD) is already an established treatment for superficial colorectal tumors. However, its technical difficulty and high adverse events rates, compared to endoscopic piecemeal mucosal resection, are a concern to some specialists and have probably contributed to discouragement in its widespread adoption. The debate mentioned above stimulated us to perform a systematic review aiming to identify risk factors for colorectal ESD-related adverse events. We conducted this study following the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement and registered in the PROSPERO (University of York) international database (CRD42016042625). We searched MEDLINE, EMBASE, Cochrane Library and LILACS for the publications focused on risk factors for colorectal ESD-related adverse events from inception until April 2020. We included a total of 22 qualified studies in this analysis. We found that fibrosis had an odds ratio (OR) for perforation of 2.90 [95% confidence interval, (1.83-4.59)], right colon location of 2.35 (1.58-3.50), colonic location of 2.20 (1.44-3.35) and larger size of 2.17 (1.47-3.21), as well as one protective factor, the endoscopist experience OR = 0.62 (0.45-0.86). For bleeding, we considered rectal location a risk factor [OR = 3.55 (2.06-6.12)]. Through the several meta-analyses that we performed in this article, we could summarize the main risk factors for perforation and bleeding on colorectal ESD. Therefore, we provide insightful information for clinical judgment on regions where colorectal ESD is already widespread and help in the learning process of this challenging technique.

Avaliação crítica de estudos de custo-efetividade de medicamentos oncológicos recomendados para incorporação pela Conitec no Brasil / Critical appraisal of cost-effectiveness studies of oncologic drugs recommended for incorporation by the Conitec in Brazil

Objetivo: Realizar uma análise descritiva e avaliar a qualidade metodológica das análises de custo-efetividade dos medicamentos recomendados para incorporação pela Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec) para o tratamento de câncer. Métodos: Um levantamento no site da Conitec foi realizado para identificar os relatórios de recomendação para medicamentos utilizados no tratamento de câncer, datados de janeiro/2012 a junho/2019. Os relatórios dos medicamentos com recomendação para incorporação e que apresentavam estudos de avaliação econômica em saúde foram incluídos. Uma análise descritiva e da qualidade metodológica (ferramenta Consensus on Health Economic Criteria [CHEC]) foi realizada. Resultados: Dez indicações diferentes, de oito medicamentos, para tratamento de câncer foram recomendadas pela Conitec de janeiro/2012 a junho/2019, porém somente cinco (50%) dispunham de estudos de avaliação econômica. Um estudo foi excluído da avaliação da qualidade devido a limitações de acesso às informações. A qualidade metodológica foi variável nos estudos apresentados, e os domínios com pior avaliação se relacionavam a medida apropriada do desfecho e custos, discussões sobre ética, conflito de interesse e generalização dos dados. Observa-se uma falta de padronização na forma como foram realizadas as avaliações econômicas dos estudos submetidos à Conitec. Conclusão: Há grande heterogeneidade em relação à qualidade dos estudos de custo-efetividade de medicamentos oncológicos recomendados para incorporação pela Conitec e limitações metodológicas relevantes foram identificadas na maioria dos estudos

Objective: To perform a descriptive analysis and evaluate the methodological quality of the costeffectiveness studies that based the "Comissão Nacional de Incorporação de Tecnologias no SUS" (Conitec) recommendations for cancer treatment. Methods: A survey on the Conitec website was performed in order to identify the recommendation reports for anticancer drugs, from January/2012 to June/2019. Reports for new drug incorporation that presented cost-effectiveness were included and analyzed. The methodological quality of these reports was assessed with the tool Consensus on Health Economic Criteria (CHEC). Results: Ten different indications of eight anticancer drugs were recommended by Conitec from 2012 to June/2019, but only five (50%) had health economic analysis. One study was excluded from quality assessment due to limited information access. Methodological quality varies among the studies. The worst domains assessed were related to appropriate measurement of outcome and costs, ethics-related discussions, conflict of interest, and generalizability of the results. A lack of standardization was observed in Conitec's assessment on health economic studies submitted. Conclusion: There is a great heterogeneity in cost-effectiveness study quality of cancer drugs recommended by Conitec and relevant methodological limitations was noticed

Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018.

Regulatory agencies around the world have been using flexible requirements for approval of new drugs, especially for cancer drugs. The US Food and Drug Administration (FDA) is mostly the first agency to approve new drugs worldwide, mainly due to the faster terms of the accelerated pathway and breakthrough therapy designation. Surrogate endpoints and preliminary data (e.g. single-arm and phase 2 studies) are used for these new approvals, however larger effect sizes are expected. We aim to compare FDA Accelerated vs Regular Pathway approvals and Breakthrough therapy designations (BTD) for lung cancer treatments between 2006 and 2018 regarding study design, sample size, outcome measures and effect size. We assessed the FDA database to collect data from studies that formed the basis of approvals of new drugs or indications for lung cancer spanning from 2006 to 2018. We found that accelerated pathway approvals are based on significantly more single-arm studies with small sample sizes and surrogate primary endpoints. However, effect size was not different between the pathways. A large proportion of studies used to support regular pathway approvals also showed these characteristics that are related to low quality and uncertain evidence. Compared to other approvals, BTD were more frequently based on single-arm studies. There was no significant difference in use of surrogate endpoints or sample size. 44% of BTD were based on studies demonstrating large effect sizes, proportionally more than approvals not receiving this designation. In conclusion, based on the indicators of evidence quality we extracted, criteria's for granting accelerated approval and breakthrough therapy designation seen not clear. Faster approvals are in the majority full of uncertainties which should be viewed with caution and the patient have to be communicated to allow shared decision making. Post-marketing validation is essential.

