Ivan Ricardo Zimmermann

Pubertal timing in girls and depression: A systematic review

BACKGROUND Because the incidence of depression increases after puberty, it is possible that pubertal timing in girls influences the onset of depression. Our objective was to assess the effect of early and late puberty in girls on the incidence of depression. METHODS We systematically searched relevant databases for controlled studies that assessed the impact of pubertal timing in girls on the incidence of depression or depressive symptoms. The last search was completed in August 2013. Two authors selected the studies, extracted the data, and assessed the quality of the evidence. Meta-analyses of the adjusted and unadjusted results were calculated using random effects. RESULTS Four cohort studies were included (n=8055 participants). Early puberty significantly increased the risk of new cases of depression in the unadjusted meta-analysis (RR=1.33; CI 95%: 1.02, 1.73) but not in the adjusted estimate of two of the included studies (RR=1.48; CI 95%: 0.69, 2.28). For late puberty, no significant associations were found (unadjusted RR=1.28; CI 95%: 0.87, 1.88). Two studies assessed the effect of early puberty on depressive symptoms and found positive associations. The quality of the available evidence was rated as very low. LIMITATIONS The polled results had wide confidence intervals, and the available evidence was of very low quality. CONCLUSIONS The available evidence supports little confidence regarding the impact of pubertal timing on the onset of depression in girls but suggests that early puberty in girls may increase the risk of depression. Further higher quality studies are needed to clarify the association between pubertal timing and the incidence of depression in girls and women.

Olanzapine plus fluoxetine for bipolar disorder: a systematic review and meta-analysis.

BACKGROUND Olanzapine plus fluoxetine combination (OFC) is one of the current approaches for treating the depressive phase of bipolar disorder. Our objective was to synthesize the evidence on the efficacy of OFC therapy in bipolar depressed patients. METHODS We searched for randomized controlled trials (RCTs) on MEDLINE, Embase and other databases. Independent researchers selected the studies and extracted the data. The GRADE approach was used to assess the quality of the evidence. The Mantel-Haenszel random effect model was used to perform the meta-analyses. RESULTS From 627 unique records retrieved, four RCTs were included (1330 patients). OFC improved the response compared to olanzapine (relative risk [RR]=1.58; 95% confidence interval [95% CI]: 1.27, 1.97) and to placebo (RR=1.99; 95% CI: 1.49, 2.65) but not to lamotrigine (low-quality evidence). Similar results were found for remission and relapse rates. No differences were identified for levels of depression and mania symptoms (low-quality evidence) and incidence of mania (moderate-quality evidence). Adverse effects were more common in patients treated with OFC than in those treated with lamotrigine (RR=1.13; 95% CI: 1.04, 1.23), but no difference was found relative to the patients treated with olanzapine (low-quality evidence). LIMITATIONS Despite the totality of the evidence included, there are few RCTs available regarding the efficacy of OFC therapy for bipolar depression. The risk of attrition and reporting bias is also a concern. CONCLUSIONS OFC therapy improved the response, remission, and relapse rates among other outcomes. However, a worse profile of adverse reactions was observed in some comparisons. These data clarify the therapeutic use of OFC as an option to olanzapine in bipolar depression. The quality of the evidence could be improved by additional comparisons and higher rates of treatment adherence.

Influenza vaccination in pregnant women: a systematic review.

Objective. To assess the effects of the inactivated influenza virus vaccine on influenza outcomes in pregnant women and their infants. Methods. We performed a systematic review of the literature. We searched for randomized controlled trials and cohort studies in the MEDLINE, Embase, and other relevant databases (inception to September 2013). Two researchers selected studies and extracted the data independently. We used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess the quality of the evidence. Results. We included eight studies out of 1,967 retrieved records. Influenza vaccination in pregnant women significantly reduced the incidence of influenza-like illness in mothers and their infants when compared with control groups (high-quality evidence) and reduced the incidence of laboratory-confirmed influenza in infants (moderate-quality evidence). No difference was found with regard to influenza-like illness with fever higher than 38°C (moderate-quality evidence) or upper respiratory infection (very-low-quality evidence) in mothers and infants. Conclusions. Maternal vaccination against influenza was shown to prevent influenza-like illness in women and infants; no differences were found for other outcomes. As the quality of evidence was not high overall, further research is needed to increase confidence and could possibly change these estimates.

Health-related quality of life and self-reported long-term conditions: a population-based survey.

