Prevalence and Clinical Conditions Related to Sarcopaenia among Older Persons Living in the Community.

(1) Background: In health care and in society at large, sarcopaenia is a disorder of major importance that can lead to disability and other negative health-related events. Our study aim is to determine the prevalence of sarcopaenia among older people attended in primary care and to analyse the factors associated with this age-related clinical condition; (2) Methods: A multicentre cross-sectional study was conducted of 333 community-dwelling Spanish adults aged 65 years or more. Sociodemographic, clinical, functional, anthropometric, and pharmacological data were collected. Sarcopaenia was defined following European Working Group on Sarcopaenia in Older People (EWGSOP) criteria; (3) Results: Sarcopaenia was present in 20.4% of the study sample, and to a severe degree in 6%. The intensity of the association between sarcopaenia and frailty was weak-moderate (Cramer V = 0.45). According to the multinomial logistic regression model performed, sarcopaenia was positively associated with age and with the presence of psychopathology (OR = 2.72; 95% CI = 1.30-5.70) and was inversely correlated with body mass index (OR = 0.73, 95% CI = 0.67-0.80; (4) Conclusions: Sarcopaenia commonly affects community-dwelling older persons and may be associated with age, body mass index, and psychopathology. The latter factor may be modifiable or treatable and is therefore a possible target for intervention.

Multilevel Zero-One Inflated Beta Regression Model for the Analysis of the Relationship between Exogenous Health Variables and Technical Efficiency in the Spanish National Health System Hospitals.

BACKGROUND: This article proposes a methodological innovation in health economics for the second stage analysis of technical efficiency in hospitals. It investigates the relationship between the installed capacity in regions and hospitals and their ownership structure. METHODS: A multilevel zero-one inflated beta regression model is employed to model pure technical efficiency more adequately than other models frequently used in econometrics. RESULTS: Compared to publicly managed hospitals, the mean efficiency index of hospitals with public-private partnership (PPP) formulas was 4.27-fold. This figure was 1.90-fold for private hospitals. Concerning the efficiency frontier, the odds ratio (OR) of PPP models vs. public hospitals was 42.06. The OR of private hospitals vs. public hospitals was 8.17. A one standard deviation increase in the percentage of beds in intensive care units increases the odds of being situated on the efficiency frontier by 50%. CONCLUSIONS: The proportion of hospital beds in intensive care units relates to a higher chance of being on the efficiency frontier. Hospital ownership structure is related to the mean efficiency index of Spanish National Health Service hospitals, as well as the odds of being situated on the efficiency frontier.

Assessing Prevalence and Factors Related to Frailty in Community-Dwelling Older Adults: A Multinomial Logistic Analysis.

Frailty is an age-related clinical condition that typically involves a deterioration in the physiological capacity of various organ systems and heightens the patient's susceptibility to stressors. For this reason, one of the main research goals currently being addressed is that of characterising the impact of frailty in different settings. The main aim of this study is to determine the prevalence of Fried's frailty phenotype among community-dwelling older people and to analyse the factors associated with frailty. In this research study, 582 persons aged 65 years or more participated in this cross-sectional study that was conducted at primary healthcare centres in Málaga, Spain. Sociodemographic, clinical, functional and comprehensive drug therapy data were compiled. The relationship between the independent variables and the different states of frailty was analysed by using a multinomial logistic regression model. Frailty was present in 24.1% of the study sample (95% CI = 20.7-27.6) of whom 54.3% were found to be pre-frail and 21.6% were non-frail. The study variable most strongly associated with frailty was the female gender (OR = 20.54, 95% CI = 9.10-46.3). Other factors found to be associated with the state of frailty included age, dependence for the instrumental activities of daily living (IADL), polymedication, osteoarticular pathology and psychopathology. This study confirms the high prevalence of frailty among community-dwelling older people. Frailty may be associated with many factors. Some of these associated factors may be preventable or modifiable and, thus, provide clinically relevant targets for intervention. This is particularly the case for depressive symptoms, the clinical control of osteoarthritis and the use of polypharmacy.

Análisis multinivel de la producción científica mundial sobre paternidad, desarrollo humano e igualdad de género / Multilevel analysis of global scientific production on parenthood, human development and gender equality

