Health data hubs: an analysis of existing data governance features for research.

BACKGROUND: Digital transformation in healthcare and the growth of health data generation and collection are important challenges for the secondary use of healthcare records in the health research field. Likewise, due to the ethical and legal constraints for using sensitive data, understanding how health data are managed by dedicated infrastructures called data hubs is essential to facilitating data sharing and reuse. METHODS: To capture the different data governance behind health data hubs across Europe, a survey focused on analysing the feasibility of linking individual-level data between data collections and the generation of health data governance patterns was carried out. The target audience of this study was national, European, and global data hubs. In total, the designed survey was sent to a representative list of 99 health data hubs in January 2022. RESULTS: In total, 41 survey responses received until June 2022 were analysed. Stratification methods were performed to cover the different levels of granularity identified in some data hubs' characteristics. Firstly, a general pattern of data governance for data hubs was defined. Afterward, specific profiles were defined, generating specific data governance patterns through the stratifications in terms of the kind of organization (centralized versus decentralized) and role (data controller or data processor) of the health data hub respondents. CONCLUSIONS: The analysis of the responses from health data hub respondents across Europe provided a list of the most frequent aspects, which concluded with a set of specific best practices on data management and governance, taking into account the constraints of sensitive data. In summary, a data hub should work in a centralized way, providing a Data Processing Agreement and a formal procedure to identify data providers, as well as data quality control, data integrity and anonymization methods.

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.

Impact of hyponatremia in patients hospitalized in Internal Medicine units: Hyponatremia in Internal Medicine units.

The aim of this study was to analyze the impact and the clinical and evolutionary characteristics of hypotonic hyponatremia in patients hospitalized in Internal Medicine units. Prospective multicenter observational study of patients with hypotonic hyponatremia (<135 mmol/L) in 5 hospitals in southern Spain. Patients were included according to point prevalence studies carried out every 2 weeks between March 2015 and October 2017, by assessing demographic, clinical, analytical, and management data; each patient was subsequently followed up for 12 months, during which time mortality and readmissions were assessed. A total of 501 patients were included (51.9% women, mean age = 71.3 ±â€…14.24 years), resulting in an overall prevalence of hyponatremia of 8.3%. The mean comorbidities rate was 4.50 ±â€…2.41, the most frequent diagnoses being heart failure (115) (23%), respiratory infections (65) (13%), and oncological pathologies (42) (6.4%). Of the total number of hyponatremia cases, 180 (35.9%) were hypervolemic, 164 (32.7%) hypovolemic, and 157 (31.3%) were euvolemic. A total of 87.4% did not receive additional diagnostic tests to establish the origin of the condition and 30% did not receive any treatment. Hospital mortality was 15.6% and the mean length of stay was 14.7 days. Euvolemic and admission hyponatremia versus hyponatremia developed during admission were significantly associated with lower mortality rates (P = .037). Mortality at 1 year and readmissions were high (31% and 53% of patients, respectively). Hyponatremia was common in Internal Medicine areas, with hypervolemic hyponatremia being the most frequent type. The mortality rate was high during admission and at follow-up; yet there is a margin for improvement in the clinical management of this condition.

Executive summary of the consensus document for the training and development of clinical ultrasound in Internal Medicine: Recommendations from the Clinical Ultrasound Working Group of the Spanish Society of Internal Medicine (GTECO-SEMI).

INTRODUCTION: Given the increasing adoption of clinical ultrasound in medicine, it is essential to standardize its application, training, and research. OBJECTIVES AND METHODS: The purpose of this document is to provide consensus recommendations to address questions about the practice and operation of clinical ultrasound units. Nineteen experts and leaders from advanced clinical ultrasound units participated. A modified Delphi consensus method was used. RESULTS: A total of 137 consensus statements, based on evidence and expert opinion, were considered. The statements were distributed across 10 areas, and 99 recommendations achieved consensus. CONCLUSIONS: This consensus defines the most important aspects of clinical ultrasound in the field of Internal Medicine, with the aim of standardizing and promoting this healthcare advancement in its various aspects. The document has been prepared by the Clinical Ultrasound Working Group and endorsed by the Spanish Society of Internal Medicine.

FAIR principles to improve the impact on health research management outcomes.

