Relationship between obesity and antipsychotic drug use in the adult population: A longitudinal, retrospective claim database study in Primary Care settings

Antoni Sicras-Mainar1, Ruth Navarro-Artieda2, Javier Rejas-Gutiérrez3, Milagrosa Blanca-Tamayo41Planning Management, Badalona Serveis Assistencials S.A., Badalona, Barcelona, Spain; 2Medical Documentation Service, Hospital Germans Trías i Pujol, Badalona, Barcelona, Spain; 3Health Outcomes Research Derpartment, Medical Unit, Pfizer Spain, Alcobendas, Madrid, Spain; 4Department of Psychiatry, Badalona Serveis Assistencials S.A., Badalona, Barcelona, SpainObjective: To describe the association between obesity and the use of antipsychotic drugs (APDs) in adult outpatients followed-up on in five Primary Care settings.Methods: A longitudinal, retrospective design study carried out between July 2004 and June 2005, in patients who were included in a claim database and for whom an APD treatment had been registered. A body mass index (BMI) <30 kg/m2 was defined as obesity. The main measurements were: use of APDs, demographics, medical background and co-morbidities, and clinical parameters. Logistic regression analysis and ANCOVA with Bonferroni adjustment were applied to correct the model.Results: A total of 42,437 subjects (mean age: 50.8 (18.4) years; women: 54.5%; obesity: 27.3% [95% confidence intervals (CI), 26.9%–27.7%]) were analyzed. A total of 1.3% of the patients were receiving APDs, without statistical differences in distribution by type of drug (typical: 48.8%; atypical: 51.2%). Obesity was associated with the use of APDs [OR = 1.5 (CI: 1.3–1.8)], hypertension [OR = 2.4 (CI: 2.2–2.5)], diabetes [OR = 1.4 (CI: 1.3–1.5)] and dyslipidemia [OR = 1.3 (CI: 1.2–1.4)], p < 0.0001 in all cases. BMI was significantly higher in subjects on APDs; 28.8 vs. 27.3 kg/m2, p = 0.002, and remained higher after adjusting by age and sex (mean difference 0.4 (CI: 0.1–0.7), p < 0.01). After adjusting by age, sex and the Charlson index, obese subjects generated higher average annual total costs than nonobese subjects; 811 (CI: 787–835) vs. 694 (CI: 679–709), respectively, p < 0.001.Conclusions: Obesity was associated with the use of APDs, regardless of the type of drug, and with the presence of hypertension, diabetes and dyslipidemia. Obesity was also associated with substantially higher health care costs.Keywords: Obesity, claim database, retrospective study, antipsychotic use, Primary Care setting, resources utilization, health care cost

Perfil de uso de recursos y costes en pacientes que demandan atención por fibromialgia o trastorno de ansiedad generalizada en el ámbito de la atención primaria de salud

