Obstetric antiphospholipid syndrome carries an increased lifetime risk for obstetric and thrombotic complications-a population-based study.

Background: Antiphospholipid syndrome (APS) can present with either a thromboembolic event (thrombotic APS, TAPS) or an obstetric complication (obstetric APS, OAPS). Data on long-term complications in the different APS phenotypes are limited. Objectives: We aimed to compare obstetric history, antiphospholipid antibody profiles, obstetric and thromboembolic complications, and pregnancy outcomes between TAPS and OAPS. Methods: This retrospective cohort study included women who delivered singleton pregnancies between 1998 and 2020. One hundred sixteen thousand four hundred nine women were included, resulting in 320,455 deliveries. Among the included patients, 71 were diagnosed with APS, 49 were classified as OAPS, and 22 as TAPS. The demographics, obstetric, neonatal, and thrombotic outcomes were compared among TAPS, OAPS, and the general obstetric population. Results: OAPS patients had an increased risk of thrombotic events compared with the general obstetric population (odds ratio [OR] 18.0; 95% CI, 8.7-37.2). In pregnancies following the diagnosis of APS, despite standard antithrombotic treatment, OAPS patients exhibited an elevated risk of placenta-related and neonatal complications compared with the general obstetric population (late fetal loss [adjusted OR {aOR}, 15.3; 95% CI, 0.5-27.5], stillbirth [aOR, 5.9; 95% CI, 2.2-15.4], placental abruption [aOR, 4.8; 95% CI, 1.5-15.3], preeclampsia [aOR, 4.4; 95% CI, 2.5-7.7], fetal growth restriction [aOR, 4.3; 95% CI, 8.5-27.5], small for gestational age neonate [aOR, 4.0; 95% CI, 2.4-6.6], and low Apgar scores [Apgar'1: aOR, 2.6; 95% CI, 1.3-10.4; Apgar'5: aOR, 3.7; 95% CI, 1.3-10.4]). TAPS patients exhibited increased risk of preeclampsia (aOR, 3.1; 95% CI, 1.2-8). Conclusion: OAPS patients exhibit a heightened risk of thrombotic events compared with the general obstetric population. Despite treatment, OAPS and TAPS still presented obstetric complications. These findings, after confirmation in prospective studies, need to be taken into consideration when planning the treatment approach for these patients.

An international multicenter study comparing COVID-19 omicron outcomes in patients with hematological malignancies treated with obinutuzumab versus rituximab.

OBJECTIVES: Hematological malignancy (HM) patients treated with anti-CD20 monoclonal antibodies are at higher risk for severe COVID-19. A previous single-center study showed worse outcomes in patients treated with obinutuzumab compared to rituximab. We examined this hypothesis in a large international multicenter cohort. METHODS: We included HM patients from 15 centers, from five countries treated with anti-CD20, comparing those treated with obinutuzumab (O-G) to rituximab (R-G) between December 2021 and June 2022, when Omicron lineage was dominant. RESULTS: We collected data on 1048 patients. Within the R-G (n = 762, 73%), 191 (25%) contracted COVID-19 compared to 103 (36%) in the O-G. COVID-19 patients in the O-G were younger (61 ± 11.7 vs. 64 ± 14.5, p = 0.039), had more indolent HM diagnosis (aggressive lymphoma: 3.9% vs. 67.0%, p < 0.001), and most were on maintenance therapy at COVID-19 diagnosis (63.0% vs. 16.8%, p < 0.001). Severe-critical COVID-19 occurred in 31.1% of patients in the O-G and 22.5% in the R-G. In multivariable analysis, O-G had a 2.08-fold increased risk for severe-critical COVID-19 compared to R-G (95% CI 1.13-3.84), adjusted for Charlson comorbidity index, sex, and tixagevimab/cilgavimab (T-C) prophylaxis. Further analysis comparing O-G to R-G demonstrated increased hospitalizations (51.5% vs. 35.6% p = 0.008), ICU admissions (12.6% vs. 5.8%, p = 0.042), but the nonsignificant difference in COVID-19-related mortality (n = 10, 9.7% vs. n = 12, 6.3%, p = 0.293). CONCLUSIONS: Despite younger age and a more indolent HM diagnosis, patients receiving obinutuzumab had more severe COVID-19 outcomes than those receiving rituximab. Our findings underscore the need to evaluate the risk-benefit balance when considering obinutuzumab therapy for HM patients during respiratory viral outbreaks.

