A Cost-per-Number Needed to Treat Analysis Assessing the Efficiency of Biologic Drugs in Moderate to Severe Plaque Psoriasis. / Evaluación de la eficiencia de los tratamientos biológicos en la psoriasis moderada a grave en España: análisis de coste por número necesario a tratar (NNT).

BACKGROUND AND OBJECTIVES: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis. METHODS: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug). RESULTS: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45mg > ustekinumab 90mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45mg > ustekinumab 90mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90mg > ustekinumab 45mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period. CONCLUSIONS: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment.

On heterogeneity of treatment effects and clinical freedom.

Three decades ago, John R Hampton announced the death of clinical freedom. Since then, evidence-based medicine has been the predominant paradigm in clinical research. By applying a population-based approach, the randomised controlled trial has become the cornerstone for demonstrating the overall effect of a treatment and for developing guidelines. The new patient-centred medicine movement is rediscovering the important implications of heterogeneity of treatment effects for clinical practice and that a better understanding of such variability can contribute to improve health outcomes for individual patients through practicing a science-based clinical freedom.

Medicina basada en la evidencia y medicina centrada en el paciente: algunas reflexiones sobre su integración / Evidence based medicine and patient centered medicine: some thoughts on their integration

La medicina basada en la evidencia (MBE) y la medicina centrada en el paciente (MCP) son dos corrientes que han surgido con fuerza en los sistemas sanitarios en los últimos años. La MBE tiene un enfoque poblacional y su objetivo primordial es la generalización y la mejora de los resultados sanitarios en el promedio de los pacientes. La MCP tiene un enfoque individual, busca la particularización y la mejora de los resultados sanitarios en los pacientes individuales. Mientras que el anclaje conceptual de la MBE es la investigación, el de la MCP es el cuidado médico. A pesar de que MBE y MCP puedan parecer corrientes antagónicas, los profundos cambios que están teniendo lugar en los sistemas sanitarios, pueden facilitar el progresivo «reencuentro» de la investigación y la práctica clínica. El presente artículo constituye una reflexión sobre cómo los métodos de investigación deberían acercarse al paciente individual y la práctica médica debería acercarse a los futuros pacientes. La MBE y la MCP, al igual que la investigación y la práctica médica, son las dos caras de la misma moneda, que deberían complementarse y nutrirse mutuamente. Es difícil entender que una de ellas pueda alcanzar todo su potencial sin tener a la otra como continua referencia. Porque no debería practicarse una MCP que no estuviese basada en la mejor evidencia disponible, ni es posible imaginar una MBE cuyo objetivo final este alejado del paciente individual (AU)

Evidence based medicine (EBM) and patient centered medicine (PCM) are two movements that have emerged with great force in health systems in recent years. EBM has a population approach, and its primary objective is the generalization and improvement of health outcomes in the average patient. PCM has a personalized approach, focuses on individualization and improving health outcomes in specific patients. While EBM has its conceptual anchor in research, PCM has it in medical care. Despite EBM and PCM may be perceived as conflicting movements, the profound changes that are currently taking place in health systems can facilitate the confluence of clinical research and medical care. This article constitutes a reflection on how research methods should approach the individual patient and medical practice should approach future patients. EBM and PCM, like research and medical practice are two sides of the same coin, which should complement and aid each other. It is difficult to see how one of them can reach its full potential without the other as a continual reference. Because PCM should not be practiced without being based on the best available evidence and it is impossible to imagine an EBM whose ultimate goal is disconnected from the individual patient (AU)

Prasugrel compared to clopidogrel in patients with acute coronary syndrome undergoing percutenaous coronary intervention: a Spanish model-based cost effectiveness analysis.