OBJETIVO: Comparar las diferencias en la producción científica mundial sobre paternidad y maternidad (cantidad, momento de inicio y evolución temporal), conocer la distribución geográfica internacional de artículos sobre paternidad, y examinar la relación del índice de desarrollo humano (IDH) y del índice global de brecha de género (IGBG) con el número de artículos sobre paternidad. MÉTODO: Análisis descriptivo de artículos sobre paternidad y maternidad de la base Scopus desde 1788 hasta 2016, y análisis longitudinal de 2006 a 2015 de la relación entre la producción científica sobre paternidad, el IDH y el IGBG, mediante un modelo multinivel con distribución de Poisson y parámetro extra-Poisson. RESULTADOS: Hay cuatro veces menos artículos sobre paternidad que sobre maternidad. Los artículos sobre paternidad se desarrollaron de forma más tardía, y la mayoría (85%) se publicaron en las dos últimas décadas, cuando se incrementaron en mayor proporción que los de maternidad. Se constatan desigualdades geográficas, con América del Norte, Europa y Oceanía a la cabeza. Hay una relación estadísticamente significativa entre el incremento del IDH y el IGBG de los países del mundo y el aumento de los artículos sobre paternidad. CONCLUSIONES: El conocimiento en torno a la paternidad y la maternidad es desigual. Resulta imprescindible desarrollar un conocimiento no parcelado, no dividido y no reduccionista en el ámbito reproductivo. Es necesario visibilizar a los hombres como padres en la esfera científica, romper estereotipos de género e incorporar la corresponsabilidad en la crianza en las políticas y en las prácticas sociales como una cuestión de derecho fundamental

OBJECTIVE: To compare worldwide differences in scientific production on fatherhood and motherhood (quantity, start time and evolution over time), to determine the international geographic distribution of articles on fatherhood, and, to examine the relationship between the human development index (HDI), the global gender gap index (GGGI), and the number of articles on fatherhood. METHOD: Descriptive analysis of articles on fatherhood and motherhood from the Scopus database 1788-2016, and longitudinal analysis 2006-2015 of the relationship between scientific production on fatherhood, the HDI and the GGGI, by means of a multilevel model with Poisson distribution and extra-Poisson parameter. RESULTS: We observed four times fewer articles on fatherhood than on motherhood. Articles on fatherhood were developed later than those on motherhood, and most (85%) were published in the last two decades, when they increased more than articles on motherhood. We identified geographical inequalities, with North America, Europe and Oceania leading the way. There is a statistically significant relationship between the increase in the HDI and the GGGI in world countries, and the increase in the articles on fatherhood. CONCLUSIONS: Socially built knowledge around fatherhood and motherhood is unequal. It is essential to develop non-parcelled, undivided and non- reductionist knowledge in the reproductive field. It is necessary to make men visible as fathers in the scientific sphere, to break gender stereotypes, and to incorporate childrearing co-responsibility in social policies and practices as a matter of right

Multilevel Analysis of the Relationship between Ownership Structure and Technical Efficiency Frontier in the Spanish National Health System Hospitals.

Objective: To evaluate the relationship between the ownership structure of hospitals and the possibility of their being positioned on the frontier of technical efficiency in the economic crisis period 2010-2012, adjusting for hospital variables and regional characteristics in the areas where the Spanish National Health System (SNHS) hospitals are located. Methods: 230 National Health System hospitals were studied over the two-year period 2010-2012 according to their ownership structure-public hospitals, private hospitals and public-private partnership (PPP)-data envelopment analysis orientated to inputs was used to measure the overall technical efficiency, pure efficiency and efficiency of scale. A generalised linear mixed model (GLMM) with binomial distribution and logit link function was used to analyse the hospital and regional variables associated with positioning on the frontier. Results: There are substantial differences between the average pure technical efficiency of public, private and PPP hospitals, as well as a greater number of PPP models being positioned on the efficiency frontier (91.67% in 2012). The odds of being positioned on the frontier are 41.7 times higher in PPP models than in public hospitals. The average annual household income per region is related to the greater odds of hospitals being positioned on the frontier of efficiency. Conclusions: During the most acute period of recession in the Spanish economy, PPP formulas favoured hospital efficiency, by increasing the odds of being positioned on the frontier of efficiency when compared to private and public hospitals. The position on the frontier of efficiency of a hospital is related to the wealth of its region.

Level of Palliative Care Complexity in Advanced Cancer Patients: A Multinomial Logistic Analysis.

The current treatment approach for patients in palliative care (PC) requires a health model based on shared and individualised care, according to the degree of complexity encountered. The aims of this study were to describe the levels of complexity that may be present, to determine their most prevalent elements and to identify factors that may be related to palliative complexity in advanced-stage cancer patients. An observational retrospective study was performed of patients attended to at the Cudeca Hospice. Socio-demographic and clinical data were compiled, together with information on the patients' functional and performance status (according to the Palliative Performance Scale (PPS)). The level of complexity was determined by the Diagnostic Instrument of Complexity in Palliative Care (IDC-Pal©) and classified as highly complex, complex or non-complex. The impact of the independent variables on PC complexity was assessed by multinomial logistic regression analysis. Of the 501 patients studied, 44.8% presented a situation classed as highly complex and another 44% were considered complex. The highly complex items most frequently observed were the absence or insufficiency of family support and/or caregivers (24.3%) and the presence of difficult-to-control symptoms (17.3%). The complex item most frequently observed was an abrupt change in the level of functional autonomy (47.6%). The main factor related to the presence of high vs. non-complexity was that of performance status (odds ratio (OR) = 10.68, 95% confidence interval (CI) = 2.81-40.52, for PPS values < 40%). However, age was inversely related to high complexity. This study confirms the high level of complexity present in patients referred to a PC centre. Determining the factors related to this complexity could help physicians identify situations calling for timely referral for specialised PC, such as a low PPS score.

