Citations

Frequently overlooked yet clinically significant, the urachus can exhibit a diverse range of pathologic conditions, which can pose a diagnostic challenge at imaging for the radiologist and which require a thorough understanding of urachal embryogenesis.

Abstract Aims To investigate the cost‐effectiveness of early initiation of metformin and usual care for gestational diabetes mellitus (GDM). Methods Economic evaluation from a healthcare perspective, based on the EMERGE randomised controlled trial. In total, 535 women with GDM were randomised to placebo in addition to usual care or metformin in addition to usual care. Economic outcomes included incremental healthcare costs and quality adjusted life years ( QALYs ) and expected cost‐effectiveness at cost‐effectiveness threshold values of €20,000, €45,000 and €100,000 per QALY gained. Uncertainty was explored using parametric, non‐parametric, deterministic and probabilistic methods and heterogeneity using subgroup analysis. Results On average, relative to the placebo arm, the early metformin arm was associated with non‐statistically significant mean increases of €193.07 (95% CI : −€789.88, €1176.01; p = 0.700) and 0.002 QALYs (95% CI : −0.009, 0.013; p = 0.771). In terms of expected cost‐effectiveness at threshold values of €20,000, €45,000 and €100,000 per QALY gained, the probability of the early metformin arm being more cost‐effective was estimated at 0.423, 0.452 and 0.524. Exploratory subgroup analyses provided more favourable but not definitive evidence in favour of the early metformin arm for cohorts with previous GDM and previous caesarean section. Conclusions We do not find definitive evidence that early initiation of metformin in addition to usual care for GDM was more cost‐effective than usual care alone. The clinical and economic evidence may be considered equivocal, but worthy of further examination.

Abstract Objectives Oral extraintestinal manifestations (OEIMs) of inflammatory bowel disease (IBD) may impact IBD treatment. The aims of this study were to: (1) determine which OEIMs are most prevalent among patients with IBD, (2) investigate the presence of a temporal association between GI luminal disease activity and OEIMs, and (3) determine how often changes in therapeutic management of IBD are needed in the presence of OEIMs. Study Design A retrospective cohort study was performed for adult patients with IBD evaluated between January 2017 and November 2021 with at least 1 oral complaint. Demographic data were collected from the charts of these patients. Kruskal-Wallis test for continuous measures and Fisher’s Exact test for categorical measures were used. Results A total of 116 patients with IBD who had presented with at least 1 oral finding during the study time period were identified. Aphthous ulcers were the most common oral presentation in both Crohn’s disease (CD) (85.1%) and ulcerative colitis (UC) (75.0%). OEIMs were associated with CD activity in the small intestine (P = .004) and colon (P < .001). UC pancolitis was associated with OEIMs (P = .002). In 32.7% of patients, OEIMs led to either an increase in dose or frequency of IBD therapy. In an additional 16.4% of patients, new systemic agents were started because of the OEIMs. Conclusions This study provides evidence that patients with IBD may develop OEIMs synchronous with IBD flares and may require escalation of IBD therapy when OEIMs occur.

Objectives/Goals: The operation of a clinical trials unit involves multifaceted tasks and stakeholders. A competent information system is critical to daily operations while ensuring smooth conduct of clinical research. We share 15 years of experience in the design and implementation of such a system at Mayo Clinic to inform other institutions with similar interests. Methods/Study Population: The Informatics team collaborated closely with nurse leaders and elicited input from additional stakeholders including nurse unit coordinators, lab managers, schedulers, investigators, study coordinators, and regulatory specialists throughout the phases of system design, development and continuous enhancements, and expansion. The stakeholders offered insights on the corresponding requirements throughout the study life cycle, from engaging with the study sponsor, operational review for protocol execution, development of study budgets, human subject protection and risk mitigation, data management and integration, to outcome monitoring, and regulatory reporting. The activities were then translated into functional components and implemented as a seamless and effective solution. Results/Anticipated Results: Patient safety, scientific rigor, operation automation, efficiency, and regulatory requirements were all considered in developing an integrated system, or the clinical research trials unit (CRTU) Tools. Our institution has leveraged the system for essential tasks from the study start-up, visit scheduling and execution, specimen collection and tracking, to individual protocol metrics and billing. We adopted a measure-as-we-go methodology so that data such as visit census, resource usage, and protocol deviation are tracked and collected during routine use of the system. Specifically, an issues/concerns/exceptions (ICE) tool is used for quality control and patient safety. Moreover, data quality greatly benefits from a task dictionary, standardizing the study activities that can be ordered and executed. Discussion/Significance of Impact: The implementation of a well-rounded clinical trials unit information system not only improves the operation efficiency and team productivity but also ensures scientific rigor and contributes to patient safety. We believe the experience can be informative to other institutions. More details will be shared in the poster.

Abstract Enterocutaneous fistulas (ECF) are challenging to treat contributing to high morbidity and high mortality rates, significantly impacting the quality of life of the patients. Its susceptibility to antibiotic‐resistant infections often leads to chronic inflammation, complicating treatment with conventional methods. Here, 18NC75‐10P‐1IL is reported, which is a multi‐functional shear‐thinning hydrogel comprised of gelatin and nanosilicates for injectability, an ionic liquid for bactericidal effects, and platelet rich fibrin fraction for pro‐healing properties; this biomaterial is engineered for the treatment of ECFs. Through rigorous testing, the mechanical properties of 18NC75‐10P‐1IL were tailored for catheter injection to achieve durable occlusion of fistulous tracts under external pressures simulating clinical scenarios. 18NC75‐10P‐1IL demonstrated pro‐healing effects and anti‐microbial activity against highly resistant patient‐derived bacteria known to be associated with ECF. Subcutaneous implantation and anorectal fistula models confirmed its biocompatibility, pro‐healing, anti‐inflammatory, and anti‐microbial properties compared to control materials, suggesting promising potential for clinical translation in the treatment of human ECFs.

