Adherence of nutritional support prescriptions to clinical practice guidelines in patients with anorexia nervosa / Adecuación de la prescripción de soporte nutricional a las guías de práctica clínica en pacientes con anorexia nerviosa

Background: nutritional support (NS) is a core element in the treatment of underweight patients with anorexia nervosa (AN). Objective: to analyze the adherence of NS prescriptions to clinical practice guidelines (CPGs) for AN patients and to compare the effectiveness, safety, and cost of NS according to adherence. Methods: this retrospective observational study included AN patients admitted to an Eating Disorders Unit between January 2006 and December 2009 and followed until December 2014. NS prescriptions were compared with guidelines published by the American Psychiatric Association (APA), the National Institute for Clinical Excellence (NICE), and the Spanish Ministry of Health and Consumption (SMHC). Adherence was defined as percentage of hospitalizations that followed all recommendations. Results: adherence to APA and NICE/SMHC was observed in 10.2% and 73.4%, respectively, of the total of 177 hospitalizations. Body weight and body mass index were higher at admission in the NICE/SMHC adherence versus non-adherence group (p < 0.001). Weight gain rate during hospitalization was higher (p = 0.009) in "APA adherence" (135.5 g/day) versus "non-adherence" (92.1 g/day) group. Hospital stay was significantly shorter (p = 0.025) in "NICE/SMHC adherence" (39.5 days) versus "non-adherence" group (50.0 days). NICE/SMHC adherence was associated with lower costs (p = 0.006). Conclusions: NS prescriptions for anorexic patients more frequently followed NICE/SMHC than APA recommendations. Over the short-term, APA adherence was associated with improved weight gain. Patients adhering to NICE/SMHC recommendations had shorter hospital stay and reduced costs, likely due to their more favorable nutritional status at admission

Introducción: el soporte nutricional (SN) es un elemento clave en el tratamiento de la anorexia nerviosa (AN). Objetivo: analizar la adecuación de las prescripciones de SN en pacientes con AN a las guías de práctica clínica (GPC) y comparar la efectividad, seguridad y coste según la adecuación. Métodos: estudio observacional retrospectivo en pacientes con AN ingresados en una Unidad de Trastornos de Conducta Alimentaria entre enero de 2006 y diciembre de 2009. Se hizo seguimiento hasta diciembre de 2014. Se compararon las prescripciones de SN con las GPC publicadas por la Asociación Americana de Psiquiatría (APA), el Instituto Nacional de Excelencia Clínica (NICE) y el Ministerio Español de Sanidad y Consumo (MSC). Se definió adecuación como porcentaje de ingresos que cumplieron todas las recomendaciones. Resultados: el grado de adecuación a APA y NICE/MSC fue del 10,2% y 73,4%, respectivamente. El peso corporal y el índice de masa corporal al ingreso fueron mayores en el grupo "sí-adecuación" al NICE/MSC versus "no-adecuación" (p < 0,001). La tasa de ganancia ponderal fue superior (p = 0,009) en el grupo "sí-adecuación" a APA (135.5 g/día) versus "no-adecuación" (92,1 g/día). La estancia hospitalaria fue menor (p = 0,025) en "sí-adecuación" al NICE/MSC (39,5 días) versus "no-adecuación" (50,0 días). La adecuación al NICE/MSC fue asociada con menores costes (p = 0,006). Conclusiones: las prescripciones de SN se ajustaron en mayor grado al NICE/MSC que a la APA. La adecuación a APA parece relacionarse con mayor tasa de ganancia ponderal. Los pacientes que se adecuaron al NICE/MSC presentaron menores estancias hospitalarias y costes, probablemente relacionado con su estado nutricional más favorable al ingreso

Adherence of nutritional support prescriptions to clinical practice guidelines in patients with anorexia nervosa.

