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Aims Caregiver characteristics and behaviours are associated with patients’ and caregivers’ outcomes. However, there is scarce evidence on interventions aimed at improving caregiver contribution (CC) to patient self-care, caregiver self-efficacy, and caregiver preparedness in heart failure (HF). This study aims to evaluate the effect of Motivational Interviewing (MI) on CC to patient self-care, caregiver self-efficacy, and caregiver preparedness in HF. Methods and results This is a secondary outcome analysis of MOTIVATE-HF randomized controlled trial. Caregivers of patients with HF were randomized into three arms: Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard care). The intervention consisted of one MI session plus three telephone contacts. Data were collected at baseline and after 3, 6, 9, and 12 months. A total of 510 patient and caregiver (median age 54 years, 76% females) dyads were enrolled, 235 caregivers and 238 patients completed the study until 12 months. Caregiver contribution to self-care maintenance and management and caregiver preparedness significantly improved over time, but without significant differences among the three arms. At 9 months, caregiver self-efficacy improved more in Arm 2 than Arm 3 [difference: 8.36, 95% confidence interval (CI) (3.13; 13.59), P = 0.001]. This improvement remained significant also at linear mixed model [β^ = 1.39, 95% CI (0.02; 2.75), P = 0.046]. Conclusion Motivational Interviewing did not improve CC to patient self-care and caregiver preparedness. However, it increased caregiver self-efficacy, which is known to be a powerful mediator of CC to self-care. Registration Clinicaltrials.gov: NCT02894502.

Posterior fossa syndrome (PFS) is a set of debilitating complications that can occur after surgery for posterior fossa tumors. This study aimed to assess the preoperative radiological and surgical risk factors for the onset of PFS in a histologically homogeneous population of children with medulloblastoma and compare it to a similar population of young adults.Included patients underwent posterior fossa surgery for medulloblastoma at 11 Italian neurosurgical wards (2003-2019) and were referred to Fondazione IRCCS Istituto Nazionale dei Tumori in Milan (INT) for postoperative treatments. We collected patients' pre- and post-operative clinical, surgical and radiological data from the INT charts. To compare the distribution of variables, we used the Mann-Whitney and Fisher tests for continuous and categorical variables, respectively.136 patients (109 children and 27 young adults) were included in the study. Among children, 29 (27%) developed PFS, and all of them had tumors at midline site with invasion of the fourth ventricle. Radiological evidence of involvement of the right superior (39% versus 12%; p = 0.011) or middle cerebellar peduncles (52% versus 18%; p = 0.002) seemed more common in children who developed PFS. Young adults showed an expected lower incidence of PFS (4 out of 27; 15%), that may be due to anatomical, physiological and oncological elements.This study confirmed some factors known to be associated with PFS onset and shed light on other debated issues. Our findings enhance an already hypothesized role of cerebellar language lateralization. The analysis of a population of young adults may shed more light on the often-neglected existence of PFS in non-pediatric patients.

Aims Intense health‐care service use and high mortality are common in heart failure (HF) patients. This secondary analysis of the MOTIVATE‐HF trial investigates the effectiveness of motivational interviewing (MI) in reducing health‐care service use (e.g. emergency service use and hospitalizations) and all‐cause mortality. Methods and results This study used a randomized controlled trial. Patients and caregivers were randomized to Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), or Arm 3 (control group). Data were collected at baseline and at 3, 6, 9, and 12 months. Face‐to‐face MI plus three telephone calls were performed in Arms 1 and 2. The sample consisted of 510 patient (median age 74 years, 58% male patients) and caregiver dyads (median age 55 years, 75% female patients). At 12 months, 16.1%, 17%, and 11.2% of patients used health‐care services at least once in Arms 1, 2, and 3, respectively, without significant difference. At 3 months, 1.9%, 0.6%, and 5.1% of patients died in Arms 1, 2, and 3, respectively. Mortality was lower in Arm 2 vs. Arm 3 at 3 months [hazard ratio (HR) = 0.112, 95% CI: 0.014–0.882, P = 0.04]; no difference was found at subsequent follow‐ups. Mortality was lower in Arm 1 vs. Arm 3 at 3 months but did not reach statistical significance (HR = 0.38, 95% CI: 0.104–1.414, P = 0.15). Conclusion This study suggests that MI reduces mortality in patients with HF if caregivers are included in the intervention. Further studies with a stronger intervention and longer follow‐up are needed to clarify the benefits of MI on health‐care service use and mortality.

Background Since the occurrence of the SARS-COV2 pandemic, there has been an increasing interest in investigating the epidemiology of delirium. Delirium is frequent in SARS-COV2 patients and it is associated with increased mortality; however, no information is available on the association between delirium duration in SARS-COV2 patients and related outcomes. Aims The aim of this study is to investigate the association between the duration of delirium symptoms and in-hospital mortality in older patients with SARS-COV2 infection. Methods Retrospective cohort study of patients 65 years of age and older with SARS-CoV 2 infection admitted to two acute geriatric wards and one rehabilitation ward. Delirium symptoms duration was assessed retrospectively with a chart-based validated method. In-hospital mortality was ascertained via medical records. Results A total of 241 patients were included. The prevalence of delirium on admission was 16%. The median number of days with delirium symptoms was 4 (IQR 2–6.5) vs. 0 (IQR 0–2) in patients with and without delirium on admission. In the multivariable Cox regression model, each day with a delirium symptom in a patient with the same length of stay was associated with a 10% increase in in-hospital mortality (Hazard ratio 1.1, 95% Confidence interval 1.01–1.2; p = 0.03). Other variables associated with increased risk of in-hospital death were age, comorbidity, CPAP, CRP levels and total number of drugs on admission. Conclusions The study supports the necessity to establish protocols for the monitoring and management of delirium during emergency conditions to allow an appropriate care for older patients. Supplementary Information The online version contains supplementary material available at 10.1007/s40520-021-01899-8.

BacKGrOUnd: Older people hospitalized for cOvid-19 are at highest risk of death. Frailty assessment can detect heterogeneity in risk among people of the same chronological age. We investigated the association between frailty and in-hospital and medium-term mortality in middle-aged and older adults with COVID-19 during the first two pandemic waves. meTHOdS: This study is an observational multicenter study. We recorded sociodemographic factors (age, sex), smoking status, date of symp-tom onset, biological data, need for supplemental oxygen, comorbidities, cognitive and functional status, in-hospital mortality. We calculated a Frailty Index (FI) as the ratio between deficits presented and total deficits considered for each patient (theoretical range 0-1). We also assessed the clinical Frailty Scale (cFS). mortality at follow-up was ascertained from a regional registry. reSULTS: in total, 1344 patients were included; median age 68 years (Q1-Q3, 56-79); 857 (64%) were men. median cFS score was 3 (Q1-Q3 2-5) and was lower in younger vs. older patients. median Fi was 0.06 (Q1-Q3 0.03-0.09) and increased with increasing age. Overall, 244 (18%) patients died in-hospital and 288 (22%) over a median follow-up of 253 days. FI and CFS were significantly associated with risk of death. In two different models using the same covariates, each increment of 0.1 in Fi increased the overall hazard of death by 35% (Hr=1.35, 95%ci 1.23-1.48), similar to the hazard for each increment of cFS (Hr=1.37, 95%ci 1.25-1.50). cOncLUSiOnS: Frailty, assessed with the Fi or cFS, predicts in-hospital and medium-term mortality and may help estimate vulnerability in middle-aged and older cOvid-19 patients.

