A randomized clinical trial of home telemonitoring in patients with advanced heart and lung diseases.

BRIEF SUMMARY: The addition of home monitoring to an integrated care model in patients with advanced chronic heart/lung diseases decreases mortality, hospital and emergency admissions, improves functional status, HRQoL, and is cost-effective. BACKGROUND: Telemonitoring is a promising implement for medicine, but its efficacy is unknown in patients with advanced heart and lung failure (AHLF). OBJECTIVE: To determine the efficacy of a telemonitoring system added to coordinated clinical care in patients with AHLF. DESIGN: Randomized phase 3 multicenter clinical trial with parallel groups in adult patients. PARTICIPANTS: Five spanish centers including patients with AHLF at discharge or in out-patient clinics. INTERVENTION: Patients were randomly assigned to receive a remote bio-parameters telemonitoring system (TELECARE) or best usual care (UCARE). TELECARE patients were provided with devices that collected symptoms and bio-parameters, and transferred them synchronously to a call-center, with a real-time health-care response. MAIN MEASURES: Primary end point was the need of admissions/emergency room visits at 45, 90, 180 days. Secondary end points included health care requirements, mortality, functional assessment, health related quality of life (HRQoL), perceived satisfaction, and cost-efficacy. RESULTS: 510 patients were included (54.5% women, median age 76.5 years; 63.1% suffered heart failure, 13.9% lung failure, and 22.9% both conditions). Clinical and functional features were comparable in both arms. TELECARE globally needed less admissions with respect UCARE after 45 days of inclusion (35.4% vs. 46.9%, p < 0.05). This tendency was maintained in the subgroups of patients with multimorbidity (34.2% vs. 46.9%, p < 0.05), intermediate risk of mortality (36.5% vs. 51.1%, p < 0.05), and those included after hospital discharge (34.9% vs. 50.5%, p < 0.01). HRQoL significantly improved (TELECARE/UCARE EuroQol baseline of 56.2 ± 18.2/55.1 ± 19.7, p = 0.054, and 64 ± 19.9/56.3 ± 21.6; p < 0.01 at the end), and perceived satisfaction was also higher (6.77 ± 0.52 vs. 6.62 ± 0.81, p < 0.001; highest possible score = 7). A trend to mortality decrease was also observed (12.9% vs. 19.3%, p = 0.13). TELECARE was cost-efficacious (TELECARE/UCARE QALY 3.94 Euros/0.81Euros). CONCLUSIONS: The addition of a telemonitoring system to an integrated care model in patients with AHLF decreases hospital and emergency admissions, improves functional status as well as HRQoL, and is cost-efficacious.

A multicenter randomized clinical trial to evaluate the efficacy of telemonitoring in patients with advanced heart and lung chronic failure. Study protocol for the ATLAN_TIC project.

BACKGROUND: Using technologies of information and communication (TICs) is emerging in medical assistance. TICs application for medical assistance is promising. Its applicability in advanced heart and/or respiratory failure is still controversial because studies have shown methodological weakness which could put in danger their conclusions. Our objective is to evaluate efficacy of the application of home monitoring biological parameters in a multi-level model of coordinated clinical care for patients with chronic diseases with advanced heart (HF) and/or respiratory failure (RF) in comparison with conventional clinical care. METHOD: /Design: Multicentric, phase III, randomized, parallel groups, controlled clinical trial. Patients with advanced HF and/or RF were eligible to participate. Patients received medical assistance by a multi-level model of coordinated clinical care with or without home monitoring. Follow up was performed until 180 days after inclusion. Primary efficacy outcome was defined as the percentage of patients with hospitalization/emergency room visits. Secondary efficacy outcomes were hospital admissions, admissions to hospital emergencies and Primary Care Emergencies, number of days of hospital stay, total cost per patient in euros, mortality, change in functional status, quality of life, assistance and technology devices. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruits patients per arm is set at 255, a total of 510 patients. DISCUSSION: This trial could provide some knowledge about the real impact of home monitoring for patients with advanced HF and/or RF within a multi-level model of integrated care.