U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer.

OBJECTIVE: This paper aims to describe the clinical and regulatory aspects of new drugs and indications that were approved for lung, breast, prostate, and colorectal cancer, from 2016 to 2018, in order to provide health technology assessment trends in oncology. METHODS: Data were collected from the US Food and Drug Administration (FDA) online database for new medications and indications approved for the above-mentioned types of cancer. Data regarding clinical study characteristics and regulatory information were collected. RESULTS: From 2016 to 2018, 53 percent of the FDA approvals of new drugs and indications for the most incident cancers were for oral protein kinase inhibitor monotherapy for advanced lung cancer. Since 2018, four drugs were approved as tumor-agnostic therapies. A biomarker was included in 72 percent of indications, and 58 percent of approvals were for targeted therapies, potentially heralding an end to research into conventional cytotoxic agents. A special designation for faster approval was granted in 78 percent of new approvals. The majority of the studies were open label randomized controlled trials (RCTs) (44 percent), followed by blind RCTs, single-arm clinical trials, and cohort studies. Only 14 percent of studies used overall survival as the primary end point; the vast majority used surrogate end points, and did not use patient-important outcomes. Three biosimilars were approved in the period. CONCLUSION: Advanced lung cancer therapy, mainly targeted drugs, accounted for 53 percent of approvals. Special designations for faster approval were used in 78 percent of FDA approvals, and four drugs were approved for tumor-agnostic treatment-a new form of approval.

Níveis de prevenção cardiovascular / Cardiovascular disease prevention levels

Epidemiologia clínica é o campo de conhecimento que estuda as melhores práticas assistenciais, com foco nos interesses do paciente de compartilhar as decisões com os médicos e demais profissionais de saúde que realizam o atendimento ou prestam cuida-dos. Vale-se da mesma metodologia usada pela epidemiologia tradicional para qualificar e desenvolver a pesquisa aplicada à prática clínica. A vacinação contra a febre amarela, mostra bem a diferença entre os interesses da epidemiologia clínica e os da epidemiologia tradicional. A estratégia populacional pode trazer muitos benefícios para a coletividade que, no geral, apresenta baixo risco e muitos malefícios para um grupo muito menor de indivíduos de alto risco. Os padrões de ações preventivas modificam-se de acordo com a evolução no tempo. Além da prevenção primordial, primária, secundária e terciária este texto discute a prevenção quaternária por meio de ações que visam evitar os danos associados ao uso excessivo de procedimentos diagnósticos e terapêuticos. O diálogo sobre saúde é um contraponto entre o saber científico e o saber popular, a informação dada a partir do conhecimento prévio do indivíduo e da comunidade deve respeitar seus valores, como exemplificado por trabalhos realizados em escolas de ensino fundamental.

Clinical Epidemiology is the field of knowledge that studies the best care practices, focusing on the patient's interest in sharing decisions with physicians and other health professionals who provide treatment or health care. It employs the same methodology used by traditional epidemiology to qualify and develop research applied to clinical practice. Vaccination against yellow fever clearly shows the difference between the interests of clinical epidemiology and those of traditional epidemiology. Population strategy can produce many benefits for society as a whole, which generally involves a lower risk, to the detriment of a much smaller group of high-risk individuals. Preventive care patterns change according to temporal evolution. In addition to primordial, primary, secondary and tertiary prevention, this text also discusses quaternary prevention through actions aimed at avoiding the damage associated with the excessive use of diagnostic and therapeutic procedures. The dialogue on health is a counterpoint between scientific knowledge and common knowledge. Information produced from the prior knowledge of the individual and the community must respect their values, as exemplified by work carried out in elementary schools

Ice pack induced perineal analgesia after spontaneous vaginal birth: Randomized controlled trial.

