Outcomes and clinical characteristics of the compassionate use of plitidepsin in COVID-19 patients with solid tumours, haematological malignancies or anti-CD20 antibody treatment.

OBJECTIVE: To study the effect of plitidepsin antiviral treatment in immunocompromised COVID-19 patients with underlying haematological malignancies or solid tumours, particularly those who have undergone anti-CD20 therapies. DESIGN: We conducted a retrospective observational study, involving 54 adults treated with plitidepsin on compassionate use as an antiviral drug. Our analysis compared outcomes between patients with solid tumours and those with haematological malignancies, and a cohort of cases treated or not with anti-CD20 monoclonal antibodies. RESULTS: Patients with a history of anti-CD20 therapies showed a prolonged time-to-negative RT-PCR for SARS-CoV-2 infection compared to non-treated patients (33 d (28;75) vs 15 (11;25); p = .002). Similar results were observed in patients with solid tumours in comparison to those with haematological malignancies (13 (10;16) vs 26 (17;50); p < .001). No serious adverse events were documented. CONCLUSIONS: Patients with haematological malignancies appear to be at a heightened risk for delayed SARS-CoV-2 clearance and subsequent clinical complications. These findings support plitidepsin as a well-tolerated treatment in this high-risk group. A phase II clinical trial (NCT05705167) is ongoing to evaluate plitidepsin as an antiviral drug in this population.KEY POINTSHaematological patients face an increased risk for severe COVID-19.Anti-CD20 therapies could increase fatal outcomes in COVID-19 patients.Persistent viral replication is increased in immunocompromised patients.Plitidepsin does not lead to new serious adverse events in immunocompromised patients.

Clustering COVID-19 ARDS patients through the first days of ICU admission. An analysis of the CIBERESUCICOVID Cohort.

BACKGROUND: Acute respiratory distress syndrome (ARDS) can be classified into sub-phenotypes according to different inflammatory/clinical status. Prognostic enrichment was achieved by grouping patients into hypoinflammatory or hyperinflammatory sub-phenotypes, even though the time of analysis may change the classification according to treatment response or disease evolution. We aimed to evaluate when patients can be clustered in more than 1 group, and how they may change the clustering of patients using data of baseline or day 3, and the prognosis of patients according to their evolution by changing or not the cluster. METHODS: Multicenter, observational prospective, and retrospective study of patients admitted due to ARDS related to COVID-19 infection in Spain. Patients were grouped according to a clustering mixed-type data algorithm (k-prototypes) using continuous and categorical readily available variables at baseline and day 3. RESULTS: Of 6205 patients, 3743 (60%) were included in the study. According to silhouette analysis, patients were grouped in two clusters. At baseline, 1402 (37%) patients were included in cluster 1 and 2341(63%) in cluster 2. On day 3, 1557(42%) patients were included in cluster 1 and 2086 (57%) in cluster 2. The patients included in cluster 2 were older and more frequently hypertensive and had a higher prevalence of shock, organ dysfunction, inflammatory biomarkers, and worst respiratory indexes at both time points. The 90-day mortality was higher in cluster 2 at both clustering processes (43.8% [n = 1025] versus 27.3% [n = 383] at baseline, and 49% [n = 1023] versus 20.6% [n = 321] on day 3). Four hundred and fifty-eight (33%) patients clustered in the first group were clustered in the second group on day 3. In contrast, 638 (27%) patients clustered in the second group were clustered in the first group on day 3. CONCLUSIONS: During the first days, patients can be clustered into two groups and the process of clustering patients may change as they continue to evolve. This means that despite a vast majority of patients remaining in the same cluster, a minority reaching 33% of patients analyzed may be re-categorized into different clusters based on their progress. Such changes can significantly impact their prognosis.

Short- and Long-Term Outcomes of an Adventure Therapy Programme on Borderline Personality Disorder: A Pragmatic Controlled Clinical Trial.

