Syncope Time Frames for Adverse Events after Emergency Department Presentation: An Individual Patient Data Meta-Analysis

Eventos adversos; Arritmia; ResultadosAdverse events; Arrhythmia; OutcomesEsdeveniments adversos; Arítmia; ResultatsBackground and Objectives: Knowledge of the incidence and time frames of the adverse events of patients presenting syncope at the ED is essential for developing effective management strategies. The aim of the present study was to perform a meta-analysis of the incidence and time frames of adverse events of syncope patients. Materials and Methods: We combined individual patients’ data from prospective observational studies including adult patients who presented syncope at the ED. We assessed the pooled rate of adverse events at 24 h, 72 h, 7–10 days, 1 month and 1 year after ED evaluation. Results: We included nine studies that enrolled 12,269 patients. The mean age varied between 53 and 73 years, with 42% to 57% females. The pooled rate of adverse events was 5.1% (95% CI 3.4% to 7.7%) at 24 h, 7.0% (95% CI 4.9% to 9.9%) at 72 h, 8.4% (95% CI 6.2% to 11.3%) at 7–10 days, 10.3% (95% CI 7.8% to 13.3%) at 1 month and 21.3% (95% CI 15.8% to 28.0%) at 1 year. The pooled death rate was 0.2% (95% CI 0.1% to 0.5%) at 24 h, 0.3% (95% CI 0.1% to 0.7%) at 72 h, 0.5% (95% CI 0.3% to 0.9%) at 7–10 days, 1% (95% CI 0.6% to 1.7%) at 1 month and 5.9% (95% CI 4.5% to 7.7%) at 1 year. The most common adverse event was arrhythmia, for which its rate was 3.1% (95% CI 2.0% to 4.9%) at 24 h, 4.8% (95% CI 3.5% to 6.7%) at 72 h, 5.8% (95% CI 4.2% to 7.9%) at 7–10 days, 6.9% (95% CI 5.3% to 9.1%) at 1 month and 9.9% (95% CI 5.5% to 17) at 1 year. Ventricular arrhythmia was rare. Conclusions: The risk of death or life-threatening adverse event is rare in patients presenting syncope at the ED. The most common adverse events are brady and supraventricular arrhythmias, which occur during the first 3 days. Prolonged ECG monitoring in the ED in a short stay unit with ECG monitoring facilities may, therefore, be beneficial.This research received no external funding

INTRAPERSONAL AND SOCIAL FACTORS FOR PROBLEMATIC INTERNET USE AMONG STUDENTS DURING THE COVID-19 PANDEMIC

Background: During the lockdown due to COVID-19, Internet use may become more frequent in students, with possible negative consequences on mental health. In this emergency situation, variables such as depression, anxiety and external locus of control could be related to a Problematic Internet Use; on the other hand, self-esteem, internal locus of control, self-efficacy, and social support can play the role of protective factors for Problematic Internet Use. The present survey aims to verify the impact of these intrapersonal and social factors on Problematic Internet Use in college and High School students during the COVID-19 pandemic through a web-based cross-sectional study. Subjects and methods: 191 students from Lombardy, one of the Italian Regions among the most affected by the COVID-19 pandemic, were included in the study. An online questionnaire has been administered during the first Italian period of forced lockdown. A logistic regression analysis was performed to assess intrapersonal and social factors as predictors of Problematic Internet Use. Results: Analysis highlighted a higher risk of Problematic Internet Use (5.77 times more) in males compared to females. Individuals with high external locus of control and severe depression have respectively 6.56 and 2.84 times more the risk of presenting Problematic Internet Use. In contrast, social support, self-efficacy, and self-esteem were negatively related to Problematic Internet Use. In total sample, the percentage of Problematic Internet Use was high (55.5%). Conclusions: An increasing use of the Internet has been observed during lockdown, leading to a progressive increase in the diffusion of Problematic Internet Use. Gender, depression and external locus of control emerge as risk factors for Problematic Internet Use, while social support, self-efficacy and self-esteem represent protective factors. The current research identifies some intrapersonal and social factors in an epidemic context for which the development of effective behavioural, supportive and/or educational interventions would be appropriate

Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study

<p>Abstract</p> <p>Background</p> <p>Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponsorship, and favourable findings, and little is known whether in terms of these items mITT trials are different with respect to trials that report a standard intention-to-treat.</p> <p>Methods</p> <p>To determine differences in the methodological quality, sponsorship, authors' conflicts of interest, and findings among trials with different "types" of intention-to-treat, we undertook a cross-sectional study of RCTs published in 2006 in three general medical journals (the Journal of the American Medical Association, the New England Journal of Medicine and the Lancet) and three specialty journals (Antimicrobial Agents and Chemotherapy, the American Heart Journal and the Journal of Clinical Oncology). Trials were categorized based on the "type" of intention-to-treat reporting as follows: ITT, trials reporting the use of standard ITT approach; mITT, trials reporting the use of a "modified intention-to-treat" approach; and "no ITT", trials not reporting the use of any intention-to-treat approach. Two pairs of reviewers independently extracted the data in duplicate. The strength of the associations between the "type" of intention-to-treat reporting and the quality of reporting (sample size calculation, flow-chart, lost to follow-up), the methodological quality of the trials (sequence generation, allocation concealment, and blinding), the funding source, and the findings was determined. Odds ratios (OR) were calculated with 95% confidence intervals (CI).</p> <p>Results</p> <p>Of the 367 RCTs included, 197 were classified as ITT, 56 as mITT, and 114 as "no ITT" trials. The quality of reporting and the methodological quality of the mITT trials were similar to those of the ITT trials; however, the mITT trials were more likely to report post-randomization exclusions (adjusted OR 3.43 [95%CI, 1.70 to 6.95]; <it>P </it>< 0.001). We found a strong association between trials classified as mITT and for-profit agency sponsorship (adjusted OR 7.41 [95%CI, 3.14 to 17.48]; <it>P </it>< .001) as well as the presence of authors' conflicts of interest (adjusted OR 5.14 [95%CI, 2.12 to 12.48]; <it>P </it>< .001). There was no association between mITT reporting and favourable results; in general, however, trials with for-profit agency sponsorship were significantly associated with favourable results (adjusted OR 2.30; [95%CI, 1.28 to 4.16]; <it>P </it>= 0.006).</p> <p>Conclusion</p> <p>We found that the mITT trials were significantly more likely to perform post-randomization exclusions and were strongly associated with industry funding and authors' conflicts of interest.</p

INTRAPERSONAL AND SOCIAL FACTORS FOR PROBLEMATIC INTERNET USE AMONG STUDENTS DURING THE COVID-19 PANDEMIC

Background: During the lockdown due to COVID-19, Internet use may become more frequent in students, with possible negative consequences on mental health. In this emergency situation, variables such as depression, anxiety and external locus of control could be related to a Problematic Internet Use; on the other hand, self-esteem, internal locus of control, self-efficacy, and social support can play the role of protective factors for Problematic Internet Use. The present survey aims to verify the impact of these intrapersonal and social factors on Problematic Internet Use in college and High School students during the COVID-19 pandemic through a web-based cross-sectional study. Subjects and methods: 191 students from Lombardy, one of the Italian Regions among the most affected by the COVID-19 pandemic, were included in the study. An online questionnaire has been administered during the first Italian period of forced lockdown. A logistic regression analysis was performed to assess intrapersonal and social factors as predictors of Problematic Internet Use. Results: Analysis highlighted a higher risk of Problematic Internet Use (5.77 times more) in males compared to females. Individuals with high external locus of control and severe depression have respectively 6.56 and 2.84 times more the risk of presenting Problematic Internet Use. In contrast, social support, self-efficacy, and self-esteem were negatively related to Problematic Internet Use. In total sample, the percentage of Problematic Internet Use was high (55.5%). Conclusions: An increasing use of the Internet has been observed during lockdown, leading to a progressive increase in the diffusion of Problematic Internet Use. Gender, depression and external locus of control emerge as risk factors for Problematic Internet Use, while social support, self-efficacy and self-esteem represent protective factors. The current research identifies some intrapersonal and social factors in an epidemic context for which the development of effective behavioural, supportive and/or educational interventions would be appropriate

