BMJ Open Gastroenterology最新文献

Objectives: Patients have difficulties in understanding how to manage their liver cirrhosis. This highlights a need for support in comprehending health-related information, which remains largely lacking within liver cirrhosis care. Involvement of registered nurses (RNs) in outpatient liver cirrhosis care has potential to improve quality of care and reduce patient mortality. However, the benefits of nursing care on patients' health-related quality of life (HRQoL) are scarcely studied. This study compared HRQoL in patients receiving either standard medical outpatient care or adjunctive, nurse-led care. The risk of malnutrition, decompensation events and mortality were also compared between the two study groups.

Methods: This was a pragmatic, multicentre, randomised trial, which enrolled 167 patients with liver cirrhosis. The primary outcome measure, HRQoL, was assessed using the RAND-36 questionnaire. The physical component summary (PCS) and the mental component summary (MCS) scores of RAND-36 were compared, using linear mixed-effects models for repeated measures, at 12 and 24 months.

Results: 83 patients received standard medical care, and 84 patients received adjunctive, nurse-led care for 24 months. Due to unforeseen circumstances, the final study population of 167 participants was less than the intended 500. Group comparisons were non-significant of the PCS and MCS scores (-1.1, p=0.53 and -0.7, p=0.67, respectively), malnutrition (p=0.62) and decompensation events (p=0.46), after 24 months. However, mortality was three times higher in the control group compared with the intervention group (12 vs 4, p=0.04) after 24 months.

Conclusions: In this study, adjunctive nurse-led care was not superior to standard medical outpatient care regarding HRQoL, risk of developing malnutrition or decompensation. However, RN involvement contributed to early identification of decompensation and reduced mortality.

Trial registration number: NCT02957253.

Objective: To develop and validate a prognostic model for risk-stratified monitoring of 5-aminosalicylate nephrotoxicity.

Methods: This UK retrospective cohort study used data from the Clinical Practice Research Datalink Aurum and Gold for model development and validation respectively. It included adults newly diagnosed with inflammatory bowel disease and established on 5-aminosalicylic acid (5-ASA) treatment between 1 January 2007 and 31 December 2019. Drug discontinuation associated with 5-ASA nephrotoxicity defined as a prescription gap of ≥90 days with decline in kidney function was the outcome. Patients prescribed 5-ASAs for ≥6 months were followed-up for up to 5 years. Penalised Cox regression was used to develop the risk equation with bootstrapping for internal validation and optimism adjustment. Model performance was assessed in terms of calibration and discrimination.

Results: 13 728 and 7318 participants who contributed 40 378 and 20 679 person-years follow-up formed the development and validation cohorts with 170 (1.2%) and 98 (1.3%) outcome events respectively. Nine predictors were included in the final model, including chronic kidney disease stage 3 and hazardous alcohol use as strong predictors. Age and Body Mass Index were weak predictors. The optimism-adjusted calibration slope, C and D statistics in the development and validation data were 0.90, 0.64 and 0.98, and 1.01, 0.66 and 0.94 respectively.

Conclusion: This prognostic model used information from routine clinical care and performed well in an independent validation cohort. It can be used to risk-stratify blood test monitoring during established 5-ASA treatment. A key limitation is that the decline in kidney function could have been due to factors other than 5-ASA nephrotoxicity.

Objective: The emergence of resistance-associated substitutions (RASs) poses a significant challenge to the effective treatment of hepatitis C virus (HCV) infection using direct-acting antivirals. This study's objective was to observe the prevalence of HCV genotypes and RAS within the Former Soviet Union (FSU) countries.

Methods: We analysed 60 NS3, 313 NS5A and 1119 NS5B sequences of HCV deposited in open-access databases from 11 FSU countries for the prevalence of genotypes and the presence of RAS using the Geno2Pheno software.

Results: The following NS3 RASs were revealed through our analyses: 156P/S/T, 168del, 80K, 55A and 174S. The most prevalent NS5A RAS was 30K (12.69%) in genotype 3a, associated with resistance to daclatasvir, elbasvir and ledipasvir, followed by 62S (8.96% in genotype 3a), linked with resistance to daclatasvir, and 93H (3.95% and 6.72% in genotypes 1b and 3a, respectively), conferring resistance to daclatasvir, ombitasvir, elbasvir, ledipasvir and velpatasvir. The NS5B RASs found in this study were 451S and 556G, associated with resistance to dasabuvir.

Conclusion: The high prevalence of HCV genotypes 1b and 3a in the FSU region and the presence of specific RASs should be considered when determining the most effective treatment regimen for HCV-infected individuals in the FSU countries.

Objective: It is controversial whether rapid lowering of triglyceride (TG) levels is associated with clinical benefits in patients with hypertriglyceridaemia-associated acute pancreatitis (HTG-AP). In particular, patients with different severity of disease may respond differently to TG-lowering therapy. In this study, we aimed to explore the association between rapid decline in serum TG levels and organ failure in patients with different severities of HTG-AP.

