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The Alimentary Pharmacology & Therapeutics journal welcomes readers to its first edition of 2024. The journal received 1266 submissions between January and September 2023, accepting 130 of them, resulting in an acceptance rate of 10.3%. The journal aims to maintain a balance between hepatology and 'luminal' gastroenterology papers and offers authors the option to transfer their papers to affiliated journals if not accepted. The journal also discusses a change in the nomenclature for steatotic liver disease and highlights its 2-year impact factor and most highly cited and downloaded papers. The editors express their gratitude to the contributors and invite suggestions for improvement. [Extracted from the article]

Summary: Background: Faecal haemoglobin (f‐Hb) testing is used in colorectal cancer (CRC) screening and increasingly to guide the investigation in patients with symptoms suggestive of CRC. Studies have demonstrated increased mortality with raised f‐Hb. Aims: To assess the association of raised f‐Hb with all‐cause, non‐CRC (any cause excluding CRC) and cause‐specific mortality. Methods: We searched Medline and Embase on 9 February 2024 to identify papers reporting mortality after faecal immunochemical (FIT) or guaiac faecal occult blood tests (gFOBT). The primary outcome was all‐cause mortality following a positive compared to a negative test. Results: The search identified 3155 papers. Ten met the inclusion criteria: three reported gFOBT and seven reported FIT results, as screening tests. These reported a total of 14,687,625 f‐Hb results. Elevated f‐Hb was associated with an increased risk of all‐cause, non‐CRC and cause‐specific mortality including death from cardiovascular, digestive and respiratory diseases. Crude risk ratios for all‐cause mortality with a positive versus negative test were derived from six papers (three reporting gFOBT, three FIT). An increased risk was demonstrated in five, with RRs ranging from 1.11 (95% CI: 1.06–1.16) to 2.95 (95% CI: 2.85–3.05). For non‐CRC mortality risk, RRs ranged from 1.09 (95% CI: 1.04–1.15) to 2.79 (95% CI: 2.70–2.89). We did not perform meta‐analysis due to a limited number of papers reporting suitable results for each type of f‐Hb test. Conclusions: All‐cause, non‐CRC and cause‐specific mortality appear higher in those with raised f‐Hb. Population‐based studies are warranted to elicit whether this association occurs in symptomatic patients. [ABSTRACT FROM AUTHOR]

Summary: Background: Drug‐induced liver injury (DILI) is a major concern for oncology drugs in clinical practice and under development. Monitoring cancer patients for hepatotoxicity is challenging as these patients may have abnormal liver tests pre‐treatment or on‐study for many reasons including liver injury due to past oncology treatments, hepatic metastases, medical co‐morbidities such as heart failure, and concomitant medications. At present, there are no regulatory guidelines or position papers that systematically address best practices pertaining to DILI detection, assessment and management in oncology patients. Aims: The goals of this review are (1) to examine and interpret the available evidence and (2) to make recommendations for detection, monitoring, adjudication, and management of suspected hepatocellular DILI during oncology clinical trials. Methods: This manuscript was developed by the IQ Consortium (International Consortium for Innovation and Quality in pharmaceutical development) DILI Initiative that consists of members from 17 pharmaceutical companies, in collaboration with academic and regulatory DILI experts. The manuscript is based on extensive literature review, expert interpretation of the literature, and several rounds of consensus discussions. Results: This review highlights recommendations for patient eligibility for clinical trials with or without primary/metastatic liver involvement, as well as changes in liver tests that should trigger increased monitoring and/or discontinuation of study drug. Guidance regarding causality assessment for suspected DILI events, rechallenge and dose‐modification is provided. Conclusions: This review brings together evidence‐based recommendations and expert opinion to provide the first dedicated consensus for best practices in detection, assessment, and management of DILI in oncology clinical trials. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Ogawa et al papers. To view these articles, visit https://doi.org/10.1111/apt.17107 and https://doi.org/10.1111/apt.17693. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Lui et al papers. To view these articles, visit https://doi.org/10.1111/apt.17654 and https://doi.org/10.1111/apt.17713 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Magherman et al papers. To view these articles, visit https://doi.org/10.1111/apt.17388 and https://doi.org/10.1111/apt.17738 [ABSTRACT FROM AUTHOR]

Dr Nick Kennedy stepped down from his position as Associate Editor with responsibility for IBD-related papers and was replaced by Dr Sree Subramanian. Randomised clinical trial: semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging. Welcome to the first edition of I AP&T i for 2023. [Extracted from the article]

LINKED CONTENT: This article is linked to Ogawa et al papers. To view these articles, visit https://doi.org/10.1111/apt.17107 and https://doi.org/10.1111/apt.17668 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Chuah et al papers. To view these articles, visit https://doi.org/10.1111/apt.17567 and https://doi.org/10.1111/apt.17634 [ABSTRACT FROM AUTHOR]

