BMJ Open Gastroenterology最新文献

{"title":"Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis.","authors":"Séverine Vermeire, David T Rubin, Laurent Peyrin-Biroulet, Marla C Dubinsky, Miguel Regueiro, Peter M Irving, Martina Goetsch, Krisztina Lazin, Guibao Gu, Joseph Wu, Irene Modesto, Aoibhinn McDonnell, Xiang Guo, Jesse Green, Alexis B Dalam, Andres J Yarur","doi":"10.1136/bmjgast-2024-001516","DOIUrl":"10.1136/bmjgast-2024-001516","url":null,"abstract":"<p><strong>Objective: </strong>Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)_1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). S1P₁ receptor expression on cardiac cells is involved in cardiac conduction. We report cardiovascular treatment-emergent adverse events (TEAEs) associated with S1P receptor modulators and other cardiovascular events in the etrasimod UC clinical programme.</p><p><strong>Methods: </strong>Patients were analysed in the Placebo-controlled UC cohort and All UC cohort. Incidence rates (IRs, per 100 patient-years) of cardiovascular-related TEAEs associated with S1P receptor modulators, including bradycardia/atrioventricular (AV) block and hypertension, and other cardiovascular events, including coronary artery disease (CAD) and cerebrovascular disease (CVD), were analysed.</p><p><strong>Results: </strong>In patients receiving etrasimod, cardiovascular-related TEAEs were infrequent (≤2.6% per AE). In the Placebo-controlled UC cohort, IRs (95% CIs) for cardiovascular-related TEAEs were higher for patients receiving etrasimod (n=577) vs placebo (n=314), respectively, for bradycardia/sinus bradycardia, 3.85 (1.58 to 6.13) vs 0 and AV block, 1.40 (0.03 to 2.76) vs 0; and numerically higher for hypertension, 5.31 (2.62 to 7.99) vs 3.40 (0.07 to 6.72). Most bradycardia/AV block events were reported on day 1. All bradycardia and hypertension TEAEs were non-serious. One serious second-degree AV block type 1 TEAE occurred in the etrasimod group; no events of second-degree AV block type 2 or higher were reported. One event each of CAD and CVD occurred in two patients receiving etrasimod.</p><p><strong>Conclusions: </strong>In the etrasimod UC clinical programme, IRs of cardiovascular-related TEAEs and other cardiovascular events were low. Most cardiovascular-related TEAEs were non-serious.</p><p><strong>Trial registration numbers: </strong>NCT02447302; NCT03945188; NCT03996369; NCT02536404; NCT03950232; NCT04176588.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the pathological and clinical implications of errors made by an artificial intelligence colon biopsy screening tool.","authors":"Harriet Evans, Naveen Sivakumar, Shivam Bhanderi, Simon Graham, David Snead, Abhilasha Patel, Andrew Robinson","doi":"10.1136/bmjgast-2024-001649","DOIUrl":"10.1136/bmjgast-2024-001649","url":null,"abstract":"<p><strong>Objective: </strong>Artificial intelligence (AI) tools for histological diagnosis offer great potential to healthcare, yet failure to understand their clinical context is delaying adoption. IGUANA (Interpretable Gland-Graphs using a Neural Aggregator) is an AI algorithm that can effectively classify colonic biopsies into normal versus abnormal categories, designed to automatically report normal cases. We performed a retrospective pathological and clinical review of the errors made by IGUANA.</p><p><strong>Methods: </strong>False negative (FN) errors were the primary focus due to the greatest propensity for harm. Pathological evaluation involved assessment of whole slide image (WSI) quality, precise diagnoses for each missed entity and identification of factors impeding diagnosis. Clinical evaluation scored the impact of each error on the patient and detailed the type of impact in terms of missed diagnosis, investigations or treatment.</p><p><strong>Results: </strong>Across 5054 WSIs from 2080 UK National Health Service patients there were 220 FN errors across 164 cases (4.4% of WSI, 7.9% of cases). Diagnostic errors varied from cases of adenocarcinoma to mild inflammation. 88.4% of FN errors would have no impact on patient care, with only one error causing major patient harm. Factors that protected against harm included biopsies being low-risk polyps or diagnostic features were detected in other biopsies.</p><p><strong>Conclusion: </strong>Most FN errors would not result in patient harm, suggesting that even with a 7.9% case-level error rate, this AI tool might be more suitable for adoption than statistics portray. Consideration of the clinical context of AI tool errors is essential to facilitate safe implementation.