Background: The FAIR principles, under the open science paradigm, aim to improve the Findability, Accessibility, Interoperability and Reusability of digital data. In this sense, the FAIR4Health project aimed to apply the FAIR principles in the health research field. For this purpose, a workflow and a set of tools were developed to apply FAIR principles in health research datasets, and validated through the demonstration of the potential impact that this strategy has on health research management outcomes. Objective: This paper aims to describe the analysis of the impact on health research management outcomes of the FAIR4Health solution. Methods: To analyse the impact on health research management outcomes in terms of time and economic savings, a survey was designed and sent to experts on data management with expertise in the use of the FAIR4Health solution. Then, differences between the time and costs needed to perform the techniques with (i) standalone research, and (ii) using the proposed solution, were analyzed. Results: In the context of the health research management outcomes, the survey analysis concluded that 56.57% of the time and 16800 EUR per month could be saved if the FAIR4Health solution is used. Conclusions: Adopting principles in health research through the FAIR4Health solution saves time and, consequently, costs in the execution of research involving data management techniques.

Physiotherapy in palliative medicine: patient and caregiver wellness.

OBJECTIVES: Despite the demonstrated efficacy of physiotherapy in palliative care programmes, there are scarce data of its real-life impact on patients' and caregivers' wellness and stress. Our aim was to assess effectiveness of a 30-day physiotherapy programme in psychological wellness and health-related quality of life (HRQoL) of patients with advanced chronic diseases or cancer and in their caregivers' stress. METHODS: Quasiexperimental before-after study applying personalised kinesitherapy, exercise with curative effects, respiratory physiotherapy, therapeutic massages and ergotherapy. Psychological wellness, HRQoL and caregiver's strain outcomes were measured. RESULTS: 207 patients (60% men, with a mean age of 73.6±12 years) were included; 129 (62.3%) with advanced cancer, and the remaining 78 with advanced chronic diseases. Psychological wellness (Emotional Stress Detection Tool decreased from 12.4±3 to 11±3; p<0.0001), caregiver's strain (Caregiver Strain Index decreased from 8.5±3.2 to 7.9±3.5; p<0.0001) and HRQoL (WHO-BREF physical health domain increased from 8.3±2.6 to 9.4±2.9; p<0.0001) showed a significant improvement after the physiotherapy programme. Global satisfaction with the physiotherapy intervention was also high (Client Satisfaction Questionnaire-8 of 28.3±3.3 points). CONCLUSIONS: A personalised physiotherapy programme incorporated to integral palliative care improved psychological wellness, HRQoL and caregivers' strain of patients with advanced chronic diseases and cancer.

Survival Impact of an On-Site Medicalization Program in the Control of COVID-19 Outbreaks in 11 Nursing Homes.

BACKGROUND: The elderly admitted to nursing homes have especially suffered the havoc of the COVID-19 pandemic since most of them are not prepared to face such health problems. METHODS: An innovative coordinated on-site medicalization program (MP) in response to a sizeable COVID-19 outbreak in three consecutive waves was deployed, sharing coordination and resources among primary care, the referral hospital, and the eleven residences. The objectives were providing the best possible medical care to residents in their environment, avoiding dehumanization and loneliness of hospital admission, and reducing the saturation of hospitals and the risk of spreading the infection. The main outcomes were a composite endpoint of survival or optimal palliative care (SOPC), survival, and referral to the hospital. RESULTS: 587 of 1199 (49%) residents were infected, of whom 123 (21%) died. Patients diagnosed before the start of the MP presented SOPC, survival, and referrals to the hospital of 83%, 74%, and 22.4%, opposite to 96%, 84%, and 10.6% of patients diagnosed while the MP was set up. The SOPC was independently associated with an MP (OR 3.4 [1.6-7.2]). CONCLUSION: During the COVID-19 outbreak, a coordinated MP successfully obtained a better rate of SOPC while simultaneously reducing the need for hospital admissions, combining optimal medical management with a more compassionate and humanistic approach in older people.

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.

Identification and characterisation of deprescribing tools for older patients: A scoping review.

