Diabetic patients have increased depression rates, diminished quality of life, and higher death rates due to depression comorbidity or diabetes complications. Treatment adherence (TA) and the ...maintenance of an adequate and competent self-care are crucial factors to reach optimal glycaemic control and stable quality of life in these patients. In this report, we present the baseline population analyses in phase I of the TELE-DD project, a three-phased population-based study in 23 Health Centres from the Aragonian Health Service Sector II in Zaragoza, Spain. The objectives of the present report are: (1) to determine the point prevalence of T2D and clinical depression comorbidity and treatment nonadherence; (2) to test if HbA1c and LDL-C, as primary DM outcomes, are related to TA in this population; and (3) to test if these DM primary outcomes are associated with TA independently of shared risk factors for DM and depression, and patients' health behaviours. A population of 7,271 patients with type-2 diabetes and comorbid clinical depression was investigated for inclusion. Individuals with confirmed diagnoses and drug treatment for both illnesses (n = 3340) were included in the current phase I. A point prevalence of 1.9% was found for the T2D-depression comorbidity. The prevalence of patients nonadherent to treatment for these diseases was 35.4%. Multivariate analyses confirmed that lower diabetes duration, increased yearly PCS visits, HbA1c and LDL-C levels were independently related to treatment nonadherence. These findings informed the development of a telephonic monitoring platform for treatment of nonadherence for people with diabetes and comorbid depression and further trial, cost-effectiveness, and prognostic studies (phases II and III).
Clinical depression is associated with poorer adherence to hypoglycaemic medication in patients with diabetes mellitus, leading to poorer glycaemic control, diabetes management, and increased ...complications. The main aim of the TELE-DD trial was to demonstrate the efficacy of a proactive and psychoeducational telephonic intervention based on motivational interviewing and collaborative care to reduce nonadherence and improve prognosis in individuals with diabetes mellitus and concurrent depression.
The TELE-DD project is a three-phased prospective study including a nested randomised controlled trial.
The baseline cohort included the entire population of adult patients diagnosed with type 2 diabetes and concurrent depression. A randomised controlled trial was conducted in a selection of patients from the baseline cohort, distributed into a control group (n = 192) and an intervention group (n = 192). Monthly telephonic interventions delivered by specifically trained research nurses were centred on a psychoeducational individualised monitoring protocol including motivational interviewing and collaborative care strategies. Clinical and patient-centred data were systematically collected during an 18-month follow-up including HbA1c, Patient Health Questionnaire, and the Diabetes Distress Scale.
During the trial, 18-month follow-up HbA1C levels significantly (
< 0.001) decreased in the intervention group at every follow-up from an average of 8.72 (SD:1.49) to 7.03 (SD:1.09), but slightly increased in the control group from 8.65 (SD:1.40) to 8.84 (SD:1.38). Similar positive results were obtained in depression severity and diabetes distress, LDL-cholesterol, and systolic and diastolic blood pressure, but only at the 18-month follow-up in body mass index reduction.
This is the first trial to concurrently decrease biological and psychological outcomes with a monthly brief telephonic intervention, pointing out that a combined biopsychosocial intervention and collaborative care strategy is essential for current world health challenges.
gov Identifier: NCT04097483. Patient or Public Contribution: Diabetic patients not belonging to the TELE-DD population or trial sample were consulted during the study design to review and guarantee the clarity and understanding of the trial psychoeducational materials.
Antiphospholipid syndrome (APS) is a thromboinflammatory disorder caused by circulating antiphospholipid autoantibodies (aPL) and characterized by an increased risk of thrombotic events. The ...pathogenic mechanisms of these antibodies are complex and not fully understood, but disturbances in coagulation and fibrinolysis have been proposed to contribute to the thrombophilic state. This study aims to evaluate the role of an emerging hemostatic molecule, FXI, in the thrombotic risk of patients with aPL. Cross-sectional and observational study of 194 consecutive and unrelated cases with aPL recruited in a single center: 82 asymptomatic (AaPL) and 112 with primary antiphospholipid syndrome (APS). Clinical and epidemiological variables were collected. The profile of aPL was determined. Plasma FXI was evaluated by Western blotting and two coagulation assays (FXI:C). In cases with low FXI, molecular analysis of the F11 gene was performed. FXI:C levels were significantly higher in patients with APS than in patients with AaPL (122.8 ± 33.4 vs. 104.5 ± 27.5; p < 0.001). Multivariate analysis showed a significant association between symptomatic patients with aPL (APS) and high FXI (>150%) (OR = 11.57; 95% CI: 1.47–90.96; p = 0.020). In contrast, low FXI (<70%), mostly caused by inhibitors, was less frequent in the group of patients with APS compared to AaPL (OR = 0.17; 95%CI: 0.36–0.86; p = 0.032). This study suggests that FXI levels may play a causal role in the prothrombotic state induced by aPLs and holds the promise of complementary treatments in APS patients by targeting FXI.
