Oral vancomycin is not associated with meaningful changes in liver-related endpoints among adults with primary sclerosing cholangitis: A randomized, placebo-controlled trial
Introduction: Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease without approved medical therapies. We examined the efficacy and safety of oral vancomycin (OV) in those with PSC. Methods: In this phase 3, 18-month, double-blind, placebo-controlled trial, we randomly assigned adults with PSC and a serum alkaline phosphatase (SAP) greater than 1.5 times the upper limit of normal to placebo or oral vancomycin (OV) with dosages ranging from 125-375 mg four times daily pending biochemical response. The primary endpoint was normalization of SAP. Results: Of the 82 patients who underwent randomization, 73 individuals had at least one outcome assessment. Individuals who withdrew early were less likely to rate their baseline health as excellent or very good (23.4% vs 54.5%, p<0.01) despite having similar PSC prognostic features to those who completed the study. SAP normalization rates were similar (5% placebo, 6.7% OV, p=1.00) after 18 months. Those who received OV had greater reduction in SAP (+1.2% placebo, -21.9% OV, p=0.03). There were no differences in the changes in either the Mayo PSC risk score (-0.1 placebo, -0.1 OV, p=0.88) or liver stiffness values (+0.1 kPa placebo, -4.0 kPa OV, p=0.15). Discoloration of the teeth and tongue was the most common side effect of OV (17.5%). Conclusions: OV was not associated with clinically significant reductions in markers of PSC disease severity. Impairments in quality of life may influence patient retention in clinical trials.
Comparison of Artificial Intelligence to Traditional Patient Education in Obstetrics and Gynecology: A Randomized Cross-Sectional Study [ID 1103]
INTRODUCTION: Online patient education materials are essential in improving access to and understanding of clinical information. Artificial intelligence (AI), specifically ChatGPT, offers a novel way to synthesize complex information and is increasingly being used for patient education, including in obstetrics and gynecology. This study compares the understandability and actionability of patient education materials about hysterectomy and uterine fibroids generated by ChatGPT with those published by the American College of Obstetricians & Gynecologists (ACOG). METHODS: In a randomized cross-sectional study, participants were allocated to one of four groups: ACOG–Fibroids, ChatGPT–Fibroids, ACOG–Hysterectomy, or ChatGPT–Hysterectomy. The ACOG groups reviewed the corresponding ACOG FAQ webpage, while the ChatGPT groups reviewed responses generated by ChatGPT to the same FAQs. Participants then completed demographic questions and the Patient Education Materials Assessment Tool (PEMAT). The primary outcome was the equivalence of PEMAT scores between ACOG and ChatGPT. RESULTS: Equivalence was not demonstrated between ChatGPT and ACOG for either topic. For fibroid material, ACOG was rated higher on both understandability (86.3 versus 82.6 points, P =.039) and actionability (65.4 versus 53.2 points, P =.003) on superiority testing. For hysterectomy content, no significant difference was observed. No interaction was found between material type and either education level or personal history of fibroids/hysterectomy. CONCLUSIONS/IMPLICATIONS: PEMAT scores for ACOG were superior to ChatGPT for fibroid content, but neither equivalent nor superior for hysterectomy content. While ChatGPT offers a responsive, iterative source of information, its understandability and actionability may depend on topic-specific factors, highlighting both the promise and limitations of AI for patient education.
Military-Civilian Partnership to Advance Standards of Performance for Simulated Combat Trauma Medical Skills: Validation of Competency Thresholds
Abstract Introduction Combat casualty care requires standardized proficiency criteria to ensure readiness in austere environments, yet gaps persist in defining performance thresholds for critical trauma skills. The Combat Medical Skills Sustainment Consortium (CMSSC), a novel military-civilian collaboration, aimed to validate competency thresholds for 21 Department of Defense-identified trauma skills. Materials and Methods A prospective cohort study (2022-2025) enrolled 1,495 military and civilian personnel across five academic centers, stratified by experience (novice, intermediate, expert). Skills, including cricothyroidotomy, whole blood transfusion, and ultrasound-guided vascular access, were assessed using validated checklists in Role 2-congruent simulations. Statistical analysis compared checklist performance against participant experience with a priori checklist scores estimated at 40% (novices) and 90% (experts). Results Competency thresholds were established, ranging from 77% (mechanical ventilation) to 100% (handoff). Experts achieved 85%-98% proficiency across most skills, with novices at 34%-97%. A ceiling effect was observed for less complex skills consistent with the power law of practice. Conclusion The Combat Medical Skills Sustainment Consortium validated standardized assessment tools, with potential to address readiness gaps through military-civilian synergy. Findings support consortium-guided curriculum development and highlight the need for longitudinal skill decay studies. Impact This study sets a benchmark for trauma care skills assessment, facilitating rapid adoption across military and civilian settings.
