Determinants of Informal Care, Burden, and Risk of Burnout in Caregivers of Stroke Survivors: The CONOCES Study.

BACKGROUND AND PURPOSE: The aim of this article was to analyze the likelihood of receiving informal care after a stroke and to study the burden and risk of burnout of primary caregivers in Spain. METHODS: The CONOCES study is an epidemiological, observational, prospective, multicenter study of patients diagnosed with stroke and admitted to a Stroke Unit in the Spanish healthcare system. At 3 and 12 months post-event, we estimated the time spent caring for the patient and the burden borne by primary caregivers. Several multivariate models were applied to estimate the likelihood of receiving informal caregiving, the burden, and the likelihood of caregivers being at a high risk of burnout. RESULTS: Eighty percent of those still alive at 3 and 12 months poststroke were receiving informal care. More than 40% of those receiving care needed a secondary caregiver at 3 months poststroke. The likelihood of receiving informal care was associated with stroke severity and the individual's health-related quality of life. When informal care was provided, both the burden borne by caregivers and the likelihood of caregivers being at a high risk of burnout was associated with (1) caregiving hours; (2) the patient's health-related quality of life; (3) the severity of the stroke measured at discharge; (4) the patient having atrial fibrillation; and (5) the degree of dependence. CONCLUSIONS: This study reveals the heavy burden borne by the caregivers of stroke survivors. Our analysis also identifies explanatory and predictive variables for the likelihood of receiving informal care, caregiver burden, and high risk of burnout.

Economic impact of patients admitted to stroke units in Spain.

OBJECTIVES: Stroke is a major social and health problem. However, since the recent incorporation of new advances in its management, little is known about the cost of stroke. The aim of this study is to find out the real cost of stroke in Spain. METHODS: This is an epidemiological, observational, prospective, multicenter study of patients diagnosed with stroke and admitted to a stroke unit. Patients were recruited from 16 hospitals throughout Spain and followed up for 1 year. Sociodemographic, clinical, and economic data were collected. Costs (€ 2012) were estimated from the social perspective and were divided into direct healthcare (inpatient, outpatient, and medication), direct non-healthcare (mainly formal and informal care) and labor productivity losses. RESULTS: A total of 321 patients were included. Mean age was 72.1 years and 176 patients (54.8 %) were male. Total average cost per patient/year was €27,711. Direct healthcare costs amounted to €8491 per patient/year (68.8 % due to inpatient costs) and non-healthcare costs to an average of €18,643 per patient/year (89.5 % due to informal care). Productivity loss costs per patient/year were €276. Total costs of hemorrhagic strokes were slightly higher than ischemic (€28,895 vs. €27,569 per patient/year, p = 0.550) without significant differences. The main variables associated with higher costs were the presence of hypertension (€30,332 vs. €23,234 per patient/year, p < 0.05) and the severity of stroke (p < 0.05), both independently associated after a multivariate analysis. CONCLUSIONS: The cost of patients admitted to stroke units in Spain is €27,711 per patient/year. More than two-thirds are social costs, mainly informal care. Stroke remains a major burden on health systems and society, so additional efforts are needed for its prevention.

UK-specific cost-effectiveness of tiotropium + olodaterol fixed-dose combination versus other LAMA + LABA combinations in patients with COPD.

OBJECTIVE: The aim of this study is to assess the cost-effectiveness of other long-acting muscarinic antagonist + long-acting ß2 agonist combinations in comparison with Spiolto® Respimat® (tiotropium + olodaterol fixed-dose combination [FDC]) for maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. METHODS: A previously published individual-level Markov model was adapted for the perspective of the UK health care system, in line with recommendations from the National Institute for Health and Care Excellence. Individuals progressed through the model based on their forced expiratory volume in 1 second (FEV1) value at baseline and the post-improvement FEV1 value. Changes in FEV1 were taken from a mixed treatment comparison. Costs were obtained from a published cost-utility analysis of tiotropium in the treatment of chronic obstructive pulmonary disease in the UK. Uncertainty was assessed by deterministic and probabilistic sensitivity analysis. RESULTS: Duaklir® Genuair® (aclidinium bromide + formoterol fumarate FDC) and the free-dose combination of tiotropium + salmeterol were dominated by tiotropium + olodaterol FDC. The quality-adjusted life years and costs were identical for Ultibro® Breezhaler® (indacaterol + glycopyrronium FDC) and Anoro™ Ellipta® (umeclidinium + vilanterol FDC) compared with tiotropium + olodaterol FDC, resulting in identical incremental cost-effectiveness ratios. CONCLUSION: This analysis shows tiotropium + olodaterol FDC to be a cost-effective option for the maintenance treatment of adults with chronic obstructive pulmonary disease in the UK.

