Consumo de recursos sanitarios y pérdida de productividad en la enfermedad por reflujo gastroesofágico: resultados de un estudio transversal en el ámbito de la atención primaria en España

ResumenObjetivoEvaluar el consumo de recursos sanitarios y la productividad en pacientes con enfermedad por reflujo gastroesofágico (ERGE), y la influencia de la gravedad de la sintomatología sobre estos factores.DiseñoSubanálisis de la población española de un estudio multinacional con una fase retrospectiva de 4 meses para la identificación y selección de pacientes, y otra transversal para recoger información clínica y consumo de recursos sanitarios, realizado entre octubre de 2007 y enero de 2008.EmplazamientoCentros de atención primaria.Participantes477 pacientes que habían consultado por algún motivo relacionado con la ERGE.Mediciones principalesConsumo de recursos sanitarios, cambios en la productividad evaluada mediante el Cuestionario de Alteración de la Actividad y Productividad Laboral (WPAI-GERD).ResultadosA pesar de recibir tratamiento farmacológico en la visita índice, tras una mediana de 5,1 meses de seguimiento (rango 2,1-8,1), en la visita de recogida de datos un 15,9% (IC 95%=12,8-19,5) de los pacientes continuaba presentando sintomatología de ERGE clínicamente relevante. Los costes médicos directos anuales asociados a pruebas diagnósticas y a consultas médicas en pacientes con y sin sintomatología de ERGE clínicamente relevante fueron 666 € (DE: 2.097 €) y 370 € (DE: 2.060 €), respectivamente. El coste medio anual de la pérdida de productividad (17%) fue de 5.316 € (DE: 8.615 €). En pacientes con síntomas clínicamente relevantes de ERGE este coste fue 4 veces superior al de pacientes sin sintomatología relevante (15.188 € [DE: 11.206 €] vs 3.926 € [DE: 7.232 €]).ConclusiónLos pacientes con ERGE consumen importantes recursos sanitarios, atribuibles a los costes médicos asociados y a la notable pérdida de productividad, incluso aunque reciban tratamiento.AbstractObjectiveTo evaluate healthcare resource use and productivity in patients with gastro-esophageal reflux disease (GERD) and the influence of disease severity on these two factors.DesignSub-analysis of the Spanish population of a multinational study with a 4-month retrospective period for the identification and selection of patients, and a clinical visit to obtain clinical information and data on use of healthcare resources, carried out between October 2007 and January 2008.PopulationA total of 477 patients attending a Primary Care centre, with a medical consultation for GERD.Main variablesUse of healthcare resources, changes in productivity based on the Work Productivity and Activity Impairment Questionnaire for GERD patients (WPAI-GERD).ResultsDespite having received pharmacological treatment at the baseline visit, after a median of 5.1 months follow-up (range 2.1-8.1), up to 15.9% (95% CI; 12.8-19.5) patients still showed clinically relevant GERD symptoms. Direct medical costs per year associated with diagnostic tests and medical consultations in patients with or without clinically relevant GERD symptoms were 666 € (SD: 2,097 €) and 370 € (SD: 2,060 €), respectively. The mean annual cost of reduced productivity (17%) was 5,316 € (SD: 8,615 €). This cost was 4 times higher for patients with clinically relevant GERD symptoms than for patients with no relevant symptoms (15,188€ [SD: 11,206 €] vs 3,926 € [SD: 7,232 €]).ConclusionPatients with GERD use significant healthcare resources, attributable to associated medical costs and marked reduction in productivity, even though they receive pharmacological treatment

Evaluación epidemiológica de tecnologías de salud

Con este documento se pretende introducir al lector en la evaluación epidemiológica de tecnologías sanitarias. Tras un primer capítulo de conceptos básicos y definiciones de términos fundamentales en evaluación de tecnologías, se revisarán las técnicas de evaluación a partir de la evidencia relevante disponible, por medio de su análisis crítico y síntesis. Este constituye el primer paso, y a veces el único, en toda evaluación y debe ser realizado de forma sistemática y rigurosa. Posteriormente se hará un breve repaso a los principales tipos de estudios epidemiológicos, tanto experimentales como observacionales, y se tratará como tema aparte, por sus características diferenciales, la evaluación de pruebas diagnósticas, haciendo especial énfasis en los conceptos de sensibilidad, especificidad y valores predictivos. Por último, se revisarán los principales conceptos de evaluación económica, un tema clave de la evaluación de tecnologías sanitarias.Agradecimientos, Índice de tablas, Índice de figuras, Introducción Conceptos básicos. Definiciones, ¿Qué entendemos por tecnologías sanitarias?, Epidemiología, Eficacia, efectividad, eficiencia. Seguridad, ¿Qué, cuándo y cómo debe ser evaluado?, Evaluación a partir de la evidencia disponible, Especificación del propósito de la evaluación, Especificación de los criterios de inclusión/exclusión de los estudios, Técnicas de búsqueda bibliográfica, Interpretación e integración de la evidencia, Revisiones narrativas de la literatura Elección de un sólo estudio, Sistema de votación, Meta análisis Juicios de expertos, Formulación de recomendaciones basadas en la calidad de la evidencia, Generación de datos nuevos, El papel de los estudios experimentales, Ensayo Clínico Aleatorio, El papel de los estudios observacionales, Estudios de cohortes, Estudios de casos y controles, Evaluación de pruebas diagnósticas, Evaluación económica Discusión, Bibliografía, Anex

