Thrombocytopenia-Absent Radius (TAR) : case report of dental implant and surgical treatment

Thrombocytopenia-absent radius (TAR) syndrome is a congenital malformation in which affected individuals present reductions in the number of platelets, hypoplasia, or absence of radial bone unilaterally or bilaterally. Hematologic, skeletal, cardiac (par

CYD-TDV dengue vaccine: systematic review and meta-analysis of efficacy, immunogenicity and safety

Introduction: Dengue virus (DENV) is a serious global health problem. CYD-TDC (Dengvaxia®) was the first vaccine to gain regulatory approval to try and address this problem. Aim: Summarize all available evidence on the immunogenicity, efficacy and safety of the CYD-TDV dengue vaccine. Method: Meta-analysis and systematic review. Results: The best and worst immunogenicity results were for DENV4 and DENV1, respectively. Vaccine efficacy of 60% was derived from studies with participants aged 2–16 years old, with DENV4 and DENV2 presenting the best and worst results, respectively. Erythema and swelling were more frequent with CYD-TDV. No differences were detected for systemic adverse events. Conclusion: CYD-TDV showed moderate efficacy in children and adolescents. From the immunogenicity results in adults, we can expect satisfactory efficacy from vaccination in this population. </jats:p

Overview of managed entry agreements : an integrative review towards policy making in Brazil

Resuminho (60 palavras): In order to provide legal and scientific embasement for policy making in Brazil, the aim of this study was to provide a panorama of Managed Entry Agreements around the world. A systematic review was conducted and the information about the agreements were summarized. It was included 25 studies, which described 446 agreements performed in 29 countries. Introduction (100 palavras): Managed Entry Agreements (MEA) are a reality in many countries. They are used as a tool to reduce the impact of uncertainty and the high cost of new drugs by providing access to new technologies under pre-established conditions. In Brazil, the Ministry of Health approved a high-cost technology under performance evaluation, being the first experience in the country. The aim of this study was to conduct a review to identify MEA performed worldwide to provide embasement to inform public health policy making in Brazil, as well as critical considerations surrounding the implementation of performance based agreements. Methods (75 palavras): A review of MEA for health technologies was conducted, using the question ‘What are the health technology managed entry agreements that have being performed around the world?’. The searches were conducted in april 2019, through PUBMED, EMBASE, LILACS and Cochrane Library databases, as well as manual search and gray literature. The selection of studies was performed by two independent reviewers and, in cases of disagreement, solved by a third reviewer. Results (75 palavras): A total of 25 studies were included, describing 446 agreements in 29 countries, being Australia (122), Italy (96), the United States (48) and Scotland (42) more frequent. Financial risk-sharing agreements were the most prevalent (43%). About 95% of the agreements involved medicines - more than half antineoplastic agents. The outcomes assessed and the impact of the agreements were not addressed in most studies, which may be due to the confidentiality character of them. Conclusions (100 palavras): We are likely to see a growth in MEA in the future with the continual launch of new high priced and complex treatments, coupled with increasing demands on available resources. They are an important tool to improve access to innovative and high cost medicines to achieve universal health coverage, although there are critical issues to consider. Besides the embedded confidentiality of most of the agreements, learning from already stablished knowledge, experiences and practices across countries can be a crucial strategy to guide Brazil’s initial experiences in this area

Effects of piezocision in orthodontic tooth movement : a systematic review of comparative studies

The aim of this systematic review was to evaluate the effects of piezocision in accelerating orthodontic tooth movement (OTM) and its possible adverse effects. The Databases Medline, Embase, CENTRAL and LILACS were searched until March 2019, for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that used piezocision associated with orthodontic treatment. A manual search was also performed. The search, studies selection, assessment of risk of bias and data collection were carried out by two independent reviewers. Eleven publications were included in this review (4 CCTs and 7 RCTs). No study presented low risk of bias. Different types of tooth movement were evaluated: lower anterior alignment, en-masse retraction, overall orthodontic treatment and canine distalization. A total of 240 participants were analyzed in the included studies. Seven studies found significant acceleration in the piezocision group, while two studies found no differences. Adverse effects regarding patient?s satisfaction, pain perception, or worsening of periodontal parameters were not observed. There was no consensus concerning anchorage loss and root resorption. The literature does not provide high-quality evidence to confirm that Piezocision results in significant OTM acceleration. Therefore, high-quality RCTs should be conducted to allow reliable conclusions about the effects of piezocision in orthodontics

Comparative effectiveness and safety of monoclonal antibodies for mCRC

Introduction: Biological medicines are increasingly used in combination with chemotherapy for patients with metastatic colorectal cancer (mCRC), resulting in increased progression-free survival (PFS). However, concerns remain over the extent of their effect on overall survival (OS) given the high costs of these monoclonal antibodies (MoAbs) (bevacizumab, cetuximab and panitumumab) and their safety. Published studies suggest no major differences in effectiveness and safety between the MoAbs; however, differences in costs with cetuximab more expensive than bevacizumab by 127% in Brazil and more expensive than panitumumab by 112%, with panitumumab more expensive than bevacizumab by 6%. Since there is rising litigation in Brazil in order to access these 3 MoAbs as they are not currently reimbursed, we wanted to compare their effectiveness and safety associated with chemotherapy or chemotherapy alone in patients with mCRC to provide future guidance to the judiciary and the healthcare system. Method: A systematic review and meta-analysis based on cohort studies published in databases up to November 2017. Effectiveness measures include PFS, post-progression survival (PPS), RECIST (Response Evaluation Criteria In Solid Tumors), response rates, metastasectomy rates, OS and safety. We also evaluated the methodological quality of the studies. Results: Overall, 21 observational cohort studies were included in the review. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus those not treated with bevacizumab (no bevacizumab arm) mainly around PFS, PPS, metastasectomy rates and OS, but not for disease control rates. However, bevacizumab increased toxicities and there were concerns with the heterogeneity of the studies. Conclusion: The results suggested an advantage in favour of bevacizumab for a number of outcome measures and costs in patients with mCRC. However, this advantage may be only clinically modest for bevacizumab. This though has to be weighed against the serious adverse events associated with bevacizumab, especially severe hypertension and gastrointestinal perforation

