Effectiveness of nirsevimab introduction against respiratory syncytial virus in the Valencian Community: A preliminary assessment.

Respiratory syncytial virus (RSV) represents a high burden of disease in children and the primary cause of hospitalization, especially in children under 1 year old. In the Valencian Community (Spain), nirsevimab, a long-acting monoclonal antibody, was introduced for the RSV 2023-2024 season as a universal pre-exposure prophylaxis for high-risk children and those under 6 months old. This study examines its impact, coverage, and effectiveness. The campaign achieved 88.5 % coverage and 73.7 % of effectiveness. Analysis of over 27,000 susceptible children (over 24,000 immunized), showed that those immunized exhibited a threefold reduction in RSV incidence compared to non-immunized ones. To prevent one case, the number needed to immunize (NNI) was 63. Hospitalizations due to acute respiratory infections were almost two times lower in immunized children compared to non-immunized ones (0.9 % vs 1.6 %, respectively). These first results showcase the preliminary positive impact of this public health intervention.

Successful use of golimumab in a patient with ulcerative colitis refractory to infliximab and adalimumab.

OBJECTIVE: To report a case of successful use of golimumab (GLB) in a patient with ulcerative colitis (UC) refractory to infliximab (IFX) and adalimumab (ADA). CASE SUMMARY: A 60-year-old man was diagnosed with left UC and was given azathioprine 2.5 mg/kg to control UC symptoms and decrease corticosteroid patient dependence. Four years later, he developed adverse reaction to azathioprine and began treatment with mercaptopurine 1.5 mg/kg/day. Despite this treatment, he developed a severe relapse (Truelove-Witts modified: 15 points). Treatment with IFX 5 mg/kg at weeks 0, 2, 6, and every 8 weeks was started. After 1 year in clinical remission, the patient developed an infusion reaction to IFX, and IFX was suspended. The patient started treatment with ADA 40 mg every other week. After 2 years in clinical remission, ADA was suspended. 20 months after ADA discontinuation, the patient developed an acute episode of UC with a Truelove-Witts modified score of 16 points. ADA plus corticosteroid therapy was restarted. Despite these treatments, the patient's clinical condition did not improved. ADA 40 mg per week was started with not clinical improvement and with corticosteroid dependence after 4 months of ADA intensive therapy. The patient denied surgery, and cyclosporine was discarded because of its inability to be used as a maintenance drug. The patient started GLB with an induction dosage regimen of 200 mg subcutaneous at week 0, followed by 100 mg at week 2, and then maintenance therapy with 100 mg every 4 weeks (patient's weight = 84 kg), combined with mercaptopurine and corticosteroids. After 6 weeks of treatment, the patient achieved clinical remission, with just three non-bleeding stools per day, without stomach ache, apyretic, and no urgency or tenesmus rectal symptoms. One year later, the patient continued to be asymptomatic with a Truelove-Witts modified score of 2 points, corticoid-free treatment, and a complete clinical and endoscopic remission and normal calprotectin levels (< 15 µg/g). We decided to suspend mercaptopurine in order to avoid side effects derived from the combined treatment. After 1 year on GLB therapy, the patient continued in clinical remission. CONCLUSIONS: Based on our case, GLB could be selected as an effective approach for patients with UC refractory to IFX and ADA. However, further studies need to be performed to evaluate the efficacy of GLB therapy as a rescue treatment.

[Description of postauthorisation observational prospective studies with drugs in the valencian region between 2010 and 2015. Factors associated with their authorisation.] / Descripción de los estudios posautorización observacionales prospectivos con medicamentos en la Comunitat Valenciana entre 2010 y 2015.

OBJECTIVE: Postauthorisation observational studies are crucial source of information on drug effectiveness and safety. The objectives of this work were to describe the characteristics of the postauthorisation observational prospective studies (EPA-SP) for which authorisation was requested in the Valencian region, as well as to explore which factors influenced the aforementioned authorisation. METHODS: We performed a retrospective analytical study comprising all the EPA-SP for which authorisation was requested in the Valencian region between 2010 and 2015.The variables associated to the studies (e.g., objectives, studied drug, target disease) as well as those concerning the authorisation process itself (e.g., authorisation status, reason for authorisation refusal, current status of the study) were obtained from relevant databases. The analysis was divided into descriptive and analytical stages. RESULTS: We included a total of 249 studies, out of which 192 (77, 1%) aimed at estimating effectiveness or quality of life. The most frequent types of drugs involved in the studies were the antineoplastic and immunomodulating agents (42%). Only 57% of the studies were granted authorisation, with prescription induction and unusual practice being the most common causes for refusal (40.1% and 39.3%, respectively). The authorisation was linked to the diagnosis (circulatory system OR 10,7, IC95% 2,3 to 49,1), ATC L group (OR 4,2, IC95% 1,9 to 49,1) as well as to whether it had been advocated by the industry (OR 0,5, IC95% 0,3 to 0,9). CONCLUSIONS: Given the importance of having information on effectiveness and safety in usual practice, it is a priority for EPA-SP to be directed towards these aims and to promote independent research.

