Evaluating Equity in Clinical Trial Accessibility: An Analysis of Demographic, Socioeconomic, and Educational Disparities in IBS Drug Trials.

BACKGROUND/AIM: Irritable Bowel Syndrome (IBS), a disorder of gut-brain interaction imposes a significant economic burden due to its high prevalence and the chronic nature of its symptoms. IBS currently has seven FDA-approved treatments. Despite efforts to improve diversity in randomized controlled trials (RCT) participation, significant disparities remain in various medical fields, yet these have not been thoroughly examined within the context of IBS. We aimed to investigate the demographic, socioeconomic, educational and geographic disparities in IBS drug trials. METHODS: We conducted a systematic review on Phase III RCTs on FDA-approved drugs for the treatment of IBS with constipation (IBS-C) and IBS with diarrhea (IBS-D) in the United States. Data on participant demographics and trial site locations were extracted and analyzed to identify disparities. RESULTS: Our analysis included 17 studies encompassing 21 trials with 17,428 participants. 77.3% of participants were female, with a mean age of 45.4 years. Race was reported in 95% of the trials, but only 35% disclosed ethnicity. White participants constituted the majority at 79.3%. Hispanics accounted for only 5.9%. Counties without trial sites had smaller average population sizes compared to trial and trial-adjacent counties. Socioeconomic indicators such as poverty rates, median household income, educational attainment, and broadband internet access were lower in counties without trial sites, with higher average Area Deprivation Index scores indicating greater deprivation. CONCLUSION: The findings highlight significant disparities in IBS trial participation across race, ethnicity, gender, and socioeconomic backgrounds. This raises potential concerns about generalizability of trial outcomes and underscores the need for strategies to enhance inclusivity in clinical research.

Ineffective esophageal motility is associated with diabetes mellitus end organ complications.

BACKGROUND: Diabetes Mellitus (DM) is known to induce a wide range of harmful effects on several organs, notably leading to ineffective esophageal motility (IEM). However, the relationship between DM and IEM is not fully elucidated. We aimed to determine the relationship between DM and IEM and to evaluate the impact of DM's end organ complications on IEM severity. METHODS: A multicenter cohort study of consecutive patients undergoing high-resolution esophageal manometry (HREM) was performed. We reviewed medical records of patients diagnosed with IEM using HREM, encompassing data on demographics, DM history, antidiabetic and other medications as well as comorbidities. KEY RESULTS: Two hundred and forty six subjects met the inclusion criteria. There was no significant difference in any of the HREM parameters between diabetics and nondiabetics. Out of 246 patients, 92 were diabetics. Diabetics with neuropathy presented a significantly lower distal contractile integral (DCI) value compared to those without neuropathy (248.2 ± 226.7 mmHg·cm·sec vs. 375.6 ± 232.4 mmHg·cm·sec; p = 0.02) Similarly, the DCI was lower in diabetics with retinopathy compared to those without retinopathy (199.9 ± 123.1 mmHg·cm·sec vs. 335.4 ± 251.7 mmHg·cm·sec; p = 0.041). Additionally, a significant difference was observed in DCI values among DM patients with ≥2 comorbidities compared to those without comorbidities (224.8 ± 161.0 mmHg·cm·sec vs. 394.2 ± 243.6 mmHg·cm·sec; p = 0.025). Around 12.6% of the variation in DCI could be explained by its linear relationship with hemoglobin A1c (HbA1c), with a regression coefficient (ß) of -55.3. CONCLUSION & INFERENCES: DM is significantly associated with IEM in patients with neuropathy, retinopathy, or multiple comorbidities. These results are pivotal for tailoring patient-specific management approaches.

Overt gastrointestinal bleeding in patients with cancer: Clinical characteristics and outcomes.

