Una INSULA en vaqueros.

"Hace poco más de un año, con el número 741 de septiembre de 2008, la revista INSULA cambiaba el formato sábana que la había contenido desde el año 1946 por otro más manejable y pensado para la vida de hoy. Fernando Valls, profesor de la Universidad Autónoma de Barcelona y miembro activo del nuevo Comité de Dirección de INSULA, la saludaba en su blog La nave de los locos titulando la entrada INSULA en vaqueros, y decía:...

¿Contratar más suplentes puede ser una herramienta para mejorar la racionalidad de la prescripción?

ObjetivoEl objetivo del presente estudio es determinar si hay asociación entre el gasto en suplencias y el gasto en medicamentos en los equipos de atención primaria (EAP).DiseñoEstudio observacional, transversal.EmplazamientoUn área de salud de Madrid (Área 2), en el año 2000.ParticipantesLos 21 EAP del Área, considerado cada uno como un individuo de estudio.Mediciones principalesEn cada EAP se midieron las siguientes variables: a) cumplimiento o no del presupuesto en suplencias; b) cumplimiento o no del presupuesto del gasto en medicamentos; c) proporción de ausencias de profesionales en los que ha habido suplente; d) indicador de ajuste a las recomendaciones del área sobre el uso racional de medicamentos (URM); e) gasto público en medicamentos por habitante (ponderado), y f) incremento del gasto público en medicamentos por habitante ponderado con respecto al año anterior.ResultadosLa asociación entre el cumplimiento presupuestario en suplentes y en medicamentos no fue estadísticamente significativa. La asociación entre el porcentaje de suplencias (esfuerzo en la absorción de ausencias sin suplente) y las variables de esfuerzo en la contención del gasto en medicamentos (ajuste URM, gasto/habitante e incremento gasto/habitante) se presentan en la tabla 1. En la ecuación de regression lineal del porcentaje de suplencias (variable dependiente, expresada en porcentaje) con el incremento gasto/habitante (variable independiente, expresada en pacientes/habitante), el coeficiente de la variable independiente, b=3.563, no resultó estadísticamente significativo (p>0,05).DiscusiónNo se ha encontrado ningún trabajo, similar al presente, que estudie la asociación entre el esfuerzo en suplencias y el esfuerzo en URM. En el presente trabajo no se ha encontrado una asociación clara entre gasto en suplentes y gasto en farmacia. A efectos prácticos, no parece que un incremento del gasto en suplentes, para mejorar la motivación, vaya a suponer una contención del gasto en farmacia por una mayor implicación (sin prejuicio de que el incremento de gasto en suplentes sea deseable por otros motivos, opinión ésta que, por cierto, sostienen los autores). Dado que la hipótesis de la que parte este estudio parece razonable a priori, podrían realizarse nuevos estudios sobre el tema en los que se determine la motivación del profesional en el aspecto gestor de prescribir y el grado de satisfacción del profesional ante la suplencia de un compañero, utilizando muestras mayores.ConclusiónNo se ha encontrado asociación entre los cumplimientos presupuestarios de suplencias y farmacia. Se ha encontrado una dudosa asociación entre el esfuerzo en suplencias y en farmacia.AgradecimientosA la Gerencia de Atención Primaria del Área 2 por autorizar y colaborar en el estudio que hemos realizado, especialmente a los departamentos de personal, farmacia y secretaría

The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)