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143000505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can GastroPanel be used as a triage tool to select patients with advanced atrophic gastritis for gastroscopy? A prospective clinical validation study.","authors":"Cinzia Papadia, Laura Marelli, Eleanor Wood, Marco Novelli, Roger Feakins, Kari Juhani Syrjänen, Ray Shidrawi","doi":"10.1136/bmjgast-2024-001559","DOIUrl":"10.1136/bmjgast-2024-001559","url":null,"abstract":"<p><strong>Objective: </strong>Gastric adenocarcinoma (GAC) is the 17th most common cancer in the UK with a 5-year survival rate of 22%. GastroPanel (Biohit Oyj; Helsinki, Finland) is an ELISA kit that measures pepsinogen I (PGI); pepsinogen II (PGII); gastrin-17 (G-17); and Helicobacter pylori IgG antibodies (Hp IgG). PGI and the PGI/PGII ratio correlate inversely with the severity of chronic atrophic gastritis (AG). The aim of this study was to assess GastroPanel performance in the identification of moderate to severe AG in dyspepsia.</p><p><strong>Methods: </strong>In this UK, single-centre, prospective diagnostic accuracy study, 324 patients [56.8% (n=184) female; median age 57 years (range 39-92 years)] were recruited for gastroscopy with biopsy and histology according to the updated Sydney System (USS). Blood (plasma) samples were collected for GastroPanel analysis. Paired samples were obtained from 268 patients [56.3% (n=151) female; median age=57 (range 39-92 years)]. GastroPanel results were interpreted using the GastroSoft app (Biohit).</p><p><strong>Results: </strong>Overall agreement between GastroPanel and the USS classification was 90% (95% CI=86.7 to 93.8%), with a weighted kappa (κw) of 0.828 (95% CI=0.781 to 0.865). In receiver operating characteristics (ROC) curve analysis, using moderate/severe atrophic gastritis of the corpus (AGC2+) as the endpoint, AUC=0.840 (95% CI 0.630 to 1.000) and 0.960 (95% CI 0.907 to 1.000) for PGI and the PGI/PGII ratio, respectively.</p><p><strong>Conclusion: </strong>GastroPanel is a reliable dyspepsia triage test distinguishing patients who can be safely treated conservatively from those with moderate to severe corpus atrophic gastritis at high risk of developing GAC.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143000490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence of gallstone disease in Africa: a systematic review and meta-analysis.","authors":"Seid Mohammed Abdu, Ebrahim Msaye Assefa","doi":"10.1136/bmjgast-2024-001441","DOIUrl":"10.1136/bmjgast-2024-001441","url":null,"abstract":"<p><strong>Objective: </strong>Gallstone disease is a prevalent global health issue, but its impact in Africa remains unclear. This study aims to summarise and synthesise available data on the prevalence of gallstone disease across populations in Africa.</p><p><strong>Design: </strong>Systematic review and meta-analysis, reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.</p><p><strong>Data sources: </strong>PubMed, Google Scholar, Hinari, and African Journal Online were searched, from 2000 up to 31 December 2023.</p><p><strong>Eligibility criteria: </strong>The review included all observational studies that reported the prevalence of gallstone disease and were published in English.</p><p><strong>Data extraction and synthesis: </strong>Two independent reviewers extracted data and assessed the risk of bias using the Joanna Briggs Institute (JBI) tool. Data were pooled using a random-effects and inverse variance method, with 95% confidence intervals (95% CI) calculated. Heterogeneity was assessed using the Cochran Q statistic and quantified with the I² statistic.</p><p><strong>Results: </strong>A total of 260 studies were identified from electronic databases, with 10 meeting the inclusion criteria. The combined prevalence of gallstone disease was 17% (95% CI 9% to 24%), but with high statistical heterogeneity (I²=99.9%). Only 8 of the 10 included studies provided prevalence data by sex, showing notably higher rates in females (15.3%) compared with males (3.7%).</p><p><strong>Conclusion: </strong>The study reveals a pooled gallstone disease prevalence of 17% in Africa, with higher rates in females. However, the significant heterogeneity, the lack of data from most countries and an imbalance in data from other countries, the diverse study populations, and the limited number of studies necessitate cautious interpretation. Future policies and interventions should prioritise reducing gallstone disease, particularly in females, while addressing the variability in data sources.</p><p><strong>Prospero registration number: </strong>CRD42024503530.