Preference for Easyhaler® Over Previous Dry Powder Inhalers in Asthma Patients: Results of the DPI PREFER Observational Study.

OBJECTIVE: To study patient preference for and satisfaction with the Easyhaler® device and to assess ease of training and use of the inhaler in patients previously treated with a variety of dry powder inhalers (DPIs). METHODS: We designed a non-interventional, cross-sectional, single-visit observational study of adult patients with persistent asthma referred to specialized care who had previously been treated with DPI inhalers for at least 3 months. Once clinical baseline data had been checked, patients filled in questionnaires on asthma control (GINA 2019), Feeling of Satisfaction with the Inhaler (FSI-10), and adherence (TAI and Morisky-Green questionnaires). Thereafter, all patients were trained in the use of Easyhaler. We assessed ease of use and satisfaction (FSI-10) with Easyhaler, as well as inhaler device preferences. RESULTS: We recruited 502 patients (mean age, 50.2 ± 16.2 y; 63.1% female), of whom 485 were evaluable. In response to the main objective of the study, we compared the values of the self-completed adapted FSI-10, to measure satisfaction with the inhaler. A significantly higher score in each item of the questionnaire was recorded for Easyhaler. Overall, 38% of patients showed exclusive preference for Easyhaler (compared with 15% for the previous device) or were evenly matched in 46% of cases. CONCLUSION: In the present study, Easyhaler achieved better patient ratings in terms of preference and satisfaction than previously used DPI devices. In order to improve asthma adherence strategies, patient preferences and device choice should be taken into account.

Análisis económico del tratamiento ambulatorio intermitente con levosimendán de la insuficiencia cardiaca avanzada en España / Economic analysis of intermittent intravenous outpatient treatment with levosimendan in advanced heart failure in Spain

INTRODUCCIÓN Y OBJETIVOS: La insuficiencia cardiaca (IC) avanzada conlleva altas tasas de hospitalización y mortalidad. El estudio LION-HEART fue un ensayo clínico aleatorizado y controlado con placebo que evaluó la eficacia y la seguridad de la administración intravenosa de dosis intermitentes de levosimendán en pacientes ambulatorios con IC avanzada. El objetivo del presente estudio es realizar un análisis de costes para determinar si la menor tasa de hospitalizaciones por IC observada en pacientes tratados con levosimendán en el estudio LION-HEART puede generar ahorros para el Sistema Nacional de Salud, en comparación con la opción de no tratar a los pacientes con IC avanzada. MÉTODOS: Se realizó un modelo económico que incluyó las tasas de hospitalización por IC del estudio LION-HEART y los costes de hospitalización por IC y de adquisición y administración intravenosa de levosimendán. El horizonte temporal del análisis fue de 12 meses. Se realizaron 2 análisis, uno determinístico y otro probabilístico (simulación de Monte Carlo de segundo orden). RESULTADOS: Según el análisis determinístico, el ahorro total por cada paciente tratado con levosimendán ascendería a -698,48 euros. En el análisis probabilístico, el ahorro por paciente tratado con levosimendán sería de -849,94 (IC95%, 133,12 a -2.255,31) euros. La probabilidad de que se produzcan ahorros con levosimendán en comparación con la opción de no tratar sería del 94,8%. CONCLUSIONES: El tratamiento ambulatorio intermitente con levosimendán puede generar ahorros para el Sistema Nacional de Salud, en comparación con la opción de no tratar a los pacientes con IC avanzada

INTRODUCTION AND OBJECTIVES: Advanced heart failure (HF) leads to high hospitalization and mortality rates. The LION-HEART study was a randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of intravenous administration of intermittent doses of levosimendan in outpatients with advanced HF. The aim of the present study was to perform a cost analysis to determine whether the lower rate of hospitalizations for HF, observed in patients treated with levosimendan in the LION-HEART study, can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF. METHODS: An economic model was used that included IC hospitalization rates from the LION-HEART study, the costs of hospitalization due to HF and those of the acquisition and intravenous administration of levosimendan. The time horizon of the analysis was 12 months. Two analyses were carried out, one deterministic and the other probabilistic (second-order Monte Carlo simulation). RESULTS: In the deterministic analysis, the total saving for each patient treated with levosimendan would amount to−€698.48. In the probabilistic analysis, the saving per patient treated with levosimendan would be−€849.94 (95%CI, €133.12 to−€2,255.31). The probability of savings with levosimendan compared with the no treatment option would be 94.8%. CONCLUSIONS: Intermittent ambulatory treatment with levosimendan can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF

Recursos asistenciales en atención primaria para manejo del asma: proyecto Asmabarómetro / Healthcare resources for asthma management at primary care level: Asthmabarometer Project

OBJETIVO: Describir la situación actual con respecto a la dotación de recursos básicos para el manejo del asma en los centros de atención primaria (AP). DISEÑO: Estudio transversal, encuesta cuantitativa ad hoc. EMPLAZAMIENTO Y PARTICIPANTES: trescientos ochenta médicos de AP en España. INTERVENCIONES Y MEDICIONES PRINCIPALES: Análisis de las percepciones de manejo y uso de recursos materiales, humanos y organizativos básicos de los que deberían estar dotados los centros de AP para garantizar una correcta asistencia clínica a los pacientes con asma. RESULTADOS: Los encuestados afirman no disponer de profesional médico o de enfermería referente en enfermedad respiratoria en su centro, en un 64% y un 62% respectivamente. El 92% dispone de espirómetro, el 70% de medidor de pico flujo y el 93% de dispositivos inhaladores placebo. Han recibido en el último año formación teórico-práctica específica promovida por el centro (46%) y por terceros (83%). Se dispone de material educativo para pacientes (78%). No existe protocolo asistencial específico (36%). El 43% no dispone de protocolo de derivación. Se utiliza entrevista clínica para el seguimiento del paciente (90%), pero no cuestionarios validados para medir la adherencia terapéutica (85%), ni checklist para verificar la técnica de inhalación (83%). Se observan diferencias en variables relevantes en el análisis por comunidades autónomas (CC. AA.). CONCLUSIONES: El acceso a determinados recursos en la atención al paciente con asma es limitado en aspectos de coordinación entre niveles, variable según CC. AA. y mejorable en la mayoría de los recursos de salud en asma

OBJECTIVE: The objective of this study was to describe the current provision of basic resources for asthma management in Primary Health Care (PHC). DESIGN: Cross-sectional study, with an ad hoc quantitative survey. LOCATION AND PARTICIPANTS: A total of 380 primary healthcare physicians in Spain. INTERVENTIONS AND MAIN MEASUREMENTS: Analysis of perceptions of management and use of basic human, organisational and material resources to ensure appropriate care provision to asthma patients. RESULTS: Survey respondents stated that their centre did not have a consultant doctor (64%) or nurse (62%) in respiratory disease. Almost all (92%) of the centres have spirometers, of which 70% have peak flow meters, and 93% have placebo inhalers. In the last year, respondents have received specific theoretical/practical training from the centre (46%), and by third parties (83%). More than three-quarters (78%) of the centres has educational material available for patients. There is no specific healthcare protocol in 36% of the centres, and 43% had no referral protocol. A clinical interview is conducted to monitor the patient (90%), but there are no validated questionnaires to measure therapeutic adherence (85%), or a checklist to check inhalation technique (83%). Differences are observed in the relevant variables in the analysis of each Spanish Autonomous Community. CONCLUSIONS: Access to certain resources in the care of patients with asthma is limited in aspects of coordination between levels, varied according to Spanish Autonomous Community, and improved in most health resources in Asthma

Economic analysis of intermittent intravenous outpatient treatment with levosimendan in advanced heart failure in Spain.