BACKGROUND: Ice-pack is widely used for alleviating postpartum perineal pain sustained after birth related perineal trauma. However, it lacks robust evidence on timing and frequency of applications, to ensure the effective and safe use of this therapy. AIMS: To evaluate if a 10min ice-pack application relieved postpartum perineal pain and if the analgesic effect was maintained for up to 2h. METHODS: A randomised controlled trial conducted from December 2012 to February 2013 with 69 primiparous women ≥18 years old, 6-24h postpartum, with perineal pain ≥3, who had not received anti-inflammatory medication or analgesics after childbirth, who were randomised to a single ice-pack application on the perineum for 10min or standard care. The primary and secondary outcomes were a reduction ≥30% in perineal pain intensity, immediately after the application and the maintenance of the analgesic effect for up to 2h, respectively. FINDINGS: Immediately post-intervention, the proportion of women whose perineal pain decreased ≥30% was significantly higher in the experimental group. Within 2h, there was no significant difference in the pain levels in both groups. Within 2h, for 61.9% and 89.3% of women in the experimental and control group, respectively, the perineal pain levels remained unchanged. For the remaining participants, perineal pain was increasing after an average time of 1h 45min and 1h 56min for the experimental and control groups, respectively. CONCLUSION: By applying an ice-pack for 10min to the perineum, effective pain relief is achieved, that is maintained for between 1h 45min and 2h.

Quality of life in patients with implantable cardioverter-defibrillator: systematic review of randomized controlled trials.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy significantly improves the survival of patients who are at high risk for sudden cardiac death. However, it is unclear whether this survival is accompanied by impairment on quality of life (QoL). OBJECTIVES: This systematic review sought to describe whether ICD therapy, as compared with standard treatment, can have an impact on QoL outcomes. METHODS: Extensive literature searches were carried out in PubMed, EMBASE, LILACS and Cochrane Library. Eligible studies were randomized controlled trials (RCTs) of ICD versus medical therapy that reported valid and reliable measures of QoL. Included studies were reviewed to determine baseline patient characteristics, mean duration of follow-up, questionnaires used to assess QoL and association between QoL scores and ICD shock therapy. RESULTS: Seven studies, enrolling a total of 5,701 patients, were included in this review. The analyzed trials showed conflicting results about the impact of ICD on QoL outcomes. Among the secondary prevention studies, CIDS reported a clear benefit from ICD and AVID showed no difference between ICD and amiodarone groups. Of the primary prevention trials, AMIOVIRT, MADIT II, DEFINITE, and SCD-HeFT found no evidence of impaired QoL in patients with an ICD. Evidence for an association between ICD shocks and QoL was mixed and seemed to depend on the interval between shocks and QoL assessment. CONCLUSION: There was no evidence of impaired QoL in patients with an ICD. However, ICD patients must be educated of all possible risks and benefits, including transitory declines in QoL after ICD shocks.

Staying in the labor force among patients with rheumatoid arthritis and associated factors in Southern Brazil.

BACKGROUND: Rheumatoid arthritis primarily affects the working-age population and may cause key functional and work limitations. As the disease progresses, individuals become increasingly unable to conduct daily activities, which has a substantial personal and socioeconomic impact. Fairly recent prior studies showed that patients with RA stop working 20 years earlier than age-matched controls. Factors related to sociodemographic, clinical, care and disease profiles might affect the loss of work capacity. The purpose of this study was to assess the factors associated with the prevalence of working patients with rheumatoid arthritis in the municipality of Blumenau. METHODS: A cross-sectional, population-based study was conducted between July 2014 and January 2015, with 296 individuals aged 20 years or older, male and female, living in Blumenau, Santa Catarina state, Brazil, and diagnosed with rheumatoid arthritis according to the 1987 American College of Rheumatology criteria. The prevalence of working patients with RA was assessed by employment status self-reporting during the interview. The chi-squared test, Wald test and Poisson regression analysis were used to test the possible associations between the independent variables and outcome. RESULTS: The prevalence of working patients with rheumatoid arthritis was 44.3%. Patients aged 20 to 59 years had a 90% higher prevalence of outcome than subjects aged 60 years or older. The prevalence of working patients was 132% and 73% higher among individuals with low income and high functional disability, measured using the Health Assessment Questionnaire (HAQ), respectively. CONCLUSION: The prevalence of working RA patients was highest among adult patients with low income and high functional disability. The first variable is directly related to the individual characteristic, the second reflects the socioeconomic context of the patient, and the third reflects the degree of disability caused by the disease, which may be modifiable by health professionals.

Prevalence of ischemic heart disease and associated factors in patients with rheumatoid arthritis in Southern Brazil.

OBJECTIVE: To estimate the prevalence of ischemic heart disease and associated factors in patients with rheumatoid arthritis. METHODS: A cross-sectional study using the American College of Rheumatology diagnostic criteria in order to select patients seen at primary or secondary health care units in Blumenau, Santa Catarina, Southern Brazil, in 2014. The presence of ischemic heart disease was defined as an acute myocardial infarction with percutaneous coronary intervention or coronary artery bypass graft surgery that has occurred after diagnosis. Fischer's exact test, Wald's linear trend test, and multivariate logistic regression analysis were used to test the associations. RESULTS: Among 296 patients (83.1% female) with a mean age of 56.6 years and a mean rheumatoid arthritis duration of 11.3 years, 13 reported having acute myocardial infarction requiring a percutaneous or surgical reperfusion procedure, a prevalence of 4.4% (95% CI 2.0-6.7). Diabetes Mellitus (odds ratio [OR] 4.9 [95% CI 1.6-13.8]) and disease duration >10 years (OR 8.2 [95% CI 1.8-39.7]) were the only factors associated with an ischemic disease that remained in the final model, after the multivariate analysis. CONCLUSION: The prevalence of acute myocardial infarction was similar to that observed in other studies. Among the traditional risk factors, Diabetes Mellitus, and among the factors related to rheumatoid arthritis, disease duration, were the variables associated with comorbidity.

