Management, development and methodology of the Clinical Practice Guidelines and Recommendations of the Spanish Society of Rheumatology.

The Spanish Society of Rheumatology (SER) brings together the majority of Spain's rheumatologists and, among the many services it offers its members, has a Research Unit (RU). This unit provides methodological support to SER members in clinical and epidemiological research, coordinates and carries out research projects, designs and maintains large patient databases, develops qualitative research projects and produces evidence-based medicine (EBM) documents. Through this last activity, the RU of the SER produces clinical practice guidelines and recommendation documents on topics relevant to rheumatology that meet the most demanding methodological standards. The aim of this article is to describe the management process and methodology followed by the UI of the SER to identify the topics of its EBM documents and how it executes and develops its guidelines and recommendations.

Latin-American guidelines of recommendations at discharge from an acute coronary syndrome.

The diagnostic criteria, treatments at the time of admission, and drugs used in patients with acute coronary syndrome are well defined in countless guidelines. However, there is uncertainty about the measures to recommend during patient discharge planning. This document brings together the most recent evidence and the standardized and optimal treatment for patients at the time of discharge from hospitalization for an acute coronary syndrome, for comprehensive and safe care in the patient's transition between care from the acute event to the outpatient care, with the aim of optimizing the recovery of viable myocardium, guaranteeing the most appropriate secondary prevention, reducing the risk of a new coronary event and mortality, as well as the adequate reintegration of patients into daily life.

Los criterios diagnósticos, los tratamientos en el momento de la admisión y los fármacos utilizados en pacientes con síndrome coronario agudo están bien definidos en innumerables guías. Sin embargo, existe incertidumbre acerca de las medidas para recomendar durante la planificación del egreso de los pacientes. Este documento reúne las evidencias más recientes y el tratamiento estandarizado y óptimo para los pacientes al momento del egreso de una hospitalización por un síndrome coronario agudo, para un cuidado integral y seguro en la transición del paciente entre la atención del evento agudo y el cuidado ambulatorio, con el objetivo de optimizar la recuperación de miocardio viable, garantizar la prevención secundaria más adecuada, reducir el riesgo de un nuevo evento coronario y la mortalidad, así como la adecuada reinserción de los pacientes en la vida cotidiana.

¿Qué condiciones deben reunir las guías de diagnóstico y tratamiento para ser verdaderas guías de práctica clinica basadas en la evidencia? / What conditions should the diagnosis and treatment guidelines meet, to be true clinical practice guidelines based on evidence?

Resumen Las guías de diagnóstico y tratamiento elaboradas por las sociedades científicas médicas, constituyen una herramienta muy útil para el ejercicio profesional de la especialidad. Sustentadas en bibliografía actualizada, representan un material de enorme valor con reco mendaciones de los expertos en los diversos temas de la especialidad. En el presente artículo se intenta determinar si las mismas podrían ser diseñadas acercándolas lo más estrechamente posible al formato de las Guías de Práctica Clínica Basadas en la Evidencia (GPC-BE), para lo cual se revisan las etapas en su elaboración y los requisitos que deberían cumplir para ser conside radas como tales. Las GPC-BE son un "conjunto de recomendaciones elaboradas de forma sistemática para ayudar a los profe sionales y a los pacientes en la toma de decisiones sobre la atención sanitaria más apropiada, seleccionando las opciones diagnósticas y/o terapéuticas más adecuadas en el abordaje de un problema de salud o una condición clínica específica". Su objetivo es mejorar la efectividad, la eficiencia y la seguridad de las decisiones clínicas, y pueden servir de base para la elaboración de políticas de salud. La elaboración de las GPC representa un proceso complejo, que requiere conocimientos, experiencia y re cursos tanto en tiempo como en dinero. Su robustez no depende de quienes la realizan, sino de cómo es realiza da. Ello implica la participación de técnicos que aporten la evaluación de la evidencia por el método GRADE, y la consideración de aspectos de costo-efectividad.

Abstract The guides for diagnosis and treatment prepared by scientific medical societies constitute a very useful tool for the professional practice of the specialty. Supported by an updated bibliography, they represent material of enormous value with recommendations from experts on the various topics of the specialty. This article attempts to determine if they could be designed as "Evidence - Based Clinical Practice Guide lines" (CPG BE), for which the stages in their develop ment and the requirements that they reviewed. The CPG BE are a "set of recommendations prepared systematically to help professionals and patients in making decisions about the most appropriate health care, selecting the most appropriate diagnostic and/or therapeutic options to address a problem of health or a specific clinical condition". Their objective is to improve the effectiveness, efficiency and safety of clinical deci sions, and they can serve a basis for the development of health policies. The preparation of CPGs represents a complex pro cess, which requires knowledge, experience and re sources, both in time and money. Its robustness does not depend on who does it, but on how it is done. This implies the participation of technicians who provide the evaluation of the evidence using the GRADE method and the consideration of cost-effectiveness aspects.

Cómo generar recomendaciones de tromboprofilaxis venosa en instituciones de salud / How to generate recommendations for venous thromboprophylaxis in health institutions?

Resumen La prevención de la enfermedad tromboembólica venosa (ETV) es motivo de continua actualización en función de nueva evidencia que se genera permanentemente. Cada institución debe contar con una estrategia activa de prevención contra la ETV y debe generar normas de tromboprofilaxis (TP) de acuerdo con la realidad local. Durante este proceso de adaptación de una guía a la región debemos siempre tener en cuenta los recursos locales disponibles, el riesgo tromboembólico y hemorrágico propio del paciente, de la enfermedad por la que se encuentra internado (ya sea clínica o quirúrgica) y las consideraciones o preferencias del paciente. La tasa de adherencia a recomendaciones locales de TP es uno de los indicadores de excelencia más importantes evaluados en organismos que califican la calidad de una institución de salud. Las medidas de profilaxis que propongamos para los centros de salud, deben ser individualizadas para cada paciente, tienen que considerar antecedentes personales y familiares del enfermo y utilizar modelos de evaluación de riesgo validados de trombosis y de sangrado. También deben incluir a la población con riesgo de trombosis persistente luego del alta. Lo ideal es tener estadísticas propias de cada nosocomio para la toma de decisiones de cómo implementar una correcta TP. Extrapolar guías de los países desarrollados a nuestro ámbito podría tener un impacto negativo, si no se conoce la propia realidad. En este documento encontraremos herramientas prácticas para las instituciones de salud de la región, que les permita orientarse al momento de confeccionar recomendaciones para una adecuada TP.