Objective: To estimate and compare the effect of self-reported long-term health conditions and sociodemographic factors on perceived health-related quality of life (HRQoL). Methods: A population-based survey of adults (18 to 65 years) living in Brasilia, Brazil, was conducted in 2012. Descriptive and multivariate analyses using a Tobit model were performed with data on sociodemographic variables, self-reported conditions, and the European Quality of Life-5 Dimensions (EQ-5D) health states, providing utility scores (preferred health state) between 0 and 1 for HRQoL estimates. Results: The mean utility of 1,820 adults interviewed (mean age: 38.4±12.6 years) was 0.883 (95%CI 0.874-0.892), with 76.2% in the highest utility range (0.8 to 1.0). EQ-5D dimensions with moderate problems were pain/discomfort (33.8%) and anxiety/depression (20.5%). Serious problems were reported by only 0.3% of the sample in the mobility and self-care domain and by 3.1% in the pain/discomfort domain. Multivariate analysis revealed reduced HRQoL in individuals with depression, diabetes, and hypertension. Living in satellite towns (outside the city core), belonging to a lower economic class, or not being formally employed were also associated with decreased HRQoL. Beta coefficients for these impacts ranged from -0.033 (not formally employed) to -0.141 (depression), reflecting the strongest impact. Conclusion: Of the long-term health conditions studied, depression had the greatest impact on HRQoL. Social class, employment status, and place of residence also affected HRQoL.

A qualidade das evidências e as recomendações sobre a incorporação de medicamentos no sistema único de saúde: uma análise retrospectiva

O Nucleo de Avaliacao de Tecnologias do Instituto Nacional de Cardiologia foi constituido em 2009 e vem acompanhando e participando ativamente das politicas e do processo de incorporacao tecnologicos no Brasil, atraves da parceria com a Comissao Nacional de Incorporacao de Tecnologias no Sistema Unico de Saude e outras unidades do Brasil e exterior. Objetivo: Documentar e analisar criticamente o funcionamento do Nucleo e seu relacionamento com a Comissao. Metodo: Descricao narrativa da criacao e funcionamento do Nucleo, no periodo de 2009 a 2015, incluindo producao tecnica e cientifica. Analise s: O artigo relata fatores de sucesso e barreiras enfrentadas, a producao tecnica e academica, inovacoes e o amadurecimento do trabalho, que se caracteriza pela independencia e investimento no ensino e pesquisa. Descreve a criacao do nucleo, as atividades realizadas e o interesse do grupo por metodologia, o investimento em ensino e pesquisa e a relacao com os parceiros no Brasil e no exterior. Consideracoes finais: a parceria foi fundamental para o desenvolvimento da equipe, criando um grupo de pesquisa aplicada ao Sistema Unico de Saude.Objetivo : Revisar o uso de avaliacao custo-efetividade na incorporacao de tecnologias em sistemas de saude e informacoes sobre o limite custo-efetividade, especialmente embasadas na experiencia do The National Institute for Health and Care Excellence – NICE no Reino Unido, a fim de pontuar os desafios que se apresentam ao caso brasileiro. Metodologia : Levantamento bibliografico sobre o uso de avaliacoes economicas na tomada de decisao em saude e do Limite Custo-Efetividade (LCE) e suas consequencias. Resultados : Ha uma tendencia atual de se adotar de forma explicita o LCE, sendo incipientes os metodos de calculo empirico. A OMS estabeleceu, em 2002, que o LCE aceitavel corresponde ao valor do PIB per capita por DALY, porem varios estudos buscaram estabelecer a disposicao a pagar por QALY, obtidas diretamente com a populacao. Nimdet calculou a razao entre a disposicao a pagar por QALY e o PIB per capita – por esta, o LCE a ser trabalhado pela CONITEC seria um valor entre R

OP40 First Case Of Disinvestment Using Real-World Evidence In Brazil

1.361 a R

Withdrawal of biologic agents in rheumatoid arthritis: a systematic review and meta-analysis

147.016. Alem do LCE, ha que se considerar o impacto orcamentario e o custo de oportunidade da incorporacao, com a elaboracao de um plano de desinvestimento que suporte o custo das novas tecnologias.

The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil

transparency (assumptions/inputs are disclosed in an understandable, timely way), inclusiveness (perspectives drawn from broad range of stakeholders), diversity (differences in subpopulations, trajectory of disease, and stage of a life should be accounted for), outcomes (includes those that patients have identified as important), and data (variety of credible data sources are used allowing for timely incorporation of new information and account for the diversity of patient populations and patient-centered outcomes). The Rubric describes each domain and includes illustrative examples of how patient engagement/centeredness can be operationalized through direct and indirect pathways.