Access to medicines by patients of the primary health care in the Brazilian Unified Health System

OBJETIVO: Avaliar o acesso aos medicamentos na Atenção Primária em Saúde do Sistema Único de Saúde na perspectiva do usuário. MÉTODOS: Estudo transversal que utilizou dados da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional no Brasil – Serviços, 2015, realizado por meio de entrevistas com 8.591 usuários em municípios das cinco regiões do Brasil. A avaliação do acesso aos medicamentos utilizou conceitos propostos por Penshansky e Thomas (1981), segundo as dimensões: disponibilidade, acessibilidade geográfica, adequação, aceitabilidade e capacidade aquisitiva. Cada uma das dimensões foi avaliada por meio de indicadores próprios. RESULTADOS: Para dimensão disponibilidade, 59,8% dos usuários declararam ter acesso total aos medicamentos, sem diferença significante entre regiões. Para acessibilidade geográfica, 60% dos usuários declararam que a unidade básica de saúde não ficava longe de sua residência, 83% afirmaram ser muito fácil/fácil chegar até a unidade e a maioria dos usuários relatou caminhar (64,5%). Para adequação, a unidade foi avaliada como muito bom/bom para os itens conforto (74,2%) e limpeza (90,9%), e 70,8% dos usuários relataram não ter de esperar para retirar seus medicamentos, embora o tempo médio de espera tenha sido 32,9 minutos. Para aceitabilidade: 93,1% dos usuários relataram ser atendidos com respeito e cortesia pelos funcionários das unidades dispensadoras e 90,5% declararam ser muito bom/bom o atendimento das unidades. Para capacidade aquisitiva 13% dos usuários relataram ter deixado de comprar algo importante para cobrir gastos com problemas de saúde, 41,8% dos participantes apontaram a despesa com medicamentos. CONCLUSÕES: Os resultados mostram 70%–90% de conformidade, compatível com países desenvolvidos. No entanto, o acesso aos medicamentos continua sendo um desafio pois ainda é fortemente comprometido pela baixa disponibilidade de medicamentos essenciais em unidades públicas de saúde, demonstrando que não ocorre de forma universal, equânime e resolutiva à populaçãoOBJECTIVE: To evaluate the access to medicines in primary health care of the Brazilian Unified Health System (SUS), from the patients’ perspective. METHODS: This is a cross-sectional study that used data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Services, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), conducted by interviews with 8,591 patients in cities of the five regions of Brazil. Evaluation of access to medicines used concepts proposed by Penshansky and Thomas (1981), according to the dimensions: availability, accessibility, accommodation, acceptability, and affordability. Each dimension was evaluated by its own indicators. RESULTS: For the “availability” dimension, 59.8% of patients reported having full access to medicines, without significant difference between regions. For “accessibility,” 60% of patients declared that the basic health unit (UBS) was not far from their house, 83% said it was very easy/easy to get to the UBS, and most patients reported that they go walking (64.5%). For “accommodation,” UBS was evaluated as very good/good for the items “comfort” (74.2%) and “cleanliness” (90.9%), and 70.8% of patients reported that they do not wait to receive their medicines, although the average waiting time was 32.9 minutes. For “acceptability,” 93.1% of patients reported to be served with respect and courtesy by the staff of the dispensing units and 90.5% declared that the units’ service was very good/good. For “affordability,” 13% of patients reported not being able to buy something important to cover expenses with health problems, and 41.8% of participants pointed out the expense with medicines. CONCLUSIONS: Results show 70%–90% compliance, which is compatible with developed countries. However, access to medicines remains a challenge, because it is still heavily compromised by the low availability of essential medicines in public health units, showing that it does not occur universally, equally, and decisively to the populatio

Budget impact analysis of medicines : updated systematic review and implications

This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001 to 2015 on "budget impact analysis" with "drug" interventions were assessed, selected based on their titles/abstracts and full texts, with their characteristics checked according to key criteria. Out of 1984 studies, 92 were identified. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 6 or 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions

Integrative review of managed entry agreements : chances and limitations

Introduction: Managed Entry Agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. Methods: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was ‘What are the health technology MEAs that have been applied around the world?’ This review was supplemented with studies not retrieved in the search known to the senior level co-authors including key South American markets. Afterall, involved senior level decision makers and advisers providing guidance on potential advantages and disadvantages of MEAs and ways forward. Results: 25 studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%), and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusion: We are likely to see a growth in MEAs with the continual launch of new high priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome based MEAs could be an important tool to improve access to new innovative medicines there are critical issues to address. Comparing knowledge, experiences and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs