bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP162 Bridging Brazil's Know-Do Gap On Social Engagement In Health Technology Assessment
Authors: Sousa Maria-Sharmila , Figueiró Mabel , Silva Aline , Silva Everton , Silva Marcus , Pereira Viviane , Barreto Jorge 
Published: January 2019

Introduction:Social engagement in health encompasses the idea of involving (parts of) society as full partners in the decision-making regarding both development and implementation of health technologies. Evidence shows that patient engagement is linked with fewer adverse events, better patient self-management, fewer diagnostic tests, decreased use of healthcare services and shorter lengths of stay in hospitals. Matching the escalating healthcare requirements to face the ongoing societal and economic challenges regarding access and coverage to (new) health technologies is not an easy task for health providers.Methods:We conducted a systematic review (CRD42017068714) designed to address the institutional implementation of social engagement by the Brazilian Ministry of Health. All systematic reviews were evaluated using the new version of AMSTAR and, once all findings are synthesized, we will use the GRADE-CERQual approach to assess for confidence.Results:From 399 publications that met the inclusion criteria, 80 described the implementation of social engagement during the development and implementation of (new) health technologies at various levels (local, regional, national, supranational), countries and for different health technologies and social actors. The remaining 319 publications constitute case studies describing barriers and enablers to implementing social engagement in HTA and coverage decision-making processes. By mapping barriers and facilitators, we explored effectiveness and sustainability, further observing how citizen science-based strategies can ultimately reform health service delivery by innovating the social engagement in health technology development and implementation.Conclusions:This systematic review addresses the know-do gap on social engagement in health technology development and implementation, from a global perspective, as a way of improving the Brazilian Ministry of Health's HTA activities and enabling a Brazilian strategy to reform health service delivery. Enabling social engagement as early as possible, during all the stages of the development cycle, grants a more effective and sustainable health care system.
PP164 Identifying Complications Of Partial Nephrectomy Using Physician Claims
Authors: Sun Jian , Stafinski Tania , Nagase Fernanda Inagaki , Menon Devidas 
Published: January 2019

Introduction:Many population-based studies identify surgical complications using hospital discharge abstract databases (DAD). With DAD, however, complications occurring after the discharge date cannot be followed up. This study used physician claims data to identify the complications of partial nephrectomy, and to compare the rates of complications of open, laparoscopic, and robot-assisted nephrectomies.Methods:Physician claims, DAD, and ambulatory care data from April 2003 to March 2016 were provided by Alberta Health. DAD and ambulatory care data were used to extract information on patients with kidney cancer who underwent partial nephrectomy. All physician claims within 30 days before and after surgery for the cohort were extracted. The numbers of the same International Classification of Diseases, Ninth Revision (ICD-9), codes before and after surgery were compared. If a number increased after surgery, this diagnosis was initially identified as a complication. All diagnoses with neoplasms were excluded. The incidence rates of complications for the three surgery groups were calculated. Chi-squared tests were conducted for the following nephrectomy comparisons: laparoscopic versus open; robot-assisted versus open; and robot-assisted versus laparoscopic.Results:A total of 1,890 kidney cancer patients had partial nephrectomies. Among them, 1,080, 411, and 399 had open, laparoscopic, and robot-assisted nephrectomies, respectively. One patient who had two different nephrectomies on the same day was excluded from analysis. The robot-assisted group had lower rates of digestive complications (ICD-9: 537–578, 787, 789, 998.6) and infections (ICD-9: 004–041, 998.5) than the open group, and higher rates of genitourinary complications (ICD-9: 584–599, 788, 997.5) than the laparoscopy group. The robot-assisted group had lower rates than the open group for most of the complication categories, but the differences were not statistically significant.Conclusions:Robot-assisted surgery appears to be superior to open surgery, but no better than laparoscopic surgery, in terms of minimizing the risk of complications following partial nephrectomy.
PD04 Cost-Utility Of Quetiapine For Schizophrenia: A Systematic Review
Authors: Santos André , Ruas Cristina 
Published: January 2019