OBJETIVO: Los estudios posautorización observacionales son una fuente de información clave sobre efectividad y seguridad de los medicamentos. Los objetivos del estudio fueron describir las características de los estudios observacionales de seguimiento prospectivo (EPA-SP) que solicitaron autorización en la Comunitat Valenciana (CV) y explorar qué factores se asociaron con su autorización. METODOS: Se realizó estudio observacional analítico retrospectivo, en el que se incluyeron todos los EPA-SP que solicitaron autorización en la CV desde 2010 hasta 2015. A partir de las bases de datos de la Dirección General de Farmacia y Productos Sanitarios y GESTO se obtuvieron variables referentes al estudio (objetivos, medicamento estudiado, enfermedad diana, etc) y referentes al procedimiento de autorización (autorización, motivo de no autorización y estado actual del estudio). El análisis se organizó en una fase descriptiva y otra analítica mediante regresión logística con variable dependiente la autorización. RESULTADOS: Fueron incluidos un total de 249 estudios, de los que 192 (77,1%) estaban diseñados para estimar efectividad o calidad de vida. Los medicamentos más frecuentemente estudiados fueron los agentes antineoplásicos e inmunomoduladores (42%). Sólo consiguieron la autorización el 57%, siendo las causas más frecuente de denegación la inducción a la prescripción (40,1%) y la práctica no habitual (39,3%). La autorización se asoció con el diagnóstico (aparato circulatorio OR 10,7, IC95% 2,3 a 49,1), grupo ATC L (OR 4,2, IC95% 1,9 a 49,1) y el haber sido promovidos por la industria (OR 0,5, IC95% 0,3 a 0,9). CONCLUSIONES: Dada la importancia de contar con información sobre efectividad y seguridad en la práctica habitual, es prioritario que los EPA-SP sean orientados a estos fines y que se potencie la investigación independiente.

Legionella pneumophila pneumonia possibly due to ustekinumab therapy in a patient with Crohn's disease.

PURPOSE: A case report of Legionella pneumophila pneumonia associated with off-label use of ustekinumab in a patient with Crohn's disease (CD) is presented. SUMMARY: A 57-year-old man with longstanding CD was hospitalized with a four-day history of fever (38.5 °C), dyspnea, left pleuritic pain, and weight loss (more than 6 kg) about six weeks after beginning treatment with ustekinumab, a human monoclonal antibody approved in the United States for two indications (plaque psoriasis and psoriatic arthritis) and currently under investigation as a potential treatment for CD and other inflammatory disorders. During the preceding 25 years, the man had been treated for severe CD with a number of agents (e.g., infliximab, adalimumab, certolizumab); ultimately, off-label ustekinumab therapy (90 mg subcutaneously weekly) was initiated due to persistent severe CD symptoms. Chest x-ray studies at the time of admission demonstrated left upper lobar consolidation, and a urine antigen test was positive for L. pneumophila. The patient was treated with i.v. levofloxacin and methylprednisolone and discharged after two weeks. Ustekinumab was reintroduced (45 mg subcutaneously every two weeks), and the patient continued to receive the drug for 16 months, with clinical remission of CD symptoms and no further adverse events. A literature search identified two case reports of pneumonia associated with ustekinumab use, but neither case involved L. pneumophila. CONCLUSION: Pneumonia caused by L. pneumophila developed in a patient with CD treated with ustekinumab. Pneumonia symptoms resolved after ustekinumab was discontinued.

