Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study

BackgroundThe use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting.MethodsMulticenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024.DiscussionThe scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript.Trial registrationNCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021

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

Stroke: roles of B vitamins, homocysteine and antioxidants

19 páginas, 1 figura, 2 tablas.In the present review concerning stroke, we evaluate the roles of B vitamins, homocysteine and antioxidant vitamins. Stroke is a leading cause of death in developed countries. However, current therapeutic strategies for stroke have been largely unsuccessful. Several studies have reported important benefits on reducing the risk of stroke and improving the post-stroke-associated functional declines in patients who ate foods rich in micronutrients, including B vitamins and antioxidant vitamins E and C. Folic acid, vitamin B6 and vitamin B12 are all cofactors in homocysteine metabolism. Growing interest has been paid to hyperhomocysteinaemia as a risk factor for CVD. Hyperhomocysteinaemia has been linked to inadequate intake of vitamins, particularly to B-group vitamins and therefore may be amenable to nutritional intervention. Hence, poor dietary intake of folate, vitamin B6 and vitamin B12 are associated with increased risk of stroke. Elevated consumption of fruits and vegetables appears to protect against stroke. Antioxidant nutrients have important roles in cell function and have been implicated in processes associated with ageing, including vascular, inflammatory and neurological damage. Plasma vitamin E and C concentrations may serve as a biological marker of lifestyle or other factors associated with reduced stroke risk and may be useful in identifying those at high risk of stroke. After reviewing the observational and intervention studies, there is an incomplete understanding of mechanisms and some conflicting findings; therefore the available evidence is insufficient to recommend the routine use of B vitamins, vitamin E and vitamin C for the prevention of stroke. A better understanding of mechanisms, along with well-designed controlled clinical trials will allow further progress in this area.Peer reviewe

Oxigen and oxidation I: Reactive oxigen species and oxidative damage to biological substrates | Oxígeno y oxidación I: Especies reactivas de oxígeno y daño oxidativo de sustratos biológicos

Human beings and eucariotic organisms need oxygen for efficient energy production by using electron transport chains with molecular oxygen as the terminal electron acceptor. Thus, oxygen is essential for human life. However, during the use of oxygen several reactive oxygen species are generated, leading to damaging effects on biological substrates. This is call the aerobic paradox. The production of reactive oxygen species and natural antioxidant defense are approximately balanced, but it is easy to tip this balance in favour of the reactive oxygen species and create the situation of oxidative stress. Oxidative stress can result from depletion of dietary antioxidants due to malnutrition or by excess production of reactive oxygen species in different situations, such as exposure to pollution or radiation, heavy sport or chronic inflammatory diseases. In this review the reactivity and physiological generation of the different reactive oxygen species is described (superoxide radical, hydrogen peroxide, oxygen molecular in triplet state, and hydroxyl radical). In addition the mechanism through biological substrates (lipids, proteins and nucleic acids) are oxidised is described.Peer Reviewe

Multifunctional in vitro antioxidant evaluation of strawberry (Fragaria virginiana Dutch.)

Berries have shown the highest potential antioxidant activity among fruits using a unique antioxidant method. The antioxidant activity of aqueous-organic extracts of strawberry (Fragaria virginiana Dutch., var. camarosa) were determined using three methods: 2,2-diphenyl-1-picrylhydrazyl (DPPH•) radical scavenging, antioxidant ferric-reducing power (FRAP), and inhibition of Cu(II)-catalysed in vitro human low-density lipoprotein (LDL) oxidation. A serving (100 g) of strawberry had a DPPH• activity equivalent to that of 183 mg vitamin C and to that of 483 mg vitamin E. In addition, strawberry extracts showed high efficiency in the FRAP assay and in the in vitro inhibition of LDL oxidation. Regression linear analysis between radical scavenging activity (EC50 parameter) and total phenol content from strawberry extracts gave a statistically significant correlation (r = 0.984, P < 0.05). In conclusion, strawberry showed significant antioxidant capacity in both aqueous and lipophilic models.Peer Reviewe

Analysis of dietary phytochemicals needs to be applauded: Glycosylated plant sterols

In this issue of European Journal of Lipid Science and Technology, Lampi and co-workers [p. 656-669] report the content of glycosylated plant sterols (steryl glycosides and acylated steryl glycosides) as minor glycolipids found in common edible plants. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.Peer Reviewe

Oxigen and oxidation II: Antioxidant defense system of cellular organisms | Oxígeno y oxidación II: Mecanismos de defensa antioxidante de los sistemas biológicos

