Citations

Introduction Targeted immunomodulators (eg, advanced therapies) effectively achieve symptomatic remission in patients with inflammatory bowel disease (IBD). However, ~25%–50% of patients with IBD achieving symptomatic remission with an advanced therapy may have continued endoscopically/radiologically active bowel inflammation, and it is uncertain whether changing alternative advanced therapies in asymptomatic patients with IBD will reduce bowel inflammation and achieve durable deep remission. Methods and analysis The QUality Outcomes Treating IBD to Target (QUOTIENT) study is an open-label, multicentre, pragmatic, randomised, controlled trial that aims to compare the efficacy and safety of switching to an alternative advanced therapy targeting endoscopic/radiological remission (treat-to-target) versus continuing the initial, or index, advanced therapy, in asymptomatic patients with IBD with moderate-to-severe endoscopic/radiological bowel inflammation. Enrolment is planned for ~250 participants in Canada/USA, randomised 1:1 to switching to alternative advanced therapy or continuing index advanced therapy, and then followed 104 weeks within routine clinical practice. Patient-reported outcomes measure efficacy and quality of life/treatment burden/safety. Primary endpoint is the time from randomisation to treatment failure. Ethics and dissemination The study is conducted in compliance with the protocol, ICH Good Clinical Practice, applicable regulatory requirements and appropriate review boards/independent ethics committees (approval numbers: Pro00077486; Pro00061437; STUDY00002062; 22-004171; i22-01269; IRB22-0890; IRB_00154397; 2000032384; SHIRB#2022.095-2; STUDY00007146; MMC#2024-18; REB#125290; 17784; Pro00142214; 20240660-01H), with documented written informed consent. Findings will be disseminated through peer-reviewed journals, scientific presentations, and publicly available Patient-Centered Outcomes Research Institute (PCORI) websites, including lay summaries. The Crohn’s & Colitis Foundation Education, Support, and Advocacy Department, and our patient advocacy stakeholder, will develop educational and marketing resources to communicate findings to a broad audience (>250 000 patients/caregivers/healthcare professionals). Trial registration number NCT05230173 .

Chronic pain is common with aging. Yet, little is known about the attitudes, beliefs, and experiences of older adults with chronic pain regarding opioids, particularly in regard to effects on daily functioning and cognition. This qualitative analysis employed semi-structured interviews in 25 community-dwelling older adults with chronic pain and current or recent prescription opioid use. Interviews focused on perceptions, beliefs, and experiences of living with chronic pain, use of prescription opioids, and the impact of opioids on pain control, cognition, and daily function. Older adults display adaptability and acceptance in living with chronic pain, desire person-centered pain care, approach the risks-benefits of opioids with regards to cognition differently, and perceive stigma as a barrier to effective partnership with clinicians.

Large language models (LLMs) transform healthcare by assisting clinicians with decision-making, research, and patient management. In gastroenterology, LLMs have shown potential in clinical decision support, data extraction, and patient education. However, challenges such as bias, hallucinations, integration with clinical workflows, and regulatory compliance must be addressed for safe and effective implementation. This manuscript presents a structured framework for integrating LLMs into gastroenterology, using Hepatitis C treatment as a real-world application. The framework outlines key steps to ensure accuracy, safety, and clinical relevance while mitigating risks associated with artificial intelligence (AI)-driven healthcare tools. The framework includes defining clinical goals, assembling a multidisciplinary team, data collection and preparation, model selection, fine-tuning, calibration, hallucination mitigation, user interface development, integration with electronic health records, real-world validation, and continuous improvement. Retrieval-augmented generation and fine-tuning approaches are evaluated for optimizing model adaptability. Bias detection, reinforcement learning from human feedback, and structured prompt engineering are incorporated to enhance reliability. Ethical and regulatory considerations, including the Health Insurance Portability and Accountability Act, General Data Protection Regulation, and AI-specific guidelines (DECIDE-AI, SPIRIT-AI, CONSORT-AI), are addressed to ensure responsible AI deployment. LLMs have the potential to enhance decision-making, research efficiency, and patient care in gastroenterology, but responsible deployment requires bias mitigation, transparency, and ongoing validation. Future research should focus on multi-institutional validation and AI-assisted clinical trials to establish LLMs as reliable tools in gastroenterology.

Abstract Background and aims This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) therapy in patients with moderate-to-severe ulcerative colitis in the phase 3 induction and maintenance studies, INSPIRE and COMMAND. Methods Patients were randomized (2:1) to 12 weeks of intravenous RZB or placebo (PBO) induction therapy; responders to intravenous RZB were randomized (1:1:1) to receive subcutaneous RZB 180 mg, 360 mg, or PBO (RZB withdrawal) maintenance therapy. Baseline corticosteroid doses were maintained during induction, with a mandatory taper beginning at maintenance week 0. Efficacy outcomes were evaluated by baseline corticosteroid use at induction week 12, while corticosteroid-free clinical and endoscopic outcomes were assessed at maintenance week 52 among the overall population and among patients on corticosteroids at baseline. Safety was also assessed. Results At baseline, 35.7% (348/975) of patients were taking corticosteroids. At induction week 12, greater rates were observed for clinical, endoscopic, and patient-reported outcomes in RZB 1200 mg-treated patients compared with PBO, regardless of baseline corticosteroid use. RZB 180 mg and 360 mg treatment resulted in higher corticosteroid discontinuation rates (RZB 180 mg 64.9% [48/74]; RZB 360 mg 54.2% [32/59]; PBO [withdrawal] 36.8% [25/68], P ≤ .01) and corticosteroid-free clinical, endoscopic, and patient-reported outcomes at week 52, compared with PBO (withdrawal). The rates of treatment-emergent adverse events were similar regardless of baseline corticosteroid use during induction and maintenance. Conclusions The efficacy of RZB induction therapy was independent of corticosteroid use, with high rates of corticosteroid-free outcomes observed in the overall population and among patients with baseline corticosteroid use, reaffirming the potential of RZB to serve as a corticosteroid-sparing therapy for patients with ulcerative colitis. Clinicaltrial.gov numbers NCT03398148 and NCT03398135

Spatial heterogeneity of liver viscoelasticity, measured at three-dimensional vector MR elastography, positively correlated with metabolic dysfunction–associated steatotic liver disease progression.