Descripción de los estudios posautorización observacionales prospectivos con medicamentos en la Comunitat Valenciana entre 2010 y 2015. Análisis de los factores relacionados con su autorización / Description of postauthorisation observational prospective studies with drugs in the valencian region between 2010 and 2015. Factors associated with their authorisation

Fundamentos: Los estudios posautorización observacionales son una fuente de información clave sobre efectividad y seguridad de los medicamentos. Los objetivos del estudio fueron describir las características de los estudios observacionales de seguimiento prospectivo (EPA-SP) que solicitaron autorización en la Comunitat Valenciana (CV) y explorar qué factores se asociaron con su autorización. Métodos: Se realizó estudio observacional analítico retrospectivo, en el que se incluyeron todos los EPA-SP que solicitaron autorización en la CV desde 2010 hasta 2015. A partir de las bases de datos de la Dirección General de Farmacia y Productos Sanitarios y GESTO se obtuvieron variables referentes al estudio (objetivos, medicamento estudiado, enfermedad diana, etc) y referentes al procedimiento de autorización (autorización, motivo de no autorización y estado actual del estudio). El análisis se organizó en una fase descriptiva y otra analítica mediante regresión logística con variable dependiente la autorización. Resultados: Fueron incluidos un total de 249 estudios, de los que 192 (77,1%) estaban diseñados para estimar efectividad o calidad de vida. Los medicamentos más frecuentemente estudiados fueron los agentes antineoplásicos e inmunomoduladores (42%). Sólo consiguieron la autorización el 57%, siendo las causas más frecuente de denegación la inducción a la prescripción (40,1%) y la práctica no habitual (39,3%). La autorización se asoció con el diagnóstico (aparato circulatorio OR 10,7, IC95% 2,3 a 49,1), grupo ATC L (OR 4,2, IC95% 1,9 a 49,1) y el haber sido promovidos por la industria (OR 0,5, IC95% 0,3 a 0,9). Conclusión: Dada la importancia de contar con información sobre efectividad y seguridad en la práctica habitual, es prioritario que los EPA-SP sean orientados a estos fines y que se potencie la investigación independiente (AU)

Background: Postauthorisation observational studies are crucial source of information on drug effectiveness and safety. The objectives of this work were to describe the characteristics of the postauthorisation observational prospective studies (EPA-SP) for which authorisation was requested in the Valencian region, as well as to explore which factors influenced the aforementioned authorisation. Methods: We performed a retrospective analytical study comprising all the EPA-SP for which authorisation was requested in the Valencian region between 2010 and 2015.The variables associated to the studies (e.g., objectives, studied drug, target disease) as well as those concerning the authorisation process itself (e.g., authorisation status, reason for authorisation refusal, current status of the study) were obtained from relevant databases. The analysis was divided into descriptive and analytical stages. Results: We included a total of 249 studies, out of which 192 (77, 1%) aimed at estimating effectiveness or quality of life. The most frequent types of drugs involved in the studies were the antineoplastic and immunomodulating agents (42%). Only 57% of the studies were granted authorisation, with prescription induction and unusual practice being the most common causes for refusal (40.1% and 39.3%, respectively). The authorisation was linked to the diagnosis (circulatory system OR 10,7, IC95% 2,3 to 49,1), ATC L group (OR 4,2, IC95% 1,9 to 49,1) as well as to whether it had been advocated by the industry (OR 0,5, IC95% 0,3 to 0,9). Conclusion: Given the importance of having information on effectiveness and safety in usual practice, it is a priority for EPA-SP to be directed towards these aims and to promote independent research (AU)

Effectiveness of a systematic vaccination program in patients with autoimmune inflammatory disease treated with anti-TNF alpha drugs.

OBJECTIVE: The objective of this is manuscript is to evaluate the impact of a vaccination protocol in the prevention of infection in autoimmune inflammatory disease (AUTID) patients treated with Anti-TNF-alpha therapies. RESEARCH DESIGN AND METHODS: The authors conducted an observational study to test the effect of a vaccination program in AUTID patients that received anti-TNF-alpha therapies in hospital admissions related to infections. This effect was evaluated by comparing patients admitted before the program started (prevaccination period, 2009-2011) and after the program (postvaccination period, 2011-2014). RESULTS: The study included 581 patients: 280 in the pre-vaccination group and 301 in the post-vaccination group. During the prevaccination period, 27.3% of patients treated with anti-TNF-alpha drugs were vaccinated before biological therapy. During the postvaccination period, this percentage increased to 97.0%. Statistically significant differences were detected in emergency room visits per 10.000 treatment days, in hospital admissions related to an infectious disease and in the rate of invasive pneumococcal disease due to Streptococcus pneumoniae infection per 10.000 days of treatment. CONCLUSIONS: This vaccination program decreases infectious complications and was associated with a lower amount of hospital admissions due to infections, emergency room visits and the rate of invasive pneumococcal disease.