INTRODUCTION AND OBJECTIVES: Advanced heart failure (HF) leads to high hospitalization and mortality rates. The LION-HEART study was a randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of intravenous administration of intermittent doses of levosimendan in outpatients with advanced HF. The aim of the present study was to perform a cost analysis to determine whether the lower rate of hospitalizations for HF, observed in patients treated with levosimendan in the LION-HEART study, can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF. METHODS: An economic model was used that included IC hospitalization rates from the LION-HEART study, the costs of hospitalization due to HF and those of the acquisition and intravenous administration of levosimendan. The time horizon of the analysis was 12 months. Two analyses were carried out, one deterministic and the other probabilistic (second-order Monte Carlo simulation). RESULTS: In the deterministic analysis, the total saving for each patient treated with levosimendan would amount to-€698.48. In the probabilistic analysis, the saving per patient treated with levosimendan would be-€849.94 (95%CI, €133.12 to-€2,255.31). The probability of savings with levosimendan compared with the no treatment option would be 94.8%. CONCLUSIONS: Intermittent ambulatory treatment with levosimendan can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF.

[Healthcare resources for asthma management at primary care level: Asthmabarometer Project]. / Recursos asistenciales en atención primaria para manejo del asma: proyecto Asmabarómetro.

OBJECTIVE: The objective of this study was to describe the current provision of basic resources for asthma management in Primary Health Care (PHC). DESIGN: Cross-sectional study, with an ad hoc quantitative survey. LOCATION AND PARTICIPANTS: A total of 380 primary healthcare physicians in Spain. INTERVENTIONS AND MAIN MEASUREMENTS: Analysis of perceptions of management and use of basic human, organisational and material resources to ensure appropriate care provision to asthma patients. RESULTS: Survey respondents stated that their centre did not have a consultant doctor (64%) or nurse (62%) in respiratory disease. Almost all (92%) of the centres have spirometers, of which 70% have peak flow meters, and 93% have placebo inhalers. In the last year, respondents have received specific theoretical/practical training from the centre (46%), and by third parties (83%). More than three-quarters (78%) of the centres has educational material available for patients. There is no specific healthcare protocol in 36% of the centres, and 43% had no referral protocol. A clinical interview is conducted to monitor the patient (90%), but there are no validated questionnaires to measure therapeutic adherence (85%), or a checklist to check inhalation technique (83%). Differences are observed in the relevant variables in the analysis of each Spanish Autonomous Community. CONCLUSIONS: Access to certain resources in the care of patients with asthma is limited in aspects of coordination between levels, varied according to Spanish Autonomous Community, and improved in most health resources in Asthma.

Programa de intervención mixta sobre el cumplimiento y calidad de vida en pacientes hipertensos / Mixed intervention programme on compliance and quality of life in hypertensive patients

El 70% de los pacientes en tratamiento antihipertensivo no controla adecuadamente sus cifras tensionales. El objetivo del estudio es comparar el impacto de diferentes intervenciones de formación de pacientes hipertensos esenciales, respecto a un grupo control sin intervención, sobre el cumplimiento terapéutico autorreferido, la presión arterial, el peso y la calidad de vida. Ensayo clínico aleatorizado multicéntrico, con tres ramas de intervención (intervención educativa, información escrita y control) incluyendo 520 pacientes hipertensos esenciales. Las variables de estudio fueron: TA, peso, cumplimiento fármacodietético, grado de conocimiento sobre la enfermedad y calidad de vida. Completaron el estudio 428 pacientes. Analizando los resultados, los pacientes del grupo de intervención tuvieron un descenso de la PAS/PAD superior al resto de los grupos. Así mismo, se aprecia un elevado nivel de cumplimiento farmacológico, menor cumplimiento higiénico dietético y mayor nivel de conocimientos en pacientes de centros hospitalarios. La mayoría de los pacientes, mostraron niveles muy altos de satisfacción hacia personal sanitario en los diferentes aspectos analizados (AU)

70% of patients on treatment for hypertension do not control their blood pressure levels adequately. The aim of the study is to compare the impact of different training interventions for essential hypertensive patients, compared to a control group with no intervention, on self-referred therapeutic compliance, blood pressure, weight and quality of life. Multi-centre randomized clinical trail with three branches of intervention (educational intervention, written information and check-up) including 520 essential hypertensive patients. The variables in the study were BP, weight, medication and diet compliance, level of knowledge of the illness and quality of life. 428 patients completed the study. Analysing the results, patients in the group with intervention had a higher reduction in systolic/diastolic BP than the other groups. The results also showed a high level of medication compliance, lower health and diet compliance, and greater knowledge in patients in hospitals. Most of the patients showed very high levels of satisfaction towards healthcare staff in the different aspects analysed (AU)

