Sullivan, Shelby

Objective: An endoscopically placed duodenal-jejunal bypass liner (DJBL) may provide a safe adjunctive therapy for those with poorly controlled type 2 diabetes mellitus (T2DM) and obesity. Background: Although some endoscopic therapies have been shown to improve glycemic indices secondary to weight loss, small bowel interventions may have direct metabolic effects. A meta-analysis of observational studies demonstrated reduction in HbA1c by 1.3% at 1 year after DJBL in patients with T2DM and obesity. Methods: This was a multicenter, double-blind, randomized, sham-controlled trial comparing DJBL to sham procedure with medical management and lifestyle modification. Primary endpoints included mean difference in changes in HbA1c at 12 months between arms, and device-related serious adverse events (SAEs). Secondary endpoints included percent total weight loss (%TWL) and subjects achieving HbA1c≤7% and TWL≥5% at 12 months. Results: Three hundred twenty subjects were randomized to DJBL (n=212) and sham (n=108). Baseline HbA1c and BMI were 8.79±0.92% and 38.45±5.75 kg/m 2 . On modified intent-to-treat analysis, change in HbA1c at 12 months was −1.10±1.45% and −0.28±1.54% for DJBL and sham groups, respectively ( P =0.0004). Rate of device-related SAEs was 9.4% including intolerance (3.7%), hemorrhage (2.8%), and hepatic abscess (2.3% stopping study early). At 12 months, DJBL group experienced greater weight loss compared with sham (7.7±9.6% TWL and 2.1±5.4% TWL, respectively; P <0.0001), with significantly more patients achieving HbA1c ≤ 7% (28.3% vs. 9.4%; P <0.0003) and TWL ≥ 5% (60.4% vs. 21.3%; P <0.0001). Conclusions: DJBL met primary glycemic control efficacy and primary safety endpoints, while providing clinically significant weight loss, and comorbidity improvement.

AbstractThis joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0–29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Background Treating patients with multiple myeloma (MM) is a complex endeavor that requires effective clinical decision-making from a team of specialists and supporting clinicians. Additionally, treatment with chimeric antigen receptor (CAR) T-cell therapy presents unique challenges, requiring communication and collaboration between the oncology clinic and CAR T-cell treatment centers. To improve collaborative MM care, we conducted a quality improvement (QI) study, bringing together community and academic oncology centers to assess current practice patterns and develop strategies to overcome barriers in the treatment of patients with MM across the continuum of care. Methods This QI initiative is comprised of baseline provider surveys (Community n = 21; Academic n = 18) and pre- and post-surveys of providers (n = 31) participating in small-group, team-based audit-feedback (AF) sessions (Table 1). Survey questions were designed to assess knowledge, confidence, and experiences in keeping up with the latest clinical evidence and guideline recommendations and collaboration and communication practices between centers. Care teams from each clinic, along with a nationally renowned expert MM physician, participated in audit and feedback sessions to (a) assess system-specific practice gaps identified via the provider surveys, (b) prioritize areas for improvement, and (c) develop action plans for addressing root causes. Results Provider Surveys: When asked their top challenge encountered in managing patients with MM, community-based providers reported keeping up with clinical evidence for new and emerging therapies (48%), whereas academic-based providers reported knowing how to optimally sequence therapies (50%). Further differences between community and academic clinicians were evident in their self-reported confidence in their ability to stay up-to-date with new data on CAR T-cell therapies and other MM treatment (high/very high confidence: 84% academic; 24% community; p &lt; .001), ability to align clinical practices with evidence-based guidelines (high/very high confidence: 72% academic; 34% community; p = .018), and ability to sequence lines of therapy and differentiate between novel therapies for MM (high/very high confidence: 72% academic; 29% community; p = .007). Despite these differences, care teams from both settings reported low percentages of eligible patients have received CAR T-cell therapy for MM, citing patient resistance, cost and difficulty gaining insurance approval as top barriers (Figure 1). When asked to rate the level of communication and collaboration between academic and community centers, 44% of academic providers and 35% of community providers rated very good/excellent. The top barrier among providers not indicating very good/excellent communication from both settings was lack of time for our clinic's staff to communicate. AF Sessions: Providers participating in the small group AF sessions reported gaining access to newer therapies (55%) as their biggest challenge regarding MM management. Clinicians indicated gains in moderate/high/very high confidence in their ability to align treatment decisions with guidelines and clinical evidence for MM (78% to 92%) and ability to sequence treatment options across multiple lines of therapy for patients with MM (80% to 100%). Care teams set goals to enhance knowledge of clinical efficacy and safety of new and emerging therapies for MM. Action plans to achieve these goals include developing a hematology disease specific tumor board to collaborate on patient care plans, further train designated staff members focused on CAR T-cell/MM, discuss relevant new data to improve the team's confidence in therapy sequencing and early referrals to CAR T-cell centers. Conclusions Through this QI initiative, clinical teams identified barriers to optimal MM care, creating and implementing specific action plans to increase knowledge of current and emerging therapies for MM to enhance individualized treatment plans. While meaningful confidence gains were demonstrated, these data underscore clinical practice gaps to address in future initiatives to support evidence-based, collaborative care plans for patients with MM. Study Sponsor Statement The study reported in this abstract was funded by educational grants from Bristol Myers Squibb. The grantors had no role in the study design, execution, analysis, or reporting.