Influencia del mes de nacimiento en la demanda asistencial por trastorno por déficit de atención/hiperactividad. Resultados de un estudio retrospectivo realizado en una consulta de neuropediatría / Influence of the month of birth on the demand for healthcare to treat attention deficit hyperactivity disorder. Results of a retrospective study conducted in a neuropaediatric clinic

Introducción. Las consultas de neuropediatría se han incrementado en los últimos años, especialmente por trastorno por déficit de atención/hiperactividad (TDAH). Se postula que los niños más jóvenes del curso tienen más riesgo de ser diagnosticados de TDAH. Objetivos. Analizar la demanda asistencial de neuropediatría, comparar su evolución por grupos diagnósticos y determinar si existe una relación entre la fecha de nacimiento de los pacientes y la sospecha de TDAH. Pacientes y métodos. Estudio retrospectivo de los pacientes remitidos a neuropediatría entre 1992 y 2012. Se compararon las distintas categorías diagnósticas según variables epidemiológicas y se exploró si existía un factor relativo a la edad. Resultados. Se incluyeron 3.469 pacientes, un 58,5% varones, con una mediana de edad de 6 años. El principal motivo de consulta fue la cefalea, y todos los grupos diagnósticos sufrieron un incremento de las consultas. El TDAH experimentó un aumento del 350% en los últimos 10 años. El 61,6% de los niños con sospecha de TDAH nació en el segundo semestre del año, y la diferencia es más notable en las niñas. Se objetiva un incremento de sospecha de TDAH en los niños nacidos antes de la fecha de corte del curso escolar que no aparece en ninguna de las otras patologías en el análisis comparativo. Conclusiones. Existe un incremento de la demanda asistencial de neuropediatría en los últimos años, principalmente por TDAH. Los niños nacidos el último semestre del año tienen un riesgo mayor de ser remitidos por sospecha de esta enfermedad (AU)

Introduction. There is an increase in the child neurology attention and, specially in attention deficit hyperactivity disorder (ADHD). It’s been proposed that the birth date affects the diagnosis of ADHD, so the youngest children more susceptible of being diagnosed. Aims. To analyse if there is a relationship between the birth date and the suspicion of ADHD, and to investigate the health demand of child neurology and its evolution regarding diagnostic categories. Patients and methods. Retrospective study of patients been attended in a child neurology clinic between 1992 and 2012. Different diagnostic groups were compared considering epidemiologic variables and trimester and semester of birth to determine whether exists a seasonal pattern. Results. 3469 patients were included, 58.5% were male with a median age of 6 years old. The first reason of consultation was the headache, and the ADHD has experienced an increase of 350% in the last 10 years of the study. 61.6% of patients with ADHD suspicion were born in the second semester of the year. The difference was higher for girls. This pattern was not observed in other neurologic diseases when a comparative analysis was done. Conclusions. There is an increase of child neurologic demand within the last years, mainly of ADHD patients. Children born in the last semester of the year have a higher risk of being sent to a neurology clinic for evaluation (AU)

[Influence of the month of birth on the demand for healthcare to treat attention deficit hyperactivity disorder. Results of a retrospective study conducted in a neuropaediatric clinic]. / Influencia del mes de nacimiento en la demanda asistencial por trastorno por deficit de atencion/hiperactividad. Resultados de un estudio retrospectivo realizado en una consulta de neuropediatria.

INTRODUCTION: There is an increase in the child neurology attention and, specially in attention deficit hyperactivity disorder (ADHD). It's been proposed that the birth date affects the diagnosis of ADHD, so the youngest children more susceptible of being diagnosed. AIMS: To analyse if there is a relationship between the birth date and the suspicion of ADHD, and to investigate the health demand of child neurology and its evolution regarding diagnostic categories. PATIENTS AND METHODS: Retrospective study of patients been attended in a child neurology clinic between 1992 and 2012. Different diagnostic groups were compared considering epidemiologic variables and trimester and semester of birth to determine whether exists a seasonal pattern. RESULTS: 3469 patients were included, 58.5% were male with a median age of 6 years old. The first reason of consultation was the headache, and the ADHD has experienced an increase of 350% in the last 10 years of the study. 61.6% of patients with ADHD suspicion were born in the second semester of the year. The difference was higher for girls. This pattern was not observed in other neurologic diseases when a comparative analysis was done. CONCLUSIONS: There is an increase of child neurologic demand within the last years, mainly of ADHD patients. Children born in the last semester of the year have a higher risk of being sent to a neurology clinic for evaluation.

