Prevalencia del estreñimiento en una población de pacientes oncológicos, en seguimiento por el equipo de cuidados paliativos / Prevalence of constipation in a cancer patient population followed up by a palliative care team

Objetivos: Determinar la prevalencia del estreñimiento en una población de pacientes oncológicos en seguimiento por el equipo de cuidados paliativos. Describir los tratamientos utilizados para el estreñimiento; comparar la frecuencia de estreñimiento según el tratamiento opioide.Material y métodos: Estudio epidemiológico, observacional y transversal. Realizado íntegramente en el Hospital Universitario Arnau de Vilanova (HUAV) de Lleida. Se utilizó un cuestionario heteroadministrado para entrevistar a pacientes en régimen ambulatorio y hospitalario, con diagnóstico de enfermedad oncológica avanzada, y en seguimiento por el equipo de cuidados paliativos durante un mínimo de 5 días.Variables: La prevalencia de estreñimiento se valoró mediante la aplicación de los criterios Roma IV. Por otra parte, se registraron variables correspondientes a las características basales de los pacientes y a su enfermedad, así como los distintos tratamientos utilizados para combatir el estreñimiento y los fármacos opioides. Para la descripción de variables cualitativas, se utilizaron las frecuencias absoluta y relativa, y para las cuantitativas la media y la desviación típica; para la comparación de las mismas se utilizó el test de Chi cuadrado y la t de Student cuando procedía, con un nivel de significación de 0,05.Resultados: De los 100 pacientes incluidos, 98 fueron aptos para el análisis. Un 19,4 % cumplía los criterios Roma IV de estreñimiento en el momento de la valoración. La proporción de pacientes con diagnóstico de estreñimiento fue mayor en régimen hospitalario sin que esta variable alcanzara la significación estadística. No se detectaron diferencias estadísticamente significativas en la prevalencia de estreñimiento entre los distintos tratamientos opioides. El 53,1 % de los pacientes seguía tratamiento habitual con algún laxante, siendo el más frecuente el hidróxido de magnesio (48,1 %), y solo un 11,5 % recibía tratamiento con más de un laxante...(AU)

Objectives: To determine the prevalence of constipation in oncological patients under follow-up by a palliative care team. To describe the treatments used for constipation, comparing the frequency of constipation according to opioid therapy status.Material and methods: An epidemiological, observational, cross-sectional study. It was completely carried out at the Arnau de Vilanova University Hospital (HUAV) in Lleida. A researcher-administered questionnaire was used to interview outpatients and inpatients diagnosed with advanced cancer disease, and followed up by a palliative care team for a minimum of 5 days.Variables: The prevalence of constipation was assessed by applying the Rome IV criteria. On the other hand, variables corresponding to the baseline characteristics of the patients and their disease were recorded, as were the different treatments used to combat constipation and the use of opioid drugs. Concerning qualitative variables, the absolute and relative frequencies were used; for quantitative variables, the mean and standard deviation were used. For comparisons, the chi-square test and Student’s t-test were used when appropriate, with a significance level of 0.05.Results: Of all 100 patients included, 98 were eligible for the analysis; 19.4 % met the Roma IV criteria for constipation at the time of assessment. No statistically significant differences were detected in the prevalence of constipation between different opioid treatments. Even though the proportion of constipated patients was higher among inpatients, this was not statistically significant. In all, 53.1 % of patients were on regular treatment with some laxative, the most frequent being magnesium hydroxide (48.1 %), and only 11.5 % received treatment with more than one laxative.Conclusions: Taking into consideration all the previous information, constipation continues to be a symptom with a non-negligible prevalence among patients with advanced cancer disease..(AU)

Eutanasia: ¿es esta la ley que necesitamos? / Euthanasia: is this the law we need?