Abstract Venous thromboembolism disease (VTE) prevention strategy has to be constantly updated based on new evidence that is generated every year. Each institution must have a formal and active prevention policy against VTE and must develop guidelines or standards for thromboprophylaxis (TP) according to the local reality. During this process of adapting a guideline to the region and the generation of hospital recommendations, we must always consider the available local resources, the thromboembolic and hemorrhagic risk of the patients, even after discharge, and also their considerations and preferences. Adherence to local TP recommendations is one of the most important items evaluated by organizations that measure institutional quality. Individualized prophylaxis should consider personal and family history of VTE, the use of validated risk assessment models or RAMs for thrombosis and bleeding events, as well as the special characteristics of each patient. Ideally, each center's own statistics should be available for decision-making. Extrapolating guidelines from developed countries could have a negative impact, if we ignore our hospital´s reality. In this document we will find practical tools for health institutions that will allow them to prepare recommendations or guidelines for adequate VTE prophylaxis.

Quality assessment of clinical practice guidelines on hypoxic-ischaemic encephalopathy in newborns using the AGREE II tool: a systematic review.

INTRODUCTION: Hypoxic-ischaemic encephalopathy is a clinical syndrome of neurological dysfunction that occurs immediately after birth following an episode of perinatal asphyxia. We conducted a scoping review to assess the methodological quality of clinical practice guidelines that address this condition. METHODOLOGY: We conducted the evaluation using the AGREE II tool. High methodological quality was defined as a score greater than 70% in every domain. RESULTS: The analysis included three clinical practice guidelines; the highest scores were in the scope and purpose domain (84.26%; SD, 14.25%) and the clarity of presentation domain (84.26%; SD, 17.86%), while the lowest score corresponded to the applicability domain (62.50%; SD, 36.62%). Two guidelines were classified as high quality and one guideline as low-quality. CONCLUSIONS: Two of the assessed guidelines were classified as being of high quality; however, the analysis identified shortcomings in the applicability domain, in addition to methodological variation between guidelines developed in middle- or low-income countries versus high-income countries. Efforts are needed to make high-quality guidelines available to approach the management of hypoxic-ischaemic encephalopathy in newborns.

Critical appraisal of the Colombian clinical practice guide for the prevention, diagnosis and treatment of suicidal ideation and/or behaviour (adoption).

INTRODUCTION: Suicide is a complex, global public health problem. The Colombian clinical practice guideline provides relevant input for its prevention, diagnosis and treatment. The objective was to evaluate the methodological quality, credibility and applicability of the Colombian clinical practice guideline for suicidal behaviour. METHODS: An academic group of 12 evaluators was established to assess the guide and its recommendations in a standardised way, using the AGREE-II and AGREE-REX instruments. The evaluations were given in the range of 0.0-1.0 with 0.7 as a cut-off point for appropriate quality. RESULTS: The global assessment of the AGREE-II was greater than 0.7 in the dimensions: "scope and objective" (0.86), "clarity of presentation" (0.89), "applicability" (0.73) and "editorial independence" (0.89). The lowest scores were for "participation of those involved" (0.67) and "rigour in preparation" (0.69). With the AGREE-REX, the results in all dimensions were below 0.70, which indicates lower quality and suitability for use. CONCLUSIONS: The adoption process of the Colombian guideline for suicidal behaviour was a rigorous methodological process, while the practice recommendations were valued as of low applicability due to low support in local evidence. It is necessary to strengthen the generation and synthesis of evidence at the national level to give greater support and applicability to the practice recommendations.

Barreras y facilitadores para el uso de las guías de práctica clínica por residentes de Medicina Familiar y Comunitaria: estudio cualitativo con grupos focales / Barriers and facilitators for the use of clinical practice guidelines by Family and Community Medicine residents: qualitative study with focus groups

Objetivo: identificar barreras y facilitadores para el uso de las guías de práctica clínica (GPC) por residentes de Medicina Familiar y Comunitaria.Métodos: metodología cualitativa. Se formaron tres grupos focales, total 28 residentes de tercer y cuarto año de las siete unidades docentes multiprofesionales de Atención Familiar y Comunitaria de Madrid. Los temas explorados fueron: conocimiento, comprensión, utilidad y uso de GPC. Las categorías elegidas para agrupar el discurso se elaboraron siguiendo el Manual metodológico de GuíaSalud. Análisis sociológico bajo la perspectiva fenomenológica.Resultados: las barreras relacionadas con la formación fueron el modelo de formación recibida para adquirir las habilidades necesarias, la falta de conocimientos para evaluar la calidad de las guías y un limitado conocimiento de los buscadores. Entre las barreras del contexto social y del sistema sanitario, se identificaron el conflicto con las expectativas del paciente, con las recomendaciones de otros especialistas, las características de los pacientes que consultan en Atención Primaria (AP) y la limitación de tiempo en las consultas. Como facilitadores se identificaron la motivación personal, los conocimientos y el modelo de práctica profesional del tutor y que las GPC fueran claras, breves y en diversos formatos.Conclusiones: los residentes dan valor a las GPC como herramientas docentes, de ayuda a la toma de decisiones y para desempeñar un mejor ejercicio profesional, aunque encuentran dificultades y limitaciones en su uso. El papel del tutor se identifica como clave; la formación, motivación y el modelo de práctica del tutor son considerados como los mayores facilitadores.(AU)

