A cross-sectional analysis of medical conditions and environmental factors associated with fractional exhaled nitric oxide (FeNO) in women and children from the ISA birth cohort, Costa Rica.

BACKGROUND: Fractional exhaled nitric oxide (FeNO) is a marker of airway inflammation. Elevated FeNO has been associated with environmental exposures, however, studies from tropical countries are limited. Using data from the Infants' Environmental Health Study (ISA) birth cohort, we evaluated medical conditions and environmental exposures' association with elevated FeNO. METHODS: We performed a cross-sectional analysis of 277 women and 293 8-year old children who participated in the 8-year post-partum visit in 2019. We measured FeNO and collected information on medical conditions and environmental exposures including smoke from waste burning, work in banana plantations, and home pesticide use. We defined elevated FeNO as >25 ppb for women and >20 ppb for children. To evaluate factors associated with elevated FeNO, we used logistic regression models adjusted for obesity in women and unadjusted in children. RESULTS: Overall elevated FeNO was common (20% of women, 13% of children). Rhinitis diagnosis was significantly associated with elevated FeNO in both women (odds ratio (OR): 3.67 95% Confidence Interval (CI): 1.81,7.35) and children (OR: 8.18 95%CI: 3.15, 21.22); wheeze was associated with elevated FeNO in women (OR: 4.50 95% CI: 2.25, 8.99). Environmental exposures were associated with elevated FeNO, but not significantly. Waste burning was associated with elevated FeNO in both women (OR: 1.58 95%CI 0.68, 4.15) and children (OR: 2.49 95%CI:0.82, 10.79). Para-occupational pesticide exposures were associated with elevated FeNO in women and children. For women, having a partner working in agriculture was associated with elevated FeNO (OR: 1.61 95%CI:0.77, 3.58) and for children, maternal work in agriculture was associated with elevated FeNO. (OR 2.08 95%CI 0.86, 4.67) CONCLUSION: Rhinitis and wheeze were associated with elevated FeNO in this rural, agricultural population. Smoke from waste burning as well as para-occupational pesticide exposure may contribute to elevated FeNO in rural communities.

Demonstrating proof of concept for value-based agreements in Europe: two real-world cases.

OBJECTIVES: Value-based agreements (VBAs) link access, reimbursement, or price to the real-world usage and impact of a medicine, thereby enabling patient access while reducing clinical or financial uncertainty for the payer. VBAs have the potential to support improved patient outcomes, given the value-oriented approach to care, and lead to overall savings, while enabling payers to share risk and reduce uncertainty. METHODS: This commentary outlines the key challenges, enablers, and a framework for successful implementation by comparing the experience of two VBAs for AstraZeneca medicines, aiming to increase confidence in their future use. RESULTS: Engagement by payers, manufacturers, physicians, and provider institutions, and robust data collection systems that are accessible, simple to use, and add little burden to physicians were key to successfully negotiating a VBA that worked for all stakeholders. In both country systems, a legal/policy framework enabled innovative contracting. CONCLUSIONS: These examples demonstrate proof of concept for VBA implementation in different settings, and may inform future VBAs.

[Playful Learning: a tool for Environmental Education]. / Aprendizaje a través de estrategias lúdicas: una herramienta para la Educación Ambiental.

Introduction: Playful learning for environmental education represents a participatory pedagogical mediation that considers the socio-environmental realities in which persons are immersed. Objective: To promote environmental education, through playful, participatory, and flexible methods, to prevent pesticide exposure. Methodology: Using geographic information systems, the distances between schools and bananas plantations were calculated. A playful and constructivism methodology was designed for primary school students (6 - 8.5 years), and their legal guardians. Subsequently, 148 workshops were developed in 37 rural Costa Rican schools, in which 2757 children and 387 adults participated. Results: Thirty-eight percent (38 %) (n=14) of the schools were located at less than 100 meters from banana plantations. Playful communication generated a participatory environment, in which local needs were identified and collective knowledge was built about the effects of pesticide exposure on the environment and human health. Participants were able to identify the main preventive actions to reduce pesticide exposure. Conclusions: Playful, participatory, and flexible methodologies in environmental education facilitate the process of sensitizing first cycle primary school students and their parents from rural communities about the risks of exposure to pesticides. The methodology used can be easily adapted for application in other environmental science studies.