Prevalence of ischemic heart disease and associated factors in patients with rheumatoid arthritis in Southern Brazil / Prevalência de doença isquêmica cardíaca e fatores associados em pacientes com artrite reumatoide no Sul do Brasil

Abstract Objective: To estimate the prevalence of ischemic heart disease and associated factors in patients with rheumatoid arthritis. Methods: A cross-sectional study using the American College of Rheumatology diagnostic criteria in order to select patients seen at primary or secondary health care units in Blumenau, Santa Catarina, Southern Brazil, in 2014. The presence of ischemic heart disease was defined as an acute myocardial infarction with percutaneous coronary intervention or coronary artery bypass graft surgery that has occurred after diagnosis. Fischer's exact test, Wald's linear trend test, and multivariate logistic regression analysis were used to test the associations. Results: Among 296 patients (83.1% female) with a mean age of 56.6 years and a mean rheumatoid arthritis duration of 11.3 years, 13 reported having acute myocardial infarction requiring a percutaneous or surgical reperfusion procedure, a prevalence of 4.4% (95% CI 2.0-6.7). Diabetes Mellitus (odds ratio [OR] 4.9 [95% CI 1.6-13.8]) and disease duration >10 years (OR 8.2 [95% CI 1.8-39.7]) were the only factors associated with an ischemic disease that remained in the final model, after the multivariate analysis. Conclusion: The prevalence of acute myocardial infarction was similar to that observed in other studies. Among the traditional risk factors, Diabetes Mellitus, and among the factors related to rheumatoid arthritis, disease duration, were the variables associated with comorbidity.

Resumo Objetivo: Estimar a prevalência da doença isquêmica cardíaca e os fatores associados em pacientes com artrite reumatoide. Métodos: Estudo transversal que usou o critério diagnóstico do Colégio Americano de Reumatologia para selecionar pacientes atendidos nas unidades de saúde da atenção primária ou secundária em Blumenau, Santa Catarina, sul do Brasil, em 2014. A presença de doença cardíaca isquêmica foi definida com infarto agudo do miocárdio com intervenção coronariana percutânea ou cirurgia de revascularização do miocárdio que tenha ocorrido depois do diagnóstico. Para testar as associações usou-se o teste exato de Fischer, o teste de tendência linear de Wald e a análise de regressão logística multivariada. Resultados: Entre 296 pacientes, 83,1% de mulheres, com média de 56,6 anos, tempo médio de artrite reumatoide de 11,3 anos, 13 relatam ter tido infarto agudo do miocárdio que necessitou de procedimento de reperfusão percutânea ou cirúrgica, prevalência de 4,4% (IC 95% 2,0-6,7). O diabetes melittus (razão de chance de 4,9 [IC 95% 1,6-13,8]) e o tempo de doença maior do que 10 anos (razão de chance de 8,2 [IC 95% 1,8-39,7]) foram os únicos fatores associados com a doença isquêmica que permaneceram no modelo final após análise multivariada. Conclusão: A prevalência de infarto agudo do miocárdio foi semelhante com a observada em outros estudos. Entre os fatores de risco tradicionais e entre os fatores relacionados à artrite reumatoide, o diabetes melittus e o tempo de doença foram as variáveis associadas à comorbidade

Impact of rheumatoid arthritis in the public health system in Santa Catarina, Brazil: a descriptive and temporal trend analysis from 1996 to 2009.

INTRODUCTION: There are few studies that carried out a descriptive and trend analysis based on available data from the Unified Health System (SUS) between pre- and post-free dispensing of pharmacological treatment of rheumatoid arthritis (RA) from the perspective of the public health system, in terms of the direct cost of the disease among adults and elderly residents of the State of Santa Catarina, Brazil. This study aims to characterize the direct cost of medical and surgical procedures before and after the dispensing of drugs in this state. METHODS: This is a time series-type study with a cross-sectional survey of data from the Hospital (SIH) and Outpatient (SIA) Information System of SUS during the period from 1996 to 2009. RESULTS: Between 1996 and 2009, the total expenditure for hospital- and outpatient pharmacological treatment of rheumatoid arthritis was R$ 26,659,127.20. After the dispensing of drug treatment by SUS a decrease of 36% in the number of hospital admissions was observed; however, an increase of 19% in clinical procedures was noted. CONCLUSION: During the observed period, a reduction in the number of hospital admissions for both clinical and orthopedic surgical procedures related to this disease was observed. Nevertheless, there was an increase in the cost of medical admissions.

Patient adherence to ischemic heart disease treatment.

