BMJ Open Gastroenterology最新文献

Objective: Colon capsule endoscopy (CCE) has emerged as a promising alternative for investigating lower gastrointestinal symptoms. However, its adoption has been limited due to concerns about cost-effectiveness, significantly influenced by follow-up endoscopy rates (FERs). Understanding CCE's FERs is crucial for its integration into routine clinical practice. We synthesised the evidence to evaluate the overall rate of further investigation in CCE.

Design: A systematic review and meta-analysis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources: Medline, Embase, and PubMed were searched through 15 August 2024.

Eligibility criteria: Studies included reporting FERs after CCE, including subsequent endoscopic procedures and radiological imaging. There were no language restrictions or limitations in CCE referral indications, patient recruitment criteria, or pathologies investigated.

Data extraction and synthesis: All studies were independently screened and extracted two times by four reviewers. A random-effects model was used for meta-analysis and meta-regression to identify key contributing factors.

Results: 2850 participants from 19 studies were included in the analysis. Compared with the key performance indicators for FERs in colonoscopy (0.10-0.15) and CT colonography (0.25), the pooled FER for CCE was found to be 0.42 (95% CI 0.34 to 0.50). The meta-regression analysis identified complete transit rates and adequate bowel cleansing quality as factors inversely associated with FERs. Furthermore, the CCE2 capsule demonstrated a higher reinvestigation risk than CCE1, likely due to its improved diagnostic accuracy. Although CCE indications were associated with lower FERs, subgroup analysis did not reach statistical significance with high heterogeneity.

Conclusion: This study highlights significant FERs for CCE and identifies key contributing factors, emphasising the importance of appropriate patient selection to reduce reinvestigation needs. Future research should focus on improving completion rates, bowel preparation protocols, and refining CCE indications. This will minimise environmental impact and enhance cost-effectiveness and patient satisfaction.

Prospero registration number: CRD42024567959.

Objective: A case-based survey was conducted to identify practice patterns and knowledge gaps in the management of Crohn's perianal fistulas (CPF) and to further understand approaches to CPF management within the USA by healthcare professionals (HCPs) from different specialties.

Methods: The web-based survey, comprising two hypothetical patient case vignettes (case 1: initial CPF presentation and progression to partial response; case 2: recurrent CPF), was distributed September-October 2020 to US gastroenterologists (GEs) and colorectal surgeons (CRSs), and nurse practitioners (NPs) and physician assistants (PAs) from these specialties, who managed ≥1 patient with CPF/month. The survey included questions on clinician evaluation and treatment approach.

Results: Across surveyed HCPs (127 GEs, 63 GE NP/PAs, 78 CRSs and 14 CRS NP/PAs), 39% stated that they did not use any standard system for classifying/scoring CPF. On initial CPF presentation, ≥98% of HCPs reported a requirement for additional diagnostic/imaging evaluation before proceeding with medical management; GEs preferred pelvic MRI (70%) and CRSs preferred examination under anaesthesia (62%). Preferred management after partial response to initial treatment varied by HCP type (23% GEs vs 71% CRSs preferred continuation of current medical therapy; 60% vs 38% preferred seton continuation; 24% vs 41% preferred seton removal, respectively). For recurrent CPF, most HCPs chose to switch from infliximab to another antitumour necrosis factor agent, while most GEs opted to switch to a different monoclonal antibody. In contrast, 44% of GEs and 27% of CRSs opted to proceed with surgery.

Conclusion: Lack of consensus in CPF management requires improved coordination in treatment approaches among specialists.

Objective: Adenoma detection rate (ADR) has been criticised as a colonoscopy key performance indicator (KPI), for excluding serrated polyps, requiring histological data and fostering a 'one-and-done' attitude. We hypothesised that a case-mix-adjusted mean number of polyps (aMNP) would address these criticisms and provide a better measure of colonoscopy quality. We aimed to develop an aMNP using the National Endoscopy Database (NED) and assess its relationship with quality metrics.