[Multilevel analysis of global scientific production on parenthood, human development and gender equality]. / Análisis multinivel de la producción científica mundial sobre paternidad, desarrollo humano e igualdad de género.

OBJECTIVE: To compare worldwide differences in scientific production on fatherhood and motherhood (quantity, start time and evolution over time), to determine the international geographic distribution of articles on fatherhood, and, to examine the relationship between the human development index (HDI), the global gender gap index (GGGI), and the number of articles on fatherhood. METHOD: Descriptive analysis of articles on fatherhood and motherhood from the Scopus database 1788-2016, and longitudinal analysis 2006-2015 of the relationship between scientific production on fatherhood, the HDI and the GGGI, by means of a multilevel model with Poisson distribution and extra-Poisson parameter. RESULTS: We observed four times fewer articles on fatherhood than on motherhood. Articles on fatherhood were developed later than those on motherhood, and most (85%) were published in the last two decades, when they increased more than articles on motherhood. We identified geographical inequalities, with North America, Europe and Oceania leading the way. There is a statistically significant relationship between the increase in the HDI and the GGGI in world countries, and the increase in the articles on fatherhood. CONCLUSIONS: Socially built knowledge around fatherhood and motherhood is unequal. It is essential to develop non-parcelled, undivided and non- reductionist knowledge in the reproductive field. It is necessary to make men visible as fathers in the scientific sphere, to break gender stereotypes, and to incorporate childrearing co-responsibility in social policies and practices as a matter of right.

Factors Associated with Health-Related Quality of Life in Community-Dwelling Older Adults: A Multinomial Logistic Analysis.

The main aim of this study was to determine the association of various clinical, functional and pharmacological factors with the physical (PCS) and mental (MCS) summary components of the health-related quality of life (HRQoL) of community-dwelling older adults. Design: Cross-sectional study. Patients and setting: Sample of 573 persons aged over 65 years, recruited at 12 primary healthcare centres in Málaga, Spain. Sociodemographic, clinical, functional, and comprehensive drug therapy data were collected. The main outcome was HRQoL assessed on the basis of the SF-12 questionnaire. A multinomial logistic regression model was constructed to study the relationship between independent variables and the HRQoL variable, divided into intervals. The average self-perceived HRQoL score was 43.2 (± 11.02) for the PCS and 48.5 (± 11.04) for the MCS. The factors associated with a poorer PCS were dependence for the instrumental activities of daily living (IADL), higher body mass index (BMI), number of medications, and presence of osteoarticular pathology. Female gender and the presence of a psychopathological disorder were associated with worse scores for the MCS. The condition that was most strongly associated with a poorer HRQoL (in both components, PCS and MCS) was that of frailty (odds ratio (OR) = 37.42, 95% confidence interval (CI) = 8.96-156.22, and OR = 20.95, 95% CI = 7.55-58.17, respectively). It is important to identify the determinant factors of a diminished HRQoL, especially if they are preventable or modifiable.

Análisis multinivel de la eficiencia técnica de los hospitales del Sistema Nacional de Salud español por tipo de propiedad y gestión / Multilevel analysis of the technical efficiency of hospitals in the Spanish National Health System by property and type of management

Objetivo: Analizar la eficiencia técnica por tipo de propiedad y gestión de los hospitales generales del Sistema Nacional de Salud español (2010-2012) y sus variables explicativas hospitalarias y regionales. Método: Se estudian 230 hospitales combinando el análisis envolvente de datos y modelos transversales de regresión lineal multinivel de efectos fijos. Con el análisis envolvente de datos se miden la eficiencia técnica global, pura y de escala, y con los modelos multinivel, las variables explicativas de eficiencia. Resultados: El índice medio de eficiencia técnica global de los hospitales sin personalidad jurídica es inferior al de los hospitales con personalidad jurídica (0,691 y 0,876 en 2012). Existe una importante variabilidad en eficiencia técnica pura (ETP) por formas de gestión directa, indirecta y mixta. Un 29% de la variabilidad en la ETP es atribuible a diferencias entre comunidades autónomas. La dotación de personalidad jurídica del hospital aumenta en 11,14 puntos la ETP. Por otra parte, la mayoría de las formas de gestión alternativas al modelo tradicional aumentan en porcentajes variables la ETP. En el ámbito regional, según el escenario considerado, la insularidad y la renta media por hogar son variables explicativas de la ETP. Discusión: Tener personalidad jurídica favorece la eficiencia técnica. El marco de regulación y gestión de los hospitales, más que la propiedad pública o privada, parecen explicar la eficiencia técnica. Las características regionales explican de forma relevante la variabilidad en la ETP