Background: The indications for intracranial pressure (ICP) monitoring in patients with acute brain injury and the effects of ICP on patients’ outcomes are uncertain. The aims of this study were to describe current ICP monitoring practises for patients with acute brain injury at centres around the world and to assess variations in indications for ICP monitoring and interventions, and their association with long-term patient outcomes. Methods: We did a prospective, observational cohort study at 146 intensive care units (ICUs) in 42 countries. We assessed for eligibility all patients aged 18 years or older who were admitted to the ICU with either acute brain injury due to primary haemorrhagic stroke (including intracranial haemorrhage or subarachnoid haemorrhage) or traumatic brain injury. We included patients with altered levels of consciousness at ICU admission or within the first 48 h after the brain injury, as defined by the Glasgow Coma Scale (GCS) eye response score of 1 (no eye opening) and a GCS motor response score of at least 5 (not obeying commands). Patients not admitted to the ICU or with other forms of acute brain injury were excluded from the study. Between-centre differences in use of ICP monitoring were quantified by using the median odds ratio (MOR). We used the therapy intensity level (TIL) to quantify practice variations in ICP interventions. Primary endpoints were 6 month mortality and 6 month Glasgow Outcome Scale Extended (GOSE) score. A propensity score method with inverse probability of treatment weighting was used to estimate the association between use of ICP monitoring and these 6 month outcomes, independently of measured baseline covariates. This study is registered with ClinicalTrial.gov, NCT03257904. Findings: Between March 15, 2018, and April 30, 2019, 4776 patients were assessed for eligibility and 2395 patients were included in the study, including 1287 (54%) with traumatic brain injury, 587 (25%) with intracranial haemorrhage, and 521 (22%) with subarachnoid haemorrhage. The median age of patients was 55 years (IQR 39–69) and 1567 (65%) patients were male. Considerable variability was recorded in the use of ICP monitoring across centres (MOR 4·5, 95% CI 3·8–4·9 between two randomly selected centres for patients with similar covariates). 6 month mortality was lower in patients who had ICP monitoring (441/1318 [34%]) than in those who were not monitored (517/1049 [49%]; p

Background Respiratory complications are frequently reported after aneurismal subarachnoid hemorrhage (aSAH), even if their association with outcome remains controversial. Acute respiratory distress syndrome (ARDS) is one of the most severe pulmonary complications after aSAH, with a reported incidence ranging from 11 to 50%. This study aims to assess in a large cohort of aSAH patients, during the first week after an intensive care unit (ICU) admission, the incidence of ARDS defined according to the Berlin criteria and its effect on outcome. Methods This is a multicentric, retrospective cohort study in 3 European intensive care units. We collected data between January 2009 and December 2017. We included adult patients (≥ 18 years) with a diagnosis of aSAH admitted to the ICU. Results A total of 855 patients fulfilled the inclusion criteria. ARDS was assessable in 851 patients. The cumulative incidence of ARDS was 2.2% on the first day since ICU admission, 3.2% on day three, and 3.6% on day seven. At the univariate analysis, ARDS was associated with a poor outcome (p = 0.005) at ICU discharge, and at the multivariable analysis, patients with ARDS showed a worse neurological outcome (Odds ratio = 3.00, 95% confidence interval 1.16–7.72; p = 0.023). Conclusions ARDS has a low incidence in the first 7 days of ICU stay after aSAH, but it is associated with worse outcome.

Aims Self‐care, an essential component of heart failure (HF) treatment, is inadequate in most patients. We evaluated if motivational interviewing (MI) (i) improves patient self‐care maintenance (primary endpoint; e.g. taking medications), self‐care management (e.g. responding to symptoms) and self‐care confidence (or self‐efficacy) 3 months after enrolment; (ii) changes self‐care over 1 year, and (iii) augments patient self‐care if informal caregivers are involved. Methods and results Parallel randomized controlled trial (1:1:1). A sample of 510 patients (median 74 years, 58% male) and caregivers (median 55 years, 75% female) was randomized to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), or Arm 3 (usual care). The intervention in Arms 1 and 2 consisted of one face‐to‐face MI session with three telephone contacts. Self‐care was evaluated with the Self‐Care of HF Index measuring self‐care maintenance, management, and confidence. Scores on each scale range from 0 to 100 with higher scores indicating better self‐care; ≥70 is considered adequate. At 3 months, self‐care maintenance improved 6.99, 7.42 and 2.58 points in Arms 1, 2, and 3, respectively (P = 0.028). Self‐care maintenance was adequate in 18.4%, 19.4%, and 9.2% of patients in Arms 1, 2 and 3, respectively (P = 0.016). Over 1 year, self‐care maintenance, management, and confidence scores in Arms 1 and 2 were significantly higher than in Arm 3 in several follow‐ups. Over 1 year, Arm 2 had the best scores in self‐care management. Conclusions MI significantly improved self‐care in HF patients. Including caregivers may potentiate the effect, especially in self‐care management. http://ClinicalTrial.gov, identifier: NCT02894502.

Purpose: To describe sex-related differences in self-care; to identify determinants of self-care according to sex, and to investigate how sex interacts with the effect of clinical and socio-demographic variables on self-care in adults with Type 2 Diabetes Mellitus (T2DM). Methods: Cross-sectional multicentre study with a consecutive sampling recruitment strategy, enrolling 540 adults with T2DM at six outpatient diabetes services. Clinical and socio-demographic variables were collected by medical records. Self-care maintenance, monitoring, management, and confidence were measured by the self-care of diabetes inventory. Results: Females reported higher disease prevention behaviors (P < 0.001), health-promoting behaviors (P < 0.001), body listening (P < 0.001), and symptom recognition (P = 0.010), but lower health-promoting exercise behaviors (P < 0.001). Determinants of self-care were different in male and female patients, where the role of task-specific self-care confidence predicted self-care monitoring (RR = 0.98; P < 0.001) and management (RR = 0.99; P < 0.001) among males, while persistence self-care confidence predicted self-care maintenance (RR = 0.97; P = 0.016) and management (RR = 0.99; P = 0.009) among females. Conclusions: Males and females differently perform self-care. Self-care confidence plays a different role predicting self-care behaviors in males and females. Future research should longitudinally describe self-care and its determinants in males and females with T2DM. Sex-specific self-care confidence interventions should be developed to improve self-care in male and female patients with T2DM.

Understanding the cause of sex disparities in COVID-19 outcomes is a major challenge. We investigate sex hormone levels and their association with outcomes in COVID-19 patients, stratified by sex and age. This observational, retrospective, cohort study included 138 patients aged 18 years or older with COVID-19, hospitalized in Italy between February 1 and May 30, 2020. The association between sex hormones (testosterone, estradiol, progesterone, dehydroepiandrosterone) and outcomes (ARDS, severe COVID-19, in-hospital mortality) was explored in 120 patients aged 50 years and over. STROBE checklist was followed. The median age was 73.5 years [IQR 61, 82]; 55.8% were male. In older males, testosterone was lower if ARDS and severe COVID-19 were reported than if not (3.6 vs. 5.3 nmol/L, p =0.0378 and 3.7 vs. 8.5 nmol/L, p =0.0011, respectively). Deceased males had lower testosterone (2.4 vs. 4.8 nmol/L, p =0.0536) and higher estradiol than survivors (40 vs. 24 pg/mL, p = 0.0006). Testosterone was negatively associated with ARDS (OR 0.849 [95% CI 0.734, 0.982]), severe COVID-19 (OR 0.691 [95% CI 0.546, 0.874]), and in-hospital mortality (OR 0.742 [95% CI 0.566, 0.972]), regardless of potential confounders, though confirmed only in the regression model on males. Higher estradiol was associated with a higher probability of death (OR 1.051 [95% CI 1.018, 1.084]), confirmed in both sex models. In males, higher testosterone seems to be protective against any considered outcome. Higher estradiol was associated with a higher probability of death in both sexes., The research was funded by Italian Ministry of Health “Fondi Ricerca Corrente, Project L1P5” for IRCCS Sacro Cuore Don Calabria Hospital.