Aim: to identify barriers and facilitators for the use of Clinical Practice Guidelines (CPG) by Family and Community Medicine residents.Method: qualitative methodology. Three focus groups were set up, with a total of 28 participants, 3rd and 4th year residents of the 7 Multiprofessional Family and Community Care Teaching Units of Madrid. The topics explored were based on knowledge, understanding, usefulness and use of CPG. The categories chosen for discussion were drawn up according to the GuiaSalud Methodological Manual. Sociological analysis was performed using a phenomenological approach.Results: the barriers related to training were the training model received to acquire the necessary skills, the lack of knowledge to evaluate the quality of guidelines and a limited knowledge of the search engines. Among the barriers related to social context and health system, conflict with the patient's expectations or with the recommendations of other specialists, the characteristics of patients who consult in primary care and the limited time available for consultations were all identified. Personal motivation, the tutor’s knowledge and professional practice model and clear, brief CPGs and in various formats were all identified as facilitators. Conclusions: residents value CPGs as teaching and decision-making tools, as well as a tool to improve their professional practice. However, they detect difficulties and limitations in their use. Training, motivation and the tutor's practice model are considered to be among the greatest facilitators.(AU)

Assessment of the quality, diagnosis, and therapeutic recommendations of clinical practice guidelines on patients with Helicobacter pylori infection: A systematic review.

We conducted this study to systematically review and assess the current clinical practice guidelines (CPGs) related to the diagnosis and treatment of Helicobacter pylori (H. pylori) infection. The aim was to evaluate the quality of these included CPGs and provide clinicians with a convenient and comprehensive reference for updating their own CPGs. We searched four databases to identify eligible CPGs focusing on H. pylori diagnosis and treatment recommendations. The results were presented using evidence mappings. Quality and clinical applicability were assessed comprehensively using AGREE-II and AGREE-REX. Statistical tests, specifically Bonferroni tests, were employed to compare the quality between evidence-based guidelines and consensus. A total of 30 eligible CPGs were included, comprising 17 consensuses and 13 guidelines. The quality showed no statistical significance between consensuses and guidelines, mainly within the moderate to low range. Notably, recommendations across CPGs exhibited inconsistency. Nevertheless, concerning diagnosis, the urea breath test emerged as the most frequently recommended method for testing H. pylori. Regarding treatment, bismuth quadruple therapy stood out as the predominantly recommended eradication strategy, with high-dose dual therapy being a newly recommended option. Our findings suggest the need for specific organizations to update their CPGs on H. pylori or refer to recently published CPGs. Specifically, CPGs for pediatric cases require improvement and updating, while a notable absence of CPGs for the elderly was observed. Furthermore, there is a pressing need to improve the overall quality of CPGs related to H. pylori. Regarding recommendations, additional evidence is essential to elucidate the relationship between H. pylori infection and other diseases and refine test indications. Clinicians are encouraged to consider bismuth quadruple or high-dose dual therapy, incorporating locally sensitive antibiotics, as empirical radical therapy. .

Encuesta a neumonólogos sobre la elección de guías de enfermedades respiratorias / Survey to Pulmonologists about the Choice of Guidelines for Respiratory Diseases

RESUMEN Introducción: Dada la existencia de variadas guías para enfermedades respiratorias, se buscó conocer cuáles eligen los médicos para utilizar en su práctica clínica. Materiales y Métodos: se realizó un estudio descriptivo, transversal, mediante una encuesta a neumonólogos de la Asociación Argentina de Medicina Respiratoria. Resultados: La guía más utilizada para EPOC fue la Iniciativa Global para la Enferme dad Pulmonar Obstructiva Crónica (GOLD) (82 %), seguida por GesEPOC (51 %). Para asma las más usadas fueron la Iniciativa Global para el Asma (GINA) 2022 (89 %) y GEMA 5.2 (68 %). En asma de difícil control, se prefirieron GINA 2022 (82 %) y GEMA 2022 (53 %). En espirometría, un 54 % de los respondedores se inclinó por NHANES III y un 22 % utilizó valores teóricos de referencia de Knudson. En neumonía, el 62 % eligió SADI, el 37 %, IDSA y el 20 %, BTS. Para nódulos pulmonares, el 62 % prefirió las guías Fleischner, 35 % se inclinó por Lung-RADS 1.1. Para neumonitis por hip ersensibilidad, un 83 % seleccionó las guías de las sociedades conjuntas ATS/JRS/ ALAT. Para imágenes de fibrosis pulmonar, el 89 % utilizó ALAT/ERS/JRS/ALAT y el 18 % White Paper. Discusión: si bien hay estudios sobre adherencia a guías, no los hay acerca de pref erencias de utilización entre varias referidas a un mismo tema. En EPOC y asma (in cluyendo la de difícil control) se eligieron GOLD y GINA y las de la Sociedad Española de Patología Respiratoria (GesEPOC y GEMA). El uso preferencial de la guía nacional para neumonía es coherente con la necesidad de contemplar la epidemiología local.