Lymphopenia; Multiple sclerosis; PharmacovigilanceLinfopenia; Esclerosis múltiple; FarmacovigilanciaLimfopènia; Esclerosi múltiple; FarmacovigilànciaBackground: Severe cases of lymphopenia have been reported during siponimod clinical trials, which may negatively impact its benefit/risk profile. Objective: We aimed to evaluate the incidence of lymphopenia following the initiation of siponimod treatment in clinical practice. The secondary objectives included the analysis of factors predisposing to and the clinical relevance of lymphopenia events. Methods: In this multicenter retrospective cohort study, information collected from the medical records of 129 patients with MS from 15 tertiary hospitals in Spain who initiated treatment with Siponimod were followed-up for at least 3 months, including at least one lymphocyte count evaluation per patient. Results: Of the 129 patients, 121 (93.6%) reported lymphopenia events, including 110 (85.3%) with grade ≤ 3 and 11 (8.5%) with grade 4 lymphopenia, higher than those reported in the pivotal clinical trial (73.3% and 3.3% for grade ≤ 3 and grade 4 lymphopenia, respectively). The study included an unexpectedly high proportion of male subjects (72.9%), which might have led to an underestimation of the actual magnitude of the risk. Conclusions: In this study, the incidence and severity of lymphopenia after starting siponimod treatment were higher than those reported in previous clinical trials. Therefore, our results reinforce the need for the closer monitoring of novel MS drugs in clinical practice, as well as larger and longer follow-up studies to properly characterize this risk

Impact of the dosimetry approach on the resulting 90Y radioembolization planned absorbed doses based on 99mTc-MAA SPEC T-CT: is there agreement between dosimetry methods?

Background: Prior radioembolization, a simulation using 99mTc-macroaggregated albumin as 90Y-microspheres surrogate is performed. Gamma scintigraphy images (planar, SPECT, or SPECT-CT) are acquired to evaluate intrahepatic 90Y-microspheres distribution and detect possible extrahepatic and lung shunting. These images may be used for pre-treatment dosimetry evaluation to calculate the 90Y activity that would get an optimal tumor response while sparing healthy tissues. Several dosimetry methods are available, but there is still no consensus on the best methodology to calculate absorbed doses. The goal of this study was to retrospectively evaluate the impact of using different dosimetry approaches on the resulting 90Y-radioembolization pre-treatment absorbed dose evaluation based on 99mTc-MAA images. Methods: Absorbed doses within volumes of interest resulting from partition model (PM) and 3D voxel dosimetry methods (3D-VDM) (dose-point kernel convolution and local deposition method) were evaluated. Additionally, a new “Multi-tumor Partition Model” (MTPM) was developed. The differences among dosimetry approaches were evaluated in terms of mean absorbed dose and dose volume histograms within the volumes of interest. Results: Differences in mean absorbed dose among dosimetry methods are higher in tumor volumes than in non-tumoral ones. The differences between MTPM and both 3D-VDM were substantially lower than those observed between PM and any 3D-VDM. A poor correlation and concordance were found between PM and the other studied dosimetry approaches. DVH obtained from either 3D-VDM are pretty similar in both healthy liver and individual tumors. Although no relevant global differences, in terms of absorbed dose in Gy, between both 3D-VDM were found, important voxel-by-voxel differences have been observed. Conclusions: Significant differences among the studied dosimetry approaches for 90Y-radioembolization treatments exist. Differences do not yield a substantial impact in treatment planning for healthy tissue but they do for tumoral liver. An individual segmentation and evaluation of the tumors is essential. In patients with multiple tumors, the application of PM is not optimal and the 3D-VDM or the new MTPM are suggested instead. If a 3D-VDM method is not available, MTPM is the best option. Furthermore, both 3D-VDM approaches may be indistinctly used

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

Association Between Preexisting Versus Newly Identified Atrial Fibrillation and Outcomes of Patients With Acute Pulmonary Embolism

