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Evaluating the Effectiveness of Pegbelfermin in MASH-Associated Hepatic Fibrosis A Meta-Analysis and Systematic Review of Randomized Controlled Trials
No full textINTRODUCTION: Metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease, is characterized by liver inflammation and fibrosis, with an emerging interest in fibroblast growth factor (FGF)-21 analogs, particularly pegbelfermin (PGBF). This study evaluates the efficacy and safety of PGBF in treating MASH-associated hepatic fibrosis.
METHODS: This meta-analysis followed Cochrane guidelines and PRISMA standards. A comprehensive search of databases up to January 2023 focused on randomized controlled trials (RCTs) comparing PGBF to placebo for MASH. Meta-analyses were performed with RevMan 5.4 using a random-effects model.
RESULTS: Data from 452 participants across three RCTs were analyzed. Significant improvements in adiponectin concentration were observed in both the 10 mg [MD = 18.23, 95% CI (6.35, 30.11), p = 0.003] and 20 mg [MD = 18.09, 95% CI (5.88, 30.31), p = 0.004] PGBF groups compared to placebo. Significant reductions in PRO-C3 concentration were noted in both the 10 mg [MD = -25.50, 95% CI (-43.95, -7.05), p = 0.007] and 20 mg [MD = -19.54, 95% CI (-33.33, -5.76), p = 0.005] groups. Significant improvement in MASH was seen in the 10 mg group [RR = 2.84, 95% CI (1.18, 6.78), p = 0.02] but not in the 20 mg group. No significant improvements in liver stiffness, Modified Ishak scores, collagen proportionate area, ALT and AST levels, or treatment-emergent adverse events (TEAEs) were observed in either dosage group.
CONCLUSIONS: Pegbelfermin, a promising therapy for MASH fibrosis, has demonstrated effectiveness at 10 mg, significantly improving MASH and biomarkers including adiponectin and PRO-C3, while maintaining a generally safe profile
Impact of frailty on outcomes and biliary drainage strategies in acute cholangitis: A retrospective cohort analysis
No full textBACKGROUND: Acute cholangitis (AC) is a potentially fatal infection of the biliary tract characterized by varying degrees of severity, with endoscopic retrograde cholangiopancreatography (ERCP) serving as the primary drainage modality. Though frailty is linked to poor outcomes in general, its implications for AC patients remain unexplored.
METHODS: Using the National Inpatient Sample Database 2017-2020, we identified adult AC hospitalizations, which were further stratified based on frailty. A multivariate regression model was used for analysis.
RESULTS: We included 32,310 AC patients, out of whom 11,230 (34.76 %) were frail. Frail patients had elevated AC severity as well as in-hospital mortality (adjusted odds ratio [aOR] 6.89; P \u3c 0.01). Additionally, frail patients were found to have significantly higher odds of complications including septic shock (aOR 15.87), acute renal failure (aOR 5.67), acute respiratory failure (aOR 11.11) and need for mechanical ventilation (aOR 13.80). From a procedural viewpoint, frail patients had higher odds of undergoing percutaneous biliary drainage (PBD) but lower odds of undergoing early ERCP (ERCP within 24 h of admission). When compared to non-frail counterparts, frail patients were more likely to undergo PBD as opposed to early ERCP (aOR 1.46; P = 0.01).
CONCLUSION: Frailty independently predicts poor AC outcomes and has a notable impact on the choice of biliary drainage procedure. Recognizing frailty instead of age alone as a determinant of AC outcomes can aid clinicians in risk stratification and guide tailored interventions in this population
Implementation of Office-Based Procedures in Large Institutions
No full textThis article discusses the background of office-based procedures in otolaryngology, including definitions of important terms related to office-based procedures. Using a framework of safety, functional logistics, and economics, this article can serve as a guide for how to implement office-based procedures at a large institution
The impact of trauma and how to intervene: a narrative review of psychotraumatology over the past 15 years
No full textTo mark 15 years of the European Journal of Psychotraumatology, editors reviewed the past 15-year years of research on trauma exposure and its consequences, as well as developments in (early) psychological, pharmacological and complementary interventions. In all sections of this paper, we provide perspectives on sex/gender aspects, life course trends, and cross-cultural/global and systemic societal contexts. Globally, the majority of people experience stressful events that may be characterized as traumatic. However, definitions of what is traumatic are not necessarily straightforward or universal. Traumatic events may have a wide range of transdiagnostic mental and physical health consequences, not limited to posttraumatic stress disorder (PTSD). Research on genetic, molecular, and neurobiological influences show promise for further understanding underlying risk and resilience for trauma-related consequences. Symptom presentation, prevalence, and course, in response to traumatic experiences, differ depending on individuals\u27 age and developmental phase, sex/gender, sociocultural and environmental contexts, and systemic socio-political forces. Early interventions have the potential to prevent acute posttraumatic stress reactions from escalating to a PTSD diagnosis whether delivered in the golden hours or weeks after trauma. However, research on prevention is still scarce compared to treatment research where several evidence-based psychological, pharmacological and complementary/ integrative interventions exist, and novel forms of delivery have become available. Here, we focus on how best to address the range of negative health outcomes following trauma, how to serve individuals across the age spectrum, including the very young and old, and include considerations of sex/gender, ethnicity, and culture in diverse contexts, beyond Western, Educated, Industrialized, Rich, and Democratic (WEIRD) countries. We conclude with providing directions for future research aimed at improving the well-being of all people impacted by trauma around the world. The 15 years EJPT webinar provides a 90-minute summary of this paper and can be downloaded here [http://bit.ly/4jdtx6k]
A Prospective Ultrasound Study of Whole Blood Metals and Incidence of Uterine Leiomyomata
No full textBACKGROUND: Uterine leiomyomata (UL), hormone-dependent neoplasms, are a major source of gynecologic morbidity. Metals are hypothesized to influence UL risk through endocrine disruption, and their effects may vary by vitamin D status.
