How is best supportive care provided in clinical trials for patients with advanced cancer? A review of registered protocols of clinical trials.

Background: In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components. Methods: We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012-2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc. Results: Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%. Summary: Most clinical trials registered during 2012-2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.

Metilfenidato en pacientes que reciben cuidados paliativos. ¿En qué momento de la investigación nos encontramos? / Methylphenidate in patiens receiving palliative care. At what stage of the we research we are today?

No disponible

¿Cómo validar un instrumento de medida de la salud? / How is an instrument for measuring health to be validated?

Cada vez es más necesario disponer de instrumentos de medida en el ámbito de la salud que se puedan utilizar en la práctica clínica e investigación. Para garantizar la calidad de su medición es imprescindible que los instrumentos sean sometidos a un proceso de validación. Este proceso consiste en adaptar culturalmente un instrumento al medio donde se quiere administrar y comprobar sus características psicométricas como: fiabilidad, validez, sensibilidad y factibilidad. Hay instrumentos de medida del ámbito de la salud, disponibles en otros idiomas pero sin validar al español. Además la metodología para validar un instrumento es poco conocida por profesionales sanitarios, lo que explica el uso indiscriminado de instrumentos sólo adaptados o validados de manera poco consistente. El objetivo de esta revisión es realizar una puesta al día del proceso de validación de un instrumento de medida de la salud y en qué consiste de manera práctica. La accesibilidad de instrumentos de evaluación adaptados culturalmente y validados en distintos idiomas facilitará comparar resultados obtenidos con el mismo instrumento y desarrollar estudios internacionales en distintas culturas(AU)

It is increasingly necessary to have a measuring instrument available in the health field that can be used in clinical practice and research. In order to guarantee the quality of their measurements it is essential that the instruments should be subjected to a process of validation. This process consists in adapting the instrument culturally to the setting where its psychometric characteristics are to be administered and checked, such as: reliability, validity, sensitivity and feasibility. There are measuring instruments from the health field available in other languages but that have not been validated into Spanish. Besides, the methodology for validating an instrument is little understood by the health professionals, which explains the indiscriminate use of instruments that have only been adapted or validated in a way that is not very consistent. The aim of this review is to bring up to date the process of validating an instrument for measuring health, and what it involves, in a practical way. The accessibility of evaluation instruments that have been culturally adapted and validated in different languages will facilitate the comparison of results obtained with the same instrument and the development international studies in different cultures(AU)

[Asthenia in advanced cancer and the use of psychostimulants]. / Astenia en cáncer avanzado y uso de psicoestimulantes.

Asthenia is the most frequent symptom in patients with advanced cancer and is probably what most affects the quality of life of oncology patients since it interferes in their physical and social activity. Treatment in the majority of cases is symptomatic. There is growing interest in the use of psychostimulants for treating asthenia. Methylphenidate and modafinil are two psychostimulants that have already been tested in controlled studies on asthenia of the patient with advanced cancer; they have proved to be efficient, particularly in patients in very advanced stages who are very tired.

Respuesta de los autores: Sobre las actitudes y los sentimientos en el trato con el paciente / No disponible

No disponible

Estudio sobre el Síndrome de Burnout en Profesionales de Enfermería de Cuidados Paliativos del País Vasco / No disponible

El síndrome de burnout tiene consecuencias devastadoras para losprofesionales y sus pacientes. El trabajo en Cuidados Paliativos (CP)se ha considerado como una fuente potencial de burnout por suscaracterísticas.Objetivo: El presente estudio se llevó a cabo con el fi n de estudiar losniveles y la prevalencia de burnout en profesionales de enfermería deCP, y detectar aspectos que determinen el riesgo de burnout.Material y Método: El estudio se llevó a cabo con una muestra deenfermeras dedicadas a CP y un grupo control de enfermeras de losmismos hospitales y otras unidades de hospitalización. Se diseñó uncuadernillo de recogida de datos con un cuestionario de burnout (MBI),una escala de apoyo social percibido y un cuestionario de satisfacciónlaboral además de una serie de variables sociodemográfi cas.Resultados: Participaron 105 enfermeras en el estudio, 64 de CP. Nose encontraron diferencias signifi cativas entre niveles y prevalencia deburnout en ambos grupos. Un 58(NCP)-62(CP)% presenta cansancioemocional elevado, un 66(NCP)-59(CP)% un nivel importante de despersonalizacióny un 66(NCP)-70(CP)% una baja realización personal.El porcentaje de enfermeras en el rango de los valores normativos paraBurnout es algo menor en paliativos que en el resto (33% vs 41%):Sin embargo las diferencias no alcanzan signifi cación estadística. Unade cada tres profesionales de enfermería se encuentra dentro de loslímites normales de burnout (33%), otra se encuentra quemada (34%)y la tercera se puede considerar muy quemada (33%), con dos o tresfactores alterados. La falta de formación está relacionada con un mayorcansancio emocional (p≤0.003) y una menor realización personal(p≤0,031). Se observa una mayor satisfacción en las enfermeras deCP, con diferencias estadísticamente signifi cativas(AU)