Adventure Therapy (AT) is a therapeutic intervention utilizing the natural environment and adventure activities as tools for psychotherapeutic interventions. It has been demonstrated to be appropriate for the intervention of patients with borderline personality disorder (BPD). This study aims to evaluate the response to AT treatment compared with the response to treatment as usual (TAU), based on cognitive behavioural therapy, in the short and long term, assessing clinical, psychosocial, and functional outcomes; quality of life; and physical health levels. This study extends the sample of and is a follow-up to a pilot study published in 2021, with a sample of 30 patients in the AT group and 10 in the control group. It does not allow us to affirm that AT provides better outcomes than TAU, as the positive effects observed immediately after therapy seem to be attenuated in the long term. Therefore, the effectiveness of long-term psychotherapy did not show differences between AT and TAU therapies in the treatment of BPD patients. However, the effects of intangibles observed during therapy by professionals and patients were not reflected in the measurements collected. Therefore, we believe it is necessary to increase the programme duration, complement treatment with a specific physical health programme, assess results with more specific instruments, and/or move towards a qualitative methodology to measure perceived changes in clinical improvement. New studies are needed to evaluate the results of the proposed changes.

Evaluation of the Kinetics of Pancreatic Stone Protein as a Predictor of Ventilator-Associated Pneumonia.

BACKGROUND: Ventilator-associated pneumonia (VAP) is a severe condition. Early and adequate antibiotic treatment is the most important strategy for improving prognosis. Pancreatic Stone Protein (PSP) has been described as a biomarker that increases values 3-4 days before the clinical diagnosis of nosocomial sepsis in different clinical settings. We hypothesized that serial measures of PSP and its kinetics allow for an early diagnosis of VAP. METHODS: The BioVAP study was a prospective observational study designed to evaluate the role of biomarker dynamics in the diagnosis of VAP. To determine the association between repeatedly measured PSP and the risk of VAP, we used joint models for longitudinal and time-to-event data. RESULTS: Of 209 patients, 43 (20.6%) patients developed VAP, with a median time of 4 days. Multivariate joint models with PSP, CRP, and PCT did not show an association between biomarkers and VAP for the daily absolute value, with a hazard ratio (HR) for PSP of 1.01 (95% credible interval: 0.97 to 1.05), for CRP of 1.00 (0.83 to 1.22), and for PCT of 0.95 (0.82 to 1.08). The daily change of biomarkers provided similar results, with an HR for PSP of 1.15 (0.94 to 1.41), for CRP of 0.76 (0.35 to 1.58), and for PCT of 0.77 (0.40 to 1.45). CONCLUSION: Neither absolute PSP values nor PSP kinetics alone nor in combination with other biomarkers were useful in improving the prediction diagnosis accuracy in patients with VAP. CLINICAL TRIAL REGISTRATION: Registered retrospectively on August 3rd, 2012. NCT02078999.

Omalizumab in Severe Asthma: Effect on Oral Corticosteroid Exposure and Remodeling. A Randomized Open-Label Parallel Study.

INTRODUCTION: Data on the clinical efficacy and remodeling of omalizumab therapy in patients on oral corticosteroids (OC) are limited. OBJECTIVE: The purpose of the study is to show that in patients with corticosteroid-dependent asthma, omalizumab is a corticosteroid-sparing therapy able to inhibit airway remodeling and to reduce disease burden (lung function impairment, exacerbations). METHODS: This study is a randomised open-label study evaluating the addition of omalizumab to the standard of care in patients with severe asthma receiving oral corticosteroids. The primary endpoint was represented by the change in OC monthly dose by the end of treatment and secondary endpoints included spirometry changes, airway inflammation (FeNO), number of exacerbations and airways remodelling assessed by bronchial biopsies studied by transmission electron microscopy. As a safety variable, adverse effects were recorded. RESULTS: Efficacy was assessed for 16 patients in the omalizumab group and 13 in the control group. The final cumulative mean monthly OC doses were 34.7 mg and 217 mg for the omalizumab and control group, respectively; the mean difference between groups adjusted for baseline was -148.1 [95% confidence interval (CI) -243.6, -52.5; p = 0.004]. OC withdrawal of 75% versus 7.7% (p = 0.001) was observed in the omalizumab and control group, respectively. Omalizumab provided a slowing of forced expiratory volume in one second (FEV1) loss (70 mL versus 260 mL), a significant decrease in FeNO values and a reduction in the annual relative risk of clinically significant exacerbations of 54%. The treatment was well tolerated. The morphological study showed a significant decrease in basement membrane thickness in the omalizumab group (6.7 µm versus 4.6 µm) compared with controls (6.9 µm versus 7 µm) [mean difference between groups adjusted for baseline was -2.4 (95% CI -3.7, -1.2; p < 0.001], as well as a decrease in intercellular spaces (1.18 µm versus 0.62 µm and 1.21 µm versus 1.20 µm, p = 0.011, respectively). A qualitative improvement was also observed in the treated group. CONCLUSIONS: Omalizumab showed a marked OC-sparing capacity and was associated with an improvement in clinical management that correlated with bronchial epithelial repair. In OC-dependent asthma, reversibility of remodelling is possible; the concepts that basement membrane enlargement is detrimental and that chronic airway obstruction is systematically irreversible are outdated (EudraCT: 2009-010914-31).