What is known and objective
Tocilizumab is an IL‐6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome ...coronavirus‐2 (SARS‐CoV‐2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID‐19.
Methods
This is a retrospective study of severe COVID‐19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records.
Results and discussion
A total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0–36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm.
What is new and conclusions
It does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.
Evolution of cytomegalovirus viral load and serology tests in one pregnant patient, in which viral reactivation was detected. She received a single dose of tocilizumab and methylprednisolone therapy for 15 days. Baseline IgM antibodies and amniotic fluid polymerase‐chain‐reaction were negative, but they became positive 6 days after tocilizumab infusion and viral load was detected on day 13.
OBJECTIVETo describe the characteristics of patients with very-late-onset myasthenia gravis (MG).
METHODSThis observational cross-sectional multicenter study was based on information in the ...neurologist-driven Spanish Registry of Neuromuscular Diseases (NMD-ES). All patients were >18 years of age at onset of MG and onset occurred between 2000 and 2016 in all cases. Patients were classified into 3 age subgroupsearly-onset MG (age at onset <50 years), late-onset MG (onset ≥50 and <65 years), and very-late-onset MG (onset ≥65 years). Demographic, immunologic, clinical, and therapeutic data were reviewed.
RESULTSA total of 939 patients from 15 hospitals were included288 (30.7%) had early-onset MG, 227 (24.2%) late-onset MG, and 424 (45.2%) very-late-onset MG. The mean follow-up was 9.1 years (SD 4.3). Patients with late onset and very late onset were more frequently men (p < 0.0001). Compared to the early-onset and late-onset groups, in the very-late-onset group, the presence of anti–acetylcholine receptor (anti-AChR) antibodies (p < 0.0001) was higher and fewer patients had thymoma (p < 0.0001). Late-onset MG and very-late-onset MG groups more frequently had ocular MG, both at onset (<0.0001) and at maximal worsening (p = 0.001). Although the very-late-onset group presented more life-threatening events (Myasthenia Gravis Foundation of America IVB and V) at onset (p = 0.002), they required fewer drugs (p < 0.0001) and were less frequently drug-refractory (p < 0.0001).
CONCLUSIONSPatients with MG are primarily ≥65 years of age with anti-AChR antibodies and no thymoma. Although patients with very-late-onset MG may present life-threatening events at onset, they achieve a good outcome with fewer immunosuppressants when diagnosed and treated properly.
SARS-CoV-2 infection increases the risk of thrombosis by different mechanisms not fully characterized. Although still debated, an increase in D-dimer has been proposed as a first-line hemostasis test ...associated with thromboembolic risk and unfavorable prognosis. We aim to systematically and comprehensively evaluate the association between thrombin generation parameters and the inflammatory and hypercoagulable state, as well as their prognostic value in COVID-19 patients. A total of 127 hospitalized patients with confirmed COVID-19, 24 hospitalized patients with SARS-CoV-2-negative pneumonia and 12 healthy subjects were included. Clinical characteristics, thrombin generation triggered by tissue factor with and without soluble thrombomodulin, and also by silica, as well as other biochemical parameters were assessed. Despite the frequent use of heparin, COVID-19 patients had similar thrombin generation to healthy controls. In COVID-19 patients, the thrombin generation lag-time positively correlated with markers of cell lysis (LDH), inflammation (CRP, IL-6) and coagulation (D-dimer), while the endogenous thrombin potential (ETP) inversely correlated with D-dimer and LDH, and positively correlated with fibrinogen levels. Patients with more prolonged lag-time and decreased ETP had higher peak ISTH-DIC scores, and had more severe disease (vascular events and death). The ROC curve and Kaplan Meier estimate indicated that the D-dimer/ETP ratio was associated with in-hospital mortality (HR 2.5; p = 0.006), and with the occurrence of major adverse events (composite end-point of vascular events and death) (HR 2.38; p = 0.004). The thrombin generation ETP and lag-time variables correlate with thromboinflammatory markers, and the D-dimer/ETP ratio can predict major adverse events in COVID-19.
