Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as First-Line Treatment in Advanced Breast Cancer: The BrasiLEEira Study.

Purpose: Cyclin inhibitors plus endocrine therapy represent the reference standard for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (ABC). Efficacy results on hard end points such as overall survival come from well-designed randomized clinical trials (RCTs). However, a limitation of RCTs is the low external results validity, and their extrapolation to a broader population may not be appropriate.

Effect of ribociclib on productivity losses due to breast cancer in young women in Brazil.

Objetive: To evaluate the effect of ribociclib versus endocrine therapy on productivity losses due to advanced breast cancer.

Methods: Productivity data from the MONALEESA-7 trial, obtained from the results of the application of the Work Productivity and Activity Impairment (WPAI) questionnaire on progression-free survival state (43-month follow-up), were extrapolated to the 10,936 Brazilian prevalent cases of premenopausal women with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer. Productivity loss was determined by quantifying the economic costs of workforce dropout over time in both treatment arms and by discounting the economic costs of absenteeism and presenteeism from workforce retention.

Cost-effectiveness of ribociclib for premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer: a Brazilian public health care system perspective.

Introduction: The MONALEESA-7 trial compared ribociclib plus endocrine therapy (ET) with placebo as first-line treatment of advanced luminal/HER2-negative breast cancer (ABC) in premenopausal and perimenopausal women (age <50 years) and showed significant benefits to progression-free survival and overall survival. This study aimed to compare the cost-effectiveness of ribociclib + ET ET alone in patients with ABC from the perspective of the Brazilian public national health system.

Methods: We calculated the incremental cost-effectiveness ratio (ICER) using a Markov model with progression-free survival, post-progression survival, and death states.

Cost-effectiveness of ribociclib plus letrozole palbociclib plus letrozole or letrozole as monotherapy in first-line treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer: a Brazilian private payer perspective.

Background: The global burden of breast cancer (BC) is high, especially in advanced stages. CDK 4/6 inhibitors represent a paradigm shift in the treatment of advanced BC HR+/HER2-, given the clinically and statistically significant gain in overall survival associated with this new class of medications. Nevertheless, as an innovation, the incorporation of these drugs impacts healthcare budgets, requiring cost-effectiveness analyses for decision-making.

Clinical practice guidelines in Brazil - developing a national programme.

In Brazil, governmental and non-governmental organisations develop practice guidelines (PGs) in order to optimise patient care. Although important improvements have been made over the past years, many of these documents still lack transparency and methodological rigour. In order to conduct a critical analysis and define future steps in PG development in Brazil, we carried out a structured assessment of strengths, weaknesses, opportunities and threats (SWOT analysis) for the development of a national guideline programme.

The Overt and Hidden Use of Animal-Derived Products in Alternative Methods for Skin Sensitisation: A Systematic Review.

methods that can replace animal testing in the identification of skin sensitisers are now a reality. However, as cell culture and related techniques usually rely on animal-derived products, these methods may be failing to address the complete replacement of animals in safety assessment. The objective of this study was to identify the animal-derived products that are used as part of methods for skin sensitisation testing.

Can Enhanced Techniques Improve the Diagnostic Accuracy of Transvaginal Sonography and Magnetic Resonance Imaging for Rectosigmoid Endometriosis? A Systematic Review and Meta-analysis.

Objective: Our aim was to perform a systematic review and meta-analysis of the most commonly used examinations for rectosigmoid lesions of deeply infiltrating endometriosis, transvaginal sonography (TVS) and magnetic resonance imaging (MRI), to compare their diagnostic accuracy and enhanced or non-enhanced techniques.

Methods: A systematic search was performed until March 2018 without time or language restrictions. Eligibility criteria included studies that compared the accuracy of TVS and MRI for diagnosis of rectosigmoid endometriosis.

Rational use of diagnostic tests for clinical decision making.

Objective: To assist clinicians to make adequate interpretation of scientific evidence from studies that evaluate diagnostic tests in order to allow their rational use in clinical practice.

Methods: This is a narrative review focused on the main concepts, study designs, the adequate interpretation of the diagnostic accuracy data, and making inferences about the impact of diagnostic testing in clinical practice.

Results: Most of the literature that evaluates the performance of diagnostic tests uses cross-sectional design.

Comparison of Biological and Mechanical Prostheses for Heart Valve Surgery: A Systematic Review of Randomized Controlled Trials.

Background: The choice of a mechanical (MP) or biological prosthesis (BP) for patients with valvular heart disease undergoing replacement is still not a consensus.

Objective: We aimed to determine the clinical outcomes of MP or BP placement in those patients.

Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared biological prostheses and mechanical prostheses in patients with valvular heart diseases and assessed the outcomes.

Viscosupplementation for Hip Osteoarthritis: A Systematic Review and Meta-Analysis of the Efficacy on Pain and Disability, and the Occurrence of Adverse Events.

Objective: To assess the efficacy of viscosupplementation (hyaluronic acid [HA]) on the pain and disability caused by hip osteoarthritis, and to determine the occurrence of adverse events.

Data Sources: PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov database, and specific journals up to March 2017.

Long-acting muscarinic antagonists vs. long-acting β 2 agonists in COPD exacerbations: a systematic review and meta-analysis.

Objective: To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting β2 agonists (LABAs) for preventing COPD exacerbations.

Methods: This was a systematic review and meta-analysis of randomized clinical trials involving patients with stable, moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria, treated with a LAMA (i.e.

Short-term effects of fine particulate matter pollution on daily health events in Latin America: a systematic review and meta-analysis.