Outcomes measured by mortality rates, quality of life and degree of autonomy in the first year in stroke units in Spain.

INTRODUCTION: The primary objective of this sub analysis of the CONOCES study was to analyse outcomes in terms of mortality rates, quality of life and degree of autonomy over the first year in patients admitted to stroke units in Spain. The secondary objective was to identify the factors determining good prognosis. METHODS: We studied a sample of patients who had suffered a confirmed stroke and been admitted to a Stroke Unit in the Spanish healthcare system. Socio-demographic and clinical variables and variables related to the level of severity (NIHSS), the level of autonomy (Barthel, modified Rankin) and quality of life (EQ-5D) were recorded at the time of admission and then three months and one year after the event. Factors determining prognosis were analysed using logistic regression and ROC curves. RESULTS: A total of 321 patients were recruited, 33% of whom received thrombolytic treatment, which was associated with better results on the Barthel and the modified Rankin scales and in terms of the risk of death. Mean quality of life measured through EQ-5D improved from 0.57 at discharge to 0.65 one year later. Full autonomy level measured by Barthel index increased from 30.1% at discharge to 52.8% at one year and by the modified Rankin scale from 51% to 71%. The rates for in-hospital and 1-year mortality were 5.9% and 17.4% respectively. Low NIHSS scores were associated with a good prognosis with all the outcome variables. The three instruments applied (NIHSS, Barthel and modified Rankin scales) on admission showed good discriminative ability for patient prognosis in the ROC curves. CONCLUSIONS: There has been a change in the prognosis for stroke in Spain in recent years as the quality of life at 1 year observed in our study is clearly higher than that obtained in other Spanish studies conducted previously. Moreover, survival and functional outcome have also improved following the introduction of a new model of care. These results clearly promote extension of the model based on stroke units and reinforced rehabilitation to the majority of the more than 100,000 strokes that occur annually in Spain.

Atrial Fibrillation and Cardiovascular Comorbidities, Survival and Mortality: A Real-Life Observational Study.

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac tachyarrhythmia encountered in clinical practice affecting up to 10% of the population over 60 years old and its prevalence rises with age. The main goals were to characterize the AF patient population after the initial diagnosis of AF and to determine overall survival. METHODS: It is a real-life observational study of 269 subjects with an AF diagnosis over 60 years old randomly selected. The collected variables were: sociodemographic, cardiovascular complications/comorbidities (CVCs) included in the CHA2DS2-VASc and HAS_BLED scores, drug assigned as clinical treatment, mean range INR and CVCs and death dates (all-cause mortality). The survival curve and the risk of death were assessed using Kaplan-Meier survival curve and comparisons with log-rank. RESULTS: The average following time was 6.2 ± 3.7 years (0.2-20.4). Eleven point five percent died. Sixty-five point four percent had some CVCs. There were no differences in the overall incidence of CVCs by gender. The survival probability was 0.86 ± DE 0.03 among men and 0.90 ± DE 0.04 among women without differences. Thirty-six point eight percent (95% CI: 30.8 - 42.7) were diagnosed vascular complications before AF diagnosis, being ischemic cardiopathy (24.2%) and ischemic stroke (23.2%) the most frequent. The mortality is higher (P < 0.036) among those who suffered ≥ 3 vascular complications and significantly lower among those treated with statins (P = 0.032). After AF diagnosis, the most frequent was the cardiac heart failure (46.7%), significantly higher among women (P = 0.037). The mortality is significantly lower in those treated with OAC (P = 0.003). CONCLUSIONS: AF is associated with ischemic heart disease, ischemic stroke and congestive heart failure, but the average mortality age is not different from the global population in Spain and Catalonia.