Background: Standard clinical methods of assessing volume and providing resuscitation are not always applicable to patients with advanced or decompensated cirrhosis. Despite this being well known from a clinical perspective, there remains relatively little evidence to guide clinicians though fluid management in patients with cirrhosis and, often, multi-organ system dysfunction. Aims: This review summarises the current understanding of the circulatory dysfunction in cirrhosis, modalities for assessing volume status, and considerations for fluid selection. It additionally provides a practical approach to fluid resuscitation. Methods: We review current literature on cirrhosis pathophysiology in steady-state and shock, clinical implications of fluid resuscitation, and strategies to assess intravascular volume. Literature reviewed here was identified by the authors through PubMed search and review of selected papers' references. Results: Clinical management of resuscitation in advanced cirrhosis remains relatively stagnant. Although several trials have attempted to establish the superior resuscitative fluid, the lack of improvement in hard clinical outcomes leaves clinicians without clear guidance. Conclusions: The absence of consistent evidence for fluid resuscitation in patients with cirrhosis limits our ability to produce a clearly evidence-based protocol for fluid resuscitation in cirrhosis. However, we propose a preliminary practical guide to managing fluid resuscitation in patients with decompensated cirrhosis. Further studies are needed to develop and validate volume assessment tools in the specific context of cirrhosis, while randomised clinical trials of protocolized resuscitation may improve care of this patient population. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Ikegami et al papers. To view these articles, visit https://doi.org/10.1111/apt.17387 and https://doi.org/10.1111/apt.17420 [ABSTRACT FROM AUTHOR]

Summary: Background: The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected drug‐induced liver injury (DILI) compared to patients with healthy livers. However, currently no regulatory guidelines or position papers systematically address best practices pertaining to DILI in NASH clinical trials. Aims: This publication focuses on best practices concerning the detection, monitoring, diagnosis and management of suspected acute DILI during clinical trials in patients with NASH. Methods: This is one of several papers developed by the IQ DILI Initiative, comprised of members from 15 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. This paper is based on extensive literature review, and discussions between industry members with expertise in drug safety and DILI experts from outside industry to achieve consensus on common questions related to this topic. Results: Recommended best practices are outlined pertaining to hepatic inclusion and exclusion criteria, monitoring of liver tests, DILI detection, approach to a suspected DILI signal, causality assessment and hepatic discontinuation rules. Conclusions: This paper provides a framework for the approach to assessment and management of suspected acute DILI during clinical trials in patients with NASH. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Kayal et al papers. To view these articles, visit https://doi.org/10.1111/apt.17731 and https://doi.org/10.1111/apt.17806 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Kochhar et al papers. To view these articles, visit https://doi.org/10.1111/apt.17570 and https://doi.org/10.1111/apt.17697 [ABSTRACT FROM AUTHOR]

Summary: Background: Anorectal malformations (ARMs) are congenital anomalies of the anorectum and the genitourinary system that result in a broad spectrum of hindgut anomalies. Despite surgical correction patients continue to have late postoperative genitourinary and colorectal dysfunction that have significant impact on quality of life. Aim: This paper will review the current evidence and discuss the evaluation and management of postoperative patients with ARMs who present with persistent defecation disorder. Methods: A literature search was conducted using PubMed/MEDLINE/EMBASE databases applying the following terms: ARMs, imperforate anus, constipation, faecal incontinence, neurogenic bowel, posterior sagittal anorectoplasty. Results: Patients who present with postoperative defecation disorders require timely diagnostic and surgical evaluation for anatomic abnormalities prior to initiation of bowel management. Goals of management are to avoid constipation in young children, achieve faecal continence in early childhood and facilitate independence in older children and adolescents. Treatment options vary from high dose stimulant laxatives to high‐volume retrograde and antegrade enemas that facilitate mechanical colonic emptying. Conclusions: Appropriate diagnostic work‐up and implementation of treatment can decrease long‐term morbidity and improve quality of life in postoperative patients with ARMs who presents with defecation disorders. [ABSTRACT FROM AUTHOR]

