Clinical Recommendations to Manage Gastrointestinal Adverse Events in Patients Treated with Glp-1 Receptor Agonists: A Multidisciplinary Expert Consensus

Gastrointestinal adverse events; Obesity; Type 2 diabetesEsdeveniments adversos gastrointestinals; Obesitat; Diabetis tipus 2Eventos adversos gastrointestinales; Obesidad; Diabetes tipo 2Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are indicated in type 2 diabetes and obesity for their high efficacy in controlling glycaemia and inducing body weight loss, respectively. Patients may develop gastrointestinal adverse events (GI AEs), namely nausea, vomiting, diarrhoea and/or constipation. To minimize their severity and duration, healthcare providers (HCPs) and patients must be aware of appropriate measures to follow while undergoing treatment. An expert panel comprising endocrinologists, nephrologists, primary care physicians, cardiologists, internists and diabetes nurse educators convened across virtual meetings to reach a consensus regarding these compelling recommendations. Firstly, specific guidelines are provided about how to reach the maintenance dose and how to proceed if GI AEs develop during dose-escalation. Secondly, specific directions are set about how to avoid/minimize nausea, vomiting, diarrhoea and constipation symptoms. Clinical scenarios representing common situations in daily practice, and infographics useful to guide both HCPs and patients, are included. These recommendations may prevent people with T2D and/or obesity from withdrawing from GLP-1 RAs treatment, thus benefitting from their superior effect on glycaemic control and weight loss.This work has been funded by Novo-Nordisk

Colombian consensus on vaccination in patients with chronic kidney disease

Introducción: los pacientes con enfermedad renal son una población de alta complejidad por sus condiciones de multimorbilidad, riesgo cardiovascular y requerimiento de terapias inmunosupresoras. La vacunación es una de las principales estrategias para mitigar el riesgo de infecciones, no obstante, la respuesta a las vacunas se ve afectada por la pérdida de la calidad de la función inmunológica, efecto que es mayor en la medida en que la enfermedad renal progresa o se requiere el uso de medicamentos inmunosupresores. Por ello, las prácticas de inmunización deben ser incentivadas en los pacientes en estadios más precoces de su enfermedad. Desafortunadamente, existe un amplio desconocimiento por parte de los prestadores de atención respecto de las mejores prácticas de inmunización, adicionalmente, en Colombia no existe cobertura de aseguramiento en el plan de beneficios de salud para muchos de los biológicos requeridos. Objetivo: generar recomendaciones informadas en evidencia sobre vacunación en pacientes con enfermedad renal y condiciones especiales relacionadas. Metodología: a partir de una revisión y un análisis crítico de evidencia, el grupo desarrollador formuló recomendaciones sobre indicaciones, contraindicaciones y consideraciones especiales de inmunización en pacientes con enfermedad renal. Se consultó a un colectivo de expertos en infectología y nefrología sobre el acuerdo con las recomendaciones propuestas. Se definió un umbral de acuerdo del 80?%. Resultados: inicialmente se formularon 135 recomendaciones, de las cuales 124 recomendaciones fueron aprobadas en la consulta virtual, aquellas que no superaron el umbral fueron consensuadas en una sesión virtual. Al final del proceso se obtuvieron 142 recomendaciones. Conclusiones: la vacunación es una estrategia de prevención altamente recomendable en pacientes con enfermedad renal, con impactos favorables sobre la carga de enfermedad y la supervivencia. Se espera que las recomendaciones propuestas permitan orientar y estandarizar las prácticas de inmunización en estos pacientes y mejorar los desenlaces en salud para esta población.Introduction: Patients with kidney disease are a highly complex population due to their multimorbidity conditions, cardiovascular risk, and requirement for immunosuppressive therapies. Vaccination is one of the main strategies to mitigate the risk of infections, however, the response to vaccines is affected by the loss of the quality of immune function, an effect that is greater as kidney disease progresses or the use of immunosuppressive drugs is required. Therefore, immunization practices should be encouraged in patients in earlier stages of their disease. Unfortunately, there is a wide lack of knowledge among care providers regarding the best immunization practices, additionally, in Colombia, there is no insurance coverage in the health benefit plan for many of the required vaccines. Purpose: Generate evidence-informed recommendations on vaccination in patients with kidney disease and related special conditions. Methodology: Based on a critical review and analysis of the evidence, the developer group formulated recommendations on the indications, contraindications and special considerations for immunization in patients with kidney disease. A group of experts in infectious diseases and nephrology were consulted about their agreement with the proposed recommendations. An agreement threshold of 80% was defined. Results: Initially, 135 recommendations were formulated, of which 124 were approved in the virtual consultation, those that did not exceed the threshold were agreed upon in a virtual session. At the end of the process, 142 recommendations were obtained. Conclusions: Vaccination is a highly recommended prevention strategy in patients with kidney disease, with favorable impacts on disease burden and survival. The proposed recommendations are expected to guide and standardize immunization practices in these patients and improve health outcomes for this population

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)