Introduction:Schizophrenia is a chronic debilitating condition characterized by disorders in thought, affect and behavior. The worldwide prevalence is around 0.3 to 1 percent. The pharmacological treatment is based on antipsychotic drugs, but their efficacy is limited, culminating in discontinuation of treatment, relapses, and readmissions to health services. Quetiapine was initially approved for use in the United States of America in 1997. The drug has moderate affinity for D2 and 5-HT2A receptors and high affinity for H1 receptors. This study aimed to conduct an assessment of the cost-utility of quetiapine for schizophrenia around the world.Methods:Cost-utility studies of head-to-head comparisons of quetiapine against other antipsychotic drugs for the treatment of patients with schizophrenia and related disorders were included, irrespective of the diagnostic criteria used. An electronic search on Medline, Lilacs, Center for Reviews and Dissemination, The Cochrane Library and PsycINFO was conducted and complemented by references of included studies, Google Scholar and conference abstracts. Monetary values were converted to PPP-USD for the same base-year of the study.Results:Six economic evaluations were included, representing four countries and a multicentric analysis. Comparisons between quetiapine and twelve other antipsychotic drugs were identified. Three studies found quetiapine to be dominated by risperidone and the remaining three found it to be more expensive and more effective with incremental cost-effectiveness ratio (ICER) values of USD 36,535, 8,786 and USD 127,600 per quality-adjusted life-year (QALY). Three studies found quetiapine, in comparison to olanzapine, to be inferior, one found it to be superior and two studies found it to be more expensive and more effective with ICER values of USD 139,699 and USD 224,000 per QALY. The reports were considered to be of reasonable quality. Yet the mixture of contexts might influence the results.Conclusions:In general, there seems to be a trend favoring olanzapine and risperidone over quetiapine. None of the studies favored quetiapine over all the other drugs.
PD34 São Paulo Congenital Heart Corrections: Three-Years' Assist Registry
Authors: Trindade Evelinda , Caneo Luiz Fernando , Turquetto Aida Luiza , Amato Luciana , Carmona Fabio , Preto Ribeirão , Vincente Walter , Arrieta Santiago Raul , Miura Nana , Manso Paulo Henrique , Furlanetto Beatriz Helena , Jatene Marcelo , Jatene Fabio , Silveira Joao Bruno , Ritchmann Marcella 
Published: January 2019

Introduction:Death from congenital heart disease (CHD) can be avoided, contributing to reduced infant mortality. The objective of this study was to identify the profile of patients undergoing surgical correction for CHD in three São Paulo State hospitals, and to determine factors that contribute to morbidity and mortality.Methods:The Voluntary Pediatric Cardiovascular Surgery Multicenter Registry (ASSIST) was created in 2014 through a Research Grant Program for the Public Healthcare System (Pesquisas para o Sistema Único de Saúde, PPSUS)* project, a federal-state joint strategic public policies research grant, coordinated by the Hospital das Clínicas of Faculdade de Medicina of Universidade de São Paulo (InCor-HCFMUSP-SP) and Ribeirão Preto's Hospital das Clínicas, both linked to the São Paulo University Medical School.Results:We analyzed 1,842 patients, with an average age of 1.2 (range 0.4–8.6) years, 50.9 percent were male. Procedural complexity was classified as “Risk Adjustment in Congenital Heart Surgery” version 1 score, RACHS-1: 18.2 percent RACHS1, 25.5 percent RACHS2, 41.2 percent RACHS3, 9.6 percent RACHS4 and 5.4 percent RACHS5–6. Overall hospital mortality was 12.2 percent, and preoperative risk factors included: age <30 days (Odds Ratio, OR = 1.7 p = 0.012), prolonged ICU admission (OR = 3.3 p = 0.001). Other significant factors were RACHS score >4 (OR = 5.3 p < 0.001), heart dysfunction (OR = 3.4 p = 0.001), sepsis (OR = 3 p = 0.001), hemodynamic or surgical re-intervention required (OR = 6.2 p < 0.001), cardiorespiratory arrest (CPR, OR = 24.9 p < 0.001) and renal failure (OR = 5.4 p<0.001). The frequency of related morbidity was 16.2 heart failure, 7.1 percent arrythmia, 5.9 percent pneumonia, 5.9 percent pneumotórax, 4.2 percent pleural and pericardial effusion, 10 percent mechanical ventiation > 7 days, 13.2 percent late sternal closure, 2.8 percent had wound infection, 3.7 percent neurological alterations, 2.3 percent diaphragmatic dysfunction, 11.5 percent CPR, 3.2 percent renal failure, 4.5 percent sepsis, 55.1 percent length of hospital stay longer than 5 days with 45.8 percent postoperative hospital admission longer than 15 days and 6.1 percent needed surgical or hemodynamic re-intervention.Conclusions:The information collected in the ASSIST registry was of great importance in the São Paulo State CHD surgical practice evaluation. Morbi-mortality related factors elicited critical points and allowed improvement actions. Excluding age and intrinsic procedure complexity, identified outcome modifier factors can be manageable, aiming to increase patient safety and program resolubility or performance.
PD41 Use Of High-Sensitivity Cardiac Troponin Assays In Real-Practice Within Emergency Departments
Authors: Marchetti Marco , Camoni Laura , Urbina Luz Irene , Biondi Alessia , Grassi Tiziana , Rolli Marianna , Sacco Adriano , Montemagno Mirko 
Published: January 2019

Introduction:Acute myocardial infarction (AMI) is one of the leading causes of death and disability worldwide. The European Society of Cardiology Guidelines have established a new definition of myocardial infarction and have strengthened the central role of cardiac troponins in cardiology diagnostics for rule-in and rule-out of non ST-elevation myocardial infarction (NSTEMI). High-sensitivity cardiac troponin I assays (hsTnI) should increase diagnostic sensitivity, and a shorter interval for ruling-in and ruling-out AMI. This analysis aims to provide an overview of the clinical, economic, organizational and ethical impact of the use of hsTnI in clinical practice of Emergency Departments (ED) in Italy.Methods:HsTnl for rule-in and rule-out of AMI in the ED is being evaluated using the EUnetHTA Core Model® framework for health technology assessment. The hsTnI HTA assessment will be completed with real-world evidence derived from a multicenter observational study which has been designed to be conducted in 12 Italian EDs, enrolling 6000 patients with chest pain of suspected cardiac origin, aiming to provide data from the Italian context on clinical, organizational and economic aspects of the use of the test in the ED. Endpoints of the study include: time lapses related to diagnosis, admission, treatment and discharge of patients; number of tests performed; and number of patients diagnosed with AMI.Results:Initial results from a literature review confirm the usefulness of the hsTnI assay in diagnosing AMI. Generated real-world data will be collected, analyzed and integrated to existing evidence to assess the utility of the test in real contexts, providing details relevant for organizational aspects of the use of the test in the ED.Conclusions:The use of hsTnl could improve diagnosis of AMI by allowing a faster ruling-in or ruling-out, and reducing inappropriate hospitalizations. Furthermore, this technology could represent an opportunity to reduce overall costs for the healthcare system.
PD43 Value-Based Procedure For Updating The Italian Health Benefit Package
Authors: Marchetti Marco , Iannone Primiano , Urbina Luz Irene , Camoni Laura , Biondi Alessia , Brino Eugenio Di , Rolli Marianna , Montemagno Mirko , Sacco Adriano 
Published: January 2019

