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OBJECTIVES: To determine whether routinary walking activity and the derived neutrophil-to-lymphocyte ratio are associated with outcomes in patients with recurrent and/or metastatic squamous cell carcinoma of head and neck. METHODS: This multicenter retrospective cohort study included 64 patients diagnosed with recurrent and/or metastatic squamous cell carcinoma of head and neck and treated with immunotherapy (Programmed Death-1 and Programmed Death-ligand-1 proteins inhibitors) at two tertiary centers. We compared a group that performed uninterrupted physical activity for 1â¯h per day and controls who performed no activity. The derived neutrophil-to-lymphocyte ratio was calculated as follows: [neutrophils / (leukocytes - neutrophils)]. Progression-free survival and overall survival were evaluated. RESULTS: We included 28 (44%) and 36 (56%) patients in the activity and non-activity groups, respectively. Patient characteristics, treatment details, and tumor Programmed Death-ligand-1 expression were not associated with either progression-free survival or overall survival. Physical activity was an independent beneficial factor for progression-free survival (pâ¯<â¯0.001) and overall survival (pâ¯<â¯0.001). By contrast, a derived neutrophil-to-lymphocyte ratio <3.5 was an independent beneficial factor for overall survival (pâ¯=â¯0.013), but not for progression-free survival (pâ¯=â¯0.328). CONCLUSIONS: Walking one hour per day and having a high proportion of lymphocytes to neutrophiles (expressed as a low derived neutrophil-to-lymphocyte ratio) independently predict a better prognosis in patients with recurrent and/or metastatic squamous cell carcinoma of head and neck treated with immunotherapy. LEVEL OF EVIDENCE: III.
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The aim of this study was to analyse the impact of treating chronic hepatitis C (CHC) with direct-acting agents (DAA) on the use of healthcare resources. We included all patients treated with DAA for CHC from January 2015 to December 2017 in Catalonia whose medical records from 12 months before to 24 months after treatment were available. Data were obtained from the Catalan Health Surveillance System. A total of 12,199 patients in Catalonia were treated with DAA for CHC. Of these, 11.3% had no-minimal fibrosis (F0-F1), 24.0% had moderate fibrosis (F2), 50.3% had significant fibrosis or cirrhosis (F3-F4), and 14.4% had decompensated cirrhosis. Use of healthcare resources decreased from the pre-treatment period to the post-treatment period for the following: hospital admissions due to complications of cirrhosis, from 0.19 to 0.12 per month per 100 patients (RR 0.57; 95% CI 0.47-0.68); length of hospital stay, from 12.9 to 12.2 days (RR 0.93; 95% CI 0.91-0.94); outpatient visits, from 65.0 to 49.2 (RR 0.75; 95% CI 0.74-0.75); and number of medication containers per patient per month, from 13.9 to 12.5 (RR 0.837; 95% CI 0.835-0.838). However, the number of invoices for antineoplastic treatment increased after DAA treatment, especially for patients with high morbidity or advanced fibrosis stage. In conclusion, a decrease in health resource use was seen in CHC patients treated with DAA, as measured by length of hospital stay, number of admissions due to cirrhosis complications, outpatient visits and overall drug invoicing. However, use of antineoplastic drugs increased significantly, especially in patients with cirrhosis and high morbidity.
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Hepatitis C Crónica , Preparaciones Farmacéuticas , Antivirales/uso terapéutico , Gastos en Salud , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/epidemiología , Humanos , Cirrosis Hepática/tratamiento farmacológico , Cirrosis Hepática/epidemiologíaRESUMEN
BACKGROUND: Orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. METHODS: The assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. RESULTS: The final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. CONCLUSIONS: The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access.