Eliminación y prevención de la deficiencia de yodo en mujeres gestantes de Perú / Elimination and prevention of iodine deficiency in pregnant women from Peru

RESUMEN La deficiencia de yodo (DI) causa daño a través de todos los ciclos de la vida, la vulnerabilidad es mayor durante la gestación y la infancia. La yodación universal de la sal (IUS) para consumo humano es la estrategia más costo-efectiva y sostenible para su control. Perú ha logrado la eliminación sostenida de los desórdenes por deficiencia de yodo (DDI) desde 1994. Objetivo: Determinar la efectividad del programa nacional de control de los DDI y la estrategia IUS para satisfacer el mayor requerimiento de yodo y asegurar la nutrición óptima de yodo de las mujeres embarazadas de la sierra, una región con severa deficiencia natural de yodo. Material y Métodos: El estudio ha incluido a 489 mujeres embarazadas de la sierra, seleccionadas entre las asistentes a control pre natal en los centros asistenciales. En cada sujeto se verificó el consumo de sal yodada y se colectó una muestra casual de orina para el análisis de la concentración de yodo y creatinina. Resultados: Según la encuesta de admisión el 99.6 % de los hogares consumen sal yodada. La mediana global de la concentración urinaria de yodo (CUI) 209 µg/L está dentro del rango adecuado para gestantes y demuestra un estado nutricional de yodo normal. La concentración de creatinina en la orina es normal. Conclusión: Estos resultados confirman la eficiencia y el éxito del programa nacional para la eliminación sostenida de los DDI, garantizando la nutrición normal de yodo durante la gestación y, por lo tanto, previniendo el riesgo de daño cerebral de los recién nacidos cada año en la sierra.

ABSTRACT Iodine is an essential element for synthesizing thyroid hormones, it is also essential for cell metabolism and tissue development, especially in the brain. Iodine requirements are higher during pregnancy and lactation. Iodine deficiency (ID) is a widespread condition all over the world; it is frequent in Peruvian highlands and rainforest. ID causes damage in all life periods, and vulnerability for this is greater during pregnancy and infancy. Universal salt iodination (USI) for human use is the most cost-effective and sustainable strategy for controlling ID. Peru has achieved the sustained elimination of iodine deficiency disorders (IDD) since 1994. Objective. To determine the effectiveness of the national program for controlling IDDs and the USI strategy for complying with the increased iodine requirement and to assure optimal iodine nutrition in pregnant women from the Peruvian highlands, a region with severe natural iodine deficiency. Material and Methods. The study included 489 pregnant women from the highlands, who were selected from those attending prenatal assessment in healthcare centers. Iodinated salty consumption was verified in each subject and a casual urine sample was collected for measuring iodine and creatinine concentration. Results. According to the admission survey, 99.6% of household use iodinated salt. The overall mean of iodine urine concentration (IUC) was 209 µg/L, which is well within the adequate range for pregnant women, and it shows a normal iodine nutrition status. The creatinine urinary concentration was normal. Conclusion. These results confirm the efficiency and success of the national program for the sustained elimination of IDDs, assuring normal iodine nutritional supply during pregnancy; and, therefore, preventing the risk for brain damage in newborns every year in the highlands.

The economic burden of disease of epithelial ovarian cancer in Spain: the OvarCost study.

OBJECTIVE: To assess the economic burden of epithelial ovarian cancer (EOC) in incident patients and the burden by disease stage in Spain. METHODS: We developed a Markov model from a social perspective simulating the natural history of EOC and its four stages, with a 10-year time horizon, 3-week cycles, 3% discount rate, and 2016 euros. Healthcare resource utilization and costs were estimated by disease stage. Direct healthcare costs (DHC) included early screening, genetic counselling, medical visits, diagnostic tests, surgery, chemotherapy, hospitalizations, emergency services, and palliative care. Direct non-healthcare costs (DNHC) included formal and informal care. Indirect costs (IC) included labour productivity losses due to temporary and permanent leaves, and premature death. Epidemiology data and resource use were taken from the literature and validated for Spain by the OvarCost group using a Delphi method. RESULTS: The total burden of EOC over 10 years was 3102 mill euros: 15.1% in stage I, 3.9% in stage II, 41.0% in stage III, and 40.2% in stage IV. Annual average cost/patient was €24,111 and it was €8,641; €14,184; €33,858, and €42,547 in stages I-IV, respectively. Of total costs, 71.2% were due to DHC, 24.7% to DNHC, and 4.1% to IC. CONCLUSIONS: EOC imposes a significant economic burden on the national healthcare system and society in Spain. Investment in better early diagnosis techniques might increase survival and patients' quality of life. This would likely reduce costs derived from late stages, consequently leading to a substantial reduction of the economic burden associated with EOC.