Introduction:In Italy, the central government sets the health benefit package (denominated “Livelli Essenziali di Assistenza” - LEAs) of the National Health System (NHS), which must be provided to all residents. In 2004, the Italian Ministry of Health established a new technical body, the National LEA Commission, responsible for updating LEAs.Methods:Recently, the Ministry has commissioned to the National Institute of Health (NIH) the development of a new value-based procedure for updating the health benefit package for the Italian NHS, supporting the National LEA Commission. A review and comparison of value frameworks and decisional models was performed in order to select a framework and a model that can be applied to the Italian context, design an administrative process for the update procedure, and propose approaches for: (i) the assessment of services currently included in the health benefit basket and of those planned to be incorporated, (ii) the process of appraisal and decision-making to be adopted by the Commission.Results:The NIH outlined an evidence and value-based three-step (i.e. priority setting, assessment and appraisal) administrative process that integrates roles and responsibilities of the different Italian healthcare institutions involved in LEA updating and HTA.Conclusions:The NIH is proposing to the Ministry of Health and to the National LEA Commission a new evidence and value-based procedure for updating the health benefit package for the Italian NHS. This procedure is entering a pilot phase in which potential gaps can be identified and minimized for its subsequent implementation.
PD58 Cost-Effectiveness Of Quinolone For Acute External Otitis In Brazil
Authors: de Oliveira Gustavo , Chacarolli Camila , Silva Sarah , de Brito Artur Felipe 
Published: January 2019

Introduction:In Brazil, the medicines marketed for acute external otitis are ciprofloxacin and the combination polymyxin B, neomycin, and fluocinolone. The aim of this study was to evaluate the proportion of cure and cost-effectiveness of quinolone versus polymyxin B, neomycin, and steroid combined (PNS) for acute external otitis from the perspective of the Brazilian Public health system.Methods:A systematic review was conducted using Medline, Cochrane Library, CRD and Lilacs databases. Studies evaluating quinolones versus PNS in the treatment of acute external otitis were included. A cost-effectiveness model was made using a decision tree, considering the direct cost of treatment. Univariate sensitivity analysis was conducted, considering the confidence interval of clinical outcomes and a 15 percent variation in cost.Results:The proportion of cure in up to 10 days was 70.1 percent with quinolone and 60.4 percent with PNS (p = 0.004). The treatment costs were BRL 16.22 (USD 5.02) with quinolone and BRL 3.04 (USD 0.94) with PNS. The incremental cost-effectiveness ratio was BRL 136.25 (USD 42.15) per cure in up to 10 days for quinolone in relation to PNS. This value was more sensitive to clinical outcomes, ranging from BRL 95.48 (USD 29.54) to BRL 254.25 (USD 78.65) for cure with quinolone and from BRL 90.77 (USD 28.08) to BRL 262.57 (USD 81.23) for cure with PNS. These values should be considered with caution because acute external otitis is resolved within a few days and treatment effectiveness is not measured by life years.Conclusions:There are few studies on therapeutic alternatives available in Brazil. Through the available evidence, there is a lack of results on the effects attributed to each drug. Considering the higher effectiveness, low cost and rational use of antibiotics, quinolone is considered a cost-effective alternative for acute external otitis in Brazil.
PD59 Formulation and Disclosure Of Information On Technologies In Health
Authors: Marra Lays , Silva Sarah , Rabelo Roberta , Chacarolli Camila , Brito Nayara , Catanheide Izamara , de Brito Artur Felipe 
Published: January 2019

Introduction:The Brazilian public health system (SUS) provides technologies based on the best available scientific evidence. However, there is a large number of lawsuits against the government for access to non-standard technologies, a phenomenon called “judicialization of the right to health”, which disrupts the system's operating logic. The aspect of judicialization that most impacts the health system involves unregistered technologies without scientific evidence of superiority being comparing to the alternatives already offered in the country. The aim of this study is to report experience of the National Committee for Health Technology Incorporation in the Brazilian Health System (CONITEC) to mitigate the effects of the judiciary, with the elaboration of informative documents about technologies directed towards policy-makers, patient, users of system health, professional health and other stakeholders.Methods:The main judicialized technologies in the country were identified and then a meeting with experts was realized to discuss a more appropriate format for these documents. After defining the format, a review of the literature was carried out to identify the best available evidence of those health technologies.Results:A question-and-answer (QA) format document was drawn. The QA addressed information on the use of the technology for a specific clinical condition. Health registry and price in Brazil, if it has already been evaluated by CONITEC and its respective recommendation, as well as strategies of care and therapeutic alternatives available in the SUS were included. Their content has been adapted to a lay language and all of the documents were made available on the CONITEC website in the “Law and Health Section”.Conclusions:The availability of QA represents a strong link between evidence and actions in health. For, they enable broad access to quality information by the lay public and stakeholders who seek information to support evidence-based decision-making.
PD61 HTA Regional Network In The Central Region Of Brazil: Survey In 2016
Authors: Elias Flavia Tavares Silva , da Motta Girardi Juliana , Moraes Rafael , Amorim Fabio , Pereira Ana Carolina , Almeida Karlo Josefo , Silva Erica , Pereira Daniella 
Published: January 2019

