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Chlormethine gel was approved for treatment of mycosis fungoides, the most common cutaneous T-cell lymphoma, on the basis of results from study 201 and study 202. A post-hoc analysis of study 201 found interesting trends regarding improved efficacy of chlormethine gel vs ointment and noted a potential association between dermatitis and clinical response.To expand these results by performing a post-hoc analysis of study 202.Patients received chlormethine gel or ointment during study 201 (12 months) and higher-concentration chlormethine gel during study 202 (7-month extension). Response was assessed using Composite Assessment of Index Lesion Severity (CAILS). Associations between treatment frequency, response, and skin-related adverse events (AEs) were assessed using multivariate time-to-event analyses. Time-to-response and repeated measures analyses were compared between patients who only used chlormethine gel and those who switched from ointment to gel.No associations were seen between treatment frequency and improved skin response (CAILS) or AE occurrence within the 201/202 study populations. However, an association was observed specifically between contact dermatitis and improved CAILS response at the next visit (p0.0001). Patients who used chlormethine gel during both studies had a significantly (p0.05) shorter time to response and higher overall response rates than patients who initiated treatment with ointment.This post-hoc analysis shows that patients who initiated treatment using chlormethine gel had faster and higher responses compared with patients who initially used chlormethine ointment for 12 months. The development of contact dermatitis may be a potential prognostic factor for response.Study 201: NCT00168064, September 14, 2002; Study 202: NCT00535470, September 26, 2007.

OBJECTIVE: Our objective was to assess the effect of sublingual fentanyl tablets (SFTs) on pain relief, quality of life, and adverse effects in patients with cancer pain, according to cancer stage and background opioid regimen. METHODS: Subgroup analyses from a recently completed study were performed according to cancer stage (locally advanced cancer [LAC] vs. metastatic cancer) and most frequent background opioid medication (fentanyl vs. oxycodone/naloxone). The efficacy and safety of SFTs were evaluated, recording pain intensity (PI), onset of pain relief, and adverse events (AEs). Health status was assessed with the Short Form 12, version 2 (SF-12v2) questionnaire and the Hospital Anxiety and Depression Scale (anxiety subscale [HADS-A] and depression subscale [HADS-D]). RESULTS: In total, 54 (67.5%) patients had LAC and 26 (32.5%) had metastatic cancer. The oxycodone/naloxone group included 39 patients (48.1%) and the fentanyl group 29 (35.8%). In all subgroups, pain relief was achieved within 5 min in an increasing number of individuals over time; at the end of the study, PI values decreased (PI-end: 44.4% for LAC vs. 57.9% for metastatic cancer; 44.4% for fentanyl vs. 38.6% for oxycodone/naloxone). HADS and mental component summary (MCS) SF-12v2 scores significantly improved in the LAC group (HADS-A 9.44-8.04; HADS-D 10.46-8.15; MCS 44.69-45.94) and in the fentanyl group (HADS-A 10.05-8.33; HADS-D 11.95-8.76; MCS 44.38-47.19). AEs were reported in few patients and were mostly mild. CONCLUSIONS: Exploratory subgroup analyses show the efficacy and safety of SFTs for the treatment of breakthrough pain in patients with cancer, regardless of their cancer stage and background opioid medication.

In the Original Publication.

Breakthrough pain (BTP) is highly prevalent in patients with cancer and is strongly associated with adverse outcomes related to health status, mood, anxiety and depression. However, studies on the effect of BTP medication on quality of life (QOL) are lacking. The purpose of this study was to provide a qualitative evaluation of the effect of sublingual fentanyl tablets (SFT), a therapy specifically developed for BTP, on the QOL of cancer pain patients.

Introduction. Up to 60% of women relate their episodes of headache to menstrual cycle. Menstrual migraine has been included in the second edition of the International Classification of Headache disorders. Menstrual tension-type headache has not yet been recognised by the International Headache Society. Aims. To evaluate the prevalence of different subtypes of menstrual headache and to analyze their clinical features and the treatment prescribed. Patients and methods. We prospectively included women attending several neurology outpatient clinics, from January to November 2008 whose headache appeared during the menstrual period. Results. A total of 108 patients were included during the study period. Mean age was 34.8 +/- 8.9 years-old. 29.3% suffered from pure menstrual migraine, 58.7% from menstrual related migraine, 4.5% from pure menstrual tension-type headache and 7.5% from menstrual related tension type headache. Conclusions. Our data suggest that menstrual related tension-type headaches exist with a prevalence found about 12%, in our neurology outpatient clinics.

