Pacientes de edad avanzada con infección por VIH: tratamiento y utilización de servicios sanitarios

INTRODUCCIÓN El porcentaje de pacientes de edad avanzada por VIH, entendido como aquellos con una edad superior a 49 años, está aumentando, debido a un tratamiento antirretroviral (TAR) más potente y seguro y a un incremento del porcentaje de pacientes diagnosticados a esta edad. Esta población de edad avanzada sufre un número de comorbilidades más elevado y a una edad más temprana que la población general, esto se acompaña de un mayor uso de fármacos concomitantes al tratamiento antirretroviral. OBJETIVO Estudiar las características clínicas y demográficas, el tratamiento antirretroviral, la medicación concomitante y la utilización de servicios sanitarios, de una población de edad avanzada con infección por VIH y comparar el consumo de medicamentos concomitantes al TAR y la utilización de servicios sanitarios, entre la población VIH y la población general. MATERIAL Y MÉTODOS El estudio se realizó en dos periodos de tiempo, 2011 y 2014, con un año de seguimiento cada uno. Se incluyeron los pacientes con infección por VIH con TAR dispensado por el Servicio de Farmacia del hospital en los dos periodos de estudio. Durante el 2011, se incluyeron pacientes que tuvieran 50 años o más y en el 2014 que tuvieran entre 50 y 64 años. Las variables recogidas fueron: demográficas; relacionadas con la infección por VIH (factor de riesgo de transmisión, año de diagnóstico de la infección, hepatitis C, carga viral y cifra de linfocitos CD4 al diagnóstico y al finalizar cada periodo de estudio); relacionadas con el TAR (año de inicio del TAR, fármacos antirretrovirales, motivo de cambio y grado de adherencia en el 2011 y 2014); relacionadas con la medicación concomitante (fármacos dispensados en oficinas de farmacia prescritos con receta médica oficial y con cargo al Servicio Aragonés de Salud durante los dos periodos de estudio); y utilización de servicios sanitarios durante el año 2014 (consultas con médicos especialistas, diferenciando entre primera y sucesivas consultas, consultas con médico de atención primaria (AP), asistencias al Servicio de Urgencias, ingresos hospitalarios y días de ingreso). La información se obtuvo de la historia clínica electrónica; del sistema informático del Servicio de Farmacia del hospital; y del sistema de información de consumo de medicamentos de Aragón. Del Servicio de Información para la Gestión del Hospital se obtuvo la información sobre asistencia sanitaria de la población general; de la base datos Integra se obtuvo el precio de los medicamentos antirretrovirales y del Servicio de Cargos a Terceros del hospital las tarifas correspondientes al año 2014. El estudio del TAR se hizo a nivel de principio activo, de familia de antirretrovirales y de combinaciones de las mismas. Se estimó el grado de adherencia de los pacientes en base al registro de dispensaciones (≥90%). Para analizar el uso de medicamentos concomitantes al TAR se utilizó el porcentaje de pacientes que recibió cada grupo de fármacos y la cantidad recibida, en forma de mediana DDD/fármaco/paciente/año. Se estudiaron las variables que podían influir en la probabilidad de ingreso hospitalario, y se comparó la utilización de servicios sanitarios entre los varones VIH y los de la población general. Por último, se evaluaron en términos monetarios las consultas médicas, asistencia a urgencias, ingresos hospitalarios y TAR recibidos durante el 2014 por la población VIH. RESULTADOS Los pacientes VIH de 50 años o más en tratamiento antirretroviral, son principalmente varones con edades comprendidas entre 50 y 59 años. Más del 60% de los pacientes VIH se diagnosticaron e iniciaron el TAR hace más de 10 años y en más del 40% se hizo con un retraso de diagnóstico (CD4<350/mcL). La mayoría tienen una buena respuesta inmunovirológica en la actualidad. Entre los dos periodos de estudio se observaron cambios de TAR en los pacientes, entre los que se encuentran para el segundo año de estudio, una mayor utilización de inhibidores de la integrasa (de 3,8% al 19,8%) y una disminución del uso de tenofovir (56,9% a 39,7%) en favor de abacavir (26,9% a 32,7%). Se observó un incremento del porcentaje