BACKGROUND: Deprescription is the revision of the therapeutic plan with the aim of simplifying it, taking into account patient preferences, prognosis and environment. This strategy is particularly relevant in older patients, mostly polymedicated individuals, since they are exposed to numerous adverse effects and interactions and tend to have less adherence to treatments. OBJECTIVE: To identify the deprescribing tools for older patients available in the scientific literature, classify them according to their design and describe their main features and potential applicability in clinical practice. METHODS: A search was conducted in PubMed and EMBASE for relevant literature published before July 2021. The PRISMA-ScR method was applied, extracting variables related to study and tool characteristics as well as potential clinical applicability. The main inclusion criteria were studies focused on designing or developing deprescribing tools for older patients and those that indicated the features of the deprescribing tool used in detail. RESULTS: Fourteen of 723 papers met the inclusion criteria, and 12 tools were identified: 6 "algorithm-based tools" and 6 "criterion-based tools". Though all tools are aimed at older patients, there are certain peculiarities regarding their design, population, application setting and variables included. Of the 6 criterion-based tools found, 4 used the Delphi method for their design and development. Furthermore, most of them agree on the pharmacological groups that are likely to be deprescribed. CONCLUSIONS: Taking into account the importance of the clinical situation and priorities in the care plan in the deprescribing process, the authors believe that tools which help to evaluate these aspects are the most suitable for application in clinical practice. However, it is necessary to continue studying applicability in real-life clinical scenarios and to obtain health results.

Prognostic Significance of Lung and Cava Vein Ultrasound in Elderly Patients Admitted for Acute Heart Failure: PROFUND-IC Registry Analysis.

Introduction: Heart failure is an extremely prevalent disease in the elderly population of the world. Most patients present signs and symptoms of decompensation of the disease due to worsening congestion. This congestion has been clinically assessed through clinical signs and symptoms and complementary imaging tests, such as chest radiography. Recently, pulmonary and inferior vena cava ultrasound has been shown to be useful in assessing congestion but its prognostic significance in elderly patients has been less well evaluated. Objectives: This study aims to compare the clinical and radiological characteristics and predictive values for mortality in patients admitted for heart failure through the determination of B lines by lung ultrasound and the degree of collapsibility of the inferior vena cava (IVC). Secondarily, the study aims to assess the prediction of 30-day mortality based on the diameter of the IVC by means of the ROC curve. Methods: This is an observational cohort study based on data collected in the PROFUND-IC study, a nationwide multicentric registry of patients admitted with decompensated heart failure. Data were collected from these patients between October 2020 and April 2022. Results: A total of 482 patients were entered into the PROFUND-IC registry between October 2020 and April 2022. Bedside clinical ultrasound was performed during admission in 301 patients (64.3%). The number of patients with more than 6 B-lines on lung ultrasound amounted to 194 (66%). Statistically significant differences in 30-day mortality (22.1% vs. 9.2%; p = 0.01) were found in these patients. The sum of patients with IVC collapsibility of less than 50% amounted to 195 (67%). Regarding prognostic value, collapsibility data were significant for the number of admissions in the last year (12.5% vs. 5.5%; p = 0.04), in-hospital mortality (10.1% vs. 3.3%, p = 0.04) and 30-day mortality (22.6% vs. 8.1%; p < 0.01), but not for readmissions. Regarding the prognostic value of IVC diameter for 30-day mortality, the area under the ROC curve (AUC) was 0.73, with a p < 0.01. The curve cut-off point with the highest sensitivity (70%) and specificity (70.3%) was for an IVC value of 22.5 mm. In the logistic regression analysis, we observed that the variable most associated with patient survival at 30 days was the presence of a collapsible inferior vena cava, with more than 50% OR 0.359 (CI 0.139−0.926; p = 0.034). Conclusions: The subgroups of patients analyzed with more than six B lines per field and IVC collapsibility less than or equal to 50%, as measured by clinical ultrasound, had higher 30-day mortality rates than patients who did not fall into these subgroups. IVC diameter may be a good independent predictor of 30-day mortality in patients with decompensated heart failure. Comparing both ultrasound variables, it seems that in our population, the assessment of the inferior vena cava may be more associated with short-term prognosis than the pulmonary congestion variables assessed by B lines.

Clinical Features and Risk Factors for Mortality Among Long-term Care Facility Residents Hospitalized Due to COVID-19 in Spain.