INTRODUCTION: Background: nutritional support (NS) is a core element in the treatment of underweight patients with anorexia nervosa (AN). Objective: to analyze the adherence of NS prescriptions to clinical practice guidelines (CPGs) for AN patients and to compare the effectiveness, safety, and cost of NS according to adherence. Methods: this retrospective observational study included AN patients admitted to an Eating Disorders Unit between January 2006 and December 2009 and followed until December 2014. NS prescriptions were compared with guidelines published by the American Psychiatric Association (APA), the National Institute for Clinical Excellence (NICE), and the Spanish Ministry of Health and Consumption (SMHC). Adherence was defined as percentage of hospitalizations that followed all recommendations. Results: adherence to APA and NICE/SMHC was observed in 10.2% and 73.4%, respectively, of the total of 177 hospitalizations. Body weight and body mass index were higher at admission in the NICE/SMHC adherence versus non-adherence group (p < 0.001). Weight gain rate during hospitalization was higher (p = 0.009) in "APA adherence" (135.5 g/day) versus "non-adherence" (92.1 g/day) group. Hospital stay was significantly shorter (p = 0.025) in "NICE/SMHC adherence" (39.5 days) versus "non-adherence" group (50.0 days). NICE/SMHC adherence was associated with lower costs (p = 0.006). Conclusions: NS prescriptions for anorexic patients more frequently followed NICE/SMHC than APA recommendations. Over the short-term, APA adherence was associated with improved weight gain. Patients adhering to NICE/SMHC recommendations had shorter hospital stay and reduced costs, likely due to their more favorable nutritional status at admission.

INTRODUCCIÓN: Introducción: el soporte nutricional (SN) es un elemento clave en el tratamiento de la anorexia nerviosa (AN). Objetivo: analizar la adecuación de las prescripciones de SN en pacientes con AN a las guías de práctica clínica (GPC) y comparar la efectividad, seguridad y coste según la adecuación. Métodos: estudio observacional retrospectivo en pacientes con AN ingresados en una Unidad de Trastornos de Conducta Alimentaria entre enero de 2006 y diciembre de 2009. Se hizo seguimiento hasta diciembre de 2014. Se compararon las prescripciones de SN con las GPC publicadas por la Asociación Americana de Psiquiatría (APA), el Instituto Nacional de Excelencia Clínica (NICE) y el Ministerio Español de Sanidad y Consumo (MSC). Se definió adecuación como porcentaje de ingresos que cumplieron todas las recomendaciones. Resultados: el grado de adecuación a APA y NICE/MSC fue del 10,2% y 73,4%, respectivamente. El peso corporal y el índice de masa corporal al ingreso fueron mayores en el grupo "sí-adecuación" al NICE/MSC versus "no-adecuación" (p < 0,001). La tasa de ganancia ponderal fue superior (p = 0,009) en el grupo "sí-adecuación" a APA (135.5 g/día) versus "no-adecuación" (92,1 g/día). La estancia hospitalaria fue menor (p = 0,025) en "sí-adecuación" al NICE/MSC (39,5 días) versus "no-adecuación" (50,0 días). La adecuación al NICE/MSC fue asociada con menores costes (p = 0,006). Conclusiones: las prescripciones de SN se ajustaron en mayor grado al NICE/MSC que a la APA. La adecuación a APA parece relacionarse con mayor tasa de ganancia ponderal. Los pacientes que se adecuaron al NICE/MSC presentaron menores estancias hospitalarias y costes, probablemente relacionado con su estado nutricional más favorable al ingreso.

Adherence of psychopharmacological prescriptions to clinical practice guidelines in patients with eating behavior disorders.