INTRODUCTION:: The effectiveness of the treatment of chronic diseases depends on the participation of the patient, influenced by different sociocultural factors, which are not fully recognized by the treatment routine. OBJECTIVE:: To search for some of these factors that hinder or facilitate adherence to treatment and use of healthcare resources, approaching patients with ischemic heart disease. METHOD:: A cross-sectional study was conducted using face-to-face interviews. We applied semi-structured questionnaires to 347 individuals and recorded 141 interviews for qualitative analysis. Descriptors were selected to identify eight categories of analyses. The quantitative data were submitted to descriptive analysis of frequency. RESULTS:: Only 2% had good medication adherence according to score on Morisky questionnaire. About 23% bought statins; the others obtained statin in the public health institution. Thirty-six speeches were selected and classified according to the following categories: knowledge about disease and medication, difficulty of acquisition, self management of treatment, difficulties of access to health services, side effect of statins, caregiver support, transportation to health services and concerns about the disease progression. However, it was noticed that about 1/3 of the care outside the research institution can be characterized as an attempt to bring rationalization to the health system. CONCLUSION:: The improved adherence to chronic treatment of ischemic heart disease depends on the establishment of effective flows for referral and counter-referral from one care unit to another, relevant information and clarification of the questions for the patients and the attention of health professionals to the many social and cultural factors involved in treatment adherence. New research should be focused on educational groups by integrated multidisciplinary teams in order to share treatment decisions, thereby increasing the patient's commitment to his own health.

A method for cohort selection of cardiovascular disease records from an electronic health record system.

INTRODUCTION: An electronic healthcare record (EHR) system, when used by healthcare providers, improves the quality of care for patients and helps to lower costs. Information collected from manual or electronic health records can also be used for purposes not directly related to patient care delivery, in which case it is termed secondary use. EHR systems facilitate the collection of this secondary use data, which can be used for research purposes like observational studies, taking advantage of improvement in the structuring and retrieval of patient information. However, some of the following problems are common when conducting a research using this kind of data: (i) Over time, systems and data storage methods become obsolete; (ii) Data concerns arise since the data is being used in a context removed from its original intention; (iii) There are privacy concerns when sharing data about individual subjects; (iv) The partial availability of standard medical vocabularies and natural language processing tools for non-English language limits information extraction from structured and unstructured data in the EHR systems. A systematic approach is therefore needed to overcome these, where local data processing is performed prior to data sharing. METHOD: The proposed study describes a local processing method to extract cohorts of patients for observational studies in four steps: (1) data reorganization from an existing local logical schema into a common external schema over which information can be extracted; (2) cleaning of data, generation of the database profile and retrieval of indicators; (3) computation of derived variables from original variables; (4) application of study design parameters to transform longitudinal data into anonymized data sets ready for statistical analysis and sharing. Mapping from the local logical schema into a common external schema must be performed differently for each EHR and is not subject of this work, but step 2, 3 and 4 are common to all EHRs. The external schema accepts parameters that facilitate the extraction of different cohorts for different studies without having to change the extraction algorithms, and ensures that, given an immutable data set, can be done by the idempotent process. Statistical analysis is part of the process to generate the results necessary for inclusion in reports. The generation of indicators to describe the database allows description of its characteristics, highlighting study results. The set extraction/statistical processing is available in a version controlled repository and can be used at any time to reproduce results, allowing the verification of alterations and error corrections. This methodology promotes the development of reproducible studies and allows potential research problems to be tracked upon extraction algorithms and statistical methods RESULTS: This method was applied to an admissions database, SI3, from the InCor-HCFMUSP, a tertiary referral hospital for cardiovascular disease in the city of São Paulo, as a source of secondary data with 1116848 patients records from 1999 up to 2013. The cleaning process resulted in 313894 patients records and 27698 patients in the cohort selection, with the following criteria: study period: 2003-2013, gender: Male, Female, age:≥18years old, at least 2 outpatient encounters, diagnosis of cardiovascular disease (ICD-10 codes: I20-I25, I64-I70 and G45). An R script provided descriptive statistics of the extracted cohort. CONCLUSION: This method guarantees a reproducible cohort extraction for use of secondary data in observational studies with enough parameterization to support different study designs and can be used on diverse data sources. Moreover it allows observational electronic health record cohort research to be performed in a non-English language with limited international recognized medical vocabulary.

Impact of rheumatoid arthritis in the public health system in Santa Catarina, Brazil: a descriptive and temporal trend analysis from 1996 to 2009 / Impacto da artrite reumatoide no sistema público de saúde em Santa Catarina, Brasil: análise descritiva e de tendência temporal de 1996 a 2009

ABSTRACT Introduction: There are few studies that carried out a descriptive and trend analysis based on available data from the Unified Health System (SUS) between pre- and post-free dispensing of pharmacological treatment of rheumatoid arthritis (RA) from the perspective of the public health system, in terms of the direct cost of the disease among adults and elderly residents of the State of Santa Catarina, Brazil. This study aims to characterize the direct cost of medical and surgical procedures before and after the dispensing of drugs in this state. Methods: This is a time series-type study with a cross-sectional survey of data from the Hospital (SIH) and Outpatient (SIA) Information System of SUS during the period from 1996 to 2009. Results: Between 1996 and 2009, the total expenditure for hospital- and outpatient pharmacological treatment of rheumatoid arthritis was R$ 26,659,127.20. After the dispensing of drug treatment by SUS a decrease of 36% in the number of hospital admissions was observed; however, an increase of 19% in clinical procedures was noted. Conclusion: During the observed period, a reduction in the number of hospital admissions for both clinical and orthopedic surgical procedures related to this disease was observed. Nevertheless, there was an increase in the cost of medical admissions.

