Bayesian analysis of the ICAT·COVID randomized clinical trial

This communication provides new effect measures in the multiplicative scale from the ICAT·COVID randomized clinical trial, obtained through Bayesian statistics. These could not be calculated using the traditional frequentist statistics included in the original publication because the benefits of icatibant (a competitive antagonist of the bradykinin B2 receptors) on top of standard care in patients with COVID-19 pneumonia were such that there were no events in the active group.1 Additive effect measures (eg, risk differences) are the most appropriate measures for identifying the population groups that will benefit most from interventions in presence of interactions acting as effect modifiers.2 However, an aspect that multiplicative measures provide where additive effect measures cannot, is an indication of how many times interventions or exposures increase or decrease disease risk (eg, risk ratio, hazard ratio). Furthermore, multiplicative measures are more commonly used in epidemiology, and are more appropriate for outcome measures with strictly positive values, such as counts and the numerators of incidence rates

Detección de pacientes con diabetes mellitus tipo 2 oculta desde las farmacias comunitarias de Valladolid. Valoración del impacto ambiental. Prueba piloto

Introducción: las complicaciones que puede desarrollar la DM2 y las cifras de población no diagnosticadas (6 %) ponen de manifiesto la importancia de realizar cribados a nivel poblacional. El objetivo de este trabajo es evaluar un programa de detección precoz de DM2 oculta desde la farmacia comunitaria y posterior derivación al médico para determinar el posible diagnóstico, así como evaluar el impacto ambiental de las actuaciones. Material y métodos: cuestionario Findrisc a los pacientes que, cumpliendo con los criterios de inclusión, aceptan participar en el estudio. Se realiza glucemia basal capilar si el resultado es ≥15 puntos y derivación al médico si la glucemia basal es ≥110 mg/dL. Resultados: participaron 44 farmacias. La muestra incluyó 434 usuarios. Se realizó la glucemia a 125 de los 135 pacientes con Findrisc ≥15 puntos, obteniéndose una media de 124,5 mg/dL (DE=33,6). Se de­rivaron al médico 89 pacientes de los que en 13 casos se confirmó el diagnóstico de diabetes, lo que supone un 3 % de la muestra total analizada y un 14,6 % de los derivados. Discusión: los nuevos diagnósticos (3 %) reflejan que la farmacia comunitaria es un buen punto de detección de diabetes oculta. Además, tras analizar la intervención del farmacéutico, se podría indicar su utilidad como educador sanitario, indicando hábitos de vida saludables a aquellos pacientes no susceptibles de derivación al médico. Por otra parte, sería precisa una mayor colaboración médico-farmacéutico en los cribados de diabetes

Bacterial immunotherapy is highly effective in reducing recurrent upper respiratory tract infections in children: a prospective observational study

Purpose Whilst immunotherapy is an appealing option as it could reduce the burden of recurrent pediatric respiratory tract infections (RTI), there is limited evidence on its effectiveness and more research was requested in order to better understand this therapeutic modality. Methods We performed a prospective cohort study involving 57 subjects to assess the safety and effectiveness a 3-month regimen of either typified or patient-specific bacterial lysates could have in reducing the number of RTIs in children aged 0 to 11 years with histories of recurrent episodes. Results After a 6-month follow-up, the number of RTIs and school absenteeism dropped sharply and significantly, from an adjusted mean (standard error) of 0.6 (0.04) episodes/month to 0.1 (0.03) episodes/month (74.7% reduction, P < 0.001), and from an adjusted mean score of 4.6 (1.06) points to 0.0 (0.01) points over 10 (99.5% reduction, P < 0.001), respectively. There was also a significant decrease in the severity of symptoms. No adverse reactions were observed. Conclusion The use of the study product is associated with a decreased risk of recurrent RTIs in children, with a very favorable safety profile that warrants further investigation in randomized clinical trials

Aprendizaje acelerado y desarrollador: alternativa para perfeccionar la expresión oral de la lengua inglesa