La Ley de Eutanasia española introduce un nuevo derecho que se incorpora a la cartera de servicios del sistema sanitario, como una prestación cuya aplicación se garantiza en el plazo de 40 días. Desde la experiencia clínica se argumenta que, sin el derecho efectivo a unos cuidados paliativos de calidad, y con el actual déficit en las ayudas a la dependencia, esta ley puede ser un mensaje coactivo para aquellas personas especialmente frágiles y dependientes, que se sientan como una pesada carga para su familia y para la sociedad.Se razona de qué modo fundamentar el derecho a morir en la dignidad de la persona, puede tener repercusiones sociales inesperadas.El texto normativo muestra debilidades propias de una ley apresurada y sin apoyo de órganos consultivos. Hay cuestiones pendientes de aclarar en su aplicación dentro del contexto de la medicina de familia. Se concluye que esta nueva norma planteará más problemas de los que pretende resolver.(AU)

The Spanish Euthanasia Law introduces a new right that is added to the portfolio of services provided by the Spanish health system and whose application is guaranteed within a period of 40 days. From the perspective of clinical experience, it is argued that without the effective right to quality palliative care and given the current shortcomings in dependant care, this law may send a threatening message to particularly fragile and dependant individuals that will lead to them feeling like a burden to their families and society.It is reasoned that basing the right to die on the dignity of the individual may have unexpected social repercussions.The text of the law presents the flaws of having been written hastily and without the support of advisory entities. There are issues that require clarification with regard to the application of euthanasia within the context of general practice. The conclusion is that this new law will pose more problems of the type it aims to resolve.(AU)

[Euthanasia: is this the law we need?] / Eutanasia: ¿es esta la ley que necesitamos?

The Spanish Euthanasia Law introduces a new right that is added to the portfolio of services provided by the Spanish health system and whose application is guaranteed within a period of 40 days. From the perspective of clinical experience, it is argued that without the effective right to quality palliative care and given the current shortcomings in dependant care, this law may send a threatening message to particularly fragile and dependant individuals that will lead to them feeling like a burden to their families and society. It is reasoned that basing the right to die on the dignity of the individual may have unexpected social repercussions. The text of the law presents the flaws of having been written hastily and without the support of advisory entities. There are issues that require clarification with regard to the application of euthanasia within the context of general practice. The conclusion is that this new law will pose more problems of the type it aims to resolve.

A prospective study examining cachexia predictors in patients with incurable cancer.

BACKGROUND: Early intervention against cachexia necessitates a predictive model. The aims of this study were to identify predictors of cachexia development and to create and evaluate accuracy of a predictive model based on these predictors. METHODS: A secondary analysis of a prospective, observational, multicentre study was conducted. Patients, who attended a palliative care programme, had incurable cancer and did not have cachexia at baseline, were amenable to the analysis. Cachexia was defined as weight loss (WL) > 5% (6 months) or WL > 2% and body mass index< 20 kg/m2. Clinical and demographic markers were evaluated as possible predictors with Cox analysis. A classification and regression tree analysis was used to create a model based on optimal combinations and cut-offs of significant predictors for cachexia development, and accuracy was evaluated with a calibration plot, Harrell's c-statistic and receiver operating characteristic curve analysis. RESULTS: Six-hundred-twenty-eight patients were included in the analysis. Median age was 65 years (IQR 17), 359(57%) were female and median Karnofsky performance status was 70(IQR 10). Median follow-up was 109 days (IQR 108), and 159 (25%) patients developed cachexia. Initial WL, cancer type, appetite and chronic obstructive pulmonary disease were significant predictors (p ≤ 0.04). A five-level model was created with each level carrying an increasing risk of cachexia development. For Risk-level 1-patients (WL < 3%, breast or hematologic cancer and no or little appetite loss), median time to cachexia development was not reached, while Risk-level 5-patients (WL 3-5%) had a median time to cachexia development of 51 days. Accuracy of cachexia predictions at 3 months was 76%. CONCLUSION: Important predictors of cachexia have been identified and used to construct a predictive model of cancer cachexia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01362816 .

Miedo a la muerte en estudiantes de Medicina / Fear of death in medical students

OBJETIVO: El presente estudio tiene como objetivo detectar, describir y analizar el miedo a la muerte de los estudiantes de Medicina de la Universidad de Lleida de los cursos comprendidos entre 1998-2014, y conocer si este miedo se relaciona con variables como el género, la edad, las pérdidas personales, las creencias hacia la muerte y la influencia del plan de estudios. MÉTODO: Forman parte del estudio 676 estudiantes de Medicina de los cursos comprendidos entre 1998-2014, a los que se administra la escala revisada de Collett-Lester de miedo a la muerte y un cuestionario de variables sociodemográficas y biográficas. Resultado: El análisis de las variables encuestadas indica que los estudiantes de Medicina presentan un nivel intermedio de miedo a la muerte y al proceso de morir; los resultados varían según el género, la edad, las pérdidas personales, las creencias hacia la muerte y el plan de estudios. CONCLUSIONES: Con los resultados obtenidos se propone la necesidad de que desde las facultades de Medicina se incluya o se enfatice en un abordaje más orientado a la muerte y el sufrimiento que permita al estudiante de Medicina obtener mayores conocimientos y formarse en acompañar al morir y la muerte

