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BackgroundCerebral palsy (CP), which is the leading cause of motor disability during childhood, can produce sensory and cognitive impairments at different degrees. Most recent therapeutic interventions for these patients have solely focused on upper extremities (UE), although more than 60% of these patients present lower extremities (LE) deficits. Recently, a new therapeutic concept, Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), has been proposed, involving the constant stimulation of UE and LE. Based on motor skill learning principles, HABIT-ILE is delivered in a day-camp setting, promoting voluntary movements for several hours per day during 10 consecutive week days. Interestingly, the effects of this intervention in a large scale of youngsters are yet to be observed. This is of interest due to the lack of knowledge on functional, neuroplastic and biomechanical changes in infants with bilateral CP. The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.MethodsThis international, multicentric study will include 50 pre-school children with CP from 12 to 60months of age, comparing the effect of 50h (2weeks) of HABIT-ILE versus regular motor activity and/or customary rehabilitation. HABIT-ILE presents structured activities and functional tasks with continuous increase in difficulty while the child evolves. Assessments will be performed at 3 period times: baseline, two weeks later and 3months later. The primary outcome will be the Gross Motor Function Measure 66. Secondary outcomes will include Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics.DiscussionThe results of this study should highlight the impact of a motor, intensive, goal-directed therapy (HABIT-ILE) in pre-school children at a functional, neuroplastic and biomechanical level. In addition, this changes could demonstrated the impact of this intervention in the developmental curve of each child, improving functional ability, activity and participation in short-, mid- and long-term.Name of the registryEvaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE).Trial registrationNCT04017871Registration dateJuly 12, 2019., This protocol and trial is funded by La Fondation Paralysie Cerebrale (https://www.fondationparalysiecerebrale.org/).The funding body has reviewed this protocol during the selection process, but after this initial point, the Fondation Paralysie Cerebrale has not participated in the design study and will not participate in data collection, analysis, interpretation data or in writing the manuscript.

Introduction Benzodiazepines (BZDs) are mainly used to treat anxiety and sleep disorders, and are often prescribed for long durations, even though prescription guidelines recommend short-term use due to the risk of dependence, cognitive impairment, and falls and fractures. Education of general practitioners (GPs) regarding the prescription of BZDs may reduce the overuse and of these drugs. The aims of this study are to analyse the effectiveness of an intervention targeted to GPs to reduce BZD prescription and evaluate the implementation process. Methods and analysis The healthcare centres in three regions of Spain (Balearic Islands, Catalonia and Community of Valencia) will be randomly allocated to receive a multifactorial intervention or usual care (control). GPs in the intervention group will receive a 2-hour workshop about best-practice regarding BZD prescription and BZD deprescribing, monthly feedback about their BZD prescribing practices and access to a support web page. Outcome measures for each GP are the defined daily dosage per 1000 inhabitants per day and the proportion of long-term BZD users at 12 months. Data will be collected from the electronic prescription database of the public health system, and will be subjected to intention-to-treat analysis. Implementation will be evaluated by mixed methods following the five domains of the Consolidated Framework For Implementation Research. Ethics and dissemination This study was approved by the Balearic Islands Ethical Committee of Clinical Research (IB3065/ 15), l'IDIAP Jordi Gol Ethical Committee of Clinical Research (PI 15/ 0148) and Valencia Primary Care Ethical Committee of Clinical Research (P16/ 024). The results will be submitted for publication in peer-reviewed journals., This study was funded by the Ministry of Economy and Competitiveness, Carlos III Institute (www.isciii.es), grant PI15/01480. We also received support from the Health Promotion and Preventive Activities-Primary Health Care Network, sustained by the Ministry of Health ISCIII-RETIC awards RD16/0007/0008, also-supported with European Union ERDF funds.

