Disease burden and costs for patients with hip and knee osteoarthritis and chronic moderate-to-severe refractory pain on treatment with strong opioids in Spain.

INTRODUCTION AND OBJECTIVES: To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. MATERIALS AND METHODS: This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. RESULTS: 2832 patients were analyzed; age was 72.0 years (SD=14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n=979; 37.6%), tapentadol (n=625; 24.0%), oxycodone (n=572; 22.0%), and buprenorphine (n=425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%-2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. DISCUSSION AND CONCLUSIONS: Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment.

Disease burden and costs for patients with hip and knee osteoarthritis and chronic moderate-to-severe refractory pain on treatment with strong opioids in Spain / Carga de la enfermedad y costes en pacientes con osteoartritis de cadera y rodilla con dolor crónico refractario moderado-severo tratados con opioides mayores en España

Introduction and objectives: To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. Materials and methods: This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. Results: 2832 patients were analyzed; age was 72.0 years (SD=14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n=979; 37.6%), tapentadol (n=625; 24.0%), oxycodone (n=572; 22.0%), and buprenorphine (n=425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%–2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. Discussion and conclusions: Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment.(AU)

Introducción y objetivos: Determinar la carga de la enfermedad y los costes en pacientes con osteoartritis de cadera y rodilla y dolor crónico refractario moderado-severo, en tratamiento con opioides mayores en España. Materiales y métodos: Se trata de un subanálisis de 36 meses de duración, procedente del estudio observacional OPIOIDS. Participaron pacientes con una edad ≥18 años, diagnosticados con osteoartritis de cadera y rodilla y dolor crónico refractario moderado-severo, en tratamiento con opioides mayores. La carga de la enfermedad incluyó la evaluación de la analgesia (escala NRS), del funcionamiento cognitivo (escala MMSE), de la capacidad para realizar las actividades de la vida diaria (índice de Barthel) y de las comorbilidades (gravedad y frecuencia). También se estimaron los costes asociados al uso de recursos sanitarios y a la productividad laboral. Resultados: Se analizaron 2.832 pacientes (edad: 72,0 años [DE: 14,3]; mujeres: 76,8%), que habían sido principalmente tratados con fentanilo (n=979; 37,6%), tapentadol (n=625; 24,0%), oxicodona (n=572; 22,0%) y buprenorfina (n=425; 16,3%). La intensidad del dolor disminuyó una unidad (13,7%), con una reducción de 2,6 unidades en la escala cognitiva (14,3% y aumento del 5,3% en los pacientes con déficit cognitivo) durante una media de 384,6 días (DE: 378,8). Las puntuaciones en la escala de Barthel disminuyeron significativamente, con un ligero aumento en la proporción de pacientes con dependencia grave/total, entre 1,2% y 2,9%. En el primer año, los costes sanitarios medios fueron 2.013€/paciente, mientras que los costes medios de pérdida de productividad fueron 12.227€/trabajador. Discusión y conclusiones: El tratamiento con opioides mayores durante 36 meses implicó elevados costes sanitarios, con una eficacia analgésica limitada, un aumento del déficit cognitivo y un ligero aumento de los pacientes con dependencia grave/total.(AU)

Development of vaccines for Chagas disease (CRUZIVAX): stakeholders' preferences and potential impacts on healthcare.

A vaccine for Chagas disease does not currently exist. This study aims to inform the development of two vaccines for the prevention and treatment of Trypanosoma cruzi infection, and guide their pre-clinical phase up to clinical phase I. The three main objectives are: 1) to explore patients' and policy makers' preferences on the candidate vaccines in Argentina and Spain; 2) to investigate health-related quality of life of patients affected by Chagas disease; and 3) to assess the potential health provider savings associated with the vaccines, in terms of resource use and health care costs. Discrete choice experiments will be employed to estimate and characterize the theoretical demand for the vaccines and investigate patients' and policy makers' preferences. Health-related quality of life will be assessed using the EQ-5D-3L questionnaire. Resources use and costs associated with Chagas disease will be investigated using information from the databases of the Hospital Clínic of Barcelona.

Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain.

BACKGROUND: Moderate-severe atopic dermatitis (AD) has a significant impact on patients' lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. METHODS: This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. RESULTS: Patients (N=1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. CONCLUSIONS: Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD.

Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain. / [Artículo traducido] Características de los pacientes, patrones de tratamiento, uso de recursos y costes en adultos con dermatitis atópica moderada-grave en la práctica habitual en España: Estudio Derma-Atopic.

BACKGROUND: Moderate-severe atopic dermatitis (AD) has a significant impact on patients' lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. METHODS: This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. RESULTS: Patients (N = 1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. CONCLUSIONS: Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD.

Development of vaccines for Chagas disease (CRUZIVAX): stakeholders’ preferences and potential impacts on healthcare / Desarrollo de vacunas para la enfermedad de Chagas (CRUZIVAX): preferencias de las partes interesadas y posibles impactos en la asistencia sanitaria

A vaccine for Chagas disease does not currently exist. This study aims to inform the development of two vaccines for the prevention and treatment of Trypanosoma cruzi infection, and guide their pre-clinical phase up to clinical phase I. The three main objectives are: 1) to explore patients’ and policy makers’ preferences on the candidate vaccines in Argentina and Spain; 2) to investigate health-related quality of life of patients affected by Chagas disease; and 3) to assess the potential health provider savings associated with the vaccines, in terms of resource use and health care costs. Discrete choice experiments will be employed to estimate and characterize the theoretical demand for the vaccines and investigate patients’ and policy makers’ preferences. Health-related quality of life will be assessed using the EQ-5D-3L questionnaire. Resources use and costs associated with Chagas disease will be investigated using information from the databases of the Hospital Clínic of Barcelona. (AU)

No existen vacunas para la enfermedad de Chagas. Este trabajo pretende informar la fase preclínica de dos vacunas para la prevención y el tratamiento de la infección por Trypanosoma cruzi. Los objetivos principales son tres: 1) investigar las preferencias de los pacientes y de los responsables de políticas sanitarias en Argentina y España; 2) investigar la calidad de vida relacionada con la salud de los pacientes afectados por la enfermedad de Chagas; y 3) estimar los ahorros potenciales asociados con las vacunas para los proveedores de salud. Se usarán experimentos de elección discreta para estimar y caracterizar la demanda teórica de las vacunas e investigar las preferencias de los pacientes y de los responsables de las políticas sanitarias. La calidad de vida relacionada con la salud se evaluará mediante el cuestionario EQ-5D-3L. Se investigarán el uso de recursos y los costes asociados a la enfermedad de Chagas utilizando bases de datos del Hospital Clínic de Barcelona. (AU)

A Prospective Study of Costs Associated With the Evaluation of Allergic Reactions to Radiological Contrast Media

Background: The prevalence of hypersensitivity reactions to radiological contrast media (RCM) is increasing owing to the improved performance of diagnostic and therapeutic tests that require RCMs. Objective: We carried out a year-long real-life observational study to prospectively evaluate patients referred to the allergy department from primary care, the emergency department, and other specialties with suspected moderate-to-severe RCM hypersensitivity reactions. Methods: To study the costs of evaluating RCM hypersensitivity reactions, we systematically recorded direct and indirect costs. Results: Sixty-nine patients with previous reactions to RCM were evaluated in the allergy department from June 1, 2017, to May 31, 2018.Total direct health care costs were €10 715.84, with a mean (SD) cost per patient of €155.30 (77.08). Specifically, direct non–health care costs reached €1605.42 (mean, €23.27 [41.14]), and indirect costs were €6490.85 (mean, €94.07 [110.61]). In summary, the total cost was €18 812.11, that is, a mean cost of €272.64 (164.77). Conclusions: Our study shows that the costs of an elective evaluation of hypersensitivity reactions to RCM are low, thus confirming that correct and safe management of affected patients are cost-effective. Therefore, our efforts should be directed toward ensuring the necessary logistics (AU)