Background Long-term pulmonary sequelae following hospitalization for SARS-CoV-2 pneumonia is largely unclear. The aim of this study was to identify and characterise pulmonary sequelae caused by SARS-CoV-2 pneumonia at 12-month from discharge. Methods In this multicentre, prospective, observational study, patients hospitalised for SARS-CoV-2 pneumonia and without prior diagnosis of structural lung diseases were stratified by maximum ventilatory support (“oxygen only”, “continuous positive airway pressure (CPAP)” and “invasive mechanical ventilation (IMV)”) and followed up at 12 months from discharge. Pulmonary function tests and diffusion capacity for carbon monoxide (DLCO), 6 min walking test, high resolution CT (HRCT) scan, and modified Medical Research Council (mMRC) dyspnea scale were collected. Results Out of 287 patients hospitalized with SARS-CoV-2 pneumonia and followed up at 1 year, DLCO impairment, mainly of mild entity and improved with respect to the 6-month follow-up, was observed more frequently in the “oxygen only” and “IMV” group (53% and 49% of patients, respectively), compared to 29% in the “CPAP” group. Abnormalities at chest HRCT were found in 46%, 65% and 80% of cases in the “oxygen only”, “CPAP” and “IMV” group, respectively. Non-fibrotic interstitial lung abnormalities, in particular reticulations and ground-glass attenuation, were the main finding, while honeycombing was found only in 1% of cases. Older patients and those requiring IMV were at higher risk of developing radiological pulmonary sequelae. Dyspnea evaluated through mMRC scale was reported by 35% of patients with no differences between groups, compared to 29% at 6-month follow-up. Conclusion DLCO alteration and non-fibrotic interstitial lung abnormalities are common after 1 year from hospitalization due to SARS-CoV-2 pneumonia, particularly in older patients requiring higher ventilatory support. Studies with longer follow-ups are needed.

BackgroundUncertainties exist regarding the indications, management, and effect of intracranial pressure (ICP) monitoring and treatment on outcome in patients with spontaneous intracranial hemorrhage (ICH).MethodsWe performed an analysis of patients with spontaneous ICH enrolled in the SYNAPSE-ICU study, an international prospective observational study on the use of ICP monitoring. This study aimed to describe, in a large cohort of patients with spontaneous ICH admitted to the intensive care unit (ICU), the clinical practice of ICP monitoring, the occurrence of intracranial hypertension, and its therapeutic management. We assessed in-hospital mortality and the association between ICP monitoring and 6-month mortality and outcome by a propensity score approach with inverse probability weighting.ResultsA total of 587 patients with ICH were included in this study; 281 (47.9%) received ICP monitoring. ICP-monitored patients, compared with nonmonitored patients, were younger (61 vs 67 years; p < 0.001), presented more frequently with both reactive pupils (67.2% vs 55.2%; p = 0.008), with better neurologic status at admission (Glasgow Coma Scale ≤8, 82.3% vs 88.8%; p = 0.038), and received higher therapy intensity level during the ICU stay. In 70.5% (170 out of 241) of ICP-monitored patients, the ICH score was equal to 3 or 4. Nearly half of monitored patients (46.6%) had at least one episode of ICP ≥20 mm Hg during the first week. An intraventricular catheter (53.6%) was the most frequently used device and was associated with fewer episodes of intracranial hypertension compared with the other monitoring devices (43.7% vs 64.9%, respectively). At weighted Cox regression model, ICP monitoring was associated with a significant reduction of 6-month mortality (hazard ratio 0.49 [95% CI 0.35–0.71; p = 0.001), but not with neurologic outcome (odds ratio 0.83 [95% CI 0.41–1.68]; p = 0.6077).ConclusionsICP monitoring in ICH was utilized mainly in moderately severe cases. ICP monitoring was associated with a reduction of in-hospital and 6-month mortality but did not improve 6-month functional outcomes. Further research and randomized controlled trials to generate higher-level medical evidence to support guidelines regarding ICP use and treatment in patients with ICH are needed.Trial Registration InformationSYNAPSE-ICU: ClinicalTrials.gov NCT03257904.

Funder: European Commission 7th Framework program, Funder: Australian Health and Medical Research Council, Funder: Università degli Studi di Milano - Bicocca, Purpose: The effect of high arterial oxygen levels and supplemental oxygen administration on outcomes in traumatic brain injury (TBI) is debated, and data from large cohorts of TBI patients are limited. We investigated whether exposure to high blood oxygen levels and high oxygen supplementation is independently associated with outcomes in TBI patients admitted to the intensive care unit (ICU) and undergoing mechanical ventilation. Methods: This is a secondary analysis of two multicenter, prospective, observational, cohort studies performed in Europe and Australia. In TBI patients admitted to ICU, we describe the arterial partial pressure of oxygen (PaO2) and the oxygen inspired fraction (FiO2). We explored the association between high PaO2 and FiO2 levels within the first week with clinical outcomes. Furthermore, in the CENTER-TBI cohort, we investigate whether PaO2 and FiO2 levels may have differential relationships with outcome in the presence of varying levels of brain injury severity (as quantified by levels of glial fibrillary acidic protein (GFAP) in blood samples obtained within 24 h of injury). Results: The analysis included 1084 patients (11,577 measurements) in the CENTER-TBI cohort, of whom 55% had an unfavorable outcome, and 26% died at a 6-month follow-up. Median PaO2 ranged from 93 to 166 mmHg. Exposure to higher PaO2 and FiO2 in the first seven days after ICU admission was independently associated with a higher mortality rate. A trend of a higher mortality rate was partially confirmed in the OzENTER-TBI cohort (n = 159). GFAP was independently associated with mortality and functional neurologic outcome at follow-up, but it did not modulate the outcome impact of high PaO2 and FiO2 levels, which remained independently associated with 6-month mortality. Conclusions: In two large prospective multicenter cohorts of critically ill patients with TBI, levels of PaO2 and FiO2 varied widely across centers during the first seven days after ICU admission. Exposure to high arterial blood oxygen or high supplemental oxygen was independently associated with 6-month mortality in the CENTER-TBI cohort, and the severity of brain injury did not modulate this relationship. Due to the limited sample size, the findings were not wholly validated in the external OzENTER-TBI cohort. We cannot exclude the possibility that the worse outcomes associated with higher PaO2 were due to use of higher FiO2 in patients with more severe injury or physiological compromise. Further, these findings may not apply to patients in whom FiO2 and PaO2 are titrated to brain tissue oxygen monitoring (PbtO2) levels. However, at minimum, these findings support the need for caution with oxygen therapy in TBI, particularly since titration of supplemental oxygen is immediately applicable at the bedside.

Introduction Huntington’s disease (HD) is a rare autosomal dominant neurodegenerative disorder caused by a CAG expansion greater than 35 in the IT-15 gene. There is an inverse correlation between the number of pathological CAG and the age of onset. However, CAG repeats between 40 and 42 showed a wider onset variation. We aimed to investigate potential clinical differences between patients with age at onset ≥ 60 years (late onset-HD) and patients with age at onset between 30 and 59 years (common-onset HD) in a cohort of patients with the same CAG expansions (40–42). Methods A retrospective analysis of 66 HD patients with 40–41–42 CAG expansion was performed. Patients were investigated with the Unified Huntington’s Disease Rating Scale (subitems I–II–III and Total Functional Capacity, Functional Assessment and Stage of Disease). Data were analysed using χ2, Fisher’s test, t test and Pearson’s correlation coefficient. GENMOD analysis and Kaplan-Meier analysis were used to study the disease progression. Results The age of onset ranged from 39 to 59 years in the CO subgroup, whereas the LO subgroup showed an age of onset from 60 to 73 years. No family history was reported in 31% of the late-onset in comparison with 20% in common-onset HD (p = 0.04). No difference emerged in symptoms of onset, in clinical manifestations and in progression of disease between the two groups. Conclusion There were no clinical differences between CO and LO subgroups with 40–42 CAG expansion. There is a need of further studies on environmental as well genetic variables modifying the age at onset.