Women's preference to apply shared decision-making in breast cancer screening: a discrete choice experiment.

OBJECTIVE: To analyse women's stated preferences for establishing the relative importance of each attribute of shared decision-making (SDM) and their willingness to pay (WTP) for more participatory care in breast cancer screening programmes (BCSP). DESIGN: A discrete choice experiment was designed with 12 questions (choice tasks). It included three attributes: 'How the information is obtained', regarding benefits and harms; whether there is a 'Dialogue for scheduled mammography' between the healthcare professional and the woman; and, 'Who makes the decision', regarding participation in BCSP. Data were obtained using a survey that included 12 choice tasks, 1 question on WTP and 7 socioeconomic-related questions. The analysis was performed using conditional mixed-effect logit regression and stratification according to WTP. SETTING: Data collection related to BCSP was conducted between June and November 2021 in Catalonia, Spain. PARTICIPANTS: Sixty-five women aged between 50 and 60. MAIN OUTCOME MEASURES: Women's perceived utility of each attribute, trade-off on these attributes and WTP for SDM in BCSP. RESULT: The only significant attribute was 'Who makes the decision'. The decision made alone (coefficient=2.879; 95% CI=2.297 to 3.461) and the decision made together with a healthcare professional (2.375; 95% CI=1.573 to 3.177) were the options preferred by women. The former contributes 21% more utility than the latter. Moreover, 52.3% of the women stated a WTP of €10 or more for SDM. Women's preferences regarding attributes did not influence their WTP. CONCLUSIONS: The participant women refused a current paternalistic model and preferred either SDM or informed decision-making in BCSP.

Factor structure of the Maslach Burnout Inventory Human Services Survey in Spanish urgency healthcare personnel: a cross-sectional study.

BACKGROUND: The Maslach Burnout Inventory (MBI) is an instrument commonly used to evaluate burnout syndrome. The goal of the present study was to assess the internal reliability and the performance of the items and the subscales of the MBI-HSS (the version for professionals working in human services) by validating its factorial structure in Spanish urgency healthcare personnel. METHODS: Cross-sectional study including 259 healthcare emergency professionals (physicians and nurses) in the Spanish health region of Lleida and the Pyrenees. Burnout was measured using the Spanish validated version of the MBI-HSS. Internal reliability was estimated using Cronbach's alpha coefficient. The sampling adequacy was assessed using the Kaiser-Meyer-Olkin measure along with the Bartlett's test of sphericity. A principal axis exploratory factor analysis with an oblique transformation of the solution and a confirmatory factor analysis with maximum likelihood estimation were performed. Goodness-of-fit was assessed by means of the chi-square ratio by the degrees of freedom, the standardized root mean square residual (SRMR), the root mean square error of approximation (RMSEA), the Tucker-Lewis Index (TLI) and the comparative fit index (CFI). RESULTS: The three subscales showed good internal reliability with Cronbach's alpha coefficients exceeding the critical value of 0.7. Exploratory factor analysis revealed five factors with eigenvalues greater than 1. Nevertheless, confirmatory factor analysis showed a relatively satisfactory fit of the three-factor structure (χ2/df = 2.6, SRMR = 0.07, RMSEA = 0.08, TLI = 0.87, CFI = 0.89), which was improved when several items were removed (χ2/df = 1.7, SRMR = 0.04, RMSEA = 0.05, TLI = 0.97, CFI = 0.98). CONCLUSIONS: Although it is necessary exploring new samples to get to more consistent conclusions, the MBI-HSS is a reliable and factorially valid instrument to evaluate burnout syndrome in health professionals from the Spanish emergency services.

Pulmonologists' Opinion on the Use of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease Patients in Spain: A Cross-Sectional Survey.