Summary: Background: Metabolic dysfunction‐associated steatotic liver disease (MASLD) is the most common cause of chronic liver disease. Its prevalence is increasing with the epidemic of obesity and metabolic syndrome. MASLD progression into metabolic dysfunction‐associated steatohepatitis (MASH) and advanced fibrosis may lead to decompensated cirrhosis and development of liver‐related events, hepatocellular carcinoma and death. Monitoring disease progression is critical in decreasing morbidity, mortality, need for transplant and economic burden. Assessing for treatment response once FDA‐approved medications are available is still an unmet clinical need. Aims: To explore the most up‐to‐date literature on testing used for monitoring disease progression and treatment response Methods: We searched PubMed from inception to 15 August 2023, using the following MeSH terms: 'MASLD', 'Metabolic dysfunction‐associated steatotic liver disease', 'MASH', 'metabolic dysfunction‐associated steatohepatitis', 'Non‐Alcoholic Fatty Liver Disease', 'NAFLD', 'non‐alcoholic steatohepatitis', 'NASH', 'Biomarkers', 'clinical trial'. Articles were also identified through searches of the authors' files. The final reference list was generated based on originality and relevance to this review's broad scope, considering only papers published in English. Results: We have cited 101 references in this review detailing methods to monitor MASLD disease progression and treatment response. Conclusion: Various biomarkers can be used in different care settings to monitor disease progression. Further research is needed to validate noninvasive tests more effectively. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Dhanda et al papers. To view these articles, visit https://doi.org/10.1111/apt.17307 and https://doi.org/10.1111/apt.17335 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Myojin.et al's paper. To view this article, visit https://doi.org/10.1111/apt.16691 and https://doi.org/10.1111/apt.16862. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Parkman et al papers. To view these articles, visit https://doi.org/10.1111/apt.17479 and https://doi.org/10.1111/apt.17800 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Staller et al papers. To view these articles, visit https://doi.org/10.1111/apt.17736 and https://doi.org/10.1111/apt.17820 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Kuo et al papers. To view these articles, visit https://doi.org/10.1111/apt.17637 and https://doi.org/10.1111/apt.17759 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Cheng et al papers. To view these articles, visit https://doi.org/10.1111/apt.17765 and https://doi.org/10.1111/apt.17793 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Parkman et al papers. To view these articles, visit https://doi.org/10.1111/apt.17479 and https://doi.org/10.1111/apt.17838 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Cheng et al papers. To view these articles, visit https://doi.org/10.1111/apt.17765 and https://doi.org/10.1111/apt.17807 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Petroni et al papers. To view these articles, visit https://doi.org/10.1111/apt.17768 and https://doi.org/10.1111/apt.17810 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Mayo et al papers. To view these articles, visit https://doi.org/10.1111/apt.17755 and https://doi.org/10.1111/apt.17798 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Riggott et al paper. To view this article, visit https://doi.org/10.1111/apt.17735 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Kuo et al papers. To view these articles, visit https://doi.org/10.1111/apt.17637 and https://doi.org/10.1111/apt.17825 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Tyson et al papers. To view these articles, visit https://doi.org/10.1111/apt.17733 and https://doi.org/10.1111/apt.17786 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Sawada et al paper. To view this article, visit https://doi.org/10.1111/apt.17773 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Bokemeyer et al papers. To view these articles, visit https://doi.org/10.1111/apt.17616 and https://doi.org/10.1111/apt.17770 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to van de Meeberg et al papers. To view these articles, visit https://doi.org/10.1111/apt.17719 and https://doi.org/10.1111/apt.17743 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Chen et al papers. To view these articles, visit https://doi.org/10.1111/apt.17602 and https://doi.org/10.1111/apt.17767 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Lenfant et al paper. To view this article, visit https://doi.org/10.1111/apt.17753 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Tyson et al papers. To view these articles, visit https://doi.org/10.1111/apt.17733 and https://doi.org/10.1111/apt.17771 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Staller et al paper. To view this article, visit https://doi.org/10.1111/apt.17736 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Bokemeyer et al papers. To view these articles, visit https://doi.org/10.1111/apt.17616 and https://doi.org/10.1111/apt.17796 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Harrison et al paper. To view this article, visit https://doi.org/10.1111/apt.17734 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Chen et al papers. To view these articles, visit https://doi.org/10.1111/apt.17602 and https://doi.org/10.1111/apt.17788 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to van de Meeberg et al papers. To view these articles, visit https://doi.org/10.1111/apt.17719 and https://doi.org/10.1111/apt.17795 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Borup et al paper. To view this article, visit https://doi.org/10.1111/apt.17739 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Li et al papers. To view these articles, visit https://doi.org/10.1111/apt.17718 and https://doi.org/10.1111/apt.17760 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Kim et al papers. To view these articles, visit https://doi.org/10.1111/apt.17726 and https://doi.org/10.1111/apt.17757 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Williams et al paper. To view this article, visit https://doi.org/10.1111/apt.17732 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Janssen et al papers. To view these articles, visit https://doi.org/10.1111/apt.17718 and https://doi.org/10.1111/apt.17745 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Kim et al papers. To view these articles, visit https://doi.org/10.1111/apt.17726 and https://doi.org/10.1111/apt.17780 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Dignass et al papers. To view these articles, visit https://doi.org/10.1111/apt.17622 and https://doi.org/10.1111/apt.17717 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Li et al papers. To view these articles, visit https://doi.org/10.1111/apt.17718 and https://doi.org/10.1111/apt.17784 [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Cheung et al papers. To view these articles, visit https://doi.org/10.1111/apt.17722 and https://doi.org/10.1111/apt.17744 [ABSTRACT FROM AUTHOR]