Antecedentes: La prevalencia de reacciones de hipersensibilidad a los medios de contraste radiológico (MCR) está aumentando debido al incremento en la realización de pruebas diagnósticas y terapéuticas que requieren MCR. Objetivo: Hemos realizado un estudio observacional de un año de duración para evaluar prospectivamente a los pacientes remitidos al Servicio de Alergología con sospecha de reacciones moderadas a graves por hipersensibilidad a MCR.Métodos: Para estudiar los costes de la evaluación de la hipersensibilidad a MCR, se registraron sistemáticamente los costes directos e indirectos. Resultados: Se evaluaron 69 pacientes con reacciones previas a MCR remitidos al Servicio de Alergología desde el 1 de junio de 2017 hasta el 31 de mayo de 2018. Los costes sanitarios directos totales fueron de 10.715,84 €, con un coste medio por paciente de 155,30 € ± 77,08. En concreto, los costes directos no sanitarios alcanzaron los 1.605,42 € (media 23,27 € ± 41,14 €) y los costes indirectos fueron de6.490,85 € (media 94,07 € ± 110,61 €). En resumen, el coste total fue de 18.812,11 €, lo que supone un coste medio de 272,64 ± 164,77 €. Conclusiones: Nuestro estudio refleja que los costes de una evaluación electiva de hipersensibilidad a MCR son bajos. Este hecho reafirma que el manejo correcto y seguro de estos pacientes podría ser rentable, por lo que nuestros esfuerzos deben estar dirigidos a implementar la logística necesaria (AU)

Epidemiology and resource use in Spanish type 2 diabetes patients without previous cardiorenal disease: CaReMe Spain study summary.

AIMS: To determine the first manifestation of cardiovascular or kidney disease (CVKD) and associated resource use in type 2 diabetes mellitus (T2DM) patients during seven years of follow-up. METHODS: Observational-retrospective secondary data study using medical records of patients aged ≥18 years with T2DM and without prior CVKD between 2013 and 2019. The index date was 01/01/2013 (fixed date). The manifestation of CVKD was defined by the first diagnosis of heart-failure (HF), chronic-kidney disease (CKD), myocardial-infarction (MI), stroke or peripheral-artery disease (PAD). The main variables were baseline characteristics, manifestation of CVKD, mortality, resource use and costs. Descriptive analyses and Cox model were applied to the data. RESULTS: 26,542 patients were selected (mean age: 66.6 years, women: 47.8%, mean duration of T2DM: 17.1 years). 18.7% (N=4974) developed a first CVKD manifestation during the seven years [distribution: HF (22.4%), CKD (36.6%), MI (14.5%), stroke (15.3%) and PAD (11.3%)]. Overall mortality was 8.3% (N=2214). The mortality risk of the group that developed HF or CKD as the first manifestation compared to the CVKD-free cohort was higher [HR: 2.5 (95% CI: 1.8-3.4) and 1.8 (95% CI: 1.4-2.3)], respectively. The cumulative costs per patient of HF (€50,942.80) and CKD (€48,979.20) were higher than MI (€47,343.20) and stroke (€47,070.30) and similar to PAD (€51,240.00) vs. €13,098.90 in patients who did not develop CVKD, p<0.001. CONCLUSIONS: In T2DM patients, HF and CKD were the first most common manifestations and had higher mortality and re-hospitalisation rates. HF and CKD were associated with the highest resource use and costs for the Spanish National-Health-System.

Comparative Analysis of the Efficiency of Two Treatment Protocols for Posterior Canal Benign Paroxysmal Positional Vertigo.

BACKGROUND AND OBJECTIVE: Benign paroxysmal positional vertigo (BPPV) is the most common vertigo of labyrinthine origin, its social and healthcare impact is remarkable. It has recently been shown that single session treatment is as safe and effective as weekly treatment, which could have impact on direct and indirect costs related to the disease. The objective of this study is to determine whether single session treatment of unilateral posterior canal BPPV canalolithiasis is more efficient than conventional treatment. MATERIALS AND METHODS: A prospective randomized controlled trial was performed in 53 consecutive patients diagnosed with unilateral posterior canal BPPV canalolithiasis previously untreated: 26 patients were assigned to single session treatment and 27 patients to weekly treatment. Average and total cost of care, consultation time and the impact in terms of temporary disability and loss of productivity for the company due to patients' medical visits were compared. RESULTS: Average and total cost of care and loss of productivity for the company due to patients' medical visits were significantly lower in the single session group. Consultation time was also better in this group when travelling time was considered. CONCLUSIONS: The single session protocol is fast, effective and reduces direct and indirect cost of care related to disease justifying high resolution consultations.