Obstinación diagnóstica en pacientes oncológicos hospitalizados en situación de últimos días / Diagnostic obstinacy in hospitalized oncologic patients during their last days of life

INTRODUCCIÓN: La limitación del esfuerzo terapéutico debería incluir la limitación de la realización de pruebas diagnósticas que no mejoran los síntomas del paciente. El objetivo de este estudio fue analizar el uso de pruebas diagnósticas en pacientes oncológicos hospitalizados en sus últimos días de vida. MÉTODOS: Se realizó un estudio descriptivo retrospectivo incluyendo todos los pacientes oncológicos estadio IV que fallecieron en el Servicio de Medicina Interna durante un periodo de dos años. Las variables analizadas fueron edad, sexo, número de pruebas de laboratorio (contabilizadas como una sola prueba por cada extracción), número de pruebas radiológicas (radiología simple, ecografía, tomografía computerizada [TC], resonancia magnética [RM]) y si se realizó extracción de analítica de sangre en las últimas 48 horas de vida. RESULTADOS: Fueron incluidos 51 pacientes (15 mujeres, 29,4 %), con una edad media de 71,94 años (desviación estándar 11,06). Se realizaron pruebas de laboratorio a 45 pacientes (88,4 %), con una mediana de 3 pruebas por paciente (rango intercuartílico 1,5). En 41 casos (80,4 %) se realizaron estudios radiológicos, con una mediana de 1 (rango intercuartílico 1,3) estudio por paciente. Las pruebas radiológicas realizadas fueron: radiografía simple (37 pacientes, 72,5 %), ecografía (17 pacientes, 33,3 %), TC (12 pacientes, 23,6 %), RM (1 paciente, 2 %). A 23 pacientes (45,1 %) se les realizó una extracción de sangre en las últimas 48 horas de vida. CONCLUSIONES: Se realiza un número elevado de pruebas diagnósticas en los últimos días de vida de pacientes oncológicos en situación terminal. Aunque las pruebas realizadas no se consideran invasivas, producen molestias innecesarias a los pacientes que no contribuyen al control de síntomas

INTRODUCTION: Any limitation of therapeutic effort should include a limitation of diagnostic tests not contributing to patient comfort. The aim of the present study was to assess the use of diagnostic tests among hospitalized cancer patients during their last days of life. METHODS: A retrospective observational study was performed on all stage-IV cancer patients who died during hospitalization in the Internal Medicine Unit over a period of two years. Analyzed variables included: age, gender, number of laboratory tests, and number of imaging tests (plain X-rays, ultrasound, computed tomography [CT], magnetic resonance imaging [MRI]), and whether a blood test had been performed wIthin the last 48 hours of life. RESULTS: A total of 51 patients were included (women, 15; 29.4 %) with an average age of 71.94 years (standard deviation, 11.06). Of these, 45 patients (88.4 %) underwent laboratory tests with a median of 3 tests per patient (interquartile range, 1.5), 41 patients (80.4 %) underwent imaging tests with a median of 1 test per patient (interquartile range, 1.3). The frequencies of imaging tests were: plain X-rays, 37 patients (72.5 %); ultrasounds, 17 patients (33.3 %); CT, 12 patients (23.6 %); MRI, 1 patient (2 %). Twenty-three patients (45.1 %) underwent at least one blood test within their last 48 hours of life. CONCLUSIONS: A large number of laboratory and imaging tests are performed during the last days of terminally ill, hospitalized cancer patients. While these tests are not considered to be invasive, they cause unnecessary discomfort to patients, and do not contribute to symptom relief

Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial.