Burnout Syndrome has devastating consequences in patients andhealth care professionals. Palliative Care (PC) work, because of itscharacteristics, has been considered a potential source of burnout.Objective: The purpose of this study was to determine the levels andprevalence of burnout in palliative care nurses and to evaluate riskfactors of burnout.Methods: The study was conducted with a sample of PC nurses anda control group of non PC (NPC) nurses from the same hospitals.Major measures included the Maslach Burnout Inventory (MBI), aperceived social support scale, a work satisfaction questionnaire andsociodemographic variables.Results: One hundred and fi ve nurses were included in this study,out of which sixty-four (61%) belonged to the PC group. Signifi cantdifferences in levels and prevalence of burnout were not found betweenthe two groups studied. In the MBI, 58(NPC)-62(PC)% have highemotional exhaustion, 66(NPC)-59(PC)% high depersonalization and66(NPC)-70(PC)% low personal accomplishment. One out of threenurses is below the regular limits of burnout, another one has burnoutand the third one has high levels, with two or three burnout factorsaltered. The lack of training is related to higher emotional exhaustion(p≤0,003) and lower personal accomplishment (p≤0,031). A bettersatisfaction in PC nurses is observed.Conclusions: The burnout levels in the nurses studied have been foundto be similar in both groups and higher than the normative scoresof Spanish nurses. PC nurses are more satisfi ed and perceive moresupport in some aspects. The experience acts as a protective factoragainst emotional exhaustion. Nurses perceive lack of specifi c trainingand communication skills. It is necessary to study selection and trainingprocesses of nurses to prevent burnout in this population(AU)

El concepto de calidad de vida en los profesionales de Cuidados Paliativos / No disponible

Introducción: la calidad de vida (CdV) tiene significados distintos según se adapte al concepto intuitivo, al metodológico o al resultado de un cuestionario. Objetivo: conocer el concepto intuitivo de CdV de los profesionales de Cuidados Paliativos para los pacientes que tratan y para ellos mismos. Conocer si se adapta a los cuestionarios validados. Material y métodos: estudio cualitativo y cuantitativo con profesionales de Cuidados Paliativos. Se planteó en pregunta abierta qué comprendían de manera intuitiva como CdV en enfermos terminales y en sí mismos. Dieron luego una estimación del peso relativo de los dominios y de la influencia de diversos problemas en la CdV. Los resultados se compararon con el perfil del QLQ-C15-PAL. Resultados: los principales componentes de la CdV en los pacientes fueron: control de síntomas, dignidad personal, familia y calidad de la atención. Este perfil no coincide con el del QLQ-C15-PAL. En los profesionales, los dominios más relevantes fueron salud, capacidad para disfrutar, familia y relaciones personales. Conclusiones: el perfil de lo que intuitivamente estiman como CdV los profesionales de Cuidados Paliativos es diferente en los pacientes y en ellos mismos. Este concepto no coincide con el modelo de los cuestionarios específicos de CdV en Cuidados Paliativos