OBJECTIVE: This study aims to detect, describe and analyse the fear of death of medical students of the University of Lleida from the academic years between 1998-2014, and to know if this fear is related to variables such as gender, age, personal losses, beliefs about death and the influence of the curriculum. Method: The study included 676 medical students, from the academic years between 1998 and 2014, who were given the revised Collett-Lester Fear of Death Scale and a questionnaire on sociodemographic and biographical variables. RESULT: The analysis of the variables surveyed indicates that medical students present an intermediate level of fear of death and the process of dying. The results vary according to gender, age, personal losses, beliefs about death and the curriculum. CONCLUSIONS: With the results obtained, it is proposed that medical schools should include or highlight a more death and suffering orientated approach to enable students to obtain greater knowledge and receive training in accompanying death and death

Development and Management of Networks of Care at the End of Life (the REDCUIDA Intervention): Protocol for a Nonrandomized Controlled Trial.

BACKGROUND: End-of-life needs can be only partly met by formalized health and palliative care resources. This creates the opportunity for the social support network of family and community to play a crucial role in this stage of life. Compassionate communities can be the missing piece to a complete care model at the end of life. OBJECTIVE: The main objective of this study is to evaluate the REDCUIDA (Redes de Cuidados or Network of Care) intervention for the development and management of networks of care around people with advanced disease or at the end of life. METHODS: The study is a 2-year nonrandomized controlled trial using 2 parallel groups. For the intervention group, we will combine palliative care treatment with a community promoter intervention, compared with a control group without intervention. Participants will be patients under a community palliative care team's supervision with and without intervention. The community promotor will deliver the intervention in 7 sessions at 2 levels: the patient and family level will identify unmet needs, and the community level will activate resources to develop social networks to satisfy patient and family needs. A sample size of 320 patients per group per 100,000 inhabitants will offer adequate information and will give the study 80% power to detect a 20% increase in unmet needs, decrease families' burden, improve families' satisfaction, and decrease the use of health system resources, the primary end point. Results will be based on patients' baseline and final analysis (after 7 weeks of the intervention). We will carry out descriptive analyses of variables related to patients' needs and of people involved in the social network. We will analyze pre- and postintervention data for each group, including measures of central tendency, confidence intervals for the 95% average, contingency tables, and a linear regression. For continuous variables, we will use Student t test to compare independent samples with normal distribution and Mann-Whitney U test for nonnormal distributions. For discrete variables, we will use Mann-Whitney U test. For dichotomous variables we will use Pearson chi-square test. All tests will be carried out with a significance level alpha=.05. RESULTS: Ethical approval for this study was given by the Clinical Research Committee of Andalusian Health Service, Spain (CI 1020-N-17), in June 2018. The community promoter has been identified, received an expert community-based palliative care course, and will start making contacts in the community and the palliative care teams involved in the research project. CONCLUSIONS: The results of this study will provide evidence of the benefit of the REDCUIDA protocol on the development and assessment of networks of compassionate communities at the end of life. It will provide information about clinical and emotional improvements, satisfaction, proxy burden, and health care resource consumption regarding patients in palliative care. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10515.

Correction: An International Consensus Definition of the Wish to Hasten Death and Its Related Factors.

[This corrects the article DOI: 10.1371/journal.pone.0146184.].

The Spanish Adaptation of the Palliative Performance Scale (Version 2) Among Cancer Patients at the End of Life: Psychometric Properties.

