[Recommendations to develop Care Models for patients with Heart Failure (MAIC Project) from macromanagement]. / Recomendaciones para desarrollar Modelos Asistenciales de atención al paciente con Insuficiencia Cardiaca (Proyecto MAIC): Estudio Delphi.

BACKGROUND: The general objective of the study was to reflect on the key factors to advance in optimal models of care for Heart Failure (HF) and specifically, on the macromanagement elements most necessary for the development of comprehensive HF management models. MATERIAL AND METHODS: An Advisory Committee, composed of 15 experts and a multidisciplinary group of 31 additional experts, was appointed, together forming a Delphi panel of 46 experts. Based on a systematic bibliographic review and the analysis of the care course of the patient with HF, an initial battery of key factors for the development of HF care models was identified by the Advisory Committee. This proposal was adjusted and prioritized by the Delphi panel applying Delphi Rand/UCLA methodology. RESULTS: After two Delphi rounds, 75 key factors grouped into 7 challenges were defined. In the first of the challenges, related to the development of HF management models, 16 key factors were identified, 7 of which were valued as high priority and related to the establishment of common objectives, resources for the continuity of care and improving the measurement of health outcomes. CONCLUSIONS: The definition of management elements at the macro level was considered a priority to advance in the development of optimal models of assistance to HF.

Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: The TACROVID trial protocol.

INTRODUCTION: Some COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients. METHODS: and analysis: TACROVID is a randomized, open-label, single-center, phase II trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature ≤37.5 °C, and PaO2/FiO2 > 400 and/or SatO2/FiO2 > 300, and respiratory rate ≤24 rpm; for 48 consecutive hours. DISCUSSION: Methylprednisolone and tacrolimus might be beneficial to treat those COVID-19 patients progressing into severe pulmonary failure and systemic hyperinflammatory syndrome. The rationale for its use is the fast effect of methylprednisolone pulses and the ability of tacrolimus to inhibit both the CoV-2 replication and the secondary cytokine storm. Interestingly, both drugs are low-cost and can be manufactured on a large scale; thus, if effective and safe, a large number of patients could be treated in developed and developing countries. TRIAL REGISTRATION NUMBER: NCT04341038 / EudraCT: 2020-001445-39.

The Hospital of the Future in 10 points. / El hospital del futuro en 10 puntos.

Over the course of 2018 and 2019, the Spanish Society of Internal Medicine carried out a project called "The Future Hospital." Based on cumulative knowledge on the Spanish National Health System, this project seeks to transfer the observations on the organization of healthcare in future hospitals made by the Royal College of Physicians in the United Kingdom to the context of the Spanish healthcare system. The project's participants included numerous scientific and medical societies, professional associations in the health sector, and patient associations. This aim of this article is to highlight, in 10 points, predictions that arose from this project that we consider to be the most relevant, reserving the last point for the challenges for the field of internal medicine that can be surmised from these proposals.

Gender differences in hereditary hemorrhagic telangiectasia severity.

BACKGROUND: Gender differences in organ involvement and clinical severity have been poorly described in hereditary hemorrhagic telangiectasia (HHT). The aim of this study was to describe differences in the severity of HHT manifestations according to gender. METHODS: Severity was measured according to Epistaxis Severity Score (ESS), Simple Clinical Scoring Index for hepatic involvement, a general HHT-score, needing for invasive treatment (pulmonary or brain arteriovenous malformations -AVMs- embolization, liver transplantation or Young's surgery) or the presence of adverse outcomes (severe anemia, emergency department -ED- or hospital admissions and mortality). RESULTS: One hundred forty-two (58.7%) women and 100 (41.3%) men were included with a mean age of 48.9 ± 16.6 and 49 ± 16.5 years, respectively. Women presented hepatic manifestations (7.1% vs 0%) and hepatic involvement (59.8% vs 47%), hepatic AVMs (28.2% vs 13%) and bile duct dilatation (4.9% vs 0%) at abdominal CT, and pulmonary AVMs at thoracic CT (35.2% vs 23%) more often than men. The Simple Clinical Scoring Index was higher in women (3.38 ± 1.2 vs 2.03 ± 1.2), and more men were considered at low risk of harboring clinically significant liver disease than women (61% vs 25.3%). These differences were mantained when considering HHT1 and HHT2 patients separetely. Duodenal telangiectasia were more frequent in men than women (21% vs 9.8%). Invasive treatments were more frequently needed in women (28.2% vs 16%) but men needed attention at the ED more often than women (48% vs 28.2%), with no differences in ESS, HHT-score, anemia hospital admissions or mortality. CONCLUSIONS: HHT women showed more severe hepatic involvement than men, also among HHT1 and HHT2 patients. Women had higher prevalence of pulmonary AVMs and needed invasive procedures more frequently, while men needed attention at the ED more often. These data might help physicians to individualize HHT patients follow-up.