Análisis comparativo de la eficiencia de dos protocolos de tratamiento del vértigo posicional paroxístico benigno del conducto semicircular posterior / Comparative Analysis of the Efficiency of Two Treatment Protocols for Posterior Canal Benign Paroxysmal Positional Vertigo

Antecedentes y objetivo: El vértigo posicional paroxístico benigno (VPPB) es la causa más frecuente de vértigo de origen laberíntico; su impacto social y en términos de cuidados de salud es notable. Recientemente se ha demostrado que es clínicamente posible realizar el tratamiento y su comprobación en la misma sesión, lo cual podría tener repercusión en los costes asistenciales directos e indirectos relacionados con la enfermedad. El objetivo de este trabajo es determinar si el protocolo de tratamiento unisesión del VPPB CP unilateral tipo conductolitiasis es más eficiente que el protocolo de tratamiento convencional. Materiales y métodos: Estudio prospectivo controlado y aleatorizado en 53 pacientes consecutivos diagnosticados de un VPPB CP unilateral tipo conductolitiasis no tratados previamente; 26 pacientes fueron asignados al grupo unisesión y 27 al semanal clásico. Se compararon los costes medio y total de la asistencia, el tiempo de consulta y el impacto en términos de incapacidad temporal y pérdida de productividad para la empresa asociada a la visita médica del paciente. Resultados: Los costes medio y total de la asistencia así como la pérdida de productividad para una empresa asociada a la visita médica de los pacientes laboralmente activos fueron significativamente menores en el protocolo unisesión. También el tiempo de consulta cuando se consideró el tiempo de desplazamiento al centro. Conclusiones: El protocolo de tratamiento unisesión es rápido, efectivo y reduce los costes asistenciales directos e indirectos relacionados con la enfermedad justificando consultas de alta resolución. (AU)

Background and objective: Benign paroxysmal positional vertigo (BPPV) is the most common vertigo of labyrinthine origin, its social and healthcare impact is remarkable. It has recently been shown that single session treatment is as safe and effective as weekly treatment, which could have impact on direct and indirect costs related to the disease. The objective of this study is to determine whether single session treatment of unilateral posterior canal BPPV canalolithiasis is more efficient than conventional treatment. Materials and methods: A prospective randomized controlled trial was performed in 53 consecutive patients diagnosed with unilateral posterior canal BPPV canalolithiasis previously untreated: 26 patients were assigned to single session treatment and 27 patients to weekly treatment. Average and total cost of care, consultation time and the impact in terms of temporary disability and loss of productivity for the company due to patients’ medical visits were compared. Results: Average and total cost of care and loss of productivity for the company due to patients’ medical visits were significantly lower in the single session group. Consultation time was also better in this group when travelling time was considered. Conclusions: The single session protocol is fast, effective and reduces direct and indirect cost of care related to disease justifying high resolution consultations. (AU)

Comparative analysis of the efficiency of two treatment protocols for posterior canal benign paroxysmal positional vertigo. / Análisis comparativo de la eficiencia de dos protocolos de tratamiento del vértigo posicional paroxístico benigno del conducto semicircular posterior.

BACKGROUND AND OBJECTIVE: Benign paroxysmal positional vertigo (BPPV) is the most common vertigo of labyrinthine origin, its social and healthcare impact is remarkable. It has recently been shown that single session treatment is as safe and effective as weekly treatment, which could have impact on direct and indirect costs related to the disease. The objective of this study is to determine whether single session treatment of unilateral posterior canal BPPV canalolithiasis is more efficient than conventional treatment. MATERIALS AND METHODS: A prospective randomized controlled trial was performed in 53 consecutive patients diagnosed with unilateral posterior canal BPPV canalolithiasis previously untreated: 26 patients were assigned to single session treatment and 27 patients to weekly treatment. Average and total cost of care, consultation time and the impact in terms of temporary disability and loss of productivity for the company due to patients' medical visits were compared. RESULTS: Average and total cost of care and loss of productivity for the company due to patients' medical visits were significantly lower in the single session group. Consultation time was also better in this group when travelling time was considered. CONCLUSIONS: The single session protocol is fast, effective and reduces direct and indirect cost of care related to disease justifying high resolution consultations.