BACKGROUND: The increasing incidence of osteoporotic hip fracture (HF) has raised the requirements of red blood cell (RBC) transfusions, whereas this scarce resource may cause morbidity and mortality. STUDY DESIGN AND METHODS: This study was a multicenter, randomized, double-blind, clinical trial that aimed to assess efficacy of ferric carboxymaltose (FCM) with or without erythropoietin (EPO) in reducing RBC transfusion in the perioperative period of HF. Participants (patients > 65 years admitted with HF and hemoglobin [Hb] levels of 90-120 g/L) were randomly assigned to receive a preoperative single dose of 1 g of FCM (short intravenous [IV] infusion over 15 min), plus 40,000 IU of subcutaneous EPO (EPOFE arm); versus 1 g of IV FCM plus subcutaneous placebo (FE arm); and versus IV and subcutaneous placebo (placebo arm). Primary endpoint was the percentage of patients who received RBC transfusion, and secondary endpoints were the number of RBC transfusions per patient, survival, hemoglobinemia, and health-related quality of life (HRQoL; by means of Short Form 36 Version 2 questionnaire). RESULTS: A total of 306 patients (85% women, mean age 83 ± 6.5 years) were included. A total of 52, 51.5, and 54% of patients required RBC transfusion in the EPOFE, FE, and placebo arms, respectively, with no significant differences in the number of RBC transfusions per patient, survival, HRQoL, and adverse events among treatment groups. A significant increase in Hb levels was achieved at discharge (102 g/L vs. 97 g/L) and 60 days after discharge (125 g/L vs. 119 g/L) in the EPOFE arm with respect to placebo arm; in addition, a higher rate of patients recovered from anemia in the EPOFE arm with respect to the placebo arm (52% vs. 39%), 60 days after discharge. CONCLUSION: Preoperative treatment with FCM alone or in combination with EPO improved recovery from postoperative anemia, but did not reduce the needs of RBC transfusion in patients with HF.

Perfil de prescripción farmacológica en pacientes con enfermedades crónicas no neoplásicas en fase avanzada / Drug prescription profile in patients with advanced chronic diseases

Objetivos. Analizar el perfil de prescripción farmacológica y los factores asociados a polifarmacia en pacientes con enfermedades crónicas no neoplásicas en fase avanzada. Material y métodos. Estudio observacional transversal, multicéntrico, realizado en 41 hospitales españoles (proyecto PALIAR). Se definió polifarmacia como el consumo habitual de 5 o más fármacos en los últimos 3 meses y polifarmacia excesiva cuando dicho número era de 10 o más. El grado de adherencia fue evaluado mediante una encuesta rellenada por el paciente o su cuidador. Se analizaron los factores relacionados con la polifarmacia y la no adherencia al tratamiento. Resultados. De 1.847 pacientes, completaron la encuesta 1.778 (96,2%). La edad media fue 78,74 ± 10 años. Los fármacos más prescritos fueron: antihipertensivos (82,6%), gastroprotectores (73,8%), antiagregantes/anticoagulantes (70,3%) y psicotrópicos (51,8%). La prevalencia de polifarmacia/polifarmacia-severa fue de 86,2-31,3% (consumo medio: 8 ± 3,5 fármacos). El 48,2% reconocía cometer errores en la toma: el 38,5% ocasionalmente y el 9,6% casi diariamente o siempre. La no-adherencia se relacionó con: cumplir criterios de paciente pluripatológico, > 3 ingresos en los últimos 3 meses, deterioro cognitivo y la toma de > 5 fármacos. La polifarmacia se asoció con cumplir criterios de paciente pluripatológico, puntuación ECOG < 3, edad < 85 años y > 3 ingresos en los últimos 3 meses. La polifarmacia severa se relacionó con cumplir criterios de paciente pluripatológico y > 3 ingresos en los últimos 3 meses. Conclusiones. La prevalencia de polifarmacia y errores en administración de fármacos en pacientes con enfermedades médicas avanzadas es elevada, por lo que es necesario desarrollar estrategias para mejorar la adherencia en esta población (AU)

Objectives. To analyze the prescription profile and the factors associated with multiple medications (polypharmacy) and non-adherence in patients with advanced chronic diseases. Material and methods. Longitudinal cross-sectional study including 41 Spanish hospitals (PALIAR project). Polypharmacy was defined as a prescribed treatment with five or more drugs, and excessive polypharmacy when the number was ten or more. The adherence was evaluated using a questionnaire completed by the patients or their caregivers. Description of drug prescription profile and analysis was performed on the risk factors associated with multiple medications and non-adherence. Results. The study included 1847 patients, and 1778 (96.2%) completed the questionnaire. Mean age was 78.74±10 years. Antihypertensives (82.6%), gastroprotectives (73.8%), anti-platelets/anticoagulants (70.3%), and psychotropic drugs (51.8%) were the most frequently prescribed drugs. Prevalence of polypharmacy/excessive polypharmacy was 86.2%/31.3%, with a mean of 8±3.5 drugs per patient. Errors in treatment compliance were detected in 48.2% of patients, but 38.5% and 9.6% referred to an occasional or almost daily failure, respectively. Factors associated with non-adherence were: to be a patient with multiple diseases, cognitive impairment, three or more 3 hospital admissions in the last three months, and having polypharmacy. Factors associated with polypharmacy were: to be a patient with multiple diseases, an ECOG score <3, age <85 years, and 3 or more hospital admissions. Factors associated with excessive polypharmacy were: to be a patient with multiple diseases and previous frequent hospital admissions. Conclusions. The prevalence of polypharmacy in patients with advanced chronic diseases is high, and mistakes in treatment compliance are frequent. Further studies with better defined objectives and more specific therapeutic limits are needed (AU)