The effect of high arterial oxygen levels and supplemental oxygen administration on outcomes in traumatic brain injury (TBI) is debated, and data from large cohorts of TBI patients are limited. We investigated whether exposure to high blood oxygen levels and high oxygen supplementation is independently associated with outcomes in TBI patients admitted to the intensive care unit (ICU) and undergoing mechanical ventilation.This is a secondary analysis of two multicenter, prospective, observational, cohort studies performed in Europe and Australia. In TBI patients admitted to ICU, we describe the arterial partial pressure of oxygen (PaOThe analysis included 1084 patients (11,577 measurements) in the CENTER-TBI cohort, of whom 55% had an unfavorable outcome, and 26% died at a 6-month follow-up. Median PaOIn two large prospective multicenter cohorts of critically ill patients with TBI, levels of PaO

Intensive care medicine 47(9), 961-973 (2021). doi:10.1007/s00134-021-06470-7, Published by Springer, Berlin

Introduction Mechanical ventilatory is a crucial element of acute brain injured patients' management. The ventilatory goals to ensure lung protection during acute respiratory failure may not be adequate in case of concomitant brain injury. Therefore, there are limited data from which physicians can draw conclusions regarding optimal ventilator management in this setting. Methods and analysis This is an international multicentre prospective observational cohort study. The aim of the a € multicentre observational study on practice of ventilation in brain injured patients' - the VENTIBRAIN study - is to describe the current practice of ventilator settings and mechanical ventilation in acute brain injured patients. Secondary objectives include the description of ventilator settings among different countries, and their association with outcomes. Inclusion criteria will be adult patients admitted to the intensive care unit (ICU) with a diagnosis of traumatic brain injury or cerebrovascular diseases (intracranial haemorrhage, subarachnoid haemorrhage, ischaemic stroke), requiring intubation and mechanical ventilation and admission to the ICU. Exclusion criteria will be the following: patients aged, SCOPUS: ar.j, info:eu-repo/semantics/published

Purpose of our study was to assess the prevalence of hypertension mediated organ damage (HMOD) in healthy subjects with high-normal Blood Pressure (BP) comparing them with subjects with BP values that are considered normal (

The illness-death model is the simplest multistate model where the transition from the initial state 0 to the absorbing state 2 may involve an intermediate state 1 (e.g., disease relapse). The impact of the transition into state 1 on the subsequent transition hazard to state 2 enables insight to be gained into the disease evolution. The standard approach of analysis is modeling the transition hazards from 0 to 2 and from 1 to 2, including time to illness as a time-varying covariate and measuring time from origin even after transition into state 1. The hazard from 1 to 2 can be also modeled separately using only patients in state 1, measuring time from illness and including time to illness as a fixed covariate. A recently proposed approach is a model where time after the transition into state 1 is measured in both scales and time to illness is included as a time-varying covariate. Another possibility is a model where time after transition into state 1 is measured only from illness and time to illness is included as a fixed covariate. Through theoretical reasoning and simulation protocols, we discuss the use of these models and we develop a practical strategy aiming to (a) validate the properties of the illness-death process, (b) estimate the impact of time to illness on the hazard from state 1 to 2, and (c) quantify the impact that the transition into state 1 has on the hazard of the absorbing state. The strategy is also applied to a literature dataset on diabetes.

To describe the type and the amount of formal and informal care received during the first year after home discharge and to identify the baseline predictors of the formal and informal care needs of stroke survivors.Longitudinal study. Data were collected between June 2013-May 2016.Survivors (N = 415) were enrolled during discharge from rehabilitation hospitals and interviewed at 3 (T1), 6 (T2), 9 (T3), and 12 (T4) months. The linear mixed effects model with random intercept and random slopes was used to trend for the amount of formal and informal care received by survivors during the four observation times.Regarding formal care, only physiotherapy and speech therapy decreased significantly over time. Stroke survivors received a mean of 17 hr of paid informal care per week at T1 and these hours did not significantly decrease after one year from discharge, while unpaid informal care decreased significantly over time. Higher numbers of paid informal caregiving were predicted by older age, higher education levels, lower physical functioning, and living without unpaid informal caregivers while higher numbers of unpaid informal care were predicted by lower physical functioning and living with unpaid informal caregivers.Stroke has a great effect on survivors' lives. During the first few months after rehabilitation hospital discharge, survivors need further care because they are often discharged before achieving independent functioning.The results of this study could be important to guide future interventions aimed at imporving stroke survivors' conditions after post rehabilitation hospital discharge.目的: 在于描述出院后第一年接受正式和非正式护理的类型和数量,并确定中风幸存者正式和非正式护理需求的基线预测指标。 设计: 纵向分析。2013年6月至2016年5月期间,收集了相关数据。 方法: 幸存者(415名)在康复医院出院时登记,并在3个月(T1)、6个月(T2)、9个月(T3)和12个月(T4)接受访谈。使用了具备随机截距和随机斜率的线性混合效应模型来预测幸存者在四次观察期间接受的正式和非正式护理数量。 结果: 关于正式护理,随着时间的推移,只有物理疗法和语言疗法在显著减少。中风幸存者在T1时每周平均接受17小时的有偿非正式护理,出院一年后这些时间没有显著减少,而无偿非正式护理却随着时间的推移显著减少。年龄越大、受教育水平越高、身体机能越差以及没有无酬非正式护理人员的生活预示着有酬非正式护理的人数会越来越多,而身体机能越差和与无酬非正式护理人员的生活预示着无酬非正式护理的人数会越来越多。 结论: 中风对幸存者的生活有很大影响。在康复医院出院后的头几个月里,幸存者需要进一步的护理,原因在于他们通常在能独立活动之前就出院了。 影响: 这项研究的结果对于指导旨在改善康复出院后中风幸存者状况的未来干预措施非常重要。.

Background: The aim of the study was to determine the effect of an educational intervention on the use of trend arrows of a real-time continuous glucose monitoring (rt-CGM) to manage daily therapy decisions in a group of adolescents with type 1 diabetes attending a camp. The secondary aim was to evaluate the variations in total daily dose (TDD) of insulin requirement. Methods: Twenty patients (15-17 years) on multiple insulin injections ( n = 8) or continuous subcutaneous insulin infusion ( n = 12) attended a training session at the beginning of the camp to learn our algorithm for the management of therapy depending on trend arrows. TDD, time in range (TIR), time above range (TAR), and time below range (TBR) (in the 24 hours and in the three hours after breakfast) before the training session (run-in) and at the end of the camp (T1) were analyzed. Results: Data showed a reduction of TAR (run-in 42.6%, T1 32.05%, P = .036) and an increase in TIR (run-in 52.9%, T1 62.4%, P = .013). Reduction of TBR (run-in 42.5%, T1 37.5%, P = .05) and improvement in TIR (run-in 49.0%, T1 57.0%, P = .02) were also observed in the post-breakfast period. Data showed a significant reduction in the TDD (run-in 52.02 ± 17.44 U/die, T1 46.49 ± 12.39 U/die, P = .024). Conclusions: Statistically significant improvement of glycemic control and reduction of TTD were observed in all patients regardless of therapy type. The improvement between run-in and T1 demonstrates the importance of patients’ education on the correct use of rt-CGM with simple algorithms for the management of therapy.

After the incidental observation of an almost complete resolution of maculopapular eruption in a patient having simultaneously secondary syphilis and trichomonas vaginalis infection, we extended the treatment with tinidazole (500 mg 4 times daily for 7 days) to 10 other early syphilis patients before the start of the conventional penicillin treatment. All patients showed marked improvement of their lesions in a few days. After the introduction of the conventional penicillin regimen, the lesions further improved and VDRL titers declined at least 4-fold within 6 months in all patients. Tinidazole is a 5-nitroimidazole derivative as well as metronidazole but with a longer plasma half-life. It is activated intracellularly by bacterial/parasitic enzymes to a redox cytotoxic intermediate that damages large protein molecules and inhibits repair and transcription of DNA affecting also the cell wall. With this action, tinidazole might also have a synergic action with penicillin and doxycycline, facilitating the entry of such drugs. It is possible that tinidazole has the same bactericidal action on spirochetes other than Borrelia, such as Treponema pallidum, explaining its rapid therapeutic action on the lesions of early syphilis. Whether this action could be confirmed by studies on larger series of patients, tinidazole might be considered in case of allergy to penicillin or other antibiotics usually prescribed in syphilis.