BACKGROUND: The aim of this study was to compare the clinical characteristics and outcomes of gastrointestinal bleeding (GIB) between cancer patients (CP) and non-cancer patients (NCP). METHODS: This was a prospective study of patients admitted with overt GIB between 2013 and 2021. GIB etiology, management and outcomes including rebleeding and mortality, were compared between CP and NCP, and among patients with different types of cancer. The associations with categorical variables were assessed with the Chi-square test, and the t-test was used for continuous variables. RESULTS: Of 674 patients admitted for GIB, 144 (21%) had cancer. 121(84%) CP had active disease, 49% had stage 4 cancer, and 78% had solid tumors, of whom 28 (20%) had luminal GI cancers. The most common were colorectal cancer, prostate cancer, and lymphomas. Compared to NCP, CP had higher age-adjusted Charlson Comorbidity Index, and were less likely to undergo endoscopy or endoscopic therapy. Severe GIB was equally prevalent in both groups, but CP had more severe anemia. Peptic ulcer was the most common etiology in both groups. Of 28 luminal cancer patients, 17(59%) bled from their tumors. Nine patients bled from cancer metastasis to the GI lumen. CP had higher in-hospital, one-month, one-year, and end-of-follow-up mortality. Length of hospital stay and re-bleeding rates did not differ between CP and NCP. CONCLUSIONS: CP with GIB are less likely to have diagnostic and therapeutic endoscopy and have higher mortality than NCP. Steps to identify CP at risk for GIB and to improve their outcomes merit further investigation.

Impact of blood transfusion on mortality and rebleeding in gastrointestinal bleeding: an 8-year cohort from a tertiary care center.

Background: The aim of this study was to investigate the impact of blood transfusion (BT) on mortality and rebleeding in patients with gastrointestinal bleeding (GIB) and whether BT at a threshold of ≤7 g/dL may improve these outcomes. Methods: A prospective study was conducted in patients admitted with GIB between 2013 and 2021. Antithrombotic (AT) use and clinical outcomes were compared between transfused and non-transfused patients, and between those transfused at a threshold of ≤7 vs. >7 g/dL. Multivariate analysis was performed to identify predictors of mortality and rebleeding. Results: A total of 667 patients, including 383 transfused, were followed up for a median of 56 months. Predictors of end-of-follow-up mortality included: age-adjusted Charlson Comorbidity Index, stigmata of recent hemorrhage (SRH), and being on anticoagulants only upon presentation (P=0.026). SRH was a predictor of end-of-follow-up rebleeding, while having been on only antiplatelet therapy (AP) upon presentation was protective (P<0.001). BT was not associated with mortality or rebleeding at 1 month or end of follow up. Among transfused patients, being discharged only on AP protected against mortality (P=0.044). BT at >7 g/dL did not affect the risk of short or long-term rebleeding or mortality compared to BT at ≤7 g/dL. Conclusions: Short- and long-term mortality and rebleeding in GIB were not affected by BT, nor by a transfusion threshold of ≤7 vs. >7 g/dL, but were affected by the use of AT. Further studies that account for AT use are needed to determine the best transfusion strategy in GIB.

Continued Diabetes Remission Despite Weight Recurrence: Gastric Bypass Long-Term Metabolic Benefit.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) demonstrates high rates of type 2 diabetes mellitus (T2DM) remission, a phenomenon hypothesized to be mediated mainly by weight loss. Compared with procedures that do not bypass the proximal small intestines, such as sleeve gastrectomy (SG), RYGB exhibits weight loss-independent intestinal mechanisms conducive to T2DM remission. We investigated continued diabetes remission (CDR) rates despite weight recurrence (WR) after RYGB compared with an SG cohort. STUDY DESIGN: A retrospective review of patients who underwent successful primary RYGB or SG with a BMI value of 35 kg/m 2 or more and a preoperative diagnosis of T2DM was performed. Patients with less than 5 years of follow-up, absence of WR, or lack of T2DM remission at nadir weight were excluded. After selecting the optimal procedure for glycemic control, rates of CDR were then stratified into WR quartiles and compared. RESULTS: A total of 224 RYGB and 46 SG patients were analyzed. The overall rate of CDR was significantly higher in the RYGB group (75%) compared with the SG group (34.8%; p < 0.001). The odds of T2DM recurrence were 5.5 times higher after SG compared with RYGB. Rates of CDR were stratified into WR quartiles (85.5%, <25%; 81.7%, 25% to 44.9%; 63.2%, 45% to 74.9%; and 60%, >75%). Baseline insulin use, higher preoperative glycosylated hemoglobin, and longer preoperative duration of T2DM were associated with T2DM recurrence, whereas WR was not. CONCLUSIONS: T2DM remission rates after RYGB are maintained despite WR, arguing for a concurrent weight loss-independent metabolic benefit likely facilitated by bypassing the proximal small intestine.