Utilidad de la ecocardiografía en la detección de la insuficiencia cardiaca en un adulto joven con síndrome de origen anómalo de la arteria coronaria izquierda del tronco de la arteria pulmonar y válvula mitral asimétrica similar al paracaídas / Use of echocardiography in the detection of heart failure in a young adult with anomalous left coronary artery from the pulmonary artery syndrome andparachute-like asymmetric mitral valve

Resumen Objetivo: describir un caso de un paciente joven con insuficiencia cardiaca, secundaria a dos malformaciones cardiacas infrecuentes, síndrome de ALCAPA y válvula mitral asimétrica, parecida al paracaídas, resaltando la utilidad de la ecocardiografía. Métodos: se analiza el caso a la luz de la literatura médica. Conclusiones: El origen anómalo de la arteria coronaria izquierda del tronco de la arteria pulmonar y la válvula mitral asimétrica parecida al paracaídas, son malformaciones raras, asociadas a insuficiencia mitral severa e insuficiencia cardiaca. No se encontraron reportes en la literatura acerca de la coexistencia de las dos patologías en un paciente.

Abstract Objective: To describe a case of a young adult with heart failure, secondary to two rare cardiac malformations, anomalous left coronary artery from the pulmonary artery (ALCAPA) syndrome and parachute-like asymmetric mitral valve, highlighting the use of echocardiography. Material and methods: A case is analysed along with a search in the medical literature. Conclusions: The anomalous origin of left coronary artery from the pulmonary artery and parachute-like asymmetric mitral valve are rare malformations associated with severe mitral insufficiency and heart failure. No reports were found in the literature as regards the existence of these two diseases in a patient.

Financial consequences of a payment-by-results scheme in Catalonia: gefitinib in advanced EGFR-mutation positive non-small-cell lung cancer.

BACKGROUND: In 2011 the first payment-by-results (PbR) scheme in Catalonia was signed between the Catalan Institute of Oncology (ICO), the Catalan Health Service, and AstraZeneca (AZ) for the introduction of gefitinib in the treatment of advanced EGFR-mutation positive non-small-cell lung cancer. The PbR scheme includes two evaluation points: at week 8, responses, stabilization and progression were evaluated, and at week 16 stabilization was confirmed. AZ was to reimburse the total treatment cost of patients that failed treatment, defined as progression at weeks 8 or 16. OBJECTIVE: To estimate the financial consequences of this PbR reimbursement model and determine the perception of the stakeholders involved in the agreement. METHODS: Differential drug costs between two scenarios, with and without the PbR, were calculated. A qualitative investigation of the organizational elements was performed by interviewing the parties involved in the agreement. RESULTS: Forty-one patients were included from June 2011 to October 2013 and assessed at two evaluation points. Clinical results were comparable to those observed in the pivotal studies of gefitinib. The difference in the cost of gefitinib using the PbR compared to the traditional purchasing scenario was 6.17% less at 8 weeks, 11.18% at 16 weeks and 4.15% less for the overall treatment. The PbR resulted in total savings of around €36,000 (€880 per patient). From an operational and organizational perspective, the availability of adequate data systems to measure outcomes and monitor accountability and the involvement of healthcare professionals were acknowledged as crucial. CONCLUSIONS: Tangible and intangible benefits were identified with respect to the interests of the parties involved. This has led to the incorporation of innovation for patients under acceptable conditions.

Caffeine stimulates locomotor activity in the mammalian spinal cord via adenosine A1 receptor-dopamine D1 receptor interaction and PKA-dependent mechanisms.