BACKGROUND: COVID-19 severely impacted older adults and long-term care facility (LTCF) residents. Our primary aim was to describe differences in clinical and epidemiological variables, in-hospital management, and outcomes between LTCF residents and community-dwelling older adults hospitalized with COVID-19. The secondary aim was to identify risk factors for mortality due to COVID-19 in hospitalized LTCF residents. METHODS: This is a cross-sectional analysis within a retrospective cohort of hospitalized patients ≥75 years with confirmed COVID-19 admitted to 160 Spanish hospitals. Differences between groups and factors associated with mortality among LTCF residents were assessed through comparisons and logistic regression analysis. RESULTS: Of 6 189 patients ≥75 years, 1 185 (19.1%) were LTCF residents and 4 548 (73.5%) were community-dwelling. LTCF residents were older (median: 87.4 vs 82.1 years), mostly female (61.6% vs 43.2%), had more severe functional dependence (47.0% vs 7.8%), more comorbidities (Charlson Comorbidity Index: 6 vs 5), had dementia more often (59.1% vs 14.4%), and had shorter duration of symptoms (median: 3 vs 6 days) than community-dwelling patients (all, p < .001). Mortality risk factors in LTCF residents were severe functional dependence (adjusted odds ratios [aOR]: 1.79; 95% confidence interval [CI]: 1.13-2.83; p = .012), dyspnea (1.66; 1.16-2.39; p = .004), SatO2 < 94% (1.73; 1.27-2.37; p = .001), temperature ≥ 37.8°C (1.62; 1.11-2.38; p = .013); qSOFA index ≥ 2 (1.62; 1.11-2.38; p = .013), bilateral infiltrates (1.98; 1.24-2.98; p < .001), and high C-reactive protein (1.005; 1.003-1.007; p < .001). In-hospital mortality was initially higher among LTCF residents (43.3% vs 39.7%), but lower after adjusting for sex, age, functional dependence, and comorbidities (aOR: 0.74, 95%CI: 0.62-0.87; p < .001). CONCLUSION: Basal functional status and COVID-19 severity are risk factors of mortality in LTCF residents. The lower adjusted mortality rate in LTCF residents may be explained by earlier identification, treatment, and hospitalization for COVID-19.

Prediction Accuracy of Serial Lung Ultrasound in COVID-19 Hospitalized Patients (Pred-Echovid Study).

The value of serial lung ultrasound (LUS) in patients with COVID-19 is not well defined. In this multicenter prospective observational study, we aimed to assess the prognostic accuracy of serial LUS in patients admitted to hospital due to COVID-19. The serial LUS protocol included two examinations (0-48 h and 72-96 h after admission) using a 10-zones sequence, and a 0 to 5 severity score. Primary combined endpoint was death or the need for invasive mechanical ventilation. Calibration (Hosmer-Lemeshow test and calibration curves), and discrimination power (area under the ROC curve) of both ultrasound exams (SCORE1 and 2), and their difference (DIFFERENTIAL-SCORE) were performed. A total of 469 patients (54.2% women, median age 60 years) were included. The primary endpoint occurred in 51 patients (10.9%). Probability risk tertiles of SCORE1 and SCORE2 (0-11 points, 12-24 points, and ≥25 points) obtained a high calibration. SCORE-2 showed a higher discrimination power than SCORE-1 (AUC 0.72 (0.58-0.85) vs. 0.61 (0.52-0.7)). The DIFFERENTIAL-SCORE showed a higher discrimination power than SCORE-1 and SCORE-2 (AUC 0.78 (0.66-0.9)). An algorithm for clinical decision-making is proposed. Serial lung ultrasound performing two examinations during the first days of hospitalization is an accurate strategy for predicting clinical deterioration of patients with COVID-19.

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.

The changing etiology of fever of intermediate duration.

BACKGROUND: Fever of intermediate duration (FID) is a common condition. Currently, its most frequent causes are not well defined. METHODS: Prospective study of FID cases attended at a hospital in 2 periods: 1983-1989 and 2004-2005. Blood cultures and serologic studies for Brucella melitensis, Coxiella burnetii, Rickettsia typhi, Rickettsia conorii, cytomegalovirus, and Epstein-Barr virus were performed on all patients. Other microbiological, serological, radiological, or invasive procedures were performed according to clinician-in-charge criteria. RESULTS: A total of 505 patients were included from 1983 to 1989, and 179 from 2004 to 2005. A diagnosis was reached in 410 (81.1%) and 109 patients (60.9%), respectively. The cause of FID was an infectious disease in 389 patients from the first period (94.8% of those with a final diagnosis) and 92 from the second (84.4%). Most were systemic infections, 328 (80%) in 1983-1989 and 74 (67.8%) in 2004-2005, followed by focal infections, 9.5% and 16.5%, respectively. Q fever was the most frequent etiology in both periods. In 2004-2005, brucellosis decreased and HIV infection emerged as a cause of FID. The origin of FID was non-infectious in 5.1% and 15.5%, respectively. CONCLUSIONS: Q fever is the most frequent cause of FID in southern Spain. Studies over time are needed to identify changes in the etiologic spectrum of this condition. Important viral etiologies, such as HIV infection, may be detected as causes of FID. Further studies are needed to determine the importance of other agents as causes of FID.