En este artículo se presenta uno de los más importantes resultados de una investigación desarrollada en la Universidad de Ciego de Ávila, Cuba, cuya finalidad era perfeccionar el proceso de enseñanza aprendizaje de la lengua inglesa en los estudiantes de primer año de las carreras de Contabilidad y Finanzas, Informática y de Turismo. Partimos de las insuficiencias que presenta este proceso en la referida universidad que dificultan el establecimiento de una comunicación eficiente en este idioma; para su solución se elaboró una Alternativa Metodológica dirigida a perfeccionar la expresión oral en la lengua inglesa, fundamentada en las concepciones actuales del aprendizaje acelerado y en las aportaciones del paradigma histórico cultural acerca del aprendizaje desarrollador que, unidos a diferentes métodos y técnicas participativas, garantizan el cumplimiento de los objetivos propuestos. Esta investigación responde a los postulados de la educación permanente presentada por la UNESCO en el informe «Aprender a Ser». Desde el punto de vista del método científico, la forma en que se realizó la investigación y se recogieron los datos es afín al diseño preexperimental de un grupo con pretest y postest. Para llevar a cabo las indagaciones empíricas y recoger los datos se emplearon diferentes técnicas e instrumentos de investigación, en correspondencia con los indicadores que se establecieron para medir el aprendizaje acelerado y desarrollador del idioma inglés. Entre los principales resultados alcanzados se encuentran la influencia positiva que se logró en la formación integral de los estudiantes y el aumento de la competencia expresiva oral junto al resto de las demás habilidades del idioma.This article presents one of the most important outcomes of a research carried out in the University Of Ciego de Ávila Cuba, with the purpose of improving the English language teaching-learning process in first-academic-year-students of Accounting and Finances, Informatics and Tourism courses. We started from the inadequacies that this process presents in this university which hinder the establishment of a steady communication in that language. In order to solve such problem, a Methodological Alternative was elaborated directed to improve the oral expression in the English language, with its foundations laid on the present day conceptions of the accelerated learning as well as on the contributions of the historical-cultural paradigm about the developing learning, which together with different methods and participative techniques; guarantee the accomplishment of the goals that have been set. The research carried out responds to the permanent education’s postulates presented by UNESCO in the report ‘’Learning to Be’’. From the scientific method point of view, the way used to do the research and to gather data is akin to the pre-experimental design of a group with pre-test and post-test. To carry out the empirical inquiries and to gather the data, several techniques and researching tools were employed according to the indicators established to measure the accelerated learning and to develop English language. The most outstanding results include the achievement of a positive influence on the students’ integral formation and the development of the oral expression as well as of the rest of the language’s skills

Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment: a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area

BackgroundChronic non-cancer pain (CNCP) treatment's primary goal is to maintain physical and mental functioning while improving quality of life. Opioid use in CNCP patients has increased in recent years, and non-pharmacological interventions such as music listening have been proposed to counter it. Unlike other auditive stimuli, music can activate emotional-regulating and reward-regulating circuits, making it a potential tool to modulate attentional processes and regulate mood. This study's primary objective is to provide the first evidence on the distinct (separate) effects of music listening as a coadjuvant maintenance analgesic treatment in CNCP patients undergoing opioid analgesia.Methods and analysisThis will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences.Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints' evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation.Methods and analysisThis will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences.Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints' evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation.Ethics and disseminationThe study protocol has been reviewed, and ethics approval has been obtained from the Bellvitge University Hospital Institutional Review Board, L'Hospitalet de Llobregat, Barcelona, Spain. The results from this study will be actively disseminated through manuscript publications and conference presentations.Trial registration numberNCT05726266

Binding Potassium to Improve Treatment With Renin-Angiotensin-Aldosterone System Inhibitors: Results From Multiple One-Stage Pairwise and Network Meta-Analyses of Clinical Trials