Caffeine is a potent psychostimulant that can have significant and widely variable effects on the activity of multiple neuronal pathways. The most pronounced caffeine-induced behavioral effect seen in rodents is to increase locomotor activity which has been linked to a dose-dependent inhibition of A1 and A(2A) receptors. The effects of caffeine at the level of the lumbar spinal central pattern generator (CPG) network for hindlimb locomotion are lacking. We assessed the effects of caffeine to the locomotor function of the spinal CPG network via extracellular ventral root recordings using the isolated neonatal mouse spinal cord preparation. Addition of caffeine and of an A1 receptor antagonist significantly decreased the cycle period accelerating the ongoing locomotor rhythm, while decreasing burst duration reversibly in most preparations suggesting the role of A1 receptors as the primary target of caffeine. Caffeine and an A1 receptor antagonist failed to stimulate ongoing locomotor activity in the absence of dopamine or in the presence of a D1 receptor antagonist supporting A1/D1 receptor-dependent mechanism of action. The use of caffeine or an A1 receptor blocker failed to stimulate an ongoing locomotor rhythm in the presence of a blocker of the cAMP-dependent protein kinase (PKA) supporting the need of this intracellular pathway for the modulatory effects of caffeine to occur. These results support a stimulant effect of caffeine on the lumbar spinal network controlling hindlimb locomotion through the inhibition of A1 receptors and subsequent activation of D1 receptors via a PKA-dependent intracellular mechanism.

Corrección del simbléfaron posquirúrgico a través de autoplastia conjuntival autóloga: reporte de un caso / Correction of postoperative symblepharon by means of conjunctival autolologous autoplasty. A case report

El simbléfaron posquirúrgico es una complicación oftalmológica que consiste en la adhesión total o parcial de la conjuntiva tarsal y el globo ocular causado por una cicatriz; donde resultan complicaciones secundarias que afectan la anatomía oculofacial y la función visual. Objetivo: Ilustrar el resultado de la autoplastia conjuntival autóloga como tratamiento del simbléfaron posquirúrgico. Presentación de caso: Se presenta un caso de simbléfaron posquirúrgico que luego de someterse a varias cirugías de pterigion evolucionó con insuficiencia de células límbicas, conjuntivalización de la córnea y simbléfaron. El paciente evolucionó favorablemente luego de recibir tratamiento quirúrgico por autoplastia conjuntival autóloga, se recuperó la motilidad ocular y se redujo el astigmatismo y un palpable ahorro de recursos sin sacrificar la efectividad del proceder quirúrgico. Conclusiones: El tratamiento del simbléfaron posquirúrgico mediante la autoplastia conjuntival autóloga, permite adoptar una conducta adecuada, reportando un saldo favorable en la recuperación del paciente(AU)

Postoperative symblepharon is an ophtalmalogical complication consisting of a total or partial adherence of the tarsal conjunctiva and the eyeball caused by a scar, resulting in secondary complications that affect both oculofacial anatomy and visual function. Objective: To illustrate the result of the conjunctival autolologous autoplasty as a treatment for postoperative symblepharon. Case presentation: A postoperative case of symblepharon is presented after having various surgical interventions of pterygium, who evolved with an insufficiency of limbic cells, conjunctiva of the cornea and symblepharon. The patient evolved satisfactorily after having the surgical treatment with conjunctival autolologous autoplasty, he recovered eye movement and astigmatism was reduced and there was a notorious saving of resources was achieved without sacrificing the effectiveness of the surgical procedure. Conclusions: The treatment of Postoperative symblepharon with conjunctival autolologous autoplasty allows to adopt an adequate medical conduct with a very favorable patient recovery(AU)

Corrección del simbléfaron posquirúrgico a través de autoplastia conjuntival autólogaReporte de un caso / Correction of postoperative symblepharon by means of conjunctival autolologous autoplastyA case report

Fundamento: El simbléfaron posquirúrgico es una complicación oftalmológica que consiste en la adhesión total o parcial de la conjuntiva tarsal y el globo ocular causado por una cicatriz; donde resultan complicaciones secundarias que afectan la anatomía oculofacial y la función visual. Objetivo: Ilustrar el resultado de la autoplastia conjuntival autóloga como tratamiento del simbléfaron posquirúrgico. Presentación de caso: Se presenta un caso de simbléfaron posquirúrgico que luego de someterse a varias cirugías de pterigion evolucionó con insuficiencia de células límbicas, conjuntivalización de la córnea y simbléfaron. El paciente evolucionó favorablemente luego de recibir tratamiento quirúrgico por autoplastia conjuntival autóloga, se recuperó la motilidad ocular y se redujo el astigmatismo y un palpable ahorro de recursos sin sacrificar la efectividad del proceder quirúrgico. Conclusiones: El tratamiento del simbléfaron posquirúrgico mediante la autoplastia conjuntival autóloga, permite adoptar una conducta adecuada, reportando un saldo favorable en la recuperación del paciente.