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic factors for transplant-free survival in patients with secondary sclerosing cholangitis associated with critical illness.","authors":"Georgios Konstantis, Dorsa Ghaffar Loy Moghadam, Alexandra Frey, Nargiz Nuruzade, Christoph Schramm, Christian Gerges, Christian M Lange, Hartmut Schmidt, Katharina Willuweit, Alisan Kahraman, Moritz Passenberg, Jassin Rashidi-Alavijeh","doi":"10.1136/bmjgast-2024-001571","DOIUrl":"10.1136/bmjgast-2024-001571","url":null,"abstract":"<p><strong>Objective: </strong>Secondary sclerosing cholangitis (SSC) represents a disease with a poor prognosis increasingly diagnosed in clinical settings. Notably, SSC in critically ill patients (SSC-CIP) is the most frequent cause. Variables associated with worse prognosis remain unclear. The primary aim of this study was to identify factors associated with transplant-free survival in SSC-CIP patients using readily available data.</p><p><strong>Methods: </strong>A cohort of 47 patients diagnosed with SSC-CIP was retrospectively analysed for clinical, biochemical and endoscopic variables. Kaplan-Meier survival curves, log-rank tests and univariate Cox proportional hazards models were used to assess associations with transplant-free survival. A multivariable Cox regression model was constructed using Lasso regularisation and validated with Bootstrap resampling. Model performance was assessed using the C-statistic for discrimination.</p><p><strong>Results: </strong>Kaplan-Meier analysis identified bile duct obstruction requiring stent placement, and cholangitis episodes, as significant prognostic factors. In univariable analysis, age over 47 years (HR 2.61 (95% CI 1.02, 7.06), p=0.04), at least one cholangitis episode (HR 2.46 (95% CI 1.005, 6.06), p=0.04), stent placement (HR 2.89 (95% CI 1.13, 7.38), p=0.03), lower albumin levels (HR 0.52 (95% CI 0.28, 0.97), p=0.04) and higher international normalised ratio (INR) (HR 3.22 (95% CI 1.09, 9.53), p=0.03) were significant. Multivariable analysis showed that age at diagnosis, albumin and INR were significant independent predictors. The C-index was 0.78 (95% CI 0.65, 0.91), surpassing the model of end-stage liver disease score's prognostic accuracy (Concordance Index at 3 years: 66.2% vs 74.9%).</p><p><strong>Conclusion: </strong>These findings provide valuable insights for establishing standard exception criteria for this rare liver disease, which could lead to improved organ allocation. Further prospective multicentre studies are necessary to validate our findings.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748924/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world analysis of acamprosate use in patients with cirrhosis and alcohol-associated hepatitis.","authors":"Christopher Oldroyd, Jonathan Wood, Michael Allison","doi":"10.1136/bmjgast-2024-001654","DOIUrl":"10.1136/bmjgast-2024-001654","url":null,"abstract":"<p><strong>Objective: </strong>Preventing return to alcohol is of critical importance for patients with alcohol-related cirrhosis and/or alcohol-associated hepatitis. Acamprosate is a widely used treatment for alcohol use disorder (AUD). We assessed the impact of acamprosate prescription in patients with advanced liver disease on abstinence rates and clinical outcomes.</p><p><strong>Methods: </strong>This was a retrospective case-control study. We reviewed data on all patients admitted to a large tertiary centre in the UK with alcohol-related cirrhosis and/or alcohol-associated hepatitis. We used propensity risk score matching to match patients prescribed acamprosate to controls. The primary outcome was repeat hospitalisation.</p><p><strong>Results: </strong>There were 451 patients who met the inclusion criteria of whom 55 patients were started on acamprosate during their admission. Before matching there were significant differences between the cohorts. Patients who received acamprosate were younger (median age 51 vs 57, p<0.005), more likely to have a purely alcohol-related admission (53% vs 24%, p<0.001), and more likely to suffer from a comorbid psychiatric diagnosis (42% vs 20%, p<0.001). On average patients who were started on acamprosate consumed more alcohol (median 155 units/week vs 80 units/week, p<0.001), were less likely to have a partner (35% vs 54%, p 0.006) and more likely to be unemployed (67% vs 44%, p<0.001). After matching for factors with significant differences between groups, we generated a cohort of 53 patients prescribed acamprosate and 53 matched controls. At 1 year there was a significantly higher rate of readmission (85% vs 57%, p<0.001) in the acamprosate group. There were no statistically significant differences in abstinence rates or mortality at 1 year.</p><p><strong>Conclusion: </strong>Acamprosate prescription was associated with higher rates of readmission in patients with cirrhosis and/or alcohol-associated hepatitis. This may reflect a greater severity of AUD in those patients or might indicate the limited ability of acamprosate to alter the disease course in this population.