Methods: We extracted colonoscopy data from NED for 1 January 2019-4 April 2019. Multiple negative binomial regression was undertaken to estimate effects of patient variables on MNP and generate aMNP. Associations between aMNP and polyp detection rate (PDR), proximal polypectomy rate (PPR), postcolonoscopy colorectal cancer (PCCRC) rate and Joint Advisory Group for GI endoscopy (JAG) Global Rating Scale (GRS) were explored.

Results: 92 892 colonoscopies were analysed. Patient age, sex and procedure indication were significantly associated with MNP and used to create aMNP. At endoscopist level, aMNP strongly correlated with PDR (Spearman rho=0.834, p<0.001) and PPR (rho=0.709, p<0.001). Median aMNP was significantly lower in Trusts with higher versus lower PCCRC rates (73.9 vs 67.0 polyps per 100 procedures, p=0.047) and higher in units with GRS A/B versus C/D (aMNP 63.5 vs 55.2, p<0.001).

Conclusions: We demonstrate a method to compute a novel case-mix-adjusted KPI, aMNP, which is significantly associated with PDR, PPR, PCCRC and JAG GRS. Histological data were unavailable. aMNP addresses many limitations of ADR, adjusts for warranted variation in detection, and hence may improve audit and feedback engagement. We propose it as a candidate gold standard KPI for reporting endoscopy quality.

Objectives: The integration of digital health technologies in gastrointestinal (GI) endoscopy presents opportunities to enhance patient experience, an important dimension of care quality. This systematic review aims to evaluate the impact of digital health interventions on patient satisfaction and experience in outpatient endoscopy settings.

Design: A systematic review and narrative synthesis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines and the Grading of Recommendations Assessment, Development and Evaluation approach.

Data sources: PubMed/Medline, EMBASE, PsycInfo, and Cochrane databases were searched through 9 March 2023.

Eligibility criteria: Studies were eligible if they involved adult patients (≥18 years) undergoing outpatient colonoscopy or gastroscopy and in English. Interventions included any form of educational digital health technology aimed at enhancing healthcare delivery. Telehealth studies were not included.

Data extraction and synthesis: Two independent reviewers extracted data and assessed risk of bias, using the Mixed Methods Appraisal Tool. A mixed-method approach was employed for the narrative synthesis, focusing on the primary outcome of patient experience and satisfaction.

Results: Nine studies met the inclusion criteria, all assessing patient satisfaction rather than experience. Five studies reported improved satisfaction associated with digital interventions, three showed no significant change, and one lacked statistical analysis. Interventions ranged from smartphone applications to online educational resources, and satisfaction measurement tools varied significantly. Overall, the evidence was characterised by heterogeneity and very low methodological quality.

Conclusion: Digital health interventions may have a positive impact on patient satisfaction in GI endoscopy, although evidence quality is very low and outcome measurement is inconsistent. Future research should focus on standardising measures of patient experience and satisfaction, ensuring robust study designs to inform the integration of digital health tools into endoscopy practice.

Prospero registration number: CRD42023428609.

Introduction: Chronic pancreatitis (CP) is a progressive inflammatory disease of the pancreas leading to permanent damage, resulting in both exocrine and endocrine insufficiency. Understanding the management of patients with CP and their outcomes is critical for improving patient care. CP is relatively rare in Italy and is characterised by various aetiologies and clinical progression requiring personalised treatment options. This registry (ITARECIPE) aims to prospectively collect and analyse data on patients with newly diagnosed CP to gain insights into its epidemiology, presentation, disease progression, and treatment outcomes.

Methods and analysis: This is a multicentre, observational, non-interventional incident cohort study supported by the Italian Association for the Study of the Pancreas and endorsed by relevant Italian gastroenterological societies. ITARECIPE is the first registry in Italy focusing on newly diagnosed CP patients, leading to a comprehensive understanding of disease onset and progression. The study plans to enrol ≥300 patients annually over a minimum of 5 years. Data are recorded in a pseudo-anonymous electronic Case Report Form (eCRF) at baseline and follow-up visits, covering patient demographics, comorbidities, chronic medications, CP aetiology, pancreatic function (exocrine and endocrine), pain, complications, imaging, laboratory tests and treatments. It will track epidemiology, clinical history and treatment outcomes, potentially improving adherence to best practices and informing health policy decisions. The ITARECIPE registry will contribute significantly to the understanding of CP by providing detailed epidemiological, clinical and examinations data into disease management, which could help the development of future clinical practice and guidelines.