Vasopressors and Mean Arterial Pressure in Septic Shock: Do We Bend the Rules for Young Adults?

BACKGROUND: Younger patient age and relatively good prognosis have been described as factors that may increase caregiver motivation in treating patients with septic shock in the intensive care unit (ICU). OBJECTIVES: To examine whether clinical teams tended to achieve unnecessarily higher map arterial pressure (MAP) values in younger patients. METHODS: We conducted a population-based retrospective cohort study of patients presenting with septic shock who were treated with noradrenaline and hospitalized in a general ICU between 2006 and 2018. The patients were classified into four age groups: 18-45 (n=129), 46-60 (n=96), 61-75 (n=157), and older than 75 years (n=173). Adjusted linear mixed models and locally weighted scatterplot smoothing (LOWESS) curves were used to assess associations and potential non-linear relationships, respectively, of age group with MAP and noradrenaline dosage. RESULTS: The cohort included 555 patients. An inverse relation was observed between average MAP value and age. Among patients aged 18-45 years, the average MAP was 4.7 mmHg higher (95% confidence interval 3.4-5.9) than among patients aged > 75 years (P-value <0.001) after adjustment for sex, death in the intensive care unit, and Sequential Organ Failure Assessment scores. CONCLUSIONS: Among patients with septic shock, the titration of noradrenaline by staff led to a higher average MAP for younger patients. Although the MAP target is equal for all age groups, staff may administer noradrenaline treatment according to a higher target of MAP due to attitudes toward patients of different ages, despite any evidence that such practice is beneficial.

Medical Cannabis Is Not Associated with a Decrease in Activities of Daily Living in Older Adults.

The proportion of older adults using medical cannabis is rising. Therefore, we aimed to assess the effects of herbal medical cannabis on the functional status of older adults. We conducted a prospective observational study of patients aged 65 years or older that initiated cannabis treatment for different indications, mostly chronic non-cancer pain, during 2018-2020 in a specialized geriatric clinic. The outcomes assessed were activities of daily living (ADL), instrumental activities of daily living (IADL), pain intensity, geriatric depression scale, chronic medication use, and adverse events at six months. A cohort of 119 patients began cannabis treatment: the mean age was 79.3 ± 8.5 and 74 (62.2%) were female. Of the cohort, 43 (36.1%) experienced adverse effects due to cannabis use and 2 (1.7%) required medical attention. The mean ADL scores before and after treatment were 4.4 ± 1.8 and 4.5 ± 1.8, respectively (p = 0.27), and the mean IADL scores before and after treatment were 4.1 ± 2.6 and 4.7 ± 3, respectively (p = 0.02). We concluded that medical cannabis in older adults has a number of serious adverse events, but was not associated with a decrease in functional status, as illustrated by ADL and IADL scores after six months of continuous treatment.

Challenging the Interpretation of White Blood Cell Counts in Patients with Sepsis Following Packed Cell Transfusion.

Critically ill patients with sepsis often require packed cell transfusions (PCT). However, PCT may affect white blood cell (WBC) counts. We conducted a population-based retrospective cohort study to trace changes in WBC count following PCT in critically ill patients with sepsis. We included 962 patients who received one unit of PCT while hospitalized in a general intensive care unit, and 994 matched patients who did not receive PCT. We calculated the mean values of WBC count for the 24 h before and 24 h after PCT. Multivariable analyses using a mixed linear regression model were performed. The mean WBC count decreased in both groups, but more in the non-PCT group (from 13.9 × 109/L to 12.2 × 109/L versus 13.9 × 109/L to 12.8 × 109/L). A linear regression model showed a mean decrease of 0.45 × 109/L in WBC count over the 24 h following the start of PCT. Every 1.0 × 109/L increase in the WBC count prior to PCT administration showed a corresponding decrease of 0.19 × 109/L in the final WBC count. In conclusion, among critically ill patients with sepsis, PCT causes only mild and clinically non-prominent changes in WBC count.