RESUMO Introdução: Poucos estudos fizeram uma análise descritiva e de tendência dos dados disponíveis do Sistema Único de Saúde (SUS) entre os períodos pré e pós-dispensação gratuita do tratamento medicamentoso da artrite reumatoide (AR) sob a perspectiva do sistema público de saúde em termos de custo direto da doença entre adultos e idosos moradores do Estado de Santa Catarina, Brasil. O presente trabalho tem o objetivo de caracterizar o custo direto de procedimentos clínicos e cirúrgicos antes e após o fornecimento de medicamentos no estado. Métodos: Estudo do tipo série temporal com levantamentos transversais entre 1996 e 2009 dos dados do Sistema de Informação Hospitalar (SIH) e Ambulatorial (SIA) do SUS. Resultados: Entre 1996 a 2009, o gasto total para o tratamento hospitalar e medicamentoso ambulatorial da artrite reumatoide foi de R$ 26.659.127,20. Após a dispensação do tratamento medicamentoso pelo SUS observou-se queda de 36% do número de internações hospitalares. Entretanto notou-se um aumento de 19% nos procedimentos clínicos. Conclusão: No período observado notou-se uma redução do número de internações hospitalares tanto para procedimentos clínicos quanto cirúrgicos ortopédicos relacionadas a essa doença. Apesar disso, ocorreu um aumento do custo das internações clínicas.

Patient adherence to ischemic heart disease treatment / Adesão do paciente ao tratamento da doença isquêmica do coração

Summary Introduction: The effectiveness of the treatment of chronic diseases depends on the participation of the patient, influenced by different sociocultural factors, which are not fully recognized by the treatment routine. Objective: To search for some of these factors that hinder or facilitate adherence to treatment and use of healthcare resources, approaching patients with ischemic heart disease. Method: A cross-sectional study was conducted using face-to-face interviews. We applied semi-structured questionnaires to 347 individuals and recorded 141 interviews for qualitative analysis. Descriptors were selected to identify eight categories of analyses. The quantitative data were submitted to descriptive analysis of frequency. Results: Only 2% had good medication adherence according to score on Morisky questionnaire. About 23% bought statins; the others obtained statin in the public health institution. Thirty-six speeches were selected and classified according to the following categories: knowledge about disease and medication, difficulty of acquisition, self management of treatment, difficulties of access to health services, side effect of statins, caregiver support, transportation to health services and concerns about the disease progression. However, it was noticed that about 1/3 of the care outside the research institution can be characterized as an attempt to bring rationalization to the health system. Conclusion: The improved adherence to chronic treatment of ischemic heart disease depends on the establishment of effective flows for referral and counter-referral from one care unit to another, relevant information and clarification of the questions for the patients and the attention of health professionals to the many social and cultural factors involved in treatment adherence. New research should be focused on educational groups by integrated multidisciplinary teams in order to share treatment decisions, thereby increasing the patient's commitment to his own health.

Resumo Introdução: A efetividade do tratamento das doenças crônicas depende da participação do paciente, influenciada por diferentes motivos socioculturais, pouco reconhecidos pela rotina assistencial. Objetivo: Identificar os fatores de adesão ao tratamento e o uso dos recursos assistenciais de pacientes com doença isquêmica do coração. Método: Estudo transversal com entrevistas presenciais de 347 indivíduos submetidos a questionários semiestruturados, com 141 delas gravadas para análise qualitativa com identificação dos descritores distribuídos por oito categorias. Os dados quantitativos tiveram análise descritiva de frequência. Resultados: Somente 2% tiveram boa adesão medicamentosa; 23% compraram estatina, os demais obtiveram o medicamento em serviços públicos. Foram classificadas 36 falas com as categorias: conhecimento sobre a doença e o tratamento, dificuldade de aquisição do medicamento, gerenciamento pessoal do tratamento, acesso aos serviços de saúde, efeito colateral das estatinas, apoio do cuidador, transporte até o ambulatório, receios quanto à evolução da doença, efeito colateral das estatinas. Foi observado que 1/3 dos atendimentos fora da instituição podem ser caracterizados como tentativa de racionalização da rede. Conclusão: A melhora da adesão ao tratamento da doença isquêmica do coração depende do estabelecimento de fluxos efetivos para referência e contrarreferência entre unidades assistenciais; adequada informação e esclarecimento das dúvidas do paciente; atenção dos profissionais de saúde aos múltiplos fatores sociais e culturais envolvidos com a adesão. São necessários novos estudos sobre o papel da assistência farmacêutica, grupos educativos e integração da equipe multiprofissional no engajamento do paciente para compartilhar as decisões sobre o tratamento, e assim ampliar seu grau de comprometimento com a própria saúde.

