Efficiency of "Prescribe Vida Saludable", a health promotion innovation. Pilot phase / Eficiencia de «Prescribe Vida Saludable», una innovación de promoción de la salud. Fase piloto

Objective: "Prescribe Vida Saludable" (PVS) is an organisational innovation designed to optimise the promotion of multiple healthy habits in primary healthcare. It aims to estimate the cost effectiveness and cost-utility of prescribing physical activity in the pilot phase of the PVS programme, compared to the routine clinical practice of promoting physical activity in primary healthcare. Methods: An economic evaluation of the quasi-experimental pilot phase of PVS was carried out. In the four control centres, a systematic sample was selected of 194 patients who visited the centre in a single year and who did not comply with physical activity recommendations. In the four intervention centres, 122 patients who received their first physical activity prescription were consecutively enrolled. The costs were evaluated from the perspective of the PVS programme using bottom-up methodology. The effectiveness (proportion of patients who changed their physical activity) as well as the utility were evaluated at baseline and after 3 months. The incremental cost-utility ratio (ICUR) and the incremental cost-effectiveness ratio (ICER) were calculated and a sensitivity analysis was performed with bootstrapping and 1,000 replications. Results: Information was obtained from 35% of control cases and 62% of intervention cases. The ICUR was Euros1,234.66/Quality Adjusted Life Years (QALY) and the ICER was Euros4.12. In 98.3% of the simulations, the ICUR was below the Euros30,000/QALY threshold. Conclusions: The prescription of physical activity was demonstrably within acceptable cost-utility limits in the pilot PVS phase, even from a conservative perspective (AU)

Objetivo: Prescribe Vida Saludable (PVS) es una innovación organizativa para optimizar la promoción de múltiples hábitos saludables en atención primaria. El objetivo es estimar el coste-efectividad y el coste-utilidad de la prescripción de actividad física en el pilotaje del programa PVS, respecto a la práctica clínica habitual de promoción de la actividad física en atención primaria. Métodos: Se llevó a cabo una evaluación económica del pilotaje cuasi experimental PVS. En los cuatro centros de control se seleccionó una muestra sistemática de 194 pacientes que visitaron el centro durante 1 año y que no cumplían las recomendaciones de actividad física. En los cuatro centros de intervención se captaron consecutivamente 122 pacientes que recibieron la primera prescripción de actividad física. Los costes se evaluaron desde la perspectiva del programa PVS con la metodología bottom-up. Tanto la efectividad (proporción de pacientes que modificaron su actividad física) como la utilidad fueron evaluadas basalmente y a los 3 meses. Se calcularon la razón de coste-utilidad incremental (RCUI) y la razón de coste-efectividad incremental (RCEI), y se realizó el análisis de sensibilidad con bootstrapping con 1000 repeticiones. Resultados: Se obtuvo información de un 35% de los casos control y de un 62% de los casos con intervención. La RCUI fue de 1234,66 Euros por año de vida ajustado por calidad (AVAC) y la RCEI fue de 4,12 Euros. En un 98,3% de las simulaciones el RCUI estuvo por debajo del umbral de 30.000 Euros/AVAC. Conclusiones: La prescripción de actividad física se muestra en unos límites aceptables de coste-utilidad en el pilotaje de PVS, incluso desde una perspectiva conservadora (AU)

Efficiency of "Prescribe Vida Saludable", a health promotion innovation. Pilot phase.