Esophageal cancer: a twenty-four-year experience at a tertiary care center with an evaluation of the prognostic significance of the neutrophil-lymphocyte ratio.

BACKGROUND: A high neutrophil-lymphocyte ratio (NLR) may be associated with worse survival in esophageal cancer (EC). Our aims were to describe the demographic and clinical data of EC in a tertiary referral center in Lebanon and to determine the prognostic value of NLR. METHODS: A retrospective cohort study based on chart review of patients diagnosed with EC was conducted at the American University of Beirut Medical Center (AUBMC). The demographic characteristics, clinical presentation and outcomes were described and compared between squamous cell carcinomas (ESCC) and adenocarcinomas (EAC). Data about esophageal cancer incidence were obtained from the National Cancer Registry, the Ministry of Public Health and GLOBOCAN 2020. Cox regression analysis was performed to determine whether the NLR is an independent predictor of survival, using variables based on clinical knowledge and previously established data. RESULTS: 110 patients were diagnosed with EC, which was the least common among other gastrointestinal malignancies. Our follow up rates reached 86.4%. The median survival was 9 months (IQR 3-25.5.) and was comparable between ESCC (median of 7 months, IQR 2-25) and EAC (median of 9 months, IQR 3-26.3), p = 0.803. Advanced stage was associated with a worse prognosis (p = 0.037). The mean NLR(±SD) was 5.20 ± 6.8, with no significant difference between EAC and ESCC (4.5 ± 3.4 vs. 5.9 ± 9.2, p = 0.420) or between early or advanced stages (5.4 ± 8.1 vs. 4.7 ± 6.8, p = 0.732). The area under the curve for the NLR was 0.560 (95% CI: 0.374-0.746, p = 0.488). After adjusting for age, gender, TNM staging and grading, cox regression analysis showed that an increased NLR was a significant predictor of mortality, with an adjusted hazard ratio of 1.095 (p = 0.011). CONCLUSION: EC is quite uncommon in Lebanon despite a high prevalence of smoking and obesity. Advanced stage and high NLR were associated with a negative prognostic value.

Endoscopic retrograde cholangiopancreatography (ERCP) approach for patients with Roux-en-Y gastric bypass: a comparative study between four ERCP techniques with proposed management algorithm.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is technically challenging in patients with Roux-en-Y gastric bypass (RYGB) due to altered anatomy. OBJECTIVE: To compare the procedural and clinical outcomes of 4 different ERCP techniques in RYGB patients. SETTING: Academic tertiary referral center in the United States. METHODS: A retrospective cohort study including patients with RYGB anatomy who underwent an ERCP between January 2015 and September 2020. We compared procedural success and adverse events (AEs) rates of balloon-assisted enteroscopy (BAE), gastrostomy-assisted ERCP (GAE), endoscopic ultrasound (EUS)-directed transgastric ERCP (EDGE), and rendezvous guidewire-assisted ERCP (RGA). RESULTS: Seventy-eight RYGB patients underwent a total of 132 ERCPs. The mean age was 60 ± 11.8 years, with female predominance (85.7%). The ERCP procedures performed were BAE (n = 64; 48.5%), GAE (n = 18; 13.7%), EDGE (n = 25; 18.9%), and RGA (n = 25; 18.9%), with overall procedure success rates of 64.1%, 100%, 89.5%, and 91.7%, respectively. All approaches were superior to BAE (GAE versus BAE, P = .003; EDGE versus BAE, P = .034; RGA versus BAE, P = .011). The overall AE rates were 10.9%, 11.1%, 15.8 %, and 25.0%, respectively. There was no statistical difference in AEs. There were also no differences in bleeding, post-ERCP pancreatitis, and perforation rates between the 4 approaches. CONCLUSION: Procedure success was similar between GAE, RGA, and EDGE, but superior to BAE. AE rates were similar between approaches.