The aim of this study was to evaluate the satisfaction of the use of telemedicine and telenursing in children and young adults with Type 1 Diabetes and their families followed in the Regional Pediatric Diabetes Center of Giannina Gaslini Institute (Liguria, Italy). An anonymous survey form was administered to 290 patients (138 filled out by caregivers and 152 by patients). The questionnaire consisted of two parts: the first one included a series of questions related to the patient's personal and medical data; the second one was directed toward the satisfaction in the use of telemedicine and telenursing during Covid-19 pandemic. The data collected showed that 92.4% of the population was overall very satisfied with the quality of the service provided. Satisfaction was much higher especially in those who live outside of the province of Genoa (p = 0.017) and in those on insulin pump treatment (p = 0.037). Telemedicine and telenursing have an essential role in diabetology and are highly appreciated in our Center, where most patients prefer to continue regular follow-up via video-call as well as in person. Telenursing was also proved to be an effective and appreciated tool for educating and supporting patients using insulin pumps and glucose sensors.

Background The availability of large epidemiological or clinical data storing biological samples allow to study the prognostic value of novel biomarkers, but efficient designs are needed to select a subsample on which to measure them, for parsimony and economical reasons. Two-phase stratified sampling is a flexible approach to perform such sub-sampling, but literature on stratification variables to be used in the sampling and power evaluation is lacking especially for survival data. Methods We compared the performance of different sampling designs to assess the prognostic value of a new biomarker on a time-to-event endpoint, applying a Cox model weighted by the inverse of the empirical inclusion probability. Results Our simulation results suggest that case-control stratified (or post stratified) by a surrogate variable of the marker can yield higher performances than simple random, probability proportional to size, and case-control sampling. In the presence of high censoring rate, results showed an advantage of nested case-control and counter-matching designs in term of design effect, although the use of a fixed ratio between cases and controls might be disadvantageous. On real data on childhood acute lymphoblastic leukemia, we found that optimal sampling using pilot data is greatly efficient. Conclusions Our study suggests that, in our sample, case-control stratified by surrogate and nested case-control yield estimates and power comparable to estimates obtained in the full cohort while strongly decreasing the number of patients required. We recommend to plan the sample size and using sampling designs for exploration of novel biomarker in clinical cohort data.

Background In patients with end stage renal disease and atrial fibrillation (AF), undergoing chronic dialysis, direct oral agents are contraindicated and warfarin does not fully prevent embolic events while increasing the bleeding risk. The high hemorrhagic risk represents the main problem in this population. Aim of the study was to estimate the safety and efficacy for thromboembolic prevention of left atrial appendage (LAA) occlusion in a cohort of dialysis patients with AF and high hemorrhagic risk. Methods Ninety-two dialysis patients with AF who underwent LAA occlusion were recruited. For comparative purposes, two cohorts of dialysis patients with AF, one taking warfarin (oral anticoagulant therapy, OAT cohort, n = 114) and the other not taking any OAT (no-therapy cohort, n = 148) were included in the study. Primary endpoints were (1) incidence of peri-procedural complications, (2) incidence of 2-year thromboembolic and hemorrhagic events, (3) mortality at 2 years. In order to evaluate the effect of the LAA occlusion on the endpoints with respect to the OAT and No-therapy cohorts, a multivariable Cox regression model was applied adjusted for possible confounding factors. Results The device was successfully implanted in 100% of cases. Two major peri-procedural complications were reported. No thromboembolic events occurred at 2-year follow-up. The adjusted multivariable Cox regression model showed no difference in bleeding risk in the OAT compared to the LAA occlusion cohort in the first 3 months of follow-up [HR 1.65 (95% CI 0.43–6.33)], when most of patients were taking two antiplatelet drugs. In the following 21 months the bleeding incidence became higher in OAT patients [HR 6.48 (95% CI 1.32–31.72)]. Overall mortality was greater in both the OAT [HR 2.76 (95% CI 1.31–5.86)] and No-Therapy [HR 3.09 (95% CI 1.59–5.98)] cohorts compared to LAA occlusion patients. Conclusions The study could open the way to a non-pharmacological option for thromboembolic protection in dialysis patients with AF and high bleeding risk.

Background and aims Uric Acid (UA) has been related to the development of Cardio-Vascular (CV) events in patients affected by Chronic Coronary Syndromes (CCS). Among various hypothesis, two arise: UA may negatively act on coronary artery determining a higher degree of atherosclerotic disease, and/or on heart determining a higher prevalence of diastolic dysfunction. Both the above hypothesized effects are object of our investigation. Methods and results 231 patients who were admitted to the cardiological department of the Niguarda Hospital (Milan, Italy) for CCS from January 2017 to June 2018 were enrolled. Coronary atherosclerotic burden was evaluated from coronary angiography as the number and type of involved vessels, as well as with both Gensini and Syntax scores. All subjects underwent a complete echocardiogram. At unadjusted and adjusted/multivariable analysis, UA levels were not significantly associated with variables analysed from the coronary angiography (number and type of vessels involved, neither the Gensini and Syntax scores) as well as with echocardiographic parameters regarding systolic and diastolic function. Conclusions In conclusion, the main finding of our work is the absence of a role for UA in determining coronary arteries disease as well as LV diastolic dysfunction in CCS subjects. Taking together the results of previous studies with ours, we hypothesize that UA could act on heart (both on coronary arteries and on LV function) in an early phase of the disease, whereas while in the advanced stages other factors (previous myocardial infarction, previous myocardial revascularization and so on) may overshadow its effects.

Background: Long-term pulmonary sequelae following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia are not yet confirmed; however, preliminary observations suggest a possible relevant clinical, functional, and radiological impairment. Objectives: The aim of this study was to identify and characterize pulmonary sequelae caused by SARS-CoV-2 pneumonia at 6-month follow-up. Methods: In this multicentre, prospective, observational cohort study, patients hospitalized for SARS-CoV-2 pneumonia and without prior diagnosis of structural lung diseases were stratified by maximum ventilatory support (“oxygen only,” “continuous positive airway pressure,” and “invasive mechanical ventilation”) and followed up at 6 months from discharge. Pulmonary function tests and diffusion capacity for carbon monoxide (DLCO), 6-min walking test, chest X-ray, physical examination, and modified Medical Research Council (mMRC) dyspnoea score were collected. Results: Between March and June 2020, 312 patients were enrolled (83, 27% women; median interquartile range age 61.1 [53.4, 69.3] years). The parameters that showed the highest rate of impairment were DLCO and chest X-ray, in 46% and 25% of patients, respectively. However, only a minority of patients reported dyspnoea (31%), defined as mMRC ≥1, or showed restrictive ventilatory defects (9%). In the logistic regression model, having asthma as a comorbidity was associated with DLCO impairment at follow-up, while prophylactic heparin administration during hospitalization appeared as a protective factor. The need for invasive ventilatory support during hospitalization was associated with chest imaging abnormalities. Conclusions: DLCO and radiological assessment appear to be the most sensitive tools to monitor patients with the coronavirus disease 2019 (COVID-19) during follow-up. Future studies with longer follow-up are warranted to better understand pulmonary sequelae.

Objectives: The aims of this study are to report the prevalence of delirium on admission to the unit in patients hospitalized with SARS-CoV-2 infection, to identify the factors associated with delirium, and to evaluate the association between delirium and in-hospital mortality. Design: Multicenter observational cohort study. Settings: Acute medical units in four Italian hospitals. Participants: A total of 516 patients (median age 78 years) admitted to the participating centers with SARS-CoV-2 infection from February 22 to May 17, 2020. Measurements: Comprehensive medical assessment with detailed history, physical examinations, functional status, laboratory and imaging procedures. On admission, delirium was determined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria, 4AT, m-Richmond Agitation Sedation Scale, or clinical impression depending on the site. The primary outcomes were delirium rates and in-hospital mortality. Results: Overall, 73 (14.1%, 95% confidence interval (CI) = 11.0–17.3%) patients presented delirium on admission. Factors significantly associated with delirium were dementia (odds ratio, OR = 4.66, 95% CI = 2.03–10.69), the number of chronic diseases (OR = 1.20, 95% CI = 1.03; 1.40), and chest X-ray or CT opacity (OR = 3.29, 95% CI = 1.12–9.64 and 3.35, 95% CI = 1.07–10.47, for multiple or bilateral opacities and single opacity vs no opacity, respectively). There were 148 (33.4%) in-hospital deaths in the no-delirium group and 43 (58.9%) in the delirium group (P-value assessed using the Gray test