BACKGROUND: Palliative Performance Scale (PPS) is a reliable tool to assess performance status in cancer patients receiving palliative care (PC). Spanish validated and culturally adapted tools are needed. OBJECTIVES: The objectives are to develop PPS translation and cross-cultural adaptation into Spanish and to assess its psychometric properties. DESIGN: Translation process with cross-cultural adaptation to produce Spanish Palliative Performance Scale (PPS-SPANISH). SETTINGS: PC Team at one University hospital in Spain. PARTICIPANTS: Fifteen advanced cancer patients (60 assessments) were included for PPS translation and validation and 250 patients for cross-sectional analysis. All participants were recruited at oncology ward, emergency area, and outpatient clinic by PC team professionals. Informed consent was given. Average age was 66.4 ± 13 years (60% men). METHODS: The process is designed in three steps. In Step 1, PPS translation and reverse translation into Spanish (three bilingual speakers) and linguistic complexity measurement were performed. In Step 2, readability and intelligibility assessment was carried out. In Step 3, a pilot study was conducted to assess test-retest reliability followed by a cross-sectional study to measure internal consistency. Inclusion criteria were the same for two samples. Demographic data were also analyzed by descriptive statistics. RESULTS: Following cultural, linguistic, and grammatical adaptation, PPS-SPANISH was readable and reliable. The analysis of the test-retest reliability after 48 hours showed intraclass correlations >0.60. Cronbach's alpha coefficient was 0.99 (0.988-0.992). There was high agreement with other functional assessment tools (Barthel Index and Karnofsky Performance Status Index). CONCLUSIONS: PPS-SPANISH showed reliability and validity, and it is suitable to assess performance status in cancer patients receiving PC.

An International Consensus Definition of the Wish to Hasten Death and Its Related Factors.

BACKGROUND: The desire for hastened death or wish to hasten death (WTHD) that is experienced by some patients with advanced illness is a complex phenomenon for which no widely accepted definition exists. This lack of a common conceptualization hinders understanding and cooperation between clinicians and researchers. The aim of this study was to develop an internationally agreed definition of the WTHD. METHODS: Following an exhaustive literature review, a modified nominal group process and an international, modified Delphi process were carried out. The nominal group served to produce a preliminary definition that was then subjected to a Delphi process in which 24 experts from 19 institutions from Europe, Canada and the USA participated. Delphi responses and comments were analysed using a pre-established strategy. FINDINGS: All 24 experts completed the three rounds of the Delphi process, and all the proposed statements achieved at least 79% agreement. Key concepts in the final definition include the WTHD as a reaction to suffering, the fact that such a wish is not always expressed spontaneously, and the need to distinguish the WTHD from the acceptance of impending death or from a wish to die naturally, although preferably soon. The proposed definition also makes reference to possible factors related to the WTHD. CONCLUSIONS: This international consensus definition of the WTHD should make it easier for clinicians and researchers to share their knowledge. This would foster an improved understanding of the phenomenon and help in developing strategies for early therapeutic intervention.

Vitamin D deficiency and its association with fatigue and quality of life in advanced cancer patients under palliative care: A cross-sectional study.

BACKGROUND: A normal vitamin D status is required for bones and muscles to maintain their function and structure, but it also contributes to the functional integrity of other multiple physiologic systems in the body. AIM: To assess the relationship of Vitamin D deficiency with health-related quality-of-life issues, fatigue, and physical functioning in advanced cancer patients. DESIGN: This is a cross-sectional study. PATIENTS/SETTINGS: Adults under palliative care, having a locally advanced or metastatic or inoperable solid cancer. RESULTS: Among 30 patients in palliative care with advanced solid cancer, 90% were vitamin D deficient. Serum Vitamin D concentration was positively correlated with patient-reported absence of fatigue (s = 0.49), and physical and functional well-being (s = 0.44 and s = 0.41, respectively, p < 0.01). Fatigue was the symptom with the highest median impact on their lives and was the only one associated with serum vitamin D (p = 0.031), with lower fatigue in patients with vitamin D concentrations in the third tertile. There was no evidence of a direct association between health-related quality of life and vitamin D status. CONCLUSION: The 90% frequency of advanced cancer patients with vitamin D deficiency, together with the positive correlation of vitamin D status with the absence of fatigue and improved physical and functional well-being, points to vitamin D supplementation as a potential therapy to enhance the patient's quality of life.

New symptom-based predictive tool for survival at seven and thirty days developed by palliative home care teams.