OBJECTIVE: To assess the long-term cost-effectiveness of 12 months treatment of prasugrel compared to clopidogrel in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in the Spanish health care system. METHODS: A Markov state transition model was developed to estimate health outcomes, quality adjusted life years (QALYs), life years (LY), and costs over patients' lifetimes. Clinical inputs were based on an analysis of the TRITON-TIMI 38 clinical trial. Hospital readmissions captured during the trial in a sub-study of patients from eight countries (and subsequent re-hospitalisations modelled to accrue beyond the time horizon of the trial), were assigned to Spanish diagnosis-related group payment schedules to estimate hospitalisation costs. RESULTS: Mean total treatment costs were ?11,427 and ?10,910 for prasugrel and clopidogrel respectively. The mean cost of the study drug was ?538 higher for prasugrel vs. clopidogrel, but rehospitalisation costs at 12 months were ?79 lower for prasugrel due to reduced rates of revascularisation. Hospitalisation costs beyond 12 months were higher with prasugrel by ?55, due to longer life expectancy (+0.071 LY and +0.054 QALYs) associated with the decreased nonfatal myocardial infarction rate in the prasugrel group. The incremental cost per life year and QALY gained with prasugrel was ?7,198, and ?9,489, respectively. CONCLUSION: Considering a willingness-to-pay threshold of ?30,000/QALY gained in the Spanish setting, prasugrel represents a cost-effective option in comparison with clopidogrel among patients with ACS undergoing PCI.

Objetivo: Evaluar a largo plazo el coste-efectividad de 12 meses de tratamiento con prasugrel frente a clopidogrel en pacientes con síndrome coronario agudo (SCA) sometidos a intervención coronaria percutánea (ICP) desde la perspectiva del sistema nacional de salud español. Métodos: Se desarrolló un modelo de Markov de transición entre estados para estimar los resultados en salud, los años de vida ajustados por calidad (AVACs), los años de vida (AV) y los costes a lo largo de la vida de los pacientes. Los datos clínicos fueron obtenidos de un análisis del ensayo clínico TRITON-TIMI 38. Los reingresos hospitalarios registrados durante el ensayo en un subestudio de pacientes provenientes de ocho países, (y las subsiguientes rehospitalizaciones fueron modeladas para acumularse más alla del horizonte temporal del ensayo) fueron asignados a grupos relacionados con el diagnóstico españoles para estimar los costes de hospitalización. Resultados: Los costes medios totales del tratamiento con prasugrel y clopidogrel fueron 11.427 ??y 10.910 ?, respectivamente. El coste medio del fármaco fue 538 ??superior para prasugrel frente a clopidogrel, pero los costes de rehospitalización a los 12 meses fueron 79 ??menores para prasugrel debido a la reducción en las tasas de revascularización. Los costes de hospitalización más allá de los 12 meses fueron 55 ??superiores con prasugrel, debido a la mayor esperanza de vida (+0,071 AV y +0,054 AVACs) asociada a la reducción de la tasa de infartos de miocardio no mortales en el grupo de prasugrel. El coste-efectividad incremental por año de vida y AVAC ganado con prasugrel fue 7.198 ??y 9.489 ?, respectivamente. Conclusión: Considerando el umbral de disponibilidad a pagar de 30.000 ?/ AVAC para España, prasugrel representa una opción coste-efectiva en comparación con clopidogrel en pacientes con SCA sometidos a ICP.

Evidence based medicine and patient centered medicine: some thoughts on thier integration.

Evidence-based medicine (EBM) and patient-centered medicine (PCM) are two movements that have emerged with great force in health systems in recent years. EBM has a population approach, and its primary objective is the generalization and improvement of health outcomes in the average patient. PCM has a personalized approach, focuses on individualization and improving health outcomes in specific patients. While EBM has its conceptual anchor in research, PCM has it in medical care. Despite EBM and PCM being perceived as conflicting movements, the profound changes that are currently taking place in health systems can facilitate the confluence of clinical research and medical care. This article constitutes a reflection on how research methods should approach the individual patient and medical practice should approach future patients. EBM and PCM, like research and medical practice, are two sides of the same coin, which should complement and aid each other. It is difficult to see how one of them can reach its full potential without the other as a continual reference, because PCM should not be practiced without being based on the best available evidence and it is impossible to imagine an EBM whose ultimate goal is disconnected from the individual patient.