Prevalencia de la fibrilación auricular desconocida y la no tratada con anticoagulantes. Estudio AFABE / Prevalence of undiagnosed atrial fibrillation and of that not being treated with anticoagulant drugs: the AFABE study

Introducción y objetivos. La fibrilación auricular significa un grave problema de salud pública por sus complicaciones, por lo que su manejo debería incluir no sólo su tratamiento, sino también la prevención de las complicaciones tromboembólicas. El objetivo principal es conocer las proporciones de la fibrilación auricular desconocida y la no tratada con anticoagulantes. Métodos. Estudio observacional, transversal, retrospectivo, de base poblacional y multicéntrico. Se seleccionó aleatoriamente a 1.043 sujetos mayores de 60 años para realizarles un electrocardiograma en visita concertada. Se registraron variables sociodemográficas, valores en las escalas CHA2DS2-VASc y HAS-BLED, razón internacional normalizada y motivos de no recibir tratamiento anticoagulante oral. Resultados. La prevalencia total de fibrilación auricular fue del 10,9% (intervalo de confianza del 95%, 9,1-12,8%), de la que el 20,1% era desconocida. De la fibrilación auricular conocida, el 23,5% con un valor de CHA2DS2-VASc ≥ 2 no recibía tratamiento anticoagulante y el 47,9% tenía un valor HAS-BLED ≥ 3. La odds ratio de no recibir tratamiento anticoagulante fue 2,04 (intervalo de confianza del 95%, 1,11-3,77) para las mujeres, 1,10 (intervalo de confianza del 95%, 1,05-1,15) para la mayor edad de diagnóstico y 8,61 (intervalo de confianza del 95%, 2,38-31,0) si el valor de CHA2DS2-VASc es < 2. El deterioro cognitivo (15,2%) fue el motivo principal de no recibir tratamiento anticoagulante. Conclusiones. El 20,1% de las fibrilaciones auriculares de pacientes mayores de 60 años son desconocidas previamente y no se trata con anticoagulantes al 23,5% del total (AU)

Introduction and objectives. Atrial fibrillation constitutes a serious public health problem because it can lead to complications. Thus, the management of this arrhythmia must include not only its treatment, but antithrombotic therapy as well. The main goal is to determine the proportion of cases of undiagnosed atrial fibrillation and the proportion of patients not being treated with oral anticoagulants. Methods. A multicenter, population-based, retrospective, cross-sectional, observational study. In all, 1043 participants over 60 years of age were randomly selected to undergo an electrocardiogram in a prearranged appointment. Demographic data, CHA2DS2-VASc and HAS-BLED scores, international normalized ratio results, and reasons for not receiving oral anticoagulant therapy were recorded. Results. The overall prevalence of atrial fibrillation was 10.9% (95% confidence interval, 9.1%-12.8%), 20.1% of which had not been diagnosed previously. In the group with known atrial fibrillation, 23.5% of those with CHA2DS2-VASc≥2 were not receiving oral anticoagulant therapy, and 47.9% had a HAS-BLED score≥3. The odds ratio for not being treated with oral anticoagulation was 2.04 (95% confidence interval, 1.11-3.77) for women, 1.10 (95% confidence interval, 1.05-1.15) for more advanced age at diagnosis, and 8.61 (95% confidence interval 2.38-31.0) for a CHA2DS2-VASc score<2. Cognitive impairment (15.2%) was the main reason for not receiving oral anticoagulant therapy. Conclusions. The prevalence of previously undiagnosed atrial fibrillation in individuals over 60 years of age is 20.1%, and 23.5% of those who have been diagnosed receive no treatment with oral anticoagulants (AU)

Sobre el coste-efectividad de dabigatrán. Respuesta / On the Cost-effectiveness of Dabigatran. Response

No disponible

Prevalence of undiagnosed atrial fibrillation and of that not being treated with anticoagulant drugs: the AFABE study.

INTRODUCTION AND OBJECTIVES: Atrial fibrillation constitutes a serious public health problem because it can lead to complications. Thus, the management of this arrhythmia must include not only its treatment, but antithrombotic therapy as well. The main goal is to determine the proportion of cases of undiagnosed atrial fibrillation and the proportion of patients not being treated with oral anticoagulants. METHODS: A multicenter, population-based, retrospective, cross-sectional, observational study. In all, 1043 participants over 60 years of age were randomly selected to undergo an electrocardiogram in a prearranged appointment. Demographic data, CHA2DS2-VASc and HAS-BLED scores, international normalized ratio results, and reasons for not receiving oral anticoagulant therapy were recorded. RESULTS: The overall prevalence of atrial fibrillation was 10.9% (95% confidence interval, 9.1%-12.8%), 20.1% of which had not been diagnosed previously. In the group with known atrial fibrillation, 23.5% of those with CHA2DS2-VASc≥2 were not receiving oral anticoagulant therapy, and 47.9% had a HAS-BLED score≥3. The odds ratio for not being treated with oral anticoagulation was 2.04 (95% confidence interval, 1.11-3.77) for women, 1.10 (95% confidence interval, 1.05-1.15) for more advanced age at diagnosis, and 8.61 (95% confidence interval 2.38-31.0) for a CHA2DS2-VASc score<2. Cognitive impairment (15.2%) was the main reason for not receiving oral anticoagulant therapy. CONCLUSIONS: The prevalence of previously undiagnosed atrial fibrillation in individuals over 60 years of age is 20.1%, and 23.5% of those who have been diagnosed receive no treatment with oral anticoagulants.