ResumenObjetivodeterminar el perfil de uso de servicios y costes en pacientes que demandan atención por fibromialgia (FM) o trastorno de ansiedad generalizada (TAG) en atención primaria (AP).Diseñoestudio retrospectivo-multicéntrico.Emplazamientocinco centros de AP urbanos, gestionados por Badalona Serveis Assistencials.Participantespacientes mayoresde 18 años atendidos durante 2006. Se formó un grupo de referencia/poblacional con el resto de los pacientes.Principales medicionesgenerales, casuística/comorbilidad, utilización de recursos sanitarios y costes ambulatorios (visitas, procedimientos diagnósticos/terapéuticos y medicamentos). Análisis: regresión logística y ANCOVA.Resultadosse atendió a 63.349 pacientes. El 1,4% (intervalo de confianza [IC] del 95%, 0,6%–2,2%) presentó FM y el 5,3% (IC del 95%, 4,5%–6,1%), TAG. El promedio de episodios atendidos/año y el de visitas realizadas/año fueron mayores en el grupo de FM que en el de TAG y que en el grupo poblacional (8,3 frente a 7,2 y 4,6 episodios/año; 12,9 frente a 12,1 y 7,4 visitas/año; p<0,001). La FM mostró relación con mujeres (odds ratio [OR]=16,8), dislipemia (OR=1,5) y síndrome depresivo (OR=3,9) (p<0,001), y el TAG, con la edad (OR=1,1), mujeres (OR=2,2), hipertensión arterial (OR=1,3), dislipemia (OR=1,2), fumadores (OR=1,4), síndrome depresivo (OR=1,2) y evento cardiovascular (OR=1,3) (p<0,02). El coste directo medio/anual corregido por edad, sexo y comorbilidades fue de 555,58 euros en el grupo de referencia, 817,37 euros en TAG y 908,67 euros en FM (p<0,001).Conclusioneslos pacientes que requirieron atención por FM o TAG muestran un importante uso de recursos y costes sanitarios en el ámbito de la AP de salud. Los sujetos con TAG se asocian a un elevado número de comorbilidades.AbstractObjectiveTo determine the use of services and costs in patients with Fibromyalgia (FM) or Generalized Anxiety Disorder (GAD) followed up in Primary Care (PC).DesignA retrospective multicenter population-based study.SettingFive primary care clinics managed by Badalona Health Service.ParticipantsPatients over 18 years seen in the 5 PC centers during the year 2006. Patients with and without GAD/FM were compared.MeasurementsMain outcomes measures were general, case/co-morbidity, health care use and primary care cost (visits, diagnostic/therapeutic tests and drugs). Statistical analysis: logistic regression and ANCOVA (P<.05).ResultsThere was a total of 63,349 patients, 1.4% (95% CI, 0.6%–2.2%) had a diagnosis of FM, and 5.3% (95% CI, 4.5%–6.1%) GAD. The average episodes/year and visits /year was higher in FM group compared to GAD group, with a marked difference observed vs. the reference group (8.3 vs. 7.2 and 4.6 episodes/year; and 12.9 vs. 12.1 and 7.4 visits/year; P<.001). FM was shown to be related to female gender (odds ratio [OR]=16.8), dyslipidemia (OR=1.5), and depressive syndrome (OR=3.9) (P<.001 in all cases). GAD was related to age (OR=1.1), female gender (OR=2.2), high blood pressure (OR=1.3), dyslipidemia (OR=1.2), smoking (OR=1.4), depressive syndrome (OR=1.2), and cardiovascular events (OR=1.3) (P<.02 in all cases). After adjusting for age, gender and co-morbidities, mean annual direct ambulatory cost was 555.58€ for the reference group, 817.37€ for GAD, and 908.67€ for FM (P<.001).ConclusionsCompared with reference group, a considerable use of health resources and costs was observed in patients with FM or TAG in medical practice in PC settings

Development and psychometric properties of the human papillomavirus‑quality of life (HPV‑QoL) questionnaire to assess the impact of HPV on women health‑related‑quality‑of‑life.

Purpose The HPV-Quality-of-Life (HPV-QoL) questionnaire was developed to determine the impact of Human-Papillomavirus (HPV) infection and related interventions on women health-related quality-of-life. This study provides the development and preliminary psychometric properties of a novel HPV-QoL questionnaire for adult women with HPV. Methods After reviewing literature and cognitive debriefing interviews in women who had experienced HPV-related conditions, instrument items and domains were developed. A draft questionnaire was pilot tested for comprehension and ease of completion. Psychometric evaluation of the final HPV-QoL scale was conducted in a psychometric study including 252 adult women derived to our centre by a positive HPV test in the cervical cancer screening program and/or presenting genital warts. Results The present study reveals that the HPV-QoL questionnaire, structured in four domains: general well-being [including psychological well-being and social well-being subdomains], health, contagiousness and sexuality, showed good metric properties of feasibility irrespective of age or educational level, and time to administer was less than 5 min. Internal consistency and temporal stability (reliability) showed values above the acceptable standards. The instrument showed its concurrent validity by means of a significant correlation with mental and sexual existing instruments; GHQ-12 and FSFI questionnaires, respectively, and also known groups validity showing significant differences among the subgroups regarding either sexual dysfunction or mental deterioration. Conclusion This study provides an HPV-QoL questionnaire with an innovative patient-reported outcomes specific measurement tool to assess HRQoL in women with HPV infection. The present study suggests this questionnaire has satisfactory psychometric properties, including validity and reliability. Results support the use of the HPV-QoL questionnaire as a HRQoL measurement instrument for daily medical practice and clinical research.pre-print927 K

Negative impact of chronic obstructive pulmonary disease on the health-related quality of life of patients. Results of the EPIDEPOC study