Decrease in mortality rate and hospital admissions for acute myocardial infarction after the enactment of the smoking ban law in São Paulo city, Brazil.

BACKGROUND: Smoking restriction laws have spread worldwide during the last decade. Previous studies have shown a decline in the community rates of myocardial infarction after enactment of these laws. However, data are scarce about the Latin American population. In the first phase of this study, we reported the successful implementation of the law in São Paulo city, with a decrease in carbon monoxide rates in hospitality venues. OBJECTIVE: To evaluate whether the 2009 implementation of a comprehensive smoking ban law in São Paulo city was associated with a reduction in rates of mortality and hospital admissions for myocardial infarction. METHODS: We performed a time-series study of monthly rates of mortality and hospital admissions for acute myocardial infarction from January 2005 to December 2010. The data were derived from DATASUS, the primary public health information system available in Brazil and from Mortality Information System (SIM). Adjustments and analyses were performed using the Autoregressive Integrated Moving Average with exogenous variables (ARIMAX) method modelled by environmental variables and atmospheric pollutants to evaluate the effect of smoking ban law in mortality and hospital admission rate. We also used Interrupted Time Series Analysis (ITSA) to make a comparison between the period pre and post smoking ban law. RESULTS: We observed a reduction in mortality rate (-11.9% in the first 17 months after the law) and in hospital admission rate (-5.4% in the first 3 months after the law) for myocardial infarction after the implementation of the smoking ban law. CONCLUSIONS: Hospital admissions and mortality rate for myocardial infarction were reduced in the first months after the comprehensive smoking ban law was implemented.

Effect of low-level laser therapy on pain and perineal healing after episiotomy: A triple-blind randomized controlled trial.

BACKGROUND AND OBJECTIVE: Episiotomy is associated with perineal pain and healing complications. The low-level laser therapy (LLLT) reduces pain and inflammation and stimulates the healing process. This study aimed to assess the effect of LLLT on pain and perineal healing after an episiotomy. DESIGN/MATERIALS AND METHODS: A randomized, triple-blind, parallel clinical trial with 54 postpartum women who had a spontaneous birth with a right mediolateral episiotomy. The women were randomized into two groups: the experimental group (applications of LLLT n = 29) or the placebo group (simulated LLLT applications n = 25). Three sessions of real or sham irradiation were performed at 6-10 hours after normal birth, and the 2nd and 3rd applications were performed at 20-24 hours and 40-48 hours after the first session, respectively. Perineal pain was recorded using a Numeric Scale ranging from 0 to 10 (0 = absence and 10 = worst pain). Perineal healing was assessed using the redness, oedema, ecchymosis, discharge, and approximation (REEDA) scale. Both groups were assessed four times: in each of the three LLLT sessions and at 7-10 days after normal birth. The groups were compared using the Student's t, Mann-Whitney, and Chi-square tests. RESULTS: There was no significant difference between the groups regarding perineal healing after LLLT. The perineal pain scores were statistically higher in the experimental group in the first assessment and after the third LLLT. There was no significant difference between the groups related to the perineal pain scores 7-10 days after normal birth. CONCLUSION: The use of LLLT does not provide any benefit for treating postpartum perineal trauma using these specific protocol and parameters. Lasers Surg. Med. 49:181-188, 2017. © 2016 Wiley Periodicals, Inc.

Primordial and primary prevention programs for cardiovascular diseases: from risk assessment through risk communication to risk reduction. A review of the literature.

The aim of this study was to identify and reflect on the methods employed by studies focusing on intervention programs for the primordial and primary prevention of cardiovascular diseases. The PubMed, EMBASE, SciVerse Hub-Scopus, and Cochrane Library electronic databases were searched using the terms 'effectiveness AND primary prevention AND risk factors AND cardiovascular diseases' for systematic reviews, meta-analyses, randomized clinical trials, and controlled clinical trials in the English language. A descriptive analysis of the employed strategies, theories, frameworks, applied activities, and measurement of the variables was conducted. Nineteen primary studies were analyzed. Heterogeneity was observed in the outcome evaluations, not only in the selected domains but also in the indicators used to measure the variables. There was also a predominance of repeated cross-sectional survey design, differences in community settings, and variability related to the randomization unit when randomization was implemented as part of the sample selection criteria; furthermore, particularities related to measures, limitations, and confounding factors were observed. The employed strategies, including their advantages and limitations, and the employed theories and frameworks are discussed, and risk communication, as the key element of the interventions, is emphasized. A methodological process of selecting and presenting the information to be communicated is recommended, and a systematic theoretical perspective to guide the communication of information is advised. The risk assessment concept, its essential elements, and the relevant role of risk perception are highlighted. It is fundamental for communication that statements targeting other people's understanding be prepared using systematic data.