First hospital admission due to heart failure: In-hospital mortality and patient profile. / Primera hospitalización por insuficiencia cardiaca: mortalidad hospitalaria y perfil del paciente.

OBJECTIVES: We evaluated the patient profile and outcomes of first heart failure (HF) related hospital admission patients in the 2010-2014 period. DESIGN: Retrospective, single-centre, cohort study. SETTING: We used administrative data from a tertiary care hospital (Hospital Universitari de Bellvitge, Barcelona, Spain). PARTICIPANTS: All patients with primary diagnosis of HF registered at the hospital discharge database from 2010 to 2014 were included, ruling out that HF was present 10 years prior to the current episode. INTERVENTION: Primary care HF diagnosis status was assessed in order to distinguish new onset from no-new onset patients. MAIN MEASURES: Descriptive, bivariate and multivariate analysis were performed using age, previous primary care HF diagnosis and in-hospital death as grouping variables. Significant variables were fitted into a Linear logistic regression model for each outcome. RESULTS: We selected 3,868 first HF-related admissions (56.8% of all HF episodes). In 1,220 patients (31.7%) HF was diagnosed by their primary care physician. Main pattern was a woman (OR=2.4), with higher prevalence of hypertension (OR=1.7), atrial fibrillation (OR=1.3), chronic kidney disease (OR=1.6) and mortality rate (9.8%). In-hospital death rate was 5.8%, age over 85 (OR=5.57), chronic kidney disease (OR=1.44) and length of stay over 7 days (OR=1.90) being the main contributors. CONCLUSIONS: First HF related admissions account for 56.7% of all HF episodes. Roughly one third of patients were already diagnosed by the time of their first hospital admission. Elderly women were the most frequent, but not the only, group of patients. Age, hospital stay and chronic kidney disease were the main contributors for in-hospital death.

First clinical symptom as a prognostic factor in systemic sclerosis: results of a retrospective nationwide cohort study.

The objective of the study is to determine the importance of the mode of onset as prognostic factor in systemic sclerosis (SSc). Data were collected from the Spanish Scleroderma Registry (RESCLE), a nationwide retrospective multicenter database created in 2006. As first symptom, we included Raynaud's phenomenon (RP), cutaneous sclerosis, arthralgia/arthritis, puffy hands, interstitial lung disease (ILD), pulmonary arterial hypertension (PAH), and digestive hypomotility. A total of 1625 patients were recruited. One thousand three hundred forty-two patients (83%) presented with RP as first symptom and 283 patients (17%) did not. Survival from first symptom in those patients with RP mode of onset was higher at any time than those with onset as non-Raynaud's phenomenon: 97 vs. 90% at 5 years, 93 vs. 82% at 10 years, 83 vs. 62% at 20 years, and 71 vs. 50% at 30 years (p < 0.001). In multivariate analysis, factors related to mortality were older age at onset, male gender, dcSSc subset, ILD, PAH, scleroderma renal crisis (SRC), heart involvement, and the mode of onset with non-Raynaud's phenomenon, especially in the form of puffy hands or pulmonary involvement. The mode of onset should be considered an independent prognostic factor in systemic sclerosis and, in particular, patients who initially present with non-Raynaud's phenomenon may be considered of poor prognosis.