Background: health-related quality of life (QoL) may have different meanings when interpreted intuitively, methodologically, or as the result of a questionnaire. Objective: to know the intuitive QoL concept in palliative care professionals regarding both the patients they treat and themselves, and to determine whether such concept is consistent with the measures provided by validated questionnaires. Material and methods: a mixed qualitative and quantitative study was performed in palliative care professionals. An open question asked about their intuitive understanding of QoL for terminal patients and themselves. They did an estimation of the relative weight of different domains, and the influence of several problems. These results were compared to the profile of the QLQ-C15-PAL questionnaire. Results: the estimated most important component of QoL in patients was symptom control, followed by personal dignity, family support, and quality of care. This profile is divergent from that of QLQ-C15-PAL, which is focused on symptoms and performance status. Regarding the QoL of professionals themselves, the most relevant domains were health, ability to enjoy, family, and personal relations. Conclusions: the intuitive QoL profile estimated by palliative care professionals is different for patients and for themselves. This intuitive concept is not consistent with the model presented by specific QoL questionnaires for palliative-care patients

[Gastrointestinal stromal tumors (GISTs): clinical aspects]. / Tumores de la estroma gastroinestinal (GIST): aspectos clínicos.

INTRODUCTION: Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors in the gastrointestinal tract. One of their features is the expression of the c-KIT/CD117 receptor. AIMS AND METHODS: We will focus on describing the symptoms, clinical studies prior to diagnosis, histologic and immunohistochemical characteristics, as well as the progression of disease in a group of patients. RESULTS: Seventeen cases were diagnosed between December 1999 and April 2005. Mean age of patients was 64.5 (+/-11.9); 47% were women. Tumor location was as follows: 52.9% in the jejunum or ileum, 29.4% were gastric, 11.7% were in the duodenum, and 5.8% were located in the mesentery. Tumor size was 6.0 cm on average (+/-5.0); 47% were asymptomatic, and to a lesser degree caused abdominal pain or digestive bleeding; 94.1% of tumors expressed CD117. Most of them were discovered while performing a laparotomy or ultrasound scan; 94.1% of tumors were removed; 35.2% (6 out of 17) of patients suffering from GIST met consensus criteria for aggressive behavior. Over 25.6 months (+/-22.5) metastasis or tumor relapse occurred in 23.5% (4 out of 17) of patients--those with more frequent high-risk criteria, symptomatic and bigger tumors, and tumors not expressing CD117. The three patients with tumor relapse were prescribed imatinib mesylate. Three patients died because of the tumor, and four from other causes unrelated to GIST. CONCLUSIONS: GIST was diagnosed in around 12 cases per million a year. Its diagnosis was usually an incidental finding during a medical evaluation, and tumors were malignant in nearly one fourth of cases. We can predict its outcome depending on different aspects.

Tumores de la estroma gastrointestinal (GIST): aspectos clínicos / Gastrointestinal stromal tumors (GISTs): Clinical aspects

Introducción: los tumores GIST son los tumores mesenquimales más frecuentes del tubo digestivo. Se caracterizan por la expresión del receptor c-KIT/CD 117. Objetivos y métodos: pretendemos describir las manifestaciones clínicas, las exploraciones que llevan al diagnóstico, los aspectos histológicos e inmunohistoquímicos, la evolución y factores predictores de esta a partir de una serie de pacientes. Resultados: se han diagnosticado 17 casos de GIST entre diciembre de 1999 y abril de 2005. La edad media de los pacientes fue 64,5 años (± 11,9). El 47% eran mujeres. La localización de los tumores por paciente fue: yeyuno-íleon en el 52,9%, gástrica en el 29,4%, duodenal en el 11,7% y mesentérica en el 5,8%. Los tumores medían 6,0 cm (± 5,0). El 47% eran tumores asintomáticos, menos frecuentemente produjeron dolor abdominal o hemorragia digestiva. El 94,1% de los tumores expresaba CD 117. Se diagnosticaron principalmente durante una laparotomía o con ecografía. Se extirparon el 94,1% de los tumores. En el 35,2% (6/17) de los pacientes había criterios de alto riesgo de malignidad según el consenso establecido. A lo largo de 25,6 meses (± 22,5) las metástasis o la recidiva tumoral se dieron en el 23,5% (4/17) de los pacientes y en estos fueron más frecuentes: los criterios de alto riesgo, los tumores sintomáticos, los de mayor tamaño y los que no expresan CD 117. Los tres pacientes con recidiva recibieron imatinib mesilato. Tres pacientes fallecieron por causa del tumor. Otros 4 pacientes fallecieron por otras causas no relacionadas con el GIST. Conclusiones: se diagnosticaron aproximadamente 12 casos por millón de habitantes y año. Su diagnóstico con frecuencia es casual. Son malignos en cerca de la cuarta parte de los casos. Existe la posibilidad de predecir la evolución en función de diferentes aspectos