PURPOSE: The purpose of this study was to analyze the adherence of psychopharmacological prescriptions to clinical practice guidelines (CPGs) for patients with eating behavior disorders (EDs) and to compare the effectiveness, safety, and cost of treatment according to adherence. METHODS: This retrospective observational study included ED patients admitted to the eating disorders unit (EDU) of Ciudad Real Hospital (Spain) between January 2006 and December 2009 and followed until December 2014. Psychopharmaceuticals prescribed during EDU stay(s) were compared with guidelines published by American Psychiatric Association (APA), National Institute for Clinical Excellence (NICE), and Spanish Ministry of Health and Consumption (SMHC). Adherence was considered as the percentage of patients whose prescription followed all recommendations. RESULTS: The study included 113 ED patients. Adherence to APA and NICE/SMHC was 30.1% and 45.1%, respectively. Weekly weight gain during hospital stay was higher (p = 0.037) in the APA "adherence" (807.6 g) versus "non-adherence" (544.4 g) group. An association was found between CPG adherence and higher 5-year full recovery rate (p < 0.040). Adherence to NICE/SMHC was associated with lower incidence (p = 0.001) of adverse effects (33.3% in adherence vs. 66.1% in non-adherence group). CPG adherence was associated with lower medication costs (p < 0.020). The age was higher and there was a greater frequency of self-harm behavior and psychiatric comorbidities in the non-adherence than adherence group (p ≤ 0.040). CONCLUSIONS: CPG adherence was low in EDU-admitted patients. Long-term follow-up showed that clinical outcomes were better and medication costs lower in patients with versus without CPG-adherent prescriptions, likely influenced by the apparently greater severity of illness in those with non-CPG-adherent prescriptions.

Impact of pharmaceutical care on cardiovascular risk among older HIV patients on antiretroviral therapy.

Background Advances in the treatment of HIV infection have enabled better control of the disease, allowing patients to enjoy a longer life expectancy. However, the ageing of patients leads to an increased prevalence of cardiovascular disease. Various studies have found that pharmaceutical care results in better control of cardiovascular risk factors. Objective To measure the impact of pharmaceutical care on cardiovascular risk in patients older than 50 years receiving combination antiretroviral therapy. Setting Outpatient pharmacy service of a tertiary hospital, Spain. Methods A pre/post-intervention quasi-experimental clinical study was conducted in which health education and pharmacist interventions to reduce cardiovascular risk factors were carried out in a single patient cohort using the Dader method of pharmacotherapy, with a 12-month follow-up period per patient. Patients included were older than 50 years, with moderate/elevated cardiovascular risk. Data were obtained from patient clinical histories, dispensing records and patient interviews, and were subjected to statistical analysis. Main outcome measure Cardiovascular risk estimated by SCORE and REGICOR equations. Results Forty-two patients completed the study. Of these, 93 % were men, with an average age of 57 years and 15 years since diagnosis of HIV. A reduction was observed in the mean values (baseline vs. 12 months) of the following cardiovascular risk factors: systolic blood pressure (P = 0.009), diastolic blood pressure (P = 0.010), total cholesterol (P = 0.006), low-density lipoprotein cholesterol (LDL-c; P = 0.039), triglycerides (P = 0.010) and total cholesterol/high-density lipoprotein cholesterol (HDL-c; P < 0.001). An increase in HDL-c (P = 0.037) was also observed. The average cardiovascular risk estimated by the SCORE instrument was reduced from 7.6 % at the beginning of the study to 6.4 % after 12 months (P = 0.039). The risk estimate according to REGICOR also decreased (P = 0.002). Over the 12-month period, 6.3 ± 3.4 interventions were carried out per patient. Quantitative ineffectiveness was the most prevalent negative outcome associated with medication throughout the study, and noncompliance was the most frequent cause. Interventions on health education were the most common, followed by interventions on improving adherence. Conclusion Pharmaceutical care, delivered as a combination of health education and pharmacotherapy follow-up to outpatients at a tertiary hospital, had a positive impact on cardiovascular risk in patients older than 50 years receiving combination antiretroviral therapy.

Novedades introducidas por el nuevo Real Decreto legislativo 1090/2015 de ensayos clínicos con medicamentos en España / News introduced by the new Real Legislative Decree 1090/2015 of clinical trials with medicines in Spain