Accuracy of ChatGPT in Common Gastrointestinal Diseases: Impact for Patients and Providers.

Since its release in 2022, Chat Generative Pre-Trained Transformer (ChatGPT) became the most rapidly expanding consumer software application in history,1 and its role in medicine is underscored by its potential to enhance patient education and physician-patient communication. Previous studies in gastroenterology and hepatology have focused primarily on the earlier Generative Pre-Trained Transformer 3 (GPT-3) model, with none investigating ChatGPT's ability to generate supportive references for its responses, or its applicability as a physician educational tool.2-6 Our study evaluated the accuracy of the more recent ChatGPT, powered by GPT-4, in addressing frequently asked questions by patients on irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), colonoscopy and colorectal cancer (CRC) screening, questions on CRC screening from a physician perspective, and reference generation and suitability.

Correlation Between Gastrojejunal Anastomosis Diameter, Distensibility Index, and Weight Regain After Roux-en-Y Gastric Bypass.

INTRODUCTION: Gastrojejunal anastomosis (GJA) dilation is an independent predictor of weight regain (WR) after Roux-en-Y gastric bypass (RYGB). However, the role of planimetric measurements in this context remains unknown. METHODS: This is a retrospective cohort study including adult RYGB patients who underwent a diagnostic endoscopy with Endoflip assessment of the GJA. We excluded patients in the early postoperative period and those with abnormal endoscopic findings (marginal ulcers and gastro-gastric fistulas). RESULTS: Thirty-four patients were initially included. Endoscopic GJA diameter had a moderate positive correlation with WR (r=+0.438, p=0.011). However, after excluding the 7 patients with GJA> 30 mm, there was no significant correlation. There was a moderate agreement between the EndoFLIP-GJA diameter at 60mL and endoscopic diameter (ICC=0.576, p=0.049). The distensibility index (DI) showed a consistent moderate negative correlation with WR. Considering the maximum DI at 40 ml, we found a cutoff of DI = 7 mm2/mmHg that split the sample in two significantly different populations in terms of WR (67.4% vs. 43.2%, p=0.04). CONCLUSION: Visual estimation of the GJA diameter correlates with EndoFLIP at 60mL. In the subset of patients with GJA ≤ 30 mm, more distensible GJAs are associated with lower rates of WR. Larger studies are needed to confirm this correlation and to validate its utility for clinical management.

Sudden-Onset Disaster Mass-Casualty Incident Response: A Modified Delphi Study on Triage, Prehospital Life Support, and Processes.

The application and provision of prehospital care in disasters and mass-casualty incident response in Europe is currently being explored for opportunities to improve practice. The objective of this translational science study was to align common principles of approach and action and to identify how technology can assist and enhance response. To achieve this objective, the application of a modified Delphi methodology study based on statements derived from key findings of a scoping review was undertaken. This resulted in 18 triage, eight life support and damage control interventions, and 23 process consensus statements. These findings will be utilized in the development of evidence-based prehospital mass-casualty incident response tools and guidelines.

Tubularization of the gastric pouch helps sustain weight loss after transoral outlet reduction for post-Roux-en-Y gastric bypass weight recurrence.