Introduction: gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors in the gastrointestinal tract. One of their features is the expression of the c-KIT / CD117 receptor. Aims and methods: we will focus on describing the symptoms, clinical studies prior to diagnosis, histologic and immunohistochemical characteristics, as well as the progression of disease in a group of patients. Results: seventeen cases were diagnosed between December 1999 and April 2005. Mean age of patients was 64.5 (± 11.9); 47% were women. Tumor location was as follows: 52.9% in the jejunum or ileum, 29.4% were gastric, 11.7% were in the duodenum, and 5.8% were located in the mesentery. Tumor size was 6.0 cm on average (± 5.0); 47% were asymptomatic, and to a lesser degree caused abdominal pain or digestive bleeding; 94.1% of tumors expressed CD117. Most of them were discovered while performing a laparotomy or ultrasound scan; 94.1% of tumors were removed; 35.2% (6 out of 17) of patients suffering from GIST met consensus criteria for aggressive behavior. Over 25.6 months (± 22.5) metastasis or tumor relapse occurred in 23.5% (4 out of 17) of patients – those with more frequent high-risk criteria, symptomatic and bigger tumors, and tumors not expressing CD117. The three patients with tumor relapse were prescribed imatinib mesylate. Three patients died because of the tumor, and four from other causes unrelated to GIST. Conclusions: GIST was diagnosed in around 12 cases per million a year. Its diagnosis was usually an incidental finding during a medical evaluation, and tumors were malignant in nearly one fourth of cases. We can predict its outcome depending on different aspects

Tumores germinales testiculares «reacción de adaptación» / No disponible

No disponible

No disponible

Expectoración espontánea de un fragmento tumoral / Spontaneous expectoration of a tumour fragment

No disponible

Desarrollo de un Curso Monográfico de Investigación en Medicina Paliativa. Declaración del Castillo de la Mota / Course on Palliative Medicine Research. Declaration of La Mota Castle

Este artículo presenta el planteamiento y algunos resultados del III Curso Monográfico de Investigación en Medicina Paliativa, organizado por elMáster de Medicina Paliativa de la Universidad de Valladolid y celebrado a lo largo de un fin de semana en mayo de 2004. Esta reunión se adapta a una serie de recomendaciones prácticas sobre la organización de cursos de formación avanzada de medicina paliativa en base a la experiencia docente de los autores. En el curso participaron 61 médicos, la mayoría profesionales de equipos de Cuidados Paliativos y, como docentes, varios profesores con dilatada experiencia en investigación clínica de España y otros países. Las actividades desarrolladas fueron de tipo muy diverso, desde presentaciones formales sobre metodología de la investigación aplicada a Cuidados Paliativos y sobre problemas clínicos especialmente debatidos, hasta tertulias abiertas o reuniones de trabajo en pequeños grupos. Al final del curso se realizó una evaluación por parte de los asistentes. Los resultados de la valoración global y de todos los contenidos formales resultaron homogéneamente altos (8-9 sobre 10). Finalmente, el trabajo incluye, en nombre de todos los participantes en el curso, la Declaración del Castillo de la Mota sobre la importancia dela investigación en Cuidados Paliativos en España (AU)

This article presents the characteristics and some results of the 3rd Monographic Course on Palliative Medicine Research organized within the Master on Palliative Medicine of the University of Valladolid. The one weekend long course was carried out in May, 2004. This meeting follows the necessary characteristics that an advanced training course in Palliative Medicine must have in the experience of the authors. In the course participated 61 doctors, most of them professionals in Palliative Care Teams, as well as professors with an extended experience in clinical research both in Spain and abroad. The different activities that were carried out included formal presentations on research methodology applied to Palliative Care, other sessions on clinical problems the special interest, get-togethers and small discussion groups. At the end, the course was evaluated by the participants. The overall assessment of the course as well as the score of its content were homogeneously high (8-9 out of 10). The article also includes on behalf of all the participants in the course, the Declaration of la Mota Castle on the importance of research on Palliative Care in Spain (AU)

[Syndrome of recommended patient]. / El síndrome del recomendado.