The IRONIC study group: Cuervo, Guillermo; Escrihuela-Vidal, Francesc; Tubau, Fe; Rodriguez Arias, Marisol; Merve Ayaz, Caglayan; Munita, Jose; Gasch, Oriol; Capilla, Silvia; Bochud, Pierre-Yves; Manuel, Oriol; Torre-Cisneros, Julian; Tabares, Salvador; Serrano Lopez, Josefina; Maschmeyer, Georg; Torres, Diego; Abdala, Edson; Bittencourt, Driele Peixoto; El Zein, Saeed; Jabbour, Jean-Francois; Bertz, Hartmut; Peyerl-Hoffmann, Gabriele; Lizasoain, Manuel; Maria Aguado, Jose; Clemencia Correa, Lina; Palop, Begona; Fortun, Jesus; Magnasco, Laura; Cespedes, Roberto; Lopez-Soria, Leire; Pablo Horcajada, Juan; Montaguti, Mia Hold; de Cueto, Marina; Rodriguez-Bano, Jesus; Greco, Raffaella; Cichero, Paola; Bassetti, Matteo; Castaldo, Nadia; Sangro del Alcazar, Paloma; Cardozo, Celia; Garcia-Vidal, Carolina; Aguilar-Company, Juan; Larrosa, Nieves; Uyan-Onal, Ayse; Nazli-Zeka, Arzu; Vasconcelos de Freitas, Wania; da Silva Machado, Amanda Aparecida, [Introduction]: Pseudomonas aeruginosa (PA) has historically been one of the major causes of severe sepsis and death among neutropenic cancer patients. There has been a recent increase of multidrug-resistant PA (MDRPA) isolates that may determine a worse prognosis, particularly in immunosuppressed patients. The aim of this study is to establish the impact of antibiotic resistance on the outcome of neutropenic onco-haematological patients with PA bacteraemia, and to identify the risk factors for MDRPA bacteraemia and mortality., [Methods and analysis]: This is a retrospective, observational, multicentre, international study. All episodes of PA bacteraemia occurring in neutropenic oncohaematological patients followed up at the participating centres from 1 January 2006 to 31 May 2018 will be retrospectively reviewed. The primary end point will be overall case-fatality rate within 30 days of onset of PA bacteraemia. The secondary end points will be to describe the following: the incidence and risk factors for multidrugresistant and extremely drug-resistant PA bacteraemia (by comparing the episodes due to susceptible PA with those produced by MDRPA), the efficacy of ceftolozane/tazobactam, the rates of persistent bacteraemia and bacteraemia relapse and the risk factors for very early (48 hours), early (7 days) and overall (30 days) case-fatality rates., [Ethics and dissemination]: The Clinical Research Ethics Committee of Bellvitge University Hospital approved the protocol of the study at the primary site. To protect personal privacy, identifying information of each patient in the electronic database will be encrypted. The processing of the patients’ personal data collected in the study will comply with the Spanish Data Protection Act of 1998 and with the European Directive on the privacy of data. All data collected, stored and processed will be anonymised. Results will be reported at conferences and in peerreviewed publications., This study was supported by Plan Nacional de I+D+i 2013‐2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001) and co-financed by European Development Regional Fund “A way to achieve Europe”, Operative Programme Intelligent Growth 2014‐2020.

El prematuro pequeño para edad gestacional experimenta hipoxia intrauterina a la que se le atribuye un efecto madurativo sobre el pulmón. Esta condición entonces lo protegería del síndrome de dificultad respiratoria, sin embargo, los reportes son controversiales. Con el objetivo de explorar la asociación: condición pequeño para edad gestacional y desarrollo de síndrome de dificultad respiratoria, se realizó un estudio de cohorte retrospectivo con información de la Red Colaborativa NEOCOSUR (2000-2012). Fueron seleccionados 10563 registros completos de prematuros menores de 32 semanas con pesos al nacer debajo del percentil 10 según la curva de Fenton (expuestos) y entre los percentiles 10 y 90 (no expuestos), de gestaciones únicas y sin malformaciones congénitas. Se estimó el OR asociativo ajustado por edad gestacional, peso, sexo, uso de corticoides antenatales, sepsis temprana, hipertensión y diabetes maternas con regresión logística multivariada y multinivel (niveles paciente y centro). Este estudio no encontró asociación entre la condición “pequeño para edad gestacional” y el desarrollo del síndrome de dificultad respiratoria al nacer (OR=1.07, 0.92-1.24). Estudios prospectivos, multicéntricos, con definiciones operacionales y curvas ponderales internacionalmente aceptadas, son necesarios para caracterizar la adaptación pulmonar frente al estrés intrauterino hipóxico y/o isquémico.