Introduction: Identifying the variables that guide decision-making in relation to the use of inhaled corticosteroids (ICS) can contribute to the appropriate use of these drugs. The objective of this study was to identify the clinical variables that physicians consider most relevant for prescribing or withdrawing ICS in COPD. Methods: A cross-sectional survey was conducted in Spain from November 2020 to May 2021. Therapeutic decisions on the use of ICS in 11 hypothetical COPD patient profiles were collected using an online survey answered by specialists with experience in the management of patients with COPD. Mixed-effects logistic regression was used to analyze the impact of patients' characteristics in the therapeutic decision for prescribing ICS or proceeding to its withdrawal. Results: A total of 74 pulmonologists agreed to collaborate in the survey and answered the questionnaire. The results showed great variability, with only 2 profiles achieving consensus for starting or withdrawing the treatment. The frequency and severity of exacerbations influenced the decision to prescribe ICS in a dose-response fashion (1 exacerbation odds ratio (OR) = 1.86, 95% confidence interval (CI) 1.02 to 3.43, two exacerbations OR = 11.6, 95% CI: 4.47 to 30.2 and three OR = 123, 95% CI: 25 to 601). Similarly, increasing blood eosinophils and history of asthma were associated with ICS use. On the other hand, pneumonia reduced the probability of initiating treatment with ICS (OR = 0.54 [0.29 to 0.98]). Lung function and dyspnea degree did not influence the clinician's therapeutic decision. The results for withdrawal of ICS were similar but in the opposite direction. Conclusion: In accordance with guidelines, exacerbations, blood eosinophils and history of asthma or pneumonia are the factors considered by pulmonologist for the indication or withdrawal of ICS. However, the agreement in prescription or withdrawal of ICS when confronted with hypothetical cases is very low, suggesting a great variability in clinical practice.

The Effect of Clusters of Double Triggering and Ineffective Efforts in Critically Ill Patients.

OBJECTIVES: To characterize clusters of double triggering and ineffective inspiratory efforts throughout mechanical ventilation and investigate their associations with mortality and duration of ICU stay and mechanical ventilation. DESIGN: Registry-based, real-world study. BACKGROUND: Asynchronies during invasive mechanical ventilation can occur as isolated events or in clusters and might be related to clinical outcomes. SUBJECTS: Adults requiring mechanical ventilation greater than 24 hours for whom greater than or equal to 70% of ventilator waveforms were available. INTERVENTIONS: We identified clusters of double triggering and ineffective inspiratory efforts and determined their power and duration. We used Fine-Gray's competing risk model to analyze their effects on mortality and generalized linear models to analyze their effects on duration of mechanical ventilation and ICU stay. MEASUREMENTS AND MAIN RESULTS: We analyzed 58,625,796 breaths from 180 patients. All patients had clusters (mean/d, 8.2 [5.4-10.6]; mean power, 54.5 [29.6-111.4]; mean duration, 20.3 min [12.2-34.9 min]). Clusters were less frequent during the first 48 hours (5.5 [2.5-10] vs 7.6 [4.4-9.9] in the remaining period [p = 0.027]). Total number of clusters/d was positively associated with the probability of being discharged alive considering the total period of mechanical ventilation (p = 0.001). Power and duration were similar in the two periods. Power was associated with the probability of being discharged dead (p = 0.03), longer mechanical ventilation (p < 0.001), and longer ICU stay (p = 0.035); cluster duration was associated with longer ICU stay (p = 0.027). CONCLUSIONS: Clusters of double triggering and ineffective inspiratory efforts are common. Although higher numbers of clusters might indicate better chances of survival, clusters with greater power and duration indicate a risk of worse clinical outcomes.

Independent effects of secondary hyperparathyroidism and hyperphosphataemia on chronic kidney disease progression and cardiovascular events: an analysis from the NEFRONA cohort.

