[Dabigatran versus acenocumarol for the prevention of stroke in atrial fibrillation: budget impact analysis in one health department in Spain]. / Dabigatrón versus acenocumarol para la prevención del ictus en la fibrilación atrial: análisis de impacto presupuestario en un departamento sanitario.

BACKGROUND: To Estimate, in the context of a Health Department of the Valencia Health Agency, the budgetary impact of the widespread use of dabigatran at doses of 110 and 150 mg in patients with non-valvular atrial fibrillation (AF), regarding the current scenario with acenocoumarol therapy. METHODS: Budget impact analysis of three scenarios of oral anticoagulation use in AF: a) current treatment with acenocoumarol, b) widespread replacement of acenocoumarol for Dabigatran 110 mg and, c) idem at doses of 150 mg. The analysis was conducted from the perspective of the Valencia Health Agency with a time horizon of one year (2009). The effectiveness and adverse effects were extrapolated from the RE-LY study, while prevalence and cost data correspond to the Health Department estimates in 2009. RESULTS: We included 5889 patients (2.4% of the population > 18 years) diagnosed with AF, of which 3726 (63.2%) were treated with acenocoumarol. The total costs of each scenario were € 1,119,412 (€ 300 patient/year) for acenocoumarol, € 4,985,095 (€ 1,337 patient/year) for dabigatran 110 and € 4,981,226 (€ 1,336 patient/year) for dabigatran 150, with a budget impact of 1,037 euros/year per patient shifted from acenocumarol to dabigatran-150. CONCLUSIONS: The high budgetary impact of moving to a scenario of widespread substitution of warfarin for Dabigatran supports the restriction of this therapeutic strategy to subgroups of patients at high risk or difficult control.

Dabigatran versus acenocumarol para la prevención del ictus ene la fibrilación atrial. Análisis de impacto presupuestario en un departamento sanitario / Dabigatran versus Acenocumarol for the prevention of stroke in atrial fibrillation. Budget impact analysis in one health department in Spain

FUNDAMENTO: La aparición de nuevas opciones terapéuticas con diferentes efectividad y costes requiere la revaluación del papel de los actuales programas de anticoagulación oral (AO) para informar la toma de decisiones. El objetivo del trabajo es estimar el impacto presupuestario de la utilización generalizada de Dabigatrán a dosis de 110mg y 150 mg en pacientes con fibrilación atrial (FA) respecto al escenario actual de tratamiento con acenocumarol. Métodos: Cálculo del impacto presupuestario en 3 escenarios diferentes de anticoagulación oral: a) tratamiento con acenocumarol, b) sustitución generalizada de acenocumarol por Dabigatrán a dosis de 110 mg y c) sustitución generalizada de acenocumarol por Dabigatrán a dosis de de 150 mg. El análisis se realizó desde la perspectiva de la Agencia Valenciana de Salud y con un horizonte temporal de 1 año (2009). La efectividad y los efectos adversos se extrapolaron del estudio RE-LY, mientras que los datos de prevalencia y costes procedieron de las estimaciones en el Departamento Sanitario. Resultados: Se incluyó a 5.889 pacientes (2,4% de la población >18 años) diagnosticados de FA de origen no valvular, de los que 3.726 (63,2%) recibían tratamiento con acenocumarol. Los costes totales de los respectivos escenarios fueron de 1.119.412 € (300 € paciente/año) para acenocumarol, 4.985.095€ (1.337€ paciente/año) para dabigatrán 110 mg y 4.981.226€ (1.336€ paciente/año) para dabigatrán 150 mg, con un impacto económico de 1.037 euros por paciente que cambiara de acenocumarol a dabigatrán 150. Conclusiones: El elevado impacto presupuestario de pasar a un escenario de sustitución generalizada de dicumarínicos a Dabigatrán apoya la restricción de esta estrategia terapéutica a subgrupos de pacientes de alto riesgo o de difícil control (AU)