Objective: To analyze technical efficiency by type of property and management of general hospitals in the Spanish National Health System (2010-2012) and identify hospital and regional explanatory variables. Method: 230 hospitals were analyzed combining data envelopment analysis and fixed effects multilevel linear models. Data envelopment analysis measured overall, technical and scale efficiency, and the analysis of explanatory factors was performed using multilevel models. Results: The average rate of overall technical efficiency of hospitals without legal personality is lower than hospitals with legal personality (0.691 and 0.876 in 2012). There is a significant variability in efficiency under variable returns (TE) by direct, indirect and mixed forms of management. The 29% of the variability in TE es attributable to the Region. Legal personality increased the TE of the hospitals by 11.14 points. On the other hand, most of the forms of management (different to those of the traditional hospitals) increased TE in varying percentages. At regional level, according to the model considered, insularity and average annual income per household are explanatory variables of TE. Discussion: Having legal personality favours technical efficiency. The regulatory and management framework of hospitals, more than public or private ownership, seem to explain technical efficiency. Regional characteristics explain the variability in TE

2015 Beers Criteria and STOPP v2 for detecting potentially inappropriate medication in community-dwelling older people: prevalence, profile, and risk factors.

PURPOSE: To comparatively assess the prevalence rates of potentially inappropriate medications (PIMs) obtained by the former and latest versions of American Geriatrics Society Beers Criteria (AGS BC) and screening tool of older person's potentially inappropriate prescriptions (STOPP), and analyze the factors of influence on PIM. METHODS: Cross-sectional study including 582 community-dwelling older adults over the age of 65. Sociodemographic, clinical, functional, and comprehensive drug therapy data were collected. The primary endpoint was the percentage of patients receiving at least one PIM. RESULTS: A total of 3626 prescriptions were analyzed. PIMs were detected in 35.4% and 47.9% of patients according to the STOPP v1 and the 2012 AGS BC, respectively. This percentage rose to 54% when 2015 AGS BC were used and reached 66.8% with STOPP v2. The kappa coefficient between STOPP v2 and its former version was lower than the one between the updated Beers Criteria and their former version (0.41 vs 0.85). The agreement was good (0.65) between both latest criteria. The number of medications, psychological disorders, and insomnia were predictors of PIM. A novel finding was that bone and joint disorders increased the odds for PIM by 78%. CONCLUSIONS: The 2015 AGS BC showed high sensitivity and good applicability to the European older patients. Both updated tools identified some pharmacological groups (benzodiazepines, PPIs, and opioids, among others) and certain health problems (insomnia, psychological disorders, and osteoarticular diseases) as factors of influence on PIM. Based on these findings, interventions aimed at promoting appropriate use of medications should be developed.

[Multilevel analysis of the technical efficiency of hospitals in the Spanish National Health System by property and type of management]. / Análisis multinivel de la eficiencia técnica de los hospitales del Sistema Nacional de Salud español por tipo de propiedad y gestión.

OBJECTIVE: To analyze technical efficiency by type of property and management of general hospitals in the Spanish National Health System (2010-2012) and identify hospital and regional explanatory variables. METHOD: 230 hospitals were analyzed combining data envelopment analysis and fixed effects multilevel linear models. Data envelopment analysis measured overall, technical and scale efficiency, and the analysis of explanatory factors was performed using multilevel models. RESULTS: The average rate of overall technical efficiency of hospitals without legal personality is lower than hospitals with legal personality (0.691 and 0.876 in 2012). There is a significant variability in efficiency under variable returns (TE) by direct, indirect and mixed forms of management. The 29% of the variability in TE es attributable to the Region. Legal personality increased the TE of the hospitals by 11.14 points. On the other hand, most of the forms of management (different to those of the traditional hospitals) increased TE in varying percentages. At regional level, according to the model considered, insularity and average annual income per household are explanatory variables of TE. DISCUSSION: Having legal personality favours technical efficiency. The regulatory and management framework of hospitals, more than public or private ownership, seem to explain technical efficiency. Regional characteristics explain the variability in TE.

Systematic Review of the Effect of Adherence to Statin Treatment on Critical Cardiovascular Events and Mortality in Primary Prevention.

AIM: Analyze the relative risks of critical cardiovascular outcomes and mortality associated with adherence to statin treatment in a clinical setting in people with no history of prior cardiovascular disease (CVD). METHODS: A systematic review of the literature was conducted up to December 2016. The outcomes of interest were cardiovascular fatal or nonfatal events and all-cause mortality. RESULTS: A total of 17 articles were included in a qualitative synthesis. Four were case-control nested in a retrospective cohort design and the other 11 were a cohort design. Seven studies compared the best adherer patients with the worst adherers. In the 3 studies (317 603 participants) that considered ischemic heart disease in this group, the pooled reduction in risk was 18% (95% confidence interval [CI]: 14%-22%, I2 = 0%); for the CVD outcome, 2 studies (131 477 participants) showed a pooled reduction in risk of 47% (95% CI: 36%-56%, I2 = 84.7%) with 1 included study showing a much larger reduction than the others; for the cerebrovascular event (CeVD) outcome, 2 studies (155 726 participants) showed a pooled reduction in risk of 26% (95% CI: 18%-34%, I2 = 0%); and for mortality, the reduction in risk was 49% (95% CI: 39%-57%, I2 = 62.4%). The other 4 studies (147 859 participants) compared the most adherent group with the rest. These showed a pooled risk reduction of CVD of 22% (95% CI: 6%-27%, I2 = 0). CONCLUSION: Adherence to statins treatment is shown as a key element for primary prevention, although these are observational data and the risk of bias from confounding cannot be ruled out. Standardization of measures of adherence to treatment would improve comparability between studies. Further research is warranted to design effective interventions to improve patients' adherence.