Validación de la versión traducida del Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Su utilidad y la del FEV1/FEV6 para el diagnóstico de enfermedad pulmonar obstructiva crónica / Validation of the Spanish version of the Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Its usefulness and that of FEV 1/FEV6 for the diagnosis of COPD

Fundamento y objectivos. La enfermedad pulmonar obstructiva crónica (EPOC) es una patología de elevado infradiagnóstico. La utilización de cuestionarios breves diseñados para detectar casos de posible obstrucción crónica al flujo aéreo puede ayudar en el diagnóstico temprano de la EPOC. Paciente y método. Estudio epidemiológico observacional y transversal de validación de la versión traducida y adaptada del cuestionario Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Se recogieron datos sociodemográficos y clínicos, así como las respuestas a los cuestionarios COPD-PS y EQ-5D y el parámetro volumen espiratorio forzado en el primer segundo/volumen espiratorio forzado en 6 segundos (FEV1/FEV6) medido mediante el dispositivo COPD-6. Se estudiaron las propiedades psicométricas del cuestionario y la capacidad diagnóstica del cociente FEV1/FEV6 tomando como referencia el cociente FEV1/capacidad vital forzada (FEV1/FVC) posbroncodilatador < 0,7. Resultados. Participaron 10 centros de atención primaria que incluyeron 94 controles y 79 casos con obstrucción crónica al flujo aéreo. Las características del cuestionario fueron: factibilidad, 2,3% de los participantes no contestó algún ítem; el tiempo medio de cumplimentación fue de 47,7 segundos; el 4,1% de la muestra obtuvo puntuación cero. Validez, correlación moderada con puntuaciones del cuestionario EQ-5D y moderada-alta con el FEV1; la puntuación en el cuestionario se asoció con todos los parámetros indicativos de EPOC estudiados. El punto de corte 4 presentó el mejor balance sensibilidad/especificidad y un 78% de individuos correctamente clasificados. Para el cociente FEV1/FEV6 un punto de corte de 0,75 clasifica correctamente al 85% de los individuos. Conclusiones. El cuestionario COPD-PS demostró buenas propiedades psicométricas. Un punto de corte 4 presenta propiedades predictivas óptimas. El cociente FEV1/FEV6<0,75 ofrece una excelente correlación con el cociente FEV1/FVC y es útil para el cribado de obstrucción crónica al flujo aéreo(AU)

Background and objectives. The chronic obstructive pulmonary disease (COPD) is a highly undiagnosed disease. The use of short screening questionnaires designed to detect chronic airflow obstruction may help to the early diagnosis of COPD. Patients and method. This was an observational, cross-sectional epidemiological study aimed to validate the translated into Spanish version of the COPD-PS questionnaire. Socio-demographic and clinical data of participants were collected, as well as their answers to the COPD-PS and EQ-5D questionnaires. The ratio FEV1/FEV6 was measured with the COPD-6 device. The psychometric properties of the questionnaire and the diagnostic yield of the FEV1/FEV6 ratio were analysed, both referred to the gold standard of post-bronchodilator FEV1/FVC < 0.7. Results. Ten primary care centers participated in the study and included 94 controls and 79 cases with chronic airflow obstruction. Questionnaire characteristics were: feasibility, 2.3% of participants did not answer at least one item; mean time to fill the questionnaire was 47.7seconds; 4.7% of individuals had a 0 score. Validity, moderate correlation with EQ-5D scores and moderate-high with FEV1; the scores of COPD-PS were related to all parameters associated with COPD. A cut off of 4 units had the best sensitivity/specificity ratio and correctly classified 78% of participants. For the FEV1/FEV6 ratio, a cut off of 0.75 correctly classified 85% of individuals. Conclusions. The COPD-PS questionnaire demonstrated good psychometric properties. A cut off score of 4 has excellent predictive value. A ratio of 0.75 in the FEV1/FEV6 provides an excellent correlation with the ratio FEV1/FVC and is useful for the identification of individuals with chronic airflow obstruction(AU)