[Persistence to treatment and resources use with inhaled fixed-dose combinations of corticosteroids and long-acting ß-adrenergic agonists for the treatment of asthma: A population-based retrospective study]. / Persistencia al tratamiento y uso de recursos con corticosteroides y agonistas ß-adrenérgicos de larga duración inhalados a dosis fijas para el tratamiento del asma: estudio retrospectivo de base poblacional.

OBJECTIVE: To determine the persistence, exacerbations, and use of resources in patients who use inhaler treatment with fluticasone propionate/formoterol (PF/Form) in relation with other combinations of inhaled corticosteroid/long-acting ß-adrenergic (ICS/LABA) at fixed doses, for the treatment of asthma in real-life practice. MATERIAL AND METHODS: Observational study conducted by reviewing medical records. The study included subjects ≥18 years of age who started treatment with ICS/LABA and who met certain inclusion/exclusion criteria. The follow-up was carried out for one year. Study groups: a) PF/Form and b) Other-combinations (Other-ICS/LABA). MAIN MEASUREMENTS: Persistence, medication possession ratio (MPR), exacerbations, and costs (direct/indirect). The statistical analysis was performed using regression models, with a P<.05. RESULTS: A total of 3,203 patients were included in the study. By groups: a) FP/Form: 7.0% and b) Other-ICS/LABA: 93.0%. The mean age was 52.2 years, and 60.8% were women. A total of 44.9% of patients had persistent-moderate asthma. Patients under treatment with FP/Form were associated with greater persistence (67.6 vs. 61.2%, P=.043), a higher RPM (80.6 vs. 74.3%, P=.002), and less exacerbations (16.0 vs. 21.9%, P=.021), particularly severe-exacerbations (4.0 vs. 7.7%, P=.043). The mean/unit of the total cost (ANCOVA) was lower in patients under treatment with PF/Form (2,033 vs. € 2,486, P=.012), respectively. The total cost was associated with: Exacerbations (ß=0.618), asthma-severity (ß=0.214), age (ß=0.073), and lack-adherence (RPM: ß=-0.031), P<.01. CONCLUSIONS: Patients undergoing treatment with PF/Form were associated with greater adherence to treatment (persistence, RPM), a circumstance that leads to less severe exacerbations and total costs for the national health system. These differences could be due to the pharmacological properties of the drug or other factors not measured.

Comorbidity, concomitant medication, use of resources and healthcare costs associated with chronic hepatitis C virus carriers in Spain. / Comorbilidad, medicación concomitante, uso de recursos y costes sanitarios asociados a los pacientes portadores del virus de la hepatitis C crónica en España.

OBJECTIVES: To assess the comorbidity, concomitant medications, healthcare resource use and healthcare costs of chronic hepatitis C virus patients in the Spanish population. PATIENTS AND METHODS: Retrospective, observational, non-interventional study. Patients included were≥18 years of age who accessed medical care between 2010-2013. Patients were divided into 2 groups based on the presence or absence of liver cirrhosis. The follow-up period was 12 months. Main assessment criteria included general comorbidity level (determined by the resource utilisation band score) and prevalence of specific comorbidities, concomitant medications, healthcare resource use and healthcare costs. Statistical analysis was performed using regression models and ANCOVA, P<.05. RESULTS: One thousand fifty-five patients were enrolled, the mean age was 57.9 years and 55.5% were male. A percentage of 43.5 of patients had a moderate level of comorbidity according to the resource utilisation band score. The mean time from diagnosis was 18.1 years and 7.5% of the patients died during the follow-up period. The most common comorbidities were dyslipidaemia (40.3%), hypertension (40.1%) and generalised pain (38.1%). Cirrhosis was associated with cardiovascular events (OR 3.8), organ failures (OR 2.2), alcoholism (OR 2.1), diabetes (OR 1.2) and age (OR 1.2); P<.05. The most commonly used medications were anti-infectives (67.8%) and nervous system medications (66.8%). The mean total cost per patient was 3,198€ (71.5% healthcare costs, 28.5% indirect/non-healthcare costs). In the corrected model, the total costs per patient-year were 2,211€ for those without cirrhosis and 7,641€ for patients with cirrhosis; P<.001. CONCLUSIONS: Chronic hepatitis C virus patients are associated with a high level of comorbidity and the use of concomitant medications, especially in patients with liver cirrhosis. Chronic hepatitis C virus infection represents a substantial economic burden on the Spanish National Health System.