ABSTRACT Introduction: Since there are various guidelines for respiratory diseases, we aimed to know which are chosen by physicians in their daily clinical practice. Materials and Methods: A descriptive, cross-sectional study was conducted through a questionnaire sent to pulmonologists of the Argentinian Association of Respiratory Medicine. Results: The most commonly used guideline for COPD (chronic obstructive pulmonary disease) was the Global Initiative for Chronic Obstructive Lung Disease (GOLD) (82 %), followed by GesEPOC (51 %). For asthma, the most commonly used guideline was the Global Initiative for Asthma (GINA) 2022 (89 %) and the Spanish Guideline on the Management of Asthma (known for its acronym in Spanish, GEMA), GEMA 5.2 (68 %). In difficult-to-control asthma, GINA 2022 (82 %) and GEMA 2022 (53 %) were used. With regard to spirometries, 54 % of respondents favored NHANES III (Third National Health and Nutrition Examination Survey) and 22 % used theoretical Knudson reference values. For pneumonia, 62 % chose the guidelines of the SADI (Argentinian Society of Infectious Diseases), 37 % preferred those of the IDSA (Infectious Diseases Society of America) and 20 %, chose the guidelines of the BTS (British Thoracic Society). For pulmonary nodules, 62 % used Fleischner guidelines, and 35 % favored Lung-RADS 1.1. For hypersensitivity pneumonitis, 83 % selected the ATS/JRS/ALAT Guidelines (American Thoracic Society/Japanese Respiratory Society/Latin American Thoracic Society). And with respect to pulmonary fibrosis imaging, 89 % used ALAT/ERS (Eu ropean Respiratory Society)/JRS recommendations, and 18 % preferred White Paper. Discussion: Although there are studies about adherence to guidelines, none of them shows which are the chosen recommendations within a group of guidelines of the same topic. In COPD and asthma (including difficult-to-control asthma) GOLD, GINA and the guidelines of the Spanish Society of Respiratory Disease (GesEPOC and GEMA) were chosen. The preference for the national guideline for pneumonia is consistent with the need to consider local epidemiology.

¿Qué hay de nuevo en el tratamiento de amiloidosis por cadenas livianas? Parte 1: cadenas livianas / What is new in light chain amyloidosis treatment? Part 1: lightweight chains

La amiloidosis AL es una enfermedad debida al depósito, en órganos y tejidos, de fibrillas formadas por cadenas livianas producidas de forma patológica por plasmocitos clonales. Su tratamiento actualmente está orientado a erradicar el clon de células plasmáticas; este históricamente se extrapoló de tratamientos disponibles y estudiados para otras discrasias sanguíneas. En el año 2020, el Grupo de Estudio de Amiloidosis (GEA) confeccionó distintas guías de práctica clínica para el tratamiento de la amiloidosis AL. Desde entonces se han publicado ensayos clínicos que arrojan contundencia al conocimiento disponible hasta el momento, y están en desarrollo nuevas líneas de investigación que robustecen y estimulan el estudio en el área. En esta revisión se realiza una actualización de las guías existentes en lo que respecta al tratamiento de la amiloidosis por cadenas livianas.Como evidencia de relevancia, en el último año estuvieron disponibles resultados de ensayos clínicos que respaldan el uso de esquemas basados en daratumumab (un anticuerpo monoclonal anti-CD38+) para pacientes con diagnóstico reciente de amiloidosis AL como primera línea. Además, para el tratamiento de la amiloidosis AL refractaria o recaída, la disponibilidad de bibliografía respaldatoria es escasa y extrapolada del tratamiento del mieloma múltiple; sin embargo, actualmente existe evidencia de calidad para recomendar el uso de ixazomib, un inhibidor de proteosoma reversible por vía oral disponible en la Argentina desde 2020. Por último, se mencionan algunas líneas de investigación con otros anticuerpos monoclonales y terapéuticas basadas en el uso de CAR-T cells. (AU)

AL amyloidosis is a disease caused by the deposit in different organs and tissues of protein fibrils formed by light chains synthetized by pathological clonal plasma cells. Its treatment is currently aimed at eradicating this plasma cell clone and it has been historically extrapolated from available and validated treatments for other blood dyscrasias. In 2020, the Amyloidosis Study Group prepared different clinical practice guidelines for the treatment of AL amyloidosis.Since then, clinical trials have been published that confirm and strengthen the knowledge available up to now, and new lines of research are being developed that stimulate study in the area. In this review, an update of the existing guidelines regarding the treatment of AL amyloidosis is made. As relevant evidence, in the last year, results of clinical trials have been made available that support the use of regimens based on Daratumumab (an anti-CD38+ monoclonal antibody) for patients with newly diagnosed AL amyloidosis as first line therapy. In addition, for the treatment of refractory or relapsed AL amyloidosis, where the availability of supporting literature is scant and extrapolated from the treatment of multiple myeloma, there is currently quality evidence to recommend the use of ixazomib, an oral reversible proteasome inhibitor, only available in Argentina since 2020. Finally, some research lines exploring the efficacy of other monoclonal antibodies and therapeutic experiments based on the use of CAR-T cells are mentioned. (AU)

Unresolved aspects in the management of renal anemia, a Delphi consensus of the Anemia Group of the S.E.N.

Anemia is a common complication of chronic kidney disease (CKD) and is associated with a decrease in quality of life and an increased risk of transfusions, morbidity and mortality, and progression of CKD. The Anemia Working Group of the Sociedad Española de Nefrología conducted a Delphi study among experts in anemia in CKD to agree on relevant unanswered questions by existing evidence. The RAND/UCLA consensus methodology was used. We defined 15 questions with a PICO structure, followed by a review in scientific literature databases. Statements to each question were developed based on that literature review. Nineteen experts evaluated them using an iterative Two-Round Delphi-like process. Sixteen statements were agreed in response to 8 questions related to iron deficiency and supplementation with Fe (impact and management of iron deficiency with or without anemia, iron deficiency markers, safety of i.v. iron) and 7 related to erythropoiesis stimulating agents (ESAs) and/or hypoxia-inducible factor stabilizers (HIF), reaching consensus on all of them (individualization of the Hb objective, impact and management of resistance to ESA, ESA in the immediate post-transplant period and HIF stabilizers: impact on ferrokinetics, interaction with inflammation and cardiovascular safety). There is a need for clinical studies addressing the effects of correction of iron deficiency independently of anemia and the impact of anemia treatment with various ESA on quality of life, progression of CKD and cardiovascular events.

