Medicinal Immunoglobulin G Products (2020) Show High Infectivity Neutralizing Activity Against Seasonal Influenza Virus Strains Selected for Future Vaccines (2020-2022).

Immunoglobulin (Ig)G medicinal products manufactured in 2020 were tested for infectivity neutralization and hemagglutination inhibition against World Health Organization-selected influenza strains included in worldwide vaccines 2020-2022. The IgG batches (from US plasma) showed potent activity. Intravenous immunoglobulin could potentially add to therapies for serious influenza cases in immunocompromised patients. Further study is warranted.

Anti-Severe Acute Respiratory Syndrome Coronavirus 2 Hyperimmune Immunoglobulin Demonstrates Potent Neutralization and Antibody-Dependent Cellular Cytotoxicity and Phagocytosis Through N and S Proteins.

BACKGROUND: Although coronavirus disease 2019 (COVID-19) vaccinations have provided a significant reduction in infections, effective COVID-19 treatments remain an urgent need. METHODS: Functional characterization of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) hyperimmune immunoglobulin (hIG) from human convalescent plasma was performed by different virus neutralization methodologies (plaque reduction, virus-induced cytotoxicity, median tissue culture infectious dose [TCID50] reduction, and immunofluorimetry) at different laboratories using geographically different SARS-CoV-2 isolates (USA [1], Italy [1], and Spain [2]; 2 containing the D614G mutation). Neutralization capacity against the original Wuhan SARS-CoV-2 strain and variants (D614G mutant, B.1.1.7, P.1, and B.1.351) was evaluated using a pseudovirus expressing the corresponding spike (S) protein. Antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) was also evaluated. RESULTS: All SARS-CoV-2 isolates were potently neutralized by hIG as shown by all 4 methodologies. Wild-type SARS-CoV-2 and variants were effectively neutralized using the pseudovirus. The hIG (IgG type) induced ADCC and ADCP against SARS-CoV-2 N and S proteins but not E protein. Very low concentrations (25-100 µg IgG/mL) were required. A potent effect was triggered by antibodies in hIG solutions against the SARS-CoV-2 S and N proteins. CONCLUSIONS: Beyond neutralization, IgG Fc-dependent pathways may play a role in combatting SARS-CoV-2 infections using COVID-19 hIG. This could be especially relevant for the treatment of more neutralization-resistant SARS-CoV-2 variants.

Effective presence of antibodies against common human coronaviruses in immunoglobulin medicinal products.

BACKGROUND: Immunoglobulin products (for intravenous, intramuscular and subcutaneous administration) prepared from geographically diverse plasma pools were tested for activity against common human coronaviruses (HCoVs). Products from plasma obtained from Germany, Czech Republic, Slovak Republic, USA and Spain were tested for antibodies to common HCoVs: 229E, OC43, NL63 and HKU1. As these products are manufactured from pooled plasma from thousands of donors, the antibodies therein are representative of HCoV exposure in the population at large. METHODS: Immunoglobulin products were tested for antibodies to four common HCoVs by enzyme-linked immunosorbent assays (ELISAs). Neutralization assays were conducted using HCoV-229E cultured on to MRC5 cells. RESULTS: ELISAs showed that when expressed as specific activity (anti-HCoV activity/mg immunoglobulin), similar activity against the four common HCoVs was seen across the immunoglobulin products regardless of concentration or geographic origin. Highest anti-HCoV activity was seen against HCoV-229E, followed by HCoV-OC43, HCoV-NL63 and HCoV-HKU1. The neutralization assays showed similar potency for two immunoglobulin products prepared by different processes. CONCLUSIONS: To the authors' knowledge, this is the first demonstration of antibodies to common HCoVs in immunoglobulin products. These results may explain the cross-reactivity seen with pre-pandemic immunoglobulin products and severe acute respiratory syndrome coronavirus-2, and contribute to differences in severity of illness between patients.

Production of anti-SARS-CoV-2 hyperimmune globulin from convalescent plasma.