OBJECTIVE: We estimated associations of a metal mixture with incident UL, overall and by vitamin D status.
METHODS: We analyzed data from the Study of Environment, Lifestyle and Fibroids, a Detroit-area prospective cohort study of 1,693 Black women aged 23-35 years. We measured concentrations of 17 metals/metalloids in whole blood and 25-hydroxyvitamin D (25[OH]D) in serum collected at baseline (2010-2012). Participants underwent ultrasonography at baseline and after 20 months to detect UL. We used Bayesian Kernel Machine Regression to estimate adjusted associations (β) of the metal mixture with probit of incident UL. We also ran Cox regression models with interaction terms to estimate incidence rate ratios (IRR) by vitamin D status.
RESULTS: Among 1,132 UL-free participants at baseline, 832 (73%) had vitamin D deficiency (25[OH]D\u3c 20 ng/mL) and 117 (10%) developed UL within 20 months. Increasing all metals from their 50(th) to 75(th) percentiles was weakly positively associated with UL overall (β=0.06, 95% credible interval [CrI]: -0.03, 0.16) and among vitamin D-deficient participants (β=0.13, 95% CrI: 0.01, 0.24), driven by cadmium (overall and vitamin D-deficient) and mercury (vitamin D-deficient only). Increasing cadmium from its 25(th) to 75(th) percentile was positively associated with UL overall (β=0.03, 95% CrI: -0.05, 0.11) and among vitamin D-deficient participants (β=0.13, 95% CrI: 0.02, 0.24). In Cox models, cadmium (IRR=1.55, 95% confidence interval [CI]: 1.07, 2.24, per 1-unit increase in standardized concentration) and mercury (IRR=1.38, 95% CI: 0.99, 1.92) were positively associated with UL among vitamin D-deficient participants.
DISCUSSION: The metal mixture was positively associated with incident UL, but the association was weak and imprecise. We observed a stronger association among vitamin D-deficient participants that was driven by cadmium and mercury
Return to intended oncologic treatment: Definitions, perioperative prognostic factors, and interventions
No full textIn the cancer survivorship journey, many patients require both medical and surgical oncologic treatments to improve survival. The return to intended oncologic treatment (RIOT) is a relatively new concept addressing the continuity of cancer treatment after surgery. While general definitions have been published, thresholds and minimal clinically important differences (MCID) have not been standardised. For many cancers, a threshold for delayed RIOT is 6–8 weeks, while the MCID in colorectal cancer may approximate 4 weeks. Studies addressing RIOT have shown multiple demographics, socioeconomic, institutional, surgical, and postoperative factors associated with a difference in rate and time to RIOT. The most influential of these variables is the surgical approach. While research on the effect of enhanced recovery after surgery on RIOT has increased, the literature is still in its early stages. Finally, the effect of anaesthetic interventions on RIOT has been largely unexplored
Objective Assessment of Skill Retention 7 Months Post-Training: Motion Analysis of Central Venous Catheter Placement
No full textBACKGROUND: Central venous catheter (CVC) placement is a technically challenging skill. Routine assessment tools, including checklists and global rating scales, require subjective expert evaluation. We hypothesized that motion analysis could be used to objectively assess skill retention in CVC placement by comparing the performance of anesthesiology residents immediately after training and 7 months later.
METHODS: After learning to perform CVC placement on a mannikin, 12 first-year anesthesiology residents each performed a baseline trial with electromagnetic motion sensors on the dorsum of their dominant hand and base of their ultrasound probe. Seven months later, they each performed a follow-up mannikin trial with an identical setup. For each trial, sensors recorded participants\u27 path length, translational motions, and rotational sum. Time was recorded for each trial as well. We defined skill retention as performance within 1 standard deviation or less of the entire cohort\u27s average at baseline (threshold). We compared the number of residents who met the threshold, which indicated less excessive motion and therefore better performance, at baseline with the number at follow-up using McNemar\u27s test across each metric for each sensor.