BACKGROUND: Secondary hyperparathyroidism (SHPT) is a complication of chronic kidney disease (CKD) and is associated with changes in calcium and phosphate. These related changes have been associated with increased cardiovascular mortality and CKD progression. It is not clear whether negative outcomes linked to SHPT are confounded by such factors. The present study was designed to assess the possible independent effects of SHPT [defined as patients with excessive parathyroid hormone (PTH) levels or on treatment with PTH-reducing agents] on the risk of CKD progression and cardiovascular event (CVE) incidence in CKD patients, as well as whether hypercalcaemia and/or hyperphosphataemia act as effect modifiers. METHODS: The study enrolled 2445 CKD patients without previous CVE from the National Observatory of Atherosclerosis in Nephrology (NEFRONA) cohort (Stage 3, 950; Stage 4, 612; Stage 5, 195; on dialysis, 688). Multivariate logistic and Fine and Gray regression analysis were used to determine the risk of patients suffering CKD progression or a CVE. RESULTS: The prevalence of SHPT in the cohort was 65.6% (CKD Stage 3, 54.7%; CKD Stage 4, 74.7%; CKD Stage 5, 71.4%; on dialysis, 68.6%). After 2 years, 301 patients presented CKD progression. During 4 years of follow-up, 203 CVEs were registered. Patients with SHPT showed a higher adjusted risk for CKD progression and CVE. Furthermore, hyperphosphataemia was shown to be an independent risk factor in both outcomes and did not modify SHPT effect. No significant interactions were detected between the presence of SHPT and hypercalcaemia or hyperphosphataemia. CONCLUSIONS: We conclude that SHPT and hyperphosphataemia are independently associated with CKD progression and the incidence of CVE in CKD patients.

Health Care Costs in Patients with and without Secondary Hyperparathyroidism in Spain.

OBJECTIVE: To analyze the economic burden of secondary hyperparathyroidism (sHPT) in Spain by quantifying differences in costs of pharmacological treatments and associated cardiovascular events (CVE) between renal patients with and without sHPT. METHODS: We used data collected in the NEFRONA cohort study and obtained treatment and CVE costs from the BOT PLUS database and Hospital Discharge Records in the Spanish Health System (CMBD-H), respectively. We examined data from 2445 renal patients followed during 2 years for chronic kidney disease (CKD) progression and 4 years for CVE, stratifying by presence of sHPT. Patient characteristics, administered treatments and CVE were directly extracted from NEFRONA registries. Dosage for each treatment regimen was assumed based on guidelines and multiplied by official unit costs to obtain treatment costs. Costs of CVE were based on ICD-9-CM. RESULTS: Prevalence of sHPT in the cohort was 65.6% (63.6; 67.6). Average yearly pharmacological costs for patients without sHPT were 610.33€, while costs were 1483.17€ for sHPT patients (average increase of 143.0%). Two hundred three patients registered CVE, resulting in 4-year average costs of 582.57€ for non-sHPT patients compared to 941.87€ for sHPT patients (61.7% average increase). Bivariate analyses considering presence of dialysis, hypercalcemia or hyperphosphatemia and stratified by sHPT showed higher costs for sHPT patients. CONCLUSIONS: These results show that sHPT is associated with substantially higher costs of both, pharmacological treatments and associated CVEs. Preventing the development of sHPT with early management in the course of CKD could possibly lead to better health outcomes and cost balance for health care systems.

A pilot study of the efficacy of an adventure therapy programme on borderline personality disorder: A pragmatic controlled clinical trial.

Adventure therapy (AT) is a therapeutic intervention that has demonstrated effectiveness in different populations, but there are no studies on this therapy in borderline personality disorder (BPD). The objective of this study was to assess the response to AT in comparison with treatment as usual (based on cognitive-behavioural therapy) in patients with BPD. Regarding the comparison of the differences post-therapy-pre-therapy between both groups, some metabolic variables improved more in the AT group, with medium-large effect sizes. Almost all psychometric variables evolved better in the AT group, with negligible effects. AT could be considered in BPD treatment because it results in healthier lifestyle habits and increases functionality and quality of life in patients who are prone to self-destruction. © 2021 John Wiley & Sons, Ltd.

REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients in Catalonia: REMOTE-CAT PROJECT.