Objectives: Ambient air pollution is among the leading risks for health worldwide and by 2050 will largely overcome deaths due to unsafe sanitation and malaria, but local evidence from Latin America (LA) is scarce. We aimed to summarize the effect of short-term exposure to fine particulate air pollution (PM) on morbidity and mortality in Latin America and evaluate evidence coverage and quality, using systematic review and meta-analysis.

Methods: The comprehensive search (six online databases and hand-searching) identified studies investigating the short-term associations between PM and daily health events in LA.

Association between high consumption of phytochemical-rich foods and anthropometric measures: a systematic review.

Phytochemical-rich foods consumption may be a valid nutritional strategy to reduce the risk of weight gain and obesity. The phytochemical index (PI) is a simple and nonspecific method to evaluate the phytochemical intake, defined as the percentage of dietary calories derived from foods rich in phytochemicals. We aimed to conduct a systematic review to evaluate whether high consumption of phytochemical-rich foods evaluated by the PI is associated with lower values of anthropometric measurements.

Echocardiography for prognostication during the resuscitation of intensive care unit patients with non-shockable rhythm cardiac arrest.

Aim: Transthoracic echocardiography (TTE) during cardiopulmonary arrest (CPA) has been studied in victims of cardiac arrests. Our objective was to evaluate the feasibility and usefulness of TTE in victims of cardiac arrest with non-shockable rhythms hospitalized in intensive care units (ICUs).

Methods: This prospective and observational cohort study evaluated ICU patients with CPA in asystole or pulseless electrical activity (PEA).

Is there evidence for recommending specific intravenous immunoglobulin formulations? A systematic review of head-to-head randomized controlled trials.

Intravenous immunoglobulins (IVIG) have been used for several licensed and off-label indications. Each IVIG product is a unique formulation of IgG and excipients, making them distinct products. How these differences impact on individual IVIG product efficacy and safety are not well established but can be investigated by head-to-head randomized controlled trials (RCT).

Robotically assisted coronary artery bypass grafting: a systematic review and meta-analysis.

Background: It remains uncertain as to whether robotically assisted coronary bypass surgery (RACBS) is superior to non-robotic procedures.

Methods: Literature searches were conducted using MEDLINE, EMBASE and LILACS. Two review authors independently screened citations, assessed trial quality and performed data extraction.

Effects of alveolar recruitment maneuvers on clinical outcomes in patients with acute respiratory distress syndrome: a systematic review and meta-analysis.

Purpose: To assess the effects of alveolar recruitment maneuvers (ARMs) on clinical outcomes in patients with acute respiratory distress syndrome (ARDS).

Methods: We conducted a search of the MEDLINE, EMBASE, LILACS, CINAHL, CENTRAL, Scopus, and Web of Science (from inception to July 2014) databases for all (i.e.

Anti-nerve growth factor in the treatment of low back pain and radiculopathy: a systematic review and a meta-analysis.

Background: Low back pain with or without radiculopathy is an important cause of disability and economic expenditure. However, many patients are not meeting optimal pain control through existing treatments. Recent studies have linked nerve growth factor (NGF) and the pathophysiology of persistent pain.

Anti-tumor necrosis factor antagonists in the treatment of low back pain and radiculopathy: a systematic review and meta-analysis.

Background: Low back pain, with or without radiculopathy, is an important cause of disability and economic expenditure. However, many patients are not achieving optimal pain control with existing medications. Tumor necrosis factor antagonists (anti-TNFα) could be an alternative drug treatment.

Angioplasty guided by intravascular ultrasound: meta-analysis of randomized clinical trials.

Background: The impact of intravascular ultrasound (IVUS) use on stenting has shown inconclusive results.

Objective: Systematic review and meta-analysis of the impact of IVUS on stenting regarding the clinical and angiographic evolution.

Methods: A search was performed in Medline/Pubmed, CENTRAL, Embase, Lilacs, Scopus and Web of Science databases.

Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial.

Objective: To evaluate the effectiveness of the Brazilian Cardioprotective Diet Program in reducing blood pressures, fasting glucose levels and body mass indices in patients with established atherothrombotic disease.

Method: This randomized controlled pilot trial included outpatients who were over 45 years of age with atherothrombotic cardiovascular disease. Group A, who received the Brazilian Cardioprotective Diet Program, had weekly sessions with dietitians.

Effect of tight blood glucose control versus conventional control in patients with type 2 diabetes mellitus: a systematic review with meta-analysis of randomized controlled trials.

Tight control of blood glucose reduces cardiovascular events and total mortality is conflicting. To summarize clinical effects of tight versus conventional glucose control in patients with type 2 diabetes. We systematically searched MEDLINE, EMBASE, Cochrane Library, and ISI Web of Knowledge with no limits of language and time.

[Analysis of cost-effectiveness of simvastatin versus atorvastatin in the secondary prevention of cardiovascular events within the Brazilian public healthcare system].

Objective: The objective of this study is to perform an economic evaluation analyzing the treatment with atorvastatin and simvastatin in comparison to placebo treatment, within the Brazilian Public Healthcare System (SUS) scenario, for patients with high risk of cardiovascular disease; analyzing if the additional cost related to statin treatment is justified by the clinical benefits expected, in terms of cardiovascular event and mortality reduction.

Methods: Cardiovascular event risk and mortality risk were used as outcomes. Statin efficacy at LDL-c and cardiovascular events levels lowering data was obtained from a systematic review of literature.

How to assess intensive care randomized trials.

Randomized controlled trials are scientific investigations considered as the gold-standard to evaluate therapeutic interventions. Randomized controlled trials may examine the safety and efficacy of new drugs and therapeutic procedures or compare the effects of two or more drugs or any other intervention. In this article, we present the essential features of these studies, as well as, factors which may bias randomized controlled trials.