[Drug prescription profile in patients with advanced chronic diseases]. / Perfil de prescripción farmacológica en pacientes con enfermedades crónicas no neoplásicas en fase avanzada.

OBJECTIVES: To analyze the prescription profile and the factors associated with multiple medications (polypharmacy) and non-adherence in patients with advanced chronic diseases. MATERIAL AND METHODS: Longitudinal cross-sectional study including 41 Spanish hospitals (PALIAR project). Polypharmacy was defined as a prescribed treatment with five or more drugs, and excessive polypharmacy when the number was ten or more. The adherence was evaluated using a questionnaire completed by the patients or their caregivers. Description of drug prescription profile and analysis was performed on the risk factors associated with multiple medications and non-adherence. RESULTS: The study included 1847 patients, and 1778 (96.2%) completed the questionnaire. Mean age was 78.74±10 years. Antihypertensives (82.6%), gastroprotectives (73.8%), anti-platelets/anticoagulants (70.3%), and psychotropic drugs (51.8%) were the most frequently prescribed drugs. Prevalence of polypharmacy/excessive polypharmacy was 86.2%/31.3%, with a mean of 8±3.5 drugs per patient. Errors in treatment compliance were detected in 48.2% of patients, but 38.5% and 9.6% referred to an occasional or almost daily failure, respectively. Factors associated with non-adherence were: to be a patient with multiple diseases, cognitive impairment, three or more 3 hospital admissions in the last three months, and having polypharmacy. Factors associated with polypharmacy were: to be a patient with multiple diseases, an ECOG score <3, age <85 years, and 3 or more hospital admissions. Factors associated with excessive polypharmacy were: to be a patient with multiple diseases and previous frequent hospital admissions. CONCLUSIONS: The prevalence of polypharmacy in patients with advanced chronic diseases is high, and mistakes in treatment compliance are frequent. Further studies with better defined objectives and more specific therapeutic limits are needed.

Development of a six-month prognostic index in patients with advanced chronic medical conditions: the PALIAR score.

CONTEXT: Efforts in developing useful tools to properly identify the end-of-life trajectory of patients with advanced medical diseases have been made, but the calibration and/or discriminative power of these tools has not been optimal. OBJECTIVES: Our objective was to develop a new, reliable prognostic tool to identify the probability of death within six months in patients with chronic medical diseases. METHODS: This was a multicenter, prospective, observational study in 41 Spanish hospitals, which included 1778 patients with one or more of the following: advanced conditions such as heart failure, respiratory failure, chronic renal failure, chronic liver disease, and/or chronic neurological disease. All patients were followed over six months. Each factor independently associated with death in the derivation cohort (884 patients from eastern areas of Spain) was assigned a prognostic weight, and the score was calculated by summing up the factors. The score's accuracy in the validation cohort (894 patients from western areas of Spain) was assessed by analyzing its calibration and discriminative power; we also calculated sensitivity, specificity, and positive and negative predictive values. RESULTS: Mortality in the derivation/validation cohorts was 37.6%/37.7%, respectively. We identified six independent predictors of mortality (≥85 years, three points; New York Heart Association Class IV/Stage 4 dyspnea on the modified Medical Research Council, 3.5 points; anorexia, 3.5 points; presence of pressure ulcer(s), three points; Eastern Cooperative Oncology Group Performance Status of three or more, four points; and albuminemia ≤2.5g/dL, four points). Mortality in the derivation/validation cohorts according to risk group was 20%/21.5% for patients with zero points; 33%/30.5% for those with 3-3.5 points; 46.3%/43% for those with four to seven points; and 67%/61% for those who reached 7.5 or more points, respectively. The calibration was good (Hosmer-Lemeshow test, P=0.39), as was the discriminative power (area under the receiver operating characteristic curve of 0.69 [0.66-0.72]). The sensitivity (85%), specificity (86%), positive and negative predictive values (64% and 80%, respectively) at 180 days were high. CONCLUSION: The PALIAR score is a precise and reliable tool for identifying the end-of-life trajectory in patients with advanced medical diseases.

Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project.

BACKGROUND: Around one third to one half of patients with hip fractures require red-cell pack transfusion. The increasing incidence of hip fracture has also raised the need for this scarce resource. Additionally, red-cell pack transfusions are not without complications which may involve excessive morbidity and mortality. This makes it necessary to develop blood-saving strategies. Our objective was to assess safety, efficacy, and cost-effictveness of combined treatment of i.v. ferric carboxymaltose and erythropoietin (EPOFE arm) versus i.v. ferric carboxymaltose (FE arm) versus a placebo (PLACEBO arm) in reducing the percentage of patients who receive blood transfusions, as well as mortality in the perioperative period of hip fracture intervention. METHODS/DESIGN: Multicentric, phase III, randomized, controlled, double blinded, parallel groups clinical trial. Patients > 65 years admitted to hospital with a hip fracture will be eligible to participate. Patients will be treated with either a single dosage of i.v. ferric carboxymaltose of 1 g and subcutaneous erythropoietin (40.000 IU), or i.v. ferric carboxymaltose and subcutaneous placebo, or i.v. placebo and subcutaneous placebo. Follow-up will be performed until 60 days after discharge, assessing transfusion needs, morbidity, mortality, safety, costs, and health-related quality of life. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruited patients per arm is set at 102, a total of 306 patients. DISCUSSION: We think that this trial will contribute to the knowledge about the safety and efficacy of ferric carboxymaltose with/without erythropoietin in preventing red-cell pack transfusions in patients with hip fracture. CLINICALTRIALS.GOV IDENTIFIER: NCT01154491.

Precisión de los criterios definitorios de pacientes con enfermedades médicas no neoplásicas en fase terminal. Proyecto PALIAR / Reliability of different criteria in identifying end-of-life trajectory of patients with chronic medical diseases. PALIAR Project

Introducción. Existe incertidumbre para identificar adecuadamente la trayectoria del final de la vida en pacientes con enfermedades médicas crónicas en fases avanzadas, hecho que dificulta en muchos casos la planificación de servicios y el proceso de transición, de unos objetivos de supervivencia a unos terapéuticos de calidad de vida. Objetivos. Evaluar la sensibilidad, especificidad, valores predictivos positivo y negativo, e índice de validez de los criterios de enfermedad médica terminal del National Hospice Organization estadounidense, la Palliative Prognostic Index y la Eastern Cooperative Oncology Group (ECOG) en pacientes con enfermedades cardíacas, neumológicas, hepáticas, renales y/o neurológicas en estadío avanzado; y construir-validar un índice específico para determinar con mayor certidumbre esta frontera. Métodos. Estudio de cohortes prospectivas multicéntrico con inclusión de pacientes con criterios predefinidos de enfermedad avanzada en órganos comentados. Recogida de datos demográficos, clínico-asistenciales, de estratificación y estadiaje de enfermedad(es), funcionales, analíticos, criterios de la National Hospice Organization, ECOG, valores predictivos positivos y Palliative Prognostic Index; y de la variable final (fallecimiento) a los 180 días de la inclusión. Análisis de sensibilidad, especifidad, valores predictivos positivos, negativos e índice de validez de los criterios de la National Hospice Organization, escala ECOG y Palliative Prognostic Index a los 30, 60, 90, 120, 150 y 180 días. Derivación, si procede, del indice PALIAR, tras análisis multivariante y ponderación de los factores de riesgo (beta del f. riesgo/beta menor del modelo) y posterior validación en cohorte de validación y cohorte histórica PROFUND...(AU)