Methods: This is a secondary analysis of data from a multicentre, prospective registry recruiting HTG-AP patients admitted within 72 hours from the onset of symptoms. Patients were dichotomised into either target reaching (TG≤5.65 mmol/L on study day 3) or not. The primary outcome was the presence of organ failure at day 14. The association between target-reaching and the primary outcome was modelled. Furthermore, subgroup analyses were conducted based on the disease severity of HTG-AP patients at enrolment.

Results: Overall, 413 patients were included for analysis, of whom 192 (46.5%) reached the target on day 3. For the overall study cohort, there was no significant difference in presence of organ failure at day 14 between patients reaching the target or not (3.1% vs 6.8%, p=0.091). In the subgroup of HTG-AP patients with organ failure at enrolment, compared with patients with TG>5.65 mmol/L on day 3, patients who reached the target had significantly lower presence of organ failure at day 14 (7.8% vs 22%, p=0.039) and lower incidence of infected pancreatic necrosis within 60 days (3.1% vs 11.9%, p=0.049). Similar findings were seen in the subgroup with more severe HTG-AP (APACHE II ≥8 at enrolment).

Conclusion: More rapid decline of serum TG levels was associated with decreased presence of organ failure at day 14 in patients with more severe HTG-AP.

Trial registration number: The Chinese Clinical Trial Registry, number ChiCTR2000039541.

Objective: The aetiology of pancreatic cancer is complex, and there is limited research on its incidence. We aimed to investigate the incidence trends of pancreatic cancer in 43 countries and predict trends up to 2030.

Methods: The annual incidence of pancreatic cancer was obtained from the Cancer Incidence in Five Continents database, which comprises 108 cancer registries from 43 countries. Based on available data, we calculated age-standardized incidence rates (ASRs) per 100 000 people for 1988-2012. A Bayesian age-period-cohort model was used to predict the number of new cases and incidence rates up to 2030.

Results: From 1988 to 2012, the global incidence rate of pancreatic cancer showed a continuously increasing trend, with the ASR increasing from 5.89 in 1988 to 6.78 in 2012, representing an overall average annual percentage change of 8.45%. This increasing trend is expected to persist in most selected countries, whereas a few countries are projected to exhibit a declining trend by 2030.

Conclusion: It appears that the future global incidence of pancreatic cancer is on the rise, but the rate of increase varies among different countries, with some showing a declining trend.

Objective: Studies in the USA examining the relationship between ethnicity and colorectal cancer (CRC) identified significant variation. This study sought to examine the relationship between ethnic group, route to diagnosis, early-onset CRC and stage at diagnosis in the English National Health Service.

Methods: Data from COloRECTal cancer data Repository for all individuals diagnosed with CRC (International Classification of Diseases version 10, C18-C20) between 2012 and 2017. A descriptive analysis of the characteristics of the study population was performed. Multivariable logistic regression models were used to assess the association between ethnicity, route to diagnosis, stage at diagnosis and early-onset CRC.

Results: Early-onset CRC was least common in those in the white ethnic group (5.5% diagnosed <50, vs 17.9% in the Asian, 15.5% in the black and 21.8% in the mixed and multiple ethnic groups, p<0.01). Diagnosis following a 2-week wait referral was significantly less common among individuals from the Asian, black, other and unknown ethnic groups than the white ethnic group (Asian OR 0.84, 95% CI 0.79 to 0.91, black OR 0.86, 95% CI 0.79 to 0.93, other OR 0.81, 95% CI 0.73 to 0.90 and unknown OR 0.70, 95% CI 0.66 to 0.73). The Asian ethnic group had significantly lower odds of emergency diagnosis than the white ethnic group (OR 0.90, 95% CI 0.83 to 0.97). Following adjustment, individuals from the Asian ethnic group were significantly less likely, than their white counterparts, to be diagnosed at stage IV (OR 0.82, 95% CI 0.76 to 0.88).

Conclusion: This study identified different demographic profiles of those diagnosed with CRC between broad ethnic groups, highlighting the need to consider access to diagnostic CRC services in the context of ethnicity.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: In the etrasimod UC clinical programme, IRs of cardiovascular-related TEAEs and other cardiovascular events were low. Most cardiovascular-related TEAEs were non-serious.

Trial registration numbers: NCT02447302; NCT03945188; NCT03996369; NCT02536404; NCT03950232; NCT04176588.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Objective: 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.

Methods: 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).

Results: 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.

Conclusion: 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.

Objective: 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.

Design: Systematic review and meta-analysis, reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.

Data sources: PubMed, Google Scholar, Hinari, and African Journal Online were searched, from 2000 up to 31 December 2023.

Eligibility criteria: The review included all observational studies that reported the prevalence of gallstone disease and were published in English.

Data extraction and synthesis: 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.

Results: 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%).

Conclusion: 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.

Prospero registration number: CRD42024503530.