TITLE: Influencia del mes de nacimiento en la demanda asistencial por trastorno por deficit de atencion/hiperactividad. Resultados de un estudio retrospectivo realizado en una consulta de neuropediatria.Introduccion. Las consultas de neuropediatria se han incrementado en los ultimos años, especialmente por trastorno por deficit de atencion/hiperactividad (TDAH). Se postula que los niños mas jovenes del curso tienen mas riesgo de ser diagnosticados de TDAH. Objetivos. Analizar la demanda asistencial de neuropediatria, comparar su evolucion por grupos diagnosticos y determinar si existe una relacion entre la fecha de nacimiento de los pacientes y la sospecha de TDAH. Pacientes y metodos. Estudio retrospectivo de los pacientes remitidos a neuropediatria entre 1992 y 2012. Se compararon las distintas categorias diagnosticas segun variables epidemiologicas y se exploro si existia un factor relativo a la edad. Resultados. Se incluyeron 3.469 pacientes, un 58,5% varones, con una mediana de edad de 6 años. El principal motivo de consulta fue la cefalea, y todos los grupos diagnosticos sufrieron un incremento de las consultas. El TDAH experimento un aumento del 350% en los ultimos 10 años. El 61,6% de los niños con sospecha de TDAH nacio en el segundo semestre del año, y la diferencia es mas notable en las niñas. Se objetiva un incremento de sospecha de TDAH en los niños nacidos antes de la fecha de corte del curso escolar que no aparece en ninguna de las otras patologias en el analisis comparativo. Conclusiones. Existe un incremento de la demanda asistencial de neuropediatria en los ultimos años, principalmente por TDAH. Los niños nacidos el ultimo semestre del año tienen un riesgo mayor de ser remitidos por sospecha de esta enfermedad.

Comparación de las complicaciones dermatológicas entre el dermatomo y el colgajo en «U» en la cirugía del BAHA / Comparison of skin complications between dermatome and U-graft technique in BAHA surgery

Introducción y objetivo: Las complicaciones dermatológicas son las complicaciones postoperatorias más frecuentes relacionadas con las prótesis BAHA (bone anchored hearing aid). En este estudio comparamos y evaluamos estas complicaciones con dos técnicas quirúrgicas diferentes: el dermatomo BAHA y el colgajo en «U». Material y método: Se estudió a 53 pacientes intervenidos en nuestro centro entre 2001 y 2008. La comparación de las complicaciones se realizó según la clasificación de Holgers et al. Hemos registrado, además, el número de curas que se requieren hasta la estabilización de la piel. Resultados: Hemos utilizado el dermatomo en 27 pacientes y el colgajo en «U» en 26 pacientes. En el grupo dermatomo hemos tenido el 74% de complicaciones (20 pacientes), que contrastan con el 34% (9 pacientes) con el colgajo en «U». La media de curas por paciente con el dermatomo y con el colgajo en «U» es de 4,1 y 2,7, respectivamente. Las diferencias encontradas son estadísticamente significativas para un intervalo de confianza del 95%. Conclusiones: En nuestra experiencia, el uso del dermatomo eléctrico en la cirugía del BAHA es un método que nos ofrece un mayor número de complicaciones dermatológicas que el colgajo en «U». Dado que ambas técnicas tienen una serie de ventajas y desventajas, quizás la selección de la técnica por utilizar según las características de cada paciente de forma individualizada permita obtener mejores resultados en el futuro (AU)

Introduction and objective: The most common postoperative complications related to BAHA prosthetic surgery are skin complications. In this study we compare and evaluate these reactions with two different surgical techniques, the BAHA dermatome and the U-graft technique. Material and method: Fifty-three patients who underwent implantation of a BAHA at our hospital between 2001 and 2008 were studied. The comparison of the skin reactions was carried out according to Holgers' classification. We also recorded the number of cures required until the skin was stabilized. Results: We used the dermatome in 27 patients and the U-graft in 26 patients. In the dermatome group we have reported a total of 74% of skin reactions (20 patients), in contrast with the 34% (9 patients) observed in the U-graft group. The average number of cures for patients in the dermatome group and those in the U-graft group was 4.1 and 2.7, respectively. The differences found were statistically significant and had a 95% confidence interval. Conclusions: In our experience, the use of the electric dermatome in BAHA surgery offers a higher incidence of skin complications in comparison with the U-graft technique. Since both techniques have a number of advantages and disadvantages, it may be that the selection of the technique to be employed according the individual characteristics of each patient may offer better results in the future (AU)

[Comparison of skin complications between dermatome and U-graft technique in BAHA surgery]. / Comparación de las complicaciones dermatológicas entre el dermatomo y el colgajo en "U" en la cirugía del BAHA.