Omega-3 fatty acids as adjunctive treatment for bexarotene-induced hypertriglyceridaemia in patients with cutaneous T-cell lymphoma.

BACKGROUND: Bexarotene is an oral retinoid approved for treating cutaneous T-cell lymphoma (CTCL) in patients resistant to first-line systemic treatment. Hypertriglyceridaemia is an unavoidable adverse effect of bexarotene therapy, and requires monitoring because of the risk of developing pancreatitis. Therefore, prophylactic hypolipidaemic therapy, usually with a fibrate alone, is required for preventing bexarotene-induced hypertriglyceridaemia. Despite these measures, a large number of patients develop very severe hypertriglyceridaemia. AIM: To assess the lipid metabolism changes before and after the use of a combination of omega-3 fatty acids (n-3 FA) plus fenofibrate compared with fenofibrate alone as a more effective lipid-lowering therapy in patients with CTCL treated with bexarotene. METHODS: From January 2005 to January 2013, we analysed all 25 patients with CTCL treated with bexarotene. The first 18 consecutively enrolled patients received fenofibrate alone as a lipid-lowering therapy, and the next 7 consecutively enrolled patients received a combination of fenofibrate and n-3 FA. RESULTS: Data for all 25 consecutive patients with CTCL treated with bexarotene were evaluated. Of these, 24 patients (96%) developed hypertriglyceridaemia despite the hypolipidaemic therapy, with this being very severe (> 11.2 mmol/L) in 20% of the cases. Of the 18 patients receiving fenofibrate alone, 5 (28%) developed very severe hypertriglyceridaemia, compared with none of the 7 patients treated with the n-3 FA combination. CONCLUSIONS: Our results suggest that the n-3 FA combination may be more effective than fibrate alone for preventing bexarotene-induced hypertriglyceridaemia.

Erectile dysfunction and cardiovascular risk factors in a Mediterranean diet cohort.

BACKGROUND: Erectile dysfunction affects more than 100 million men worldwide, with a wide variability in prevalence. An overall association of cardiovascular risk factors, lifestyle and diet in the context of ED in a Mediterranean population is lacking. AIM: To assess ED prevalence and associated factors in a Mediterranean cohort of non-diabetic patients with cardiovascular risk factors. METHODS: Observational, cross-sectional study of patients aged over 40 treated at cardiovascular risk units in Catalonia. Anthropometric data, risk factors, lifestyle and diet habits were recorded. ED was assessed using the International Index of Erectile Function. RESULTS: Four hundred and forty patients included, 186 (42.3%) with ED (24.8% mild, 6.8% moderate and 10.7% severe). ED presence and severity were associated with age, obesity, waist circumference, hypertension, antihypertensive treatment and ischaemic disease. Patients with ED were more frequently smokers, sedentary and consumed more alcohol. In multivariate analysis, consumption of nuts (> twice a week) (OR 0.41 (95% CI 0.25 to 0.67) and vegetables (≥ once a day) (OR 0.47 (95% CI 0.28-0,77)), were inversely related to ED. Obesity (as BMI ≥ 30 kg/m(2) ) (OR 2.49 (95% CI 1.48-4.17)), ischaemic disease (OR 2.30 (95% CI 1.22 to 4.33), alcohol consumption (alcohol-units a day) (OR 1.14 (95% CI 1.04 to 1.26), and age (year) (OR = 1.07 (95% CI 1.04-1.10) were directly related to ED. CONCLUSION: Erectile dysfunction is a common disorder in patients treated in lipid units in Catalonia for cardiovascular risk factors. This condition is associated with age, obesity, ischaemic disease and unhealthy lifestyle habits.

Effectiveness of a Surgery Admission Unit for patients undergoing major elective surgery in a tertiary university hospital.