Introducción: La participación de España en ensayos clínicos es una prueba fehaciente de su desarrollo en I+D en el sector salud y de intentar seguir a la vanguardia en cuanto a investigación médica se refiere. El nuevo reglamento del Parlamento Europeo y del Consejo sobre ensayos clínicos de medicamentos de uso humano (Reglamento UE 536/2014, de 16 de abril) deroga la legislación hasta ahora vigente (Directiva 2001/20/CE, de 4 de abril) obligando a modificar el Real Decreto español (RD 223/2004, de 16 de febrero), desarrollando aquellos aspectos que se dejan en mano de la legislación nacional. Objetivo: Analizar las principales modificaciones introducidas por el nuevo RD en investigación clínica (RD 1090/2015, de 4 de diciembre) que regula los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos (CEIm) y el Registro español de ensayos clínicos y compararlas respecto a la normativa anterior. Material y Métodos: Se revisaron los RD 1090/2015, de 4 de diciembre y 223/2004, de 16 de febrero y se compararon las diferencias más destacables entre ambas normativas. Resultados: El nuevo desarrollo normativo introduce novedades importantes. Se abre la opción para la unificación del análisis de las solicitudes, de manera que junto con la autorización del ensayo clínico emitida por la AEMPS, únicamente haga falta que un CEIm acreditado emita su dictamen positivo que será vinculante. Regula nuevas definiciones, como la de ensayo clínico de bajo nivel de intervención, sujeto a normas menos rigurosas. Diferencia entre Comité de ética de la investigación (CEI) y CEIm, estableciendo los requisitos adicionales para pasar de ser CEI a CEIm. Define investigación clínica sin ánimo comercial (en la que el promotor es una universidad, hospital, organización científica pública, organización sin ánimo de lucro, organización de pacientes o investigador individual sin participación de la industria farmacéutica). Abre la opción de contratar un ensayo clínico previamente a su autorización. Define las indemnizaciones por daños y cómo se lleva a cabo la evaluación de los ensayos clínicos. Incorpora la figura del representante legalmente designado para sujetos incapaces y menores. Estipula las condiciones en situaciones de urgencia, embarazadas y periodos de lactancia así como del consentimiento informado. La principal novedad es el expediente único del ensayo clínico con dos partes, una de documentación para la Unión Europea (parte I) y otra de documentación nacional (parte II). Todos los datos tienen que ser enviados a una base de datos y un portal web de la Unión Europea de acceso público. Conclusiones: La nueva normativa propone dar un importante impulso a la investigación clínica en España con medicamentos, simplificando las trabas administrativas y agilizando la realización de estudios multicéntricos simultáneos en toda Europa. Mejora la delimitación de responsabilidades de los agentes que participan, aumenta la seguridad de los sujetos del ensayo, y a la vez, incrementa la eficiencia en los procesos de evaluación y comunicación implicados

Introduction: The participation of Spain in clinical trials is a reliable proof of its development in I+D in the health sector and of trying to follow at the vanguard of medical research. The new Regulation of the European Parliament and of the Council on Clinical Trials on medicines for human use (EU Regulation 536/2014, 16th April) derogates the legislation currently in force (Directive 2001/20/EC, 4th April) and it obliges to modify the Spanish Royal Decree (RD 223/2004, 16th February) to develop those aspects that are left in the hands of national legislation. Objetives: To analyze the main changes introduced by the new RD in clinical research (RD 1090/2015, 4th December), which regulates clinical trials with medicines, the Committees on Ethics of Research with Medicines (CERm) and the Spanish Registry of Clinical Trials and to compare them with the previous legislation. Material and methods: RD 1090/2015, 4th December was analyzed against RD 223/2004, 16th February, and the most important differences between the two regulations were compared. Results: The new regulatory development introduces important innovations. It opens the option for the unification of the analysis of the applications, so that, together with the authorization of the clinical trial issued by the SAMHP, it is only necessary that an accredited CERm emits its positive opinion that it will be binding. It regulates new definitions, such as the low-level clinical trial, subject to less stringent standards. It differentiates between Research Ethics Committee (REC) and CERm, establishing additional requirements to move from being REC to CERm. It defines non-commercial clinical research (in which the sponsor is a university, hospital, public scientific organization, non-profit organization, patient organization or individual researcher without involvement of the pharmaceutical industry). It opens the option to contract a clinical trial prior to its authorization. It defines compensation for damages and how the evaluation of clinical trials is conducted. It incorporates the figure of the legally designated representative for incapable and minor subjects. It stipulates the conditions in situations of urgency, pregnant and periods of lactation as well as informed consent. The main novelty is the single dossier of the two-part clinical trial, one for European Union (Part I) and another one for National Documentation (Part II). All data must be sent to a database and a European public access web portal. Conclusions: The new regulation proposes to give an important impulse to the clinical research in Spain with medicines, simplifying the administrative obstacles and speeding up the realization of multicentric studies simultaneously in all Europe. It improves the delimitation of the responsibilities of the agents involved, it increases the safety of the test subjects, and at the same time, it increases the efficiency in the evaluation and communication processes involved

