Análisis comparativo frente a la evidencia del manejo de la osteoporosis en una comarca de atención primaria

ObjetivoConocer la adecuación a las guías de práctica clínica del proceso diagnostico y terapéutico de la osteoporosis en una comarca.DiseñoEstudio transversal.EmplazamientoComarca de 276.000 habitantes, agrupada en 9 centros de salud.ParticipantesMujeres mayores de 45 años con prescripción de fármacos para la osteoporosis.IntervencionesCuestionario estandarizado rellenado por las pacientes y contrastado con las historias clínicas.Mediciones principalesAdecuación de la indicación de pruebas diagnósticas, proporción de tratamientos soportados en criterios diagnósticos y ajuste de dichos tratamientos a la evidencia.ResultadosAnalizamos a 332 mujeres cuya media de edad fue 65,3 ± 9,6 años. De las mujeres analizadas, el 73,2% (n = 243) tenía indicación de densitometría y sólo el 60,2% (n = 200) la había realizado. El resultado de las densitometrías fue: el 14% (n = 28), normal; el 31% (n = 62), osteopenia, y el 55% (n = 110), osteoporosis. Entre las mujeres con indicación de densitometría, el 39,5% (n = 96) no la había realizado. Entre las mujeres sin factores de riesgo y sin indicación de densitometría (n = 89), el 59,6% (n = 53) la había realizado. Por otro lado, el 78,7% (n = 261) de las mujeres no tenía una densitometría de control. Hubo diferencias estadísticamente significativas (p < 0,05) en la adecuación de las indicaciones de densitometría y de los tratamientos entre las diferentes especialidades. Finalmente, el 42,4% (n = 81) de las mujeres con prueba densitométrica realizada estaban inadecuadamente tratadas.ConclusionesLa indicación de densitometría es claramente mejorable y hay una alta variabilidad en su adecuación en todas las especialidades. La prescripción para la osteoporosis en gran medida no está sustentada en pruebas diagnósticas y se contrapone a los estudios de calidad publicados recientemente.ObjectiveTo find out how physicians are managing osteoporosis in a primary care setting.DesignCross-sectional study.ContextPrimary care setting with a target population of 276 000 inhabitants, grouped into 9 basic health areas, Spain.ParticipantsWomen older than 45 years old on treatments for osteoporosis.InterventionsStandardised questionnaire self-filled in by women and compared with clinical records.Main measurementsSuitability of the indication of diagnostic tests, proportion of treatments supported by diagnostic tests and according to evidence.ResultsThe mean age of the sample was 65.3 (9.6) years. Of the women included, 73.2% (n=243) had an indication for densitometry and only 60.2% (n=200) of them had this performed. The results of the densitometries were: 14% (n=28) normal, 31% (n=62) osteopenia and 55% (n=110) osteoporosis. Based on risk factors, in those women with densitometry indication, 39.5% (n=96) did not have it performed. In those women with no risk factors to justify the indication of densitometry (n=89), 59.6% (n=53) did have it performed. The two-year follow densitometry was not carried out on 78.7% (n=261) of women. Statistically significant differences were observed in the percentages of adequacy of the indications of densitometry and in the percentages of adequacy of the treatments in the different medical specialities analyzed (P<.05). Of the women who had densitometry, 42.4% (n=81) were inadequately treated.ConclusionsThe indication of densitometry is clearly improvable and there is a high variability in its adequacy in all the medical specialities studied.To a great extent, the indication of treatments for osteoporosis is not based on densitometry and is against the recommendations of the evidence based studies recently published

Mesoporous Silica Nanoparticles Decorated with Carbosilane Dendrons as New Non-viral Oligonucleotide Delivery Carriers

A novel nanosystem based on mesoporous silica nanoparticles covered with carbosilane dendrons grafted on their external surface is reported. This system is able to transport single oligonucleotide strands into cells, avoiding the electrostatic repulsion between the cell membrane and the negatively charged nucleic acids thanks to the cationic charge provided by the dendron coating in physiological conditions. Moreover, the presence of the highly ordered pore network inside the silica matrix would make possible to allocate other therapeutic agents within the mesopores with the aim of achieving a double delivery. First, carbosilane dendrons of second and third generation pos- sessing ammonium or tertiary amine groups as peripheral functional groups were prepared. Hence, different strategies were tested in order to obtain their suitable grafting on the nanoparticles outer surface. As nucleic acid model, a single stranded DNA oligonucleotide tagged with a fluorescent Cy3 moiety was used to evaluate the DNA adsorption capacity. The hybrid material functionalized with the third generation of neutral dendron showed excellent DNA binding properties. Finally, the cytotoxicity as well as the capability to deliver DNA into cells, was tested using a human osteoblast-like cell line, achieving good levels of internalization of the vector DNA/carbosilane dendron functionalized material without affecting cellular viability.Ministerio de Economía y Empres