Background and study aims Traditional transoral outlet reduction (TORe) is a minimally invasive endoscopic approach focused on reducing the aperture of the gastrojejunal (GJ) anastomosis, while the tubular transoral outlet reduction (tTORe) consists of tabularization of the distal pouch utilizing an O-shape gastroplasty suturing pattern. The primary aim of this study was to compare short-term weight loss between TORe and tTORe. Patients and methods Retrospective analysis of a prospectively maintained database was conducted at a tertiary care bariatric center of excellence. The study included patients with history of Roux-en-Y gastric bypass (RYGB) who had an endoscopic revision by TORe or tTORe and had follow-up data in their electronic medical record. The primary outcome was percent total body weight loss (%TBWL). Results A total of 128 patients were included (tTORe=85, TORe=43). At 3 and 6 months, the tTORe and TORe cohorts presented similar %TBWL (3 months: 8.5±4.9 vs. 7.3±6.0, P = 0.27 and 6 months: 8.1±7.4 vs. 6.8±5.6, P = 0.44). At 9 months, there was a trend toward greater weight loss in the tTORe cohort (9.7±8.6% vs. 5.1±6.8%, P = 0.053). At 12 months, the %TBWL was significantly higher in the tubularization group compared to the standard group (8.2±10.8 vs. 2.3±7.3%, P = 0.01). Procedure time was significantly different between both groups (60.5 vs. 53.4 minutes, P = 0.03). The adverse events rate was similar between groups (8.2% vs. 7.0% for tTORe and TORe, respectively, P = 0.61). Conclusions The tTORe enhances efficacy and durability of the standard procedure without adding significant procedure-related risks.

Pitfalls of EUS-guided gastrojejunostomy in a patient with history of Roux-en-Y gastric bypass and a frozen abdomen.

Video 1Case of EUS-guided gastrojejunostomy in a patient with a history of Roux-en-Y gastric bypass and a frozen abdomen.

Management of a refractory marginal ulcer following Roux-en-Y gastric bypass with EUS-guided Roux-en-Y gastric bypass reversal.

Video 1EUS-guided Roux-en-Y gastric bypass reversal procedure to treat a refractory marginal ulcer following Roux-en-Y gastric bypass.

Long-term follow-up after transoral outlet reduction following Roux-en-Y gastric bypass: Back to stage 0?

Background and study aims Significant weight regain affects up to one-third of patients after Roux-en-Y gastric bypass (RYGB) and demands treatment. Transoral outlet reduction (TORe) with argon plasma coagulation (APC) alone or APC plus full-thickness suturing TORe (APC-FTS) is effective in the short term. However, no study has investigated the course of gastrojejunostomy (GJ) or quality of life (QOL) data after the first post-procedure year. Patients and methods Patients eligible for a 36-month follow-up visit after TORe underwent upper gastrointestinal endoscopy with measurement of the GJ and answered QOL questionnaires (RAND-36). The primary aim was to evaluate the long-term outcomes of TORe, including weight loss, QOL, and GJ anastomosis (GJA) size. Comparisons between APC and APC-FTS TORe were a secondary aim. Results Among 39 eligible patients, 29 returned for the 3-year follow-up visit. There were no significant differences in demographics between APC and APC-FTS TORe groups. At 3 years, patients from both groups regained all the weight lost at 12 months, and the GJ diameter was similar to the pre-procedure assessment. As to QOL, most improvements seen at 12 months were lost at 3 years, returning to pre-procedure levels. Only the energy/fatigue domain improvement was kept between the 1- and 3-year visits. Conclusions Obesity is a chronic relapsing disease. Most effects of TORe are lost at 3 years, and redilation of the GJA occurs. Therefore, TORe should be considered iterative rather than a one-off procedure.

Diagnostic stewardship in infectious diseases: a continuum of antimicrobial stewardship in the fight against antimicrobial resistance.

Antimicrobial resistance (AMR) has been exacerbated by the inappropriate use of diagnostics, leading to excessive prescription of antimicrobials, and is an imminent threat to global health. Diagnostic stewardship (DS) is an auxiliary to antimicrobial stewardship (AMS) and comprises ordering the right tests, for the right patient, at the right time. It also promotes the judicious use of rapid and novel molecular diagnostic tools to enable the initiation of proper antibiotic therapy, while avoiding excessive use of broad-spectrum antibiotics. Proper interpretation of test results is crucial to avoid overdiagnosis and excessive healthcare costs. Although many rapid diagnostic tools have been developed with a high diagnostic yield, they are often limited by accessibility, cost, and lack of knowledge regarding their use. Careful consideration of clinical signs and symptoms with knowledge of the local epidemiology are essential for DS. This enables appropriate interpretation of microbiological results. Multidisciplinary teams that include well trained professionals should cooperate to promote DS. Challenges and barriers to the implementation of DS are mostly caused by scarcity of resources and lack of trained personnel and, most importantly, lack of knowledge. The lack of resources is often due to absence of awareness of the impact that good medical microbiology diagnostic facilities and expertise can have on the proper use of antibiotics.