La depresión: una hipoteca social. Últimos avances en el conocimiento del coste de la enfermedad / Depression: a social mortgage. Latest advances in knowledge of the cost of the diasease

Introducción. Tras la realización del último examen sobre la situación mundial de la salud mental, la Organización Mundial de la Salud ha estimado que la depresión produce la mayor disminución en salud en comparación con otras enfermedades crónicas y ha instado a todos los países a aumentar las inversiones y la cobertura de servicios en esta materia. Metodología. A la hora de invertir recursos en el cuidado de los pacientes con depresión, los estudios de costes de la enfermedad son complementarios a los de morbimortalidad y de gran relevancia a la hora de establecer políticas sanitarias. La finalidad de este trabajo es describir el impacto económico de la depresión en nuestro entorno a la luz de las últimas publicaciones a este respecto. Resultados. El coste total de la depresión en Europa se ha estimado en 118 billones de euros, y la mayor parte de esta cifra (61%) se debe a los costes indirectos referidos a bajas por enfermedad y pérdidas de productividad. La carga económica de la depresión en España ascendería a 5.005 millones de euros anuales, con una distribución por categoría de recursos muy parecida a la europea. Conclusiones. Los sistemas sanitarios y la sociedad tienen que hacer frente al alto coste de la depresión dado que conlleva una elevada utilización de recursos, principalmente fuera del sector sanitario. Existen diversas áreas de mejora con el objetivo de reducir la carga social de la depresión, pero la incorporación de la economía de la salud mental a las políticas sanitarias debe convertirse en una prioridad (AU)

Introduction. Following the latest examination of the worldwide mental health situation, the World Health Organization has estimated that depression produces the greatest decrement in health compared with other chronic diseases, and has encouraged to all countries to increase investment and resources in this field. Methodology. On investing resources for the care of patients with depression, cost of illness studies are a complement to morbidity-mortality studies, and are of great relevance in defining health care policies. The present study describes the economic impact of depression in our setting, in the light of the most recent publications on this subject. Results. The total cost of depression in Europe has been estimated to reach 118 billion euros, and most of this amount (61 %) is due to indirect costs associated with sick leave and productivity losses. The economic burden of depression in Spain could add up to 5.005 million euros a year, with a resource category distribution very similar to that found in Europe as a whole. Conclusions. Health care systems and society must cope with the important costs of depression, which implies intense resource utilization, fundamentally outside the health care sector as such. There are a number of areas in which improvements can be made in order to reduce this important burden associated with depression, though the incorporation of health economics to public health care policies must become a priority (AU)

[Depression: a social mortgage. Latest advances in knowledge of the cost of the disease]. / La depresión: una hipoteca social. Ultimos avances en el conocimiento del coste de la enfermedad.

INTRODUCTION: Following the latest examination of the worldwide mental health situation, the World Health Organization has estimated that depression produces the greatest decrement in health compared with other chronic diseases, and has encouraged to all countries to increase investment and resources in this field. METHODOLOGY: On investing resources for the care of patients with depression, cost of illness studies are a complement to morbidity-mortality studies, and are of great relevance in defining health care policies. The present study describes the economic impact of depression in our setting, in the light of the most recent publications on this subject. RESULTS: The total cost of depression in Europe has been estimated to reach 118 billion euros, and most of this amount (61 %) is due to indirect costs associated with sick leave and productivity losses. The economic burden of depression in Spain could add up to 5.005 million euros a year, with a resource category distribution very similar to that found in Europe as a whole. CONCLUSIONS: Health care systems and society must cope with the important costs of depression, which implies intense resource utilization, fundamentally outside the health care sector as such. There are a number of areas in which improvements can be made in order to reduce this important burden associated with depression, though the incorporation of health economics to public health care policies must become a priority.