RESULTS: For path length, translational motions, and rotational sum of the probe, significantly more residents met the threshold at baseline than at follow-up (P \u3c .04). No significant differences were detected for any metrics of the dorsum or time.
CONCLUSIONS: Motion analysis can objectively assess skill decay in anesthesiology residents performing CVC placement. Residents exhibited skill retention in tasks involving their dominant hand and skill decay in tasks involving the ultrasound probe (nondominant hand)
Health Care Resource Utilization for Patients With Suspected Myocardial Infarction: A Secondary Analysis of the RACE-IT Randomized Clinical Trial
No full textIMPORTANCE: Evaluation for myocardial infarction (MI) in emergency departments (EDs) is a common, resource-intensive process. High-sensitivity cardiac troponin I (hs-cTnI) assays have become a key tool in rapidly ruling out MI, with the potential to reduce health care resource utilization.
OBJECTIVE: To determine whether a 0-hour and 1-hour (hereafter referred to as 0/1-hour) hs-cTnI accelerated protocol reduces health care resource utilization compared with a traditional 0/3-hour standard care protocol for MI exclusion in the ED.
DESIGN, SETTING, AND PARTICIPANTS: This is a prespecified secondary analysis of the RACE-IT trial, a stepped-wedge randomized clinical implementation trial conducted across 9 EDs in Michigan. The trial enrolled 32 608 consecutive ED patients evaluated for suspected MI between July 8, 2020, and April 3, 2021. Statistical analysis was conducted from July 10 to September 5, 2024.
INTERVENTIONS: The 0/1-hour hs-cTnI accelerated protocol for MI exclusion was compared with the traditional 0/3-hour standard care protocol.
MAIN OUTCOMES AND MEASURES: Main outcomes were ED discharge to home, ED length of stay, rates of cardiac stress testing, cardiology consultation, left heart catheterization, and cardiac revascularization within 30 days.
RESULTS: A total of 32 608 patients (median age, 59 years [IQR, 45-71 years]; 18 705 women [57.4%]) were included in the analysis. The rate of ED discharge to home was 58.0% for the accelerated protocol group (11 082 of 19 103) and 59.8% for the standard care group (8070 of 13 505) (adjusted odds ratio [AOR], 1.05; 95% CI, 0.95-1.15). The accelerated protocol group showed significant reductions in the odds of cardiac stress testing (3.3% [623 of 19 103] vs 3.9% [526 of 13 505]; AOR, 0.62; 95% CI, 0.49-0.78), cardiology consultations (8.6% [1640 of 19 103] vs 12.2% [1651 of 13 505]; AOR, 0.57; 95% CI, 0.49-0.67), and left heart catheterization rates (1.0% [198 of 19 103] vs 1.2% [167 of 13 505]; AOR, 0.65; 95% CI, 0.43-0.99) compared with the standard protocol group. The median ED length of stay decreased by 20 minutes (IQR, 18-24 minutes) in the accelerated protocol group, with no significant change in revascularization rates.
CONCLUSIONS AND RELEVANCE: This secondary analysis of a randomized clinical trial of a 0/1-hour hs-cTnI protocol to rule out MI in the ED found that there was a reduction in cardiac evaluations and ED length of stay without increasing revascularization rates compared with the standard 0/3-hour hs-cTnI protocol. This approach could optimize health care resources in EDs.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04488913
Impact of Chronic Total Occlusion PCI in Non-LAD Coronary Arteries on Patients With Cardiomyopathy
No full textTo evaluate the impact of left circumflex artery (LCX) or right coronary artery (RCA) chronic total occlusion percutaneous coronary intervention (CTO PCI) on left ventricular ejection fraction (LVEF) in heart failure patients with reduced ejection fraction (HFrEF). The effect of RCA or LCX CTO PCI on HFrEF patients remains understudied. We conducted a retrospective analysis of patients with HFrEF (EF \u3c 40%) who underwent LCX or dominant RCA CTO PCI at a high-volume center. The primary outcome was LVEF change, while secondary outcomes included in-hospital and long-term major adverse cardiovascular events (MACE). Subgroup analyses assessed the influence of myocardial viability testing and optimal heart failure therapy (OHFT) on LVEF change. From December 2014 to February 2022, 111 HFrEF patients underwent non-LAD CTO PCI, with a 93.6% technical success rate and 5.4% in-hospital MACE rate. At a median 27.4-month follow-up, LVEF significantly improved by 8.2% (95% CI 5.9% to 10.7%, p \u3c 0.001). RCA CTO PCI led to a 9.6% LVEF increase (95% CI 6.7% to 12.6%, p \u3c 0.001), while LCX PCI resulted in a 5.6% improvement (95% CI 1.3% to 9.8%, p = 0.011). Preprocedure viability testing (p = 0.310) and postprocedural OHFT (defined as three classes of guideline-directed medical therapy, p = 0.673) were not significantly associated with LVEF changes. Non-LAD CTO PCI significantly improved LVEF (8.2%) in HFrEF patients over 2 years, regardless of preprocedure viability testing or postprocedural medical therapy