The main aim of this paper was to characterize the Autonomic Nervous System response in hyperbaric environments using electrocardiogram (ECG) and pulse-photoplethysmogram (PPG) signals. To that end, ...26 subjects were introduced into a hyperbaric chamber and five stages with different atmospheric pressures (1 atm; descent to 3 and 5 atm; ascent to 3 and 1 atm) were recorded. Respiratory information was extracted from the ECG and PPG signals and a combined respiratory rate was studied. This information was also used to analyze Heart Rate Variability (HRV) and Pulse Rate Variability (PRV). The database was cleaned by eliminating those cases where the respiratory rate dropped into the low frequency band (LF: 0.04-0.15 Hz) and those in which there was a discrepancy between the respiratory rates estimated using the ECG and PPG signals. Classical temporal and frequency indices were calculated in such cases. The ECG results showed a time-related dependency, with the heart rate and sympathetic markers (normalized power in LF and LF/HF ratio) decreasing as more time was spent inside the hyperbaric environment. A dependence between the atmospheric pressure and the parasympathetic response, as reflected in the high-frequency band power (HF: 0.15-0.40 Hz), was also found, with power increasing with atmospheric pressure. The combined respiratory rate also reached a maximum in the deepest stage; thus, highlighting a significant difference between this stage and the first one. The PPG data gave similar findings and also allowed the oxygen saturation to be computed; therefore, we propose the use of this signal for future studies in hyperbaric environments.
Objective
The coronavirus has spread around the world, causing an ongoing pandemic. After the lockdown and quarantine protocols, an evaluation of the population's current emotional state was made ...through a web-based survey available in both English and Spanish. The objective was to observe how respondents perceived stress and worry as a result of COVID-19.
Methods
The survey gathered data across three sections: socio-demographic data, the Perceived Stress Scale (PSS-10) by Cohen, and additional queries on current worries and behaviors due to this pandemic.
Results
The survey received 1523 respondents from 48 countries. The mean of the PSS-10 score was 17.4 (SD 6.5). Significantly higher scores were observed among women, young adults, students, and those who expressed concern about getting infected and considered themselves high-risk. No significant differences were observed between health professionals and other professions.
Conclusions
We describe an increase in stress levels due to the COVID-19 and point out groups at high risk. These findings could help to address the mental health care that is needed.
Our long-term goal is the development of an automatic identifier of attentional states. In order to accomplish it, we should first be able to identify different states based on physiological signals. ...So, the first aim of this paper is to identify the most appropriate features to detect a subject's high performance state. For that, a database of electrocardiographic (ECG) and photoplethysmographic (PPG) signals is recorded in two unequivocally defined states (rest and attention task) from up to 50 subjects as a sample of the population. Time and frequency parameters of heart/pulse rate variability have been computed from the ECG/PPG signals, respectively. Additionally, the respiratory rate has been estimated from both signals and also six morphological parameters from PPG. In total, 26 features are obtained for each subject. They provide information about the autonomic nervous system and the physiological response of the subject to an attention demand task. Results show an increase of sympathetic activation when the subjects perform the attention test. The amplitude and width of the PPG pulse were more sensitive than the classical sympathetic markers (PLFn and RLF/HF) for identifying this attentional state. State classification accuracy reaches a mean of 89 ± 2%, a maximum of 93%, and a minimum of 85%, in the 100 classifications made by only selecting four parameters extracted from the PPG signal (pulse amplitude, pulsewidth, pulse downward slope, and mean pulse rate). These results suggest that attentional states could be identified by PPG.
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•Several enzymes were immobilized on octyl-glyoxyl supports.•4M sodium phosphate readily inactivated the enzymes while the enzymes kept the activity in 6M NaCl.•6M NaCl has positive ...or negative effects on thermostability depending on the enzyme.•100mM sodium phosphate presented moderate destabilizing effects in immobilized enzymes but not on all free enzymes.•Fluorescence spectrum suggested a massive structural change produced by sodium phosphate.
We have analyzed the effects of the buffer nature on the stability of immobilized lipases. Commercial phospholipase Lecitase Ultra (LU), lipase B from Candida antarctica (CALB) and lipase from Thermomyces lanuginosus (TLL) have been immobilized on octyl-glyoxyl agarose beads. The enzymes were readily inactivated using 4M sodium phosphate but 6M NaCl did not inactivate them. Using 2M of sodium phosphate, the inactivation of the 3 immobilized enzymes still was very significant even at 25°C but at lower rate than with higher phosphate concentration. Thermal stress inactivations of the immobilized enzymes revealed that even 100mM sodium phosphate produced a significant decrease in enzyme stability; this effect was less pronounced for Lecitase but dramatic for CALB. While 6M NaCl presented slightly positive (LU) or negative (TLL) effects on their thermal stabilities of, CALB was thermally stabilized under the same conditions. Results were very different using free enymes. Fluorescence spectroscopy revealed dramatic structural rearrangements of the immobilized enzymes in the presence of high phosphate concentration. From these results, the use of sodium phosphate does not seem to be recommended for studies on thermal stability of lipases, although this should be verified for each enzyme and immobilized preparation.
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