Introducción: A pesar de que la enfermedad ganglionar negativa es un factor pronóstico de importancia en la supervivencia global de pacientes con adenocarcinoma ampular (AA), un subgrupo muere por cáncer. Existe sólida evidencia que la invasión linfovascular (ILV) puede sugerir micrometástasis ocultas en pacientes con enfermedad ganglionar negativa (N0) en cáncer gástrico y de colon. Sin embargo, su importancia en el AA aún se desconoce. El objetivo fue evaluar el hazard de ILV en la supervivencia global (SG) de pacientes con (N0) operados mediante duodenopancreatectomía (DPC). Métodos: Se desarrolló un estudio retrospectivo multicéntrico de pacientes con DPC por AA N0 entre 2001 y 2011 en Lima, Perú. Se revisaron los informes patológicos de todos los pacientes. Se utilizó el método Kaplan Meier para calcular las curvas de supervivencia desde el momento post-cirugía hasta la muerte por cualquier causa y su relación con la presencia o no de ILV. El análisis bivariado y de múltiples variables se desarrolló mediante el modelo de Regresión de Cox. Se calculó Hazard Ratio (HR) con sus intervalos de confianza al 95% (IC95%). Resultados: Se incluyeron 144 pacientes e ILV estuvo presente en 54 pacientes (37%). Las características demográficas y patológicas fueron similares entre los pacientes con y sin ILV. La presencia de ILV se incrementó de acuerdo al estadio T (T1, 14%; T2, 31%; T3, 47% and T4, 73%; p=0,002). Los pacientes con ILV tuvieron una mediana de supervivencia global corta (31 meses) en comparación con los pacientes sin ILV (60 meses, p

COACH study investigators., [Background] A thorough evaluation of the adequacy of clinical practice in a designated health care setting and temporal context is key for clinical care improvement. This study aimed to perform a clinical audit of primary care to evaluate clinical care delivered to patients with COPD in routine clinical practice., [Methods] The Community Assessment of COPD Health Care (COACH) study was an observational, multicenter, nationwide, non-interventional, retrospective, clinical audit of randomly selected primary care centers in Spain. Two different databases were built: the resources and organization database and the clinical database. From January 1, 2015 to December 31, 2016 consecutive clinical cases of COPD in each participating primary care center (PCC) were audited. For descriptive purposes, we collected data regarding the age at diagnosis of COPD and the age at audit, gender, the setting of the PCC (rural/urban), and comorbidities for each patient. Two guidelines widely and uniformly used in Spain were carefully reviewed to establish a benchmark of adequacy for the audited cases. Clinical performance was analyzed at the patient, center, and regional levels. The degree of adequacy was categorized as excellent (> 80%), good (60–80%), adequate (40–59%), inadequate (20–39%), and highly inadequate (, [Results] During the study 4307 cases from 63 primary care centers in 6 regions of the country were audited. Most evaluated parameters were judged to fall in the inadequate performance category. A correct diagnosis based on previous exposure plus spirometric obstruction was made in an average of 17.6% of cases, ranging from 9.8 to 23.3% depending on the region. During the audited visit, only 67 (1.6%) patients had current post-bronchodilator obstructive spirometry; 184 (4.3%) patients had current post-bronchodilator obstructive spirometry during either the audited or initial diagnostic visit. Evaluation of dyspnea was performed in 11.1% of cases. Regarding treatment, 33.6% received no maintenance inhaled therapies (ranging from 31.3% in GOLD A to 7.0% in GOLD D). The two most frequently registered items were exacerbations in the previous year (81.4%) and influenza vaccination (87.7%)., [Conclusions] The results of this audit revealed a large variability in clinical performance across centers, which was not fully attributable to the severity of the disease., This study received an unrestricted grant from Boehringer Ingelheim, Spain.