Análisis coste-efectividad de dabigatrán para la prevención de ictus y embolia sistémica en fibrilación auricular no valvular en España / Cost-effectiveness of dabigatran for stroke prevention in non-valvular atrial fibrillation in Spain

Introducción y objetivos. Análisis coste-efectividad de dabigatrán para la prevención de ictus y embolia sistémica por fibrilación auricular no valvular en España, según la perspectiva del Sistema Nacional de Salud. Métodos. Adaptación de un modelo de Markov secuencial que simula la historia natural de la enfermedad para una cohorte de 10.000 pacientes con fibrilación auricular no valvular a lo largo de su vida. Los comparadores son warfarina en un primer escenario y el patrón de prescripción habitual (el 60% con antagonistas de la vitamina K, el 30% con ácido acetilsalicílico y el 10% no tratados) en el segundo. Se realizaron análisis de sensibilidad determinístico y probabilístico. Resultados. En ambos escenarios dabigatrán disminuyó los eventos sufridos y consiguió ganancias en cantidad y calidad de vida. La razón coste-efectividad incremental de dabigatrán comparado con warfarina fue de 17.581 euros/año de vida ajustado por calidad ganado y de 14.118 euros/año de vida ajustado por calidad ganado respecto al patrón de prescripción habitual. Se demostró eficiencia en subgrupos. Incorporando los costes sociales al análisis, dabigatrán es una estrategia dominante (más efectiva y de menor coste). El modelo demostró ser robusto. Conclusiones. Desde la perspectiva del Sistema Nacional de Salud, dabigatrán resulta una estrategia eficiente para la prevención de ictus en pacientes con fibrilación auricular no valvular en comparación con warfarina y con el patrón de prescripción habitual; en ambas comparaciones realizadas, los valores de la razón coste-efectividad incremental estuvieron por debajo del umbral de 30.000 euros/año de vida ajustado por calidad. Desde la perspectiva de la sociedad, dabigatrán sería además una estrategia dominante que aporta más efectividad y menores costes que las dos alternativas (AU)

Introduction and objectives. Assessment of the cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Spain, from the perspective of the National Health System. Methods. Adaptation of a Markov chain model that simulates the natural history of the disease over the lifetime of a cohort of 10 000 patients with non-valvular atrial fibrillation. Model comparators were warfarin in a first scenario, and a real world prescribing pattern in a second scenario, in which 60% of the patients were treated with vitamin K antagonists, 30% with acetylsalicylic acid, and 10% received no treatment. Deterministic and probabilistic sensitivity analyses were performed. Results. Dabigatran reduced the occurrence of clinical events in both scenarios, providing gains in quantity and quality of life. The incremental cost-effectiveness ratio for dabigatran compared to warfarin was 17581 euros/quality-adjusted life year gained and 14118 euros/quality-adjusted life year gained when compared to the real world prescribing pattern. Efficiency in subgroups was demonstrated. When the social costs were incorporated into the analysis, dabigatran was found to be a dominant strategy (ie, more effective and less costly). The model proved to be robust. Conclusions. From the perspective of the Spanish National Health System, dabigatran is an efficient strategy for the prevention of stroke in patients with non-valvular atrial fibrillation compared to warfarin and to the real-world prescribing pattern; incremental cost-effectiveness ratios were below the 30 000 euros/quality-adjusted life year threshold in both scenarios. Dabigatran would also be a dominant strategy from the societal perspective, providing society with a more effective therapy at a lower cost compared to the other 2 alternatives (AU)

Cost-effectiveness of dabigatran for stroke prevention in non-valvular atrial fibrillation in Spain.