Persistence profile to nucleos(t)ide analogue treatment for patients with chronic hepatitis B.

BACKGROUND: There are currently five approved nucleos(t)ide analogues (NUCs) for the management of chronic hepatitis B (CHB): lamivudine, adefovir dipivoxil, telbivudine, entecavir, and tenofovir disoproxil fumarate. OBJECTIVE: To determine the persistence rates among patients receiving NUCs for CHB at weeks 48, 96 and 144, compare them in these periods, and analyse the evolution of treatment persistence. METHODS: We conducted a retrospective study that included patients with CHB who initiated antiviral therapy and were attended to by the pharmaceutical care office between January 2002 and December 2011. Patients included in a clinical trial or patients who did not collect their medication personally were excluded. There were two different analyses: a comparative analysis of the persistence rates in three periods (weeks 1-48, weeks 48-96, and weeks 96-144); and a Kaplan-Meier analysis to evaluate the evolution of persistence. RESULTS: A total of 102 patients were included. Persistence rates were different in the three periods. They decreased during the course of the different periods, and the decline was more rapid between the first and second period. There were statistically significant differences in the non-persistence of the five drugs (p<0.005). Entecavir had the best profile of persistence, followed by tenofovir. CONCLUSIONS: This study showed that high genetic barrier drugs had a better profile of persistence in the initial treatment of patients with CHB. Data seem to suggest entecavir may offer better persistence rates than tenofovir, and the persistence rates for all five medications dropped in weeks 48-96.

The use of adalimumab, etanercept, golimumab and infliximab in rheumatic pathologies: variation between label dosage and real-world use.

Rheumatoid arthritis (AR), psoriatic arthritis (PSA) and ankylosing spondylitis (AS) are autoimmune systemic diseases characterized by inflammation, pain and joint degeneration. The objective of this study is to evaluate, under the actual conditions of use, dosing patterns of adalimumab, etanercept, golimumab and infliximab in these pathologies, and compare them with the label regimens recommended, as well as evaluating the financial implications of these regimen modifications. The study population included all adult patients diagnosed with RA, PSA or AS who had been treated with adalimumab, etanercept, golimumab and infliximab for at least 6 months between 1 January 2011 and 31 December 2013. The main variable of this study was to assess the dose dispensed for drugs administered subcutaneously and the dose prepared/administered for drugs administered intravenously, and the annual costs of the treatment. A total of 5,428 episodes were included. The mean weekly dose was lower than the standard dose in the three pathologies studied in the patients treated with adalimumab and etanercept (84.3% vs 81.2% for RA, 85.0% vs 78.0% for PSA and 87.8% vs 81.6% for AS). The drugs with highest dose optimization in RA are etanercept (46.3%) followed by adalimumab (46%); however, the highest percentage of patients with major dose optimization corresponds to etanercept (11.6%). Both in the PA and the AS group, we also observed that etanercept is the drug more optimized, corresponding to 53.9 and 43% of patients, respectively. By contrast, 48.5% of patients with RA treated with infliximab required dose intensification; however, infliximab dose intensification in PSA and AS is not so pronounced. The practice of optimization of dose regimens in patients with rheumatic diseases under treatment with anti-TNFα is spreading among professionals, resulting in annual cost reduction in the treatment of rheumatic arthropathies. However, long term follow-up will be necessary to assess the influence of this optimization on health outcomes.