Therapeutic management, adherence, and clinical outcomes of heart failure in Andalucía. ANDALIC Protocol. / Manejo terapéutico, adherencia y resultados clínicos de la insuficiencia cardiaca en Andalucía. Protocolo ANDALIC.

Heart failure is a prevalent syndrome with high mortality rates, representing a significant economic burden in terms of healthcare. The lack of systematic information about the treatment and adherence of patients with heart failure limits the understanding of these aspects and potentially the improvement of clinical outcomes. OBJECTIVE: To describe the clinical characteristics, therapeutic management, adherence, persistence and clinical results, as well as the association between these variables, in a cohort of patients with heart failure in Andalusia. DESIGN: This study will be an observational, population-based, retrospective cohort study. Data of patients discharged from an Andalusian hospital with a diagnosis of heart failure between 2014 and 2023 will be extracted from the Andalusian population health database. ANALYSIS: The statistical analysis will incorporate the following strategies: 1) Descriptive analysis of the characteristics of the population cohort, adherence measures, and clinical outcomes. 2) Bivariate analyses to study the association of covariates with adherence, persistence and clinical results. 3) Multivariate logistic regression and Cox regression analysis including relevant covariates. 4) To evaluate changes over time, multivariate Poisson regression models will be used. By conducting this comprehensive study, we aim to gain valuable insights into the clinical characteristics, treatment management, and adherence of heart failure patients in Andalusia, as well as to identify factors that may influence clinical outcomes. These findings could be critical both for the development of optimized strategies that improve medical care and quality of life of patients and for mitigating the health burden of HF in the region.

Machine Learning-Based Prediction of Changes in the Clinical Condition of Patients With Complex Chronic Diseases: 2-Phase Pilot Prospective Single-Center Observational Study.

BACKGROUND: Functional impairment is one of the most decisive prognostic factors in patients with complex chronic diseases. A more significant functional impairment indicates that the disease is progressing, which requires implementing diagnostic and therapeutic actions that stop the exacerbation of the disease. OBJECTIVE: This study aimed to predict alterations in the clinical condition of patients with complex chronic diseases by predicting the Barthel Index (BI), to assess their clinical and functional status using an artificial intelligence model and data collected through an internet of things mobility device. METHODS: A 2-phase pilot prospective single-center observational study was designed. During both phases, patients were recruited, and a wearable activity tracker was allocated to gather physical activity data. Patients were categorized into class A (BI≤20; total dependence), class B (2060; moderate or mild dependence, or independent). Data preprocessing and machine learning techniques were used to analyze mobility data. A decision tree was used to achieve a robust and interpretable model. To assess the quality of the predictions, several metrics including the mean absolute error, median absolute error, and root mean squared error were considered. Statistical analysis was performed using SPSS and Python for the machine learning modeling. RESULTS: Overall, 90 patients with complex chronic diseases were included: 50 during phase 1 (class A: n=10; class B: n=20; and class C: n=20) and 40 during phase 2 (class B: n=20 and class C: n=20). Most patients (n=85, 94%) had a caregiver. The mean value of the BI was 58.31 (SD 24.5). Concerning mobility aids, 60% (n=52) of patients required no aids, whereas the others required walkers (n=18, 20%), wheelchairs (n=15, 17%), canes (n=4, 7%), and crutches (n=1, 1%). Regarding clinical complexity, 85% (n=76) met patient with polypathology criteria with a mean of 2.7 (SD 1.25) categories, 69% (n=61) met the frailty criteria, and 21% (n=19) met the patients with complex chronic diseases criteria. The most characteristic symptoms were dyspnea (n=73, 82%), chronic pain (n=63, 70%), asthenia (n=62, 68%), and anxiety (n=41, 46%). Polypharmacy was presented in 87% (n=78) of patients. The most important variables for predicting the BI were identified as the maximum step count during evening and morning periods and the absence of a mobility device. The model exhibited consistency in the median prediction error with a median absolute error close to 5 in the training, validation, and production-like test sets. The model accuracy for identifying the BI class was 91%, 88%, and 90% in the training, validation, and test sets, respectively. CONCLUSIONS: Using commercially available mobility recording devices makes it possible to identify different mobility patterns and relate them to functional capacity in patients with polypathology according to the BI without using clinical parameters.