Context Heart failure (HF) patients experience high burden of physical symptoms during their disease trajectory. Objective To evaluate the effects of Motivational Interviewing (MI) on the burden of physical symptoms in HF patients. Methods We performed a secondary analysis of data from the MOTIVATE-HF randomized controlled trial. A sample of 510 patients (median 74 years, 58% male) and their caregivers (median 55 years, 75.5% female) was randomly allocated to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard of care). The MI intervention consisted of one face-to-face session plus three telephone calls conducted within two months from enrollment. Symptoms’ burden was assessed with the Heart Failure Somatic Perception Scale (HFSPS) with the dimensions of Chest Discomfort, Dyspnea, Early and subtle and Edema. Data were collected at baseline and at 3, 6, 9, and 12 months after enrollment. Results At 12 months, Chest Discomfort improved in Arms 1 and 2 vs Arm 3 (Δ: -8.13, 95% CI: -14.61; -1.65). Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95% CI: -13.18; -0.82 and -6.78, 95% CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95% CI: -9.05; -0.05). Over 1 year, Chest Discomfort and HFSPS total score in Arm 2 improved compared to Arm 3 (β= -2.61, 95% CI: -4.21; -1.00, P = 0.0015 and β=-1.35, 95% CI: -2.50; -0.21, P = 0.02). Conclusion MI reduces the burden of physical HF symptoms, particularly when caregivers are involved in the intervention.

We focused on the role of Uric Acid (UA) as a possible determinant of Heart Failure (HF) related issues in Acute Coronary Syndromes (ACS) patients. Main outcomes were acute HF and cardiogenic shock at admission, secondary outcomes were the use of Non Invasive Ventilation (NIV) and the admission Left Ventricular Ejection Fraction (LVEF). We consecutively enrolled 1269 ACS patients admitted to the cardiological Intensive Care Unit of the Niguarda and San Paolo hospitals (Milan, Italy) from June 2016 to June 2019. Median age was 68 (first-third quartile 59-77) years and males were 970 (76%). All the evaluated outcomes occurred more frequently in the hyperuricemic subjects (UA higher than 6 mg/dL for females and 7 mg/dL for males, n = 292): acute HF 35.8 vs 11.1% (p 0.0001), cardiogenic shock 10 vs 3.1% (p 0.0001), NIV 24.1 vs 5.1% (p 0.0001) and lower admission LVEF (42.9±12.8 vs 49.6±9.9, p 0.0001). By multivariable analyses, UA was confirmed to be significantly associated with all the outcomes with the following Odds Ratio (OR): acute HF OR = 1.119; 95% CI 1.019;1.229; cardiogenic shock OR = 1.157; 95% CI 1.001;1.337; NIV use OR = 1.208; 95% CI 1.078;1.354; LVEF β = -0.999; 95% CI -1.413;-0.586. We found a significant association between UA and acute HF, cardiogenic shock, NIV use and LVEF. Due to the cross-sectional nature of our study no definite answer on the direction of these relationship can be drawn and further longitudinal study on UA changes over time during an ACS hospitalization are needed.

Context Colonic polyps occur in 30–40% of acromegalic patients, increasing the risk of colon carcinoma. Although debated, there is emerging evidence that metformin may play a protective role in diabetic and non-diabetic patients with colonic polyps and its use in chemoprevention is currently explored. Objective Evaluate the prevalence of colonic polyps in acromegalic patients treated or not with metformin and explore its possible protective role. Design Exploratory cross-sectional study in two tertiary Italian referral centres. Met hods: Out of 153 acromegalic patients, we selected 58 patients (36–82 years; f: 33) who had at least one colonoscopy performed within the first 2 years of diagnosis. Presence of colonic polyps/cancer and related risk factors, current metformin and acetylsalicylic acid intake, disease duration, therapies for acromegaly, hormonal and metabolic parameters were assessed. Results An overall prevalence of 36% polyps was found. Based on the presence of polyps, we identified two groups, comparable for age, BMI, disease duration, glucose, insulin, HOMA-IR, HbA1c, GH and IGF-I levels. Of the patients with polyps (including three adenocarcinomas) only 24% were treated with metformin vs 57% of patients without polyps. Multivariate analysis confirmed a significant negative association between colonic polyps and metformin intake (OR: 0.22, 95% CI: 0.06-0.77, P = 0.01), whereas no significant association was found between polyps and age (P = 0.10), overweight/obesity (P = 0.54), smoking (P = 0.15), acetylsalicylic acid intake (P = 0.99), disease duration (P = 0.96), somatostatin analogues treatment (P = 0.70). Conclusions These findings, though deriving from an exploratory study, could suggest a protective role of metformin on the development of colonic polyps in acromegaly, and need to be confirmed in an extended study population.

BACKGROUND: There is a high prevalence of atrial fibrillation (AF) in patients undergoing haemodialysis. Oral anticoagulant therapy with vitamin K antagonists (VKAs) is the only accepted treatment for the prevention of thromboembolism in haemodialysis patients with AF. However, in this population, the risk of bleeding is greatly increased. The aim of the study was to evaluate the ability of treatment quality indicators of VKA therapy to predict mortality and bleedings in a population of haemodialysis patients with AF. MATERIALS AND METHODS: A total of 129 patients were included in this cohort study. Deaths and bleeding events were recorded during a follow-up of 4 years. In all patients, International Normalized Ratio (INR) values were assessed at least once a month. Time in therapeutic range (TTR) and INR variability, as measured by the standard deviation of INR, were updated at each INR measurement. A Cox model with time-dependent co-variates and sandwich variance was applied. RESULTS: During follow-up, 71 patients died and 55 bleeding episodes occurred in 31 patients. INR variability was the only indicator associated with both mortality (hazard ratio [HR]=1.67, 95% confidence interval [CI] 1.12; 2.49, p=0.012) and bleeding (HR=2.85, 95% CI: 1.71; 4.75, p=0.0001). HR of mortality was higher in patients with INR >3 (HR=2.06, 95% CI: 1.09; 3.88, p=0.0259) than in subjects in therapeutic range 2

Introduction: In primary biliary cholangitis (PBC), macrophages are involved in liver inflammation and fibrosis. The macrophage activation markers, soluble (s)CD163 and mannose receptor (sMR) are associated with liver disease severity and prognosis in other chronic liver diseases. We aimed to investigate sCD163 and sMR in patients with PBC. Methods: We investigated PBC patients from the Italian PBC Study Group cohort and measured macrophage activation markers in serum at study enrolment. Patients were followed from enrolment until they experienced an event or were censored at their last visit. Events were defined as follows: (a) death from a liver-related cause; or (b) liver transplantation (LT) for PBC. We used Cox regression to investigate the associa- tion between sCD163 and sMR and long-term prognosis. Results: In total, 202 PBC patients were included. Median age was 62 years (inter- quartile range (IQR), 53-71) at enrolment and 93% were women. Median sCD163 was 3.43 mg/L (IQR 2.48-5.35) and median sMR was 0.35 mg/L (IQR 0.28-0.45). There was an increase in sCD163 and sMR with increasing alkaline phosphatase. Two hundred and one patients were followed for a median of 8.6 years, and sCD163 and sMR pre- dicted long-term risk of liver-related death or LT in univariate analyses, while sCD163 was also associated with outcome after confounder adjusting (adjusted HR = 1.14, 95% CI 1.00-1.30). Finally, we showed an increase in the prediction accuracy of poor outcome by adding sCD163 to the UK-PBC risk score. Conclusion: The macrophage activation markers sCD163 and sMR represent a non- invasive measure of PBC disease severity that provides useful long-term prognostic information.