Assessment of off-label prescribing: profile, evidence and evolution / Evaluación de las prescripciones fuera de ficha técnica: perfil, evidencia y evolución

Objective: The objectives of the study were to describe the extent and profile of off-label prescriptions, to evaluate the level of evidence supporting these indications, to assess the research activity in these conditions, and to determine to what extent these were authorized as new indications five years after the application. Methods: A cross-sectional study including all applications conducted in the Hospital Universitario Reina Sofía in Córdoba during 2010. Analysis: level of evidence according to the criteria by SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) and CEBM (Centre for Evidence-based Medicine), registered clinical trials (source: ClinicalTrials.gov), and review of product specifications and monthly newsletters from the Spanish Agency of Medicines and Medical Devices. Results: There were 190 applications for off-label prescription for 82 different indications. The most requested medications were: tacrolimus, mycophenolate, colistimethate and everolimus; the immunosuppressant group had the highest number of uses for non-approved indications. Out of the applications, 52.4% were based on some clinical trial, while the rest had a low level of evidence (observational studies and case reports). We have found on-going clinical trials for 67% of the indications, but new indications in their product specifications have only been authorized for nine drugs (bevacizumab, deferasirox, everolimus, lenalidomide, methotrexate, sildenafil, sorafenib, raltegravir and tenofovir). Conclusions: We have detected a major volume of off-label prescription without good supporting evidence, which identifies these indications and medications as interesting research lines, but that require follow-up in terms of effectiveness and costs (AU)

Objetivo: Los objetivos del estudio fueron describir la magnitud y el perfil de las prescripciones fuera de ficha técnica (off-label), evaluar el nivel de evidencia en el que se sustentan estas indicaciones, valorar la actividad investigadora en estas enfermedades y determinar en qué grado se autorizan como nuevas indicaciones transcurridos cinco años desde la solicitud. Métodos: Estudio transversal que incluyó todas las solicitudes realizadas en el Hospital Universitario Reina Sofía de Córdoba durante 2010. Análisis: nivel de evidencia según criterios de SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) y del CEBM (Centre for Evidence-based Medicine), ensayos clínicos registrados (fuente: ClinicalTrials.gov) y la revisión de fichas técnicas e informes mensuales de la Agencia Española del Medicamento. Resultados: Hubo 190 solicitudes offlabel para 82 indicaciones distintas. Los medicamentos más solicitados fueron tacrolimus, micofenolato, colistimetato y everolimus, constituyéndose el grupo de inmunosupresores como el de mayor número de usos en indicaciones no aprobadas. El 52,4% de las solicitudes estaban basadas en algún ensayo clínico, mientras que el resto tuvo un bajo nivel de evidencia (estudios observacionales y casos). Hemos encontrado ensayos clínicos en activo para el 67% de las indicaciones, pero solo nueve fármacos han visto autorizadas nuevas indicaciones en su ficha técnica (bevacizumab, deferasirox, everolimus, lenalidomida, metotrexato, sildenafilo, sorafenib, raltegravir y tenofovir). Conclusiones: Se ha detectado un importante volumen de usos offlabel en ausencia de buena evidencia, lo que identifica a estas indicaciones y medicamentos como líneas de investigación interesantes pero con necesidad de seguimiento de efectividad y costes (AU)

Assessment of off-label prescribing: profile, evidence and evolution.

OBJECTIVES: The objectives of the study were to describe the extent and profile of off-label prescriptions, to evaluate the level of evidence supporting these indications, to assess the research activity in these conditions, and to determine to what extent these were authorized as new indications five years after the application. METHODS: A cross-sectional study including all applications conducted in the Hospital Universitario Reina Sofía in Córdoba during 2010. ANALYSIS:  level of evidence according to the criteria by SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) and CEBM (Centre for Evidence-based Medicine), registered clinical trials (source: ClinicalTrials.gov), and review of product specifications and monthly newsletters from the Spanish Agency of Medicines and Medical Devices. RESULTS: There were 190 applications for off-label prescription for 82 different indications. The most requested medications were: tacrolimus, mycophenolate, colistimethate and everolimus; the immunosuppressant group had the highest number of uses for non-approved indications. Out of the applications, 52.4% were based on some clinical trial, while the rest had a low level of evidence (observational studies and case reports). We have found on-going clinical trials for 67% of the indications, but new indications in their product specifications have only been authorized for nine drugs (bevacizumab, deferasirox, everolimus, lenalidomide, methotreate, sildenafil, sorafenib, raltegravir and tenofovir). CONCLUSIONS: We have detected a major volume of off-label prescription without good supporting evidence, which identifies these indications and medications as interesting research lines, but that require follow-up in terms of effectiveness and costs.