BACKGROUND: The increasing demand on hospitalisation, either due to elective activity from the waiting lists or due to emergency admissions coming from the Emergency Department (ED), requires looking for strategies that lead to effective bed management. The aim of this study was to evaluate the effectiveness of a surgery admission unit for major elective surgery patients who were admitted for same-day surgery. METHODS: We included all patients admitted for elective surgery in a university tertiary hospital between the 1st of September and the 31st of December 2006, as well as those admitted during the same period of 2008, after the introduction of the Surgery Admission Unit. The main outcome parameters were global length of stay, pre-surgery length of stay, proportion of patients admitted the same day of the surgery and number of cancellations. Differences between the two periods were evaluated by the T-test and Chi-square test. Significance at P < 0.05 was assumed throughout. RESULTS: We included 6,053 patients, 3,003 during 2006 and 3,050 patients during 2008. Global length of stay was 6.2 days (IC 95%:6.4-6) in 2006 and 5.5 days (IC 95%:5.8-5.2) in 2008 (p < 0.005). Pre-surgery length of stay was reduced from 0.46 days (IC 95%:0.44-0.48) in 2006 to 0.29 days (IC 95%:0.27-0.31) in 2008 (p < 0.005). The proportion of patients admitted for same-day surgery was 67% (IC 95%:69%-65%) in 2006 and 76% (IC 95%:78%-74%) in 2008 (p < 0.005). The number of cancelled interventions due to insufficient preparation was 31 patients in 2006 and 7 patients in 2008. CONCLUSIONS: The implementation of a Surgery Admission Unit for patients undergoing major elective surgery has proved to be an effective strategy for improving bed management. It has enabled an improvement in the proportion of patients admitted on the same day as surgery and a shorter length of stay.

Effectiveness and safety of an emergency department short-stay unit as an alternative to standard inpatient hospitalisation.

BACKGROUND: Emergency department short-stay units (EDSSUs) are currently emerging worldwide as an alternative to standard inpatient hospitalisation. In our hospital, a 960-bed teaching tertiary institution in Barcelona, Spain, an EDSSU has been in operation during winter periods (November-March) since 1997. AIM: To determine the efficacy and safety of our EDSSU. METHODS: Retrospective analysis of activity and quality outcomes, assessment of patient satisfaction levels and determination of the diagnostic-related groups that were mainly responsible for admissions to the EDSSU, comparing the clinical characteristics of those patients with the characteristics of patients with similar clinical diagnoses admitted to standard hospitalisation units. RESULTS: 5666 patients were treated in the EDSSU, with a progressive increase in the number of patients admitted per period, ranging from 707 in 1997-8 to 1227 in 2003-4 (73.5% increase). The mean length of stay ranged from 3.1 to 2.8 days, mortality from 2.5% to 5.1%, home discharge rate from 84% to 90%, and hospital readmission rate within the first week after discharge from 3.9% to 6.2%. In all, 98% of patients were satisfied with their stay at the EDSSU. The main diagnostic-related groups were chronic obstructive pulmonary disease (COPD = 50%) and acute heart failure (28%). Patients with COPD admitted at the EDSSU (n = 545) showed significantly (p = 0.05) lower mean length of stay (3.4 v 12 days) and mortality (1.7% v 8.1%), but a higher hospital readmission rate (9.9% v 7%) than those admitted to standard inpatient units (n = 1961). CONCLUSIONS: In our experience, the EDSSU proved to be an effective and safe alternative to standard inpatient hospitalisation.

Efficacy of colistin versus beta-lactams, aminoglycosides, and rifampin as monotherapy in a mouse model of pneumonia caused by multiresistant Acinetobacter baumannii.