Cost of severe hypoglycaemia in patients with type 1 diabetes in Spain and the cost-effectiveness of insulin lispro compared with regular human insulin in preventing severe hypoglycaemia.

OBJECTIVES: To determine the costs of severe hypoglycaemia (SH) in a population of patients with type 1 diabetes mellitus in the Spanish healthcare system and the cost-effectiveness of insulin lispro over regular insulin in preventing SH episodes. METHODS: A retrospective study of 100 patients in three Spanish health centres was performed. Resource utilisation data were collected only for interventions specifically relating to the hypoglycaemic episode. The direct medical costs determined in the analyses were: costs of hospitalisation, diagnostic tests carried out, costs of treatment administered and other associated costs such as visits to the endocrinologist and re-training in glucose control, transportation and assistance of a care-giver. In addition, indirect costs such as days of lost productivity were measured. The incidence rates of SH for insulin lispro and regular insulin were obtained from the literature. The incremental cost-effectiveness of insulin lispro over regular insulin was calculated. RESULTS: The overall mean cost per episode of SH was 366 euro, comprised of 65.4% direct costs and 35.6% indirect costs. The largest cost was for hospitalisation at 183 euro per episode. The SH episodes incidence rates for 100 patients per year were 33 and 73 for insulin lispro and 48 (p < 0.05) and 117 (p < 0.01) for regular insulin, in the two clinical trials found in the literature. The additional cost to prevent one episode of SH with insulin lispro over regular insulin ranged from 277 euro to insulin lispro dominance. CONCLUSIONS: Severe hypoglycaemia has a significant impact on the total cost of diabetes. The use of insulin lispro is associated with reductions in annual costs because of SH and, possibly, the overall effect may be cost neutral or cost saving when total costs are considered. The cost of SH should be included in the analysis of total socio-economic burden of diabetes.

Tabaquismo: de remedio a enfermedad / Tobaccco smoke: from remedy to disease

El tabaquismo es la principal causa evitable de incapacidad y muerte en la mayoría de los países desarrollados. Para muchos gobiernos es un problema de salud pública y por tanto su prevención y consumo exige medidas reguladoras. No siempre se ha tenido una conciencia tan clara, como ahora, del daño físico del tabaquismo sobre el organismo. En este artículo hacemos un repaso de la relación tabaco-sociedad a lo largo de los siglos, desde su introducción en Europa hasta nuestros días (AU)

Tobacco addiction is the main avoidable cause of incapacity and eath in the majority of the developed countries. It is a public health problem for many governments and it´s prevention and consume requires regulation norms so. Not always existed a clear conscience, as now, of the physical damage to the organism done by tobacco. In this article we make a review of the tobacco-society relationship beyond the centuries, from it´s European introduction to our days (AU)

[Spanish scientific production in diagnostic and therapeutic research area of respiratory system in international journals from 1990 to 2002]. / Producción española en revistas internacionales en el área de técnicas diagnósticas y terapéuticas del sistema respiratorio en el periodo 1990 a 2002.

OBJECTIVE: The aim of this study were: to analyze the spanish production in diagnostic and therapeutics research area of respiratory system in international journals from 1990 to 2002. MATERIAL AND METHODS: Papers published in diagnostic and therapeutics area of respiratory system during this period of time were selected by the PUBMED system. We delimited the production with key words: respiratory system and the one that is used by the diagnostic and therapeutics research area. RESULTS: We obtain a total of 67 document published in international journals by spanish authors. The scientific production in the diagnostic and therapeutics area have stabilized in this 12 years period. The distribution of articles by the institutional affiliation and province of authors also showed a wide dispersion: Barcelona and Clinic and Provincial Hospital of Barcelona were responsible for 43.1% and 23.8% of all the production. Bronchoalveolar lavage and the use of telescopic catheter were the type of diagnostic and therapeutic procedure more productive. CONCLUSIONS: The scientific production in the diagnostic and therapeutics area of respiratory system have stabilized in this 12 years period, this evidence contrast with the high growth detected in respiratory system in general.