Purpose. To survey the management of patients with neovascular age-related macular degeneration (nvAMD) in Spain.Methods. An observational retrospective multicenter study was conducted. The variables analyzed were sociodemographic characteristics, foveal and macular thickness, visual acuity (VA), type of treatment, number of injections, and the initial administration of a loading dose of an antiangiogenic drug.Results. 208 patients were followed up during 23.4 months in average. During the first and second years, patients received a mean of4.5±1.8and1.6±2.1injections of antiangiogenic drugs, and5.4±2.8and3.6±2.2follow-up visits were performed, respectively. The highest improvement in VA was observed at 3 months of follow-up, followed by a decrease in the response that stabilized above baseline values until the end of the study. Patients who received an initial loading dose presented greater VA gains than those without.Conclusions. Our results suggest the need for a more standardized approach in the management and diagnosis of nvAMD receiving VEGF inhibitors. To achieve the visual outcomes reported in pivotal trials, an early diagnosis, proactive approach (more treating than follow-up visits), and a close monitoring might be the key to successfully manage nvAMD.

Background— The purpose of this study was to assess the incidence of neurological complications in patients with infective endocarditis, the risk factors for their development, their influence on the clinical outcome, and the impact of cardiac surgery. Methods and Results— This was a retrospective analysis of prospectively collected data on a multicenter cohort of 1345 consecutive episodes of left-sided infective endocarditis from 8 centers in Spain. Cox regression models were developed to analyze variables predictive of neurological complications and associated mortality. Three hundred forty patients (25%) experienced such complications: 192 patients (14%) had ischemic events, 86 (6%) had encephalopathy/meningitis, 60 (4%) had hemorrhages, and 2 (1%) had brain abscesses. Independent risk factors associated with all neurological complications were vegetation size ≥3 cm (hazard ratio [HR] 1.91), Staphylococcus aureus as a cause (HR 2.47), mitral valve involvement (HR 1.29), and anticoagulant therapy (HR 1.31). This last variable was particularly related to a greater incidence of hemorrhagic events (HR 2.71). Overall mortality was 30%, and neurological complications had a negative impact on outcome (45% of deaths versus 24% in patients without these complications; P Conclusions— Moderate to severe ischemic stroke and brain hemorrhage were found to have a significant negative impact on the outcome of infective endocarditis. Early appropriate antimicrobial treatment is critical, and transitory discontinuation of anticoagulant therapy should be considered.

Propósito Reportar la incidencia y las características clínicas de los pacientes que experimentaron pérdida no entendida de la visión después de la extracción del aceite de silicona (AS). Métodos Estudio retrospectivo multicéntrico de pacientes que experimentaron pérdida de visión significativa luego del retiro de aceite de silicona (AS) durante el periodo 2000-2012. Se consideró pérdida de visión significativa a aquella pérdida igual o mayor a dos líneas de la cartilla de Snellen. Resultados Un total de 324 ojos de 324 pacientes experimentaron pérdida de visión luego del retiro del AS durante el período de estudio. Cuarenta y dos (13%) ojos sufrieron pérdida de visión significativa después de la extracción del AS. Veintitrés (7.1%) de estos ojos perdieron visión secundaria a causas conocidas. En los restantes 19 ojos (5.9%) la pérdida de la visión no fue explicada por cualquier otra patología. Once de estos 19 pacientes (57,9%) eran hombres. La edad media de este grupo fue de 49.2 ± 16,4 años. Los ojos que perdieron visión sin causa entendible tuvieron el aceite durante 14.8 ± 4,4 meses y durante este tiempo la presión intraocular (PIO) media fue de 19,6 ± 6,9 mm Hg. En comparación, los ojos que no experimentaron pérdida de visión tuvieron el aceite 9,3 ± 10,9 meses (p < 0.0001) y una PIO media de 14 ± 7,3 mm Hg (p < 0,0002). Conclusiones Observamos pérdida de visión no explicada después del retiro del aceite de silicona en el 5,9% de los ojos. Los factores asociados a este fenómeno incluyen una PIO más alta y mayor duración del taponamiento con AS.