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667394/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Helicobacter pylori</i> infection and staple-line leak in patients with class III obesity undergoing laparoscopic sleeve gastrectomy: a retrospective study.","authors":"Albaraa H Kazim, Fahad Y Bamehriz, Aldanah M Althwanay, Abdullah Aldohayan, Al-Bandari Zamil Abdullah, Bandar AlShehri, Rakan Masoud AlTuwayr, Habeeb I A Razack, Hani Tamim, Fahad Alsohaibani, Saleh A Alqahtani","doi":"10.1136/bmjgast-2024-001622","DOIUrl":"10.1136/bmjgast-2024-001622","url":null,"abstract":"<p><strong>Objective: </strong>Globally, over 50% of the population is affected by <i>Helicobacter pylori</i>, yet research on its prevalence and impact in patients with obesity undergoing laparoscopic sleeve gastrectomy (LSG) is inconclusive. This study aimed to assess the prevalence of <i>H. pylori</i> infection in individuals with obesity undergoing LSG, evaluate the percentage of postoperative staple-line leaks, and explore the potential link between <i>H. pylori</i> infection and staple-line leaks.</p><p><strong>Methods: </strong>This retrospective analysis assessed adult patients with class III obesity who underwent LSG between 2015 and 2020 at a tertiary care hospital in Riyadh, Saudi Arabia. Patient characteristics with and without postoperative staple-line leaks were compared, exploring the link between <i>H. pylori</i> infection and these leaks.</p><p><strong>Results: </strong>Of the 2099 patients (mean age, 34.7±12.2 years; female, 53.5%) included, 35% had <i>H. pylori</i> infection and 2% experienced post-LSG staple-line leaks. Patients with <i>H. pylori</i> were older (36.1±11.8 vs 34.0±12.3 years, p<0.0001). Patients with leaks were older, mostly male, and had higher body mass index (p<0.05). However, only 29% of those with leaks were <i>H. pylori</i>-positive. A non-significant association was found between <i>H. pylori</i> infection and staple-line leaks (adjusted OR 0.73, 95% CI 0.33 to 1.60, accounting for age, body mass index, and sex).</p><p><strong>Conclusions: </strong>Although over one-third of patients with class III obesity undergoing LSG had <i>H. pylori</i> infection, a non-significant association was observed with post-LSG staple-line leaks, suggesting routine preoperative <i>H. pylori</i> screening may not be necessary.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Economic evaluation of proton pump inhibitors in patients with gastro-oesophageal reflux disease: a systematic review.","authors":"Seidamir Pasha Tabaeian, Sajad Moeini, Aziz Rezapour, Somayeh Afshari, Aghdas Souresrafil, Mohammad Barzegar","doi":"10.1136/bmjgast-2024-001465","DOIUrl":"10.1136/bmjgast-2024-001465","url":null,"abstract":"<p><strong>Objectives: </strong>Our aim was to systematically review the cost-effectiveness of proton pump inhibitor (PPI) therapies and surgical interventions for gastro-oesophageal reflux disease (GORD).</p><p><strong>Design: </strong>The study design was a systematic review of economic evaluations.</p><p><strong>Data sources: </strong>We searched PubMed, Embase, Scopus, and Web of Science for publications from January 1990 to March 2023. Only articles published in English were eligible for inclusion.</p><p><strong>Eligibility criteria: </strong>Studies were included if they were full economic evaluations comparing PPIs with surgical or alternative therapies for GORD. Excluded were narrative reviews, non-peer-reviewed articles, and studies not reporting cost-effectiveness outcomes.</p><p><strong>Data extraction and synthesis: </strong>Two reviewers independently extracted data on study design, comparators, time horizon, and cost-effectiveness outcomes. The quality of studies was assessed using the Joanna Briggs Institute (JBI) checklist for economic evaluations.</p><p><strong>Results: </strong>A total of 25 studies met the inclusion criteria. Laparoscopic Nissen fundoplication (LNF) was found to be cost-effective in long-term horizons, while PPIs were preferred for short- to medium-term outcomes. Differences in healthcare settings and methodological approaches influenced the study findings.</p><p><strong>Conclusions: </strong>Strategic purchasing decisions for GORD treatment should consider the time horizon, healthcare setting, and cost structures. LNF may provide better long-term value, but PPIs remain effective for managing symptoms in the short term.</p><p><strong>Study registration: </strong>PROSPERO, CRD42023474181.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimising fatigue, abdominal pain and faecal incontinence in people with inflammatory bowel disease (IBD-BOOST Optimise): feasibility study of a checklist and algorithm for initial nurse-led management.","authors":"Imogen Stagg, Ailsa Hart, Fionn Cléirigh Büttner, Asma Fikree, John McLaughlin, Jean-Frederic LeBlanc, Sonia Bouri, Thomas Hamborg, Laura Miller, Christine Norton","doi":"10.1136/bmjgast-2024-001585","DOIUrl":"10.1136/bmjgast-2024-001585","url":null,"abstract":"<p><strong>Objective: </strong>Many people with inflammatory bowel disease (IBD) experience fatigue, pain and faecal incontinence that some feel are inadequately addressed. It is unknown how many have potentially reversible medical issues underlying these symptoms.