Ethics and dissemination: The study was approved by the Ethics Committee (EC) of the promoter centre (San Raffaele Hospital, Milan, Italy; approval code 178/2022) and subsequently by the EC of each participating centre. All patients will be included after signing written informed consent and will be recorded in a pseudo-anonymous manner in a specific eCRF, in accordance with international principles and recommendations for observational studies. The ongoing results may be presented at national or international conferences and will be reported in peer-reviewed publications.

Trial registration number: NCT05733130.

Objectives: Since proton pump inhibitors (PPI) have been introduced, many concerns were raised regarding potential gastric carcinogenicity. We aim to summarise and weigh the epidemiological evidence and address possible causality.

Design: Systematic literature review, evidence synthesis and life-course assessment.

Data sources: PubMed, Web of Science and Cochrane database (from inception up to October 2024), and back- and forward citation tracking (Web of Science).

Eligibility criteria: Original studies and quantitative evidence syntheses assessing the association between PPIs and gastric cancer in humans, without language restrictions.

Data extraction and synthesis: Study design, definitions (and participant numbers) of PPI use and gastric cancer, study characteristics (setting, period, follow-up, lag-time), age and sex distribution presented in tables and evidence mapping.

Results: We identified 33 original studies, 21 meta-analyses, three umbrella meta-analyses, one individual patient data meta-analysis and a Markov model (2006-2023). PPIs were consistently associated with an increased gastric cancer risk with 20/21 meta-analyses reporting pooled relative risks between 1.3 and 2.9. Available trials were underpowered. Reverse causation/protopathic bias, residual confounding (by indication) and lag time seem the largest methodological challenges, as well as disentangling the effects of Helicobacter pylori and its' eradication. Insufficient data are available on age and sex-specific risks, with no studies specifically addressing PPIs in young populations. We hypothesise a sensitive-period exposure model, in which PPI use during pregnancy and early life may be particularly damaging regarding long-term cancer risk. An exploration of Swedish cancer incidence data suggests potential cohort effects as overall gastric cancer risk decreased over time (1970-2022). The risk has increased in young (<40 years) men since the early 2000s, ~10 years after the introduction of Helicobacter pylori eradication and PPIs.

Conclusion: Although for older individuals with valid indications, the gastric cancer risk related to PPI use may be limited, we do argue for a more rational and evidence-supported use of PPIs in young populations.

Objective: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a growing global health concern, with increasing mortality rates driven by the obesity pandemic. Weight loss has been shown to improve MASLD outcomes, yet the effectiveness of eHealth interventions in MASLD management remains uncertain. We aimed to evaluate the effectiveness of eHealth interventions compared with standard care in improving health outcomes among patients with MASLD.

Design: A systematic review and meta-analysis were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources: Relevant studies were retrieved from PubMed, Cochrane Central and Embase databases from inception to 26 April 2024.

Eligibility criteria: Only double-arm clinical trials involving human participants diagnosed with MASLD were included. Eligible studies were limited to those published in English.

Data extraction and synthesis: eHealth interventions-including internet-based platforms, smartwatches, telephone follow-ups and mobile applications for dietary and exercise modifications-were compared against traditional intervention methods. The primary outcomes assessed were changes in body weight, abdominal/waist circumference, aspartate aminotransferase (AST) and alanine transaminase (ALT). Secondary outcomes were changes in body mass index (BMI), diastolic blood pressure, systolic blood pressure, MASLD fibrosis score, high-density lipoprotein, gamma-glutamyl transferase and triglycerides.