Fourth dose of BNT162b2 vaccine for patients with autoimmune rheumatic diseases in a nationwide setting.

OBJECTIVE: The effectiveness of COVID-19 vaccinations wanes due to immune evasion by the B.1.1.529 (Omicron) variant and diminished antibody titres over time. We aimed to evaluate the benefit of a fourth vaccination dose in patients with autoimmune rheumatic diseases (ARDs). METHODS: This retrospective analysis included ARD patients aged 18 years or older and members of Clalit Health Services in Israel (which at the time of the study insured 52% of the entire population), and covered the period from 16 January 2022 to 31 March 2022, when the predominant SARS-CoV-2 variant was Omicron. We compared patients without previous COVID-19 infection who had received three doses of the BNT162b2 vaccine (the control group) with those who had received the fourth dose. The primary outcome was COVID-19 infection, which was analysed using multivariate Cox regression in the entire cohort and within ARD subgroups. Secondary outcomes were COVID-19-related hospitalizations and COVID-19-related death. RESULTS: We included 43 748 ARD patients, of whom 27 766 and 15 982 were in the control and fourth vaccination groups, respectively. COVID-19 infection occurred in 6942 (25.0%) of the control group and 1754 (11.0%) of the fourth dose group (P < 0.001). Patients vaccinated with the fourth dose had a lower risk of COVID-19 infection than the entire cohort [Hazard Ratio (HR) 0.54, 95% CI 0.52, 0.58] and throughout every subgroup regardless of the baseline characteristic or medical treatment, except for rituximab. A similar association was observed for risk of COVID-19-related hospitalization (HR 0.36, 95% CI 0.22, 0.61) and of COVID-19-related death (HR 0.41, 95% CI 0.24, 0.71). CONCLUSION: A fourth BNT162b2 vaccination of ARD patients was associated with favourable outcomes compared with three doses among patients with no history of COVID-19 infection.

Glucose variability is a marker for COVID-19 severity and mortality

ABSTRACT Objective: We aimed to investigate the association between glucose coefficient of variation (CV) and mortality and disease severity in hospitalized patients with coronavirus disease-19 (COVID-19). Subjects and methods: Retrospective cohort study in a tertiary center of patients with COVID-19 admitted to designated departments between March 11th, 2020, and November 2nd, 2020. We divided patients based on quartiles of glucose CV after stratification to those with and without diabetes mellitus (DM). Main outcomes were length of stay and in-hospital mortality. Results: The cohort included 565 patients with a mean age of 67.71 ± 15.45 years, and 62.3% were male. Of the entire cohort, 44.4% had DM. The median glucose CV was 32.8% and 20.5% in patients with and without DM, respectively. In patients with DM, higher glucose CV was associated with a longer hospitalization in the unadjusted model (OR = 2.7, 95% CI [1.3,5.6] for Q4), and when adjusted for age, sex, comorbidities, and laboratory markers, this association was no longer statistically significant (OR = 1.3, 95% CI [0.4,4.5] for Q4). In patients with and without DM, higher glucose CV was associated with higher rates of in-hospital mortality in the unadjusted model, but adjustment for comorbidities and laboratory markers eliminated the association (OR = 0.5, 95% CI [0.1,3.4] for Q4 in patients with DM). Conclusion: Higher glucose CV was associated with increased in-hospital mortality and length of stay, but this association disappeared when the adjustment included laboratory result data. Glucose CV can serve as a simple and cheap marker for mortality and severity of disease in patients with COVID-19.

Glucose variability is a marker for COVID-19 severity and mortality.

