Search

Background: High placebo responses have limited drug development in eosinophilic oesophagitis. The optimal configuration of trial outcomes is uncertain. Aims: To inform more efficient future trial designs, to characterise clinical, endoscopic and histologic placebo responses in eosinophilic oesophagitis randomised controlled trials (RCTs). Methods: We updated a Cochrane systematic review and meta‐analysis, searching multiple databases to January 1, 2024, to identify placebo‐controlled RCTs evaluating medical therapies for patients with eosinophilic oesophagitis. The primary outcome was the pooled proportion of study‐defined clinical, endoscopic and histologic responders and remitters randomised to placebo, using an intention‐to‐treat approach and random‐effects model. Sources of heterogeneity were explored using meta‐regression. Results: We included 25 RCTs. The pooled proportion of clinical response was 41.0% [95% CI: 29.7%–52.8%] with substantial heterogeneity (I2 = 74.9%). On meta‐regression, older age and a higher probability of being randomised to placebo reduced the likelihood of clinical response to placebo. The pooled proportion of histologic remission defined as a peak eosinophil count [PEC] ≤ 6 eosinophils per high power field [HPF] or ≤ 1 eosinophil/HPF was 4.3% [95% CI: 2.6%–6.2%] (I2 = 23.6%) and 1.3% [95% CI: 0.5%–2.5%] (I2 = 0%), respectively. The standardised mean difference in the Eosinophilic Oesophagitis Endoscopic Reference Score to placebo was −0.25 [95% CI: −0.41, −0.10]. Conclusions: Over 40% of patients in eosinophilic oesophagitis trials respond clinically to placebo, and this is associated with trial design factors such as randomisation ratio and trial population. Objective endoscopic and histologic measures are associated with very low placebo responses. [ABSTRACT FROM AUTHOR]

Endoscopic retrograde cholangiopancreatography (ERCP) is a commonly performed procedure for pancreaticobiliary disease. While ERCP is highly effective, it is also associated with the highest adverse event (AE) rates of all commonly performed endoscopic procedures. Thus, it is critical that endoscopists and caregivers of patients undergoing ERCP have clear understandings of ERCP-related AEs. This narrative review provides a comprehensive overview of the available evidence on ERCP-related AEs. For the purposes of this review, we subdivide the presentation of each ERCP-related AE according to the following clinically relevant domains: definitions and incidence, proposed mechanisms, risk factors, prevention, and recognition and management. The evidence informing this review was derived in part from a search of the electronic databases PubMed, Embase, and Cochrane, performed on 1 May 20231 May 2023. Knowledge of ERCP-related AEs is critical not only given potential improvements in peri-procedural quality and related care that can ensue but also given the importance of reviewing these considerations with patients during informed consent. The ERCP community and researchers should aim to apply standardized definitions of AEs. Evidence-based knowledge of ERCP risk factors should inform patient care decisions during training and beyond. [ABSTRACT FROM AUTHOR]

There continues to be an ongoing need for fair and equitable organ allocation. The Model for End-Stage Liver Disease (MELD) score has evolved as a calculated framework to evaluate and allocate patients for liver transplantation objectively. The original MELD score has undergone multiple modifications as it is continuously scrutinized for its accuracy in objectively representing the clinical context of patients with liver disease. Several refinements and iterations of the score have been developed, including the widely accepted MELD-Na score. In addition, the most recent updated iteration, MELD 3.0, has been created. The MELD 3.0 calculator incorporates new variables such as patient sex and serum albumin levels and assigns new weights for serum sodium, bilirubin, international normalized ratio, and creatinine levels. It is anticipated that the use of MELD 3.0 scores will reduce overall waitlist mortality and enhance access for female liver transplant candidates. However, despite the emergence of the MELD score as one of the most objective measures for fair organ allocation, various countries and healthcare systems employ alternative methods for stratification and organ allocation. This review article will highlight the origins of the MELD score, its iterations, the current MELD 3.0, and future directions for managing liver transplantation organ allocation. LAY SUMMARY: Organ donation is crucial for the management of patients unwell with liver disease, but organs must be allocated fairly and equitably. One method used for this is the Model for End-Stage Liver Disease (MELD) score, which helps objectively decide which patient is a candidate for liver transplant. Over time, the MELD score has been refined to better reflect patients' needs. For example, the latest version, MELD 3.0, now considers factors like nutrition and gender. This should ensure that more patients, especially females, are candidates and receive appropriate access to liver transplantation. However, not every country uses the MELD score. Some countries have created their own scoring systems based on local research. This review will explain where the MELD score came from, how it has changed, the current characteristics of the MELD 3.0 score, and what the future might hold for organ allocation in liver transplants., Competing Interests: None declared., (Thieme. All rights reserved.)

Background:  Post-endoscopic retrograde cholangiopancreatography (ERCP) adverse events (AEs) are common, as is unplanned healthcare utilization (UHU). We aimed to assess potential etiologic associations between intra-/post-procedural patient-reported experience measures (PREMs) and post-ERCP AEs and UHU. METHODS : Prospective data from a multicenter collaborative were used. A 0-10 Likert-based PREM assessing intra- and post-procedural symptoms was applied to patients following ERCP, and follow-up was performed at 30 days to identify AEs and UHU for reasons not meeting the definitions of any AE. Multivariable logistic regression was conducted using PREM domains as exposures and AEs and UHU as outcomes, with a priori selected covariates. Odds ratios (ORs) and 95 %CIs for each PREM domain were reported., Results:  From 2018 to 2023, 3434 patients were included. A post-procedural abdominal pain score > 3 was associated with pancreatitis (OR 3.71 [95 %CI 2.37-5.73]), while a score > 6 was associated with perforation (OR 9.54 [95 %CI 1.10-59.37]). Post-procedural pain was also associated with UHU within 30 days when used as a continuous exposure (OR 1.08 per point [95 %CI 1.01-1.16]), and when partitioned at a score > 3 (OR 1.79 [95 %CI 1.13-2.74]) and a score > 6 (OR 1.93 [95 %CI 1.02-3.46]). No other intra- or post-procedural PREMs were associated with any AEs or UHU., Conclusions:  Patient-reported abdominal pain from a Likert-based PREM at the time of discharge from ERCP was associated with pancreatitis, perforation, and UHU within 30 days. Applying PREMs could potentially prevent UHU and/or facilitate earlier management and improved outcomes for patients with post-ERCP AEs., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)