INTRODUCTION AND OBJECTIVES: Assessment of the cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Spain, from the perspective of the National Health System. METHODS: Adaptation of a Markov chain model that simulates the natural history of the disease over the lifetime of a cohort of 10,000 patients with non-valvular atrial fibrillation. Model comparators were warfarin in a first scenario, and a real world prescribing pattern in a second scenario, in which 60% of the patients were treated with vitamin K antagonists, 30% with acetylsalicylic acid, and 10% received no treatment. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Dabigatran reduced the occurrence of clinical events in both scenarios, providing gains in quantity and quality of life. The incremental cost-effectiveness ratio for dabigatran compared to warfarin was 17,581 euros/quality-adjusted life year gained and 14,118 euros/quality-adjusted life year gained when compared to the real world prescribing pattern. Efficiency in subgroups was demonstrated. When the social costs were incorporated into the analysis, dabigatran was found to be a dominant strategy (ie, more effective and less costly). The model proved to be robust. CONCLUSIONS: From the perspective of the Spanish National Health System, dabigatran is an efficient strategy for the prevention of stroke in patients with non-valvular atrial fibrillation compared to warfarin and to the real-world prescribing pattern; incremental cost-effectiveness ratios were below the 30,000 euros/quality-adjusted life year threshold in both scenarios. Dabigatran would also be a dominant strategy from the societal perspective, providing society with a more effective therapy at a lower cost compared to the other 2 alternatives. Full English text available from:www.revespcardiol.org.

Preferencias por los tratamientos anticoagulantes orales para la prevención a medio y largo plazo del ictus en la fibrilación auricular no valvular / Preferences for oral anticoagulant treatment in the medium and long term prevention of stroke in non valvular atrial fibrillation

Introducción. Un 40% de los pacientes con anticoagulación oral no iniciaría el tratamiento con antagonistas de la vitamina K por la necesidad de controles periódicos y sus interferencias con la dieta y medicación concomitante. Objetivo. Analizar las preferencias de los pacientes con fibrilación auricular no valvular por anticoagulantes orales (AO) para la prevención del ictus. Pacientes y métodos. Estudio observacional, transversal, multicéntrico, de preferencias y disponibilidad a pagar: se definieron los atributos de los AO mediante revisión de la bibliografía, grupos focales y entrevistas semiestructuradas con médicos y pacientes. Posteriormente, se definieron escenarios que los pacientes ordenaron según sus preferencias. Se analizaron los datos de la muestra total y por conglomerados agrupados por sus preferencias. Resultados. Se definieron ocho escenarios basados en cinco atributos: eficacia, seguridad, dosis fija, necesidad de controles de la coagulación, e interacciones con la dieta y medicación. Se entrevistó a 295 pacientes ambulatorios (edad media: 71,76 ± 9,81 años) que recibían AO. El atributo preferido fue el ‘menor número de embolias/año’ (importancia: 30,15%), seguido de ‘dosis fija del AO’ (25,45%) y ‘menor número de hemorragias intracraneales anuales’ (21,57%). En la muestra se identificaron tres segmentos de población con preferencias diferentes. La máxima disponibilidad a pagar (media) por un AO fue 66,76 ± 54,64 euros mensuales. Conclusiones. Eficacia, dosis fija y seguridad son los atributos de los AO más valorados por los pacientes con fibrilación auricular no valvular. Estas preferencias deberían considerarse al instaurar o cambiar el tratamiento con AO para mejorar el cumplimiento y prevención en pacientes (AU)

Introduction. About 40% of patients who receive oral anticoagulation would not start treatment with vitamin K antagonists due to the regular control they require and their interference with the diet and other concomitant medications. Aim. To analyze the preferences of patients with non valvular atrial fibrillation for oral anticoagulants (OAs) for the stroke prevention. Patients and methods. Observational, multicentric study on preferences and maximum willingness to pay based on conjoint analysis: literature review, focus groups and semi-structured interviews with physicians and patients (n = 295) to define the attributes of OAs and their levels. Definition of scenarios that patients ordered according to their preferences. Clusters analysis to identify population groups by their preferences. Results. Eight scenarios were defined based on five attributes: efficacy, security, a fixed dose, need for coagulation controls and interactions with diet and medication. The most preferred attribute was the smaller number of embolisms in a year (importance: 30.15%) followed by the fixed dose of the OA (25.45%) and the smaller number of intracranial hemorrhage in a year (21.57%). Three clusters population were identified. The maximum amount patients’ were willingness to pay for the OA was 66.76 ± 54.64 euros (mean) per month. Conclusions. Efficacy and a fixed dose are the attributes of OA most valued by non valvular atrial fibrillation patients. There are groups of patients who differ in their preferences. This differences should be taken into account when deciding instauration or change on the OA treatment to ameliorate the accomplishment and prevention in this patients (AU)

[Preferences for oral anticoagulant treatment in the medium and long term prevention of stroke in non valvular atrial fibrillation]. / Preferencias por los tratamientos anticoagulantes orales para la prevencion a medio y largo plazo del ictus en la fibrilacion auricular no valvular.