[A retrospective, observational and multicentre study on patients with hyperactive bladder on treatment with mirabegron and oxybutinine under usual clinical practice conditions]. / Estudio observacional retrospectivo multicéntrico de pacientes con vejiga hiperactiva en tratamiento con mirabegrón y oxibutinina en condiciones de práctica clínica habitual.

OBJECTIVE: To evaluate therapeutic persistence, healthcare resources, medical costs and adverse events of oxybutynin and mirabegron treatments in patients with overactive bladder in routine medical practice. PATIENTS AND METHODS: An observational, retrospective, multicentre study was carried out using the records of patients attended to in 3 different geographic locations (Barcelona, Girona, Asturias). An analysis was made on the 2 study groups (oxybutynin and mirabegron). Follow-up time was one year. Persistence was defined as the time (months), without discontinuation of the initial treatment, or without change of treatment at least 60 days after the initial prescription. Primary endpoints: comorbidity, healthcare resources used, and adverse events. The data was analysed using the SPSSWIN Program, with a significance of P<.05. RESULTS: Of the total of1,277 patients included in the study, 42.9% were on oxybutynin and 57.1% mirabegron. The mean age was 69.3 years and 53.2% were female. Demographic characteristics and morbidity were similar between the drugs and had a similar persistence (35.0% oxybutynin vs. 32.2% mirabegron, P=.294), although their costs were lower (1,151.2 vs. €1,809.6, P<.001). The biggest differences were observed in the price of medication (279.2 vs. €692.3, P<.001; a variation of: -€413.1); and adverse events (9.7 vs. 4.9%, P<.001). CONCLUSIONS: Patients treated with oxybutynin vs. mirabegron for overactive bladder had similar persistence with the treatment, lower healthcare costs, but with higher oxybutynin vs. mirabegron adverse reaction rates.

[Persistence to treatment by type of inhaler device in patients with asthma and chronic obstructive pulmonary disease]. / Persistencia en el tratamiento según el tipo de dispositivo inhalador en pacientes con asma y enfermedad pulmonar obstructiva crónica.

OBJECTIVE: To assess the initial treatment persistence with inhaled corticosteroids and long-acting beta-2 adrenergic bronchodilators (ICS/LABA) depending on the inhaler device used (pMDI or DPI), for the treatment of asthma and COPD. MATERIAL AND METHODS: An multicenter observational study. Subjects in initial treatment with ICS/LABA during 2007-2011 were included, and a follow-up period of 3 years. 2 groups of study (asthma, COPD) and 2 subgroups were prepared according to the device type inhaler (pMDI or DPI). The main measurements were: sociodemographic, comorbidity, adherence (rate possession medication -RPM-), persistence, drugs, exacerbation rates, resources use, and their costs (direct and indirect costs). Multivariate methods were used for the variables correction, with significance level of P<.05. RESULTS: The study included 2,082 asthma patients (pMDI: N = 566, 27.2%; DPI = 1,516, 72.8%). Patients with MDI devices showed a higher degree of persistence (32.5 vs. 27.8%; P=.037), treatment adherence (RPM: 83.1 vs. 80.5%; P<.001), fewer exacerbations (17.7 vs. 24.9%; P=.001) and lower health care costs (2,583 vs. 2,938 EUR; P = 0.042). 1,418 patients with COPD also were analyzed (pMDI: N = 524, 41.9%; DPI: N = 824, 58.1%) were analyzed. Patients with MDI devices also showed a higher degree of persistence (31.5 vs. 24.8%; P=.005), treatment adherence (RPM: 83.3 vs. 80.1%; P= .001), less exacerbations (40.1 vs. 48.2%; P=.002) and lower health care costs (3,922 vs. 4,588 EUR; P=.021). CONCLUSIONS: pMDI devices (as ICS/LABA initial treatment) are associated with higher treatment persistence either in asthma or COPD, with lower exacerbation rates, and use of health resources and cost.

Healthcare costs of people with type 2 diabetes mellitus in the Basque Country (Spain). / Costes sanitarios de la población con diabetes mellitus tipo 2 en el País Vasco (España).