Rationale: Remote ischemic perconditioning during cerebral ischemia (RIPerC) refers to the application of brief episodes of transient limb ischemia commonly to a limb, it represents a new safe, simple and low-cost paradigm in neuroprotection. Aim and/or Hypothesis: To evaluate the effects of RIPerC on acute ischemic stroke (AIS) patients, applied in the ambulance, to improve functional outcomes compared with standard of care. Sample Size Estimates: A sample size of 286 patients in each arm achieves 80% power to detect treatment differences of 14% in the outcome, using a two-sided binomial test at significance level of 0.05, assuming that 40% of the control patients will experience good outcome and an initial misdiagnosis rate of 29%. Methods and Design: We aim to conduct a multicentre study of pre-hospital RIPerC application in AIS patients. A total of 572 adult patients diagnosed of suspected clinical stroke within 8 h of symptom onset and clinical deficit >0 according to prehospital rapid arterial occlusion evaluation (RACE) scale score will be randomized, in blocks of size 4, to RIPerC or sham. Patients will be stratified by RACE score scale. RIPerC will be started in the ambulance before hospital admission and continued in the hospital if necessary. It will consist of five cycles of electronic tourniquet inflation and deflation (5 min each). The cuff pressure for RIPerC will be 200 mmHg during inflation. Sham will only simulate vibration of the device. Study Outcome(s): The primary outcome will be the difference in the proportion of patients with good outcomes as defined by a mRS score of 2 or less at 90 days. Secondary outcomes to be monitored will include early neurological improvement rate, treatment related serious adverse event rates, size of the infarct volume, symptomatic intracranial hemorrhage, metabolomic and lipidomic response to RIPerC and Neuropsychological evaluation at 90 days. Discussion: Neuroprotective therapies could not only increase the benefits of available reperfusion therapies among AIS patients but also provide an option for patients who are not candidates for these treatments. REMOTE-CAT will investigate the clinical benefit of RIC as a new neuroprotective strategy in AIS. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03375762.

Machine learning analysis of serum biomarkers for cardiovascular risk assessment in chronic kidney disease.

BACKGROUND: Chronic kidney disease (CKD) patients show an increased burden of atherosclerosis and high risk of cardiovascular events (CVEs). There are several biomarkers described as being associated with CVEs, but their combined effectiveness in cardiovascular risk stratification in CKD has not been tested. The objective of this work is to analyse the combined ability of 19 biomarkers associated with atheromatous disease in predicting CVEs after 4 years of follow-up in a subcohort of the NEFRONA study in individuals with different stages of CKD without previous CVEs. METHODS: Nineteen putative biomarkers were quantified in 1366 patients (73 CVEs) and their ability to predict CVEs was ranked by random survival forest (RSF) analysis. The factors associated with CVEs were tested in Fine and Gray (FG) regression models, with non-cardiovascular death and kidney transplant as competing events. RESULTS: RSF analysis detected several biomarkers as relevant for predicting CVEs. Inclusion of those biomarkers in an FG model showed that high levels of osteopontin, osteoprotegerin, matrix metalloproteinase-9 and vascular endothelial growth factor increased the risk for CVEs, but only marginally improved the discrimination obtained with classical clinical parameters: concordance index 0.744 (95% confidence interval 0.609-0.878) versus 0.723 (0.592-0.854), respectively. However, in individuals with diabetes treated with antihypertensives and lipid-lowering drugs, the determination of these biomarkers could help to improve cardiovascular risk estimates. CONCLUSIONS: We conclude that the determination of four biomarkers in the serum of CKD patients could improve cardiovascular risk prediction in high-risk individuals.

Confidence interval reporting for measures of association in multivariable regression models in observational studies / Reporte de los intervalos de confianza en medidas de asociación en modelos de regresión multivariable en estudios observacionales

Background/Objectives: To assess the adherence to reporting confidence intervals (CI) for measures of association in multivariable regression models (MRM) in articles with observational design indexed in MEDLINE. Material and methods: A literature search was conducted using the MEDLINE bibliographic database to obtain a representative sample of studies with observational design and applying MRM (logistic, linear, and Cox regression) (n=428). Proportions and 95% CI of articles reporting CI for measures of association in MRM were calculated. Percentage ratios (PRs) were also calculated to describe the change in CI reporting before and after the publication of the STROBE statement. Results: 188 of the 236 abstracts with measures of association (79.7%; 95% CI 74.5, 84.8) and 360 of the 428 main texts (84.1%; 80.6, 87.6) were provided with CI. A non-significant increase of 1% in the abstract, PR=1.01 (0.77, 1.29), and 7% in the main text, PR=1.07 (0.87, 1.28), occurred in the CI reporting after the publication of the STROBE guideline. Conclusions: The STROBE guideline recommendation on reporting CI should be more thoroughly followed