Producción española en revistas internacionales en el área de técnicas diagnósticas y terapéuticas del sistema respiratorio en el periodo 1990 a 2002 / Spanish scientific production in diagnostic and therapeutic research area of respiratory system in interantional journals from 1999 to 2002

Objetivo: El objetivo de este trabajo fue determinar la aportación de autores españoles a la ciencia internacional en el área temática de técnicas diagnósticas y terapéuticas del sistema respiratorio, en el período 1990 a 2002. Material y métodos: Se efectuó una búsqueda de los artículos publicados entre 1990 a 2002 incluidos en PUB-MED. La estrategia de busca se centró en las palabras clave (PC): respiratory system y en aquellas relacionadas con los procedimientos diagnósticos y terapéuticos empleados en sistema respiratorio. Resultados: Se obtuvieron 67 artículos, sobre el motivo a estudio, de autores españoles publicados en revistas internacionales. Se ha mantenido una producción estable a lo largo de los años entre 2 y 5 artículos por año, siendo los neumólogos los más productivos en este tema. Aunque existe una dispersión de la producción según la distribución de los artículos por provincias e instituciones españolas fue Barcelona (43,1%) y el Hospital Clinic i Provincial de Barcelona (23,8%) quienes concentraron un mayor número de artículos en el período estudiado. Los procedimientos diagnóstico terapéuticos más productivos fueron el lavado broncoalveolar y el uso del catéter telescopado en la fibrobroncoscopia. Conclusiones: La producción, en el área de técnicas diagnósticas y terapéuticas de sistema respiratorio en revistas internacionales, se mantiene estable, sin una tendencia definida, lo que contrasta con el gran aumento de producción que ha experimentado el sistema respiratorio

Objective: The aim of this study were: to analyze the spanish production in diagnostic and therapeutics research area of respiratory system in international journals from 1990 to 2002. Material and methods: Papers published in diagnostic and therapeutics area of respiratory system during this period of time were selected by the PUB-MED system. We delimited the production with key words: respiratory system and the one that is used by the diagnostic and therapeutics research area. Results: We obtain a total of 67 document published in international journals by spanish authors. The scientific production in the diagnostic and therapeutics area have stabilized in this 12-years period. The distribution of articles by the institutional affiliation and province of authors also showed a wide dispersion: Barcelona and Clinic and Provincial Hospital of Barcelona were responsible for 43,1% and 23,8% of all the production. Bronchoalveolar lavage and the use of telescopic catheter were the type of diagnostic and therapeutic procedure more productive. Conclusions: The scientific production in the diagnostic and therapeutics area of respiratory system have stabilized in this 12-years period, this evidence contrast with the high growth detected in respiratory system in general

The validity and reliability of the global index of safety (GIS).

OBJECTIVE: The global index of safety (GIS) is an adverse event (AE) based instrument designed to evaluate the safety profile of drugs. This paper presents the evaluation of the inter-rater reliability and validity of a 94-item GIS for antipsychotics through Rasch analysis. RESEARCH DESIGN AND METHODS: A total of 194 psychiatrists participating in an outpatient pharmacoepidemiologic study of olanzapine in schizophrenia rated the severity that each AE would have on a 5-point scale. Reliability was determined through a paired comparison design involving the new independent ratings of 101 different psychiatrists participating in another study of olanzapine in acute inpatient units. Spearman's, Pearson's and Intra-class correlation (ICC) coefficients were used to estimate the inter-rater reliability of the AE weights. Validity was analyzed through the Rasch rating scale model. RESULTS: Reliability coefficient estimates were excellent (Spearman = 0.99, Pearson = 0.99, ICC = 0.98), supporting the inter-rater reliability of the item weights. Through goodness-of-fit statistics and the investigation of the hierarchy of item calibrations, Rasch analysis confirmed the validity of the instrument. CONCLUSION: The data presented here on inter-rater reliability estimates of adverse events related to antipsychotic drugs indicate that GIS is a promising alternative for the evaluation of the safety profile of drugs.