Purpose: The association between serum uric acid (SUA) and pulse wave velocity (PWV), has been extensively evaluated but with some discrepancies in results. A further limitation refers to the fact that only few data were analyzed taking into account the possible effects of gender. The purpose of this study was to estimate the association between SUA and arterial stiffness in general population and hypertensive patients, as a whole population and as divided by gender, by pooling results from existing studies. Materials and methods: Carotid-femoral and brachial-ankle PWV (cf- and ba-PWV) have been analyzed separately and subgroup analyses by gender are reported. Among 692 potentially relevant works, 24 articles were analyzed. Results: Seven studies referred to cf-PWV in the general population with an overall positive association at adjusted analysis for both males and females (beta regression coefficient (β): 0.07; 95%CI: 0.03; 0.11 and β: 0.06; 95%CI: 0.03; 0.09, respectively). Twelve studies referred to ba-PWV in the general population with the finding of a positive association at adjusted analysis for females (β: 0.04; 95% confidence interval (CI): 0.01;0.07), but not for males (β: 0.13; 95%CI: −0.09; 0.34). In hypertensive patients only four studies evaluated cf-PWV and one ba-PWV with only one study (with cf-PWV) finding positive association. Conclusion: The association between SUA and cf-PWV resulted significant in general population in both males and females while it was only significant for female regarding ba-PWV. Furthermore, the few available studies found no significant relationship between SUA and both cf- and ba-PWV in hypertensive subjects.

Background The Informative System of Nursing Performance was developed to measure complexity of nursing care based on the actual interventions performed by nurses at the point of care. The association of this score with in-hospital mortality was not investigated before. Having this information is relevant to define evidence-based criteria that hospital administrators can use to allocate nursing workforce according to the real and current patients’ need for nursing care. The aim of this study is to assess the association between complexity of nursing care and in-hospital mortality. Methods Register-based cohort study on all patients admitted to acute medical wards of a middle-large hospital in the North of Italy between January 1, 2014, to December 31, 2015 and followed up to discharge. Out of all the eligible 7247 records identified in the Hospital Discharge Register, 6872 records from 5129 patients have been included. A multivariable frailty Cox model was adopted to estimate the association between the Informative System of Nursing Performance score, both as continuous variable and dichotomized as low (score Results The median age of the 5129 included patients was 76 [first-third quartiles 64–84] and 2657(52%) patients were males. Over the 6872 admissions, there were 395 in-hospital deaths among 2922 patients at high complexity of nursing care (13.5%) and 74/3950 (1.9%) among those at low complexity leading to a difference of 11.6% (95% CI: 10.3–13.0%). Adjusting by relevant confounders, the hazard rate of mortality in the first 10 days from admission resulted 6 times significantly higher in patients at high complexity of nursing care with respect to patients at low complexity (hazard ratio, HR 6.58, 95%CI: 4.50;9.62, p Conclusion Complexity of nursing care is strongly associated to in-hospital mortality of acute patients admitted to medical departments. It predicts in-hospital mortality better than widely used indicators, such as comorbidity.

Purpose: To evaluate how self-care maintenance, self-care monitoring, and self-care management affect glycated haemoglobin in type 2 diabetes mellitus patients and to set cut-off points of the Self-Care of Diabetes Inventory scales using glycated haemoglobin as outcome of interest. Methods: A secondary analysis of a previous multicentre observational cross-sectional study was conducted. Overall, 540 adults with type 2 diabetes mellitus confirmed diagnosis were involved. Socio-demographic and clinical data were collected. Self-care maintenance, self-care monitoring, and self-care management were measured by the Self-Care of Diabetes Inventory. Linear regression models were performed to assess the relationship between self-care maintenance, self-care monitoring, and self-care management and glycated haemoglobin. Receiver operating characteristics curves were carried out to identify the best cut-off score for each self-care scale considering glycated haemoglobin >7% as outcome of interest. Results: Self-care monitoring and self-care management were associated to glycated haemoglobin in both patients without (self-care monitoring p = 0.0008; self-care management p = 0.0178) and with insulin therapy (self-care monitoring p = 0.0007; self-care management p = 0.0224). Self-care maintenance was associated to glycated haemoglobin in patients without insulin therapy (p = 0.0118). Cut-off scores providing the best performance were 70 points for self-care maintenance and self-care monitoring, and 60 points for self-care management. Conclusions: Self-care maintenance, self-care monitoring, and self-care management differently affect glycated haemoglobin in patients with type 2 diabetes mellitus. Clinicians could implement tailored interventions to improve glycaemic control considering the lacking area of self-care.

International audience; The end of deep reading is a commonplace in public debates, whenever societies talk about youth, books, and the digital age. In contrast to this, we show for the first time and in detail, how intensively young readers write and comment literary texts at an unprecedented scale. We present several analyses of how fiction is transmitted through the social reading platform Wattpad, one of the largest platforms for user-generated stories, including novels, fanfiction, humour, classics, and poetry. By mixed quantitative and qualitative methods and scalable reading we scrutinise texts and comments on Wattpad, what themes are preferred in 13 languages, what role does genre play for readers behaviour, and what kind of emotional engagement is prevalent when young readers share stories. Our results point out the rise of a global reading culture in youth reading besides national preferences for certain topics and genres, patterns of reading engagement, aesthetic values and social interaction. When reading Teen Fiction social-bonding (affective interaction) is prevalent, when reading Classics social-cognitive interaction (collective intelligence) is prevalent. An educational outcome suggests that readers who engage in Teen Fiction learn to read Classics and to judge books not only in direct emotional response to character’s behaviour, but focusing more on contextualised interpretation of the text.

Background and aims Prevention of decompensation is a primary therapeutic target in patients with compensated cirrhosis (CC). However, a major problem is the large sample size and long follow-up required to demonstrate a significant treatment effect because of the relatively low baseline risk. For this reason, it has been recently suggested that ordinal outcomes may be used in this area to gain power and reduce sample size. The aim of this study was to assess the applicability of ordinal outcomes in cirrhosis. Approach and results An inception cohort of 202 patients with CC (no ascites, gastrointestinal bleeding, encephalopathy, or jaundice) without esophageal varices was included, and 5-year outcome is reported. Etiology was mostly viral and alcoholic, and there were no dropouts. Ordinal outcome was set according to six grades with a previously established prognostic ordinality: grade 1 = no disease progression; grade 2 = development of varices; grade 3 = bleeding alone; grade 4 = nonbleeding single decompensation; grade 5 = more than one decompensating event; and grade 6 = death. At the 60-month time point, patients were distributed in grades 1 through 6 as follows: 129, 43, 2, 7, 5, and 16, respectively. Emulation of a clinical trial performed by dividing patients based on baseline platelet count into two groups (cutoff, 150 × 109 /L) demonstrated a statistically significant outcome difference between groups when using ordinal outcomes not detectable by binary logistic or chi-square or time-to-event analyses. Additionally, using ordinal outcomes in a hypothetical study to prevent decompensation resulted in sample-size estimates 3-to 4-fold lower than using a binary composite endpoint. Conclusions Compared to traditional binary outcomes, the use of ordinal outcomes in trials of cirrhosis decompensation may provide more power and thus may require a smaller sample size.

Functional status and chronic health status are important baseline characteristics of critically ill patients. The assessment of frailty on admission to the intensive care unit (ICU) may provide objective, prognostic information on baseline health. To determine the impact of frailty on the outcome of critically ill patients, we performed a systematic review and meta-analysis comparing clinical outcomes in frail and non-frail patients admitted to ICU.We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PubMed, CINAHL, and Clinicaltrials.gov. All study designs with the exception of narrative reviews, case reports, and editorials were included. Included studies assessed frailty in patients greater than 18 years of age admitted to an ICU and compared outcomes between fit and frail patients. Two reviewers independently applied eligibility criteria, assessed quality, and extracted data. The primary outcomes were hospital and long-term mortality. We also determined the prevalence of frailty, the impact on other patient-centered outcomes such as discharge disposition, and health service utilization such as length of stay.Ten observational studies enrolling a total of 3030 patients (927 frail and 2103 fit patients) were included. The overall quality of studies was moderate. Frailty was associated with higher hospital mortality [relative risk (RR) 1.71; 95% CI 1.43, 2.05; p 0.00001; IFrailty is common in patients admitted to ICU and is associated with worsened outcomes. Identification of this previously unrecognized and vulnerable ICU population should act as the impetus for investigating and implementing appropriate care plans for critically ill frail patients. Registration: PROSPERO (ID: CRD42016053910).