[Disability as a barrier to drug adherence in polypathological patients: role of main carer]. / La discapacidad como barrera a la adherencia terapéutica en pacientes pluripatológicos: papel del cuidador principal.

OBJECTIVES: To determine which social and individual factors may predict adherence to medication in patients with more than two chronic symptomatic diseases (polypathological patients) under polypharmacy. METHODS: Cross-sectional observational study. In a primary care area assigned to our teaching hospital 265 patients with multiple chronic diseases and polypharmacy were recruited over a 6 month period. 84 patients with uncompleted data or died before finishing our study were excluded. An structured interview performed by a investigator different from responsible physicians was used. Drug adherence was assessed by a subjective method. RESULTS: Disability measured by Barthel index was was the main predictor of drug adherence. Patients without carer support and Barthel Index lower than 100 showed the poorer drug adherence. In the later group number of drugs also affected adherence. However, in patients with carer available, medication adherence was better, mostly in more disabled ones, and unaffected by other factors. CONCLUSIONS: In patients with multiple chronic diseases, social support by a carer may allow disabled patients to overcome the barrier of disability leading to a better drug adherence, even than non-disabled ones. These findings may help to design future prospective studies on medication adherence performed in this peculiar frail population.

[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.

Oxidative Stress, Telomere Shortening, and Apoptosis Associated to Sarcopenia and Frailty in Patients with Multimorbidity.

BACKGROUND: The presence of oxidative stress, telomere shortening, and apoptosis in polypathological patients (PP) with sarcopenia and frailty remains unknown. METHODS: Multicentric prospective observational study in order to assess oxidative stress markers (catalase, glutathione reductase (GR), total antioxidant capacity to reactive oxygen species (TAC-ROS), and superoxide dismutase (SOD)), absolute telomere length (aTL), and apoptosis (DNA fragmentation) in peripheral blood samples of a hospital-based population of PP. Associations of these biomarkers to sarcopenia, frailty, functional status, and 12-month mortality were analyzed. RESULTS: Of the 444 recruited patients, 97 (21.8%), 278 (62.6%), and 80 (18%) were sarcopenic, frail, or both, respectively. Oxidative stress markers (lower TAC-ROS and higher SOD) were significantly enhanced and aTL significantly shortened in patients with sarcopenia, frailty or both syndromes. No evidence of apoptosis was detected in blood leukocytes of any of the patients. Both oxidative stress markers (GR, p = 0.04) and telomere shortening (p = 0.001) were associated to death risk and to less survival days. CONCLUSIONS: Oxidative stress markers and telomere length were enhanced and shortened, respectively, in blood samples of polypathological patients with sarcopenia and/or frailty. Both were associated to decreased survival. They could be useful in the clinical practice to assess vulnerable populations with multimorbidity and of potential interest as therapeutic targets.

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.

Concordance between the Clinical Definition of Polypathological Patient versus Automated Detection by Means of Combined Identification through ICD-9-CM Codes.

It is unknown whether the digital application of automated ICD-9-CM codes recorded in the medical history are useful for a first screening in the detection of polypathological patients. In this study, the objective was to identify the degree of intra- and inter-observer concordance in the identification of in-patient polypathological patients between the standard clinical identification method and a new automatic method, using the basic minimum data set of ICD-9-CM codes in the digital medical history. For this, a cross-sectional multicenter study with 1518 administratively discharged patients from Andalusian hospitals during the period of 2013-2014 has been carried out. For the concordance between the clinical definition of a polypathological patient and the polypathological patient classification according to ICD-9-CM coding, a 0.661 kappa was obtained (95% confidence interval (CI); 0.622-0.701) with p < 0.0001. The intraclass correlation coefficient between both methods for the number of polypathological patient categories was 0.745 (95% CI; 0.721-0.768; p < 0.0001). The values of sensitivity, specificity, positive-, and negative predictive values of the automated detection using ICD-9-CM coding were 78%, 88%, 78%, and 88%, respectively. As conclusion, the automatic identification of polypathological patients by detecting ICD-9-CM codes is useful as a screening method for in-hospital patients.