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Producción de Medicamentos sin Interés Comercial/métodos , Análisis Costo-Beneficio , Toma de Decisiones , Técnicas de Apoyo para la Decisión , HumanosRESUMEN
OBJECTIVES: The aim of this study was to adapt and assess the value of a Multi-Criteria Decision Analysis (MCDA) framework (EVIDEM) for the evaluation of Orphan drugs in Catalonia (Catalan Health Service). METHODS: The standard evaluation and decision-making procedures of CatSalut were compared with the EVIDEM methodology and contents. The EVIDEM framework was adapted to the Catalan context, focusing on the evaluation of Orphan drugs (PASFTAC program), during a Workshop with sixteen PASFTAC members. The criteria weighting was done using two different techniques (nonhierarchical and hierarchical). Reliability was assessed by re-test. RESULTS: The EVIDEM framework and methodology was found useful and feasible for Orphan drugs evaluation and decision making in Catalonia. All the criteria considered for the development of the CatSalut Technical Reports and decision making were considered in the framework. Nevertheless, the framework could improve the reporting of some of these criteria (i.e., "unmet needs" or "nonmedical costs"). Some Contextual criteria were removed (i.e., "Mandate and scope of healthcare system", "Environmental impact") or adapted ("population priorities and access") for CatSalut purposes. Independently of the weighting technique considered, the most important evaluation criteria identified for orphan drugs were: "disease severity", "unmet needs" and "comparative effectiveness", while the "size of the population" had the lowest relevance for decision making. Test-retest analysis showed weight consistency among techniques, supporting reliability overtime. CONCLUSIONS: MCDA (EVIDEM framework) could be a useful tool to complement the current evaluation methods of CatSalut, contributing to standardization and pragmatism, providing a method to tackle ethical dilemmas and facilitating discussions related to decision making.
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Técnicas de Apoyo para la Decisión , Evaluación de Medicamentos , Producción de Medicamentos sin Interés Comercial , Toma de Decisiones , Humanos , Reproducibilidad de los ResultadosAsunto(s)
Antineoplásicos , Neoplasias , Evaluación de Medicamentos , Humanos , España , Reino UnidoRESUMEN
BACKGROUND: Introduction of new drugs is a dynamic process with a high impact on consumption and expenditure. OBJECTIVE: To analyze the prescription of new drugs and the associated costs in public health care in Catalunya, Spain, in 2002. The analysis also attempts a perspective of consumption in relation to the grade of therapeutic innovation of the new drugs. METHODS: Prescription data on all 86 new drugs licensed for use during 1998-2002 were analyzed, using the prescription item as unit and the cost. RESULTS: Prescription for new drugs in 2002 represented 4% of overall items prescribed and 13% of the cost. The mean new drug item cost was 39, while that of overall drugs was 13. New drug item increase over the previous year was 18.6% compared with 5.2% of the overall drugs, and the proportional cost increased by 25.7% and 9.9%, respectively. Ten new drugs represented 55.1% of the expenditure of this group. Antiasthmatic drugs represented 20.7% of the expenditure on new drugs, angiotensin-receptor blockers represented 18.6%, antiaggregants 9.7%, and nonsteroidal antiinflammatory drugs 6.9%. New drugs providing significant or modest therapeutic improvement represented 25.6% of overall new drug items and 32.3% of their cost. CONCLUSIONS: New drugs have a mean cost growth rate greater than that of existing drugs, with only a quarter of them offering advantages over existing drugs. More detailed evaluations of new medications are warranted before they can be recommended for general use so that a better distribution of the limited resources available may be made when prescribing drugs that are newly available through prescription.
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Aprobación de Drogas/economía , Prescripciones de Medicamentos/economía , Utilización de Medicamentos/economía , Gastos en Salud , Humanos , Estudios Retrospectivos , EspañaRESUMEN
No disponible
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Humanos , Errores de Medicación/estadística & datos numéricos , Anticoagulantes/efectos adversos , Factores de RiesgoRESUMEN
BACKGROUND: Our goal was to investigate the epidemiological characteristics and etiology of an outbreak of food-borne disease caused by Norwalk-like viruses, genogroup II. PATIENTS AND METHOD: We performed a historical cohort study on the consumption of 21 food items and clinical symptoms. We assessed RNA Norwalk-like viruses by RT- PCR in stool samples from 5 patients and 2 food-handlers. The potential involvement of each food item was assessed by relative risk at 95% confidence intervals (CI). RESULTS: The overall attack rate was 70.0% (7/10). The median incubation period was 35.0 hours. Symptoms included: vomits 85.7% (6/7), fever 85.7% (6/7) and diarrhoea 71.4% (5/7). Four food items were involved [fish (RR = 1.7; CI 95% 0.9-3.3); 'selection of cold meats' (RR = 1.6; CI 95% 0.9-2.7); yoghurt (RR = 1.5; CI 95% 1.0-2.4) and lamb (RR = 1.3; CI 95% 0.6-3.0)]. Three stool sample gave positive results for Norwalk-like viruses genogroup II. Important oversights in food-handlers' work were detected. CONCLUSIONS: RT-PCR enabled us to confirm the etiology of this outbreak as Norwalk-like viruses genogroup II. Although patients recovered quickly, the outbreak caused considerable public alarm.