Post-incident psychosocial interventions after a traumatic incident in the workplace: a systematic review of current research evidence and clinical guidance.

Background: After a traumatic incident in the workplace organisations want to provide support for their employees to prevent PTSD. However, what is safe and effective to offer has not yet been established, despite many organisations offering some form of intervention after a traumatic event.Objective: To systematically review the evidence for post-incident psychosocial interventions offered within one month of a workplace trauma, and to compare the content, effectiveness and acceptability of these interventions. Given the lack of a yet clearly established evidence-base in this field, we sought to examine both published empirical research as well as guidelines published by expert groups working with staff in high-risk roles.Methods: We conducted systematic searches for empirical research across bibliographic databases and searched online for clinical practice guidelines to April 2023. We were also referred to potentially relevant literature by experts in workplace trauma. Both empirical research and clinical guidelines were appraised for their quality.Results: A total of 80 research studies and 11 clinical practice guidelines were included in the review. Interventions included Critical Incident Stress Debriefing (CISD), Critical Incident Stress Management (CISM), unspecified Debriefing, Trauma Risk Management (TRiM), Psychological First Aid (PFA), EMDR, CBT and group counselling. Most research and guidance were of poor quality. The findings of this review do not demonstrate any harm caused by CISD, CISM, PFA, TRiM, EMDR, group counselling or CBT interventions when delivered in a workplace setting. However, they do not conclusively demonstrate benefits of these interventions nor do they establish superiority of any specific intervention. Generic debriefing was associated with some negative outcomes. Current clinical guidelines were inconsistent with the current research evidence base. Nevertheless, interventions were generally valued by workers.Conclusions: Better quality research and guidance is urgently needed, including more detailed exploration of the specific aspects of delivery of post-incident interventions.

Organisations often seek to provide some form of psychosocial intervention after a traumatic event in the workplace.Previous reviews have contraindicated particular forms of 'debriefing', however, the evidence for post-incident psychosocial interventions in the workplace has not previously been systematically reviewed.Research evidence was generally of poor quality with limited evidence of effectiveness and clinical guidelines were inconsistent with the evidence. Nevertheless, research did not demonstrate harm from most established interventions and support was valued by workers.

Aspectos no resueltos en el manejo de la anemia renal, un consenso Delphi del Grupo de Anemia de la SEN / Unresolved aspects in the management of renal anemia, a Delphi consensus of the Anemia Group of the SEN

La anemia es una complicación frecuente de la enfermedad renal crónica (ERC) y se asocia con una disminución en la calidad de vida y a un mayor riesgo de transfusiones, de morbimortalidad y de progresión de la ERC. El Grupo de Trabajo en Anemia de la Sociedad Española de Nefrología realizó un estudio Delphi entre expertos en anemia de la ERC para consensuar respuestas a preguntas relevantes que no se hubieran podido resolver con la evidencia existente. Se empleó la metodología de consensos RAND/UCLA. Se definieron 15 preguntas con una estructura PICO, seguida de una revisión en bases de datos de literatura científica. A partir de la evidencia se formularon enunciados. Diecinueve expertos los evaluaron mediante un proceso iterativo tipo Delphi a dos rondas. Se consensuaron 16 enunciados en respuesta a 8 preguntas referidas a la ferropenia y suplementación con Fe (impacto y gestión de ferropenia con o sin anemia, marcadores de ferropenia, seguridad de hierro i.v.) y a 7 relacionadas con agentes estimuladores de la eritropoyesis (AEE) y/o con estabilizadores del factor inducible por la hipoxia (HIF), alcanzándose consenso en todos ellos (individualización del objetivo de Hb, impacto y gestión de resistencia a AEE, AEE en el periodo inmediato post trasplante y estabilizadores de HIF: impacto sobre la ferrocinética, interacción con inflamación y seguridad cardiovascular). Existe una necesidad de estudios clínicos que aborden los efectos de la corrección del déficit de Fe con independencia de la anemia y el impacto del tratamiento de esta con diversos AEE sobre la calidad de vida, la progresión de ERC y los eventos cardiovasculares. (AU)

Anemia is a common complication of chronic kidney disease (CKD) and is associated with a decrease in quality of life and an increased risk of transfusions, morbidity and mortality, and progression of CKD. The Anemia Working Group of the Sociedad Española de Nefrología conducted a Delphi study among experts in anemia in CKD to agree on relevant unanswered questions by existing evidence. The RAND/UCLA consensus methodology was used. We defined 15 questions with a PICO structure, followed by a review in scientific literature databases. Statements to each question were developed based on that literature review. Nineteen experts evaluated them using an iterative Two-Round Delphi-like process. Sixteen statements were agreed in response to 8 questions related to iron deficiency and supplementation with Fe (impact and management of iron deficiency with or without anemia, iron deficiency markers, safety of i.v. iron) and 7 related to erythropoiesis stimulating agents (ESAs) and/or hypoxia-inducible factor stabilizers (HIF), reaching consensus on all of them (individualization of the Hb objective, impact and management of resistance to ESA, ESA in the immediate post-transplant period and HIF stabilizers: impact on ferrokinetics, interaction with inflammation and cardiovascular safety). There is a need for clinical studies addressing the effects of correction of iron deficiency independently of anemia and the impact of anemia treatment with various ESA on quality of life, progression of CKD and cardiovascular events. (AU)

Optimización de los tratamientos de la insuficiencia cardiaca con fracción de eyección reducida en la práctica diaria: propuesta de un grupo de expertos / Optimisation of treatments for heart failure with reduced ejection fraction in routine practice: a position statement from a panel of experts