OBJECTIVE: "Prescribe Vida Saludable" (PVS) is an organisational innovation designed to optimise the promotion of multiple healthy habits in primary healthcare. It aims to estimate the cost effectiveness and cost-utility of prescribing physical activity in the pilot phase of the PVS programme, compared to the routine clinical practice of promoting physical activity in primary healthcare. METHODS: An economic evaluation of the quasi-experimental pilot phase of PVS was carried out. In the four control centres, a systematic sample was selected of 194 patients who visited the centre in a single year and who did not comply with physical activity recommendations. In the four intervention centres, 122 patients who received their first physical activity prescription were consecutively enrolled. The costs were evaluated from the perspective of the PVS programme using bottom-up methodology. The effectiveness (proportion of patients who changed their physical activity) as well as the utility were evaluated at baseline and after 3 months. The incremental cost-utility ratio (ICUR) and the incremental cost-effectiveness ratio (ICER) were calculated and a sensitivity analysis was performed with bootstrapping and 1,000 replications. RESULTS: Information was obtained from 35% of control cases and 62% of intervention cases. The ICUR was €1,234.66/Quality Adjusted Life Years (QALY) and the ICER was €4.12. In 98.3% of the simulations, the ICUR was below the €30,000/QALY threshold. CONCLUSIONS: The prescription of physical activity was demonstrably within acceptable cost-utility limits in the pilot PVS phase, even from a conservative perspective.

Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR / Baseline characteristics and changes in treatment after a period of optimization of the patients included in the study EFICAR

OBJETIVO: Se describen los datos basales de clase y capacidad funcional, comorbilidades, calidad de vida y cambios en la medicación durante la optimización del tratamiento, en pacientes con insuficiencia cardiaca y función sistólica deprimida (ICFSD) incluidos en el estudio EFICAR. DISEÑO: Ensayo clínico aleatorizado multicéntrico. EMPLAZAMIENTO: Siete Centros de Salud. PARTICIPANTES: Ciento cincuenta pacientes con ICFSD; edad 68 ± 10 años, 77% varones. Mediciones: Variables sociodemográficas e índice de Charlson. Se evaluó la calidad de vida y la capacidad funcional Se realizó optimización del tratamiento. RESULTADOS: La etiología principal fue la cardiopatía isquémica (45%). Índice de Charlson global: 2,03 ± 1,05. El 31% ingresaron durante el último año por insuficiencia cardiaca. Fracción de eyección media: 37% ± 8. Clase funcional ii: 89%. Capacidad funcional con prueba de esfuerzo: 6,3 ± 1,6. Test 6 min: 446 ± 78 m. Test de la silla: 13,7 ± 4,4 s. Dinamómetro: 34,53 ± 10,12 kgf y 0,58 ± 0,16 bar. Short Form-36 Health Survey: salud física: 43,3 ± 8,4; salud mental: 50,1 ± 10,6. Minnesota Living with Heart Failure Questionnaire global: 22,8 ± 18,7. Tras optimizar el tratamiento no varió el porcentaje de pacientes ni la dosis media de fármacos analizados. CONCLUSIONES: La mayoría de los sujetos están en clase funcional ii, con capacidad funcional y calidad de vida disminuida e índice de comorbilidad elevado. Un ajuste protocolizado del tratamiento no consigue aumentar la dosis ni el número de pacientes con fármacos eficaces para la insuficiencia cardiaca con función cardiaca deprimida

OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68 ± 10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class ii. The Charlson index was 2.03 ± 1.05. The ejection fraction mean was 37% ± 8, 19% with ejection fraction < 30%. With the stress test 6.3 ± 1.6 mean was reached, with the 6 minutes test 446 ± 78 meters and the chair test 13.7 ± 4.4 seconds. The overall quality of life with ejection fraction was 22.8 ± 18.7 and with the Short Form-36 Health Survey, physical health 43.3 ± 8.4 and mental health 50.1 ± 10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class ii, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function

[Baseline characteristics and changes in treatment after a period of optimization of the patients included in the study EFICAR]. / Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR.

OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68±10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class II. The Charlson index was 2.03±1.05. The ejection fraction mean was 37%±8, 19% with ejection fraction <30%. With the stress test 6.3±1.6 mean was reached, with the 6 minutes test 446±78 meters and the chair test 13.7±4.4 seconds. The overall quality of life with ejection fraction was 22.8±18.7 and with the Short Form-36 Health Survey, physical health 43.3±8.4 and mental health 50.1±10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class II, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function.

Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.