INTRODUCTION: About 40% of patients who receive oral anticoagulation would not start treatment with vitamin K antagonists due to the regular control they require and their interference with the diet and other concomitant medications. AIM: To analyze the preferences of patients with non valvular atrial fibrillation for oral anticoagulants (OAs) for the stroke prevention. PATIENTS AND METHODS: Observational, multicentric study on preferences and maximum willingness to pay based on conjoint analysis: literature review, focus groups and semi-structured interviews with physicians and patients (n = 295) to define the attributes of OAs and their levels. Definition of scenarios that patients ordered according to their preferences. Clusters analysis to identify population groups by their preferences. RESULTS: Eight scenarios were defined based on five attributes: efficacy, security, a fixed dose, need for coagulation controls and interactions with diet and medication. The most preferred attribute was the smaller number of embolisms in a year (importance: 30.15%) followed by the fixed dose of the OA (25.45%) and the smaller number of intracranial hemorrhage in a year (21.57%). Three clusters population were identified. The maximum amount patients' were willingness to pay for the OA was 66.76 ± 54.64 euros (mean) per month. CONCLUSIONS: Efficacy and a fixed dose are the attributes of OA most valued by non valvular atrial fibrillation patients. There are groups of patients who differ in their preferences. This differences should be taken into account when deciding instauration or change on the OA treatment to ameliorate the accomplishment and prevention in this patients.

[Validation of the Spanish version of the Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Its usefulness and that of FEV1/FEV6 for the diagnosis of COPD]. / Validación de la versión traducida del Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Su utilidad y la del FEV1/FEV6 para el diagnóstico de enfermedad pulmonar obstructiva crónica.

BACKGROUND AND OBJECTIVES: The chronic obstructive pulmonary disease (COPD) is a highly undiagnosed disease. The use of short screening questionnaires designed to detect chronic airflow obstruction may help to the early diagnosis of COPD. PATIENTS AND METHOD: This was an observational, cross-sectional epidemiological study aimed to validate the translated into Spanish version of the COPD-PS questionnaire. Socio-demographic and clinical data of participants were collected, as well as their answers to the COPD-PS and EQ-5D questionnaires. The ratio FEV(1)/FEV(6) was measured with the COPD-6 device. The psychometric properties of the questionnaire and the diagnostic yield of the FEV(1)/FEV(6) ratio were analysed, both referred to the gold standard of post-bronchodilator FEV(1)/FVC < 0.7. RESULTS: Ten primary care centers participated in the study and included 94 controls and 79 cases with chronic airflow obstruction. Questionnaire characteristics were: feasibility, 2.3% of participants did not answer at least one item; mean time to fill the questionnaire was 47.7 seconds; 4.7% of individuals had a 0 score. Validity, moderate correlation with EQ-5D scores and moderate-high with FEV(1); the scores of COPD-PS were related to all parameters associated with COPD. A cut off of 4 units had the best sensitivity/specificity ratio and correctly classified 78% of participants. For the FEV(1)/FEV(6) ratio, a cut off of 0.75 correctly classified 85% of individuals. CONCLUSIONS: The COPD-PS questionnaire demonstrated good psychometric properties. A cut off score of 4 has excellent predictive value. A ratio of 0.75 in the FEV(1)/FEV(6) provides an excellent correlation with the ratio FEV(1)/FVC and is useful for the identification of individuals with chronic airflow obstruction.

Treatment patterns, use of resources, and costs of advanced non-small-cell lung cancer patients in Spain: results from a Delphi panel.