INTRODUCTION AND OBJECTIVE: The most common postoperative complications related to BAHA prosthetic surgery are skin complications. In this study we compare and evaluate these reactions with two different surgical techniques, the BAHA dermatome and the U-graft technique. MATERIAL AND METHOD: Fifty-three patients who underwent implantation of a BAHA at our hospital between 2001 and 2008 were studied. The comparison of the skin reactions was carried out according to Holgers' classification. We also recorded the number of cures required until the skin was stabilized. RESULTS: We used the dermatome in 27 patients and the U-graft in 26 patients. In the dermatome group we have reported a total of 74% of skin reactions (20 patients), in contrast with the 34% (9 patients) observed in the U-graft group. The average number of cures for patients in the dermatome group and those in the U-graft group was 4.1 and 2.7, respectively. The differences found were statistically significant and had a 95% confidence interval. CONCLUSIONS: In our experience, the use of the electric dermatome in BAHA surgery offers a higher incidence of skin complications in comparison with the U-graft technique. Since both techniques have a number of advantages and disadvantages, it may be that the selection of the technique to be employed according the individual characteristics of each patient may offer better results in the future.

[Hypopharyngeal cancer: analysis of the evolution and treatment results]. / Cáncer de hipofaringe: análisis de la evolución y los resultados del tratamiento en nuestro medio.

OBJECTIVE: Hypopharyngeal carcinoma is an aggressive malignancy usually diagnosed at a late state, thereby resulting in overall poor prognosis and low survival rates for these patients. The purpose of this study is to present the progress and outcomes of patients treated for hypopharyngeal carcinoma at our department. MATERIAL AND METHOD: We retrospectively reviewed 89 patients who had been diagnosed with hypopharygeal carcinoma between 1980 and 2005. Most of the tumours were advanced (T3 and T4) and 73 % showed palpable regional metastases at presentation. RESULTS: The five-year survival rate was 40.7 %. The overall incidence of distant metastases and subsequent primary neoplasms was 7.5 % and 23.5 %, respectively. CONCLUSIONS: Hypopharyngeal cancer is still the one with the worst prognosis in the head and neck area. The poor survival rate seems to be related primarily to advanced stage disease at presentation and particularly to the status of cervical lymph-node metastases.

Cáncer de hipofaringe: análisis de la evolución y los resultados del tratamiento en nuestro medio / Hypopharyngeal cancer: analysis of the evolution and treatment results

Objetivo: el cáncer de hipofaringe es un cáncer muy agresivo que generalmente se diagnostica en estadios muy avanzados, su pronóstico es desalentador y la tasa de supervivencia, muy baja. El objetivo de este estudio es presentar la evolución y los resultados de los pacientes tratados de cáncer de hipofaringe en nuestro servicio. Material y método: realizamos un estudio retrospectivo en 89 pacientes diagnosticados de cáncer de hipofaringe entre los años 1980 y 2005. En su mayoría se trataba de tumores avanzados (T3 y T4) y el 73 % presentaba adenopatías palpables en el momento del diagnóstico. Resultados: la supervivencia a los 5 años fue del 40,7 %. Encontramos una incidencia de metástasis a distancia y segundos tumores primarios de un 7,5 y un 23,5 %, respectivamente. Conclusiones: el carcinoma de hipofaringe continúa siendo el cáncer de cabeza y cuello de pronóstico peor. La tasa de supervivencia parece estar relacionada primariamente con el estadio tumoral de presentación y, de forma particular, con el estado de los ganglios linfáticos cervicales (AU)

Objective: hypopharyngeal carcinoma is an aggressive malignancy usually diagnosed at a late state, thereby resulting in overall poor prognosis and low survival rates for these patients. The purpose of this study is to present the progress and outcomes of patients treated for hypopharyngeal carcinoma at our department. Material and method: We retrospectively reviewed 89 patients who had been diagnosed with hypopharygeal carcinoma between 1980 and 2005. Most of the tumours were advanced (T3 andT4) and 73 % showed palpable regional metastases at presentation. Results: The five-year survival rate was 40.7 %. The overall incidence of distant metastases and subsequent primary neoplasms was 7.5 % and 23.5 %, respectively. Conclusions: Hypopharyngeal cancer is still the one with the worst prognosis in the head and neck area. The poor survival rate seems to be related primarily to advanced stage disease at presentation and particularly to the status of cervical lymph-node metastases (AU)

[Hemithyroidectomy: when it is necessary an intraoperative frozen-section biopsy?]. / Hemitiroidectomías: Ecuándo es necesaria la biopsia intraoperatoria?