de pacientes en monoterapia y otras combinaciones de fármacos diferentes a la triple terapia. La estimación de pacientes adherentes al TAR fue del 77,8% en el 2011 y del 73,4% en el 2014. Un mayor porcentaje de pacientes VIH respecto, a la población general, consumieron al menos 5 fármacos no antirretrovirales diferentes durante el 2014, en varones un 43,8% vs 27,8%, p<0,001, y en mujeres un 47,2% vs 40,4% p=0,321. En los dos periodos de estudio, un mayor porcentaje, estadísticamente significativo, de varones VIH en comparación con los varones de la población general utilizaron antibióticos, psicolépticos, antiepilépticos y medicamentos para alteraciones obstructivas pulmonares. Además en el 2014 se obtuvo un mayor porcentaje de varones VIH (p<0,05) que utilizaron antiácidos, beta-bloqueantes, analgésicos, psicoanalépticos y antihistamínicos. Respecto al consumo de medicamentos en mujeres, en el 2014, se obtuvo un mayor porcentaje de mujeres VIH respecto a la población general que utilizaron psicoanalépticos. En cuanto al número de días al año en tratamiento con medicamentos, en base a las medianas de DDD entre los pacientes en tratamiento, en 2011 y 2014 los varones VIH estuvieron más días en tratamiento con antibióticos y psicolépticos que los varones de la población general, y además en el 2014 también estuvieron más días con antitrombóticos, agentes modificadores de lípidos y analgésicos. En el 2014, las mujeres VIH estuvieron un mayor número de días al año en tratamiento con antiácidos, agentes modificadores de lípidos y psicolépticos que las mujeres de la población general. Cuando la comparación se realizó en medicamentos agrupados por aparatos o sistemas, se obtuvo una mayor proporción de varones VIH, respecto a los de población general, que utilizaron analgésicos, antiinfecciosos, fármacos para el aparato digestivo, respiratorio y para el sistema nervioso central (SNC) (p<0,05). En cambio, no se hallaron diferencias en el porcentaje de pacientes que consumieron medicamentos para el aparato cardiovascular entre ambas poblaciones. En cuanto al número de días en tratamiento, basado en la mediana de DDD, fue mayor en los varones VIH respecto a los varones de la población general en antiinfecciosos y fármacos para el SNC, con diferencias estadísticamente significativas. En el análisis en detalle de uso de antibióticos, hubo un mayor consumo en la población VIH respecto a la población general, fundamentalmente para los antibióticos, trimetropim/sulfametoxazol (14,9% vs 1,4%, p<0,001), azitromicina (30,9% vs 21,1%, p=0,024), levofloxacino (13,8% vs 5,0%, p<0,001) y moxifloxacino (13,8% vs 5,1% p<0,001), y además consumieron un mayor número de días por paciente y año de sulfamidas y macrólidos. Los predictores de tener un ingreso hospitalario en la población VIH fueron, la mayor utilización de otros servicios sanitarios y una menor cifra de CD4. Se observó una mayor utilización de servicios sanitarios en los varones de la población VIH, respecto a los de población general, en cuanto a la primera consulta con médico especialista e ingreso hospitalario en los grupos de edad de 50 a 54 años y de 55 a 59 años, y una mayor utilización del Servicio de Urgencias en todos los tramos de edad. La mediana del coste sanitario anual por paciente VIH es de 8.929€, en su mayoría debido al tratamiento antirretroviral, 7.520€. El coste sanitario es mayor en pacientes con inmunosupresión severa y en los que presentan algún ingreso. CONCLUSIONES El porcentaje de pacientes de edad avanzada con infección por VIH está en aumento. Estos consumen un número de medicamentos concomitantes al TAR mayor que la población general, así como una mayor utilización de recursos sanitarios. El coste sanitario es mayor en aquellos con inmunosupresión severa. Es necesario realizar un esfuerzo para diagnosticar de forma precoz la infección por VIH, reforzar la adherencia al TAR y revisar de forma sistemática factores de riesgo cardiovascular y utilización de medicación concomitante, para atender de una forma más integral y adecuada a estos pacientes de edad avanzada con infección por VIH

Systematic review for development of a medicinal products and medical devices prioritization framework