Feasibility of the Implementation of LESS-CHRON in Clinical Practice: A Pilot Intervention Study in Older Patients With Multimorbidity.

Background and Objectives: Potentially inappropriate medication refers to the prescription of drugs whose risks outweigh the benefits. There are different pharmacotherapeutic optimization strategies to detect and avoid potentially inappropriate medications (PIMs), namely deprescription. The List of Evidence-Based Deprescribing for Chronic Patients (LESS-CHRON) criteria were designed as a tool to systematize the deprescribing process. LESS-CHRON has established itself as one of the most suitable to be applied in older (≥65 years) multimorbid patients. However, it has not been applied to these patients, to measure the impact on their treatment. For this reason, a pilot study was conducted to analyze the feasibility of implementing this tool in a care pathway. Research Design and Methods: A pre-post quasi-experimental study was conducted. Older outpatients with multimorbidity from the Internal Medicine Unit of a benchmark Hospital were included. The main variable was feasibility in clinical practice, understood as the likelihood that the deprescribing intervention recommended by the pharmacist would be applied to the patient. Success rate, therapeutic, and anticholinergic burden, and other variables related to health care utilization were analyzed. Results: A total of 95 deprescribing reports were prepared. Forty-three were evaluated by the physician who assessed the recommendations made by pharmacists. This translates into an implementation feasibility of 45.3%. The application of LESS-CHRON identified 92 PIMs. The acceptance rate was 76.7% and after 3 months 82.7% of the stopped drugs remained deprescribed. A reduction in anticholinergic burden and enhanced adherence was achieved. However, no improvement was found in clinical or health care utilization variables. Discussion and Implications: The implementation of the tool in a care pathway is feasible. The intervention has achieved great acceptance and deprescribing has been successful in a not insignificant percentage. Future studies with a larger sample size are necessary to obtain more robust results in clinical and health care utilization variables.

Adaptación transcultural y validación al español del cuestionario de desprescripción en el paciente de edad avanzada / Cross-cultural adaptation and validation into Spanish of the deprescription questionnaire in the elderly patient

Antecedentes y objetivo: En 2017 se desarrolló un cuestionario en italiano que tenía como objetivo determinar las percepciones de los clínicos ante la desprescripción en población de edad avanzada.El objetivo fue traducir y adaptar transculturalmente al español este cuestionario de desprescripción.MétodosTraducción directa y retrotraducción, seguidas de una síntesis y adaptación por un tercer traductor. Desarrollo de un panel de expertos para evaluar la adecuación de la traducción, comprensibilidad de la pregunta traducida y utilidad de cada cuestión. Se realizó un análisis de comprensibilidad a médicos familiarizados con la desprescripción.ResultadosSe obtuvo la versión española del cuestionario, donde el grado de dificultad medio en la traducción directa e inversa fue baja/moderada. En la primera fase del panel de expertos 4 preguntas tuvieron apartados considerados «indeterminados» y una fue «dudosa». Tras la segunda fase, todas las cuestiones fueron «adecuadas» a excepción de una.ConclusionesSe trata de la primera adaptación transcultural al español de este cuestionario, lo que permitirá disponer de una herramienta para valorar la percepción de los clínicos y establecer mejoras en la realización de esta práctica. (AU)

Background and objective: In 2017, a questionnaire was developed in Italian with the aim of determining clinicians’ perceptions of deprescription in the elderly population.The objective was to translate and cross-culturally adapt this deprescription questionnaire to Spanish.MethodsForward and blind-back translations, followed by a synthesis and adaptation by a third translator. Development of an expert panel to evaluate the adequacy of the translation, the understandability of the translated question and the usefulness of each question. A comprehensibility analysis was carried out on physicians familiar with deprescription.ResultsThe Spanish version of the questionnaire was obtained, where the average degree of difficulty in the direct and the back-translation was low/moderate. In the first phase of the panel of experts, 4 questions had sections considered “indeterminate” and one question was “doubtful”. After the second phase, all the questions were considered “adequate” except for one.ConclusionsThis is the first cross-cultural adaptation to Spanish of this questionnaire, which will provide a tool to assess clinicians’ perception of this practice and establish improvements to carry out this activity. (AU)

[Cross-cultural adaptation and validation into Spanish of the deprescription questionnaire in the elderly patient]. / Adaptación transcultural y validación al español del cuestionario de desprescripción en el paciente de edad avanzada.