BACKGROUND: The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time. DESIGN/METHODS: We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance. DISCUSSION: As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01786122 Registration date: 02/05/2013.

Calidad de vida y sobrecarga de los cuidadores de pacientes con daño cerebral adquirido / Quality of life and burden of carers of patients with acquired brain injury

Introducción. El impacto en salud del daño cerebral adquirido (DCA) se manifiesta no solo en los pacientes sino también en la pérdida de calidad de vida relacionada con la salud (CVRS) de sus cuidadores. Los objetivos de este estudio fueron medir tanto la pérdida de CVRS como la sobrecarga de los cuidadores de pacientes con DCA. Material y métodos. Se llevó a cabo un estudio retrospectivo con 76 cuidadores de pacientes con DCA. La encuesta recogió información acerca de las características sociodemográficas, la carga de los cuidados (escala de Zarit) y la CVRS (cuestionario EuroQol) de los cuidadores. Para analizar el efecto de las diferentes variables se construyeron modelos de regresión lineal múltiple y regresión logística. Resultados. Los cuidadores fueron predominantemente mujeres de más de 50 años, jubiladas o dedicadas a las tareas domésticas y que cuidaban a su marido o a uno de sus padres. Un tercio mostró un riesgo alto de claudicación. La media de la CVRS obtenida con EuroQol pasó de una cifra similar a la de la población general (0,90) en el grupo sin sobrecarga a 0,67 en el grupo con riesgo de claudicación. Los modelos de regresión explicaron mejor la sobrecarga que la pérdida de calidad de vida. Conclusiones. Los cuidadores de pacientes con daño cerebral sufren una importante pérdida de CVRS con relación a la población general. El deterioro radica en las dimensiones mentales y depende del nivel de la sobrecarga(AU)

Introduction. The health impact of acquired brain injury (ABI) is not only apparent in the patient, but also in the loss of health related quality of life (HRQol) of their carers. The objectives of this study were to measure the loss of HRQol as well as the burden of the carers of patients with ABI. Material and methods. A retrospective study was conducted with 76 carers of patients with ABI. A questionnaire was used to collect information on the sociodemographic aspects, carer burden (Zarit Scale) and the HRQol (EuroQol Questionnaire) of the carers. A multiple linear regression model was constructed to analyse the effect of the different variables. Results. The carers were predominantly women over 50years, retired or dedicated to domestic tasks and who cared for their husband or one of their parents. One third showed a high risk of claudication. The mean HRQol obtained with the EuroQol went from a similar score to that of the general population (0.9) in the group without burden, to 0.67 in the group with risk of claudication. The regression models explained the burden better than the loss in quality of life. Conclusions. Carers of patients with brain injury suffer a significant loss in HRQol compared to the general population. The deterioration arises from the mental dimensions and depends on the level of burden(AU)

[Quality of life and burden of carers of patients with acquired brain injury]. / Calidad de vida y sobrecarga de los cuidadores de pacientes con daño cerebral adquirido.

INTRODUCTION: The health impact of acquired brain injury (ABI) is not only apparent in the patient, but also in the loss of health related quality of life (HRQol) of their carers. The objectives of this study were to measure the loss of HRQol as well as the burden of the carers of patients with ABI. MATERIAL AND METHODS: A retrospective study was conducted with 76 carers of patients with ABI. A questionnaire was used to collect information on the sociodemographic aspects, carer burden (Zarit Scale) and the HRQol (EuroQol Questionnaire) of the carers. A multiple linear regression model was constructed to analyse the effect of the different variables. RESULTS: The carers were predominantly women over 50 years, retired or dedicated to domestic tasks and who cared for their husband or one of their parents. One third showed a high risk of claudication. The mean HRQol obtained with the EuroQol went from a similar score to that of the general population (0.9) in the group without burden, to 0.67 in the group with risk of claudication. The regression models explained the burden better than the loss in quality of life. CONCLUSIONS: Carers of patients with brain injury suffer a significant loss in HRQol compared to the general population. The deterioration arises from the mental dimensions and depends on the level of burden.