This manuscript presents findings from the first dichotomous data pooling analysis on clinical trials (CT) regarding the effectiveness of binding potassium. The results emanated from pairwise and network meta-analyses aiming evaluation of response to commercial potassium-binding polymers, that is, to achieve and maintain normal serum potassium (n = 1,722), and the association between this response and an optimal dosing of renin-angiotensin-aldosterone system inhibitors (RAASi) needing individuals affected by heart failure (HF) or resistant hypertension, who may be consuming other hyperkalemia-inducing drugs (HKID) (e.g., b-blockers, heparin, etc.), and frequently are affected by chronic kidney disease (CKD) (n = 1,044): According to the surface under the cumulative ranking area (SUCRA), sodium zirconium cyclosilicate (SZC) (SUCRA >0.78), patiromer (SUCRA >0.58) and sodium polystyrene sulfonate (SPS) (SUCRA 5.1 mEq/L), and, when normokalemia is achieved, patiromer 16.8–25.2 g/day (SUCRA = 0.94) and patiromer 8.4–16.8 g/day (SUCRA = 0.41) can allow to increase the dose of spironolactone up to 50 mg/day in subjects affected by heart failure (HF) or with resistant hypertension needing treatment with other RAASi. The potential of zirconium cyclosilicate should be explored further, as no data exists to assess properly its capacity to optimize dosing of RAASi, contrarily as it occurs with patiromer. More research is also necessary to discern between benefits of binding potassium among all type of hyperkalemic patients, for example, patients with DM who may need treatment for proteinuria, patients with early hypertension, etc.Fil: Lizaraso Soto, Frank. Universidad de Valladolid; EspañaFil: Gutiérrez Abejón, Eduardo. Universidad de Valladolid; EspañaFil: Bustamante Munguira, Juan. Universidad de Valladolid; EspañaFil: Martín García, Débora. Universidad de Valladolid; EspañaFil: Chimeno, María Montserrat. Hospital Virgen de la Concha; EspañaFil: Nava Rebollo, Álvaro. Hospital Virgen de la Concha; EspañaFil: Maurtua Briseño Meiggs, Álvaro. Woodland Medical Practicenhs; Reino UnidoFil: Fernández, Darío. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Nordeste; Argentina. Universidad Nacional de Cuyo; Argentina. Universidad de Burgos. Departamento de Didácticas Específicas; EspañaFil: Bustamante Munguira, Elena. Universidad de Valladolid; EspañaFil: de Paz, Félix Jesús. Universidad de Valladolid; EspañaFil: Grande Villoria, Jesús. Universidad de Valladolid; España. Universite de Lausanne; SuizaFil: Ochoa Sangrador, Carlos. Sanidad de Castilla y León; EspañaFil: Pascual, Manuel. Universite de Lausanne; SuizaFil: Álvarez, F. Javier. Universidad de Valladolid; EspañaFil: Herrera Gómez, Francisco. Universite de Lausanne; Suiza. Universidad de Valladolid; Españ

Graves’ ophthalmopathy: Visa versus Eugogo classification, assessment, and management

Graves’ ophthalmopathy (Go) is an autoimmune inflammatory disorder associated with thyroid disease which affects ocular and orbital tissues. Go follows a biphasic course in which an initial active phase of progression is followed by a subsequent partial regression and a static inactive phase. Although the majority of GO patients have a mild, self-limiting, and nonprogressive ocular involvement, about 3–7% of GO patients exhibit a severe sight-threatening form of the disease due to corneal exposure or compressive optic neuropathy. An appropriate assessment of both severity and activity of the disease warrants an adequate treatment. The VISA (vision, inflammation, strabismus, and appearance), and the European Group of Graves’ Orbitopathy (EUGOGO) classifications are the two widely used grading systems conceived to assess the activity and severity of GO and guide the therapeutic decision making. A critical analysis of classification, assessment, and management systems is reported. A simplified “GO activity assessment checklist” for routine clinical practice is proposed. Current treatments are reviewed and management guidelines according to the severity and activity of the disease are provided. New treatment modalities such as specific monoclonal antibodies, TSH-R antagonists, and other immunomodulatory agents show a promising outcome for GO patients

Tolerancia inmunológica y trasplante renal

Producción CientíficaEl papel crucial de las células T reguladoras en la tolerancia de los injertos se ha visto claramente en numerosos modelos animales. No obstante, delimitar este rol en trasplante con humanos es tarea difícil. Alternativamente, la exploración del componente regulador de la respuesta alo-inmune podría convertirse en un biomarcador diagnóstico y pronóstico muy útil para el seguimiento a largo plazo de los pacientes trasplantados

Grado de adherencia y conocimiento previo a la conciliación terapéutica en pacientes en diálisis peritoneal

Producción CientíficaEl empleo de medicamentos implica a pacientes y profesionales sanitarios, y puede dar lugar a errores con importantes repercusiones clínicas. A estos errores contribuyen la pluripatologìa, la polimedicaciòn, la fragmentación del sistema de salud (con múltiples médicos prescriptores sin registro único de salud), así como al desconocimiento del tratamiento por parte del paciente, familiares o cuidadores. Para disminuir estos errores de medicación se han propuesto varios procesos entre los que se incluyen la conciliación de la medicación (crear lista de medicación exacta que recoja todos los fármacos que el paciente toma), revisión del tratamiento (evaluar la lista para adecuación, efectividad, seguridad y conveniencia en conjunción con el estado de salud del paciente) y manejo individualizado de la terapia (comprobando adherencia, conocimiento de fármacos y lista de medicación «en la cartera»