BACKGROUND: COPD is currently the fourth cause of morbidity and mortality in the developed world. Patients with COPD experience a progressive deterioration and disability, which lead to a worsening in their health-related quality of life (HRQoL). The aim of this work is to assess the Health-Related Quality of Life (HRQoL) of patients with stable COPD followed in primary care and to identify possible predictors of disease. METHODS: It is a multicenter, epidemiological, observational, descriptive study. Subjects of both sexes, older than 40 years and diagnosed of COPD at least 12 months before starting the study were included. Sociodemographic data, severity of disease, comorbidity, and use of health resources in the previous 12 months were collected. All patients were administered a generic quality-of-life questionnaire, the SF-12, that enables to calculate two scores, the physical (PCS-12) and the mental (MCS-12) component summary scores. RESULTS: 10,711 patients were evaluated (75.6% men, 24.4% women), with a mean age of 67.1 years (SD 9.66). The mean value of FEV(1 )was 35.9 ± 10.0%. Mean PCS-12 and MCS-12 scores were 36.0 ± 9.9 and 48.3 ± 10.9, respectively. Compared to the reference population, patients with COPD had a reduction of PCS-12, even in mild stages of the disease. The correlation with FEV(1 )was higher for PCS-12 (r = 0.38) than for MCS-12 (r = 0.12). Predictors for both HRQoL components were sex, FEV(1), use of oxygen therapy, and number of visits to emergency rooms and hospital admissions. Other independent predictors of PCS-12 were age, body mass index and educational level. CONCLUSION: Patients with stable COPD show a reduction of their HRQoL, even in mild stages of the disease. The factors determining the HRQoL include sex, FEV(1), use of oxygen therapy, and number of visits to emergency rooms and hospital admissions

Use of aspirin for primary and secondary prevention of cardiovascular disease in diabetic patients in an ambulatory care setting in Spain

<p>Abstract</p> <p>Background</p> <p>This study was conducted in order to determine the use of aspirin and to assess the achievement of therapeutic targets in diabetic patients according to primary (PP) or secondary prevention (SP).</p> <p>Methods</p> <p>This is a retrospective, observational study including patients ≥18 years with diabetes mellitus followed in four primary care centers. Measurements included demographics, use of aspirin and/or anticoagulant drugs, co-morbidities, clinical parameters and proportion of patient at therapeutic target (TT). Descriptive statistics, chi-square test and logistic regression model were used for significance.</p> <p>Results</p> <p>A total of 4,140 patients were analyzed, 79.1% (95% confidence intervals [CI]: 77.7–80.5%) in PP and 20.9% (95% CI: 18.2–23.7%) in SP. Mean age was 64.1 (13.8) years, and 49.3% of patient were men (PP: 46.3, SP: 60.7, p = 0.001). Aspirin was prescribed routinely in 20.8% (95% CI: 19.4–22.2%) in PP and 60.8% (95% CI: 57.6–64.0%) in SP. Proportion of patient at TT was 48.0% for blood pressure and 59.8% for cholesterol. Use of aspirin was associated to increased age [OR = 1.01 (95% CI: 1.00–1.02); p = 0.011], cardiovascular-risk factors [OR = 1.14 (95% CI: 1.03–1.27); p = 0.013], LDL-C [OR = 1.42 (95% CI: 1.06–1.88); p = 0.017] and higher glycated hemoglobin [OR = 1.51 (95% CI: 1.22–1.89); p = 0.000] were covariates associated to the use of aspirin in PP.</p> <p>Conclusion</p> <p>Treatment with aspirin is underused for PP in patients with diabetes mellitus in Primary Care. Achievement of TT should be improved.</p

Resultados comunicados por el paciente en las fichas técnicas de medicamentos aprobados en España durante el período 2000-2012

Background: The term "Patient Reported Outcomes" (PRO) is defined as any result assessed directly by the patient and based on his perception of the illness and its treatment. The scope of the study is to determine and compare the use of PRO measures with other types of effectiveness endpoints in the summary of the products characteristics (SPC) of medicines with active substances approved by first time from 2000 to 2012 in Spain. Methods: A review and descriptive analysis of the effectiveness endpoints used in the clinical trials described in the SPCs studied, classifying them into the following categories: PRO, clinician-reported outcomes (CROs), and laboratory test/device measurement endpoints (ML). Chi-square and Fisher exact texts were used for comparative purposes, and odds ratio to determine the strongest of association. Results: PROs were included in 65 (19.7%) of the SPCs studied. CRO were the most frequently reported 188 (57%) cases, followed by ML:128 (38,7%). PROs were included as only effectiveness endpoint in 6 medicines. A growing trend toward statistical significance (R2=0.525; p=0.079) has been observed in reporting PROs during the period of time studied. Conclusion: The use frequency of PRO in SPCs is clearly minor compared to other efficacy endpoints considered, being the difference significantly higher in case of its use as only efficacy endpoint. The therapeutic areas where PROs were most reported were nervous system medicines, immunologic system modulator medicines, respiratory system, muscle and skeleton system.Fundamentos: El término Patient Reported Outcomes (PRO) es definido como el resultado de la evaluación de un medicamento por el paciente y basada en su percepción de la enfermedad y su(s) tratamientos(s). El objetivo del estudio es determinar la utilización de PRO y compararla con otros tipos de variables de la eficacia contenidas en las fichas técnicas (FT) de medicamentos. Métodos: Revisión y análisis descriptivo de las variables de eficacia utilizadas en los ensayos clínicos de principios activos aprobados en España durante el período 2000-2012, descritas en las fichas técnicas clasificándolas en las siguientes categorías: PRO, resultados informados por el clínico (CRO) y resultados finales basados en pruebas de laboratorio (ML). Para las comparaciones se realizaron la prueba chi2 o la prueba exacta de Fisher, y se calcularon odd ratios para valorar la intensidad de la asociación. Resultados: De las 330 FT estudiadas se incluyeron PROs en 65 (19,7%), los CRO en 188 (57%) y los ML en 128 (38,7%). Los PRO se utilizaron como único resultado final de eficacia en 6 medicamentos. Se observó una tendencia creciente de la significación estadística en la utilización de PRO a lo largo del tiempo estudiado (R2=0,525; p=0,079). Conclusiones: La frecuencia de utilización de PRO en FT es claramente inferior a la de las otras medidas de la eficacia, siendo la diferencia significativamente mayor en el caso de su inclusión como variable única final. La utilización de PROs fue más frecuente en medicamentos del sistema nervioso, agentes inmunomoduladores, sistema respiratorio y sistema musculoesquelético