Mycosis fungoides (MF) and Sezary syndrome (SS), the major forms of cutaneous T-cell lymphoma, have unique characteristics that distinguish them from other types of non-Hodgkin's lymphomas. Clinical trials in MF/SS have suffered from a lack of standardization in evaluation, staging, assessment, end points, and response criteria. Recently defined criteria for the diagnosis of early MF, guidelines for initial evaluation, and revised staging and classification criteria for MF and SS now offer the potential for uniform staging of patients enrolled in clinical trials for MF/SS. This article presents consensus recommendations for the general conduct of clinical trials of patients with MF/SS as well as methods for standardized assessment of potential disease manifestations in skin, lymph nodes, blood, and visceral organs, and definition of end points and response criteria. These guidelines should facilitate collaboration among investigators and collation of data from sponsor-generated or investigator-initiated clinical trials involving patients with MF or SS. J Clin Oncol 29:2598-2607. (C) 2011 by American Society of Clinical Oncology

Introduccion. Mas del 60% de las mujeres refieren presentar cefalea relacionada con el ciclo menstrual. Se ha incluido la `migrana menstrual´ en la segunda edicion de la Clasificacion Internacional de las Cefaleas; sin embargo, la `cefalea tensional durante la menstruacion´ es una entidad no reconocida por la Sociedad Internacional de Cefaleas. Objetivos. Evaluar la prevalencia de los diferentes subtipos de cefalea menstrual y analizar sus caracteristicas clinicas y el tratamiento prescrito. Pacientes y metodos. Evaluamos de forma prospectiva a todas las mujeres atendidas en varias consultas de neurologia, desde enero a noviembre de 2008, cuya cefalea aparecia durante el periodo menstrual. Resultados. Se incluyeron un total de 108 pacientes durante el periodo del estudio, con una edad media de 34,8 ± 8,9 anos. El 29,3% presentaba migrana menstrual pura, el 58,7% migrana menstrual relacionada con la menstruacion, el 4,5% cefalea tensional pura durante la menstruacion y el 7,5% cefalea tensional relacionada con la menstruacion. Conclusiones. Nuestros resultados sugieren que la cefalea tensional en el contexto de la menstruacion existe, con una prevalencia en torno al 12% en las pacientes valoradas en nuestras consultas.

Objetivo. Describir el sistema de atencion telefonica (SAT) implantado en una unidad de demencias y conocer la utilidad percibida y la satisfaccion de los usuarios y profesionales implicados. Materiales y metodos. Analizamos retrospectivamente las llamadas recibidas durante 12 meses. Recogimos sistematicamente: tipo de llamada, sexo y parentesco de quien llama, motivo, tipo de respuesta y puntuacion del paciente en la escala de deterioro global (Global Deterioration Scale, GDS). Valoramos mediante cuestionario semiestructurado la satisfaccion de pacientes/familiares con: accesibilidad, demora, dificultad en comprender la respuesta, utilidad y satisfaccion global. Valoramos la opinion de los profesionales mediante entrevista semiestructurada para: impresion global, sobrecarga asistencial, utilidad y satisfaccion del SAT. Resultados. Se registraron 444 llamadas, el 58,3% de familiares de pacientes con GDS 5-6. Las causas mas frecuentes fueron sintomas psicoconductuales (32,6%) y efectos adversos de la medicacion (22%). Las respuestas mas frecuentes fueron modificar el tratamiento (43,2%) o adelantar la siguiente visita (18,9%). Los usuarios valoraron positivamente los siguientes conceptos: accesibilidad (58,3%), demora en la respuesta (83,3%), utilidad del servicio (91,6%), satisfaccion global (86,5%) y comprension de la respuesta (93,8%). Los profesionales senalaron la necesidad de confeccionar una agenda especifica, mejorar la accesibilidad telefonica y programar tiempos especificos para la atencion telefonica. Conclusiones. El SAT constituye un sistema de atencion formal, estructurado y complementario a la visita tradicional, con capacidad para resolver los problemas planteados. Su caracter diferido permite gestionar los tiempos de atencion y mejorar la calidad de la respuesta al disponer de toda la informacion del paciente. Es satisfactorio para usuarios y profesionales.