The therapeutic effect of mesenchymal stem cell transplantation in experimental autoimmune encephalomyelitis is mediated by peripheral and central mechanisms

Stem cells are currently seen as a treatment for tissue regeneration in neurological diseases such as multiple sclerosis, anticipating that they integrate and differentiate into neural cells. Mesenchymal stem cells (MSCs), a subset of adult progenitor cells, differentiate into cells of the mesodermal lineage but also, under certain experimental circumstances, into cells of the neuronal and glial lineage. Their clinical development, however, has been significantly boosted by the demonstration that MSCs display significant therapeutic plasticity mainly occurring through bystander mechanisms. These features have been exploited in the effective treatment of experimental autoimmune encephalomyelitis, an animal model of multiple sclerosis where the inhibition of the autoimmune response resulted in a significant amelioration of disease and decrease of demyelination, immune infiltrates and axonal loss. Surprisingly, these effects do not require MSCs to engraft in the central nervous system but depend on the cells' ability to inhibit pathogenic immune responses both in the periphery and inside the central nervous system and to release neuroprotective and pro-oligodendrogenic molecules favoring tissue repair. These results paved the road for the utilization of MSCs for the treatment of multiple sclerosis

The diagnostic accuracy of carbon monoxide pulse oximetry in adults with suspected acute carbon monoxide poisoning: a systematic review and meta-analysis

IntroductionAcute carbon monoxide poisoning (COP) is one of the leading causes of intoxication among patients presenting to the emergency department (ED). COP symptoms are not always specific and may vary from mild to critical. In the last few years, COHb pulse oximeters have been developed and applied to the setting of suspected COP. The aim of this systematic review is to assess the diagnostic accuracy of CO pulse oximetry (SpCO) with carboxyhemoglobin (COHb) levels measured by blood gas analysis, used as a reference standard, in patients with suspected COP.MethodsWe developed our search strategy according to the PICOS framework, population, index/intervention, comparison, outcome, and study, considering the diagnostic accuracy of SpCO compared to COHb levels measured by blood gas analysis, used as a reference standard, in patients with suspected COP enrolled in cross-sectional studies in English. The search was performed on MEDLINE/PubMed and EMBASE in February 2022. Quality assessment was performed using the QUADAS-2 methodology. A COHb cutoff of 10% was chosen to test the sensitivity and specificity of the index test. A bivariate model was used to perform the meta-analysis. The protocol was registered on PROSPERO (CRD42022359144).ResultsA total of six studies (1734 patients) were included. The pooled sensitivity of the test was 0.65 (95% CI 0.44–0.81), and the pooled specificity was 0.93 (95% CI 0.83–0.98). The pooled LR+ was 9.4 (95% CI 4.4 to 20.1), and the pooled LR- was 0.38 (95% CI 0.24 to 0.62).ConclusionOur results show that SpCO cannot be used as a screening tool for COP in the ED due to its low sensitivity. Because of its high LR+, it would be interesting to evaluate, if SpCO could have a role in the prehospital setting as a tool to quickly identify COP patients and prioritize their transport to specialized hospitals on larger samples with a prospective design

An Exploratory Study of Field Failures

Field failures, that is, failures caused by faults that escape the testing phase leading to failures in the field, are unavoidable. Improving verification and validation activities before deployment can identify and timely remove many but not all faults, and users may still experience a number of annoying problems while using their software systems. This paper investigates the nature of field failures, to understand to what extent further improving in-house verification and validation activities can reduce the number of failures in the field, and frames the need of new approaches that operate in the field. We report the results of the analysis of the bug reports of five applications belonging to three different ecosystems, propose a taxonomy of field failures, and discuss the reasons why failures belonging to the identified classes cannot be detected at design time but shall be addressed at runtime. We observe that many faults (70%) are intrinsically hard to detect at design-time