BACKGROUND: After discharge from a rehabilitation hospital, stroke survivors and their families may face considerable stroke-related direct costs. The total amount could be ascribed to the costs of formal and informal care and to the equipment or materials needed for care. OBJECTIVES: This study aims to describe the direct costs incurred after a stroke by survivors during their first poststroke year and to analyze the basic predictors of these costs. METHODS: Stroke survivors (N = 415) were enrolled for this study during discharge from rehabilitation hospitals (baseline) and interviewed at 3, 6, 9, and 12 months after discharge for a longitudinal study. The trend of the direct costs incurred during the follow-up (from T1 to T4; n = 239) was evaluated using a linear mixed-effects model. The mixed-effects model was used to identify the baseline predictors of the incurred direct costs from the stroke survivors. RESULTS: During the first year after discharge, stroke survivors spent approximately $3700 on stroke-related direct (ie, medical and nonmedical) costs. The highest direct costs occurred during the first 6 months, although there was not a significant change over time. The higher direct costs incurred were predicted by the linear effect of time, by the educational level (higher vs low), and by the lower Barthel Index score, whereas a higher perceived cost was predicted only by the linear effect of time and by the lower Barthel Index score. CONCLUSION: In the first poststroke year, direct costs have remained stable over time and can be predicted by the level of education and physical functioning. The identification of specific direct cost predictors would be helpful for developing more socially and economically tailored interventions for stroke survivors in their first year after their stroke

The aims of this study were to describe self-care in US T2DM patients and to identify clinical and sociodemographic determinants of self-care maintenance, monitoring, and management in US T2DM patients. A secondary analysis was performed using data from a cross-sectional study done to test the psychometric performance of the Self-Care of Diabetes Inventory in US English speaking adults with diabetes. In our sample ( n = 207), self-care maintenance was adequately performed (median = 75), self-care monitoring was borderline (median = 67.6) and self-care management was poor (median = 55.6). Low income ( p = .0019) and low self-care confidence ( p < .0001) were associated with relatively lower self-care maintenance. Not taking insulin ( p = .0153) and low self-care confidence ( p < .0001) were associated with relatively low self-care monitoring. Low self-care confidence ( p < .0001) was associated with low self-care management. Self-care confidence is a strong determinant of self-care. Interventions designed to improve self-care confidence are urgently needed.

Background: To assess the association between admission serum uric acid (SUA) levels and in-hospital outcomes in a real-world patients population with acute coronary syndrome (ACS) and to investigate the potential incremental prognostic value of SUA added to GRACE score (GRACE-SUA score). Methods: The data of consecutive ACS patients admitted to Coronary Care Unit of San Paolo and Niguarda hospitals in Milan (Italy) were retrospectively analyzed. Results: 1088 patients (24% female) were enrolled. Mean age was 68 years (IQR 60–78). STEMI and NSTE-ACS patients were 504 (46%) and 584 (54%) respectively. SUA (OR 1.72 95%CI 1.33–2.22, p < 0.0001) and GRACE score (OR 1.04 95%CI 1.02–1.06, p < 0.0001) were significantly associated with an increased risk of in-hospital death at the multivariate analysis. Admission values of SUA were stratified in four quartiles. Rates of acute kidney injury, implantation of intra-aortic balloon pump and non-invasive ventilation use were significantly higher in the last quartile compared to Q1, Q2 and Q3 (p < 0.01). The areas under the ROC curve (AUC) for GRACE score and for SUA were 0.91 (95% CI 0.89–0.93, p < 0.0001) and 0.79 (95% CI 0.76–0.81, p < 0.0001) respectively. The AUC was larger for predicting in-hospital mortality with the GRACE-SUA score (0.94; 95% CI 0.93–0.95). Conclusions: High admission levels of SUA are independently associated with in-hospital adverse outcomes and mortality in a contemporary population of ACS patients. The inclusion of SUA to GRACE risk score seems to lead to a more accurate prediction of in-hospital mortality in this study population.

In type 2 diabetes mellitus (T2DM) patients, human values have been identified as having a possible impact on self-care. Despite this, basic human values have never been described in the T2DM population and the association between basic human values and self-care has not been assessed. The aims of this study were to describe basic human values and self-care, and investigate the associations between basic human values and self-care in adults with T2DM. The study was cross-sectional multicentre with T2DM patients ( n = 390). Sociodemographic and clinical data were collected from charts, and two questionnaires were administered. The Portrait Values Questionnaire (PVQ) measured basic human values and allowed us to group patients into four groups based on the value profile: (A) Openness to Change and Self-Transcendence, (B) Conservation and Self-Transcendence, (C) Conservation and Self-Enhancement, and (D) Openness to Change and Self-Enhancement. The Self-care of Diabetes Inventory measured self-care maintenance, self-care monitoring, self-care management, and self-care confidence, according to the Middle-Range Theory of Self-Care of Chronic Illness. Multiple regression models were used to assess associations between the basic human values and self-care. Group D (Openness to Change and Self-Enhancement) performed significantly lower self-care maintenance ( p = .024) and self-care monitoring ( p = .031) when compared with Group A, and lower self-care monitoring ( p = .008) and self-care management ( p = .018) when compared with Group B. Group D showed significantly lower self-care monitoring ( p = .027) when compared with Group C. People with T2DM who value more self-enhancement and openness to change might be more prone to perform worse self-care compared with those who value conservation and self-transcendence. Clinicians should consider this when designing interventions aimed at improving self-care behaviors in patients with T2DM.

Herpes zoster (HZ) is typically characterized by pain involving the area of vesicular eruption. Several patients, however, complain of unilateral radicular pain without rash (zoster sine herpete [ZSH]). To evaluate whether the severity and duration of pain and the use of analgesics are greater in ZSH patients than in typical HZ with rash, 16 consecutive patients with acute unilateral pain, without vesicular eruption (ZSH), were compared with 16 controls suffering from typical HZ eruption. Only patients with laboratory evidence of varicella-zoster virus (VZV) reactivation were selected. Serum samples were obtained from all patients at their initial visit and 1 and 2 months later. Monthly, the administered therapies and the average pain score (visual analog scale [VAS] score) were recorded. VZV DNA persisted statistically higher in ZSH sera than HZ sera 1 month after onset (P = 0.0007). ZSH patients averaged greater pain than HZ patients, scoring VAS 76.88 and 66.88 ( P = 0.0012), respectively. ZSH patients used significantly more opioid therapy than HZ patients ( P = 0.0449; OR, 9.00). This is the first study comparing pain in ZSH and HZ patients: greater severity and duration of pain and more opioid use was detected in patients with ZSH.

Aims: To describe self-care as defined by the Middle Range Theory of Self-Care of Chronic Illness and to identify clinical and socio-demographic determinants in a T2DM population. Methods: A multicentre observational cross-sectional study was conducted involving 540 adults with a confirmed diagnosis of T2DM from six outpatient diabetes services in Italy. Socio-demographic and clinical data were collected from medical records. The Self-Care of Diabetes Inventory (SCODI) was used to measure self-care maintenance, monitoring, management, and confidence dimensions. For each separate scale, scores were standardized 0–100 with higher SCODI scores indicating better self-care; a score ≥ 70 is adequate. Multiple quantile regression models were performed to identify determinants of each self-care dimension. Results: Self-care maintenance (median = 81.3) and self-care confidence (median = 79.5) were adequate in most of the subjects. Self-care monitoring was adequate in only half of the sample (median = 70.6). Self-care management was poor (median = 59.4). Lower self-care maintenance was associated with lower self-care confidence (p < 0.001). Lower self-care monitoring was associated with being male (p < 0.001), having lower self-care confidence (p < 001), and having diabetes for < 10 years (p < 0.001). Lower self-care management was associated with being male (p = 0.002), being older (p = 0.005), having a low income (p = 0.030), being employed (p = 0.008), having missed diabetes education in the last year (p = 0.002), and lower self-care confidence (p < 0.0001). Lower self-care confidence was associated with having diabetes for < 10 years (p = 0.008), and having at least one comorbid condition (p = 0.006). Conclusions: Determinants of self-care maintenance, monitoring, management and confidence include both clinical and socio-demographic variables. Modifiable determinants such as self-care confidence and diabetes self-care management education could be used to tailor interventions to improve diabetes self-care