Objetivo: Los objetivos del estudio fueron describir la magnitud y el perfil de las prescripciones fuera de ficha técnica (off-label), evaluar el nivel de evidencia en el que se sustentan estas indicaciones, valorar la actividad investigadora en estas enfermedades y determinar en qué grado se autorizan como nuevas indicaciones transcurridos cinco años desde la solicitud.Métodos: Estudio transversal que incluyó todas las solicitudes realizadas en el Hospital Universitario Reina Sofía de Córdoba durante 2010. Análisis: nivel de evidencia según criterios de SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) y del CEBM (Centre for Evidence-based Medicine), ensayos clínicos registrados (fuente: ClinicalTrials.gov) y la revisión de fichas técnicas e informes mensuales de la Agencia Española del Medicamento.Resultados: Hubo 190 solicitudes off-label para 82 indicaciones distintas. Los medicamentos más solicitados fueron tacrolimus, micofenolato, colistimetato y everolimus, constituyéndose el grupo de inmunosupresores como el de mayor número de usos en indicaciones no aprobadas. El 52,4% de las solicitudes estaban basadas en algún ensayo clínico, mientras que el resto tuvo un bajo nivel de evidencia (estudios observacionales y casos). Hemos encontrado ensayos clínicos en activo para el 67% de las indicaciones, pero solo nueve fármacos han visto autorizadas nuevas indicaciones en su ficha técnica (bevacizumab, deferasirox, everolimus, lenalidomida, metotrexato, sildenafilo, sorafenib, raltegravir y tenofovir).Conclusiones: Se ha detectado un importante volumen de usos offlabel en ausencia de buena evidencia, lo que identifica a estas indicaciones y medicamentos como líneas de investigación interesantes pero con necesidad de seguimiento de efectividad y costes.

Análisis de la eficiencia técnica en los hospitales del Sistema Nacional de Salud español / Analysis of the technical efficiency of hospitals in the Spanish National Health Service

Objetivo: Analizar la eficiencia técnica y la productividad de los hospitales generales del Sistema Nacional de Salud (SNS) español (2010-2012) e identificar variables hospitalarias y regionales explicativas. Métodos: Se estudian 230 hospitales del SNS mediante análisis envolvente de datos midiendo la eficiencia técnica global, pura, de escala, y el índice de Malmquist. La robustez del análisis se evalúa con modelos input-output alternativos. Se emplean modelos multinivel lineales transversales de efectos fijos para analizar las variables explicativas de eficiencia. Resultados: El índice medio de eficiencia técnica global (ETG) es de 0,736 en 2012, con una importante variabilidad por comunidades autónomas. El índice de Malmquist (2010-2012) es de 1,013. Un 23% de la variabilidad en ETG es atribuible a la comunidad autónoma. Las variables exógenas estadísticamente significativas (residentes por cada 100 facultativos, índice de envejecimiento, renta media anual por hogar, gasto en servicios públicos fundamentales y gasto público sanitario per cápita) explican el 42% de la variabilidad de ETG entre hospitales y el 64% entre comunidades autónomas. El número de residentes es estadísticamente significativo. En todas las comunidades autónomas existe una relación lineal directa significativa entre la ETG y la renta anual per cápita y el gasto en servicios públicos fundamentales, e indirecta con el índice de envejecimiento y el gasto público sanitario per cápita. Discusión El importante margen de mejora en eficiencia de los hospitales está condicionado por características específicas de cada comunidad autónoma, particularmente el envejecimiento, la riqueza y las políticas de gasto público de cada una (AU)

Objective: To analyse the technical efficiency and productivity of general hospitals in the Spanish National Health Service (NHS) (2010-2012) and identify explanatory hospital and regional variables. Methods: 230 NHS hospitals were analysed by data envelopment analysis for overall, technical and scale efficiency, and Malmquist index. The robustness of the analysis is contrasted with alternative input-output models. A fixed effects multilevel cross-sectional linear model was used to analyse the explanatory efficiency variables. Results: The average rate of overall technical efficiency (OTE) was 0.736 in 2012; there was considerable variability by region. Malmquist index (2010-2012) is 1.013. A 23% variability in OTE is attributable to the region in question. Statistically significant exogenous variables (residents per 100 physicians, aging index, average annual income per household, essential public service expenditure and public health expenditure per capita) explain 42% of the OTE variability between hospitals and 64% between regions. The number of residents showed a statistically significant relationship. As regards regions, there is a statistically significant direct linear association between OTE and annual income per capita and essential public service expenditure, and an indirect association with the aging index and annual public health expenditure per capita. Discussion: The significant room for improvement in the efficiency of hospitals is conditioned by region-specific characteristics, specifically aging, wealth and the public expenditure policies of each one (AU)

[Analysis of the technical efficiency of hospitals in the Spanish National Health Service]. / Análisis de la eficiencia técnica en los hospitales del Sistema Nacional de Salud español.