The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis

Introduction: Dravet Syndrome (DS) is a severe, developmental epileptic encephalopathy (DEE) that begins in infancy and is characterized by pharmaco-resistant epilepsy and neurodevelopmental delay. Despite available antiseizure medications (ASMs), there is a need for new therapeutic options with greater efficacy in reducing seizure frequency and with adequate safety and tolerability profiles.Fenfluramine is a new ASM for the treatment of seizures associated with DS as add-on therapy to other ASMs for patients aged 2 years and older. Fenfluramine decreases seizure frequency, prolongs periods of seizure freedom potentially helping to reduce risk of Sudden Unexpected Death in Epilepsy (SUDEP) and improves patient cognitive abilities positively impacting on patients' Quality of Life (QoL).Reflective Multi-Criteria Decision Analysis (MCDA) methodology allows to determine what represents value in a given indication considering all relevant criteria for healthcare decision-making in a transparent and systematic manner from the perspective of relevant stakeholders. The aim of this study was to determine the relative value contribution of fenfluramine for the treatment of DS in Spain using MCDA.Method: A literature review was performed to populate an adapted a MCDA framework for orphan-drug evaluation in Spain. A panel of ten Spanish experts, including neurologists, hospital pharmacists, patient representatives and decision-makers, scored four comparative evidence matrices.Results were analyzed and discussed in a group meeting through reflective MCDA discussion methodology. Results: Dravet syndrome is considered a severe, rare disease with significant unmet needs. Fenfluramine is perceived to have a higher efficacy profile than all available alternatives, with a better safety profile than stiripentol and topiramate and to provide improved QoL versus studied alternatives. Fenfluramine results in lower other medical costs in comparison with stiripentol and clobazam. Participants perceived that fenfluramine could lead to indirect costs savings compared to available alternatives due to its efficacy in controlling seizures. Overall, fenfluramine's therapeutic impact on patients with DS is considered high and supported by high-quality evidence.Conclusions: Based on reflective MCDA, fenfluramine is considered to add greater benefit in terms of effi-cacy, safety and QoL when compared with available ASMs.(c) 2022 The Authors. Published by Elsevier Inc

Everolimus plus minimized tacrolimus on kidney function in liver transplantation: REDUCE, a prospective, randomized controlled study

Background and aim: reduction in calcineurin inhibitor levels is considered crucial to decrease the incidence of kidney dysfunction in liver transplant (LT) recipients. The aim of this study was to evaluate the safety and impact of everolimus plus reduced tacrolimus (EVR + rTAC) vs. mycophenolate mofetil plus tacrolimus (MMF + TAC) on kidney function in LT recipients from Spain. Methods: the REDUCE study was a 52-week, multicenter, randomized, controlled, open-label, phase 3b study in de novo LT recipients. Eligible patients were randomized (1:1) 28 days post-transplantation to receive EVR + rTAC (TAC levels <_ 5 ng/mL) or to continue with MMF + TAC (TAC levels = 6-10 ng/mL). Mean estimated glomerular filtration rate (eGFR), clinical benefit in renal function, and safety were evaluated. Results: in the EVR + rTAC group (n = 105), eGFR increased from randomization to week 52 (82.2 [28.5] mL/min/1.73 m2 to 86.1 [27.9] mL/min/1.73 m2) whereas it decreased in the MMF + TAC (n = 106) group (88.4 [34.3] mL/min/1.73 m2 to 83.2 [25.2] mL/min/1.73 m2), with significant (p < 0.05) differences in eGFR throughout the study. However, both groups had a similar clinical benefit regarding renal function (improvement in 18.6 % vs. 19.1 %, and stabilization in 81.4 % vs. 80.9 % of patients in the EVR + rTAC vs. MMF + TAC groups, respectively). There were no significant differences in the incidence of acute rejection (5.7 % vs. 3.8 %), deaths (5.7 % vs. 2.8 %), and serious adverse events (51.9 % vs. 44.0 %) between the 2 groups. Conclusion: EVR + rTAC allows a safe reduction in tacrolimus exposure in de novo liver transplant recipients, with a significant improvement in eGFR but without significant differences in renal clinical benefit 1 year after liver transplantation