Background: Postoperative symblepharon is an ophtalmalogical complication consisting of a total or partial adherence of the tarsal conjunctiva and the eyeball caused by a scar, resulting in secondary complications that affect both oculofacial anatomy and visual function. Objective: To illustrate the result of the conjunctival autolologous autoplasty as a treatment for postoperative symblepharon. Case presentation: A postoperative case of symblepharon is presented after having various surgical interventions of pterygium, who evolved with an insufficiency of limbic cells, conjunctiva of the cornea and symblepharon. The patient evolved satisfactorily after having the surgical treatment with conjunctival autolologous autoplasty, he recovered eye movement and astigmatism was reduced and there was a notorious saving of resources was achieved without sacrificing the effectiveness of the surgical procedure. Conclusions: The treatment of Postoperative symblepharon with conjunctival autolologous autoplasty allows to adopt an adequate medical conduct with a very favorable patient recovery.

Intervención educativa sobre quemaduras por agentes físicos al personal de enfermería del Policlínico Universitario Norte de Morón / Educative intervention on burns by physical agents to the nursing personnel from North Moron University Policlinic

Se realizó un estudio pre-experimental en el periodo comprendido entre los meses de mayo y junio del 2010, con el objetivo de aumentar el nivel de conocimiento del personal de enfermería del Policlínico Universitario Norte de Morón, acerca de las quemaduras por agentes físicos, a través de un programa de intervención educativa. El universo del trabajo lo constituyeron los 166 enfermeros de este centro y se tomó una muestra al azar de 64 de estos, se les aplicó una encuesta para evaluar el nivel de conocimiento. Luego se implementó el programa educativo que constó con 6 sesiones, que se ejecutaron con una frecuencia de dos veces por semana y por espacio de 3 semanas. Se cumplió los objetivos propuestos en la investigación, se aplicó nuevamente la encuesta y se comprobaron los resultados obtenidos antes y después de la intervención educativa, los resultados mostraron, que el porciento más elevado de la muestra fue de licenciados en enfermería de los cuales la mayoría tenían entre 10 y 14 años de experiencia laboral y que al realizar la intervención se aumentó significativamente el nivel de conocimiento del personal de enfermería (AU)

A pre-experimental study was carried out in the period between May and June 2010, with the objective to increase the knowledge level of the nursing personnel from North Moron University Policlinic, about burns by physical agents, through an educative intervention program. The universe was constituted by 166 nurses of this center and the sample was 64, that a survey was applied to evaluate the knowledge level. Then it was implemented the educative program that consisted of 6 sections, that it was executed with a frequency of twice a week and at least 3 weeks, allowing fulfill the objectives proposed in the investigation, soon the survey was applied again and the results obtained before and after the educative intervention were verified, the results showed, that the most elevated percent of the sample was nursing professional of which the majority were between 10 and 14 years of work experience and when the intervention was made, the level of nursing personnel knowledge increased (AU)

Costes y factores asociados a las respuestas óptima y subóptima al tratamiento del trastorno depresivo mayor en atención primaria / Costs and associated factors with optimal and suboptimal responses to the treatment of major depressive disorder