INTRODUCTION: Many surgeons use intraoperative frozen section biopsy of the thyroid nodules to confirm malignant disease, but it continues to generate considerable controversy. We reviewed our recent experience to determinate de clinical utility of frozen section in our surgical management and intraoperative decision-making. PATIENTS AND METHOD: All patients who had operations for the thyroid nodular disease between 2000 and 2006 were included in this retrospective study. We compared the results of frozen section diagnosis and definitive histologic results in a population of 212 patients. RESULTS: Frozen section was false negative in 3 patients (1.66 %) and false positive in 1 (0.47 %) and avoided 12 reoperations (5.6 %). When there was not suspicious malignant disease had a sensitivity of 0.75 %. In the group of follicular disease the sensitivity was 3.7 %, and in the group with suspicious malignant disease was 37.5 %. CONCLUSIONS: Frozen section was more helpful in the group of suspicious for malignant disease. It does not seem to be necessary when fine-needle biopsy indicates bening or follicular disease.

Hemitiroidectomías: ¿cuándo es necesaria la biopsia intraoperatoria? / Hemithyroidectomy: when it is necessary an intraoperative frozen-section biopsy?

Introducción: Muchos cirujanos utilizan la biopsia intraoperatoria de los nódulos tiroideos para confirmar malignidad, pero continúa generando bastante controversia. Hemos revisado nuestra experiencia reciente para determinar la utilidad clínica de la biopsia extemporánea en la toma de decisiones intraoperatorias. Pacientes y método: Se incluyó en este estudio retrospectivo a todos los pacientes sometidos a una cirugía tiroidea por nódulo tiroideo entre 2000 y 2006. Comparamos los resultados de la biopsia introperatoria con los de la anatomía patológica definitiva en una población de 212 pacientes. Resultados: La biopsia extemporánea tuvo un resultado falso negativo en 3 (1,67 %) pacientes y falso positivo en 1 (0,47 %). Evitó 12 (5,6 %) reintervenciones. Cuando no hubo sospecha previa de malignidad, su sensibilidad fue del 0,75 %. En el grupo de lesiones foliculares su sensibilidad fue del 3,7 % y en el sospechoso de malignidad del 37,5 %. Conclusiones: La biopsia extemporánea fue más útil en el grupo con sospecha de malignidad. No parece ser necesaria cuando la punción-aspiración con aguja fina indica que es benigna o de tipo folicular

Introduction: Many surgeons use intraoperative frozen section biopsy of the thyroid nodules to confirm malignant disease, but it continues to generate considerable controversy. We reviewed our recent experience to determinate de clinical utility of frozen section in our surgical management and intraoperative decision-making. Patients and method: All patients who had operations for the thyroid nodular disease between 2000 and 2006 were included in this retrospective study. We compared the results of frozen section diagnosis and definitive histologic results in a population of 212 patients. Results: Frozen section was false negative in 3 patients (1.66 %) and false positive in 1 (0.47 %) and avoided 12 reoperations (5.6 %). When there was not suspicious malignant disease had a sensitivity of 0.75 %. In the group of follicular disease the sensitivity was 3.7 %, and in the group with suspicious malignant disease was 37.5 %. Conclusions: Frozen section was more helpful in the group of suspicious for malignant disease. It does not seem to be necessary when fine-needle biopsy indicates bening or follicular disease

[Supraglottic and glottic carcinomas. Study of the incidence in the last 31 years]. / Carcinomas supraglóticos y glóticos. Estudio de la incidencia en los últimos 31 años.