Evidencias de terremotos cuaternarios en una sima hipogénica: La Sima de Benís (Murcia, SE España)

[EN] The interaction between karst hypogenic processes and Late Pleistocene active faulting determines the present topography and shape of the Benís Cave within the Cieza Ranges in the eastern Betic Cordillera (SE Spain). This cave represents the explored deepest cave within the Murcia region, reaching the deepest point at -320 m, and showing "in situ" fossil remains of mammal carnivores (Lynx pardinus spelaeus) as well. In addition, this cave displays evidence of paleoseismic activity from broken speleothems, but also from instrumental earthquakes collapsing the cave ceiling hall at -150 m depth (1999 Mula Event). The geometry and speleogenesis of Benís cave from the Late Pleistocene is a combination of two processes: (1) a shallow hypogenic origin related to upwards movement of confined aquifer located between 0 and 150 m depth, with lots of outlets and megascallops, and (2) a deep fault-cave related to the Benís fault developed between 150 - 320 m depth. This fault is N-S trending with normal kinematics and evidence of Late Pleistocene paleoseismic activity. Related to this, different fossil bones of Lynx pardinus spelaeus, was found in situ, which were dated by amino acid racemization in 65 ± 17.6 ka (OIS 4). The estimated size of the last paleoearthquake was around 6 Mw according to the measured coseismic displacement at depth and the length of the Benís fault trace at surface. The combination of the two processes (hypogenic confined aquifer and a seismogenic faulting), controlled the development, geometry and speleogenesis of the Benís Cave during at least the last 250 ka.[ES] La interacción entre una cueva hipogénica y la actividad de una falla cuaternaria es la principal responsable de la génesis de la cueva más profunda de la Región de Murcia y una de las mayores cavidades hipogénicas del sur de la península. La Sima de Benís presenta una amplia y única variedad de espeleotemas y de estructuras de disolución que se encuentran afectadas por deformaciones sísmicas producidas tanto por paleoterremotos durante el Pleistoceno Superior, como por terremotos instrumentales (Mw 4,8; VI EMS-98, 1999; Mula). Además, dentro de las zonas más profundas de la cueva aparecen restos fósiles “in situ” de macromamíferos (Lynx pardinus spelaeus), los cuales hemos relacionado con la actividad sísmica en el interior de la caverna. En cuanto a su topografía, esta cavidad presenta dos sectores bien diferenciados: (1) un primer sector de 150-160 m de desarrollo vertical con pozos de origen hipogénico con desarrollo de golpes de gubia y conductos de disolución ascendentes (con “outlets” y “megascallops”) y (2) un segundo sector entre los 150 - 160 m y los 320 m de profundidad, el cual se desarrolla sobre un plano de falla normal de dirección N-S (Falla de Benís). Este segundo sector de la sima es el que presenta evidencias paleosísmicas cuaternarias, dividiéndose a su vez en dos zonas en relación a la dinámica kárstica dominante: (2.a) una zona vadosa dominada por estructuras hipogénicas (donde aparecen folias y corales), junto con marcas cinemáticas de movimiento de la falla (estrías con recristalizaciones y concreciones carbonatadas) y (2.b) una zona freática profunda controlada por la precipitación de nubes de calcita bajo lámina de agua y de tamaño métrico que se desarrolla hasta los - 320 m de profundidad. En cuanto a la parte hipogénica superior de la sima, se desarrolla a favor de una fractura con relleno de calcita y de orientación E-W sobre carbonatos del Cretácico superior y el Paleoceno, con un espesor centimétrico y evidencias de relleno posterior y circulación de fluidos. La potencial actividad paleosísmica ha podido ser datada en 65 ± 17,6 ka (OIS 4) mediante el análisis de racemización de aminoácidos de los colmillos de un lince de las cavernas, el cual pudo ser afectado por un terremoto. Por último, se ha estimado el tamaño del último sismo relacionado con la actividad de la falla a partir de relaciones empíricas, con un valor de Mw oscilando entre 5,5 y 6. Para ello se ha estimado la longitud en superficie de la traza de falla que controla la cueva en profundidad y se ha comparado con el último salto cosísmico observable en el interior de la sima. Estimaciones del salto de falla acumulado y la datación del último paleoterremoto, sugieren que parte de la evolución hipogénica con paleoterremotos de esta cavidad de forma conjunta se produjo al menos, desde hace 250 ka (OIS 7)

