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

INTRODUCTION: Irritable bowel syndrome (IBS), a disorder of gut-brain interaction, imposes a significant economic burden because of its high prevalence and the chronic nature of its symptoms. IBS currently has 7 United States Food and Drug Administration-approved treatments. Despite efforts to improve diversity in randomized controlled trials' 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 of phase 3 randomized controlled trials on United States Food and Drug Administration-approved drugs for the treatment of IBS with constipation and IBS with diarrhea 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. Approximately 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 with 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. DISCUSSION: 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.

Gastric myoelectrical activity based AI-derived threshold predicts resolution of gastroparesis post-pyloric balloon dilation.

BACKGROUND: A patient subset with gastroparesis (GP) has normal gastric myoelectrical activity (GMA) and pyloric dysfunction. AIMS: (1) To determine pyloric balloon dilation (BD) effect on symptoms and gastric emptying in GP patients with normal 3 cycles per minute (cpm) GMA. (2) To demonstrate GMA-based artificial intelligence (AI)-derived formulae predict BD success at 10-12-month follow-up. METHODS: Cohort subjects completed baseline electrogastrogram w/water load satiety test (WLST), solid-phase nuclear gastric emptying, Gastrointestinal Cardinal Symptom Index (ANMS GCSI-DD) and Leeds questionnaires. Subjects were divided into two groups based on response to the WLST. Group 1 (n = 26) with hypernormal/normal 3 cpm GMA and Group 2 (n = 4) hyponormal/normal range 3 cpm GMA, compared to healthy normals. All subjects underwent endoscopic pyloric BD. After 10-12 months, gastric emptying and dyspepsia questionnaires were repeated to evaluate outcomes. RESULTS: Group 1 ANMS GCSI-DD scores improved from 2 points at baseline (BL) to 0 at follow-up (f/u) (p < 0.001); Group 2 ANMS GSCI-DD scores were 2 at BL and 1.6 at f/u (p = 0.25). Leeds scores improved (p < 0.001) only for Group 1. Group 1 gastric emptying improved (54.5% retained at 2 h at BL vs. 12.2% at f/u, p < 0.001) in contrast to Group 2 patients (51.25% at BL vs. 56.25% at f/u, p = 0.252). Percentage 3 cpm GMA decreased (41.1% at BL vs. 24.9% at f/u, p ≤ 0.005) in Group 1 versus Group 2 (15.3% at BL vs. 23.4% at f/u, p = 0.114). AI-derived GMA threshold (GMAT) of 0.59 predicted positive pyloric BD outcomes at 10-12 months with sensitivity 96%, specificity 75%, and 93% correct classification. CONCLUSIONS: Pyloric BD improved symptoms and gastric emptying long term in patients with GP and hypernormal/normal 3 cpm GMA. AI-derived GMAT predicted pyloric BD success. GMA post-WLST and GMAT are objective measures for improved selection and outcomes for endoscopic pyloric BD.

Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort.

BACKGROUND: Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring symptoms and need for continuous medication use. Refractory LNF patients may receive radiofrequency energy delivery to the lower esophageal sphincter (Stretta) to ameliorate symptoms and medication requirements. The aim was to assess and compare long-term patient-reported outcomes of Stretta in refractory patients with and without previous LNF. METHODS: We prospectively assessed and compared patient-reported outcomes in 18 refractory LNF patients and 81 standard refractory GERD patients that all underwent Stretta during 10-year follow-up. Patient-reported outcomes measured were GERD-HRQL (health-related quality of life), patient satisfaction scores, and daily medication requirements. RESULTS: The refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6 months to 10 years, which was significant from a baseline of both on- and off-medications (p < 0.05). Specifically at 10 years, median GERD-HRQL decreased from 36 to 7 (p < 0.001), satisfaction increased from 1 to 4 (p < 0.001), and medication score decreased from 7 to 6 (p = 0.040). Nine patients decreased medication use by half at 10 years. No significant differences existed between refractory LNF and standard refractory GERD subsets at any follow-up time point ≥6 months to 10 years (p > 0.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (p = 0.088), patient satisfaction (p = 0.573), and GERD-HRQL (p = 0.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events. CONCLUSION: Within a small cohort of refractory LNF patients, Stretta resulted in sustained improvement over 10 years with equivalent outcomes to non-LNF standard Stretta patients. Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by Stretta with fewer complications compared to redo of Nissen or chronic medication use.

Bidirectional ventricular tachycardia of unknown etiology.

A 45 years old male presented to the emergency department with palpitations, headache and apprehension. His electrocardiogram revealed bidirectional ventricular tachycardia. He remained vitally stable and responded to intravenous beta-blocker. Initially digitalis toxicity was suspected but history was negative for digitalis intake. The cause remained unidentified in patient despite detailed investigations. During a short follow-up (of 6 months) he remained asymptomatic and no cause was further identified during this period. Some other unseen causes of bidirectional ventricular tachycardia need to be explored.