INTRODUCTION: Laryngeal carcinoma is a common neoplasia in our country. It is well-known that the supraglottis is more frequently involved in Mediterranean countries. We present our results on the incidence of neoplasias affecting supraglottis and glottis and we find a change in the normal trend. OBJECTIVE: To study the incidence of glottic and supraglottic tumours in our hospital over the last 31 years. We also analyze risk factors such as smoking and alcohol in the population of the Valencian Region. PATIENTS AND METHOD: We performed a retrospective review of 991 patients diagnosed as having carcinomas of the glottis and supraglottis between 1974 and 2005. The epidemiological data about the consumption of tobacco and alcohol in the population of the Valencian Region, Spain, are obtained from descriptive epidemiological studies (Health Statistics and the 2003 National Health Survey). CONCLUSIONS: With a total of 548 carcinomas of the glottis and 443 of the supraglottis, we find a change in the incidence maintained since 1990, with statistically significant differences (P=.0056). Thus, we can state that the glottis is more frequently affected than the supraglottis. Changes in the consumption of tobacco and alcohol cannot explain this current change.

Carcinomas supraglóticos y glóticos. Estudio de la incidencia en los últimos 31 años / Supraglottic and glottic carcinomas. Study of the incidence in the last 31 years

Introducción: Los carcinomas de laringe son una neoplasia frecuente en nuestro país. Por todos es conocido que en los países mediterráneos predomina la localización supraglótica sobre la glótica. Hemos estudiado la incidencia en nuestro medio de ambas localizaciones y hemos comprobado una inversión. Objetivo: Estudiar la incidencia de los tumores glóticos y supraglóticos en el Hospital Universitario Dr. Peset en los últimos 31 años. También se analizan los hábitos tóxicos de la población de la Comunidad Valenciana relacionados con la aparición de este tipo de neoplasias. Pacientes y método: Realizamos un estudio retrospectivo de 991 pacientes diagnosticados de carcinomas glóticos y supraglóticos desde 1984 a 2005. Los datos epidemiológicos respecto al consumo de tabaco y alcohol en la población de la Comunidad Valenciana se obtienen a través de estudios epidemiológicos descriptivos de ámbito nacional (Estadísticas de Salud y Encuesta Nacional de Salud 2003). Conclusiones: Con un total de 548 carcinomas de localización glótica y 443 de localización supraglótica, hemos observado una inversión en la incidencia desde el año 1990 que se mantiene hasta la actualidad, con diferencias estadísticamente significativas (p = 0,0056). Por lo tanto, se puede afirmar que actualmente la incidencia de tumores glóticos es mayor que la de los supraglóticos en nuestro medio. Los cambios en el estilo de vida de nuestra población actualmente no permiten explicar este cambio

Introduction: Laryngeal carcinoma is a common neoplasia in our country. It is well-known that the supraglottis is more frequently involved in Mediterranean countries. We present our results on the incidence of neoplasias affecting supraglottis and glottis and we find a change in the normal trend. Objective: To study the incidence of glottic and supraglottic tumours in our hospital over the last 31 years. We also analyze risk factors such as smoking and alcohol in the population of the Valencian Region. Patients and method: We performed a retrospective review of 991 patients diagnosed as having carcinomas of the glottis and supraglottis between 1974 and 2005. The epidemiological data about the consumption of tobacco and alcohol in the population of the Valencian Region, Spain, are obtained from descriptive epidemiological studies (Health Statistics and the 2003 National Health Survey). Conclusions: With a total of 548 carcinomas of the glottis and 443 of the supraglottis, we find a change in the incidence maintained since 1990, with statistically significant differences (P=.0056). Thus, we can state that the glottis is more frequently affected than the supraglottis. Changes in the consumption of tobacco and alcohol cannot explain this current change

Análisis de supervivencia y tiempos de respuesta de las reclamaciones en un hospital de agudos / Survival analysis of the claims answering time in an acute care hospital

Fundamento: El estudio de las reclamaciones es un paso importante en el conocimiento de la opinión del usuario. En este trabajo se utilizó la metodología del análisis de supervivencia para estudiar los factores que influyen en el tiempo de respuesta. Material y métodos: Estudio observacional y analítico retrospectivo en el que se estudian los tiempos de respuesta de las reclamaciones generadas en un hospital de agudos entre 1994 y 1999. Se han recogido variables temporales, sociodemográficas y organizativas. La variable principal fue el tiempo de contestación de la reclamación. Se utilizó la metodología del análisis de supervivencia (Estimador de Kaplan-Meier y Regresión de Cox).Resultados: Se analizaron un total de 1.383 reclamaciones observando que la mediana del tiempo de contestación fue de 41 días. En el modelo ajustado las variables año, mes, área sanitaria, motivo y tipo de contestación influyen significativamente en el tiempo de respuesta. Conclusiones: El área urgencias, los motivos demora en la asistencia y hostelería producen un retraso en la contestación por parte de la Administración, mientras que los tipos de contestación solución y archivo lo acortan (AU)