INTRODUCTION: Approximately 80-85% of lung cancer patients are diagnosed with non-small-cell lung cancer (NSCLC), of which 50% of patients present with advanced or metastatic disease. The objective of this study was to describe treatment patterns, use of resources and costs associated with treating advanced or metastatic NSCLC patients in Spain. METHODS: A two-round Delphi consensus panel of clinical experts was carried out to describe local clinical patterns based on treatment algorithms from SEOM and ASCO treatment guidelines. The panel consisted of 19 oncologists and 1 hospital pharmacist, who were asked during the first round to define therapeutic pathways for NSCLC by the patients' performance status, age and histology; to quantify the use of resources associated with the preparation and administration of anticancer pharmacotherapy; management of adverse events associated with anticancer pharmacotherapy; and best supportive care (BSC). The second round was used to try to reduce the variability of responses in some questions and to further describe differences between intravenous and oral therapy. 2009 unit costs were applied to the use of resources described by the clinical experts. The perspective of the study was from the Spanish National Healthcare System. RESULTS: Performance status guided therapy decision and led to differences in costs. Patients with a performance status of 0-2 were expected to receive anticancer pharmacotherapy while patients with a performance status of 3-4 received BSC including analgesics and corticosteroids. Anticancer pharmacotherapies containing cisplatin or carboplatin were used preferably in first-line treatment, while the usual second- and third-line treatments were docetaxel, erlotinib or pemetrexed monotherapy. The importance of the cost of anticancer pharmacotherapy as a proportion of total healthcare costs was higher for combination therapies containing bevacizumab or pemetrexed. The anticancer pharmacotherapies associated with adverse events like febrile neutropenia or infection increased the total treatment cost. Administration costs were more relevant in regimens containing cisplatin and were low for orally administered therapies. The total cost per patient with advanced or metastatic NSCLC from starting anticancer therapy until death was estimated to be between €11,301 and €32,754 depending on the number of treatment lines received. CONCLUSIONS: In the treatment of advanced or metastatic NSCLC, healthcare costs are impacted by line of treatment, patient performance status, type of administration of therapy and adverse event management.

An economic analysis of pharmacological treatment of COPD in Spain.

BACKGROUND: COPD is a prevalent disease that generates high use of resources. The objective of this study was to quantify the economic consequences of non-adherence to GOLD guidelines for the management of COPD patients. METHOD: An economic model was generated to compare different scenarios of observed vs. expected costs of COPD treatment. A pooled analysis of data derived from a systematic review of studies describing treatment of COPD in Spain was combined with drug costs (using different assumptions) to obtain the observed cost of COPD treatment. An expected cost was obtained with the minimum and maximum treatment intensity derived from the GOLD recommendations. RESULTS: A total of 8 studies were identified, comprising 6339 patients. Average medication cost of COPD patients was estimated as being between euro 1218 and euro 1314 per patient per year, higher than the ideal expected average cost (between euro 1007 and euro 1021 per patient/year). Thus, implementation of guidelines would result in a mean reduction of euro 198-euro 293 per patient/year. Sensitivity analysis showed that about 13% of patients had higher treatment costs than the maximum expected cost. This proportion is much higher in moderately/severely affected patients than in mildly affected patients (28.0% and 11.1%, respectively). CONCLUSIONS: Treatment of COPD allows for the identification of areas of inefficiency. An improvement in the adherence to the GOLD guidelines would imply potential savings of medication costs of about 20% of the observed costs.

Epidemiology and costs of screening and management of precancerous lesions of the cervix in Spain.

OBJECTIVE: Oncogenic human papillomaviruses (HPVs) are essential causes of cervical cancer. Screening prevents cancer by detecting precancerous lesions (cervical intraepithelial neoplasia, CIN). Our aim was to assess the annual number of Pap smears and CIN diagnoses in Spain and to estimate associated management costs. MATERIALS AND METHODS: A 1-year retrospective cross-sectional study was conducted among 65 gynecologists from public primary health care centers in 6 autonomous regions in Spain. We documented the total number of Pap smears performed and the management of women with CIN. Data on health care resource use related to CIN management for 2 years after diagnosis were collected and combined with unit costs to assess the mean cost per patient. We extrapolated to the general female Spanish population to estimate the total cost of screening and CIN management from the third-party payer's perspective. RESULTS: In our study sample, 3.5% of routine Pap smears were abnormal. We estimated that 7.6 million Pap smears are performed annually in Spain, at a cost of 622 million euro (US$987). Furthermore, 40,530 women are annually diagnosed with CIN 1, 26,243 with CIN 2, and 28,423 with CIN 3. The mean cost of CIN management per patient was 1,115 euro for CIN 1, 1,626 euro for CIN 2, and 2,090 euro for CIN 3. The total cost of CIN management was estimated at 147 million euro (US$233). CONCLUSIONS: This study shows that the costs of screening and management of CIN represent a heavy burden to the public health system in Spain.