The treatment of life-threatening infections due to carbapenem-resistant Acinetobacter baumannii has become a serious challenge for physicians worldwide. Often, only colistin shows in general good in vitro activity against these carbapenem-resistant strains, but its antibacterial efficacy in comparison with the antibiotics most used in clinical practice is not well known. We studied the efficacy of colistin versus those of imipenem, sulbactam, tobramycin, and rifampin in an experimental pneumonia model with immunocompetent mice. We used three strains of A. baumannii corresponding to the main clones (A, D, and E) involved in the outbreaks of our hospital, with different grades of resistance to imipenem (imipenem MICs of 1, 8, and 512 microg/ml, respectively) and to the other antibiotics. The MIC of colistin was 0.5 microg/ml for the three strains. Reduction of log(10) CFU/g in lung bacterial counts, clearance of bacteremia, and survival versus results with controls were used as parameters of efficacy. Imipenem and sulbactam (Deltalung counts: -5.38 and -4.64 log(10) CFU/ml) showed the highest level of bactericidal efficacy in infections by susceptible and even intermediate strains. Tobramycin and rifampin (-4.16 and -5.15 log(10) CFU/ml) provided good results against intermediate or moderately resistant strains, in agreement with killing curves and pharmacodynamics. On the contrary, colistin showed the weakest antibacterial effect among the antibiotics tested, both in killing curves and in the in vivo model (-2.39 log(10) CFU/ml; P < 0.05). We conclude that colistin did not appear as a good option for treatment of patients with pneumonia due to carbapenem-resistant A. baumannii strains. Other alternatives, including combinations with rifampin, may offer better therapeutic profiles and thus should be studied.

Short-term effect of the application of selective decontamination of the digestive tract on different body site reservoir ICU patients colonized by multi-resistant Acinetobacter baumannii.

The effect of a selective decontamination of the digestive tract (SDD) regimen including polymyxin and tobramycin on several body site reservoirs was compared between a test group and a control group in intensive care unit (ICU) patients with faecal multi-resistant Acinetobacter baumannii colonization. SDD significantly reduced faecal and pharyngeal carriage when compared with the control group at the end of ICU stay (48% versus 91%, P = 0.001, and 38.5% versus 78%, P = 0.01, respectively), but failed to reduce axillary colonization (75% versus 78%, P = 0.6). In addition, the isolation of A. baumannii from new clinical samples was lower in patients with SDD (45.5% versus 81%, P = 0.05). No resistance to polymyxin was observed. We conclude that the digestive tract reservoir of A. baumannii in ICU patients may be decreased by a SDD regimen.

Impact of a resident strike on emergency department quality indicators at an urban teaching hospital.

OBJECTIVE: To evaluate the indicators of activity and quality within the emergency department (ED) during a resident physicians' strike. METHODS: This was an observational study comparing a strike period (SP) and a non-strike period (NSP) in the ED of a 1,000-bed tertiary care teaching hospital in Barcelona, Spain, with an annual census of 100,000 emergency visits. During a period of nine nonconsecutive days, the resident physicians were on strike. Emergency visits were handled by staff members. Data were compared between all patients treated in the ED during the SP and those treated during the NSP, matched by the weekday. The authors compared lengths of stay (LOSs), rates of use of laboratory tests and radiology procedures, numbers of patient walkouts, patient/physician ratios, emergency hospital admission rates, home discharge rates, unscheduled return rates, and mortality rates. RESULTS: The two groups (SP 2,610 patients and NSP 3,634 patients) were comparable in terms of average daily attendance rate (SP: 290 +/- 12 vs NSP: 302 +/- 21; p = 0.13), elective hospital admission rate, and severity of illness. Statistically significant differences were found in terms of mean total patients' LOS (SP: 206.75 +/- 12.27 vs NSP: 235.10 +/- 27.08 minutes; p < 0.001), number of laboratory tests per patient (SP: 0.30 +/- 0.05 vs NSP: 0.38 +/- 0.04; p < 0.001), and radiographs per patient (SP: 0.78 +/- 0.06 vs NSP: 0.88 +/- 0.09; p = 0.021). CONCLUSIONS: This study demonstrated that replacing residents with staff physicians resulted in fewer laboratory tests ordered, fewer radiographs ordered, and shorter lengths of stays in the ED.