Qualitative methodology for a palliative care resources and services questionnaire validation

Objetivo: Establecer la validez de composición, contenido y criterios de un cuestionario de recursos para la provisión de servicios en Cuidados Paliativos (CP) a través de una metodología cualitativa, mediante grupos focales con profesionales de CP; en el marco de un proyecto de validación y evaluación de los resultados de un cuestionario de recursos para la provisión de servicios en (CP) en la Comunidad de Madrid (CM). Método: Se lleva a cabo un abordaje cualitativo para la validación del cuestionario de recursos. Se selecciona el grupo de discusión como técnica de elección para obtener un discurso en base a la experiencia personal de los profesionales implicados en el ámbito de los CP. Los grupos se componen de médicos, enfermeras, psicólogos, trabajadores sociales y agente de pastoral. Resultado: Los temas de discusión en los grupos fueron: dispersión geográfica de los recursos humanos, motivación laboral y personal, “ayuda psico-emocional” para profesionales, valoración integral y holística del paciente, equidad de los equipos, presupuesto social, apoyo al cuidador, ayuda entre equipos, sobrecarga laboral y humana, relación con la gerencia, futuro de los equipos: “estar quemados”, trabajo en equipo, formación en CP, labor enfermería en CP, protocolo de acogida en CP y aclaraciones terminológicas o conceptuales. Conclusiones: Este trabajo pretende ser el punto de partida para la elaboración y validación de un cuestionario en la provisión de servicios en CP, y así evaluar los recursos humanos y técnicos de nuestra red asistencial sanitaria paliativa.Objective: To establish the composition, content and criteria validity of a questionnaire of resources for services provision in Palliative Care (PC) through a qualitative methodology using focus groups with PC professionals. This is a part of a validation and evaluation research project for the provision of services (CP) in the Community of Madrid (CM). Methods: We performed a qualitative approach to the resource questionnaire validation. It was selected the focus group technique based on the personal experience of the professionals involved in PC. The groups were made up of physicians, nurses, psychologists, social workers and pastoral agent. Results: Discussion items in the groups were: human resources, geographical dispersion, work and personal motivation, “psycho-emotional” help for professionals, comprehensive and holistic patient approach, equipment equity, social budget, caregiver support , support between teams, overburden and human relationship with CEOs, future of teams: “be burned”, team-working, teaching in PC, PC nursing work, PC welcome protocol and terminological and conceptual clarifications. Conclusions: This study tries to be the starting point for the development questionnaire. It will be useful to assess the human and technical resources of our palliative health care network

GRADE workshop: grading the quality of evidence and strength of recommendations

In December 2013, the Public Health Policy Support Unit at the European Commission's Joint Research Centre organised a two-day workshop on developing evidence-based guidelines and healthcare recommendations using GRADE. GRADE stands for Grading of Recommendations Assessment, Development and Evaluation. It is a method for grading the quality of evidence and going from this evidence to the corresponding healthcare recommendation. The aims of the workshop were: 1) To explain how to develop evidence-based guidelines and health recommendations using the GRADE approach. 2) To build a template for future trainings organised by the JRC on the guideline development process. Twenty participants, without experience using GRADE, attended the workshop—including 14 JRC staff, as well as representatives from the Directorate General for Health and Consumers (DG SANCO), the European Centre for Disease Prevention and Control (ECDC) and various external institutions. The workshop consisted of lectures on the theory behind guidelines development, group work and computer-based exercises. Organisers and participants deemed the training a success and the Public Health Policy Support Unit is planning additional GRADE-oriented workshops in the future.JRC.I.2-Public Health Policy Suppor

Systematic review of drug therapy for chorea in NXK2-1- related disorders: Efficacy and safety evidence from case studies and series

Background: The NKX2-1-related disorders (NKX2-1-RD) is a rare disorder characterized by choreiform movements along with respiratory and endocrine abnormalities. The European Reference Network of Rare Neurological Disorders funded by the European Commission conducted a systematic review to assess drug treatment of chorea in NKX2-1-RD, aiming to provide clinical recommendations for its management. Methods: A systematic pairwise review using various databases, including MEDLINE, Embase, Cochrane, CINAHL, and PsycInfo, was conducted. The review included patients diagnosed with chorea and NKX2-1-RD genetic diagnosis, drug therapy as intervention, no comparator, and outcomes of chorea improvement and adverse events. The methodological quality of the studies was assessed, and the study protocol was registered in PROSPERO. Results: Of the 1417 studies examined, 28 studies met the selection criteria, consisting of 68 patients. The studies reported 22 different treatments for chorea, including carbidopa/ levodopa, tetrabenazine, clonazepam, methylphenidate, carbamazepine, topiramate, trihexyphenidyl, haloperidol, propranolol, risperidone, and valproate. No clinical improvements were observed with carbidopa/levodopa, tetrabenazine, or clonazepam, and various adverse effects were reported. However, most patients treated with methylphenidate experienced improvements in chorea and reported only a few negative effects. The quality of evidence was determined to be low. Conclusions: The management of chorea in individuals with NKX2-1-RD presents significant heterogeneity and lack of clarity. While the available evidence suggests that methylphenidate may be effective in improving chorea symptoms, the findings should be interpreted with caution due to the limitations of the studies reviewed. Nonetheless, more rigorous and comprehensive studies are necessary to provide sufficient evidence for clinical recommendationsThis study is supported by the European Commission within the contract SANTE/2018/B3/030-SI2.813822 under which the European Reference Networks (ERNs) Guidelines programme is being developed. This work is produced within the framework of the European Reference Network for Rare Neurological Diseases, Project ID 739510.Departamento de Psicología Evolutiva y de la Educació