Primordial and primary prevention programs for cardiovascular diseases: from risk assessment through risk communication to risk reduction. A review of the literature

The aim of this study was to identify and reflect on the methods employed by studies focusing on intervention programs for the primordial and primary prevention of cardiovascular diseases. The PubMed, EMBASE, SciVerse Hub-Scopus, and Cochrane Library electronic databases were searched using the terms ‘effectiveness AND primary prevention AND risk factors AND cardiovascular diseases’ for systematic reviews, meta-analyses, randomized clinical trials, and controlled clinical trials in the English language. A descriptive analysis of the employed strategies, theories, frameworks, applied activities, and measurement of the variables was conducted. Nineteen primary studies were analyzed. Heterogeneity was observed in the outcome evaluations, not only in the selected domains but also in the indicators used to measure the variables. There was also a predominance of repeated cross-sectional survey design, differences in community settings, and variability related to the randomization unit when randomization was implemented as part of the sample selection criteria; furthermore, particularities related to measures, limitations, and confounding factors were observed. The employed strategies, including their advantages and limitations, and the employed theories and frameworks are discussed, and risk communication, as the key element of the interventions, is emphasized. A methodological process of selecting and presenting the information to be communicated is recommended, and a systematic theoretical perspective to guide the communication of information is advised. The risk assessment concept, its essential elements, and the relevant role of risk perception are highlighted. It is fundamental for communication that statements targeting other people’s understanding be prepared using systematic data.

Custo-efetividade do uso associado de estabilizadores de humor e antipsicóticos atípicos na terapia de manutenção do transtorno bipolar no Sistema Único de Saúde / Cost-effectiveness of mood stabilizers and atypical antipsychotics in maintenance therapy of bipolar disorder in the Brazilian Unified Health System

RESUMOObjetivo: Avaliar a custo-efetividade da associação de antipsicóticos atípicos e estabilizadores de humor na terapia de manutenção do transtorno bipolar no Sistema Único de Saúde (SUS). Métodos: Assumindo os custos diretos na perspectiva do SUS, construiu-se um modelo de Markov com as transições entre eutimia, mania, depressão, descontinuação e morte. Dados foram obtidos de ensaios clínicos, coortes prospectivas e bases assistenciais do SUS (valores correntes de 2015). Com uma coorte hipotética (n = 2000, idade = 40 anos), foram simulados ciclos trimestrais no horizonte de até 30 anos (ou efetividade < 1 dia em remissão). Adotaram-se taxas de desconto, correção de meio de ciclo e análises de sensibilidade. Resultados: Os dados de eficácia permitiram apenas a análise da associação com a quetiapina. No horizonte temporal de 12 anos (48 ciclos), ocorreram 512 episódios agudos (depressão: 285, mania: 227) com a monoterapia de lítio ou valproato e 306com associação de quetiapina (depressão: 166, mania: 139). A razão de custo-efetividade incremental (RCEI) da associação com a quetiapina foi de R$ 807,95 por mês adicional em remissão. A análise de sensibilidade demonstrou robustez do modelo, sendo a variação da dose e do preço da quetiapina seus maiores modificadores (amplitude da RCEI de R$ 541,60 a R$ 1.770,05). Conclusões: A terapia de manutenção com a associação da quetiapina ao lítio ou valproato demonstrou ser potencialmentecusto-efetiva. Considerando que o uso de antipsicóticos atípicos não é desprovido de riscos, a estratégia estudada pode ser uma alternativa terapêutica em populações específicas do SUS

ABSTRACTObjective: To evaluate the cost-effectiveness of the combination of atypical antipsychotic and mood stabilizers in maintenance treatment of bipolar disorder in the Brazilian Unified Health System (SUS). Methods: Taking direct costs, from the perspective of SUS, we built a Markov model withtransitions between the states: euthymia, mania, depression, discontinuation and death. Data were extracted from clinical trials, prospective cohorts and SUS databases (current values of 2015). In a hypothetical cohort (n = 2,000, age = 40 years), maintenance therapy was simulated over quarterly cycles through a timeframe up to 30 years (until effectiveness < 1 day in remission). Discount rates and half-cycle correction were applied and sensitivity analyses were run. Results: The efficacy data enabled to include only a combination with quetiapine in the analysis. After twelve years (48 cycles), there were 512 acute episodes (depression: 285, mania: 227) for monotherapy with lithium or valproate against 306 (depression: 166, mania 139) for the quetiapine combination. The incremental cost-effectiveness ratio (ICER) for the quetiapine combination was R$ 807.95 per additional month in remission. The sensitivity analysis demonstrated the model?s robustness, while dosage and quetiapine-price variations had most impact in ICER (ranging from R$ 541.60 to R$ 1,770.05 per additional month in remission). Conclusion: Maintenance therapy with the combination of quetiapine andlithium or valproate seems to be cost-effective. As the use of atypical antipsychotics is also associated with risks, the studied strategy can be a therapeutic alternative for specific populations in SUS.