[Economic analyses of olanzapine in the treatment of schizophrenia and bipolar disorder]. / Análisis económico de la olanzapina en el tratamiento de la esquizofrenia y el trastorno bipolar.

Schizophrenia generates important costs for society both direct, as a consequence of hospitalization and outpatient treatment, and indirect; related to loss of productivity. The atypical antipsychotics, such as olanzapine, have supposed an important advance in the treatment of schizophrenia. The greater cost of atypical antipsychotics with respect to conventional drugs has led to the conduction of pharmacoeconomic studies to determine its efficiency. This article reviews the complete pharmacoeconomic studies that compare olanzapine with haloperidol and risperidone in the treatment of schizophrenia. Cost analyses comparing olanzapine and haloperidol show that the former drug does not add increased cost to therapy, and even contributes to lessen expenses fundamentally as a result of a decrease in hospitalizations. In the economic evaluations comparing olanzapine and risperidone, the results are not conclusive, and in general, the total costs associated with both treatments were similar. In the treatment of bipolar disorder, although few studies have estimated the economic impact of olanzapine, it has been observed a reduction of hospitalization costs associated to the treatment with olanzapine.

Análisis económico de la olanzapine en el tratamiento de la esquizofrenia y el trastorno bipolar / Economic analyses of olanzapine in the treatment of shizophrenia and bipolar disorder

La esquizofrenia es una enfermedad que genera importantes costes para la sociedad, tanto directos, derivados principalmente de la hospitalización y el tratamiento ambulatorio, como indirectos, debidos a la pérdida de productividad de los pacientes. Los antipsicóticos atípicos como la olanzapina han supuesto un avance muy importante en el tratamiento de la esquizofrenia. Su mayor coste respecto a los antipsicóticos convencionales como el baloperidol ha impulsado la realización de estudios farmacoeconómicos encaminados a evaluar su rentabilidad. En el presente trabajo se revisan las evaluaciones farmacoeconómicas completas que comparan la olanzapina con el haloperidol y la risperidona comparando olazanzapina con el haloperidol y la risperidona en el tratamiento de la esquizofrenia. Los análisis de costes comparando olanzapina y haloperidol ponen de manifiesto que la olanzapina no añade costes al tratamiento de la esquizofrenia, produciendo incluso disminución en los mismos debido fundamentalmente a una menor hospitalización. En las evaluaciones económicas que comparaban olanzapina y risperidona los resultados no son concluyentes y en general los costes totales asociados a ambos tratamientos fueron similares. En el tratamiento del trastorno bipolar; aunque las evaluaciones económicas realizadas hasta la fecha son escasas, se observó una reducción en los costes de hospitalización asociada al tratamiento con olanzapina (AU)

Schizophrenia generates important cost for society-both direct. As a consequence of hospitalization and outpatient treatment, and indirect; related to loss of productivity. The atypical antipsychotics, such as olanzapine, have supposed an important advance in the treatment of schizophrenia. The greater cost of atypical antipsychotics with respect to conventional drugs had led to the conduction of pharmacoeconomic studies to determine its efficiency. This article reviews the complete pharmacoeconomic studies that compare olanzapine with haloperidol and risperidone in the treatment of schizophrenia. Cost analyses comparing olanzapine and haloperidol show that the former drug does not add increased cost to therapy, and even contributes to lessen expenses fundamentally as a result of a decrease in hospitalizations. In the economic evaluations comparing olanzapine and risperidone, the results are not conclusive, and in general, the total cost associated with both treatment were similar. In the treatments were similar: In the treatment of bipolar disorder, although few studies have estimated the economic impact of olanzapine, it has been observed a reduction of hospitalization costs associated to the treatment with olanzapine (AU)

Endobronchial brachytherapy in the treatment of malignant lung tumours.