BACKGROUND: To Estimate, in the context of a Health Department of the Valencia Health Agency, the budgetary impact of the widespread use of dabigatran at doses of 110 and 150 mg in patients with non-valvular atrial fibrillation (AF), regarding the current scenario with acenocoumarol therapy. METHODS: Budget impact analysis of three scenarios of oral anticoagulation use in AF: a) current treatment with acenocoumarol, b) widespread replacement of acenocoumarol for Dabigatran 110 mg and, c) idem at doses of 150 mg. The analysis was conducted from the perspective of the Valencia Health Agency with a time horizon of one year (2009). The effectiveness and adverse effects were extrapolated from the RE-LY study, while prevalence and cost data correspond to the Health Department estimates in 2009. RESULTS: We included 5889 patients (2.4% of the population > 18 years) diagnosed with AF, of which 3726 (63.2%) were treated with acenocoumarol. The total costs of each scenario were € 1,119,412 (€ 300 patient/year) for acenocoumarol, € 4,985,095 (€ 1,337 patient/year) for dabigatran 110 and € 4,981,226 (€ 1,336 patient/year) for dabigatran 150, with a budget impact of 1,037 euros/year per patient shifted from acenocumarol to dabigatran-150. CONCLUSIONS: The high budgetary impact of moving to a scenario of widespread substitution of warfarin for Dabigatran supports the restriction of this therapeutic strategy to subgroups of patients at high risk or difficult control

Lo que no hay que hacer para desburocratizar la atención primaria / What has to be done to debureaucratise primary care

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[Evaluation of a protocol to monitor cardiovascular risk factors in diabetic patients attended in primary care]. / Evaluación de un protocolo de control de factores de riesgo cardiovascular en pacientes diabéticos atendidos en atención primaria.

OBJECTIVE: To evaluate a primary care protocol for intensive monitoring of cardiovascular risk (CVR) factors in type-2 diabetes patients versus usual care. DESIGN: Randomised trial with clusters. SETTING: Primary care clinics. PARTICIPANTS: Sixty family physicians. INTERVENTIONS: Participants were randomised between following a protocol of intensive monitoring of CVR factors and maintaining their habitual practice with DM2 patients. Follow-up lasted 12 months. Data on HbA1C, CVR factors and CVR were collected at the start of the study and at 12 months. RESULTS: In all, 188 patients (94 intervention group and 94 control group) were included. At baseline measurement, CVR in control group (CG) was 36.3% (95% CI, 33.9%-38.6%); and in intervention group (IG), 35.9% (95% CI, 33.5%-38.4%), with no significant differences between groups. At one year, CVR in CG was 33.1% (95% CI, 30%-36.1%) and in IG 30.5% (95% CI, 27.8%-33.2%). The CVR difference between baseline and 1-year measurements was 2.9% (95% CI, 0.2%-5.7%) in CG and 5.4% (95% CI, 2.8%-7.1%) in IG. CONCLUSIONS: Although improvement of CVR is greater in the IG, the difference between the two groups is not significant. The characteristics of the doctors chosen may have meant that the patients of the two groups received similar treatment.

Evaluación de un protocolo de control de factores de riesgo cardiovascular en pacientes diabéticos atendidos en atención primaria / Evaluation of a protocol to monitor cardiovascular risk factors in diabetic patients attended in primary care

Objetivo. Valorar un protocolo de control intensivo de factores de riesgo cardiovascular (FRCV) frente al control habitual en pacientes con diabetes mellitus tipo 2 (DM2) en atención primaria. Diseño. Estudio aleatorizado de grupos. Emplazamiento. Consultas de atención primaria. Participantes. En total participaron 60 médicos de familia. Intervenciones. Los participantes fueron aleatorizados a seguir un protocolo de tratamiento intensivo de FRCV o a mantener su práctica habitual en pacientes con DM2. El seguimiento fue de 12 meses. Se recogieron datos acerca de la hemoglobina glucosilada, los FRCV y el riesgo cardiovascular al inicio del estudio y a los 12 meses. Resultados. Se incluyó a 188 pacientes (94 en el grupo de intervención y 94 en el grupo control). El riesgo cardiovascular basal en el grupo control (GC) fue del 36,3% (intervalo de confianza [IC] del 95%, 33,9-38,6%) y en el grupo de intervención (GI), del 35,9% (IC del 95%, 33,5-38,4%), sin diferencias significativas entre grupos. El riesgo cardiovascular a los 12 meses en el GC fue del 33,1% (IC del 95%, 30,0-36,1%) y en el GI del 30,5% (IC del 95%, 27,8-33,2%). La diferencia de riesgo cardiovascular a los 12 meses fue del ­2,9% (IC del 95%, 0,2-5,7%) en el GC y del ­5,4% (IC del 95%, 2,8-7,1%) en el GI. Conclusiones. Aunque se observa una disminución mayor del riesgo cardiovascular en el GI, la diferencia entre los grupos no es significativa. Las características de los médicos seleccionados pueden haber condicionado que los pacientes de ambos grupos hayan recibido un tratamiento similar