Background: We sought to develop and externally validate a nomogram and web-based calculator to individually predict the development of serious complications in seemingly stable adult patients with solid tumours and episodes of febrile neutropenia (FN). Patients and methods: The data from the FINITE study (n = 1133) and University of Salamanca Hospital (USH) FN registry (n = 296) were used to develop and validate this tool. The main eligibility criterion was the presence of apparent clinical stability, defined as events without acute organ dysfunction, abnormal vital signs, or major infections. Discriminatory ability was measured as the concordance index and stratification into risk groups. Results: The rate of infection-related complications in the FINITE and USH series was 13.4% and 18.6%, respectively. The nomogram used the following covariates: Eastern Cooperative Group (ECOG) Performance Status >= 2, chronic obstructive pulmonary disease, chronic cardiovascular disease, mucositis of grade >= 2 (National Cancer Institute Common Toxicity Criteria), monocytes 0.1). The concordance index was 0.855 and 0.831 in each series. Risk group stratification revealed a significant distinction in the proportion of complications. With a >= 116-point cutoff, the nomogram yielded the following prognostic indices in the USH registry validation series: 66% sensitivity, 83% specificity, 3.88 positive likelihood ratio, 48% positive predictive value, and 91% negative predictive value. Conclusions: We have developed and externally validated a nomogram and web calculator to predict serious complications that can potentially impact decision-making in patients with seemingly stable FN.

Journal Article; ClinicalTrials.gov NCT01437241. Etravirine (ETV) is recommended in combination with a boosted protease inhibitor plus an optimized background regimen for salvage therapy, but there is limited experience with its use in combination with two nucleos(t)ide reverse-transcriptase inhibitors (NRTIs). This multicenter study aimed to assess the efficacy of this combination in two scenarios: group A) subjects without virologic failure on or no experience with non-nucleoside reverse-transcriptase inhibitors (NNRTIs) switched due to adverse events and group B) subjects switched after a virologic failure on an efavirenz- or nevirapine-based regimen. The primary endpoint was efficacy at 52 weeks analysed by intention-to-treat. Virologic failure was defined as the inability to suppress plasma HIV-RNA to 200 copies/mL in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion. Two hundred eighty seven patients were included. Treatment efficacy rates in group A and B were 88.0% (CI95, 83.9-92.1%) and 77.4% (CI95, 65.0-89.7%), respectively; the rates reached 97.2% (CI95, 95.1-99.3%) and 90.5% (CI95, 81.7-99.3), by on-treatment analysis. The once-a-day ETV treatment was as effective as the twice daily dosing regimen. Grade 1-2 adverse events were observed motivating a treatment switch in 4.2% of the subjects. In conclusion, ETV (once- or twice daily) plus two analogs is a suitable, well-tolerated combination both as a switching strategy and after failure with first generation NNRTIs, ensuring full drug activity. TRIAL REGISTRATION ClinicalTrials.gov NCT01437241. Yes