Objective: We aimed to investigate the association between glucose coefficient of variation (CV) and mortality and disease severity in hospitalized patients with coronavirus disease-19 (COVID-19). Subjects and Methods: Retrospective cohort study in a tertiary center of patients with COVID-19 admitted to designated departments between March 11th, 2020, and November 2nd, 2020. We divided patients based on quartiles of glucose CV after stratification to those with and without diabetes mellitus (DM). Main outcomes were length of stay and in-hospital mortality. Results: The cohort included 565 patients with a mean age of 67.71 ± 15.45 years, and 62.3% were male. Of the entire cohort, 44.4% had DM. The median glucose CV was 32.8% and 20.5% in patients with and without DM, respectively. In patients with DM, higher glucose CV was associated with a longer hospitalization in the unadjusted model (OR = 2.7, 95% CI [1.3,5.6] for Q4), and when adjusted for age, sex, comorbidities, and laboratory markers, this association was no longer statistically significant (OR = 1.3, 95% CI [0.4,4.5] for Q4). In patients with and without DM, higher glucose CV was associated with higher rates of in-hospital mortality in the unadjusted model, but adjustment for comorbidities and laboratory markers eliminated the association (OR = 0.5, 95% CI [0.1,3.4] for Q4 in patients with DM). Conclusion: Higher glucose CV was associated with increased in-hospital mortality and length of stay, but this association disappeared when the adjustment included laboratory result data. Glucose CV can serve as a simple and cheap marker for mortality and severity of disease in patients with COVID-19.

Herbal Cannabis Use Is Not Associated with Changes in Levels of Endocannabinoids and Metabolic Profile Alterations among Older Adults.

Activation of the endocannabinoid system has various cardiovascular and metabolic expressions, including increased lipogenesis, decreased blood pressure, increased heart rate, and changes in cholesterol levels. There is a scarcity of data on the metabolic effects of exogenous cannabis in older adults; therefore, we aimed to assess the effect of exogenous cannabis on endocannabinoid levels and the association with changes in 24 h ambulatory blood pressure and lipid levels. We conducted a prospective study of patients aged 60 years or more with hypertension treated with a new prescription of herbal cannabis. We assessed changes in endocannabinoids, blood pressure, and metabolic parameters prior to and following three months of cannabis use. Fifteen patients with a mean age of 69.47 ± 5.83 years (53.3% male) underwent complete evaluations. Changes in 2-arachidonoylglycerol, an endocannabinoid, were significantly positively correlated with changes in triglycerides. Changes in arachidonic acid levels were significantly positively correlated with changes in C-reactive protein and with changes in mean diastolic blood pressure. Exogenous consumption of cannabidiol was negatively correlated with endogenous levels of palmitoylethanolamide and oleoylethanolamide. On average, cannabis treatment for 3 months does not result in a significant change in the levels of endogenous cannabinoids and thus has a safe metabolic risk profile.

Current use of D-dimer for the exclusion of venous thrombosis in hospitalized patients.

D-dimer assay's utility for excluding venous thromboembolism (VTE) in hospitalized patients is debatable. We aimed to assess the current use of D-dimer as a diagnostic tool for excluding VTE in hospitalized patients and examine a mandatory age-adjusted D-dimer (AADD) threshold for diagnostic imaging. Retrospective cohort study between 2014 to 2019 that included patients from medical and surgical wards with a positive AADD result drawn during their hospitalization. The outcomes were determining a D-dimer threshold requiring further evaluation and assessing the prognostic value of D-dimer in predicting clinically relevant VTE in hospitalized patients. The cohort included 354 patients, 56% of them underwent definitive diagnostic imaging, and 7.6% were diagnosed with VTE after a positive AADD within 90 days of follow-up. Mortality rates were higher in patients diagnosed with VTE (33.3% vs. 15.9%, p = 0.03). Patients with pneumonia and other infectious etiologies were less likely to be further evaluated by definitive imaging (p = 0.001). Patients with a respiratory complaint (p = 0.02), chest pain (p < 0.001), or leg swelling (p = 0.01) were more likely to undergo diagnostic imaging. Patients with D-dimer levels > X2 the AADD were at increased risk of VTE [OR 3.87 (1.45-10.27)]. At 90 days of follow-up, no excess mortality was observed for patients without diagnostic evaluation following elevated AADD. D-dimer may be used in hospitalized patients to exclude VTE using the traditional AADD thresholds, with a high negative predictive value. D-dimer levels > X2 the AADD usually mandates further diagnostic imaging, while lower levels, probably do not require additional workup, with a sensitivity of almost 80% and no excess mortality.