BACKGROUND: The purpose of the research question is to develop an explicit priority setting methodology to support decision-making regarding Medicinal Products and Medical Devices to be included in hospital pharmacy practice. The development of a comprehensive prioritization system is the outcome essential for an important benefit to the healthcare system. The aim of this paper is to identify and analyze the processes and decision criteria used internationally for priority setting in order to establish a comprehensive set of strategic criteria for starting point for the development of a Medicinal Products and Medical Devices prioritization framework. METHODS: A systematic search of the literature was carried out in December 2017, in the main biomedical electronic databases: Medline/PubMed, Embase, Centre for Reviews and Dissemination (CRD), and Cochrane. Eligibility criteria for inclusion were based on set of predefined criteria. Systematic reviews and/or qualitative studies (interviews, surveys, expert consensus, etc) that aimed to identify prioritization criteria or develop general operational frameworks for the selection of health priorities were included. Data of the studies were analyzed and synthesized qualitatively. RESULTS: A total of 17 documents complied with eligibility criteria, 15 were published in scientific journals and 2 were identified through web pages. The studies showed great heterogeneity. A total of 56 potentially relevant priority setting criteria were identified, which could be grouped in 8 categories: 1) Need for intervention; 2) Outcomes of intervention; 3) Type of benefit; 4) Economic consequences; 5) Existing knowledge/quality of evidence and uncertainties; 6) Implementation complexity/feasibility; 7) Priority, justice and equity; and 8) Context. DISCUSSION: There are no standardized processes for priority setting, despite the fact some general consensus and common trends have been identified regarding criteria, models and strategies, and key actors. This research provides a thorough analysis of these approaches and offers recommendations for implementing successful prioritization approaches

Systematic review for the development of a pharmaceutical and medical products prioritization framework

Objective To identify and analyze the criteria, approaches, and conceptual frameworks, used for national/international priority setting. Data sources We performed a search of the main biomedical databases (Medline/PubMed, Embase, Centre for Reviews and Dissemination, and Cochrane), and we reviewed assessment agency websites, among other sources. Study design An systematic review of the literature was carried out. Data collection Eligibility criteria for inclusion were based on set of predefined criteria. Systematic reviews and/or qualitative studies (interviews, surveys, expert consensus, etc) that aimed to identify prioritization criteria or develop general operational frameworks for the selection of health priorities were included. A critical analysis is made of all the aspects that may be useful for any public body that intends to establish priorities in health. Principal findings We found that there are no standardized criteria for priority setting, although common trends have been identified regarding key elements. Eight key domains were identified: 1) need for intervention; 2) health outcomes; 3) type of benefit of the intervention; 4) economic consequences; 5) existing knowledge on the intervention/quality and uncertainties of the regarding evidence; 6) implementation and complexity of the intervention/feasibility; 7) justice and ethics; and 8) overall context. Conclusions Our review provides a thorough analysis of the relevant issues and offers key recommendations regarding considerations for developing a national prioritization framework. Findings are envisioned to be useful for different public organizations that are aiming to establish healthcare priorities

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy:Study protocol of a cluster randomized clinical trial (Multi-PAP project)

This study was funded by the Fondo de Investigaciones Sanitarias ISCIII (Grant Numbers PI15/00276, PI15/00572, PI15/00996), REDISSEC (Project Numbers RD12/0001/0012, RD16/0001/0005), and the European Regional Development Fund ("A way to build Europe").Background: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12months, as compared with usual care. Methods/Design: Design:pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. Scope: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). Population: patients aged 65-74years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3months). Sample size: n=400 (200 per study arm). Intervention: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. Outcomes: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. Statistical analysis: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. Discussion: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. Trial registration: Clinicaltrials.gov, NCT02866799Publisher PDFPeer reviewe