Introduccion. El topiramato ha demostrado recientemente ser seguro y efectivo en la prevencion de la migrana y en la actualidad es el unico farmaco neuromodulador con indicacion para la prevencion de la migrana en Espana. Objetivo. Evaluar la adherencia, la eficacia y la seguridad del tratamiento preventivo con topiramato en pacientes diagnosticados de migrana. Pacientes y metodos. Se realizo un estudio multicentrico prospectivo observacional en las consultas de neurologia general. Se incluyeron pacientes con migrana mayores de 14 anos que requerian un tratamiento preventivo y en los que habian fallado otros tratamientos preventivos o en los que cuales se consideraba mas adecuado el topiramato en funcion de su perfil de efectos adversos. Se evaluo la eficacia del tratamiento, la satisfaccion del paciente, los efectos adversos y la reduccion del peso corporal. La eficacia del tratamiento se valoro a traves de la reduccion en la frecuencia de migranas y en la puntuacion del Headache Impact Test (HIT-6). Resultados. Se evaluaron 79 pacientes. La dosis de topiramato oscilo entre 25 y 200 mg/dia, con una mediana de 100 mg/dia. El 19% de los pacientes abandono el estudio por efectos adversos. La causa mas frecuente de abandono fueron las parestesias. No se observaron efectos adversos graves. El 14% de los pacientes experimento una perdida de peso superior al 5% del basal. El porcentaje de pacientes respondedores fue del 58%. El grado de satisfaccion de los pacientes que completaron el seguimiento fue buena (80%), regular (11%) y mala (9%). Conclusiones. El tratamiento preventivo con topiramato reduce significativamente el impacto y la discapacidad de la migrana. El tratamiento es satisfactorio y mejora la calidad de vida en un porcentaje importante de pacientes.

Introduccion. El dolor neuropatico (DN) se define como aquel dolor iniciado o causado por una lesion primaria o por una disfuncion en el sistema nervioso. Objetivo. Evaluar la frecuencia con la que los pacientes con DN como motivo principal de derivacion se remiten a una consulta ambulatoria de Neurologia. Pacientes y metodos. Se trata de un estudio descriptivo, transversal sobre utilizacion de los servicios sanitarios; se incluyeron consecutivamente los pacientes atendidos por primera vez en una consulta de Neurologia de seleccion; variables estudiadas: numero de primeras visitas y numero total de pacientes atendidos por sesion de consulta, tasa de pacientes con DN por dia de consulta, la topografia y probable etiologia del DN, y la tasa de pacientes remitidos a la consulta monografica de DN; las diferentes variables cuantitativas se expresaran con su media y desviacion estandar (DE), mientras que en las variables cualitativas esto se hara con su valor absoluto y el porcentaje. Se atendieron 1.972 pacientes, de los cuales 1.422 (72,1%) fueron primeras visitas, con una media de 17,5 (DE: 2,5) pacientes nuevos por sesion de consulta. Resultados. Se identificaron 113 pacientes con diagnostico clinico de DN, lo que supone una tasa del 7,95% de las primeras visitas. Conclusiones. El DN puede estar entre las causas mas frecuentes de demanda de asistencia neurologica ambulatoria. Las causas mas frecuentes de DN fueron la neuralgia del trigemino, la neuralgia posherpetica y la polineuropatia diabetica.