Calidad de vida y otras medidas de salud informadas por el paciente

Calidad de vida y otras medidas de salud informadas por el paciente

Territorios en disputa: un estudio de caso en la España vaciada = Disputed territories: a case study in rural emptied Spain

p. 371-390Se analiza la trayectoria de las políticas públicas ante la gravedad del problema de la despoblación, tanto a nivel socioeconómico como por los impactos en la vida de quienes están siendo desplazados. Se parte de un diagnóstico para caracterizar la dimensión del problema; a continuación, reflexionamos sobre el modelo de desarrollo socioeconómico y sus impactos espaciales. Problematizamos el tema de la despoblación y los procesos de despoblamiento incorporando los enfoques de la geografía del poder, las concepciones de espacio y territorio y los retos del “espacio vacío” en un contexto de disputa por los recursos naturales y estratégicos. Finalizamos con un análisis del impacto sociocultural y de los vínculos comunitarios. El trabajo se inscribe a nivel nacional, pero se centra en la Comunidad de Castilla y León, y con especial referencia a León, por ser una de las provincias con mayor despoblación y menos apoyos institucionales.S

Análisis coste-efectividad del empleo de celecoxib en el tratamiento de la artrosis

Antecedentes: Los antiinflamatorios no esteroideos (AINE), utilizados en el tratamiento de la artrosis, pueden producir reacciones adversas gastrointestinales (GI) graves. Celecoxib, un inhibidor específico de la ciclooxigenasa 2 (COX-2), ha demostrado una eficacia equivalente a los AINE convencionales con un mejor perfil de tolerabilidad y seguridad. Objetivo: La finalidad de este estudio ha sido realizar un análisis coste-efectividad sobre el uso de celecoxib frente a los AINE clásicos en el tratamiento de la artrosis. Material y métodos: El análisis coste-efectividad se ha diseñado mediante un modelo farmacoeconómico, definiéndose como unidad de efectividad a cada año de vida ganado tras la toma de celecoxib o AINE. La probabilidad de que aparezcan los diferentes resultados clínicos se ha obtenido de artículos publicados y de asunciones incorporadas. Sólo se han valorado los costes directos médicos (medicación, hospitalización, pruebas complementarias, analíticas, visitas extras, etc.), sin haberse incluido otros costes. La perspectiva del estudio ha sido la del Sistema Nacional de Salud y el horizonte temporal elegido ha sido de 6 meses. Resultados: El coste adicional por cada año de vida ganado secundario al uso de celecoxib frente a los AINE clásicos asciende a 8.017 ¿ (1.333.834 ptas.). El análisis de sensibilidad muestra cómo estos valores son sensibles a la modificación del coste de AINE y gastroprotector, así como a la inclusión de grupos poblacionales con edades más bajas. Conclusiones: Celecoxib puede ser considerado como una opción coste-efectiva en el tratamiento de la artrosis, ya que va a evitar muertes y a ganar años de vida para los pacientes con un coste adicional razonable y moderado, cuando se compara con los AINE. Su eficiencia aumenta a medida que se utiliza en poblaciones con menor edad media y, probablemente, en aquellas con mayor riesgo de desarrollar complicaciones GI