Background Atrial fibrillation (AF) may exist before or occur early in the course of pulmonary embolism (PE). We determined the PE outcomes based on the presence and timing of AF. Methods and Results Using the data from a multicenter PE registry, we identified 3 groups: (1) those with preexisting AF, (2) patients with new AF within 2 days from acute PE (incident AF), and (3) patients without AF. We assessed the 90-day and 1-year risk of mortality and stroke in patients with AF, compared with those without AF (reference group). Among 16 497 patients with PE, 792 had preexisting AF. These patients had increased odds of 90-day all-cause (odds ratio [OR], 2.81; 95% CI, 2.33-3.38) and PE-related mortality (OR, 2.38; 95% CI, 1.37-4.14) and increased 1-year hazard for ischemic stroke (hazard ratio, 5.48; 95% CI, 3.10-9.69) compared with those without AF. After multivariable adjustment, preexisting AF was associated with significantly increased odds of all-cause mortality (OR, 1.91; 95% CI, 1.57-2.32) but not PE-related mortality (OR, 1.50; 95% CI, 0.85-2.66). Among 16 497 patients with PE, 445 developed new incident AF within 2 days of acute PE. Incident AF was associated with increased odds of 90-day all-cause (OR, 2.28; 95% CI, 1.75-2.97) and PE-related (OR, 3.64; 95% CI, 2.01-6.59) mortality but not stroke. Findings were similar in multivariable analyses. Conclusions In patients with acute symptomatic PE, both preexisting AF and incident AF predict adverse clinical outcomes. The type of adverse outcomes may differ depending on the timing of AF onset.info:eu-repo/semantics/publishedVersio

Una INSULA en vaqueros.

"Hace poco más de un año, con el número 741 de septiembre de 2008, la revista INSULA cambiaba el formato sábana que la había contenido desde el año 1946 por otro más manejable y pensado para la vida de hoy. Fernando Valls, profesor de la Universidad Autónoma de Barcelona y miembro activo del nuevo Comité de Dirección de INSULA, la saludaba en su blog La nave de los locos titulando la entrada INSULA en vaqueros, y decía:...

Impact of the dosimetry approach on the resulting 90Y radioembolization planned absorbed doses based on 99mTc-MAA SPEC T-CT: is there agreement between dosimetry methods?

Background: Prior radioembolization, a simulation using 99mTc-macroaggregated albumin as 90Y-microspheres surrogate is performed. Gamma scintigraphy images (planar, SPECT, or SPECT-CT) are acquired to evaluate intrahepatic 90Y-microspheres distribution and detect possible extrahepatic and lung shunting. These images may be used for pre-treatment dosimetry evaluation to calculate the 90Y activity that would get an optimal tumor response while sparing healthy tissues. Several dosimetry methods are available, but there is still no consensus on the best methodology to calculate absorbed doses. The goal of this study was to retrospectively evaluate the impact of using different dosimetry approaches on the resulting 90Y-radioembolization pre-treatment absorbed dose evaluation based on 99mTc-MAA images. Methods: Absorbed doses within volumes of interest resulting from partition model (PM) and 3D voxel dosimetry methods (3D-VDM) (dose-point kernel convolution and local deposition method) were evaluated. Additionally, a new “Multi-tumor Partition Model” (MTPM) was developed. The differences among dosimetry approaches were evaluated in terms of mean absorbed dose and dose volume histograms within the volumes of interest. Results: Differences in mean absorbed dose among dosimetry methods are higher in tumor volumes than in non-tumoral ones. The differences between MTPM and both 3D-VDM were substantially lower than those observed between PM and any 3D-VDM. A poor correlation and concordance were found between PM and the other studied dosimetry approaches. DVH obtained from either 3D-VDM are pretty similar in both healthy liver and individual tumors. Although no relevant global differences, in terms of absorbed dose in Gy, between both 3D-VDM were found, important voxel-by-voxel differences have been observed. Conclusions: Significant differences among the studied dosimetry approaches for 90Y-radioembolization treatments exist. Differences do not yield a substantial impact in treatment planning for healthy tissue but they do for tumoral liver. An individual segmentation and evaluation of the tumors is essential. In patients with multiple tumors, the application of PM is not optimal and the 3D-VDM or the new MTPM are suggested instead. If a 3D-VDM method is not available, MTPM is the best option. Furthermore, both 3D-VDM approaches may be indistinctly used