Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state: a multicentre cohort study (SAM-COVID-19)

Objectives: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters. Methods: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs). Results: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22-0.47; p < 0.001) for tocilizumab, 0.82 (0.71-1.30; p 0.82) for IHDC, 0.61 (0.43-0.86; p 0.006) for PDC, and 1.17 (0.86-1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02-0.17; p < 0.001). Conclusions: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situatio

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy:Study protocol of a cluster randomized clinical trial (Multi-PAP project)

This study was funded by the Fondo de Investigaciones Sanitarias ISCIII (Grant Numbers PI15/00276, PI15/00572, PI15/00996), REDISSEC (Project Numbers RD12/0001/0012, RD16/0001/0005), and the European Regional Development Fund ("A way to build Europe").Background: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12months, as compared with usual care. Methods/Design: Design:pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. Scope: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). Population: patients aged 65-74years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3months). Sample size: n=400 (200 per study arm). Intervention: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. Outcomes: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. Statistical analysis: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. Discussion: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. Trial registration: Clinicaltrials.gov, NCT02866799Publisher PDFPeer reviewe

Situación cultural, socio-económica y legal de los vendedores informales del micro centro de Florencia, Caquetá

Una de las grandes problemáticas que afectan la actividad comercial en Colombia, son las ventas informales, es así como generan efectos negativos principalmente de carácter económico y social, este fenómeno registra un crecimiento constante; a diario, pese a los controles de las autoridades, se puede observar un importante volumen de distribución de productos, e incluso servicios como la telefonía celular. Por esta razón, en la presente investigación se realizó un análisis partiendo de un censo obtenido de la base de datos de vendedores informales de la ciudad de Florencia Caquetá, así como de la información primaria recolectada en el microcentro, en donde se hizo énfasis en factores como el nivel educativo, los ingresos mensuales, la rentabilidad, entre otros datos importantes, con ello se logró identificar la situación socioeconómica, financiera y cultural de los vendedores informales; durante esta labor se detectó el completo desconocimiento que se tiene en la parte legal que rige esta actividad comercial, la población comprometida con esta labor es diversa, sin que se logre identificar una configuración homogénea que agrupe grupos mayoritarios de raza, credo, género o edad. Esta diversidad existe debido a que las condiciones para la vinculación a esta acción productiva son simplemente la necesidad de crear una fuente de ingresos para el sustento diario de las familias en la que no se exija calificación o experiencia. El comercio informal es un oficio aparentemente fácil y rentable, debido a que no obliga a asumir impuestos y gastos administrativos; sin embargo, los individuos que lo desarrollan deben enfrentarse a diversos obstáculos como condiciones climáticas adversas, extensas jornadas laborales, controles de las autoridades del espacio público, multas, entre otros, además, los efectos del comercio informal cobran trascendencia debido a que las empresas legalmente constituidos se ven afectadas por la actividad que ejercen los vendedores informales, al generar una competencia desleal debido a que quienes venden productos y servicios al margen de la formalidad pueden ofrecer precios más bajos por su mínimo nivel de gastos de operación y tributación; además los vendedores informales ocupan los andenes, obstaculizan los ingresos a los locales comerciales y ocasionalmente generan disturbios durante los procesos de control municipal, hechos que en los peores casos generan el cierre de los establecimientos comerciales