BACKGROUND: In late 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus emerged in China and quickly spread into a worldwide pandemic. Prior to the development of specific drug therapies or a vaccine, more immediately available treatments were sought including convalescent plasma. A potential improvement from convalescent plasma could be the preparation of anti-SARS-CoV-2 hyperimmune globulin (hIVIG). STUDY DESIGN AND METHODS: Convalescent plasma was collected from an existing network of plasma donation centers. A caprylate/chromatography purification process was used to manufacture hIVIG. Initial batches of hIVIG were manufactured in a versatile, small-scale facility designed and built to rapidly address emerging infectious diseases. RESULTS: Processing convalescent plasma into hIVIG resulted in a highly purified immunoglobulin G (IgG) product with more concentrated neutralizing antibody activity. hIVIG will allow for the administration of greater antibody activity per unit of volume with decreased potential for several adverse events associated with plasma administration. IgG concentration and IgG specific to SARS-CoV-2 were increased over 10-fold from convalescent plasma to the final product. Normalized enzyme-linked immunosorbent assay activity (per mg/ml IgG) was maintained throughout the process. Protein content in these final product batches was 100% IgG, consisting of 98% monomer and dimer forms. Potentially hazardous proteins (IgM, IgA, and anti-A, anti-B, and anti-D) were reduced to minimal levels. CONCLUSIONS: Multiple batches of anti-SARS-CoV-2 hIVIG that met regulatory requirements were manufactured from human convalescent plasma. The first clinical study in which the hIVIG will be evaluated will be Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) [NCT04546581].

Effect of comorbidities on survival in patients >80 years of age at onset of renal replacement therapy: data from the ERA-EDTA Registry.

BACKGROUND: The number of elderly patients on renal replacement therapy (RRT) is increasing. The survival and quality of life of these patients may be lower if they have multiple comorbidities at the onset of RRT. The aim of this study was to explore whether the effect of comorbidities on survival is similar in elderly RRT patients compared with younger ones. METHODS: Included were 9333 patients ≥80 years of age and 48 352 patients 20-79 years of age starting RRT between 2010 and 2015 from 15 national or regional registries submitting data to the European Renal Association-European Dialysis and Transplantation Association Registry. Patients were followed until death or the end of 2016. Survival was assessed by Kaplan-Meier curves and the relative risk of death associated with comorbidities was assessed by Cox regression analysis. RESULTS: Patients ≥80 years of age had a greater comorbidity burden than younger patients. However, relative risks of death associated with all studied comorbidities (diabetes, ischaemic heart disease, chronic heart failure, cerebrovascular disease, peripheral vascular disease and malignancy) were significantly lower in elderly patients compared with younger patients. Also, the increase in absolute mortality rates associated with an increasing number of comorbidities was smaller in elderly patients. CONCLUSIONS: Comorbidities are common in elderly patients who enter RRT, but the risk of death associated with comorbidities is less than in younger patients. This should be taken into account when assessing the prognosis of elderly RRT patients.

La atención sanitaria a pacientes con multimorbilidad. La percepción de los profesionales / Health care for patients with multimorbidity. The perception of professionals

OBJETIVO: Explorar las percepciones de los profesionales sanitarios sobre las características de la atención sanitaria a pacientes con multimorbilidad. DISEÑO: Estudio cualitativo de trayectoria fenomenológica realizado entre enero y septiembre de 2015 mediante 3 entrevistas grupales (grupos de discusión) y 15 individuales. Emplazamiento: Servicio Aragonés de Salud. PARTICIPANTES: Profesionales médicos y de enfermería del Servicio Aragonés de Salud pertenecientes a distintos servicios: Medicina Interna, Atención Primaria, Urgencias y Gestión. También se incluyó un farmacéutico. MÉTODOS: Se realizó un muestreo intencional no probabilístico que permitiese configurar las unidades muestrales buscando criterios de representatividad del discurso, permitiendo conocer e interpretar el fenómeno estudiado en profundidad, en sus diferentes visiones. Se entrevistó a profesionales sanitarios con perfiles diferentes que conociesen en profundidad la atención a pacientes con multimorbilidad. Las entrevistas fueron grabadas, transcritas literalmente e interpretadas, mediante el análisis social del discurso. RESULTADOS: Se identifica una cultura profesional orientada a la atención de enfermedades individuales, falta de coordinación entre especialidades, pacientes sometidos a numerosas prescripciones, Guías de Práctica Clínica y formación especialmente centradas en enfermedades individuales. CONCLUSIONES: Tanto la cultura profesional como la organización del sistema sanitario se encuentran orientadas a la atención de enfermedades individuales, lo que redunda en dificultades para ofrecer una atención más integral a los pacientes con multimorbilidad