High fever in myelin oligodendrocyte glycoprotein-associated disorder (MOGAD): A diagnostic challenge.

The phenotypic spectrum of myelin oligodendrocyte glycoprotein (MOG)-IgG associated disorders (MOGAD) has broadened in the past few years, and atypical phenotypes are increasingly recognized. Febrile meningoencephalitis has rarely been reported as a feature of MOGAD and represents a diagnostic challenge. We report the case of 24-year-old women with high-grade fever, meningoencephalomyelitis, and persistently positive MOG-IgG, for whom an extensive infectious work-up was negative and who responded to high-dose intravenous methylprednisolone. The full clinical spectrum of MOGAD is yet to be completely elucidated. In patients presenting with febrile meningoencephalitis, MOG-IgG testing should be considered particularly if infectious work-up is negative.

Development and Validation of a Novel 1-year Mortality Risk Score That Includes the Use of Antithrombotic in Patients With Overt Gastrointestinal Bleeding.

GOALS AND BACKGROUND: We aimed to develop a novel 1-year mortality risk-scoring system that includes use of antithrombotic (AT) drugs and to validate it against other scoring systems in patients with acute gastrointestinal bleeding (GIB). STUDY: We developed a risk-scoring system from prospectively collected data on patients admitted with GIB between January 2013 and August 2020, who had at least 1- year of follow-up. Independent predictors of 1-year mortality were determined after adjusting for the following confounders: the age-adjusted Charlson Comorbidity Index (CCI) (divided into 4 groups: CCI-0=0, CCI-1=1 to 3, CCI-2=4 to 6, CCI-3 ≥7), need for blood transfusion, GIB severity, need for endoscopic therapy, and type of AT. The risk score was based on independent predictors. RESULTS: Five hundred seventy-six patients were included and 123 (21%) died at 1-year follow-up. Our risk -score was based on the following: CCI-2 (2 points), CCI-3 (4 points), need for blood transfusion (1 point), and no use of aspirin (1 point), as aspirin use was protective (maximum score=6). Patients with higher risk scores had higher mortality. The model had a better predictive accuracy [AUC=0.82, 95% confidence interval (0.78-0.86), P <0.0001] than the Rockall score for upper GIB (Area Under the Curve (AUC)=0.68, P <<0.0001), the Oakland score for lower GIB (AUC=0.69, p =0.004), or the Shock Index for all (AUC=0.54, P <0.0001). CONCLUSION: A simple and novel score that includes use of AT upon admission accurately predicts 1-year mortality in patients with GIB. This scoring system may help guide follow-up decisions and inform the prognosis of patients with GIB.

Challenges of coronavirus disease 2019 (COVID-19) in Lebanon in the midst of the economic collapse.

Lebanon, one of the smallest countries in the Middle East, has held for decades a reputation for being the premier medical hub for patients from the Arab world as well as neighboring countries and for offering world-class treatment and advanced medical services. However, this once world-renowned healthcare sector is now facing a risk of imminent collapse as overlapping crises have struck the country since October 2019. In this article, we describe the concomitant political, economic, and financial challenges that Lebanon is facing, which have strained the national healthcare system and have undermined its ability to respond to the coronavirus disease 2019 (COVID-19) pandemic. We present an overview of the political instability, the Lebanese revolution with countrywide protests, as well as the devaluation of the Lebanese currency representing one of the worst economic meltdowns since the 19th century. We describe the unprecedented energy crisis the country is facing and the disastrous consequences of the Beirut port explosion of August 2020. We review the efforts and measures taken by different stakeholders to contain the COVID-19 pandemic amid the multifaceted challenges and the large exodus of healthcare personnel.