Factors associated with health-related quality of life in adults with asthma. A cross-sectional study

Background: The measurement of health-related quality of life (HRQoL) is increasingly recognized as an important endpoint, as a reflection of the effects of the disease from a patient perspective. Our aim was to evaluate the factors determining the HRQoL in patients with asthma, according to the EQ-5D questionnaire. Methods: Patients were included using multi-stage sampling, from Primary Care clinics from all the Autonomous Communities in Spain. The patients included were: over 18 years-old, with a confirmed diagnosis of asthma for at least one year, and had visited a Health Centre in the previous 2 years. The characteristics of the asthma disease, the adherence to treatment, the socio-demographic variables, the smoking habits, and the asthma control were collected using a questionnaire. The influence of the different variables included in the study on the EQ-5D was evaluated using multivariate logistic regression analysis. Results: A total of 2,125 patients were finally included (57.7% females, mean age 48 years). The response rate was 95.4%. Some factors showed a considerable detrimental effect on the HRQoL of asthmatics. Advanced age, lower educational level and poor control of asthma are significantly associated with a worse quality of life in all the dimensions assessed by the EQ-5D scale. The baseline severity of the asthma, and having been admitted to hospital are related to a worse quality of life in 5 of the 6 dimensions analyzed. Conclusion: In our study, we could identify some factors related to quality of life in asthma patients. The most important were advanced age, lower education level, and poor control of the asthma.S

Excess risk attributable to traditional cardiovascular risk factors in clinical practice settings across Europe - The EURIKA Study

<p>Abstract</p> <p>Background</p> <p>Physicians involved in primary prevention are key players in CVD risk control strategies, but the expected reduction in CVD risk that would be obtained if all patients attending primary care had their risk factors controlled according to current guidelines is unknown. The objective of this study was to estimate the excess risk attributable, firstly, to the presence of CVD risk factors and, secondly, to the lack of control of these risk factors in primary prevention care across Europe.</p> <p>Methods</p> <p>Cross-sectional study using data from the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA), which involved primary care and outpatient clinics involved in primary prevention from 12 European countries between May 2009 and January 2010. We enrolled 7,434 patients over 50 years old with at least one cardiovascular risk factor but without CVD and calculated their 10-year risk of CVD death according to the SCORE equation, modified to take diabetes risk into account.</p> <p>Results</p> <p>The average 10-year risk of CVD death in study participants (N = 7,434) was 8.2%. Hypertension, hyperlipidemia, smoking, and diabetes were responsible for 32.7 (95% confidence interval 32.0-33.4), 15.1 (14.8-15.4), 10.4 (9.9-11.0), and 16.4% (15.6-17.2) of CVD risk, respectively. The four risk factors accounted for 57.7% (57.0-58.4) of CVD risk, representing a 10-year excess risk of CVD death of 5.66% (5.47-5.85). Lack of control of hypertension, hyperlipidemia, smoking, and diabetes were responsible for 8.8 (8.3-9.3), 10.6 (10.3-10.9), 10.4 (9.9-11.0), and 3.1% (2.8-3.4) of CVD risk, respectively. Lack of control of the four risk factors accounted for 29.2% (28.5-29.8) of CVD risk, representing a 10-year excess risk of CVD death of 3.12% (2.97-3.27).</p> <p>Conclusions</p> <p>Lack of control of CVD risk factors was responsible for almost 30% of the risk of CVD death among patients participating in the EURIKA Study.</p

Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state: a multicentre cohort study (SAM-COVID-19)

Objectives: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters. Methods: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs). Results: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22-0.47; p < 0.001) for tocilizumab, 0.82 (0.71-1.30; p 0.82) for IHDC, 0.61 (0.43-0.86; p 0.006) for PDC, and 1.17 (0.86-1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02-0.17; p < 0.001). Conclusions: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situatio

Sesgos de confusión por indicación y gravedad en estudios observacionales Confounding bias due to indication and severity in observational studies

Los estudios observacionales están sujetos a sesgos que pueden conducir a una interpretación errónea de los resultados. El presente estudio tuvo como objetivo determinar la influencia del tratamiento con omeprazol sobre la duración de la baja laboral en pacientes con esguince de tobillo que tomaban antiinflamatorios no esteroideos. Se utilizaron los registros de la base de datos de la mutua Ibermutuamur. En contra de lo esperado, se observó que los pacientes que recibieron omeprazol presentaron una baja más prolongada que los que no recibieron omeprazol. Es probable que estos hallazgos se deban a la influencia de un sesgo de confusión por gravedad, pues los pacientes que recibieron omeprazol presentaban un esguince más grave, aunque no se puede descartar un sesgo de confusión por indicación. Para evitar la influencia de estos errores sistemáticos se deben controlar los sesgos a lo largo de todo el estudio, desde el diseño hasta el análisis de los datos.<br>Observational studies are subject to biases that may lead to misinterpretation of the results. This study aimed to determine the influence of omeprazole treatment on the duration of sick leave in patients with ankle sprains treated with non-steroidal anti-inflammatory drugs. We used the Ibermutuamur database. Contrary to our expectations, sick leave was longer in patients who received omeprazole than in those who did not. These findings were probably due to the influence of a bias due to confounding by severity, given that patients who received omeprazole had a worse kind of ankle sprain; however, a bias due to confounding by indication cannot be excluded. To avoid the influence of these systematic errors, biases should be monitored from the design stage to the data analysis stage

EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics

Background : There is limited information about patterns of use of newer antithrombotic drugs in patients with acute coronary syndromes (ACS) in a real-life setting. The effectiveness, safety and cost-effectiveness of potential combinations during hospitalization, the duration of therapies, interruptions, or discontinuations as well as their reasons and possible consequences are unknown. Methods : EPICOR (NCT01171404) is a prospective, multinational, observational study on patients discharged after a hospitalization for an ACS with 2-year follow-up. The study is designed to describe the patterns of antithrombotic use and to evaluate potential differences in short-and long-term clinical outcomes (ischemic and bleeding events), quality of life and economic impact associated with initial combinations during hospitalization, and treatment duration, discontinuations, or interruptions and their reasons after discharge in different clinical environments. Results : Between September 1, 2010, and March 31, 2011, 10,568 consecutive patients surviving an ACS (4943 with ST-segment elevation myocardial infarction, and 5625 with non-ST-segment elevation ACS) were enrolled from 555 hospitals in 20 countries from 4 pre-defined regions: Northern Europe (n = 3,782), Southern Europe (n = 2,337), Eastern Europe (n = 2,380), and Latin America (n = 2,069). Pre- and in-hospital management and outcomes were recorded, with a special focus on antithrombotic therapies and ischemic and bleeding events. Changes in antithrombotic treatments and outcomes are currently being registered during the planned 24-month follow-up. Conclusion : EPICOR will show current patterns of antithrombotic use during hospitalization and after discharge in 'real-world' patients with ACS, allowing exploration of potential differences in clinical outcomes, quality of life, and costs related to the different antithrombotic practice patterns

Factors associated with health-related quality of life in adults with asthma. A cross-sectional study

Abstract Background The measurement of health-related quality of life (HRQoL) is increasingly recognized as an important endpoint, as a reflection of the effects of the disease from a patient perspective. Our aim was to evaluate the factors determining the HRQoL in patients with asthma, according to the EQ-5D questionnaire. Methods Patients were included using multi-stage sampling, from Primary Care clinics from all the Autonomous Communities in Spain. The patients included were: over 18 years-old, with a confirmed diagnosis of asthma for at least one year, and had visited a Health Centre in the previous 2 years. The characteristics of the asthma disease, the adherence to treatment, the socio-demographic variables, the smoking habits, and the asthma control were collected using a questionnaire. The influence of the different variables included in the study on the EQ-5D was evaluated using multivariate logistic regression analysis. Results A total of 2,125 patients were finally included (57.7% females, mean age 48 years). The response rate was 95.4%. Some factors showed a considerable detrimental effect on the HRQoL of asthmatics. Advanced age, lower educational level and poor control of asthma are significantly associated with a worse quality of life in all the dimensions assessed by the EQ-5D scale. The baseline severity of the asthma, and having been admitted to hospital are related to a worse quality of life in 5 of the 6 dimensions analyzed. Conclusion In our study, we could identify some factors related to quality of life in asthma patients. The most important were advanced age, lower education level, and poor control of the asthma.</p

Structured management strategy versus usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials

Background: Gastroesophageal reflux disease (GERD) has a major impact at the primary care level and there is a need to evaluate whether the diagnosis and therapeutic management of GERD in Europe needs to be improved

Teleost IgD + IgM - B cells mount clonally expanded and mildly mutated intestinal IgD responses in the absence of lymphoid follicles

Immunoglobulin D (IgD) is an ancient antibody with dual membrane-bound and fluid-phase antigen receptor functions. The biology of secreted IgD remains elusive. Here, we demonstrate that teleost IgD+IgM- plasmablasts constitute a major lymphocyte population in some mucosal surfaces, including the gut mucosa. Remarkably, secreted IgD binds to gut commensal bacteria, which in turn stimulate IgD gene transcription in gut B cells. Accordingly, secreted IgD from gut as well as gill mucosae, but not the spleen, show a V(D)J gene configuration consistent with microbiota-driven clonal expansion and diversification, including mild somatic hypermutation. By showing that secreted IgD establishes a mutualistic relationship with commensals, our findings suggest that secreted IgD may play an evolutionary conserved role in mucosal homeostasis.Lucia González and Beatriz Abós are greatly acknowledged for technical assistance. This work was supported by the European Research Council (ERC Consolidator Grant 725061), the Spanish Ministry of Science, Innovation, and Universities (project AGL2017-85494-C2-1-R), and the Comunidad de Madrid (grant 2016-T1/BIO-1672)