El tratamiento de los pacientes con insuficiencia cardiaca con fracción de eyección reducida (IC-FEr) con una combinación de 4 clases de fármacos se recomienda en las principales guías de práctica clínica internacionales. Sin embargo, no especifican cómo deben introducirse y ajustarse estos tratamientos. En consecuencia, muchos pacientes con IC-FEr no pasan a un régimen de tratamiento optimizado. El objetivo de esta revisión es proponer un algoritmo pragmático para optimizar el tratamiento, diseñado para que sea lo más fácil posible de aplicar en la práctica diaria. El primer objetivo es garantizar que las 4 clases de medicación recomendadas se inicien cuanto antes para establecer una terapia eficaz, incluso a dosis bajas. Esto se considera preferible a iniciar menos medicamentos a una dosis máxima. El segundo objetivo es garantizar que los intervalos entre la introducción de los medicamentos y entre los distintos pasos de titulación sean lo más breves posible, por la seguridad del paciente. Se hacen propuestas específicas para los pacientes de edad avanzada (> 75 años) frágiles, y para aquellos con trastornos del ritmo cardiaco. La aplicación de este algoritmo debería permitir alcanzar un protocolo de tratamiento óptimo en un plazo de 2 meses para la mayoría de los pacientes. Este debe ser nuestro objetivo en el tratamiento de la IC-FEr. (AU)

Major international practice guidelines recommend the use of a combination of 4 medication classes in the treatment of patients with heart failure with reduced ejection fraction (HFrEF) but do not specify how these treatments should be introduced and up-titrated. Consequently, many patients with HFrEF do not receive an optimized treatment regimen. This review proposes a pragmatic algorithm for treatment optimization designed to be easily applied in routine practice. The first goal is to ensure that all 4 recommended medication classes are initiated as early as possible to establish effective therapy, even at a low dose. This is considered preferable to starting fewer medications at a maximum dose. The second goal is to ensure that the intervals between the introduction of different medications and between different titration steps are as short as possible to ensure patient safety. Specific proposals are made for older patients (> 75 years) who are frail, and for those with cardiac rhythm disorders. Application of this algorithm should allow an optimal treatment protocol to be achieved within 2-months in most patients, which should the treatment goal in HFrEF. (AU)

Control de la hipercolesterolemia en España: una misma situación con diferentes realidades autonómicas / Hypercholesterolaemia control in Spain: The same situation with different regional realities

Introducción y objetivos: La estrategia de prevención cardiovascular en las comunidades autónomas (CCAA) puede ser variable, al estar transferidas las competencias en sanidad. El objetivo del estudio fue conocer el control de la dislipemia y la terapia hipolipemiante utilizada en pacientes de alto/muy alto riesgo cardiovascular (RCV) por CCAA. Métodos: Estudio descriptivo, transversal, multicéntrico no aleatorizado basado en una metodología de consenso. Se recogió información de práctica clínica en 145 áreas sanitarias de 17CCAA españolas mediante reuniones presenciales y cuestionarios realizados a los 435 médicos participantes. Se recopilaron datos agregados no identificables de 10 pacientes dislipémicos consecutivos que cada participante hubiera visitado recientemente. Resultados: De los 4.010 pacientes compilados, 649 (16%) eran de alto y 2.458 (61%) de muy alto RCV. La distribución de los 3.107 pacientes de alto/muy alto RCV fue equilibrada entre regiones, pero hubo diferencias interterritoriales (p<0,0001) en la consecución del objetivo de cLDL<70 e <55mg/dl, respectivamente. Las estatinas de alta intensidad en monoterapia o combinadas con ezetimiba y/o inhibidores PCSK9 se utilizaron en el 44, el 21 y el 4% de los pacientes de alto RCV, mientras que en los de muy alto RCV era del 38, del 45 y del 6%, respectivamente. El uso de estas terapias hipolipemiantes a nivel nacional fue significativamente diferente entre regiones (p=0,0079). Conclusiones: A pesar de que la distribución de los pacientes de alto/muy alto RCV fue similar entre CCAA, se identificaron diferencias interterritoriales en el grado de consecución del objetivo terapéutico en cLDL y de utilización de la terapia hipolipemiante. (AU)

Introduction and objective: The cardiovascular prevention strategy by autonomous communities can be variable since the competences in health are transferred. The objective of the study was to determine the degree of dyslipidaemia control and the lipid-lowering pharmacological therapy used in patients at high/very high cardiovascular risk (CVR) by autonomous communities. Methods: Observational, cross-sectional, descriptive study based on a consensus methodology. Information on the clinical practice of 145 health areas belonging to 17 Spanish autonomous communities was collected through face-to-face meetings and questionnaires administered to the 435 participating physicians. Furthermore, aggregate non-identifiable data were compiled from 10 consecutive dyslipidaemic patients that each participant had recently visited. Results: Of the 4010 patients collected, 649 (16%) had high and 2458 (61%) very high CVR. The distribution of the 3107 high/very high CVR patients was balanced across regions, but there were inter-regional differences (P<.0001) in the achievement of target LDL-C <70 and <55mg/dL, respectively. High-intensity statins in monotherapy or in combination with ezetimibe and/or PCSK9 inhibitors were used in 44, 21 and 4% of high CVR patients, while in those at very high CVR it rose to 38, 45 and 6%, respectively. The use of these lipid-lowering therapies at national level was significantly different between regions (P=.0079). Conclusions: Even though the distribution of patients at high/very high CVR was similar between autonomous communities, inter-territorial differences were identified in the degree of achievement of LDL cholesterol therapeutic goal and use of lipid-lowering therapy. (AU)

Control hospitalario de la diabetes y de la hiperglucemia: una auditoría en hospitales españoles / Inpatient management of diabetes and hyperglycemia: an audit of Spanish hospitals