Riesgo quirúrgico tras resección pulmonar anatómica en cirugía torácica. Modelo predictivo a partir de una base de datos nacional multicéntrica

Introduction: the aim of this study was to develop a surgical risk prediction model in patients undergoing anatomic lung resections from the registry of the Spanish Video-Assisted Thoracic Surgery Group (GEVATS). Methods: data were collected from 3,533 patients undergoing anatomic lung resection for any diagnosis between December 20, 2016 and March 20, 2018. We defined a combined outcome variable: death or Clavien Dindo grade IV complication at 90 days after surgery. Univariate and multivariate analyses were performed by logistic regression. Internal validation of the model was performed using resampling techniques. Results: the incidence of the outcome variable was 4.29% (95% CI 3.6-4.9). The variables remaining in the final logistic model were: age, sex, previous lung cancer resection, dyspnea (mMRC), right pneumonectomy, and ppo DLCO. The performance parameters of the model adjusted by resampling were: C-statistic 0.712 (95% CI 0.648-0.750), Brier score 0.042 and bootstrap shrinkage 0.854. Conclusions: the risk prediction model obtained from the GEVATS database is a simple, valid, and reliable model that is a useful tool for establishing the risk of a patient undergoing anatomic lung resection

Database of spatial distribution of non indigenous species in Spanish marine waters

Research in marine Spanish waters are focused on several actions to achieve an effectively management on protected areas, with the active participation of the stakeholders and research as basic tools for decision-making. Among these actions, there is one about the knowledge and control on NIS. One of its objectives is the creation of NIS factsheets, which are going to be added to the National Marine Biodiversity Geographical System (GIS) providing complementary information about taxonomic classification, common names, taxonomic synonyms, species illustrations, identification morphological characters, habitat in the native and introduced regions, biological and ecological traits, GenBank DNA sequences, world distribution, first record and evolution in the introduced areas, likely pathways of introduction, effects in the habitats and interaction with native species, and potential management measures to apply. The database will also provide data for (1) the European online platforms, (2) the environmental assessment for the Descriptor 2 (D2-NIS) of the EU Marine Strategy Framework Directive (MSFD), as well as (3) supporting decisions made by stakeholders. It is the result of extensive collaboration among scientist, manager’s and citizen science in the Spanish North-Atlantic, South-Atlantic, Gibraltar Strait-Alboran, Levantine-Balearic and Canary Islands marine divisions, providing an updated overview of the spatial distribution of relevant extended and invasive NIS of recent and established NIS introduced by maritime transport and aquaculture pathways, as well as on cryptogenic or native species in expansion due to the climatic water warming trend

Correction : Chaparro et al. Incidence, Clinical Characteristics and Management of Inflammatory Bowel Disease in Spain: Large-Scale Epidemiological Study. J. Clin. Med. 2021, 10, 2885

The authors wish to make the following corrections to this paper [...]

Incidence, Clinical Characteristics and Management of Inflammatory Bowel Disease in Spain : Large-Scale Epidemiological Study

(1) Aims: To assess the incidence of inflammatory bowel disease (IBD) in Spain, to describe the main epidemiological and clinical characteristics at diagnosis and the evolution of the disease, and to explore the use of drug treatments. (2) Methods: Prospective, population-based nationwide registry. Adult patients diagnosed with IBD-Crohn's disease (CD), ulcerative colitis (UC) or IBD unclassified (IBD-U)-during 2017 in Spain were included and were followed-up for 1 year. (3) Results: We identified 3611 incident cases of IBD diagnosed during 2017 in 108 hospitals covering over 22 million inhabitants. The overall incidence (cases/100,000 person-years) was 16 for IBD, 7.5 for CD, 8 for UC, and 0.5 for IBD-U; 53% of patients were male and median age was 43 years (interquartile range = 31-56 years). During a median 12-month follow-up, 34% of patients were treated with systemic steroids, 25% with immunomodulators, 15% with biologics and 5.6% underwent surgery. The percentage of patients under these treatments was significantly higher in CD than UC and IBD-U. Use of systemic steroids and biologics was significantly higher in hospitals with high resources. In total, 28% of patients were hospitalized (35% CD and 22% UC patients, p < 0.01). (4) Conclusion: The incidence of IBD in Spain is rather high and similar to that reported in Northern Europe. IBD patients require substantial therapeutic resources, which are greater in CD and in hospitals with high resources, and much higher than previously reported. One third of patients are hospitalized in the first year after diagnosis and a relevant proportion undergo surgery