BNT162b2 mRNA COVID-19 vaccine and booster in patients with autoimmune rheumatic diseases: a national cohort study.

INTRODUCTION: Emerging evidence supports the immunogenic response to mRNA COVID-19 vaccine in patients with autoimmune rheumatic diseases (ARD). However, large-scale data about the association between vaccination, and COVID-19 outcomes in patients with ARD is limited. METHODS: We used data from Clalit Health Services, which covers more than half of the population in Israel. Patients with ARD older than 18 were included between 20 December 2020 and 30 September 2021, when the BNT162b2 mRNA COVID-19 vaccine, and later a third booster dose, were available. The primary outcome was a documented positive SARS-CoV-2 PCR test. We used a Cox regression models with vaccination status as time-dependent covariate and calculated the HR for the study outcome. RESULTS: We included 127 928 patients with ARD, of whom, by the end of the study follow-up, there were 27 350 (21.3%) unvaccinated patients, 31 407 (24.5%) vaccinated patients and 69 171 (54.1%) patients who also received a third booster-dose. We identified 8470 (6.6%) patients with a positive SARS-CoV-2 PCR test during the study period. The HR for SARS-CoV-2 infection among the vaccination group was 0.143 (0.095 to 0.214, p<0.001), and among the booster group was 0.017 (0.009 to 0.035, p<0.001). Similar results were found regardless of the type of ARD group or antirheumatic therapy. CONCLUSION: Our results indicate that both the BNT162b2 mRNA COVID-19 vaccine and the booster are associated with better COVID-19 outcomes in patients with ARD.

Intensive care unit capacity and mortality in older adults: a three nations retrospective observational cohort study.

BACKGROUND: Intensive care unit (ICU) admissions among older adults are expected to increase, while the benefit remains uncertain. The availability of ICU beds varies between hospitals and between countries and is an important factor in the decision to admit older adults in the ICU. We aimed to assess if a non-restrictive approach to ICU older adults admission is associated with a corresponding change in survival. METHODS: Retrospective cohort study that included patients ≥ 80 years who were admitted to each of the three participating hospitals in Australia, Israel, and the United States (USA), between the years 2006-2015, each with distinct ICU capacities and admission criteria. The primary outcomes were in-hospital mortality and all-cause mortality at 6, 12, 18, and 24 months following index hospitalization. RESULTS: The cohort included 62,866 patients with a mean age of 85.9 ± 4.6 years and 58.8% were women. The ICU admission rates were 22.5%, 2.6% and 2.3% in USA, Australia, and Israel, respectively. We constructed a model for ICU admissions based on the USA cohort (highest availability of ICU beds) and then calculated the expected probabilities for the Israeli and Australian cohorts. For the patients in the highest quintile of the admission model, actual ICU admission rates were 67.6% in USA, 22.1% in Australia and 6.0% in Israel. Of these, in-hospital death rates were 52.3% in Israel, 29.8% in Australia, and 22.1% in USA. Two years after hospital discharge, the survival rates in the USA and Australia were 53%, while in Israel 48%. CONCLUSION: ICU admission of adults ≥ 80 years is associated with increased in-hospital survival compared to ward admission, but survival rates 2 years later are similar.

Fecal microbiota transplant as a potential treatment for Parkinson's disease - A case series.