Metodología cualitativa para la validación de un cuestionario de recursos y servicios en cuidados paliativos

Objetivo: Establecer la validez de composición, contenido y criterios de un cuestionario de recursos para la provisión de servicios en Cuidados Paliativos (CP) a través de una metodología cualitativa, mediante grupos focales con profesionales de CP; en el marco de un proyecto de validación y evaluación de los resultados de un cuestionario de recursos para la provisión de servicios en (CP) en la Comunidad de Madrid (CM). Método: Se lleva a cabo un abordaje cualitativo para la validación del cuestionario de recursos. Se selecciona el grupo de discusión como técnica de elección para obtener un discurso en base a la experiencia personal de los profesionales implicados en el ámbito de los CP. Los grupos se componen de médicos, enfermeras, psicólogos, trabajadores sociales y agente de pastoral. Resultado: Los temas de discusión en los grupos fueron: dispersión geográfica de los recursos humanos, motivación laboral y personal, “ayuda psico-emocional” para profesionales, valoración integral y holística del paciente, equidad de los equipos, presupuesto social, apoyo al cuidador, ayuda entre equipos, sobrecarga laboral y humana, relación con la gerencia, futuro de los equipos: “estar quemados”, trabajo en equipo, formación en CP, labor enfermería en CP, protocolo de acogida en CP y aclaraciones terminológicas o conceptuales. Conclusiones: Este trabajo pretende ser el punto de partida para la elaboración y validación de un cuestionario en la provisión de servicios en CP, y así evaluar los recursos humanos y técnicos de nuestra red asistencial sanitaria paliativa

Evaluación de tecnología basada en mSalud para aplicaciones móviles

mSalud; Aplicaciones móviles; Tecnologías sanitarias; EvaluaciónmHealth; Mobile applications; Health technologies; EvaluationmSalut; Aplicacions mòbils; Tecnologies sanitàries; AvaluacióLa actual proliferación del uso de tecnologías de mSalud en el campo de la promoción de la salud y la prevención y/o el control de enfermedades ha hecho necesario el diseño de marcos evaluativos que permitan conocer su aceptabilidad, factibilidad, usabilidad, validez, fiabilidad o sus potenciales efectos sobre variables de salud. La aplicación de estos marcos evaluativos a aplicaciones móviles es indispensable para pilotar su adecuación y viabilidad. El objeto de este desarrollo metodológico es proponer una herramienta para la evaluación de tecnologías sanitarias de mSalud.The current proliferation of the use of mHealth technologies in the field of health promotion and prevention and/ or disease control requires the necessity to design evaluation frameworks to know their acceptability, feasibility, usability, validity, reliability or their potential effects on health variables. The application of evaluation frameworks to assess the quality of mobile solutions is essential to pilot their suitability and viability. The objective of this methodological development is to propose a tool for the evaluation mHealth solutions.L’actual proliferació de l’ús de tecnologies de mSalud en el camp de la promoció de la salut i la prevenció i/o el control de malalties ha fet necessari el disseny de marcs avaluatius que en permetin conèixer l’acceptabilitat, factibilitat, usabilitat, validesa, fiabilitat o els efectes potencials sobre variables de salut. L’aplicació d’aquests marcs avaluatius en aplicacions mòbils és indispensable per pilotar-ne l’adequació i la viabilitat. L’objecte d’aquest desenvolupament metodològic és proposar una eina per a l’avaluació de tecnologies sanitàries de mSalud

Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial.