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Botulismo/epidemiología , Botulismo/virología , Infecciones por Caliciviridae/complicaciones , Gastroenteritis/complicaciones , Norovirus/aislamiento & purificación , Infecciones por Caliciviridae/genética , Brotes de Enfermedades , Gastroenteritis/genética , Genotipo , Humanos , ARN Viral/genética , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , España/epidemiologíaRESUMEN
FUNDAMENTO: Investigar las características epidemiológicas y la etiología de un brote de toxiinfección alimentaria. PACIENTES Y MÉTODO: Se realizó un estudio de cohortes históricas sobre el consumo de 21 alimentos, síntomas clínicos y se determinó por PCR-RT la presencia del ARN del virus Norwalk-like en heces de 5 enfermos y de tres manipuladores. La implicación de cada alimento se determinó con el riesgo relativo (RR) y el intervalo de confianza (IC) del 95 por ciento. RESULTADOS: La tasa de ataque fue del 70,0 por ciento (7/10), la mediana del período de incubación de 35,0 h y los principales síntomas: vómitos (85,7 por ciento; 6/7), fiebre (85,7 por ciento; 6/7) y diarrea (71,4 por ciento; 5/7). Cuatro alimentos resultaron implicados: pescado a la marinera (RR = 1,7; IC del 95 por ciento, 0,9-3,3); entremeses (RR = 1,6; IC del 95 por ciento, 0,9-2,7); yogur (RR = 1,5; IC del 95 por ciento, 1,0-2,4) y cordero (RR = 1,3; IC del 95 por ciento, 0,63,0). Tres muestras de heces resultaron positivas para el virus Norwalk-like genogrupo II. Se detectaron defectos de manipulación de alimentos. CONCLUSIONES: La técnica de PCR permitió confirmar la etiología del brote como virus Norwalk genogrupo II. A pesar de que los enfermos se recuperan rápido, estos brotes tienen gran repercusión social. (AU)
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Humanos , ARN Viral , España , Infecciones por Caliciviridae , Mortalidad , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , Norovirus , Botulismo , Causas de Muerte , Brotes de Enfermedades , Gastroenteritis , GenotipoRESUMEN
Fundamento: El objetivo del estudio fue la investigación clínica, epidemiológica y microbiológica de un brote de toxiinfección alimentaria por el consumo de ostras. Pacientes y métodos: Se realizó un estudio de cohortes históricas sobre consumo de 15 alimentos y sintomatología de los casos. La implicación de cada alimento se estudió con el riesgo relativo estratificado de Mantel-Haenszel (RRM-H) y su intervalo de confianza (IC) del 95 por ciento y se confirmó mediante el análisis de dosis-respuesta con la prueba de la *2 de tendencia. Se investigaron las heces de 5 enfermos y de 2 manipuladores. Resultados: La tasa de ataque global fue del 38,0 por ciento (19/50). La mediana del período de incubación fue de 39,0 h (máximo de 62 y mínimo de 3 h). La proporción de síntomas fue: fiebre 17,6 por ciento (3/17), diarrea 57,9 por ciento (11/19), vómitos 84,2 por ciento (16/19), náuseas 89,5 por ciento (17/19) y dolor abdominal 89,5 por ciento (17/19). En el análisis estratificado, mientras las ostras mantuvieron su relación (RRM-H = 3,3; IC del 95 por ciento: 1,1-8,7), los caracoles de mar presentaron una reducción del valor de la RRM-H resultando no significativo (RRM-H = 2,8; IC del 95 por ciento: 0,9-41,1). El consumo de ostras presentó una prueba dosis-respuesta estadísticamente significativa (p = 0,005). El examen por microscopia electrónica detectó partículas virales de pequeño tamaño compatibles con virus Norwalk-like. La implicación de las ostras se comunicó a las autoridades sani- tarias. Conclusiones: Esta investigación demuestra la utilidad del análisis dosis-respuesta para aportar evidencias epidemiológicas, la implicación potencial del consumo de ostras en las toxiinfecciones por virus Norwalk-like y la necesidad de la investigación de los centros de producción para la prevención y control. (AU)