OBJECTIVE: We aimed to determine whether fecal microbiota transplant (FMT) is safe and possibly efficacious in treating constipation, motor, and non-motor symptoms in Parkinson's disease (PD) patients. METHODS: Patients with PD, constipation and an indication for screening colonoscopy were treated with FMT. The study was conducted from December 2017 to November 2019, and clinical outcomes assessing motor, non-motor and constipation symptoms were compared at baseline (week 0) and at 2, 4, 8, 12, 16, 20, and 24 weeks after the FMT. RESULTS: Six patients (3 men, age range 47-73, median age 52) were treated with FMT. Four weeks following the FMT, motor, non-motor and constipation scores were improved in 5 of 6 patients. At week 24, compared to before the FMT, the changes in motor scores ranged from - 13-7 points, in non-motor scores from - 2 to - 45 points, and in constipation scores from - 12-1 point. One patient had a serious adverse event requiring admission for observation only, and no adverse events were observed in all other patients. CONCLUSIONS: In this preliminary uncontrolled case series of 6 PD patients, a treatment with donor FMT infused via colonoscopy, was safe and resulted in improvement of PD motor and non-motor symptoms, including constipation, at 6 months. Further research is needed to assess longer-term maintenance of efficacy and safety, including in large scale randomized controlled trials. TRIAL REGISTRATION: ClinicalTrials.gov - NCT03876327.

Examination of the association of steroids with fluid accumulation in critically ill patients, considering the possibility of biases.

Glucocorticoids might have significant influence on positive fluid balance, mostly due to their mineralocorticoid effect. We assessed the association between glucocorticoid therapy and fluid balance in septic patients, in the intensive care unit (ICU). We considered two definitions of exposure: daily exposure to glucocorticoids and glucocorticoid treatment at any time. Of 945 patients, 375 were treated with glucocorticoids in the ICU. We applied four regression models. In the first, fluid balance did not differ during days with and without glucocorticoid treatment, among patients treated and not treated with glucocorticoids in the ICU. In our second model, daily fluid balance was increased in patients who were ever treated with glucocorticoids during their ICU stay compared to untreated patients. In the third model, which included only patients treated with glucocorticoids during their ICU stay, glucocorticoid treatment days were not associated with daily fluid balance. In the last model, on "steroid-free days", patients who received glucocorticoid treatment during their ICU stay had a positive fluid balance compared to those who were never treated with steroids. Despite their known mineralocorticoid activity, glucocorticoids themselves appear not to contribute substantially to fluid retention. This work highlights the importance of precise selection of variables to mitigate biases.

Cannabis is associated with blood pressure reduction in older adults - A 24-hours ambulatory blood pressure monitoring study.

BACKGROUND: Medical cannabis use is increasing rapidly in the past several years, with older adults being the fastest growing group. Nevertheless, the evidence for cardiovascular safety of cannabis use is scarce. The aim of this study was to assess the effect of cannabis on blood pressure, heart rate, and metabolic parameters in older adults with hypertension. METHODS: We conducted a prospective study of patients aged 60 years or more with hypertension and a new prescription of cannabis. We have performed the following assessments: 24-hours ambulatory blood pressure monitoring, ECG, blood tests, and anthropometric measurements prior to the initiation of cannabis therapy and 3 months afterward. The primary outcome was change in mean 24-h blood pressure at 3 months. RESULTS: Twenty-six patients with a mean age of 70.42 ± 5.37 years, 53.8% females completed the study. At 3 months follow-up, the mean 24-hours systolic and diastolic blood pressures were reduced by 5.0 mmHg and 4.5 mmHg, respectively (p<0.001 for both). The nadir for the blood pressure and heart rate was achieved at 3 hours post-administration. The proportion of normal dippers changed from 27.3% before treatment to 45.5% afterward. No significant changes were seen in the different metabolic parameters assessed by blood tests, anthropometric measurements, or ECG exam. CONCLUSION: amongst older adults with hypertension, cannabis treatment for 3 months was associated with a reduction in 24-hours systolic and diastolic blood pressure values with a nadir at 3 hours after cannabis administration.

Factor VII Deficiency in Patients Receiving Chronic Packed Cell Transfusions.