Importance: It is estimated that only 27% of patients with acute ischemic stroke and large vessel occlusion who undergo successful reperfusion after mechanical thrombectomy are disability free at 90 days. An incomplete microcirculatory reperfusion might contribute to these suboptimal clinical benefits. Objective: To investigate whether treatment with adjunct intra-arterial alteplase after thrombectomy improves outcomes following reperfusion. Design, setting, and participants: Phase 2b randomized, double-blind, placebo-controlled trial performed from December 2018 through May 2021 in 7 stroke centers in Catalonia, Spain. The study included 121 patients with large vessel occlusion acute ischemic stroke treated with thrombectomy within 24 hours after stroke onset and with an expanded Treatment in Cerebral Ischemia angiographic score of 2b50 to 3. Interventions: Participants were randomized to receive intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) infused over 15 to 30 minutes (n = 61) or placebo (n = 52). Main outcomes and measures: The primary outcome was the difference in proportion of patients achieving a score of 0 or 1 on the 90-day modified Rankin Scale (range, 0 [no symptoms] to 6 [death]) in all patients treated as randomized. Safety outcomes included rate of symptomatic intracranial hemorrhage and death. Results: The study was terminated early for inability to maintain placebo availability and enrollment rate because of the COVID-19 pandemic. Of 1825 patients with acute ischemic stroke treated with thrombectomy at the 7 study sites, 748 (41%) patients fulfilled the angiographic criteria, 121 (7%) patients were randomized (mean age, 70.6 [SD, 13.7] years; 57 women [47%]), and 113 (6%) were treated as randomized. The proportion of participants with a modified Rankin Scale score of 0 or 1 at 90 days was 59.0% (36/61) with alteplase and 40.4% (21/52) with placebo (adjusted risk difference, 18.4%; 95% CI, 0.3%-36.4%; P = .047). The proportion of patients with symptomatic intracranial hemorrhage within 24 hours was 0% with alteplase and 3.8% with placebo (risk difference, -3.8%; 95% CI, -13.2% to 2.5%). Ninety-day mortality was 8% with alteplase and 15% with placebo (risk difference, -7.2%; 95% CI, -19.2% to 4.8%). Conclusions and relevance: Among patients with large vessel occlusion acute ischemic stroke and successful reperfusion following thrombectomy, the use of adjunct intra-arterial alteplase compared with placebo resulted in a greater likelihood of excellent neurological outcome at 90 days. However, because of study limitations, these findings should be interpreted as preliminary and require replication. Trial registration: ClinicalTrials.gov Identifier: NCT03876119; EudraCT Number: 2018-002195-40

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

: In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe

Climate changes in mangrove forests and salt marshes

Abstract This synthesis is framed within the scope of the Brazilian Benthic Coastal Habitat Monitoring Network (ReBentos WG 4: Mangroves and Salt Marshes), focusing on papers that examine biodiversity-climate interactions as well as human-induced factors including those that decrease systemic resilience. The goal is to assess difficulties related to the detection of climate and early warning signals from monitoring data. We also explored ways to circumvent some of the obstacles identified. Exposure and sensitivity of mangrove and salt marsh species and ecosystems make them extremely vulnerable to environmental impacts and potential indicators of sea level and climate-driven environmental change. However, the interpretation of shifts in mangroves and salt marsh species and systemic attributes must be scrutinized considering local and setting-level energy signature changes; including disturbance regime and local stressors, since these vary widely on a regional scale. The potential for adaptation and survival in response to climate change depends, in addition to the inherent properties of species, on contextual processes at the local, landscape, and regional levels that support resilience. Regardless of stressor type, because of the convergence of social and ecological processes, coastal zones should be targeted for anticipatory action to reduce risks and to integrate these ecosystems into adaptation strategies. Management must be grounded on proactive mitigation and collaborative action based on long-term ecosystem-based studies and well-designed monitoring programs that can 1) provide real-time early warning and 2) close the gap between simple correlations that provide weak inferences and process-based approaches that can yield increasingly reliable attribution and improved levels of anticipation

Limiting outdoor sport in the evolution of the Covid-19 pandemic. Executive summary.

YesLa aplicación conjunta, simultánea y heterogénea de las medidas de intervención no-farmacológica durante la pandemia complica la valoración de la efectividad de cada una de las medidas tomadas de forma desagregada. La cantidad de estudios que cumplieron los criterios de inclusión fue muy baja. Solamente se incluye un estudio primario valuado con una calidad baja. Los documentos de organismos oficiales indican un aumento de la eficacia de las medidas de intervención no-farmacológica cuando se aplican de forma conjunt

Mobility limitation in the context of the COVID-19 pandemic. Executive summary

Este informe se ha realizado en el marco de la Red Española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del Sistema Nacional de Salud (RedETS), financiada por el Ministerio de Sanidad.YesLa aplicación conjunta, simultánea y heterogénea de las medidas de intervención no-farmacológica durante la pandemia complica la valoración de la efectividad de cada una de las medidas tomadas de forma desagregada. La calidad de los estudios que cumplieron los criterios de inclusión fue moderada-baja. Se incluyeron 10 revisiones sistemáticas y 2 documentos de organismos oficiales. Todos los estudios incluidos refieren una disminución de la incidencia, transmisión, hospitalizaciones y fallecimientos tras la aplicación de medidas de limitación de la movilidad. Las revisiones indican la baja calidad de la evidencia aportada por los estudios incluidos. Son numerosos los estudios que se basan en modelización, es decir, la predicción o estimación de las variables resultado utilizando modelos teóricos matemáticos