Spread of a SARS-CoV-2 variant through Europe in the summer of 2020

[EN] Following its emergence in late 2019, the spread of SARS-CoV-21,2 has been tracked by phylogenetic analysis of viral genome sequences in unprecedented detail3,4,5. Although the virus spread globally in early 2020 before borders closed, intercontinental travel has since been greatly reduced. However, travel within Europe resumed in the summer of 2020. Here we report on a SARS-CoV-2 variant, 20E (EU1), that was identified in Spain in early summer 2020 and subsequently spread across Europe. We find no evidence that this variant has increased transmissibility, but instead demonstrate how rising incidence in Spain, resumption of travel, and lack of effective screening and containment may explain the variant’s success. Despite travel restrictions, we estimate that 20E (EU1) was introduced hundreds of times to European countries by summertime travellers, which is likely to have undermined local efforts to minimize infection with SARS-CoV-2. Our results illustrate how a variant can rapidly become dominant even in the absence of a substantial transmission advantage in favourable epidemiological settings. Genomic surveillance is critical for understanding how travel can affect transmission of SARS-CoV-2, and thus for informing future containment strategies as travel resumes.S

CARB-ES-19 Multicenter Study of Carbapenemase-Producing Klebsiella pneumoniae and Escherichia coli From All Spanish Provinces Reveals Interregional Spread of High-Risk Clones Such as ST307/OXA-48 and ST512/KPC-3

ObjectivesCARB-ES-19 is a comprehensive, multicenter, nationwide study integrating whole-genome sequencing (WGS) in the surveillance of carbapenemase-producing K. pneumoniae (CP-Kpn) and E. coli (CP-Eco) to determine their incidence, geographical distribution, phylogeny, and resistance mechanisms in Spain.MethodsIn total, 71 hospitals, representing all 50 Spanish provinces, collected the first 10 isolates per hospital (February to May 2019); CPE isolates were first identified according to EUCAST (meropenem MIC &gt; 0.12 mg/L with immunochromatography, colorimetric tests, carbapenem inactivation, or carbapenem hydrolysis with MALDI-TOF). Prevalence and incidence were calculated according to population denominators. Antibiotic susceptibility testing was performed using the microdilution method (EUCAST). All 403 isolates collected were sequenced for high-resolution single-nucleotide polymorphism (SNP) typing, core genome multilocus sequence typing (cgMLST), and resistome analysis.ResultsIn total, 377 (93.5%) CP-Kpn and 26 (6.5%) CP-Eco isolates were collected from 62 (87.3%) hospitals in 46 (92%) provinces. CP-Kpn was more prevalent in the blood (5.8%, 50/853) than in the urine (1.4%, 201/14,464). The cumulative incidence for both CP-Kpn and CP-Eco was 0.05 per 100 admitted patients. The main carbapenemase genes identified in CP-Kpn were blaOXA–48 (263/377), blaKPC–3 (62/377), blaVIM–1 (28/377), and blaNDM–1 (12/377). All isolates were susceptible to at least two antibiotics. Interregional dissemination of eight high-risk CP-Kpn clones was detected, mainly ST307/OXA-48 (16.4%), ST11/OXA-48 (16.4%), and ST512-ST258/KPC (13.8%). ST512/KPC and ST15/OXA-48 were the most frequent bacteremia-causative clones. The average number of acquired resistance genes was higher in CP-Kpn (7.9) than in CP-Eco (5.5).ConclusionThis study serves as a first step toward WGS integration in the surveillance of carbapenemase-producing Enterobacterales in Spain. We detected important epidemiological changes, including increased CP-Kpn and CP-Eco prevalence and incidence compared to previous studies, wide interregional dissemination, and increased dissemination of high-risk clones, such as ST307/OXA-48 and ST512/KPC-3

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Invasive device-associated infections caused by pseudomonas aeruginosa in critically ill patients: evolution over 10 years

Invasive device-associated infections caused by Pseudomonas aeruginosa over 10 years (2007-2016) were assessed based on data from the ENVIN-HELICS registry (200 Spanish intensive care units). P. aeruginosa was the leading pathogen except in the last two years in which there was a slight decrease, with Escherichia coli as the leading aetiology. The rate of infections caused by P. aeruginosa remained between 12.0% and 14.6% throughout the study period. There was a significant increase of isolates resistant to imipenem, meropenem, ceftazidime, cefepime, and piperacillin-tazobactam. Multidrug-resistant and the sum of extensively drug- and pandrug-resistant strains also increased. Resistance to anti-pseudomonal antimicrobials remains a matter of concern