Eficacia de un programa de intervención sobre el control del peso en pacientes obesos hipertensos / Efficacy of a weight control intervention programme in obese hypertensive patients

La obesidad supone un importante riesgo añadido en la población de pacientes hipertensos, por su prevalencia y por su agregación a otros factores de riesgo. Nuestro objetivo fue cuantificar las diferencias en la reducción de peso de dos tipos de intervención educacional conducidos por enfermería: intensiva frente a información escrita. Para ello se diseñó un estudio clínico prospectivo, comparativo entre dos ramas de intervención no farmacológica, en la que se realizan dos tipos distintos de intervenciones que se asignarán de forma aleatoria por el investigador: 1) programa de intervención intensiva de 6 meses de duración con 6 visitas educativas individuales basado en el programa "FORMA" (grupo intervención) y 2) Aporte de información verbal y material escrito, en una única ocasión, para recomendar la pérdida de peso, sin que se realicen visitas de seguimiento, hasta los 6meses (grupo control).Se reclutaron pacientes, hipertensos esenciales, obesos, no diabéticos y sin complicaciones cardiovasculares, atendidos de forma consecutiva y que cumplían los criterios de selección: edad 18-70 años, IMC: 28-40 kg/m2. Completaron el estudio 145 pacientes (53.7±12 años de edad, 58.8% mujeres), reclutados en 16 centros. El programa de intervención intensiva indujo una reducción promedio de peso significativa frente al grupo 2 (3.7± 3.4 vs. 0.66± 2.9 kg, p=0.001). Los factores que influían significativamente en la reducción, según un modelo de regresión lineal múltiple, fueron el sexo (mayor en los hombres) y el centro. Los niveles de presión al inicio (146±17/88±13mmHg) eran similares en ambos grupos, siendo la reducción de presión mayor en el grupo de intervención intensiva, sin alcanzar la significación (9.0±19.5 vs4.5±12.9 mmHg), aunque en los hombres, la diferencia si fue significativa (15.1±19.3 vs. 6.48±11.4mmHg)...(AU)

Obesity is an important added risk factor in the population of hypertensive patients, because of its prevalence and its aggregation to other risk factors. Our aim was to quantify the differences in weight loss of two types of nursing-led educational intervention: intensive compared to written information. For this purpose a prospective clinical study was designed comparing two branches of non-pharmacological intervention, in which two different types of intervention were conducted, which were assigned at random by the researcher: 1) 6-month intensive intervention programme with 6 individual educational visits, based on the “FITNESS” programme (intervention group) and 2) Distribution of verbal information and written material, on a single occasion, to recommend losing weight, but without any follow-up visits until 6 months later (control group).Essential hypertensive, obese non-diabetic patients without cardiovascular complications were recruited and were attended consecutively, in line with the following selection criteria: age 18-70, BMI: 28-40kg/m2. A total of 145 patients completed the study (aged 53.7±12 years, 58.8% women), recruited in16 centres. The intensive intervention programmeled to significant average weight loss compared to group 2 (3.7± 3.4 v. 0.66± 2.9 kg, p=0.001). The factors that had a significant influence on the weight loss, according to a multiple linear regression model, were sex (greater in men) and the centre. Blood pressure levels at the start (146±17/88±13mmHg) were similar in both groups, with the biggest reduction in blood pressure occurring in the intensive intervention group, without achieving a significant level(9.0±19.5 v 4.5±12.9 mmHg), although in men the difference was significant (15.1±19.3 v. 6.48±11.4mmHg). In the multivariant model, the fall in blood pressure depended on the weight loss obtained, the sex and the centre...(AU)

¿Cuántas determinaciones de presión arterial son necesarias en consulta para una evaluación adecuada del control de presión arterial? / How many blood pressure measurement are necessary in a consultation to adequately evaluate the control of blood pressure?

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