Objetivo: Evaluar el cumplimiento, la persistencia y los costes del tratamiento del trastorno depresivo mayor (TDM) en el ámbito de atención primaria, haciendo énfasis en aspectos diferenciales de aquellos pacientes con una respuesta subóptima al tratamiento antidepresivo (AD) inicial. Diseño: Diseño observacional retrospectivo realizado a partir de registros poblacionales de Badalona Serveis Assistencials. Criterios de inclusión: edad ≥ 18 años, inicio del episodio durante 2008-2009 y estar en tratamiento AD al menos 8 semanas tras la primera prescripción. El seguimiento fue de 12 meses. Dos grupos de estudio: pacientes con respuesta subóptima/remisión. Principales mediciones: sociodemográficas, cumplimiento y persistencia del tratamiento, costes sanitarios (directos e indirectos). Resultados: Se analizaron 2.260 sujetos (media edad: 58,8 años, 74% mujeres). El 42,7% (IC95%: 40,0-46,4%) presentó respuesta subóptima al tratamiento. Estos pacientes tenían una media de edad mayor, mayor proporción de mujeres y de pensionistas respecto al grupo de remisión, así como de comorbilidad. También peores porcentajes de cumplimiento (65,1 frente a 67,7%) y persistencia del tratamiento a los 12 meses (31,8 frente a 53,2%), respectivamente; p<0,001. Los costes sanitarios/anuales fueron de 826,1 € para pacientes con respuesta subóptima frente a 451,2 € en los pacientes en remisión; pérdidas de productividad de 1.842,0 frente a 991,4 €, respectivamente; p<0,001. Los factores asociados a la respuesta subóptima fueron: falta de cumplimiento (OR=1,7), años de enfermedad (OR=1,2), edad (OR=1,1) y presencia de comorbilidad (OR=1,1). Conclusiones: Los pacientes con respuesta subóptima al tratamiento AD inicial presentaron mayor comorbilidad, menor cumplimiento terapéutico y ocasionaron mayores costes totales, especialmente en pérdidas de productividad laboral(AU)

Objective: To evaluate the compliance, persistence and costs of the treatment of major depressive disorder (MDD) in the setting of Primary Care, placing emphasis on the different aspects of those patients with an initial suboptimal response to antidepressant treatment. Design: A retrospective observational study using the population registers of Badalona Healthcare Services. The inclusion criteria consisted of; age ≥18 years, initial episode during 2008-2009, and to be on antidepressant treatment for at least 8 weeks after the first prescription. The follow-up was 12 months. Two study groups were formed, patients with suboptimal response, and remission. Main measurements: Sociodemographic data, compliance and adherence to treatment, health costs (direct and indirect).ResultsA total of 2,260 subjects were analysed (mean age 58.8 years, 74% women). Just under half (42.7%, 95% CI; 40.0-46.4%) had a suboptimal response to the treatment. These patients had a higher mean age, a higher proportion of women, and pensioners, as well as higher comorbidity, compared to the remission group. They also had poorer compliance percentages (65.1% vs. 67.7%) and treatment persistence at 12 months (31.8% vs. 53.2%), respectively, P<0.001. The annual health costs were, 826.1€ for patients with a suboptimal response vs. 451.2€ in patients in remission; loss of productivity 1,842.0€ vs. 991.4€, respectively; P<0.001. The factors associated to a suboptimal response were; lack of compliance (OR=1.7), years with the disorder (OR=1.2), age (OR=1.1) and presence of comorbidity (OR=1.1). Conclusions: The patients with an initial suboptimal response to antidepressant treatment had a higher comorbidity, lower therapeutic compliance, and incurred higher total costs, particularly in losses in work productivity(AU)

Assessment of pharmacological strategies for management of major depressive disorder and their costs after an inadequate response to first-line antidepressant treatment in primary care.

BACKGROUND: The aim of the study was to determine the most common treatment strategies and their costs for patients with an inadequate response to first-line antidepressant treatment (AD) in primary care. METHOD: A retrospective cohort study of medical records from six primary care centers was conducted. Adults with a major depressive disorder diagnosis, at least 8 weeks of AD treatment after the first prescription, and patient monitoring for 12 months were analyzed. Healthcare (direct cost) and non-healthcare costs (indirect costs; work productivity losses) were described. RESULTS: A total of 2,260 patients were studied. Forty-three percent of patients (N = 965) presented an inadequate response to treatment. Summarizing the different treatment approaches: 43.2% were switched to another AD, 15.5% were given an additional AD, AD dose was increased in 14.6%, and 26.7% remained with the same antidepressant agent. Healthcare/annual costs were 451.2 Euros for patients in remission vs. 826.1 Euros in those with inadequate response, and productivity losses were 991.4 versus 1,842.0 Euros, respectively (p < 0.001). CONCLUSION: Antidepressant switch was the most common therapeutic approach performed by general practitioners in naturalistic practice. A delay in treatment change when no remission occurs and a significant heterogeneity in management of these patients were also found.