INTRODUCTION: Cerebral infarction (CI) can be classified aetiologically in several different ways using explicit diagnostic criteria. However, the extent to which these diagnostic criteria are actually implemented in clinical practice is unknown. Aims. The aim of this study was to analyse the management and use of diagnostic tests in the aetiological diagnosis of CI in two county hospitals and to compare this with the most common recommendations. We also sought to analyse the clinical and demographic variables that may help to explain why these guidelines are not followed. PATIENTS AND METHODS: We reviewed the discharge abstracts of 307 cases of CI attended in two county hospitals between 1999 and 2000 and we analysed the clinical data, diagnostic tests and the final diagnosis. The diagnoses were reorganised using the TOAST, Laussane, NINDS and SEN 98 classifications and we analysed the frequency with which the diagnostic tests were employed in each aetiological subtype. RESULTS: Average age: 71.3 years; 59.3% were males. CAT scans were performed in 97.1% of cases, neurosonology was used in 40.1% and echocardiography was performed in 8.5%. The aetiological diagnosis was: atherothrombotic 22.4%, cardioembolic 10.7%, lacunar 26%, unusual causes 0.3% and unknown causes 1.6%. In 37.4% of cases the diagnosis was given as unspecified CI. On reclassifying the diagnoses according to SEN 98 criteria, we obtained the following: atherothrombotic 19.5%, cardioembolic 2.8%, lacunar 13.7% and of unknown origin 63.5%. 0.6% of the cases were unclassifiable. Factors that exerted an influence on the fact that diagnostic tests were less frequently carried out included age, level of awareness and mortality. The most frequent cause of incomplete studies was the absence of carotid Doppler. CONCLUSIONS: The guidelines for aetiological diagnosis of CI are not often followed. Systematic performance of a neurosonological study would improve aetiological diagnosis of CI.

OBJECTIVES To determine the prevalence and characteristics of multiple sclerosis (EM) in the Marina Alta health district. PATIENTS AND METHODS A descriptive, retrospective study localizing cases (crossed register method). Day of prevalence: 1/05/01. Registers of the area analyzed: hospital admission, Neurology Clinic, Emergency Department of the hospital and Health Centres. The criteria of Poser were used for diagnosis. We analyzed the demographic, clinical and paraclinical aspects of the episodes and treatment (interferon-beta). RESULTS Male/female ratio: 2.4. Average age: 46.6 years. Prevalence of definite EM: 40.3/100,000. Prevalence of autochthonous cases of EM: 28.7/100,000. Average age at onset: 32.6 years. Average duration of illness: 12.5 years. Commonest clinical form: remitting relapsing (48.1%), followed by progressive relapsing (7%), benign (5.5%) and primary progressive (1.8%). 5.5% died, all with the progressive secondary form. EDSS disability: greater in the progressive secondary form. Magnetic resonance (MR) was the commonest investigation used (84% of the results in concordance and 13% normal). Positive BOC in 70% of cases. We studied 202 episodes. The systems most affected were: sensory and pyramidal. Worsening of EDSS after recovery from the episode: 51.7%. 29% received interferon-beta, with five cases (31%) of major side effects (one psychotic outbursts, three with neutropenia and one generalized allergic reaction). CONCLUSIONS In the Marina Alta the prevalence of EM adjusted for the autochthonous population is in the medium risk zone. The clinical features and course of the disease in our patients are similar to those seen in other national and foreign series. The most worthwhile tests were cranial MR and BOC CSF. Treatment with interferon-beta requires strict control in view of the high frequency of serious side effects seen.

OBJECTIVES To analyze the frequency, reasons and characteristics of patients who missed their appointments (NP) at the Neurology Clinic (CEN). To compare the characteristics of the NP with the patients who did not miss their appointment. Suggest measures to reduce avoidable causes of NP. PATIENTS AND METHODS During the period 1/10/99 to 30/4/2000 the cases of NP were prospectively recorded and compared with a sample of patients who attended the CEN during the same period. We analyze the data on age, sex, distance of home from CEN, diagnosis, type of consultation and date of last consultation. The NP were contacted by phone and asked why they had not gone for their appointments. The reasons given were then classified as avoidable or unavoidable. RESULTS Of the 1,842 consultations scheduled, 19% were NP. When the NP and the patients who did attend were compared we found statistically significant differences regarding the distance home/CEN. According to the diagnosis, the NP had more 'symptoms/signs' and other MIA, whilst those who attended the clinic had more 'neuropathies' and 'awaiting diagnosis'. The commonest avoidable reasons (55.8%) for NP were forgetting, administrative error and communication failure, and for unavoidable reasons (44.2%) physical disability, other priorities and improvement. CONCLUSIONS There is a large proportion of NP in the CEN of the Marina Alta. The distance from home to CEN (over 25 km) was the main factor affecting the rate of NP. Since 56% of the NP were due to avoidable causes, strategies could be designed to reduce this percentage. In the NP group, the main causes were forgetting, administrative errors and communication failure.