BACKGROUND AND OBJECTIVE: In 2017, a questionnaire was developed in Italian with the aim of determining clinicians' perceptions of deprescription in the elderly population. The objective was to translate and cross-culturally adapt this deprescription questionnaire to Spanish. METHODS: Forward and blind-back translations, followed by a synthesis and adaptation by a third translator. Development of an expert panel to evaluate the adequacy of the translation, the understandability of the translated question and the usefulness of each question. A comprehensibility analysis was carried out on physicians familiar with deprescription. RESULTS: The Spanish version of the questionnaire was obtained, where the average degree of difficulty in the direct and the back-translation was low/moderate. In the first phase of the panel of experts, 4 questions had sections considered "indeterminate" and one question was "doubtful". After the second phase, all the questions were considered "adequate" except for one. CONCLUSIONS: This is the first cross-cultural adaptation to Spanish of this questionnaire, which will provide a tool to assess clinicians' perception of this practice and establish improvements to carry out this activity.

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.

Dorsalgia tras colangiopancreatografía retrógrada endoscópica / Back pain after endoscopic retrograde cholangiopancreatography

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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.

Ketoacidosis Due to Empagliflozin, a Paradigm Shift: Case Report and Review of Literature.

INTRODUCTION: Sodium-glucose cotransporter 2(SGLT2)-inhibitors are new antihyperglycemic agents that have shown a reduction in cardiovascular events in type 2 diabetes mellitus. Recent warnings have been developed about an increased risk of euglycemic and moderate hyperglycemic diabetic ketoacidosis with the use of SGLT2 inhibitors, but its real incidence is not available yet. CASE REPORT: We present a case of DKA with moderate hyperglycemia in a patient treated with metformin and empagliflozin. CONCLUSION: DKA in patients treated with SGLT2 inhibitors can be presented as euglycemic and moderated hyperglycemia. This special presentation poses a physician's challenge.

Oral anticoagulation in patients with atrial fibrillation and medical non-neoplastic disease in a terminal stage.

Many patients with non-neoplastic disease develop atrial fibrillation in advanced stages of their disease. The aim of this study is to determine the factors associated with the use of oral anticoagulants in patients with atrial fibrillation and non-neoplastic medical disease in a terminal stage, and whether their use is associated with a longer survival. Design is prospective, observational, multicentre study. Patients with atrial fibrillation and non-neoplastic disease (severe not reversible organ insufficiency) in a terminal stage were included between February 2009 and September 2010. A 6-month follow-up was carried out. We included 314 patients with a mean (SD) age of 82.6 (7.0) years. Their mean (SD) scores in CHADS2 and ATRIA scales were 3.4 (1.2) and 4.7 (2.0), respectively. Anticoagulants were prescribed to 112 (37.5 %) patients. The use of anticoagulants was associated with age (OR 0.96 95 % CI 0.93-0.99, p = 0.046) and to the Barthel index (OR 1.01 95 % CI 1.00-1.02; p = 0.034). After performing a propensity score matching analysis, 262 patients were included in the survival analysis. After 6 months, 133 (50.8 %) patients were dead. The mortality is higher among patients who are not treated with oral anticoagulants (57.1 vs. 39.4 %; p = 0.006), but it is independently associated only with the Barthel index score (HR 0.99 95 % CI 0.98-1.00; p = 0.039), delirium (HR 1.60, 95 % CI 1.08-2.36; p = 0.018), anorexia (HR 1.58 95 % CI 1.05-2.38; p = 0.027), and with the use of calcium channel blockers (HR 0.50 95 % CI 0.30-0.84; p = 0.009). In patients with atrial fibrillation and non-neoplastic disease in a terminal stage, the use of oral anticoagulants is not independently associated with a higher probability of survival.

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.

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.