Results: 11 studies met the inclusion criteria, of which 10 provided relevant outcomes and were included. The mean age of participants across the studies ranged from 39.3 to 57.9 years, with intervention durations spanning 3 to 24 months. Our results indicate significant improvements with eHealth interventions compared with control comparators, including reductions in AST (standardised mean difference (SMD): -0.35 (95% CI -0.61, -0.10); p<0.05), ALT (SMD: -0.38 (95% CI -0.65, -0.11); p<0.05), weight loss (SMD: -0.38 (95% CI -0.60, -0.17); p<0.05) and BMI (SMD: -0.37 (95% CI -0.54, -0.21); p<0.05).

Conclusions: The utilisation of eHealth interventions showed significant improvements in outcomes related to AST, ALT, abdominal circumference, weight loss and BMI. However, future studies with larger sample sizes and longer follow-ups are warranted to assess the sustainability of these outcomes.

Objective: Early warning and screening of colorectal adenoma (CRA) is important for colorectal cancer (CRC) prevention. This study aimed to construct a non-invasive prediction model to improve CRA screening efficacy.

Methods: This study incorporated three cohorts, comprising 9747 participants who underwent colonoscopy. In cohort 1, 683 participants were prospectively recruited with comprehensive lifestyle information and faecal samples. CRA-associated bacteria were identified through 16S rRNA sequencing and quantitative real-time PCR. CRA prediction models were established using lifestyle and gut microbiota information. Cohort 2 prospectively enrolled 1529 participants to validate the lifestyle-based model, while cohort 3 retrospectively analysed 7535 individuals to determine the recommended initial colonoscopy screening ages for different risk groups based on age-specific CRA incidence rates.

Results: Multivariable logistic regression yielded a prediction model incorporating 14 variables, demonstrating robust discrimination (c-statistic=0.79, 95% CI 0.75, 0.82). Other machine learning approaches showed comparable performance (random forest: 0.78, 95% CI 0.73, 0.81; gradient boosting: 0.78, 95% CI 0.76, 0.83). The ages for starting colonoscopy screening were established at 42 years for the high-risk group vs 53 years for the low-risk group. The inclusion of Fusobacterium nucleatum and pks⁺ Escherichia  coli enhanced the model's performance (c-statistic=0.84-0.86).

Conclusion: Integrated mathematical modelling incorporating lifestyle parameters and gut microbial signatures provides an effective non-invasive strategy for CRA risk stratification, while the accompanying machine learning-assisted prediction application enables cost-effective, population-level screening implementation to optimise CRC prevention protocols.

Objective: The use of glucagon-like peptide 1 receptor agonists has been associated with gastroparesis, but little is known about the risk of gastroparesis in those with obesity but without type 2 diabetes (T2D), and how that risk compares with other treatment modalities for obesity. This study aims to characterise the relationship between different treatment modalities for obesity and the risk of gastroparesis in a population without pre-existing T2D.

Methods: A retrospective cohort study using Merative MarketScan Research Databases of individuals with obesity who underwent treatment with semaglutide, bupropion-naltrexone or sleeve gastrectomy from 1 January 2018 to 31 December 2022. The incidence of gastroparesis diagnosis was evaluated using International Classification of Diseases, Version 10 codes. The risk of gastroparesis was compared between three intervention groups using Cox proportional hazards regression models.

Results: Of the 55 460 individuals included, 36 990 (66.7%) were treated with semaglutide, 7369 (13.3%) with bupropion-naltrexone and 11 101 (13.7%) with sleeve gastrectomy. Gastroparesis rates among those treated with semaglutide versus bupropion-naltrexone versus sleeve gastrectomy were 6.5 per 1000 person-years (PY) vs 2.1 per 1000 PY vs 1.1 per 1000 PY, respectively. After adjusting for baseline characteristics, individuals treated with semaglutide had a higher risk of gastroparesis than those treated with bupropion-naltrexone (adjusted HR 3.33, 95% CI 2.27, 4.98) and sleeve gastrectomy (adjusted HR 6.14, 95% CI 3.94, 9.57).

Conclusions: There is an increased incidence of gastroparesis among individuals with obesity without T2D who are using semaglutide as compared with bupropion-naltrexone and sleeve gastrectomy. Understanding these potential side effects, though rare, may help guide personalised treatment regimens.

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.