AIM: This study sought to develop models to predict survival at 7 and 30 days based on symptoms detected by palliative home care teams (PHCTs). MATERIALS AND METHODS: This prospective analytic study included a 6-month recruitment period with patient monitoring until death or 180 days after recruitment. The inclusion criteria consisted of age greater than 18 years, advanced cancer, and treatment provided by participating PHCTs between April and July 2009. The study variables included death at 7 or 30 days, survival time, age, gender, place of residence, type of tumor and extension, presence of 11 signs and symptoms measured with a 0-3 Likert scale, functional and cognitive status, and use of a subcutaneous butterfly needle. The statistics applied included a descriptive analysis according to the percentage or mean±standard deviation. For symptom comparison between surviving and nonsurviving patients, the χ(2) test was used. Classification and regression tree (CART) methodology was used for model development. An internal validation system (cross-validation with 10 partitions) was used to ensure generalization of the models. The area under the receiver operating characteristics (ROC) curve was calculated (with a 95% confidence interval) to assess the validation of the models. RESULTS: A total of 698 patients were included. The mean age of the patients was 73.7±12 years, and 60.3% were male. The most frequent type of neoplasm was digestive (37.6%). The mean Karnofsky score was 51.8±14, the patients' cognitive status according to the Pfeiffer test was 2.6±4 errors, and 8.3% of patients required a subcutaneous butterfly needle. Each model provided 8 decision rules with a probability assignment range between 2.2% and 99.1%. The model used to predict the probability of death at 7 days included the presence of anorexia and dysphagia and the level of consciousness, and this model produced areas under the curve (AUCs) of 0.88 (0.86-0.90) and 0.81 (0.79-0.83). The model used to predict the probability of death at 30 days included the presence of asthenia and anorexia and the level of consciousness, and this model produced AUCs of 0.78 (0.77-0.80) and 0.77 (0.75-0.79). CONCLUSION: For patients with advanced cancer treated by PHCTs, the use of classification schemes and decision trees based on specific symptoms can help clinicians predict survival at 7 and 30 days.

Sedación paliativa: situación actual y áreas de mejora / Palliative sedation: current situation and areas of improvement

Objetivo. Conocer la prevalencia, las características epidemiológicas y la calidad del registro relativos a la sedación paliativa (SP) en un hospital universitario. Establecer áreas de mejora. Material y método. nálisis descriptivo retrospectivo de los registros clínicos de pacientes oncológicos fallecidos en nuestro centro entre octubre y diciembre de 2010. Las variables analizadas incluyeron: datos epidemiológicos y ubicación de los pacientes, presencia de SP, síntoma que la motivó, grado de participación del paciente y la familia en la toma de decisiones, fármacos y dosis utilizados. El análisis cualitativo se desarrolló mediante 2 rondas Delphi en las que cada participante recibió los resultados globales del grupo. Fueron seleccionados aquellos ítems en los que existía un consenso completo o elevado. Resultados. Identificamos 53 defunciones por cáncer, el 51% recibieron SP. La edad media fue de 67 años, y el 64% fueron varones. El cáncer de pulmón supuso el 32%. Quince pacientes dependían de Oncología, 7 de Hematología y 4 del Servicio de Urgencias. En el 53,85% existió intervención de cuidados paliativos. Los síntomas que motivaron la SP fueron: disnea en 11 casos y delirium en 5. El tiempo medio ingreso-SP fue de 9,5 días (duración media, 1,2 días). La media de fármacos utilizados fue de 2,6, con empleo de morfina en el 100% y midazolam en el 98%. En 20 casos constatamos el registro de consentimiento para su inicio (100% verbal). Doce profesionales participaron en el análisis cualitativo fruto del cual consensuamos una plantilla para mejorar los registros de selección, toma de decisiones y evolución en los casos de SP. Conclusiones. La SP fue motivada por disnea o delirium y se aplicó en la mitad de los pacientes fallecidos. Las áreas de mejora detectadas afectaban al registro de los criterios de selección, al tipo de sedación y a la participación del paciente en la toma de decisiones. Por ello hemos consensuado un conjunto mínimo de datos que facilitará la recogida de información de los profesionales (AU)