INTRODUCTION Appraisal of the process of assistance is a fundamental step in determination of the quality of medical assistance given. DEVELOPMENT AND CONCLUSIONS In this paper we review the concept of medical assistance as a product, establishing a parallel between medical assistance and a process of industrial production. We consider the similarities and differences between them. From the point of view of production management we may distinguish different elements: the setting, structure, process of production, result and evaluation. All these are also found in healthcare assistance. We review the concept of the process of assistance both from the limited point of view of the management of disease and its complications, and from a broader perspective which includes the activities of patients in seeking and obtaining assistance. Different aspects and methods of appraisal of the process of assistance are considered: medical audit and monitoring. Finally, we approach the problem of appraisal of the process in outpatient assistance, the importance of this and the methods used in evaluation. We comment on experience of this aspect obtained in the Neurology Unit of the Hospital Marina Alta in Denia.

INTRODUCTION Studies of the use of resources is a method recommended for the determination of health care requirements in order to improve planning for this. OBJECTIVE To analyze outpatient neurological care in the Autonomous Region of Valencia (CR). PATIENTS AND METHODS A transverse multicentric study was done in different Neurology Clinics in the CV. For three days, chosen randomly, forms were filled in. RESULTS Twenty neurologists participated. Analysis was done of 954 consultations. In 30% of these cases the neurologist was satisfied and in 30% he was not. Consultation took 9.5% more time than anticipated. Urgent unscheduled consultations made up 8.6%. Women made up 52% and were of an average age of 52 years. Delay was 29 days. Primary care services referred 42% of the patients. The commonest diagnoses were: cerebral infarct, migraine and parkinsonism. The conditions referred from Primary Care Services were similar to those from non-neurological specialists. First visits took 17.6 minutes and following visits 11.7 minutes. The most usual 'destination' was follow-up (75.2%), followed by AP (24%). CONCLUSIONS Neurological care in the Neurology Clinics of the CV is easily accessible and of good quality. However, it is overloaded by the large demand, due to ambiguity of the health care system available. The different degrees of professional satisfaction felt by neurologists are probably due to the quality of health care available to patients depending on where they live and the type of centre they attend.

Purpose Advanced-stage mycosis fungoides (MF; stage IIB to IV) and Sézary syndrome (SS) are aggressive lymphomas with a median survival of 1 to 5 years. Clinical management is stage based; however, there is wide range of outcome within stages. Published prognostic studies in MF/SS have been single-center trials. Because of the rarity of MF/SS, only a large collaboration would power a study to identify independent prognostic markers. Patients and Methods Literature review identified the following 10 candidate markers: stage, age, sex, cutaneous histologic features of folliculotropism, CD30 positivity, proliferation index, large-cell transformation, WBC/lymphocyte count, serum lactate dehydrogenase, and identical T-cell clone in blood and skin. Data were collected at specialist centers on patients diagnosed with advanced-stage MF/SS from 2007. Each parameter recorded at diagnosis was tested against overall survival (OS). Results Staging data on 1,275 patients with advanced MF/SS from 29 international sites were included for survival analysis. The median OS was 63 months, with 2- and 5-year survival rates of 77% and 52%, respectively. The median OS for patients with stage IIB disease was 68 months, but patients diagnosed with stage III disease had slightly improved survival compared with patients with stage IIB, although patients diagnosed with stage IV disease had significantly worse survival (48 months for stage IVA and 33 months for stage IVB). Of the 10 variables tested, four (stage IV, age > 60 years, large-cell transformation, and increased lactate dehydrogenase) were independent prognostic markers for a worse survival. Combining these four factors in a prognostic index model identified the following three risk groups across stages with significantly different 5-year survival rates: low risk (68%), intermediate risk (44%), and high risk (28%). Conclusion To our knowledge, this study includes the largest cohort of patients with advanced-stage MF/SS and identifies markers with independent prognostic value, which, used together in a prognostic index, may be useful to stratify advanced-stage patients.