OBJECTIVE: The aim of the study was to estimate the direct costs of healthcare provided to patients with type 2 diabetes mellitus (T2DM) in the Basque Country and to compare them with those of the population with chronic diseases. MATERIAL AND METHODS: A retrospective, cross-sectional, population-based study. Direct healthcare costs for patients aged over 35 years diagnosed with T2DM in the Basque Country (n=126,894) were calculated, stratified by age, sex and deprivation index, and compared to the costs for the population diagnosed with a chronic disease other than T2DM (n=1,347,043). RESULTS: The annual average healthcare cost of a person with T2DM was €3,432. Cost gradually increased with age to €4,313 in patients aged 80 to 84 years. Cost in males were €161 higher as compared to costs in females (P<.001). In the most socioeconomically disadvantaged areas, cost per patient was €468 (14.9%) greater than in the most privileged areas (P<.001). Moreover, cost was 68.5% higher (P<.001) for patients with T2DM than for patients with other chronic diseases. Total annual direct costs amounted to €435.5 million, or 12.78% of total public health expenditure in the region. CONCLUSIONS: Direct mean healthcare costs in the Basque Country for patients with T2DM were higher in males, in the most underprivileged areas, in patients with comorbidities, and in older age groups, and represented €3,432 per person per year.

Use of healthcare resources and costs associated to the start of treatment with injectable drugs in patients with type 2 diabetes mellitus. / Consumo de recursos sanitarios y costes asociados al inicio del tratamiento con fármacos inyectables en pacientes con diabetes mellitus tipo 2.

OBJECTIVES: The main objective was to assess resource use and costs of starting treatment with insulin or injectable GLP-1 receptor analogues (GLP-1 RAs) in a Spanish population of patients with type 2 diabetes mellitus. Treatment adherence and persistence were also determined for both treatment groups. PATIENTS AND METHODS: A retrospective, non-interventional, observational study was conducted. Patients aged ≥20 years who started treatment with insulin or GLP-1 RAs in the 2010-2012 period were recruited. Use of healthcare resources was estimated to evaluate healthcare costs in these two groups of patients (medical visits, hospital stay, emergency visits, diagnostic or treatment requests, medication). Clinical information including body mass index (BMI, kg/m2), metabolic control (HbA1c), adherence, persistence, and complications (hypoglycemia, and cardiovascular events (CVE) was collected. The follow-up period was 12 months. Only direct healthcare costs were considered. RESULTS: A total of 1301 patients with a mean age of 67.6 years (51.6% males) were recruited. Of these, 71.9% and 28.1% were on treatment with insulin and GLP-1 RA respectively. After one year of follow-up, patients treated with GLP-1 RAs were found less visits to primary care (8 vs. 11; P<.001) and specialized care (1.0 vs. 1.8; P<.001), hospital stays (0.3 vs. 0.7; P=.030) and less visits to the emergency room (0.8 vs. 1.6; P<.001). Patients treated with GLP-1 showed greater adherence (88.1% vs. 82.7%; P<.001) and persistence (62.0% vs. 55.9%; P=.046), and had less hypoglycemia episodes (13.4% vs. 18.7%; P=.022), with similar metabolic control (HbA1c: 7.2% vs. 7.4%; P=.049), BMI (29.1 vs. 30.9kg/m2), and CVE rate (9.1% vs. 11.5%; P=.330) respectively. The mean corrected direct healthcare cost per patient was €1787 vs. €2005 (P=.046.) CONCLUSIONS: Patients treated with GLP-1 RAs caused lower direct healthcare costs for the National Health System than patients treated with insulin. The results may be explained by greater treatment adherence and lower hypoglycemia rates in patients treated with GLP-1 RAs. Additional studies are needed to confirm these possibilities.

Clinical and financial implications of disease-related malnutrition in a department of Internal Medicine: prospective cohort study. / Repercusiones clínicas y económicas de la desnutrición relacionada con la enfermedad en un servicio de Medicina Interna: estudio de cohortes prospectivas.