OBJETIVO: Analisar questões não redundantes sobre independência nas atividades da vida diária de idosos que representem o espectro de dependência em idosos.MÉTODOS: Projeto multicêntrico com amostra populacional probabilística de 5.371 idosos residentes em São Paulo, SP, Rio de Janeiro, RJ, Bambuí, MG, e Fortaleza, CE, em 2008. Foi realizado inquérito domiciliar e aplicado questionário com 20 atividades da vida diária dos idosos para autoavaliação da dificuldade/necessidade de ajuda para realizá-las. As respostas foram analisadas segundo: a prevalência de alguma dificuldade ou necessidade de ajuda para cada atividade da vida diária; a frequência de não resposta; e o agrupamento das atividades numa análise fatorial.RESULTADOS: As atividades pessoais (e.g., vestir-se) tiveram prevalência de dificuldade ou necessidade de ajuda referida baixa quando comparadas às atividades instrumentais (e.g., fazer compras), além de terem taxas de respostas inválidas mais baixas. Foram identificados três fatores de agrupamento das atividades da vida diária: mobilidade (andar 100 m); necessidades pessoais (tomar banho); e o que outra pessoa pode fazer pelo idoso (lavar roupa). As atividades da vida diária com maiores autovalores em cada grupo foram analisadas à luz da prevalência de necessidade de ajuda referida e da proporção de respostas válidas. Três atividades foram selecionadas como representativas do espectro de dependência e bem compreendidas pelos idosos: levantar da cama, banhar-se e andar 100 m.CONCLUSÕES: Com três atividades da vida diária podemos ter um instrumento de rastreio simples e confiável capaz de identificar idosos com necessidade de ajuda no dia a dia. A estimativa de demanda por cuidados na vida diária é um indicador importante para o planejamento e gestão dos serviços de saúde dentro do paradigma das doenças crônicas e do envelhecimento populacional. OBJETIVO: Analizar aspectos no redundantes sobre independencia en las actividades de la vida diaria de ancianos que representen el espectro de dependencia en ancianos.MÉTODOS: Proyecto multicéntrico con muestra poblacional probabilística de 5.371 ancianos residentes en Sao Paulo, SP, Rio de Janeiro, RJ, Bambuí, MG y Fortaleza, CE, (Brasil), en 2008. Se realizó pesquisa domiciliar y se aplicó cuestionario con 20 actividades de la vida diaria de los ancianos para auto-evaluación de la dificultad/necesidad de ayuda para realizarlas. Las respuestas fueron analizadas de acuerdo a: la prevalencia de alguna dificultad o necesidad de ayuda en cada actividad de la vida diaria; la frecuencia de respuesta no válidas; y el agrupamiento de las actividades en un análisis factorial.RESULTADOS: Las actividades personales (ej: vestirse) tuvieron prevalencia de dificultad o necesidad de ayuda referida baja al compararse con las actividades instrumentales (ej: hacer compras), además de tener tasas de respuestas: inválidas más bajas. Se identificaron tres factores de agrupamiento de las actividades de la vida diaria: movilidad (andar 100m); necesidades personales (bañarse) y lo que otra persona puede hacer por el anciano (lavar ropa). Las actividades de la vida diaria con mayores auto-valores en cada grupo fueron analizadas a la luz de la prevalencia de necesidad de ayuda referida y de la proporción de respuestas válidas. Tres actividades fueron seleccionadas como representativas del espectro de dependencia y bien comprendidas por los ancianos: levantar de la cama, bañarse y andar 100 m.CONCLUSIONES: Con tres actividades de la vida diaria podemos tener un instrumento de rastreo simple y confiable capaz de identificar ancianos con necesidad de ayuda en el día a día. La estimativa de demanda por cuidados en la vida diaria es un indicador importante para la planificación y gestión de los servicios de salud dentro del paradigma de las enfermedades crónicas y del envejecimiento poblacional. OBJECTIVE: To analyze non-redundant questions on independence in activities of daily living in the elderly, representing the spectrum of dependency.METHODS: Multicenter project with a probabilistic population sample of 5,371 elderly residents in Sao Paulo, SP, Rio de Janeiro, RJ, Fortaleza, CE and Bambui, MG in 2008. A household survey was carried out and a questionnaire with 20 activities of daily living applied for the elderly to self-assess the difficulty/need for help in performing them. The responses were analyzed according to: the prevalence of some kind of difficulty/need for help for each activities of daily living, the frequency of non-response, and the grouping of activities in factor analysis.RESULTS: The personal activities (e.g., dressing) have, on average, a low prevalence of difficulty or need for help, compared to instrumental activities (e.g., shopping), and have lower rates of non- response. In factor analysis it was possible to identify three factors grouping the activities of daily living: one relative to mobility (e.g., walking 100 m), another for personal needs (e.g., bathing) and one relative to what someone else can do for the elderly (e.g., washing clothes). The activities of daily living with the highest eigenvalues in each group were also analyzed in the light of the prevalence of reported need for help and the proportion of non response. Three activities of daily living were selected as representing the spectrum of dependency and being well understood by the elderly - getting out of bed, bathing and walking 100 m.CONCLUSIONS: With only three activities of daily living we can have a simple and reliable screening instrument capable of identifying elderly in need of help in daily life. Estimating demand for care on a daily basis is an important indicator for planning and administration of health services within the paradigm of chronic diseases and population aging.