Antecedentes/objetivos: Evaluar la adherencia al reporte de los intervalos de confianza (IC) en medidas de asociación en modelos de regresión multivariable (MRM) en artículos con diseño observacional indexados en MEDLINE. Material y métodos: Se realizó una búsqueda bibliográfica usando la base de datos bibliográfica MEDLINE para obtener una muestra representativa de estudios con diseño observacional y que aplicaran MRM (regresión logística, lineal y Cox) (n=428). Se calcularon las proporciones e IC 95% de los artículos que reportaban IC en las medidas de asociación en MRM. También se calcularon las razones de porcentaje (RP) para describir el cambio en el reporte de los IC antes y después de la publicación de la declaración STROBE. Resultados: 188 de los 236 resúmenes con medidas de asociación (79,7%; IC 95% 74,5-84,8) y 360 de los 428 textos principales (84,1%; 80,6-87,6) estaban provistos de IC. Un incremento no significativo del 1% en el resumen, RP=1,01 (0,77-1,29), y del 7% en el texto principal, RP=1,07 (0,87-1,28), tuvo lugar en el reporte de los IC después de la publicación de la guía STROBE. Conclusiones: La recomendación de reportar IC dada por la guía STROBE debería ser seguida más exhaustivamente

Age- and Sex-Specific Risk Profiles and In-Hospital Mortality in 13,932 Spanish Stroke Patients.

BACKGROUND: In-hospital stroke death rate is an important sanitary issue. Despite advances in the acute phase management of stroke patients, mortality and disability rates remain high. In aging populations and with different mortality between the sexes in general, the study of sex- and age-related differences becomes increasingly relevant for optimization of post-acute clinical care of stroke patients. METHODS: We designed a cohort follow-up study with 13,932 consecutive ischemic stroke (IS) patients from 19 Spanish hospitals. Data was obtained from the Spanish Stroke Registry; transient ischemic attacks and ages <18 years were excluded. Patients were organised by age group and sex. We compared female and male patient cohorts within and across age groups univariately and used multivariable logistic regression to adjust for confounders in differential in-hospital mortality. RESULTS: The median (percentiles 2.5 and 97.5%) age was 78 (41-92) years old for women and 71 (41-92) for men. IS women were more likely to be older, to exhibit cardio-embolic aetiology, and less likely to have been admitted to a stroke unit or to have had a stroke code activated. Both pre-stroke modified Rankin Scale and National Institute of Health Stroke Scale (NIHSS) scores at admission increased significantly with age and were higher in women than those in men. Differences in distributions of common risk factors for IS and of in-hospital outcomes between women and men actually changed with patient's age. It is to be noted here that although there were no statistically significant differences (p > 0.05) between the sexes within any age group, in-hospital mortality appeared significantly higher in women than that in men when analysed overall, due to confounding. Death was more closely related to stroke in women than in men and occurred earlier. Although there were some age-specific sex differences between the predictors for in-hospital mortality, stroke severity measured by NIHSS was the main predictor of in-hospital mortality for both sexes. Topographic classifications - partial anterior circulatory infarct and total anterior circulatory infarct - were significant prognostic factors for men aged <60 years and for those in the 60-69 years range respectively. CONCLUSION: Although most of our findings were consistent with previous studies, it is important to take into account and highlight differences in in-hospital mortality between the sex and age group. Not to account for age-related differences between the sexes can give false results that may mislead management decisions. As most deaths in women were related to stroke, it is important to improve their early management, stroke code activation, access to stroke units and/or revascularisation therapies, especially in the older age groups.

An in-depth analysis shows a hidden atherogenic lipoprotein profile in non-diabetic chronic kidney disease patients.