Introduction. It is a challenge to reliably identify the end-of-life trajectory in patients with advanced-stage chronic medical conditions. This makes advanced supportive care planning and transition from survival to comfort objectives more difficult in these emergent patient populations. Objectives. To evaluate the sensitivity (Se), specificity (Sp), positive predictive values (PPV) and negative (NPV), and validity index (IV) of NHO criteria for terminal medical conditions, PPI and ECOG in patients with advanced heart, lung, liver, kidney and/or neurological diseases, and to build and validate an accurate index to determine this border-line. Methods. A multicentre prospective cohort study, with inclusion of patients with the predefined advanced medical diseases. Demographic, clinical, care, stratification and staging of disease(s), functional, analytical, NHO criteria, ECOG, PPS and PPI data collection; The end-point (death) will be assessed 180 days after inclusion. Analysis of Se, Sp, PPV, NPV, and IV of the NHO criteria, ECOG scale and PPI at 30, 60, 90, 120, 150 and 180 days. Derivation of PALIAR Index, after multivariate analysis and appropriate weighting of risk factors (beta of risk factor/lowest beta of the model), and validation in the validation cohort, and in the historical PROFUND cohort. Results. The project is still ongoing, with 50 investigators from 33 hospitals throughout Spain, who have already included 1138 patients (92.5% during hospital admissions, 51.4% of them are male, with a mean age of 78.5 years). Mean inclusion chronic diseases were 1.4 per patient (44.5% of patients suffered chronic neurological diseases, 38.6% with heart failure, 34.2% with lung diseases, 12% with liver diseases, and 6.5% with renal diseases)...(AU)

[Reliability of different criteria in identifying end-of-life trajectory of patients with chronic medical diseases. PALIAR Project]. / Precisión de los criterios definitorios de pacientes con enfermedades médicas no neoplásicas en fase terminal. Proyecto PALIAR.

INTRODUCTION: It is a challenge to reliably identify the end-of-life trajectory in patients with advanced-stage chronic medical conditions. This makes advanced supportive care planning and transition from survival to comfort objectives more difficult in these emergent patient populations. OBJECTIVES: To evaluate the sensitivity (Se), specificity (Sp), positive predictive values (PPV) and negative (NPV), and validity index (IV) of NHO criteria for terminal medical conditions, PPI and ECOG in patients with advanced heart, lung, liver, kidney and/or neurological diseases, and to build and validate an accurate index to determine this border-line. METHODS: A multicentre prospective cohort study, with inclusion of patients with the predefined advanced medical diseases. Demographic, clinical, care, stratification and staging of disease(s), functional, analytical, NHO criteria, ECOG, PPS and PPI data collection; The end-point (death) will be assessed 180 days after inclusion. Analysis of Se, Sp, PPV, NPV, and IV of the NHO criteria, ECOG scale and PPI at 30, 60, 90, 120, 150 and 180 days. Derivation of PALIAR Index, after multivariate analysis and appropriate weighting of risk factors (beta of risk factor/lowest beta of the model), and validation in the validation cohort, and in the historical PROFUND cohort. RESULTS: The project is still ongoing, with 50 investigators from 33 hospitals throughout Spain, who have already included 1138 patients (92.5% during hospital admissions, 51.4% of them are male, with a mean age of 78.5 years). Mean inclusion chronic diseases were 1.4 per patient (44.5% of patients suffered chronic neurological diseases, 38.6% with heart failure, 34.2% with lung diseases, 12% with liver diseases, and 6.5% with renal diseases). Around 69% fulfilled the criteria of polypathological patients (mean Charlson index 3.4), and were prescribed around 8 drugs chronically. Mean Barthel index was 40 points, and 77% of them were dependent on a caregiver. Around 46% were ECOG-PS stage III or IV, and mean PPS score was 45 points. CONCLUSION: The availability of an accurate and powerful tool that could enable us to identify the end-of-life trajectory of these patients could allow us to establish specific intervention strategies for these populations. Therefore, and with these preliminary data, we believe that the PALIAR PROJECT will answer with rigour the questions and objectives of the study.

El razonamiento clínico como fuente de error / Clinical reasoning as a source of error

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Uso inadecuado del término 'fiebre de origen desconocido' / Misuse of the term "fever of unknown origin"

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