Objective. To determine the prevalence, epidemiology and registration status of palliative sedation (PS) prevalence in a teaching hospital, and to establish areas for improvement. Methods. A descriptive retrospective analysis was designed using the records from cancer patients who died between October and December 2010. The variables included were: epidemiological, inpatient unit, refractory symptom, drugs and dosages, and patient participation in the decision making process. The qualitative analysis followed a Delphi process: each participant received the overall performance of the group referred to as mean, median, 25th and 75th percentile. Items selected were those in which there was total or a high consensus. Results. A total of 53 deaths were identified. Just over half (51.92%) received PS. The mean age was 67.46 and 64% were males. The most frequent diagnosis was lung cancer (32.14%). Fifteen of the patient patients were in the Oncology ward, 7 in Hematology, and 4 at the Emergency Department. The PC team took part in 14 of the sedations performed. A refractory symptom was identified in 20. There were 11 cases of dyspnea and 5 cases of delirium. The mean time between admission and PS was 9.5 days. The mean duration of PS was 1.2 days, with a mean number of 2.6 drugs used. There were 20 informed consents which were all verbal. The mean time from last chemotherapy to death was 82 days. For the Delphi process, 12 oncology or palliative care health professionals were included. A consensus was reached on the minimum data to be recorded in case of PS. This list includes: selection criteria, decision-making process and the sedation evolution. Conclusions. PS was applied in half of the patients who died due to dyspnea or delirium. Selection criteria were identified, as well as the type of PS and patient involvement in decision making process. A consensus was also reached on a minimum dataset that would help the clinician to record relevant information in PS (AU)

[Palliative sedation: Current situation and areas of improvement]. / Sedación paliativa: situación actual y áreas de mejora.

OBJECTIVE: To determine the prevalence, epidemiology and registration status of palliative sedation (PS) prevalence in a teaching hospital, and to establish areas for improvement. METHODS: A descriptive retrospective analysis was designed using the records from cancer patients who died between October and December 2010. The variables included were: epidemiological, inpatient unit, refractory symptom, drugs and dosages, and patient participation in the decision making process. The qualitative analysis followed a Delphi process: each participant received the overall performance of the group referred to as mean, median, 25th and 75th percentile. Items selected were those in which there was total or a high consensus. RESULTS: A total of 53 deaths were identified. Just over half (51.92%) received PS. The mean age was 67.46 and 64% were males. The most frequent diagnosis was lung cancer (32.14%). Fifteen of the patient patients were in the Oncology ward, 7 in Hematology, and 4 at the Emergency Department. The PC team took part in 14 of the sedations performed. A refractory symptom was identified in 20. There were 11 cases of dyspnea and 5 cases of delirium. The mean time between admission and PS was 9.5 days. The mean duration of PS was 1.2 days, with a mean number of 2.6 drugs used. There were 20 informed consents which were all verbal. The mean time from last chemotherapy to death was 82 days. For the Delphi process, 12 oncology or palliative care health professionals were included. A consensus was reached on the minimum data to be recorded in case of PS. This list includes: selection criteria, decision-making process and the sedation evolution. CONCLUSIONS: PS was applied in half of the patients who died due to dyspnea or delirium. Selection criteria were identified, as well as the type of PS and patient involvement in decision making process. A consensus was also reached on a minimum dataset that would help the clinician to record relevant information in PS.

Policy statement on multidisciplinary cancer care.

BACKGROUND: Cancer care is undergoing an important paradigm shift from a disease-focused management to a patient-centred approach, in which increasingly more attention is paid to psychosocial aspects, quality of life, patients' rights and empowerment and survivorship. In this context, multidisciplinary teams emerge as a practical necessity for optimal coordination among health professionals and clear communication with patients. The European Partnership for Action Against Cancer (EPAAC), an initiative launched by the European Commission in 2009, addressed the multidisciplinary care from a policy perspective in order to define the core elements that all tumour-based multidisciplinary teams (MDTs) should include. To that effect, a working group conference was held in January 2013 within the EPAAC Work Package 7 (on Healthcare) framework. METHODS: The consensus group consisted of high-level representatives from the following European scientific societies, patient associations and stakeholders: European CanCer Organisation (ECCO), European SocieTy for Radiology & Oncology (ESTRO), European Society for Medical Oncology (ESMO), European Society of Surgical Oncology (ESSO), International Society of Geriatric Oncology (SIOG), European Association for Palliative Care (EAPC), European Oncology Nursing Society (EONS), International Psycho-Oncology Society (IPOS),European Cancer Patient Coalition (ECPC), EuropaColon, Europa Donna - The European Breast Cancer Coalition, Association of European Cancer Leagues (ECL), Organisation of European Cancer Institutes (OECI), EUSOMA - European Society of Breast Cancer Specialists, European Hospital and Healthcare Federation (HOPE) and EPAAC Work Packages 5 (Health promotion and prevention), 7, 8 (Research), 9 (Information systems) and 10 (Cancer plans). A background document with a list of 26 core issues drawn from a systematic review of the literature was used to guide the discussion. Five areas related to MDTs were covered: care objectives, organisation, clinical assessment, patients' rights and empowerment and policy support. Preliminary drafts of the document were widely circulated for consultation and amendments by the working group before final approval. RESULTS: The working group unanimously formulated a Policy Statement on Multidisciplinary Cancer Care to define the core elements that should be implemented by all tumour-based MDTs. This document identifies MDTs as the core component in cancer care organisation and sets down the key elements to guide changes across all European health systems. CONCLUSION: MDTs are an essential instrument of effective cancer care policy, and their continued development crucial to providing patients the care they need and deserve. While implementation must remain in local hands, European health systems can still benefit from having a basis for an effective multidisciplinary model of cooperation. This policy statement is intended to serve as a reference for policymakers and healthcare providers who wish to improve the services currently provided to the cancer patients whose lives and well-being depend on their action.