Case: Three cases of pediatric patients with knee injuries from cactus thorns are included. These cases are variable in presentation ranging from acute inflammatory responses to permanent limb deformity secondary to growth arrest. Definitive treatment also varied widely from nonoperative conservative management to multiple arthroscopic and open surgeries. Conclusion: Pediatric cactus thorn injuries have varied presentations, requiring a high level of clinical suspicion for diagnosis and treatment to prevent permanent damage.

Background: Underrepresented minority (URM) patients enroll in cancer clinical trials at low rates. We studied the perspectives of health care professionals to better understand the challenges and potential facilitators of recruiting URM patients into clinical trials. Methods: A purposeful sampling approach was utilized to recruit health care professionals and clinical research staff who recruited and cared for URM patients in a therapeutic cancer clinical trial at any Mayo Clinic site, from July 2018 through October 2021.Data were gathered using a semistructured qualitative interviews. Participants were interviewed about the challenges of recruiting URM patients into cancer clinical trials and possible strategies for improving URM patient enrollment. Data were analyzed using a thematic analysis. Results: Of the key themes that emerged from participant interviews ( n = 28), perceived barriers to recruiting URM patients into clinical trials included lack of workforce diversity, underutilization of patient navigators, ineffective community outreach and patient recruitment, restricted access to diverse patient populations, and restrictive clinical trial eligibility criteria. Other barriers reported were lack of insurance and access to care and transportation, low socioeconomic status, and mistrust of health care and research. Strategies suggested for improving the recruitment of URM patients into clinical trials included: diversifying and adding research staff, increasing and improving community outreach and advocacy, partnering with clinics closer to patients, increasing monetary and logistical support for patient participation, creating opportunities that build and enhance trust, and systematically examining and modifying clinical trial eligibility criteria. Conclusions: Our findings reveal barriers that have limited URM patient inclusion in cancer clinical trials and highlight strategies to overcoming these barriers.

Objective: To describe a step-by-step guide for successful implementation of transmeatal urethral surgery for obliterated membranous urethral strictures. Patient and Methods: The patient is placed in the dorsal lithotomy position. Cystoscopy will be performed through both the suprapubic tube above and transmeatally from below. A Libri rigid endoscopic needle will be passed under guidance, with placement of a 0.38 wire through the inner lumen. Subsequently, over the wire, a tiger tail catheter will be placed and the wire exchanged for a rigid sensor wire, over which a charger balloon will be passed and used for dilation. The Olympus resectoscope will be used to resect the area of the stricture. The RD180 from LSI solutions will be used to situate the graft over the area of the stricture. Results: Our number of cases is five, of which 4 have had no recurrence. The median follow-up is 6 months. We have three from radiation and two from pelvic fractures. In the radiation population, one patient did recur. However, he was not obliterated and has been voiding even though he has a 14 French urethra. Conclusion: This technique appears to be a safe and effective repair option for management of obliterated membranous urethra strictures. Author disclosure statement: J.N.W. is a consultant for Olympus. The other authors have no conflicts of interest to disclose. Authors have received and archived patient consent for video recording/publication in advance of video recording of procedure . Runtime of video: 7 min 38 sec.

Background: There are limited evidence-based guidelines to predict which osteochondritis dissecans (OCD) lesions will heal with nonoperative treatment. Purpose: To train a set of classification algorithms to predict nonoperative OCD healing while identifying new clinically meaningful predictors. Study Design: Case-control study; Level of evidence, 3. Methods: Patients with OCD of the knee with open physes undergoing nonoperative management were prospectively queried from the Research on OCD of the Knee (ROCK) cohort ( https://kneeocd.org ) in April 2022. Patients were included if they met the study criteria for nonoperative treatment success or failure. Nonoperative treatment success was defined as complete healing on magnetic resonance imaging (MRI) and total return to sports participation. Failure was defined as the crossover from nonoperative management to surgery at any point at or beyond the 3-month follow-up. If a patient did not meet one of these criteria, they were not included. Normalized lesion size, lesion location, patient characteristics, and symptoms were used as clinically relevant predictors. Results: A total of 64 patients were included, of whom 24 (37.5%) patients successfully healed with nonoperative management. Multivariate logistic regression revealed that a 1% increase in normalized lesion width was associated with an increase in the likelihood of nonoperative failure (odds ratio [OR], 1.41 [95% CI, 1.17-1.81]; P < .01). By contrast, lesions in the posterior sagittal zone (OR, 0.08 [95% CI, 0.009-0.43]; P < .01) or the medial-most coronal zone (for lesions of the medial femoral) and lateral-most coronal zone (for lesions of the lateral femoral condyle) on MRI (OR, 0.05 [95% CI, 0.004-0.44]; P < .01) were associated with a decrease in the likelihood of nonoperative treatment failure. Support vector machines had a cross-validated area under the receiver operating characteristic curve of 0.89 and a classification accuracy of 83.3%. Conclusion: Lesion location in the posterior aspect of the condyle on sagittal MRI and lesion location in the medial-most or lateral-most locations on coronal MRI were identified as statistically significant predictors of increased nonoperative treatment success on multivariate analysis. Machine learning models can predict which OCD lesions will heal with nonoperative management with superior accuracy compared with previously published models.