</p><p><strong>Methods: </strong>We conducted a study testing the feasibility of a patient-reported symptom checklist and nurse-administered management algorithm ('Optimise') to manage common medical causes of IBD-related fatigue, pain and faecal incontinence. We conducted qualitative interviews with nurses implementing the algorithm.</p><p><strong>Results: </strong>515 individuals reporting IBD-related symptoms were invited to participate, of whom 201 (39%) consented. 194/201 (97%) returned the symptom checklist, of whom 157 (81%) returned a postal faecal calprotectin sample. Five (3%) participants reported 'red flags' and 31/157 (20%) participants had a faecal calprotectin result ≥200 µg/g, of whom 12 (8%) were judged to have likely active inflammation when clinical symptoms and disease history were reviewed. The algorithm suggested at least one clinical test or intervention for fatigue, pain or faecal incontinence in 67 (43%) participants, of whom 25 (37%) declined. Among 87 participants for whom clinical actions were indicated, 57 (66%) completed follow-up outcomes 3 months after algorithm implementation. Three nurses interviewed found the Optimise algorithm easy to administer.</p><p><strong>Conclusion: </strong>Implementing the Optimise checklist and algorithm appears feasible in UK clinical practice, with adjustments needed to minimise missing items. Not all patients accepted algorithm-indicated interventions, but a yield of 43% with symptoms having potentially reversible causes detected is clinically useful. Nurses endorsed ease and utility of the implementation process. Optimise now needs clinical effectiveness to be assessed.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Parallel randomised trial testing community fibrosis assessment for suspected non-alcoholic fatty liver disease: outcomes from LOCATE-NAFLD.","authors":"Ruth Tulleners, Adrian Barnett, James O'Beirne, Elizabeth Powell, Ingrid J Hickman, Patricia C Valery, Sanjeewa Kularatna, Katherine Stuart, Carolyn McIvor, Elen Witness, Melanie Aikebuse, David Brain","doi":"10.1136/bmjgast-2024-001418","DOIUrl":"10.1136/bmjgast-2024-001418","url":null,"abstract":"<p><strong>Objective: </strong>Non-alcoholic fatty liver disease (NAFLD) is estimated to affect a third of Australian adults, and its prevalence is predicted to rise, increasing the burden on the healthcare system. The LOCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD) trialled a community-based fibrosis assessment service using FibroScan to reduce the time to diagnosis of high-risk NAFLD and improve patient outcomes.</p><p><strong>Methods: </strong>We conducted a 1:1 parallel randomised trial to compare two alternative models of care for NAFLD diagnosis and assessment. Participants had suspected NAFLD and were referred to a hepatology clinic in one of three major hospitals in South-East Queensland. Eligible consenting participants were randomised to receive usual care or the intervention (LOCATE). Participants in the intervention arm received a FibroScan outside of the hospital setting, with results provided to their primary care provider and the referring hepatologist. All participants were followed up 12 months after randomisation to measure their clinical and patient-reported outcomes.</p><p><strong>Results: </strong>97 participants were recruited from October 2020 to December 2022. Of the 50 participants randomised to the intervention arm, one failed to attend their appointment, and of the 48 (98%) who had a FibroScan 13 (27%) had a liver stiffness measurement of 8.0 kPa or greater. The HR for the time to diagnosis of high risk was 1.28 (95% CI 0.59 to 2.79), indicating a faster average time to diagnosis with the intervention, but failing to conclusively demonstrate a faster time. The intervention did greatly reduce the time to FibroScan by almost 1 year (median difference 0.92 years, 95% CI 0.56 to 1.45). Other clinical outcomes showed minimal changes.</p><p><strong>Conclusion: </strong>The LOCATE model shows potential for impact, particularly in reducing waiting times for patients at high risk of developing severe liver disease due to NAFLD. A larger sample and longer follow-ups are needed to measure additional clinical outcomes.</p><p><strong>Trial registration number: </strong>ACTRN12620000158965.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664381/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}