Objective. To evaluate a primary care protocol for intensive monitoring of cardiovascular risk (CVR) factors in type-2 diabetes patients versus usual care. Design. Randomised trial with clusters. Setting. Primary care clinics. Participants. Sixty family physicians. Interventions. Participants were randomised between following a protocol of intensive monitoring of CVR factors and maintaining their habitual practice with DM2 patients. Follow-up lasted 12 months. Data on HbA1C, CVR factors and CVR were collected at the start of the study and at 12 months. Results. In all, 188 patients (94 intervention group and 94 control group) were included. At baseline measurement, CVR in control group (CG) was 36.3% (95% CI, 33.9%-38.6%); and in intervention group (IG), 35.9% (95% CI, 33.5%-38.4%), with no significant differences between groups. At one year, CVR in CG was 33.1% (95% CI, 30%-36.1%) and in IG 30.5% (95% CI, 27.8%-33.2%). The CVR difference between baseline and 1-year measurements was 2.9% (95% CI, 0.2%-5.7%) in CG and 5.4% (95% CI, 2.8%-7.1%) in IG. Conclusions. Although improvement of CVR is greater in the IG, the difference between the two groups is not significant. The characteristics of the doctors chosen may have meant that the patients of the two groups received similar treatment

[How does intensive therapy of cardiovascular risk factors affect health-related quality of life in diabetic patients?]. / Cómo influye el tratamiento intensivo de los factores de riesgo cardiovascular en la calidad de vida relacionada con la salud de los pacientes diabéticos?

OBJECTIVE: To assess the health-related quality of life (HRQoL) in diabetic patients who have followed a protocol of intensive treatment of cardiovascular risks (CVR). DESIGN: Clinical trial randomised by cluster. A convenience sample of 65 primary care practitioners, randomly assigned to a control or intervention group. Patients were selected by systematic sampling from diabetic lists. The follow-up for the control group was by normal practice and the intervention group by using the intensive control of cardiovascular risk factors (CVRF) protocol. SETTING: Seventeen health-centres in the Valencia Community, Spain. PARTICIPANTS: One hundred and eighty-four patients, 93 in the control group and 91 in the intervention group. INCLUSION CRITERIA: patients diagnosed with diabetes mellitus (DM) type 2, aged between 45-75 years, DM for more than 2 years and less than 20 years and a cardiovascular risk (CVR) >20% after 10 years (Framingham equation). The exclusion criteria were: history of ischaemic heart disease, terminal illness, hepatic cirrhosis, renal failure, grade III-IV cardiac failure, and mental disorders. The patients self-completed the Spanish versions of the COOP/WONCA charts and a diabetes-specific tool (ADDQol questionnaire) at the start, and after 6 months and 12 months. MAIN MEASUREMENTS: Means of COOP/WONCA charts and ADDQol. Comparison between groups using Mann-Whitney U test, and the group follow ups using the Wilcoxon test. RESULTS: No significant differences were found in the COOP/WONCA charts. At 12 months the only significant difference was in the feelings chart (P=.024; control group 1.86+/-1.03: intervention group 2.23+/-1.11). A negative impact of diabetes was seen in all the dimensions of ADDQoL. The most negative impact of diabetes was related to diet. There were no significant differences between groups in the ADDQoL throughout the study. CONCLUSIONS: The HRQoL in diabetic patients is not affected by intensive therapy of cardiovascular risk factors. Diabetes has a negative impact on HRQoL in the patients studied.

¿Cómo influye el tratamiento intensivo de los factores de riesgo cardiovascular en la calidad de vida relacionada con la salud de los pacientes diabéticos? / How does the intensive therapy to control cardiovascular risk factors affect health-related quality of life in diabetic patients?

