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?

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

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.

¿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

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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)

Hidratación por vía subcutánea en pacientes con cáncer avanzado / No disponible

Introducción: La vía subcutánea se emplea con frecuencia en enfermosde cáncer avanzado o ancianos para administrar medicación por víaparenteral. Sin embargo, la hidratación por vía subcutánea es excepcionalen nuestro medio aunque ya se está utilizando en algunos centros. Pretendemosconocer si es factible administrar hidratación subcutánea enenfermos oncológicos, las características de la técnica y las difi cultadesque se pueden presentar en su aplicación.Pacientes, material y métodos: Se incluyeron pacientes oncológicos concáncer avanzado con deshidratación o riesgo de padecerla de la Unidadde Medicina Paliativa del Hospital Grey Nuns, Edmonton (Canadá) y delHospital Universitario de Valladolid que recibieron hidratación subcutáneacon volumen y ritmo de infusión adaptados a cada enfermo.Resultados: Se realizaron 101 punciones en 33 pacientes (Edmonton24; Valladolid 9), con un total de 314 días de infusión. El volumen fue1.000 cc/día durante una mediana de 10 días (1 a 21 días) y un ritmode 20 a 400 cc/hora. El punto de infusión se cambió cada tres días (1a 15 días), principalmente por acumulación en zona de punción. Solodos enfermos precisaron asociar hialuronidasa a la solución utilizadapor absorción defi ciente. Hubo diferencias entre Hospitales en las característicasde los pacientes (peor pronóstico: grupo español) y tipo deinfusión (mayor volumen y duración: grupo canadiense). La incidenciade complicaciones fue similar similares en ambos grupos y en generalde carácter leve.Conclusión: La vía subcutánea para la hidratación de pacientesoncológicos terminal es sencilla y parece exenta de complicacionesimportantes(AU)

Introduction: Subcutaneous infusion allows the administration of parenteraltreatments. However, subcutaneous hydration is exceptional in ourenvironment. We developed this trial in order to assess the feasibilityof such hydration in cancer patients, the procedures and potentialcomplications.Patients, material and methods: We included dehydrated terminally illcancer patients and patients at risk of developing dehydration from thePalliative Care Unit of The Grey Nuns Hospital, Edmonton (Canada)and Hospital Universitario de Valladolid (Spain). They received subcutaneoushydration; the volume and rhythm of infusion were adaptedto each patient.Results: We performed 101 clyses in 33 patients (Edmonton 24; Valladolid9), with a total of 314 days of infusion. Volume infused was1,000 cc/day over a median of three days (1 to 21 days) and a rhythmof 20 cc/hour. Clyses were changed every three days (1 to 15 days),mainly because of fl uid retention in the puncture area. Two patientsrequired hyaluronidase. There were differences between Hospitals incharacteristics of patients (worse prognosis in the Spanish group) andconditions of infusion (higher volume and duration in Canadians). Theincidence of complications was low, being similar in both groups.Conclusions: Subcutaneous hydration of terminally ill cancer patients iseasy and seems to be free of severe complications(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

Heart metastases and superior vena cava syndrome.

Superior vena cava syndrome (SVCS) may be due to a tumour infiltrating the right atrium. We present two patients with SVCS. The first one was secondary to solitary atrial metastases of rectal adenocarcinoma and benefited from palliative chemotherapy. The second patient had a disseminated large cell B-cell lymphoma with rapid clinical complete response, but she eventually died after relapse.

Heart metastases and superior vena cava síndrome

Superior vena cava syndrome (SVCS) may be due to a tumour infiltrating the right atrium. We present two patients with SVCS. The first one was secondary to solitary atrial metastases of rectal adenocarcinoma and benefited from palliative chemotherapy. The second patient had a disseminated large cell B-cell lymphoma with rapid clinical complete response, but she eventually died after relapse (AU)

[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

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