[Costs and associated factors with optimal and suboptimal responses to the treatment of major depressive disorder]. / Costes y factores asociados a las respuestas óptima y subóptima al tratamiento del trastorno depresivo mayor en atención primaria.

OBJECTIVE: To evaluate the compliance, persistence and costs of the treatment of major depressive disorder (MDD) in the setting of Primary Care, placing emphasis on the different aspects of those patients with an initial suboptimal response to antidepressant treatment. DESIGN: A retrospective observational study using the population registers of Badalona Healthcare Services. The inclusion criteria consisted of; age ≥18 years, initial episode during 2008-2009, and to be on antidepressant treatment for at least 8 weeks after the first prescription. The follow-up was 12 months. Two study groups were formed, patients with suboptimal response, and remission. MAIN MEASUREMENTS: Sociodemographic data, compliance and adherence to treatment, health costs (direct and indirect). RESULTS: A total of 2,260 subjects were analysed (mean age 58.8 years, 74% women). Just under half (42.7%, 95% CI; 40.0-46.4%) had a suboptimal response to the treatment. These patients had a higher mean age, a higher proportion of women, and pensioners, as well as higher comorbidity, compared to the remission group. They also had poorer compliance percentages (65.1% vs. 67.7%) and treatment persistence at 12 months (31.8% vs. 53.2%), respectively, P<.001. The annual health costs were, 826.1€ for patients with a suboptimal response vs. 451.2€ in patients in remission; loss of productivity 1,842.0€ vs. 991.4€, respectively; P<.001. The factors associated to a suboptimal response were; lack of compliance (OR=1.7), years with the disorder (OR=1.2), age (OR=1.1) and presence of comorbidity (OR=1.1). CONCLUSIONS: The patients with an initial suboptimal response to antidepressant treatment had a higher comorbidity, lower therapeutic compliance, and incurred higher total costs, particularly in losses in work productivity.

The subjective well-being under neuroleptic scale - short version (SWN-K) and the SF-36 health survey as quality of life measures in patients with schizophrenia.

PURPOSE: The desired outcome in schizophrenia treatment has evolved from symptom management to maximization of quality of life and functional recovery. The aim of this study was to assess the relationship between a specific well-being measure, the Subjective Well-being under Neuroleptic Scale - short version (SWN-K), and the SF-36 Health Survey as a generic quality of life measure. PATIENTS AND METHODS: A multicenter, cross-sectional study was conducted with clinically stable outpatients diagnosed with schizophrenia. Spearman's rank correlation was used to assess the associations between the SWN-K total score, its five subscales, and the SF-36 domains. RESULTS: Ninety-seven patients were included in the study. The mean age was 35 years (standard deviation = 10) and 72% were male. All correlations among domains were positive and most were statistically significant. The bodily pain domain of the SF-36 presented the lower correlations with the SWN-K (rho range 0.10-0.25), whereas the other seven domains correlated significantly (rho range 0.49-0.60, all P < 0.001). The largest correlations were obtained between the SWN-K and the SF-36 domains of general health (rho = 0.53), mental health (rho = 0.60), and vitality (rho = 0.54). CONCLUSION: The positive but nevertheless moderate correlations observed between a specific well-being instrument and a generic quality of life scale supports the inclusion of diagnosis-specific tools for outcome assessment of patients with schizophrenia.

Estimation of a multiattribute utility function for the Spanish version of the TooL questionnaire.