Glucocorticosteroids for people with alcoholic hepatitis (Cochrane review)

Alcoholic hepatitis (AH) is a form of alcoholic liver disease. Glucocorticosteroids (GCS) are used as anti - inflammatory drugs for people with alcoholic hepatitis. Aim. To assess the benefits and harms of GCS in people with AH. Material and methods. We identified trials through electronic searches in Cochrane Hepato-Biliary's (CHB) Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, and Science Citation Index Expanded. We considered for inclusion randomised clinical trials (RCTs) assessing GCS versus placebo/no intervention in adult participants with AH. We allowed co - interventions in the trial groups if they were similar. We followed Cochrane methodology, CHB Group methodology using Review Manager 5 and Trial Sequential Analysis(TSA) to perform meta - analysis (M-A), assessed bias risk of the trials, certainty of evidence using GRADE. Results and discussion. Sixteen trials fulfilled the inclusion criteria. Fifteen trials provided data for analysis (927 participants received GCS, 934 - placebo/no intervention). The GCS were administered to adult participants at different stages of AH orally or parenterally for a median of 28 days. There was no evidence of effect of GCCs on our primary outcomes all - cause mortality up to 3 months following randomisation (RR 0.90, 95% CI 0.70-1.15; n=1861), on health - related quality of life (MD - 0.04 points; 95% CI -0.11-0.03; n=377; trial = 1) (EQ-5D-3L scale), on the occurrence of serious adverse events during treatment (RR 1.05, 95% CI 0.85-1.29; n=1861). We found no evidence of a difference between the intervention groups. The risk of bias was high in all the trials except one. The certainty of evidence was very low or low. One of the trials seems to be not industry - funded. Conclusion. We found no evidence of a difference between GCS and placebo or no intervention on all - cause mortality, health - related quality of life, and serious adverse events during treatment. We cannot exclude increases in adverse events and cannot rule out significant benefits and harms of GCSs. Future trials ought to report depersonalised individual participant data

Rituximab as Maintenance Treatment for Systemic Lupus Erythematosus: A Multicenter Observational Study of 147 Patients.

OBJECTIVE: The efficacy of rituximab (RTX) in systemic lupus erythematosus (SLE) is a subject of debate. This study was undertaken to investigate the outcomes of RTX treatment in a European SLE cohort, with an emphasis on the role of RTX as a maintenance agent. METHODS: All patients with SLE who were receiving RTX as induction therapy in 4 centers were included. Patients who received a single course of RTX and those who received RTX maintenance treatment (RMT) were followed up after treatment. Disease flares during the follow-up period were defined as an increase in disease activity and the number or dose of immunosuppressive drugs. RESULTS: Of 147 patients, 27% experienced treatment failure at 6 months. In a multivariate analysis, a low number of previous immunosuppressive therapies (P = 0.034) and low C4 levels (P = 0.008) reduced the risk of treatment failure. Eighty patients received RMT over a median of 24.5 months during which 85 relapses, mainly musculoskeletal, were recorded (1.06 per patient). At the time of the last RTX course, 84% of the patients were in remission. Twenty-eight (35%) of 80 patients never experienced a flare during RMT and had low damage accrual. Active articular disease at the time of the first RTX administration was associated with a risk of flare during RMT (P = 0.011). After RMT, relapse-free survival was similar to that in patients receiving a single RTX course (P = 0.72). CONCLUSION: RMT is a potential treatment option for patients with difficult-to-treat disease. Relapses occur during RMT and are more likely in those with active articular disease at the time of the first RTX administration. Relapse risk after RMT remains high and apparently comparable to that seen after a single RTX course