JR Valdizán-Usón,1 A Cánovas-Martínez,2 MT De Lucas-Taracena,3 F Díaz-Atienza,4 LS Eddy-Ives,5 A Fernández-Jaén,6 M Fernández-Pérez,7 M García-Giral,8 P García-Magán,9 M Garraus-Oneca,10 MA Idiazábal-Alecha,11 M López-Benito,12 G Lorenzo-Sanz,13 J Martínez-Antón,14 MA Martínez-Granero,15 F Montañés-Rada,16 F Mulas-Delgado,17 G Ochando-Perales,18 E Ortega-García,19 A Pelaz-Antolín,20 JA Ramos-Quiroga,21 FC Ruiz-Sanz,22 J Vaquerizo-Madrid,23 A Yusta-Izquierdo241Unidad Trastornos Neurofuncionales, Clínica Montpellier, Zaragoza, 2Hospital Dr Peset, Valencia, 3Hospital 12 de Octubre, Madrid, 4Hospital Virgen de las Nieves, Granada, 5Centre Mèdic Sant Ramon, Santa Coloma de Gramenet, Barcelona, 6Hospital Universitario Quirón, Madrid, 7Centro de Salud La Felguera, Langreo, Asturias, 8Hospital Clínic, Barcelona, 9Unidad Salud Mental, Talavera de la Reina, 10Clínica Universitaria de Navarra, Pamplona, 11Hospital Ntra. Sra. del Pilar, Barcelona, 12Centro Salud Contrueces, Gijón, 13Hospital Ramón y Cajal, Madrid, 14Complejo Hospitalario Carlos Haya, Málaga, 15Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, 16Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, 17Hospital Universitario La Fe, Valencia, 18Hospital Universitario La Fe, Valencia, 19Complejo Asistencial Universitario de León, 20Centro Salud Mental, Alcalá de Henares, 21Hospital Universitari Vall d'Hebron. CIBERSAM. Department of Psychiatry and Legal Medicine. Universitat Autònoma de Barcelona, 22Hospital General Rio Carrión, Palencia, 23Hospital Materno-Infantil, Badajoz, 24Hospital Universitario, Guadalajara, SpainBackground: The purpose of this multicenter Spanish study was to evaluate the response to immediate-release methylphenidate by children and adults diagnosed with attention-deficit/hyperactivity disorder (ADHD), as well as to obtain information on current therapy patterns and safety characteristics.Methods: This multicenter, observational, retrospective, noninterventional study included 730 patients aged 4–65 years with a diagnosis of ADHD. Information was obtained based on a review of medical records for the years 2002–2006 in sequential order.Results: The ADHD predominantly inattentive subtype affected 29.7% of patients, ADHD predominantly hyperactive-impulsive was found in 5.2%, and the combined subtype in 65.1%. Overall, a significant lower Clinical Global Impression (CGI) score and mean number of DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) symptoms by subtype were found after one year of treatment with immediate-release methylphenidate; CGI decreased from 4.51 to 1.69, symptoms of inattention from 7.90 to 4.34, symptoms of hyperactivity from 6.73 to 3.39, and combined subtype symptoms from 14.62 to 7.7. Satisfaction with immediate-release methylphenidate after one year was evaluated as “very satisfied” or “satisfied” by 86.90% of the sample; 25.75% of all patients reported at least one adverse effect. At the end of the study, 41.47% of all the patients treated with immediate-release methylphenidate were still receiving it, with a mean time of 3.80 years on therapy.Conclusion: Good efficacy and safety results were found for immediate-release methylphenidate in patients with ADHD.Keywords: attention deficit hyperactivity disorder, ADHD, pharmacologic treatment, methylphenidate, satisfaction

The study of cross-reactivity in allergy is key to both understanding. the allergic response of many patients and providing them with a rational treatment In the present study, protein microarrays and a co-sensitization graph approach were used in conjunction with an allergen microarray immunoassay. This enabled us to include a wide number of proteins and a large number of patients, and to study sensitization profiles among members of the LTP family. Fourteen LTPs from the most frequent plant food-induced allergies in the geographical area studied were printed into a microarray specifically designed for this research. 212 patients with fruit allergy and 117 food-tolerant pollen allergic subjects were recruited from seven regions of Spain with different pollen profiles, and their sera were tested with allergen microarray. This approach has proven itself to be a good tool to study cross-reactivity between members of LTP family, and could become a useful strategy to analyze other families of allergens. Yes