Objetivos. Valorar la calidad de vida relacionada con la salud (CVRS) de los diabéticos tras la aplicación de un protocolo de tratamiento intensivo para control de los factores de riesgo cardiovascular (FRCV). Diseño. Ensayo clínico aleatorizado por agrupaciones. Muestreo de conveniencia de 65 médicos de atención primaria (AP), asignación aleatoria al grupo control e intervención. Muestreo aleatorio sistemático de los diabéticos de cada médico. El seguimiento de los pacientes del grupo control se realizó mediante la práctica habitual y del grupo intervención a través del protocolo de tratamiento intensivo para el control de los FRCV. Emplazamiento. El estudio se realizó en 17 centros de salud de la Comunidad Valenciana. Participantes. Se incluyó a 184 pacientes, 93 en el grupo control y 91 en el grupo de intervención. Los criterios de inclusión fueron: diabéticos tipo 2 entre 45 y 70 años, diabetes de 2 a 20 años de evolución y riesgo cardiovascular mayor del 20% a los 10 años (ecuación de Framingham). Los criterios de exclusión fueron: antecedentes de cardiopatía isquémica, enfermedad terminal, cirrosis hepática, insuficiencia renal, insuficiencia cardíaca de grados III-IV y alteraciones mentales. Los pacientes autocumplimentaron los cuestionarios de calidad de vida relacionada con la salud: COOP/WONCA y ADDQoL al inicio y a los 6 y 12 meses. Mediciones principales. Valores medios de viñetas COOP/WONCA y ADDQoL. Comparación entre grupos mediante el test de la U de Mann-Whitney. El seguimiento de cada grupo se realizó con la prueba de Wilcoxon. Resultados. No encontramos diferencias significativas en las viñetas COOP/WONCA. A los 12 meses sólo encontramos diferencias significativas en la viñeta sentimientos (p = 0,024; grupo control 1,86 ± 1,03; grupo intervención 2,23 ± 1,11). Se observa un impacto negativo de la diabetes en todas las dimensiones del ADDQoL. No se han encontrado diferencias en el ADDQoL entre los grupos ni a lo largo del estudio. El impacto más negativo se obtiene en las dimensiones relacionadas con la dieta. Conclusiones. La CVRS en pacientes con diabetes tipo 2 no resulta afectada por el tratamiento intensivo de los FRCV. La diabetes tiene un impacto negativo en la CVRS de los individuos del estudio

Objective. To assess the health-related quality of life (HRQoL) in diabetic patients who have followed a protocol of intensive treatment of cardiovascular risks (CVR). Design. Clinical trial randomised by cluster. A convenience sample of 65 primary care practitioners, randomly assigned to a control or intervention group. Patients were selected by systematic sampling from diabetic lists. The follow-up for the control group was by normal practice and the intervention group by using the intensive control of cardiovascular risk factors (CVRF) protocol. Setting. Seventeen health-centres in the Valencia Community, Spain. Participants. One hundred and eighty-four patients, 93 in the control group and 91 in the intervention group. Inclusion criteria: patients diagnosed with diabetes mellitus (DM) type 2, aged between 45-75 years, DM for more than 2 years and less than 20 years and a cardiovascular risk (CVR) >20% after 10 years (Framingham equation). The exclusion criteria were: history of ischaemic heart disease, terminal illness, hepatic cirrhosis, renal failure, grade III-IV cardiac failure, and mental disorders. The patients self-completed the Spanish versions of the COOP/WONCA charts and a diabetes-specific tool (ADDQol questionnaire) at the start, and after 6 months and 12 months. Main measurements. Means of COOP/WONCA charts and ADDQol. Comparison between groups using Mann-Whitney U test, and the group follow ups using the Wilcoxon test. Results. No significant differences were found in the COOP/WONCA charts. At 12 months the only significant difference was in the feelings chart (P=.024; control group 1.86±1.03: intervention group 2.23±1.11). A negative impact of diabetes was seen in all the dimensions of ADDQoL. The most negative impact of diabetes was related to diet. There were no significant differences between groups in the ADDQoL throughout the study. Conclusions. The HRQoL in diabetic patients is not affected by intensive therapy of cardiovascular risk factors. Diabetes has a negative impact on HRQoL in the patients studied

Sociodemographic associations of physical, emotional, and sexual intimate partner violence in Spanish women.

PURPOSE: To measure the lifetime prevalence of physical, emotional, and sexual Intimate Partner Violence (IPV) in women attending general practice in Spain and to assess sociodemographic factors associated with the different types of abuse. METHODS: The sample included 1402 randomly selected women, aged 18 to 65 years, attending general practice in three Spanish regions. A self-administered structured questionnaire specifically developed for the study was used. Given the overlap between the different types of lifetime abuse, various categories were created by combining the different types. Multiple logistic regression models were developed to identify the sociodemographic factors independently associated with the different categories of abuse. RESULTS: Lifetime prevalence of IPV was 32%, and 14.4% referred having experienced emotional abuse alone. Factors independently associated with all categories of abuse included being separated/divorced/widowed, having three or more children, and lacking social support. Increasing age was protective for physical and emotional abuse (odds ratio = 0.96; 95% confidence interval = 0.93-0.99). Women with the lowest monthly family income (< 600 euro) (1 euro = 1.32 euro) were most likely to experience all IPV categories, except for emotional abuse alone. CONCLUSIONS: IPV is a common problem in general practice. The identification of factors associated with this public health problem is essential for its prevention and treatment.