Introduction:The Federal District in Brazil has about 2.9 million inhabitants and the public health system is focused on medical specialties, with one university hospital and twenty regional hospitals. This ecosystem is favorable for fostering health technology assessment (HTA) to improve the efficiency and effectiveness of health care. The objective was to identify institutions that could form a HTA network to support decision-oriented evidence in the public health system.Methods:Stakeholders from the hospitals and training/research institutions in the Federal District were surveyed. An online questionnaire (Google Docs) was developed to identify the potential and capacity of institutions to analyze or produce clinical and economic evidence. Two HTA seminars were held to spread knowledge about HTA and to encourage stakeholders to complete the survey.Results:The questionnaire response rate was thirty-five percent (25/70). Fifteen institutions were cited by the respondents as having the potential to build a HTA network. Twelve of the institutions produced rapid reviews and clinical guidelines, but only three of these had an organized priority setting process or produced assessments at the request of the hospital manager. The challenges identified were training and willingness of decision makers to organize HTA units in the hospitals.Conclusions:An executive group was created which defined a strategy to support the implementation of HTA units as part of the HTA National Network (REBRATS). A regulation proposal was also created to encourage decision makers to activate a HTA network in the Federal District.
PD65 The Acquisition Of Eculizumab By Judicial Proceeding In Brazil
Authors: Salomon Flavia , Simabuku Eliete , Beutel Jose , Oliveira Eduardo De , Rabelo Roberta , Petramale Clarice , de Brito Artur Felipe , Souza Kathiaja Miranda 
Published: January 2019

Introduction:Eculizumab is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or with atypical hemolytic uremic syndrome (aHUS). In Brazil in recent years eculizumab was the most expensive drug requested through court orders, obliging public health managers to import it from the USA. From 2012 to 2016, approximately BRL 424 million (USD 112 million) was spent on eculizumab. The purpose of this study was to assess the regulatory situation and the scientific evidence on the safety and efficacy of eculizumab.Methods:A literature search was conducted in PubMed, The Cochrane Library, and the Centre for Reviews and Dissemination databases on September 2017. The websites of regulatory agencies were also searched.Results:In 2007, the use of eculizumab was approved by the United States Food and Drug Administration and the European Medicines Agency. In Brazil, despite the provision of eculizumab through judicial proceedings since 2009, the manufacturer of eculizumab only requested a licence for it in 2017, after several meetings with the government when the company agreed to provide the drug at approximately half the price of the imported product. The efficacy of eculizumab in PNH patients was assessed in one randomized, placebo controlled study, one single arm study, and one long-term extension study. The drug reduced hemolysis and the need for transfusion, although the studies had methodological problems. The efficacy of eculizumab in the treatment of aHUS was assessed in four prospective, controlled open-label studies, two long-term extension studies, and one retrospective study. Eculizumab normalized platelet counts and reduced the need for plasmapheresis, although the studies had no control group. Eculizumab was well tolerated, with no meningococcal infections occurring after patients were immunized.Conclusions:Some companies have no interest in licensing their products in Brazil because their provision by judicial proceedings is more lucrative. This situation promotes litigation and irrational prescription of drugs, and also obligates the Brazilian government to import expensive health products.