OBJECTIVE: To analyse the technical efficiency and productivity of general hospitals in the Spanish National Health Service (NHS) (2010-2012) and identify explanatory hospital and regional variables. METHODS: 230 NHS hospitals were analysed by data envelopment analysis for overall, technical and scale efficiency, and Malmquist index. The robustness of the analysis is contrasted with alternative input-output models. A fixed effects multilevel cross-sectional linear model was used to analyse the explanatory efficiency variables. RESULTS: The average rate of overall technical efficiency (OTE) was 0.736 in 2012; there was considerable variability by region. Malmquist index (2010-2012) is 1.013. A 23% variability in OTE is attributable to the region in question. Statistically significant exogenous variables (residents per 100 physicians, aging index, average annual income per household, essential public service expenditure and public health expenditure per capita) explain 42% of the OTE variability between hospitals and 64% between regions. The number of residents showed a statistically significant relationship. As regards regions, there is a statistically significant direct linear association between OTE and annual income per capita and essential public service expenditure, and an indirect association with the aging index and annual public health expenditure per capita. DISCUSSION: The significant room for improvement in the efficiency of hospitals is conditioned by region-specific characteristics, specifically aging, wealth and the public expenditure policies of each one.

Assessing Potentially Inappropriate Prescribing in Community-Dwelling Older Patients Using the Updated Version of STOPP-START Criteria: A Comparison of Profiles and Prevalences with Respect to the Original Version.

Emerging and changing evidence made it necessary to update STOPP-START criteria, and version 2 was published recently. In this study the objectives were to determine the prevalence of potentially inappropriate medication prescribing (PIM) in primary care using STOPP versions 1 (v1) and 2 (v2), as well as 2012 AGS Beers criteria, and analyze the factors associated with inappropriate prescribing according to STOPP/START v2. A cross-sectional study was carried out including community-dwelling older adults over the age of 65. Sociodemographic, clinical, functional and comprehensive drug therapy data were collected. The primary endpoint was the percentage of patients receiving at least one PIM. This variable was measured using three tools: STOPP v1, 2012 AGS Beers criteria and STOPP v2. Similarly, the percentage of patients receiving at least one potential prescribing omission (PPO) was calculated using START versions 1 and 2. A total of 1,615 prescriptions were reviewed. The median number of medications per patient was 7.1 drugs (±3.8). The prevalence of elderly people exposed to polypharmacy (≥5 medications) was 72.9%, whereas 28.4% of the participants took ≥10 drugs regularly. PIM were present in 18.7%, 37.3% and 40.4% of participants, according to the STOPP v1, 2012 Beers criteria and STOPP v2, respectively. According to STOPP v2, the number of medications taken (OR: 1.14, 1.06-1.25), the presence of a psychological disorder (OR: 2.22, 1.13-4.37) and insomnia (OR: 3.35, 1.80-6.32) were risk factors for taking a PIM. The prevalence of PPOs was 34.7% and 21.8% according to version 1 and 2, respectively. In conclusion, STOPP-START criteria have been remarkably modified, which is evidenced by the different prevalence rates detected using version 2, as compared to version 1. In fact, the level of agreement between version 1 and the updated version is only moderate. Special attention should be paid on benzodiazepines, which keep being the most frequent PIM.

Geographical and Temporal Variations in Female Breast Cancer Mortality in the Municipalities of Andalusia (Southern Spain).

The last published figures have shown geographical variations in mortality with respect to female breast cancer in European countries. However, national health policies need a dynamic image of the geographical variations within the country. The aim of this paper was to describe the spatial distribution of age-specific mortality rates from female breast cancer in the municipalities of Andalusia (southern Spain) and to analyze its evolution over time from 1981 to 2012. An ecological study was devised. Two spatio-temporal hierarchical Bayesian models were estimated. One of these was used to estimate the age-specific mortality rate for each municipality, together with its time trends, and the other was used to estimate the age-specific rate ratio compared with Spain as a whole. The results showed that 98% of the municipalities exhibited a decreasing or a flat mortality trend for all the age groups. In 2012, the geographical variability of the age-specific mortality rates was small, especially for population groups below 65. In addition, more than 96.6% of the municipalities showed an age-specific mortality rate similar to the corresponding rate for Spain, and there were no identified significant clusters. This information will contribute towards a reflection on the past, present and future of breast cancer outcomes in Andalusia.

Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica / Drug prescriptions study in the outpatient setting: assessment of off-label uses in children

OBJETIVO: Evaluar el perfil de prescripción y los usos off-label (fuera de ficha técnica [FT]) y unlicensed(medicamentos no autorizados específicamente para niños) de medicamentos a nivel ambulatorio. DISEÑO: Estudio transversal. Emplazamiento: Consultas de pediatría de 2 centros de salud urbanos y sala de urgencia general del Hospital Materno-Infantil de Málaga. PARTICIPANTES: Niños de 0-14 años que acudiesen a consulta y se les prescribiese al menos un medicamento. MEDICIONES PRINCIPALES: Variables sociodemográficas, motivo de consulta y medicación. Clasificación de las prescripciones según información contenida en FT. RESULTADOS: Se incluyeron un total de 388 niños, una submuestra de 105 (27%) atendidos en urgencias, y se valoraron 462 prescripciones, que involucraron 74 principios activos diferentes. Cada niño recibió un promedio de 1,7 fármacos (IC 95%: 1,6-1,9), siendo los más prescritos ibuprofeno, paracetamol, amoxicilina-clavulánico y budesonida. El grupo terapéutico más empleado y con mayor variedad de fármacos fue el respiratorio. El 27,4% de las prescripciones (IC 95%: 23,5-31) fueron off-label, constituyéndose como causa más frecuente el uso del fármaco para una edad distinta de la autorizada (60%; IC 95%: 54,1-63), seguida de distinta dosis (21,5%; IC 95%: 18-25), diferente indicación (12%; IC 95%: 9,2-15) y el 7% por distinta vía de administración (IC 95%: 5,4-10). CONCLUSIONES: La tasa de usos off-label presenta cifras intermedias, pudiendo recibir este tipo de prescripciones una tercera parte de los niños. Esto no significa que sean prescripciones incorrectas, pero es recomendable respaldarlas con la mejor evidencia, así como seguir las directrices de la normativa sobre medicamentos en situaciones especiales

OBJECTIVE: to evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric PATIENTS: DESIGN: cross-sectional study. SETTING: pediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga). MAIN MEASUREMENTS: sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC). RESULTS: A total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group.27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10). CONCLUSIONS: The rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations

Efectos de la edad, el periodo de defunción y la cohorte de nacimiento en la mortalidad por enfermedad isquémica del corazón en el sur de España / Age, period, and cohort effects on mortality from ischemic heart disease in southern Spain

Introducción y objetivos: La cardiopatía isquémica es la primera causa de muerte y una de las cuatro principales causas de carga de enfermedad en el mundo. El objetivo de este trabajo es evaluar los efectos edad-periodo-cohorte la mortalidad por cardiopatía isquémica en Andalucía (sur de España) y en cada una de sus provincias durante el periodo 1981-2008. Métodos: Se realizó un estudio ecológico poblacional. Se analizaron las 145.539 defunciones por cardiopatía isquémica ocurridas en Andalucía durante el periodo de estudio a edades comprendidas entre 30 y 84 años. Se estimó un modelo de regresión no lineal con funciones spline para cada sexo y área geográfica. Resultados: En la tasa de mortalidad masculina y femenina a partir de 30 años de edad se observa tendencia a aumentar. El riesgo de muerte para varones y mujeres fue descendiente para las cohortes nacidas después de 1920 y con una pendiente más pronunciada después de 1960 entre los varones. El análisis del efecto periodo mostró que el riesgo de mortalidad masculina y femenina se mantuvo estable desde 1981 hasta 1990, aumentó entre 1990 y 2000 y volvió a disminuir desde 2000 hasta 2008. Conclusiones: Los efectos edad-periodo-cohorte en la mortalidad fueron similares en todas las provincias de Andalucía y el conjunto de la comunidad autónoma. Si los efectos cohorte y periodo persisten, la mortalidad masculina y femenina por enfermedad isquémica cardiaca continuará disminuyendo (AU)

Introduction and objectives: Ischemic heart disease is the leading cause of death and one of the top 4 causes of burden of disease worldwide. The aim of this study was to evaluate age-period-cohort effects on mortality from ischemic heart disease in Andalusia (southern Spain) and in each of its 8 provinces during the period 1981-2008. Methods: A population-based ecological study was conducted. In all, 145 539 deaths from ischemic heart disease were analyzed for individuals aged between 30 and 84 years who died in Andalusia in the study period. A nonlinear regression model was estimated for each sex and geographical area using spline functions. Results: There was an upward trend in male and female mortality rate by age from the age of 30 years. The risk of death for men and women showed a downward trend for cohorts born after 1920, decreasing after 1960 with a steep slope among men. Analysis of the period effect showed that male and female death risk first remained steady from 1981 to 1990 and then increased between 1990 and 2000, only to decrease again until 2008. Conclusions: There were similar age-period-cohort effects on mortality in all the provinces of Andalusia and for Andalusia as a whole. If the observed cohort and period effects persist, male and female mortality from ischemic heart disease will continue to decline (AU)