The effect on quality of life of vitamin D administration for advanced cancer treatment (VIDAFACT study): protocol of a randomised controlled trial.

INTRODUCTION: Vitamin D is related to resistance to chronic diseases, physiological parameters and functional measures. All of these relationships underscore the potential benefits of cholecalciferol or D3 (nutritional vitamin D) in cancer. This is the first study designed to obtain conclusive evidence on the effect of cholecalciferol in advanced patients with cancer. The main goal is to assess its effects on the patient's perceived quality of life. Cholecalciferol's impact on fatigue and physical performance, as well as its cost utility, will also be assessed. METHODS AND ANALYSIS: A randomised triple-blind phase II/III placebo-controlled multicentre trial has been designed. Patients satisfying the inclusion and exclusion criteria will be randomly assigned to receive cholecalciferol or placebo. Eligible patients will be adults with a locally advanced or metastatic or inoperable solid cancer in palliative care, who have given signed informed consent and have matched inclusion and exclusion criteria. The randomisation will be based on a computer-generated procedure and centralised by the pharmacy service of the coordinating centre. The assigned treatment will be administered by the hospital's pharmacy to conceal group allocation for patients and healthcare providers. Cholecalciferol (4000 IU/day) or placebo, starting at day 15 and continuing up to day 42, will be added to palliative care treatment. Outpatient visits will be scheduled every 14 days. ETHICS AND DISSEMINATION: Ethical approval was received from the Medical Ethical Commitee of the HUAV (CEIC-1169). Participants and their families will receive the research findings which will also be disseminated on local and national media, presented at national and international meetings of the specialty, and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: EudraCT: 2013-003478-29.

Nuevo curso: nuevos retos y compromisos / A new course: New challenges and commitments

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Patients attended by palliative care teams: are they always comparable populations?

Patients attended by palliative care teams: are they always comparable populations? To answer this question we have compared the basic epidemiological characteristics of patients attended by home palliative care teams (HPCT) in two autonomous regions of Spain. We carried out a coordinated analytical, observational and prospective study in two Spanish autonomous regions: Aragon and Catalonia. Data were kept during each home care visit according to patients' needs. Inclusion criteria were: advanced cancer, over 18 years old and first contact with a HPCT. The recruitment period was 6 months. Variables included were: Survival time (days), age, sex, primary disease and extension, place of residence. Functional and cognitive state, and co-morbidity. 10 signs/symptoms: asthenia, anorexia, cachexia, dysphagia, xerostomy, dyspnoea, oedemas, level of consciousness, presence of delirium, presence of pressure ulcers and some treatment data. Others variables considered were: responsible team, origin, destination when discharge, date and place of death, number of visits made and duration of monitoring. We developed a comparison between groups by Chi-squared test or the non-parametric Mann-Whitney U test and a survival analysis by Kaplan-Meier curves and the logrank test to determine differences between factors. The SPSS version 15.0 software package was used. 698 patients were included, 56.2% from Aragon and 43.8% from Catalonia. 60.3% were males, without differences between the regions. Characteristics relative to age, sex, place of residence and extension of oncological diseases were similar for both groups. We found significant differences between the two populations relative to survival time, co-morbidity, functional state, presence and intensity of a number of symptoms and the treatments, patient monitoring and the their destination after discharge. We can conclude that palliative care teams cover different profiles of patients with regard to their co-morbidity, functional, cognitive and symptomatic states. It must be pointed that the organization of palliative care services and their experience appears to condition the profile of patients they attend. There is a need of consensus on the basic descriptors for palliative care patients in order to ensure that results will be comparable.

Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC.

Here we provide the updated version of the guidelines of the European Association for Palliative Care (EAPC) on the use of opioids for the treatment of cancer pain. The update was undertaken by the European Palliative Care Research Collaborative. Previous EAPC guidelines were reviewed and compared with other currently available guidelines, and consensus recommendations were created by formal international expert panel. The content of the guidelines was defined according to several topics, each of which was assigned to collaborators who developed systematic literature reviews with a common methodology. The recommendations were developed by a writing committee that combined the evidence derived from the systematic reviews with the panellists' evaluations in a co-authored process, and were endorsed by the EAPC Board of Directors. The guidelines are presented as a list of 16 evidence-based recommendations developed according to the Grading of Recommendations Assessment, Development and Evaluation system.

The role of paracetamol and nonsteroidal anti-inflammatory drugs in addition to WHO Step III opioids in the control of pain in advanced cancer. A systematic review of the literature.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol are used widely in the management of mild to moderate cancer pain and are frequently combined with opioids in the treatment of moderate to severe pain. AIM: To perform a systematic literature review of the evidence of the efficacy and toxicity of NSAIDs or paracetamol added to WHO Step III opioid treatment for cancer pain. DESIGN AND DATA SOURCES: A systematic literature review of MedLine, EMBASE and Cochrane Central register of controlled trials database was carried out using both text words and MeSH/EMTREE terms. RESULTS: Seven eligible papers were retrieved from the new search and five from the Cochrane review. Five of seven studies showed an additive effect of NSAIDs when combined with opioids either by improving analgesia (three studies) or by reducing the opioid dose (two studies). Paracetamol was only marginally effective in one of five trials. The study designs were not adequate to assess differences in side effects between the opioids alone and opioids in combination with NSAIDs or paracetamol. CONCLUSIONS: The evidence from the available clinical trials is of limited amount and quality, but it weakly supports the proposal that the addition of an NSAIDs to WHO Step III opioids can improve analgesia or reduce opioid dose requirement. There is insufficient evidence to support the use of paracetamol in combination with Step III opioids. Data on the toxicity of NSAIDs in this indication are insufficient owing to the small number of patients and the short duration of treatment reported in the studies.

Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients.

INTRODUCTION: Methylphenidate is a psychostimulant that has been used to relieve depressive symptoms in advanced cancer patients. No studies compare its efficacy against placebo in this group of patients. OBJECTIVE: To explore the efficacy of methylphenidate compared with placebo in the relief of depressive symptoms in advanced cancer patients. MATERIAL AND METHODS: A multicentre, double-blind, randomised placebo-controlled clinical trial was undertaken comparing the efficacy of methylphenidate and placebo in depressive symptoms. Advanced stage cancer patients were eligible if they scored at least two points on the Two Question Screening Survey for depression. A reduction of at least two points on the Edmonton Symptom Assessment Scale for depression (0-10) was considered as a response. RESULTS: Sixty-nine patients were included (methylphenidate: n=31, placebo: n=38); median daily dose of methylphenidate was 25 mg. Fifty-eight patients (84%) who completed the first week of treatment were considered suitable for evaluation. In the intention to treat analysis, there were 14/31 (45%) responses with methylphenidate and 10/38 (26%) responses with placebo (difference: 19%; 95% CI: 4% to 39%; p=0.10). With the Hospital Anxiety and Depression Scale, 11/19 (58%) patients with methylphenidate and 10/24 (42%) with placebo improved from a score compatible with depression in the first 7 days (difference 16%; 95% CI 13% to 42%; p=0.29). The proportion of patients indicating adverse effects was similar for both cohorts (p=0.99). CONCLUSION: Compared with the placebo, methylphenidate demonstrated a positive trend in the incidence of response for depressive symptoms in advanced cancer patients.