Objetivos Evaluación de la calidad de la asistencia a los pacientes con diabetes mellitus ingresados en España. Métodos Estudio transversal que incluyó a 1.193 (26,7%) pacientes con diabetes tipo 2 o hiperglucemia de un total de 4.468 pacientes ingresados en los servicios de medicina interna de 53 hospitales (España). Se recogieron datos demográficos, adecuación de la monitorización de la glucemia capilar, tratamiento administrado durante el ingreso y terapia recomendada al alta. Resultados La edad mediana fue de 80 años (74-87), 561 (47%) pacientes eran mujeres, con un índice de Charlson de 4 (2-6) puntos, siendo clasificados frágiles 742 (65%). La mediana de glucemia al ingreso fue de 155 (119-213) mg/dL. Al tercer día de ingreso el número de glucemias capilares en objetivo (80-180mg/dL) fue de 792/1.126 (70,3%) en el predesayuno, 601/1.083 (55,4%) en la precomida, 591/1.073 (55,0%) en la precena y 317/529 (59,9%) durante la noche. Se observó hipoglucemia en 35 (0,9%) pacientes. El tratamiento durante el ingreso fue realizado con insulina en escala móvil en 352 (40,5%) pacientes, insulina basal y análogos de insulina rápida en 434 (50%) y dieta exclusivamente en 101 (9,1%). Un total de 735 (61,6%) pacientes disponían de un valor reciente de HbA1c. En el alta se incrementó el uso de iSGLT2 (30,1 vs. 21,6%; p<0,001) y el uso de insulina basal (25,3 vs. 10,1%; p<0,001). Conclusiones Existe un excesivo uso de insulina en escala móvil, una deficiente información de los valores de HbA1c y una prescripción aún deficiente de tratamientos con beneficio cardiovascular al alta (AU)

Objectives Evaluation of the quality of care for patients with diabetes mellitus admitted to hospitals in Spain. Methods Cross-sectional study in one day that included 1193 (26.7%) patients with type 2 diabetes or hyperglycemia out of 4468 patients admitted to the internal medicine departments of 53 hospitals in Spain. We collected demographic data, adequacy of capillary glycemic monitoring, treatment administered during admission, and recommended therapy at discharge. Results The median age of the patients was 80 years (74-87), of which 561 (47%) were women, with a Charlson index of 4 points (2-6), and 742 (65%) were fragile. Median blood glucose on admission was 155mg/dL (119-213). On the third day, the number of capillary blood glucose levels in target (80-180mg/dL) was pre-breakfast 792/1126 (70.3%), pre-lunch 601/1083 (55.4%), pre-dinner 591/1073 (55.0%) and night 317/529 (59.9%). A total of 35 patients (0.9%) were suffering from hypoglycemia. Treatment during hospitalization was performed with sliding scale insulin in 352 (40.5%) patients, with basal insulin and rapid insulin analogs in 434 (50%), or with diet exclusively in 101 (9.1%). A total of 735 (61.6%) patients had a recent HbA1c value. At the time of discharge, the use of iSGLT2 increased significantly (30.1% vs. 21.6%; p<0.001), as well as the use of basal insulin (25.3% vs. 10.1%; p<0.001). Conclusions There is an excessive use of insulin on a sliding scale as well as deficient information on HbA1c values and an even deficient prescription at the discharge of treatments with cardiovascular benefit (AU)

La construcción del conocimiento en cirugía: un proceso artesanal / Knowledge-building in surgery: an evolving craft

En cirugía la construcción de conocimiento está moldeada en 2escenarios: la medicina basada en la evidencia y el aprendizaje experiencial. La primera se ha constituido como un pilar esencial en este proceso. A partir de ella se han desarrollado las guías de práctica clínica. Sin embargo, su temporalidad, su constante renovación y la falta de individualización las distancian del actuar diario. Por otro lado está la construcción de conocimiento mediante el aprendizaje vicario y experiencial. Su existencia va ligada al inicio de la medicina y su importancia es irrefutable. No obstante, va cargada del «efecto verdad», del dogma quirúrgico y del singularismo. El desarrollo de un sentido crítico frente a la integración de la constricción del conocimiento en estos escenarios es primordial y necesario para guiar al cirujano en la toma de decisiones en el dinamismo quirúrgico. El presente artículo explora esta situación y su impacto. (AU)

In surgery, the construction of knowledge is shaped in 2scenarios, evidence-based medicine, and experiential learning. The first has become an essential pillar in this process. Based on this, clinical practice guidelines have been developed. However, their temporality, their constant renewal and lack of individualization distance them from daily action. On the other hand, there is the construction of knowledge through vicarious and experiential learning. Its existence is linked to the beginning of medicine, and its importance is irrefutable. However, it is loaded with the «truth effect», surgical dogma and singularism. The development of a critical sense against the integration of the construction of knowledge in these scenarios is paramount and necessary to guide the surgeon in decision-making in surgical dynamism. This article explores this situation and its impact. (AU)

Luces y sombras de la Guía Europea ESC-2021 de Prevención de la Enfermedad Cardiovascular en la Práctica Clínica / Lights and shadows of the 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice

Los médicos de familia atienden un importante número de pacientes con alto riesgo vascular (RV). LasGuías Europeas de Prevención Cardio-vascular (2021) proponen una nueva clasificación del riesgo y estrategias de intervención sobre los factores de riesgo (FRV), orientada a la tomade decisiones compartidas entre profesionales y pacientes. En el presente trabajo realizamos un análisis crítico de dichas guías, ofreciendoposibles soluciones prácticas para la Atención Primaria.Son destacables aspectos positivos (luces) que los modelos de RV SCORE2 (entre cuarenta y sesenta y nueve años) y SCORE2-OP (entre setenta yochenta y nueve años) se basan en cohortes más actuales y miden con mayor exactitud y discriminación dicho riesgo. Además, se propone actuardiferenciadamente sobre el riesgo según la edad. Pragmáticamente, se presentan nuevos modelos informáticos para calcular el riesgo. Sin embargo,entre los aspectos negativos (sombras), parece colegirse una mayor dificultad de implementación al proponerse nueve subgrupos de sujetos segúnsu edad o nivel de riesgo, con un dintel definitorio de alto RV subjetivo que podría ocasionar un incremento sustancial en el número de sujetossusceptibles de tratar sin una discriminación objetiva que lo sustente. Además, las intervenciones sobre los FRV en dos pasos podrían retrasar laconsecución de objetivos terapéuticos, sobre todo en pacientes de muy alto riesgo, diabéticos o con enfermedad cardiovascular.Ante las dificultades que plantea la valoración del riesgo, proponemos unificar criterios y simplificar los mensajes claves para hacer unas guíasmás atractivas y que realmente ayuden a los profesionales de Atención Primaria en su práctica habitual.(AU)

