Adaptación de una metodología para los procesos de adquisición de sistemas de aire acondicionado en servicios de salud

The effective acquisition of health technologies is focused on improving the quality and efficiency in the provision of health services as it is a complex process. Within this process the technical and clinical evaluation are highlighted. The objective of the health technology assessment is to collect, analyze, and synthesize information and knowledge to help improve decisionmaking in medical practice and health policy. This paper presents an evaluation process of acquiring air conditioning systems in health care facilities, based on the definition of variables into a field evaluation; these variables quantify the technical and functional team in their clinical and economic environment. Similarly, it is intended to promote in clinical engineering departments, the implementation of widely accepted methodologies and effectiveness that have, as its primary objective, the acquisition of technologies in evidence-based health.A aquisição efetiva das tecnologias da saúde é focada na melhoria da qualidade e eficiência na prestação de serviços de saúde, pois é um processo complexo. Dentro deste processo se destaca a avaliação técnica e clínica. O objetivo da avaliação de tecnologias em saúde é coletar, analisar e sintetizar informações e conhecimentos para ajudar a melhorar a tomada de decisão na prática médica e a política de saúde. Neste trabalho se apresenta um processo de avaliação de aquisição de sistemas de ar condicionado nos serviços de saúde, com base na definição de variáveis no campo da avaliação; essas variáveis vão quantificar o técnico e o funcional do equipamento em seu ambiente clínico e econômico. Da mesma forma, pretende-se promover nos departamentos clínicos de engenharia a aplicação de metodologias amplamente aceitas e eficácia que têm como objetivo principal a aquisição de tecnologias em saúde baseada em evidências.La adquisición efectiva de tecnologías en salud está enfocada al mejoramiento de la calidad y eficiencia, en la prestación de los servicios de salud ya que es un proceso complejo. Dentro de este proceso se destacan la evaluación técnica y clínica. El objetivo de la evaluación de tecnologías en salud es recolectar, analizar y sintetizar información y conocimiento para contribuir a mejorar la toma de decisiones en la práctica médica y en las políticas de salud. En este trabajo se presenta una evaluación en procesos de adquisición de sistemas de aire acondicionado en servicios de salud, basada en la definición de variables en campos de evaluación; dichas variables cuantifican lo técnico y funcional del equipo en su entorno clínico y económico. De igual manera, se pretende impulsar en los departamentos de ingeniería clínica la implementación de metodologías de amplia aceptación y efectividad que tienen como objetivo primordial la adquisición de tecnologías en salud basados en la evidencia

Rivaroxaban with or without aspirin in stable cardiovascular disease

BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=−4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group. CONCLUSIONS: Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events

Edoxaban versus warfarin in patients with atrial fibrillation

Contains fulltext : 125374.pdf (publisher's version ) (Open Access)BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.)