(149) 49,422 QUICK QUESTIONS: CHARACTERIZING THE PATIENT MESSAGE BURDEN OF A MEN’S HEALTH PRACTICE
Abstract Introduction The Electronic Medical Record (EMR) has had a positive impact on healthcare but it has also increased administrative burden on physicians. One reason for this is the patient portal, which grants patients 24/7 access to ask their physician questions. Objective To characterize the patient message volume of urologists with a Men’s Health Practice by quantifying message volume per case, identifying procedures linked to high message volume, and examining demographics affecting patient portal use. We then assess the clinical utility of patient portal messages by examining their effect on Emergency Department (ED) utilization. Methods We queried the EMR of a health system spanning the southeast, midwest, and southwest using internal procedure and surgical codes for all office and operating room based urologic procedures from March 2017-November 2023. We identified procedures related to Men’s Health focusing on andrology, sexual medicine, and male reconstructive procedures. Patients identifying as women, those with multiple procedures within 6 months, and patients without research authorization were excluded. To identify factors associated with active portal users and message volume, we performed univariate and multivariable logistic and linear regression models. Multivariable models consisted of all statistically significant factors on univariate analysis. In models utilizing the procedure variable to compare message volume, vasectomy was chosen as the reference procedure due to it having the highest case volume. To assess the impact of active portal use (defined as sending at least 1 message within 6 months of their procedure) on risk of subsequent ED visit, we performed univariate Kaplan–Meier analysis and univariate and multivariable Cox Proportional Hazard models treating portal use as a time-dependent covariate. Results We examined 16,299 procedures which generated 49,422 messages within 6 months of their procedure (Table 1). Demographic data can be seen in table 2. On average, 3.04 ± 6.88 messages were generated after each procedure. The highest message generating procedures were testosterone Injection/pellets (5.83 ± 9.57), Itind (5.73 ± 14.18), and Transurethral Incision of the Prostate (5.19 ± 13.19). The lowest message generating procedures were vasectomy (1.30 ± 3.10), spermatocelectomy (1.67 ± 3.80), and circumcision (2.32 ± 5.26). The types of cases that generated the highest overall message burden were male reconstructive procedures (4.53 ± 8.57) and BPH procedures (4.07 ± 8.40) and. Slightly less than half of our cohort were active on the portal (45%) within 6 months of their procedure (Table 1). The procedures that were the most likely to have active portal users were microtese (OR 5.03 95% CI 2.38,10.67), testosterone injection/pellets (OR 4.86 95% CI 3.13, 7.54), and Itind (OR 3.02 95% CI 2.16, 4.24). On time to event analysis we found that portal usage decreased the risk of presenting to the Emergency Department (ED) by 15% within 90 days of their procedure [HR (95% CI) 0.65 0.85 (0.77, 0.93)] (Fig. 1). Conclusions Urologists practicing Men’s Health receive a high number of messages per procedure that they perform, however the use of the patient portal reduces ED utilization. Resources should be allocated to help urologists manage their patient messages as it lowers healthcare costs. Disclosure No.
A Tale of 102,726 Messages: Characterizing the Modern Urologist's Portal Message Burden After Common Urologic Surgeries
ABSTRACTBackgroundAlternate complement dysregulation postrenal transplantation can result in thrombotic microangiopathy (TMA). There is a scarcity of data regarding outcomes based on the timing of TMA post‐transplant, coupled with a lack of follow‐up biopsy findings post TMA diagnosis. This study aims to assess allograft and patient outcomes in individuals developing early TMA, defined within 4 months post‐transplantation, and explore any differences in follow‐up surveillance biopsies compared to a non‐TMA group.DesignThis is a single center retrospective study between January 1, 2002 and October 10, 2019. Patients who developed TMA within 4 months post‐transplantation were compared to a propensity matched non‐TMA group.ResultsThirty‐one patients developed TMA within 4 months of renal transplantation. Index TMA biopsy featured noticeable glomerular, and vascular lesions along with acute tubular injury. Four‐month surveillance biopsy showed significant glomerulitis, transplant glomerulopathy and chronic interstitial fibrosis as compared to non‐TMA group. However, at 1 year, these differences were no longer significant. There was no significant difference in patient survival (TMA vs. non‐TMA,p = 0.083); however, death censored graft survival was significantly lower in the TMA group (p < 0.001). TMA patients had a significantly lower estimated glomerular filtration rate at 4 months and at 1 year as compared to the non‐TMA group.ConclusionEarly onset TMA post renal transplant leads to decreased renal function and lower graft survival. Early recognition and prompt treatment may help in reducing the adverse outcomes.