General practitioners see in their consultation a a significant number of patients at high vascular risk (VR). The European Guidelines forCardiovascular Disease Prevention (2021) recommend a new risk classification and intervention strategies on on vascular risk factors (RF), withthe aim of providing a shared decision-making recommendations between professionals and patients. In this document we present a criticalanalysis of these guidelines, offering possible solutions that can be implemented in Primary Care.It should be noted that there are positive aspects (lights) such as that the SCORE2 (from forty to sixty-nine years) and SCORE2-OP models (fromseventy to eighty-nine years) are based on more current cohorts and measure cardiovascular risk in a more accurately manner. In addition, it isproposed to differentiate different risk thresholds according to age-groups. For sake of practicality, cardiovascular risk can be estimated usingdifferent websites with the new computer models. However, among the negative aspects (shadows), it seems to be add complexity implemen-ting nine subgroups of subjects according to their age or level of risk, with a defined thresholds that could cause a substantial increase in thepotential number of subjects susceptible to treatment without a clear evidence that supports it. In addition, two-step RF interventions coulddelay achievement of therapeutic goals, especially in very high-risk patients, diabetics, or patients with cardiovascular disease.Given these limitations, in this document we propose practical recommendations in order to simplify and facilitate the implementation of theguideline in primary care.(AU)

Manejo del ictus agudo. Tratamientos y cuidados específicos de enfermería en la Unidad de Ictus / Management of acute stroke. Specific nursing care and treatments in the stroke unit

Objetivo: Proporcionar un conjunto de recomendaciones actualizadas y basadas en la evidenciadisponible para el manejo del ictus agudo. Nuestro objetivo es proporcionar una base para eldesarrollo de los protocolos internos de cada centro, sirviendo de referencia para los cuidadosde enfermería. Métodos: Revisión de evidencias disponibles sobre los cuidados del ictus agudo. Se han consultado las guías nacionales e internacionales más recientes. Los niveles de evidencia y grados derecomendación se han basado en la clasificación del Centro de Medicina Basada en la Evidenciade Oxford. Resultados: Se describen la atención y los cuidados del ictus agudo en la fase prehospitalaria,el funcionamiento de código ictus, la atención por el equipo de ictus a la llegada al hospital,los tratamientos de reperfusión y sus limitaciones, el ingreso en la Unidad de Ictus, los cuidadosde enfermería en la Unidad de Ictus y el alta hospitalaria. Conclusiones: Estas pautas proporcionan recomendaciones generales basadas en la evidenciaactualmente disponible para guiar a los profesionales que atienden a pacientes con ictus agudo.En algunos casos, sin embargo, existen datos limitados demostrando la necesidad de continuarinvestigando sobre el manejo del ictus agudo.(AU)

Objective: This study provides a series of updated, evidence-based recommendations for the management of acute stroke. We aim to lay a foundation for the development of individual centres’ internal protocols, serving as a reference for nursing care. Methods: We review the available evidence on acute stroke care. The most recent national and international guidelines were consulted. Levels of evidence and degrees of recommendation are based on the Oxford Centre for Evidence-Based Medicine classification. Results: The study describes prehospital acute stroke care, the operation of the code stroke protocol, care provided by the stroke team upon the patient’s arrival at hospital, reperfusion treatments and their limitations, admission to the stroke unit, nursing care in the stroke unit, and discharge from hospital. Conclusions: These guidelines provide general, evidence-based recommendations to guide professionals who care for patients with acute stroke. However, limited data are available on some aspects, showing the need for continued research on acute stroke management.(AU)

Statement of the Spanish Interdisciplinary Vascular Prevention Committee on the updated European Guidelines on Cardiovascular Disease Prevention.

We present the Spanish adaptation of the 2021 European Guidelines on Cardiovascular Disease (CVD) prevention in clinical practice. The current guidelines besides the individual approach greatly emphasize on the importance of population level approaches to the prevention of cardiovascular diseases. Systematic global CVD risk assessment is recommended in individuals with any major vascular risk factor. Regarding LDL-Cholesterol, blood pressure, and glycemic control in patients with diabetes mellitus, goals and targets remain as recommended in previous guidelines. However, it is proposed a new, stepwise approach (Step 1 and 2) to treatment intensification as a tool to help physicians and patients pursue these targets in a way that fits patient profile. After Step 1, considering proceeding to the intensified goals of Step 2 is mandatory, and this intensification will be based on 10-year CVD risk, lifetime CVD risk and treatment benefit, comorbidities and patient preferences. The updated SCORE algorithm-SCORE2, SCORE-OP- is recommended in these guidelines, which estimates an individual's 10-year risk of fatal and non-fatal CVD events (myocardial infarction, stroke) in healthy men and women aged 40-89 years. Another new and important recommendation is the use of different categories of risk according different age groups (< 50, 50-69, ≥70 years). Different flow charts of CVD risk and risk factor treatment in apparently healthy persons, in patients with established atherosclerotic CVD, and in diabetic patients are recommended. Patients with chronic kidney disease are considered high risk or very high-risk patients according to the levels of glomerular filtration rate and albumin-to-creatinine ratio. New lifestyle recommendations adapted to the ones published by the Spanish Ministry of Health as well as recommendations focused on the management of lipids, blood pressure, diabetes and chronic renal failure are included.