Acquired factor VII deficiency is a rare coagulopathy that has not been reported in transfusion-dependent patients so far. In this study, we reviewed files of 26 transfusion-dependent patients for coagulation profiles, factor V levels, factor VII levels, possible environmental factors influencing factor VII levels, and bleeding history. In 26 of 29 patients (89.6%), we found mild factor VII deficiency (<60%) with levels ranging between 35% and 56%. Bleeding history was unremarkable. We concluded that transfusion-dependent patients may have mild factor VII deficiency with no bleeding tendency under physiologic conditions.

A Randomized Clinical Trial of Linagliptin vs. Standard of Care in Patients Hospitalized With Diabetes and COVID-19.

Objective: To assess the effect of linagliptin vs. standard therapy in improving clinical outcomes in patients hospitalized with diabetes and coronavirus disease 2019 (COVID-19). Materials and Methods: We did an open-label, prospective, multicenter, randomized clinical trial in 3 Israeli hospitals between October 1, 2020, and April 4, 2021. Eligible patients were adults with type 2 diabetes mellitus and a diagnosis of COVID-19. A total of 64 patients, 32 in each group, were randomized to receive linagliptin 5 mg PO daily throughout the hospitalization or standard of care therapy. The primary outcome was time to clinical improvement within 28 days after randomization, defined as a 2-point reduction on an ordinal scale ranging from 0 (discharged without disease) to 8 (death). Results: The mean age was 67 ± 14 years, and most patients were male (59.4%). Median time to clinical improvement was 7 days (interquartile range (IQR) 3.5-15) in the linagliptin group compared with 8 days (IQR 3.5-28) in the standard of care group (hazard ratio, 1.22; 95% CI, 0.70-2.15; p = 0.49). In-hospital mortality was 5 (15.6%) and 8 (25.0%) in the linagliptin and standard of care groups, respectively (odds ratio, 0.56; 95% CI, 0.16-1.93). The trial was prematurely terminated due to the control of the COVID-19 outbreak in Israel. Conclusions: In this randomized clinical trial of hospitalized adult patients with diabetes and COVID-19 who received linagliptin, there was no difference in the time to clinical improvement compared with the standard of care. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT04371978.

A Simulation-Based Prospective Cohort Study on Teaching Best Practices in Firearms Safety.

BACKGROUND: Gun violence in the United States is a significant public health concern. The high rate of weapons carriage by Americans places medical providers at risk for exposure to firearms in the workplace and provides an opportunity for patient safety counseling. Few curricular interventions have been published on teaching firearms safety principles to medical providers. Given the risk of encountering firearms in the workplace and the opportunity to engage patients in firearms safety counseling, providers may benefit from dedicated training on safely handling firearms. METHODS: This was a prospective cohort pilot study of a simulation-based educational intervention for third- and fourth-year medical students enrolled in an emergency medicine subinternship and emergency medicine bootcamp elective. Before undergoing the educational intervention, students completed a preintervention simulation case during which they discovered a model firearm in the patient's belongings and were asked to remove it. Students then received the intervention that included a discussion and demonstration on how to safely remove a firearm in the clinical setting. Two weeks later, the students were presented with a model firearm in a different simulation case, which they needed to remove. During the preintervention and postintervention simulations, students were evaluated on their performance of the critical actions in firearm removal using an 8-item checklist. Students' scores on this checklist were compared. RESULTS: Fifty-three students participated in the study, 25 of whom completed the postintervention assessment. The median number of correctly performed critical actions preintervention was 5 (interquartile range = 4-6) and postintervention was 7 (interquartile range = 6-8, P < 0.001). Students showed particular improvement in 4 steps: holding the firearm by the grip only, pointing the firearm in a safe direction at all times, removing the firearm from the immediate patient care area and placing it in a safe area, and ensuring that the firearm is monitored and untouched until police or security personnel arrive to secure it. CONCLUSIONS: This educational intervention is the first to formally teach students about the safe handling of firearms found in the clinical care space. This low-cost pilot project is easily transferrable to other training centers for teaching principles of safe firearms handling.