A prospective study was made to assess the short-term clinical and endoscopic response to high-dose-rate endobronchial brachytherapy (HDREB) in patients with malignant endobronchial tumours. From July 1995 to May 2000, 288 HDREB sessions were carried out on 81 patients. The mean patient age was 61.57 yrs (range 34-82); males were predominant (87.65%). Tumours were primary in 76 patients (93.82%) and metastatic in five patients (6.18%). The inclusion criteria were malignant endobronchial tumour and either palliative treatment for incurable disease or intent-to-cure treatment for residual malignancy on the bronchial resection surface after surgery or an inoperable tumour. The exclusion criteria were as follows: impediments to catheter placement, expected survival <2 months, Karnofsky index <60, or absence of informed consent. The clinical response of a symptom was categorised as complete (disappearance of the symptom), partial (less than complete) or absent. The endoscopic response was considered to be complete if lesions disappeared and biopsy findings remained negative 1 month after the last radiation session; partial if lesions improved to some extent, but the biopsy findings were positive; and absent if there was no change in relation to baseline. The technique consisted of delivering high-dose irradiation from an Ir192 source to a target volume using one or two endobronchial catheters inserted under optical or video bronchoscopic guidance. Four sessions were scheduled at weekly intervals and 500 cGy was applied per session over a length of 1-9 cm, measured 0.5-1 cm from the centre of the source. In total, 85% of the symptoms analysed (haemoptysis, cough, dyspnoea, expectoration, and stridor) disappeared with HDREB, which was categorised as a complete response. The endoscopic response was complete in 56.79% of patients, partial or less than complete in 40.74% and absent in 2.46%. One major complication occurred (bronchial fistula 1.2%), but no lethal haemoptysis. Minor complications (pneumonitis, bronchospasm and bronchial stenosis) each occurred in one patient (1.2%). High-dose-rate endobronchial brachytherapy is a good palliative treatment for endoluminal lung neoplasms, effectively alleviating symptoms and endoscopic evidence in many cases with an acceptable rate of complications. High-dose-rate endobronchial brachytherapy can be carried out as an intent-to-cure procedure in highly selected cases.

Psychometric validation of a generic health-related quality of life measure (EQ-5D) in a sample of schizophrenic patients.

OBJECTIVE: The aim of this study was to evaluate the construct validity of a generic health related quality of life (HRQOL) instrument - the EQ-5D - in a sample of schizophrenic patients receiving antipsychotic treatment. RESEARCH DESIGN AND METHODS: A total of 2128 schizophrenic patients treated with olanzapine, 417 treated with risperidone, and 112 with haloperidol responded to the EQ-5D. The study also assessed the effect of patient age, gender, and co-morbidity variables on patient's HRQOL Main outcomes measures: EQ-5D scores at the start of treatment and after 3 and 6 months of therapy were compared with results from the Clinical Global Impression (CGI) severity of illness scale and the (GAF) scale. The effect of antipsychotics and sociodemographic variables on patient's HRQOL over time was tested through a three-factor doubly multivariate repeated measures MANCOVA. RESULTS: High scores in the GAF scale and low scores in the CGI were linked with high scores on the EQ-5D scale. The correlational effects observed between the EQ-5D and the clinical indices ranged from 0.33 to 0.54. A significant effect of 'visit time' as well as an interaction of 'visit time' x drug, 'visit time' x gender, and 'visit time' x co-morbidity was observed. CONCLUSIONS: Results suggest the EQ-5D is a valid instrument capable of detecting HRQOL differences between schizophrenic patients with different degrees of severity of illness.

Bone mineral density referral for dual-energy X-ray absorptiometry using quantitative ultrasound as a prescreening tool in postmenopausal women from the general population: a cost-effectiveness analysis.