"Syndrome of recommended patient" is manifested as the presence of numerous unexpected and unusual complications in patients that the treating physician is trying to give a better assistance. Even assuming that a few complications may appear by chance, there are several factors from daily clinical practice that facilitate the presence of such a syndrome, and some of them can be corrected in order to reduce its incidence. All of them come from the change on daily clinical practice on these patients, as if they do not fit for the attention provided for other people. These factors favouring the presence of this syndrome come from: patients' attitude, inefficient use of health resources, absence of an adequate register of clinical data and change in usual clinical practice on interpretation of diagnostic tests as well as in the indication of treatment of these patients. The best way to prevent this "syndrome of recommended patient" is to maintain, even within these patients, an attitude based on solid clinical knowledge and to follow up the same clinical rules accepted for other patients.

El síndrome del recomendado / Syndrome of recommended patient

El "síndrome del recomendado" se manifiesta como la aparición de imprevistos y de complicaciones no habituales en pacientes con los que se pretende desarrollar una atención más esmerada. Aparte de lo que pueda ser debido al azar, hay factores de la práctica clínica habitual que favorecen la manifestación de este síndrome, muchos de los cuales se pueden corregir. Todos provienen del cambio de la práctica habitual que se da con estos pacientes, como si en ellos no fuera adecuado seguir la misma actitud que con los demás. Algunos de los factores que favorecen la aparición de este síndrome son: la actitud del propio paciente, el empleo ineficiente de los recursos sanitarios, la ausencia de un registro adecuado de datos en la historia clínica y el cambio en la conducta habitual en la indicación y la interpretación de los estudios diagnósticos y en el tratamiento de estos enfermos. El mejor modo de prevenir este "síndrome del recomendado" es mantener, también con estos pacientes, una actitud clínica basada en unos conocimientos sólidos y seguir la misma línea de conducta que con los demás enfermos (AU)

"Syndrome of recommended patient" is manifested as the presence of numerous unexpected and unusual complications in patients that the treating physician is trying to give a better assistance. Even assuming that a few complications may appear by chance, there are several factors from daily clinical practice that facilitate the presence of such a syndrome, and some of them can be corrected in order to reduce its incidence. All of them come from the change on daily clinical practice on these patients, as if they do not fit for the attention provided for other people. These factors favouring the presence of this syndrome come from: patients' attitude, inefficient use of health resources, absence of an adequate register of clinical data and change in usual clinical practice on interpretation of diagnostic tests as well as in the indication of treatment of these patients. The best way to prevent this "syndrome of recommended patient" is to maintain, even within these patients, an attitude based on solid clinical knowledge and to follow up the same clinical rules accepted for other patients (AU)

Formación en el uso de opioides: ¿repercute en la práctica diaria? / Formation in opioid use: does it a ffect daily clinical practice?

Introducción: Muchos pacientes oncológicos no reciben aún un tratamiento analgésico adecuado. La formación del personal sanitario en el control del dolor debería ayudar a mejorar las pautas de tratamiento de estos enfermos .Material y métodos: Se analizan las horas lectivas impartidas en la Universidad de Valladolid en cursos de tercer ciclo de 1995 a 1999 sobre cuidados paliativos y control del dolor. Se revisa la cantidad de morfina y fentanilo administrados en este tiempo en el Hospital Universitario de Valladolid (HUV) y en la provincia de Valladolid .Resultados: El consumo de morfina y fentanilo en el Servicio de Oncología del HUV ha crecido de manera pareja a la asistencia de sus miembros a cursos de postgrado sobre medicina paliativa; desde 2446 dosis diarias definidas (DDD) en 1995, a 6156 DDD en 1999. El incremento ha sido proporcionalmente menor en el conjunto del HUV y prácticamente nulo en los Servicios dependientes de Medicina Interna. En la provincia el único cambio significativo aparece en 1999: el consumo de morfina y fentanilo era de 180,45 DDD por millón de habitantes y día en 1998 y creció a 490,57 en 1999; este gran aumento parece deberse únicamente a la difusión del fentanilo transdérmico. Conclusión: Los cursos universitarios de postgrado con formación específica en cuidados paliativos y control del dolor tienen una repercusión positiva pero muy limitada en el empleo de opioides (AU)