BACKGROUND: Disease-related malnutrition is a challenge for Spanish hospitals. Our objective was to assess the feasibility and importance of establishing a nutritional screening strategy in our community. PATIENTS AND METHODS: A prospective cohort study was conducted in a department of internal medicine for 3 months. The nutritional screening was conducted at admission and was repeated weekly using the Malnutrition Universal Screening Tool. We analysed the clinical data, mean stay and expenses. RESULTS: The study included 330 patients (53.9% men), with a mean age of 77.8 years. The mean stay was 7 days, and the Charlson comorbidity index was 5.4. At admission, the Malnutrition Universal Screening Tool detected 26.9% of patients with a risk of malnutrition. Eighteen percent of the patients with a good nutritional state developed malnutrition during the hospitalisation. The patients with initially severe malnutrition had a longer mean stay. The patients whose nutritional state worsened during the hospitalisation had a significantly longer stay (2.5 days) compared with those whose state did not worsen. These cases of malnutrition caused a cost overrun of €767 per hospitalisation (35% greater), which entailed a malnutrition-related excess expenditure of €646,419.93 annually in the studied department. The appropriate coding resulted in an increase in mean weight from 2.11 to 2.81, which represented €82,568.52 and has not been previously quantified. CONCLUSION: The high prevalence and clinical and financial implications of Disease-related malnutrition in patients hospitalised in internal medicine warrants establishing protocols for its early detection and treatment.

The determinants of defensive medicine in Italian hospitals: The impact of being a second victim.

BACKGROUND: Defensive medicine affects healthcare systems worldwide. The concerns and perception about medical liability could lead practitioners to practise defensive medicine. Second victim is a healthcare worker involved in an unanticipated adverse patient event. The role of being second victim and the other possible determinants for defensive medicine is mostly unclear. OBJECTIVE: To study the condition of being second victim as a possible determinants of defensive medicine among Italian hospital physicians. DESIGN, SETTING AND PARTICIPANTS: A secondary analysis of the database of the national survey study on the prevalence and the costs of defensive medicine in Italy that was carried out between April 2014 and June 2014 in 55 Italian hospitals was performed for this study. The demographic section of the questionnaire was selected including the physician's age, gender, specialty, activity volume, grade and the variable being a second victim after an adverse event. RESULTS: A total sample of 1313 physicians (87.5% response rate) was used in the data analyses. Characteristics of the participants included a mean age 49.2 of years and 19.4 average years of experience. The most prominent predictor for practising defensive medicine was the physicians' experience of being a second victim after an adverse event (OR=1.88; 95%CI, 1.38-2.57). Other determinants included age, years of experience, activity volume and risk of specialty. CONCLUSIONS: Malpractice reform, effective support to second victims in hospitals together with a systematic use of evidence-based clinical guidelines, emerged as possible recommendations for reducing defensive medicine.

[Variability and opportunity costs among the surgical alternatives for breast cancer]. / Variabilidad y coste de oportunidad de las alternativas quirúrgicas en cáncer de mama.

OBJECTIVE: To analyze medical practice variation in breast cancer surgery (either inpatient-based or day-case surgery), by comparing conservative surgery (CS) plus radiotherapy vs. non-conservative surgery (NCS). We also analyzed the opportunity costs associated with CS and NCS. METHODS: We performed an observational study of age- and sex-standardized rates of CS and NCS, performed in 199 Spanish healthcare areas in 2008-2009. Costs were calculated by using two techniques: indirectly, by using All-Patients Diagnosis Related Groups (AP-DRG) based on hospital admissions, and directly by using full costing from the Spanish Network of Hospital Costs (SNHC) data. RESULTS: Standardized surgery rates for CS and NCS were 6.84 and 4.35 per 10,000 women, with variation across areas ranging from 2.95 to 3.11 per 10,000 inhabitants. In 2009, 9% of CS was performed as day-case surgery, although a third of the health care areas did not perform this type of surgery. Taking the SNHC as a reference, the cost of CS was estimated at 7,078 € and that of NCS was 6,161 €. Using AP-DRG, costs amounted to 9,036 € and 8,526 €, respectively. However, CS had lower opportunity costs than NCS when day-case surgery was performed frequently-more than 46% of cases (following SNHC estimates) or 23% of cases (following AP-DRG estimates). CONCLUSIONS: Day-case CS for breast cancer was found to be the best option in terms of opportunity-costs beyond a specific threshold, when both CS and NCS are elective.