OBJECTIVE: To explore the perceptions of health professionals about the characteristics of health care for patients with multimorbidity. DESIGN: Qualitative study of phenomenological trajectory made between January and September 2015 through 3 group interviews and 15 individual interviews. LOCATION: Aragonese Health Service. PARTICIPANTS: Medical and nursing professionals of the Aragon Health Service belonging to various services: Internal Medicine, Primary Care, Emergency and Management. A pharmacist was also included. METHODS: A non-probabilistic intentional sampling was carried out that allowed for the selection of professionals in terms of discourse representation criteria, allowing to know and interpret the phenomenon studied in depth, in its different visions. We interviewed health professionals with different profiles who knew in depth the characteristics of care provided to patients with multimorbidity. The interviews were recorded, transcribed literally and interpreted, through the social analysis of the discourse. RESULTS: Professional culture oriented to individual pathologies, lack of coordination among professionals, high prevalence of multi-prescriptions, Clinical Practice Guidelines oriented to individual pathologies and specialist training focused on individual diseases. CONCLUSIONS: Both the professional culture and the organization of the healthcare system have been oriented towards the attention to individual pathologies, which results in the difficulty to offer a more integrated care to patients with multimorbidity

[Health care for patients with multimorbidity. The perception of professionals]. / La atención sanitaria a pacientes con multimorbilidad. La percepción de los profesionales.

OBJECTIVE: To explore the perceptions of health professionals about the characteristics of health care for patients with multimorbidity. DESIGN: Qualitative study of phenomenological trajectory made between January and September 2015 through 3 group interviews and 15 individual interviews. LOCATION: Aragonese Health Service. PARTICIPANTS: Medical and nursing professionals of the Aragon Health Service belonging to various services: Internal Medicine, Primary Care, Emergency and Management. A pharmacist was also included. METHODS: A non-probabilistic intentional sampling was carried out that allowed for the selection of professionals in terms of discourse representation criteria, allowing to know and interpret the phenomenon studied in depth, in its different visions. We interviewed health professionals with different profiles who knew in depth the characteristics of care provided to patients with multimorbidity. The interviews were recorded, transcribed literally and interpreted, through the social analysis of the discourse. RESULTS: Professional culture oriented to individual pathologies, lack of coordination among professionals, high prevalence of multi-prescriptions, Clinical Practice Guidelines oriented to individual pathologies and specialist training focused on individual diseases. CONCLUSIONS: Both the professional culture and the organization of the healthcare system have been oriented towards the attention to individual pathologies, which results in the difficulty to offer a more integrated care to patients with multimorbidity.

The association of living donor source with patient and graft survival among kidney transplant recipients in the ERA-EDTA Registry - a retrospective study.

In this study we aimed to compare patient and graft survival of kidney transplant recipients who received a kidney from a living-related donor (LRD) or living-unrelated donor (LUD). Adult patients in the ERA-EDTA Registry who received their first kidney transplant in 1998-2017 were included. Ten-year patient and graft survival were compared between LRD and LUD transplants using Cox regression analysis. In total, 14 370 patients received a kidney from a living donor. Of those, 9212 (64.1%) grafts were from a LRD, 5063 (35.2%) from a LUD and for 95 (0.7%), the donor type was unknown. Unadjusted five-year risks of death and graft failure (including death as event) were lower for LRD transplants than for LUD grafts: 4.2% (95% confidence interval [CI]: 3.7-4.6) and 10.8% (95% CI: 10.1-11.5) versus 6.5% (95% CI: 5.7-7.4) and 12.2% (95% CI: 11.2-13.3), respectively. However, after adjusting for potential confounders, associations disappeared with hazard ratios of 0.99 (95% CI: 0.87-1.13) for patient survival and 1.03 (95% CI: 0.94-1.14) for graft survival. Unadjusted risk of death-censored graft failure was similar, but after adjustment, it was higher for LUD transplants (1.19; 95% CI: 1.04-1.35). In conclusion, patient and graft survival of LRD and LUD kidney transplant recipients was similar, whereas death-censored graft failure was higher in LUD. These findings confirm the importance of both living kidney donor types.

New Male Users of Lipid-Lowering Drugs for Primary Prevention of Cardiovascular Disease: The Impact of Treatment Persistence on Morbimortality. A Longitudinal Study.