Background: Chronic kidney disease (CKD) is an independent risk factor for atherosclerotic disease. We hypothesized that CKD promotes a proatherogenic lipid profile modifying lipoprotein composition and particle number. Methods: Cross-sectional study in 395 non-diabetic individuals (209 CKD patients and 186 controls) without statin therapy. Conventional lipid determinations were combined with advanced lipoprotein profiling by nuclear magnetic resonance, and their discrimination ability was assessed by machine learning. Results: CKD patients showed an increase of very-low-density (VLDL) particles and a reduction of LDL particle size. Cholesterol and triglyceride content of VLDLs and intermediate-density (IDL) particles increased. However, low-density (LDL) and high-density (HDL) lipoproteins gained triglycerides and lost cholesterol. Total-Cholesterol, HDL-Cholesterol, LDL-Cholesterol, non-HDL-Cholesterol and Proprotein convertase subtilisin-kexin type (PCSK9) were negatively associated with CKD stages, whereas triglycerides, lipoprotein(a), remnant cholesterol, and the PCSK9/LDL-Cholesterol ratio were positively associated. PCSK9 was positively associated with total-Cholesterol, LDL-Cholesterol, LDL-triglycerides, LDL particle number, IDL-Cholesterol, and remnant cholesterol. Machine learning analysis by random forest revealed that new parameters have a higher discrimination ability to classify patients into the CKD group, compared to traditional parameters alone: area under the ROC curve (95% CI), .789 (.711, .853) vs .687 (.611, .755). Conclusions: non-diabetic CKD patients have a hidden proatherogenic lipoprotein profile.

Empathy and big five personality model in medical students and its relationship to gender and specialty preference: a cross-sectional study.

BACKGROUND: Given the influence that personality can have on empathy, this study explores the relationship between empathy and personality, using three different measures of empathy, and taking into account gender and specialty preference. METHODS: Cross-sectional study. One hundred and ten medical students completed the Jefferson Scale of Physician Empathy, the Interpersonal Reactivity Index, the Empathy Quotient, and the NEO-FFI Big Five personality model. Multivariable linear regression was performed to assess the association between personality traits and empathy. RESULTS: Empathy scales showed weak and moderate correlation with personality. The strongest correlations were observed between IRI-Fantasy and Openness, and between IRI-Personal Distress and Neuroticism. Gender and specialty preference can modify this relationship. The extreme groups of Empathy Quotient had significant differences in most personality traits. CONCLUSIONS: This study confirmed that empathy is related to personality. Using three empathy scales allows personalizing the evaluation of different empathy models and its relation with personality. These results can help to design programs to study if some personalized intervention strategies could improve the empathy in medical students.

Confidence interval reporting for measures of association in multivariable regression models in observational studies.

BACKGROUND/OBJECTIVES: To assess the adherence to reporting confidence intervals (CI) for measures of association in multivariable regression models (MRM) in articles with observational design indexed in MEDLINE. MATERIAL AND METHODS: A literature search was conducted using the MEDLINE bibliographic database to obtain a representative sample of studies with observational design and applying MRM (logistic, linear, and Cox regression) (n=428). Proportions and 95% CI of articles reporting CI for measures of association in MRM were calculated. Percentage ratios (PRs) were also calculated to describe the change in CI reporting before and after the publication of the STROBE statement. RESULTS: 188 of the 236 abstracts with measures of association (79.7%; 95% CI 74.5, 84.8) and 360 of the 428 main texts (84.1%; 80.6, 87.6) were provided with CI. A non-significant increase of 1% in the abstract, PR=1.01 (0.77, 1.29), and 7% in the main text, PR=1.07 (0.87, 1.28), occurred in the CI reporting after the publication of the STROBE guideline. CONCLUSIONS: The STROBE guideline recommendation on reporting CI should be more thoroughly followed.

Quality of care indicators for a resuscitation unit: A descriptive study and proposal.

There are lack of indicators of quality of care in resuscitation units of emergency departments. With the aim of proposing a series of indicators to evaluate the quality of care delivered in hospital resuscitation areas, we conducted a descriptive study of 7579 admissions to the resuscitation unit of an emergency department at a Spanish hospital between 2012 and 2016. The proposed indicators were the percentage of patients attending to the emergency department admitted to the resuscitation area by level of triage, the length of stay, the percentage of patients moved to intensive care and surgery at disposition, the mortality in the area or in the emergency department within 24 hours of disposition, and the data completeness. A majority of the patients (62.6%) were men and the median age was 68 years. Over 99% of the required data were recorded. Median length of stay in the resuscitation unit was 0.87 hours (interquartile range, 0.5-1.5). Approximately 80% of patients categorized as an emergency on admission to the emergency department were admitted to the resuscitation unit, although the proportion of urgency patients was higher. The main disposition destination was a trauma cubicle (82.3% of cases). Mortality was 0.41%.Specific indicators are needed to assess the quality of care delivery in resuscitation units. We believe that our findings will provide new insights into the work done to date in this field.