In the human organism the production of reactive oxygen species and natural antioxidant defense are approximately balanced, but it is easy to tip this balance in favour of the reactive oxygen species and create the situation of oxidative stress. The antioxidant defense system of cellular organisms includes four levels of protection: prevention, interaction, repair, and adaptation. In this review, a description of endogen and dietetic antioxidants is made. In this description if the antioxidant action is produced before or during the exposure of the substrate to oxidative agent, or later when the damage have occurred, is considered. The preventive role of the enzymatic systems superoxide dismutase, catalase, and glutation peroxidase, of the metal quelating proteic systems transferrine, ceruloplasmine and haemoglobine, and of the dietetic antioxidant carotenoids, flavonoids, and vitamin C towards oxidation are analysed. In addition, the interaction role in the oxidative process of hydrosoluble (vitamin C, uric acid, bilirrubine) and liposoluble (vitamin E, ubiquinol, carotenoids, flavonoids) endogen and dietetic antioxidants is described. At least, a brief mention of the repair and adaptation processes in the defense system towards oxidative damage of biological substrates is done.Peer Reviewe

Fibra dietética antioxidante y concentrado de antioxidantes naturales de alga Fucus y sus procedimientos de obtención

Referencia OEPM: P200002514.-- Fecha de solicitud: 19/10/2000.-- Titulares: Consejo Superior de Investigaciones Científicas (CSIC).Fibra dietética antioxidante y concentrado de antioxidantes naturales de alga Fucus y sus procedimientos de obtención. Se desarrolla un procedimiento de obtención de fibra dietética antioxidante en polvo a partir del alga Fucus. El producto presenta un alto contenido en fibra dietética (superior al 50% de materia seca) y en antioxidantes naturales asociados (3 a 7% materia seca). Durante su preparación se han utilizado métodos físicos que permiten preservar su actividad biológica. La actividad antioxidante y secuestrante de radicales libres de 1 g. de producto resulta equivalente a 10-26 mg de vitamina C y 65-80 mg de vitamina E. También se desarrolla un procedimiento para la obtención de un concentrado de antioxidantes naturales a partir del alga Fucus, por extracción con diversos disolventes y posterior concentración.Peer reviewe

Dietary fibre from edible seaweeds: Chemical structure, physicochemical properties and effects on cholesterol metabolism

This brief review outlines the chemical structure, physicochemical properties and effects of seaweed polysaccharides on serum cholesterol levels. Some seaweed polysaccharides are used by the food industry as texture modifiers because of their high viscosity and gelling properties. In Asia, seaweeds have been used for centuries in salads, soups and as low-calorie dietetic foods. The dietary fibre which constitutes 25-75% of the dry weight of marine algae and represents their major component, is primarily soluble fibre. Nowadays, dietary fibre from different sources is known to decrease the risk of coronary heart disease, mainly due to its characteristics of dispersibility in water (water-holding capacity), viscosity, binding ability, absorPtive capacity, faecal bulking capacity and fermentability in the alimentary canal. Indigestible viscous seaweed polysaccharides such as alginates, carrageenans and funorans, which are capable of forming ionic colloids, have shown positive effects on serum lipid levels in rats. The capacity of seaweed polysaccharides to lower serum cholesterol levels seems to be due to their ability to disperse in water, retain cholesterol and related physiologically active compounds and inhibit lipid absorption in the gastrointestinal tract. (C) 2000 Elsevier Science Inc.This brief review outlines the chemical structure, physicochemical properties and effects of seaweed polysaccharides on serum cholesterol levels. Some seaweed polysaccharides are used by the food industry as texture modifiers because of their high viscosity and gelling properties. In Asia, seaweeds have been used for centuries in salads, soups and as low-calorie dietetic foods. The dietary fibre which constitutes 25–75% of the dry weight of marine algae and represents their major component, is primarily soluble fibre. Nowadays, dietary fibre from different sources is known to decrease the risk of coronary heart disease, mainly due to its characteristics of dispersibility in water (water-holding capacity), viscosity, binding ability, absorptive capacity, faecal bulking capacity and fermentability in the alimentary canal. Indigestible viscous seaweed polysaccharides such as alginates, carrageenans and funorans, which are capable of forming ionic colloids, have shown positive effects on serum lipid levels in rats. The capacity of seaweed polysaccharides to lower serum cholesterol levels seems to be due to their ability to disperse in water, retain cholesterol and related physiologically active compounds and inhibit lipid absorption in the gastrointestinal tract.Peer Reviewe