The objective of this study was to analyse persistence to lipid-lowering drug use for primary prevention of cardiovascular disease (CVD) in a new users cohort, to explore all-cause and cardiovascular related morbidity, comorbidity and mortality in this group and, finally, to study the relationship between persistence and morbimortality. We selected subjects who started lipid-lowering treatment for primary prevention of CVD between 1 January 2010 and 31 December 2017 (N = 1424), and classified them as treatment-persistent or -nonpersistent. Bivariate analyses were performed to compare sociodemographic and clinical variables, morbimortality and time to event between groups. The association between morbidities was explored using comorbidity network analysis. The effect of persistence was analysed using logistic regression and Cox survival analyses. Only 38.7% of users were persistent with treatment. Persistent and nonpersistent users had similar sociodemographic and clinical profiles, although differed in age, smoking status, and glycemia. Comorbidity networks revealed that the number of co-occurring diagnoses was higher in nonpersistent than persistent users. Adjusted analyses indicated a protective effect of treatment persistence, especially against major adverse cardiovascular events (MACE), but this effect was not statistically significant. Observational studies are crucial to characterize real-world effectiveness.

Competencias digitales clave de los profesionales sanitarios / Key digital skills for healthcare professionals

La evolución de Internet y de la tecnología digital en la sociedad y en los sectores productivos ha planteado en los sistemas sanitarios la necesidad de una transformación digital que aporte mejoras en calidad y eficiencia. A pesar de los avances tecnológicos y de la creciente demanda social para incorporarlos en la práctica clínica diaria, el grado de implementación de la innovación digital en el sector sanitario es todavía escaso y lento, en parte debido a la brecha digital. Por ello, resulta imprescindible que todos los agentes de salud incorporen ciertos conocimientos y habilidades específicas relacionadas con el entorno digital y la transformación que conlleva. Se presentan una serie de nuevas competencias que pueden facilitar esta transición a los profesionales de la salud y ayudarles a mejorar su desempeño profesional con la ayuda de Internet y las tecnologías asociadas. Como profesionales de la información y del conocimiento, los sanitarios no debemos vivir ajenos a esta transformación, ya que la salud digital supone una oportunidad para la mejora continua en áreas tan transversales e importantes como la gestión de la información, la comunicación, la investigación, la innovación, la docencia y la publicación científica

The evolution of the Internet and digital technology in society and in all productive sectors has led to health systems establishing the need for changing to digital/computerised systems that can provide improvements in quality and efficiency. Despite technological advances and growth of social demand to incorporate them into daily clinical practice, the level of implementation of digital innovation in the healthcare sector is still limited and slow, partly due to the digital divide. This is why it is essential that accurate knowledge and skills related to the digital environment are acquired by all health workers, as well as patients. This article presents a series of digital skills for different health workers in order to facilitate this transition and improve their professional performance with the help of the Internet and associated technologies. We must not remain outside this transformation, since digital healthcare is a great opportunity for continuous improvement in such wide and important areas as information management, communication, research, innovation, teaching and scientific publication

Cross-neutralization activity against SARS-CoV-2 is present in currently available intravenous immunoglobulins.

Background: Cross-reactivity against human coronaviruses with Flebogamma® DIF and Gamunex®-C, two available intravenous immunoglobulins (IVIG), has been reported. In this study, these IVIG were tested for neutralization activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), SARS-CoV and Middle East respiratory syndrome CoV (MERS-CoV). Materials & methods: Neutralization capacity of lots of IVIG manufactured prior to COVID-19 pandemic was assessed against these viruses in cell culture. Infectivity neutralization was quantified by percent reduction in plaque-forming units and/or cytopathic/cytotoxic methods. Results: All IVIG preparations showed neutralization of SARS-CoV-2 isolates. All IVIG lots produced neutralization of SARS-CoV. No IVIG preparation showed significant neutralizing activity against MERS-CoV. Conclusion: The tested IVIG contain antibodies with significant in vitro cross-neutralization capacity against SARS-CoV-2 and SARS-CoV, but not MERS-CoV. These preparations are currently under evaluation as potential therapies for COVID-19.

Currently available intravenous immunoglobulin contains antibodies reacting against severe acute respiratory syndrome coronavirus 2 antigens.