OBJECTIVES: To estimate and assess the psychometric properties of a multiattribute utility function (MAUF) for the Spanish version of the Tolerability and Quality of Life (TooL questionnaire). METHODS: Balanced data on 243 patients diagnosed with schizophrenia or bipolar disorder were gathered. In addition to the demographic and clinical variables and the usual generic health-related quality of life (HRQoL) questionnaires (EuroQol-5D [EQ-5D] and Short Form-6D [SF-6D]), instruments considered included the Spanish versions of the Positive and Negative Symptoms of Schizophrenia Scale (PANSS), Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Rating Scale (MADRS), Udvalg for Kliniske Undersogelser (UKU), and Clinical Global Impression Severity (CGIS) scale. MAUF parameters estimation involved a number of visual analogue scale (VAS) and time trade-off (TTO) ratings that proved difficult to be performed by the patients. After checking for inconsistencies in patient responses, the original sample was reduced to a still balanced subsample of 70 individuals. A multiplicative-form MAUF was estimated following the standard methodology. RESULTS: Good convergent validity was demonstrated because utility estimates from the MAUF presented strong correlations with utilities from the generic HRQoL instruments included: SF-6D (0.66, P < 0.01), EQ-5D (0.69, P < 0.01), and moderate correlations with the rest of instruments considered: PANSS (-0.27, P = 0.10), YMRS (-0.30, P = 0.08), MADRS (-0.48, P < 0.01), UKU (-0.35, P < 0.01). Criterion validity was also met because differences in mean utilities by clinical severity were found (P < 0.01). Utilities from the MAUF covered a wider range of health states [0.04,1.00] than those from the SF-6D [0.53,1.00] and EQ-5D [0.23,0.96]. CONCLUSIONS: Utilities from the MAUF showed good psychometric properties, serving as a complement to generic health utilities. If misapplied, however, utilities from this instrument might favor the positive evaluation of drugs showing fewer associated side effects.

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. Encontra 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, desdeel diseño hasta el análisis de los datos (AU)

Observational studies are subject to biases that may lead to mis interpretation of the results. This studyaimed 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 (AU)

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

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.

Validation of a specific measure to assess health-related quality of life in patients with schizophrenia and bipolar disorder: the 'Tolerability and quality of life' (TOOL) questionnaire.

BACKGROUND: Perception of quality of life may differ depending on the perspective. The aim of the study was to assess the psychometric properties of the Spanish version of the 'TOlerability and quality Of Life' (TOOL) questionnaire, a specific self-rated instrument to evaluate the impact of side effects of antipsychotic drugs on health-related quality of life (HRQoL). The questionnaire consists of eight items answered on a four-point Likert scale. METHODS: A psychometric study was conducted with clinically stable outpatients with schizophrenia and bipolar disorder under antipsychotic treatment. The translation and cultural adaptation of the questionnaire was performed according to international standards. Internal consistency using the Cronbach α coefficient and test-retest reliability using the intraclass correlation coefficient (ICC) was used to assess the reliability of the instrument. Patients completed generic and specific measures of quality of life and clinical severity. RESULTS: A total of 238 patients were analysed, with a mean age of 42 years (SD 10.9). The mean completion time was 4.9 min (SD 4.4). Internal consistency and intraclass correlation coefficient were adequate (Cronbach α = 0.757 and ICC = 0.90). Factorial analysis showed a unidimensional structure (a single eigenvalue >1, accounting for 39.1% of variance). Significant Spearman's rank correlations between the TOOL and both generic and specific measures were found. The questionnaire was able to discriminate among the Clinical Global Impression - Severity scores (Mann-Whitney U test, P < 0.001). CONCLUSIONS: The TOOL questionnaire shows appropriate feasibility, reliability, and discriminative performance as a patient-reported outcome. TOOL constitutes a valuable addition to measure the impact of adverse events of antipsychotic drugs from the patient perspective.

Pattern of healthcare resource utilization and direct costs associated with manic episodes in Spain.

BACKGROUND: Although some studies indicate that bipolar disorder causes high health care resources consumption, no study is available addressing a cost estimation of bipolar disorder in Spain. The aim of this observational study was to evaluate healthcare resource utilization and the associated direct cost in patients with manic episodes in the Spanish setting. METHODS: Retrospective descriptive study was carried out in a consecutive sample of patients with a DSM-IV diagnosis of bipolar type I disorder with or without psychotic symptoms, aged 18 years or older, and who were having an active manic episode at the time of inclusion. Information regarding the current manic episode was collected retrospectively from the medical record and patient interview. RESULTS: Seven hundred and eighty-four evaluable patients, recruited by 182 psychiatrists, were included in the study. The direct cost associated with healthcare resource utilization during the manic episode was high, with a mean cost of nearly 4,500 euros per patient, of which approximately 55% corresponded to the cost of hospitalization, 30% to the cost of psychopharmacological treatment and 10% to the cost of specialized care. CONCLUSIONS: Our results show the high cost of management of the patient with a manic episode, which is mainly due to hospitalizations. In this regard, any intervention on the management of the manic patient that could reduce the need for hospitalization would have a significant impact on the costs of the disease.