Rafael Gálvez1, Victoria Ribera2, José Ramón González-Escalada3, Alicia Souto4, María Luz Cánovas4, Andrés Castro4, Begoña Herrero5, María de los Ángeles Maqueda5, Matilde Castilforte6, José Javier Marco-Martínez7, Concepción Pérez8, Lorenza Vicente-Fatela9, Consuelo Nieto MD10, Maria José Orduña11, Anna Padrol12, Enrique Reig13, Joaquín Carballido14, José Manuel Cózar151Pain and Palliative Care Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain; 2Pain Unit, Hospital Vall d’Hebron, Barcelona, Spain; 3Pain Unit, Hospital Ramón y Cajal, Madrid, Spain; 4Pain Unit, Hospital Cristal Piñor, Ourense, Spain; 5Pain Unit, Hospital Virgen de la Macarena, Sevilla, Spain; 6Pain Unit, Fundación Jiménez Díaz, Madrid, Spain; 7Pain Unit, Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain; 8Pain Unit, Hospital La Princesa, Madrid, Spain; 9Pain Unit, Hospital Universitario 12 de Octubre, Madrid, Spain; 10Pain Unit, Fundación Alcorcón, Madrid, Spain; 11Pain Unit, Hospital Xeral-Calde, Lugo, Spain; 12Pain Unit, Hospital Joan XXIII, Tarragona, Spain; 13Pain Unit, Hospital Puerta del Hierro, Madrid, Spain; 14Urology Service, Hospital Puerta del Hierro, Madrid, Spain; 15Urology Service, Hospital Universitario Virgen de las Nieves, Granada, SpainObjectives: A multi-centered observational study evaluated the efficacy of zoledronic acid for improving pain and mobility, and preventing skeletal-related events (SRE) (fracture, spinal compression, pain-relieving radiotherapy), in patients with prostate cancer and bone metastasis.Materials and Methods: Males (n = 218) with prostate cancer and bone metastasis undergoing oncologic therapy received zoledronic acid (4 mg iv/month) for 6 months. Parameters evaluated were: 1) pain and movement after 2 consecutive doses; 2) quality of life; 3) SRE incidence and time-to-appearance. Medication tolerance and treatment satisfaction were assessed using a questionnaire.Results: A total of 170 that matched all the inclusion criteria (78%) out of 218 were evaluable for efficacy. There was a measurable statistically significant reduction in pain at rest and on movement as well as an improvement in the quality of life compared with baseline. Best results were obtained with early treatment. Overall incidence of bone events was 11.2%. Of the 212 patients (97.2%) evaluable for safety, 16% suffered adverse events and 66% expressed satisfaction with the treatmentDiscussion: Zoledronic acid is effective for reducing pain, improving mobility, and increasing the quality of life in patients with prostate cancer with bone metastasis. Its easy administration and good tolerability make zoledronic acid one of the principal therapeutic tools in the management of patients with pain associated with bone metastasis from prostate cancer.Keywords: bone metastasis, pain, prostate cancer, zoledronic acid

Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. Discussion The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.

Journal Article; Research Support, Non-U.S. Gov't; BACKGROUND Advanced heart failure (HF) is associated with high morbidity and mortality; it represents a major burden for the health system. Episodes of acute decompensation requiring frequent and prolonged hospitalizations account for most HF-related expenditure. Inotropic drugs are frequently used during hospitalization, but rarely in out-patients. The LAICA clinical trial aims to evaluate the effectiveness and safety of monthly levosimendan infusion in patients with advanced HF to reduce the incidence of hospital admissions for acute HF decompensation. METHODS The LAICA study is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group trial. It aims to recruit 213 out-patients, randomized to receive either a 24-h infusion of levosimendan at 0.1 μg/kg/min dose, without a loading dose, every 30 days, or placebo. RESULTS The main objective is to assess the incidence of admission for acute HF worsening during 12 months. Secondarily, the trial will assess the effect of intermittent levosimendan on other variables, including the time in days from randomization to first admission for acute HF worsening, mortality and serious adverse events. CONCLUSIONS The LAICA trial results could allow confirmation of the usefulness of intermittent levosimendan infusion in reducing the rate of hospitalization for HF worsening in advanced HF outpatients. Yes