Aim: There is a critical need for effective therapies that are immediately available to control the spread of COVID-19 disease. Material & methods: Gamunex®-C and Flebogamma® DIF (Grifols) intravenous immunoglobulin (IVIG) products were tested using ELISA techniques for antibodies against several antigens of human common betacoronaviruses that may crossreact with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. Results: Both IVIGs showed consistent reactivity to components of the tested viruses. Positive crossreactivity was seen in SARS-CoV, middle east respiratory syndrome-CoV and SARS-CoV-2. For SARS-CoV-2, positive reactivity was observed at IVIG concentrations ranging from 100 µg/ml with Gamunex-C to 1 mg/ml with Flebogamma 5% DIF. Conclusion: Gamunex-C and Flebogamma DIF contain antibodies reacting against SARS-CoV-2 antigens. Studies to confirm the utility of IVIG preparations for COVID-19 management may be warranted.

Bacteriemias por staphylococcus aureus: factores de riesgo asociados a la resistencia a meticilina / Bacteriemias caused by staphylococcus aureus: risk factors associated to methicillin resistance

INTRODUCCION: el objetivo del trabajo ha sido identificar los factores de riesgo que podrían favorecer la aparición de resistencia a meticilina en aislamientos de Staphylococcus aureus y aquellos que influirían en la mortalidad por las bacteriemias producidas por este patógeno. METODOS: se realizó un estudio observacional de casos y controles en los 57 pacientes diagnosticados de bacteriemia por Staphylococcus aureus en el Hospital de Barbastro. Para el análisis se utilizaron los test estadísticos de Chi cuadrado de Pearson, test de Fisher y regresión logística múltiple. RESULTADOS: del total de bacteriemias, 63,15% correspondieron a Staphylococcus aureus sensible a meticilina y 36,84% a Staphylococcus aureus resistente a meticilina. Se asociaron a resistencia a meticilina, la adquisición nosocomial de la infección, el uso previo de antibióticos y la edad mayor de 65 años. La mortalidad de los casos de bacteriemia por SARM y SAMS fue respectivamente del 28,57% y del 36,11%, siendo estas diferencias estadísticamente no significativas. Todos los aislamientos fueron sensibles in vitro a vancomicina. CONCLUSIONES: en nuestro sector sanitario, las estrategias más efectivas para disminuir la incidencia de bacteriemias por SARM serían el control y uso adecuado de antimicrobianos y la aplicación de programas de prevención de infecciones nosocomiales. En los pacientes con bacteriemia por Staphylococcus aureus, la resistencia a meticilina no se asocia a más mortalidad.

INTRODUCTION: the objective of this work has been to identify the risk factors that could favor the appearance of methicillin resistance in isolates of Staphylococcus aureus (SA) and those that would influence mortality due to bacteremia produced by this pathogen. METHODS: an observational case-control study was carried out in 57 patients diagnosed with bacteremia by SA at the Barbastro's Hospital. Pearson Chi square statistical test, Fisher test and multiple logistic regression were used for the analysis. RESULTS: of the total Bacteriemias, 63.15% corresponded to methicillin-sensitive Staphylococcus aureus (MSSA) and 36.84% to methicillin-resistant Staphylococcus aureus (MRSA). Nosocomial acquisition of the infection, previous use of antibiotics and the age over 65 years, were associated with methicillin resistance. The mortality of cases of MRSA and SAMS bacteremia was 28.57% and 36.1 1% respectively, these differences being statistically not significant. All isolates were sensitive in vitro to vancomycin. CONCLUSIONS: in our health sector, the most effective strategies to reduce the incidence of MRSA bacteremia would be the control and proper use of antimicrobials and the application of nosocomial infection prevention programs. Patients with SA bacteremia, are not associated with more mortality caused by MRSA.

Performance of an easy-to-use prediction model for renal patient survival: an external validation study using data from the ERA-EDTA Registry.

Background: An easy-to-use prediction model for long-term renal patient survival based on only four predictors [age, primary renal disease, sex and therapy at 90 days after the start of renal replacement therapy (RRT)] has been developed in The Netherlands. To assess the usability of this model for use in Europe, we externally validated the model in 10 European countries. Methods: Data from the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry were used. Ten countries that reported individual patient data to the registry on patients starting RRT in the period 1995-2005 were included. Patients <16 years of age and/or with missing predictor variable data were excluded. The external validation of the prediction model was evaluated for the 10- (primary endpoint), 5- and 3-year survival predictions by assessing the calibration and discrimination outcomes. Results: We used a data set of 136 304 patients from 10 countries. The calibration in the large and calibration plots for 10 deciles of predicted survival probabilities showed average differences of 1.5, 3.2 and 3.4% in observed versus predicted 10-, 5- and 3-year survival, with some small variation on the country level. The concordance index, indicating the discriminatory power of the model, was 0.71 in the complete ERA-EDTA Registry cohort and varied according to country level between 0.70 and 0.75. Conclusions: A prediction model for long-term renal patient survival developed in a single country, based on only four easily available variables, has a comparably adequate performance in a wide range of other European countries.