The aim of our study was to assess, from the perspective of the National Health Services in Spain, the cost-effectiveness of quantitative ultrasound (QUS) as a prescreen referral method for bone mineral density (BMD) assessment by dual-energy X-ray absorptiometry (DXA) in postmenopausal women of the general population. Using femoral neck DXA and heel QUS. We evaluated 267 consecutive postmenopausal women 65 years and older and attending primary care physician offices for any medical reason. Subjects were classified as osteoporotic or nonosteoporotic (normal or osteopenic) using the WHO definition for DXA. Effectiveness was assessed in terms of the sensitivity and specificity of the referral decisions based on the QUS measurement. Local costs were estimated from health services and actual resource used. Cost-effectiveness was evaluated in terms of the expected cost per true positive osteoporotic case detected. Baseline prevalence of osteoporosis evaluated by DXA was 55.8%. The sensitivity and specificity for the diagnosis of osteoporosis by QUS using the optimal cutoff thresholds for the estimated heel BMD T-score were 97% and 94%, respectively. The average cost per osteoporotic case detected based on DXA measurement alone was 23.85 euros. The average cost per osteoporotic case detected using QUS as a prescreen was 22.00 euros. The incremental cost-effectiveness of DXA versus QUS was 114.00 euros per true positive case detected. Our results suggest that screening for osteoporosis with QUS while applying strict cufoff values in postmenopausal women of the general population is not substantially more cost-effective than DXA alone for the diagnosis of osteoporosis. However, the screening strategy with QUS may be an option in those circumstances where the diagnosis of osteoporosis is deficient because of the difficulty in accessing DXA equipment.

A Rasch model analysis to test the cross-cultural validity of the EuroQoL-5D in the Schizophrenia Outpatient Health Outcomes Study.

OBJECTIVE: To investigate the pan-European, cross-cultural validity of the EuroQol-5D (EQ-5D) for assessing quality of life in the Schizophrenia Outpatient Health Outcomes (SOHO) Study. METHOD: The EQ-5D items investigated were mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A Rasch rating scale model (a form of differential item functioning) was used to identify invariance of item calibrations for the 10 European countries participating in the SOHO study. RESULTS: There was general congruence in the EQ-5D item calibration pattern. The rank of average EQ-5D item calibrations was similar for all countries except Denmark. Denmark showed slight misfits for mobility and pain/discomfort. CONCLUSION: The EQ-5D is an appropriate measure of health-related quality of life across European countries and translations.

[What is an efficient health technology in Spain?]. / Qué es una tecnología sanitaria eficiente en España?

INTRODUCTION: Despite the growing recognition of the potential applications of cost-effectiveness assessments, a criterion to establish what is an efficient health technology does not exist in Spain. The objective of this work is to describe the limits and the criteria used in Spain to recommend the adoption of health interventions. METHOD: A review of the economic evaluations of health technologies published in Spain from 1990 to 2001 was conducted. Complete economic assessments in which the cost-effectiveness ratio was expressed as cost per life-year gained (LYG), cost per quality-adjusted-life-year (QALY) or cost per saved live were selected. Those interventions in which the authors established recommendations (adoption or rejection) and the criteria used were analyzed. RESULTS: Twenty (20%) of the 100 complete economic evaluations fulfilled the selection criteria. In16 studies, the results were expressed as cost per LYG, in 6 studies as cost per QALY and in 1 as cost per saved live. A total of 82 health interventions were assessed and some kind of recommendation was established in 44 of them. All technologies with a cost-effectiveness ratio lower than 30,000 euros (5 million pesetas) per LYG were recommended for adoption by the authors. Up to that limit there was no a clear tendency. CONCLUSIONS: Although the results must be interpreted with much precaution, given the limitations of the study, the limits of cost-effectiveness presented in this work could be a first reference to which would be an efficient health intervention in Spain.