Human mesenchymal stem cells maintain their phenotype, multipotentiality, and genetic stability when cultured using a defined xeno-free human plasma fraction.

BACKGROUND: Mesenchymal stem cells (MSCs) show promising characteristics for their use in advanced therapy medicinal products. However, there are some unresolved concerns, such as the use of animal components for their expansion. In this study we assessed the suitability of a xeno-free supplement for cell culture (SCC) derived from human plasma, to culture and expand human MSCs (hMSCs) from different origins. Characteristics of viable cultured hMSCs such as genetic stability, phenotype and multipotentiality were qualitatively evaluated. METHODS: hMSCs from adipose tissue (AT), bone marrow (BM) and umbilical cord (UC) and supplier sources (commercial/non-commercial) were used. After hMSCs expansion in a xeno-free medium, classical hMSCs markers were studied by immunocytochemistry, and genetic stability was tested by classic karyotyping. The capacity of hMSCs to differentiate into adipogenic, osteogenic, and chondrogenic cells in differentiation media was assessed using different staining. Different lots of SCC were used to assure consistency between batches. RESULTS: All hMSCs tested maintained their morphology and adherence to plastic during their expansion, and preserved their genetic stability, phenotype and differentiation potential. No differences were observed when using different lots of SCC. Moreover, the proliferation rate, evaluated as population doubling time (PDT) of commercial BM and AT hMSCs, was higher in the xeno-free medium than in the control media provided by the suppliers of the cells (PDT of 4.6 for BM-hMSC and 6.4 for AT-hMSC in xeno-free medium, and 7.0 and 14.7 respectively in the commercial media). UC-hMSCs PDT was similar in all the media tested. When using non-commercial BM-hMSCs, PDT was lower in the xeno-free medium, but reverted to the control level with the addition of growth factors. CONCLUSIONS: SCC-containing medium can be a feasible xeno-free alternative to expand hMSCs for advanced therapies.

Renal replacement therapy in Europe: a summary of the 2013 ERA-EDTA Registry Annual Report with a focus on diabetes mellitus.

BACKGROUND: This article provides a summary of the 2013 European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report (available at http://www.era-edta-reg.org), with a focus on patients with diabetes mellitus (DM) as the cause of end-stage renal disease (ESRD). METHODS: In 2015, the ERA-EDTA Registry received data on renal replacement therapy (RRT) for ESRD from 49 national or regional renal registries in 34 countries in Europe and bordering the Mediterranean Sea. Individual patient data were provided by 31 registries, while 18 registries provided aggregated data. The total population covered by the participating registries comprised 650 million people. RESULTS: In total, 72 933 patients started RRT for ESRD within the countries and regions reporting to the ERA-EDTA Registry, resulting in an overall incidence of 112 per million population (pmp). The overall prevalence on 31 December 2013 was 738 pmp (n = 478 990). Patients with DM as the cause of ESRD comprised 24% of the incident RRT patients (26 pmp) and 17% of the prevalent RRT patients (122 pmp). When compared with the USA, the incidence of patients starting RRT pmp secondary to DM in Europe was five times lower and the incidence of RRT due to other causes of ESRD was two times lower. Overall, 19 426 kidney transplants were performed (30 pmp). The 5-year adjusted survival for all RRT patients was 60.9% [95% confidence interval (CI) 60.5-61.3] and 50.6% (95% CI 49.9-51.2) for patients with DM as the cause of ESRD.

Percepciones de pacientes y profesionales sobre la calidad de la atención a personas con enfermedad pulmonar obstructiva crónica / Perceptions of patients and health professionals about the quality of care provided to chronic obstructive pulmonary disease patients

Objetivo: Explorar la percepción y el conocimiento de pacientes y profesionales sanitarios sobre factores que influyen en la calidad de los cuidados prestados en atención primaria (AP) a personas con enfermedad pulmonar obstructiva crónica (EPOC). Diseño: Estudio cualitativo realizado entre febrero y marzo de 2010. Emplazamiento: Centros de salud urbanos. Participantes: Profesionales médicos y de enfermería de AP y pacientes con EPOC. Métodos: Muestreo intencional no probabilístico con criterios de representatividad del discurso. Se realizaron 2 entrevistas grupales y 6 individuales. Las entrevistas fueron grabadas, transcritas literalmente e interpretadas mediante el análisis social del discurso. Resultados: Los pacientes no identifican bien la sintomatología ni asumen la importancia de la EPOC hasta estadios avanzados. La falta de conocimiento sobre la evolución de la enfermedad y el impacto en la calidad de vida dificulta la adopción de los cambios necesarios. Los profesionales refieren problemas con la realización de espirometrías. Entre los médicos se identifica escepticismo respecto a la efectividad de las intervenciones dirigidas al cambio de conductas. Como factores organizativos destacan la existencia de Guías de Práctica Clínica (GPC), la coordinación entre profesionales y el alineamiento de prioridades entre gestores y profesionales. Conclusiones: Los factores identificados sugieren la posibilidad de mejorar la asistencia sanitaria, adecuando la comunicación con los pacientes para motivarlos a adoptar las modificaciones conductuales necesarias y mejorar la adherencia a los tratamientos. Para ello puede mejorarse la concienciación y la formación de los profesionales, la coordinación asistencial, la implementación de GPC y la utilización de indicadores en un proceso de evaluación de la calidad (AU)

Objective: To explore the understanding and knowledge of patients and health professionals about factors that influence the quality of care provided in Primary Care to people with Chronic Obstructive Pulmonary Disease (COPD). Design: Qualitative study performed between February and March 2010. Location: Primary Care Centers. Participants: Medical and nursing professionals and patients with COPD. Methods: Non-probabilistic intentional sampling with representation criterion of the discourse. Two group (focus group) and 6 individual interviews were performed. The interviews were recorded, literally transcribed and interpreted by social discourse analysis. Results: Patients neither identify properly the symptomatology nor they assume the COPD importance until advanced states. The lacks of knowledge about the evolution of the disease and the impact on quality of life hinders the necessary changes. Professionals reports problems with performing spirometry. Among doctors, scepticism regarding to the effectiveness of the interventions aimed at change of behaviour is identified. The existence of Clinical Guides, the improvement of the coordination between professionals and the alignment of priorities between managers and professionals stand out as organizational factors. Conclusions: The identified factors suggest the possibility of improving the health care through improved communication to motivate them to take the recommended changes and to increase the adherence to treatments. To this effect, the awareness and training of professionals, the healthcare coordination, the implementation of Clinical Guides and the use of indicators in a process of quality assessment (AU)

Non-adherence to antihypertensive medication: The role of mental and physical comorbidity.

BACKGROUND: Multiple parameters influence adherence to drug treatment, including socio-economic, healthcare, condition, therapy, and patient-related factors. However, studies of the impact of patient-related factors, particularly regarding comorbid conditions, have produced conflicting results. OBJECTIVES: To analyse the association between mental and physical comorbidity and non-adherence to antihypertensive medication in patients attending primary care, after including a comprehensive range of chronic comorbidities and potential confounders. METHODS: Cross-sectional study of 113,397 adults with a diagnosis of hypertension in 2010 assigned to the public health service of a region in northeastern Spain. Pharmacy billing records were linked to data from electronic health records at individual level. Non-adherence was defined as an antihypertensive medication possession ratio (MPR) <80%. Multivariable logistic regression models were used to estimate the odds ratio for non-adherence. Potential predictors included mental and physical comorbidity, age, sex, blood pressure level, nationality, rurality, polypharmacy, and number of visits to the GP and to different specialties. RESULTS: One fifth of the study population showed poor adherence levels. Female sex, younger age, foreign nationality, living in a rural area, low blood pressure levels, polypharmacy, and mental comorbidity were positively and significantly associated with non-adherence. Conversely, non-adherence was negatively and significantly associated with the presence of cardiovascular risk factors and higher annual rates of GP visits. CONCLUSION: The majority of patient-related determinants identified here (e.g., the presence of mental comorbidity, polypharmacy, foreign nationality) underscores the need for a patient- rather than a disease-centred care approach, as well as adequate physician-patient communication.