BMJ Open Gastroenterology最新文献

{"title":"Associations between prior healthcare use, time to diagnosis, and clinical outcomes in inflammatory bowel disease: a nationally representative population-based cohort study.","authors":"Nishani Jayasooriya, Sonia Saxena, Jonathan Blackwell, Alex Bottle, Hanna Creese, Irene Petersen, Richard C G Pollok","doi":"10.1136/bmjgast-2024-001371","DOIUrl":"10.1136/bmjgast-2024-001371","url":null,"abstract":"<p><strong>Background: </strong>Timely diagnosis and treatment of inflammatory bowel disease (IBD) may improve clinical outcomes.</p><p><strong>Objective: </strong>Examine associations between time to diagnosis, patterns of prior healthcare use, and clinical outcomes in IBD.</p><p><strong>Design: </strong>Using the Clinical Practice Research Datalink we identified incident cases of Crohn's disease (CD) and ulcerative colitis (UC), diagnosed between January 2003 and May 2016, with a first primary care gastrointestinal consultation during the 3-year period prior to IBD diagnosis. We used multivariable Cox regression to examine the association of primary care consultation frequency (n=1, 2, >2), annual consultation intensity, hospitalisations for gastrointestinal symptoms, and time to diagnosis with a range of key clinical outcomes following diagnosis.</p><p><strong>Results: </strong>We identified 2645 incident IBD cases (CD: 782; UC: 1863). For CD, >2 consultations were associated with intestinal surgery (adjusted HR (aHR)=2.22, 95% CI 1.45 to 3.39) and subsequent CD-related hospitalisation (aHR=1.80, 95% CI 1.29 to 2.50). For UC, >2 consultations were associated with corticosteroid dependency (aHR=1.76, 95% CI 1.28 to 2.41), immunomodulator use (aHR=1.68, 95% CI 1.24 to 2.26), UC-related hospitalisation (aHR=1.43, 95% CI 1.05 to 1.95) and colectomy (aHR=2.01, 95% CI 1.22 to 3.27). For CD, hospitalisation prior to diagnosis was associated with CD-related hospitalisation (aHR=1.30, 95% CI 1.01 to 1.68) and intestinal surgery (aHR=1.71, 95% CI 1.13 to 2.58); for UC, it was associated with immunomodulator use (aHR=1.42, 95% CI 1.11 to 1.81), UC-related hospitalisation (aHR=1.36, 95% CI 1.06 to 1.95) and colectomy (aHR=1.54, 95% CI 1.01 to 2.34). For CD, consultation intensity in the year before diagnosis was associated with CD-related hospitalisation (aHR=1.19, 95% CI 1.12 to 1.28) and intestinal surgery (aHR=1.13, 95% CI 1.03 to 1.23); for UC, it was associated with corticosteroid use (aHR=1.08, 95% CI 1.04 to 1.13), corticosteroid dependency (aHR=1.05, 95% CI 1.00 to 1.11), and UC-related hospitalisation (aHR=1.12, 95% CI 1.03 to 1.21). For CD, time to diagnosis was associated with risk of CD-related hospitalisation (aHR=1.03, 95% CI 1.01 to 1.68); for UC, it was associated with reduced risk of UC-related hospitalisation (aHR=0.83, 95% CI 0.70 to 0.98) and colectomy (aHR=0.59, 95% CI 0.43 to 0.80).</p><p><strong>Conclusion: </strong>Electronic records contain valuable information about patterns of healthcare use that can be used to expedite timely diagnosis and identify aggressive forms of IBD.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11131120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141157388","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":"Clinical, endoscopic and therapeutic features of bleeding Dieulafoy's lesions: case series and literature review.","authors":"Basma Aabdi, Ghizlane Kharrasse, Abdelkrim Zazour, Hajar Koulali, Ouiam Elmqaddem, Ismaili Zahi","doi":"10.1136/bmjgast-2023-001299","DOIUrl":"10.1136/bmjgast-2023-001299","url":null,"abstract":"<p><strong>Objective: </strong>Dieulafoy's lesions (DLs) are a rare but potentially life-threatening source of gastrointestinal (GI) haemorrhage. They are responsible for roughly 1%-6.5% of all cases of acute non-variceal GI bleeding.Here, we describe retrospectively the clinical and endoscopic features, review the short-term and long-term outcomes of endoscopic management of bleeding DLs and we identify rate and risk factors, of recurrence and mortality in our endoscopic unit.</p><p><strong>Design: </strong>Data were collected from patients presenting with GI haemorrhagic secondary to DLs between January 2018 and August 2023. Patients' medical records as well as endoscopic databases were retrospectively reviewed. Demographic data, risk factors, bleeding site, outcomes of endoscopy techniques, recurrence and mortality rate were taken into account.</p><p><strong>Results: </strong>Among 1170 cases of GI bleeding, we identified only seven cases involving DLs. Median age was 74 years, with a male-to-female ratio of 2.5. 75% of patients had significant comorbidities, mainly cardiovascular diseases. Only anticoagulant and antiplatelet agents were significantly associated with DLs. All patients were presented with GI bleeding as their initial symptom. The initial endoscopy led to a diagnosis in 85% of the cases. Initial haemostasis was obtained in all patients treated endoscopically. Nevertheless, the study revealed early recurrence in two out of three patients treated solely with epinephrine injection or argon plasma coagulation. In contrast, one of three patients who received combined therapy, experienced late recurrence (average follow-up of 1 year). Pathological diagnosis was necessary in one case. One patient (14%) died of haemorrhagic shock. Average length of hospital stay was 3 days.</p><p><strong>Conclusion: </strong>Although rare, DLs may be responsible for active, recurrent and unexplained GI bleeding. Thanks to the emergence of endoscopic therapies, the recurrence rate has decreased and the prognosis has highly improved. Therefore, the endoscopic approach remains the first choice to manage bleeding DLs.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11129027/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141092714","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":"Impact of antitumour necrosis factor therapy on surgery in inflammatory bowel disease: a population-based study.","authors":"A Barney Hawthorne, Bradley Arms-Williams, Rebecca Cannings-John, Richard C G Pollok, Alexander Berry, Philip Harborne, Anjali Trivedi","doi":"10.1136/bmjgast-2024-001373","DOIUrl":"10.1136/bmjgast-2024-001373","url":null,"abstract":"<p><strong>Objective: </strong>It is unclear whether widespread use of biologics is reducing inflammatory bowel disease (IBD) surgical resection rates. We designed a population-based study evaluating the impact of early antitumour necrosis factor (TNF) on surgical resection rates up to 5 years from diagnosis.</p><p><strong>Design: </strong>We evaluated all patients with IBD diagnosed in Cardiff, Wales 2005-2016. The primary measure was the impact of early (within 1 year of diagnosis) sustained (at least 3 months) anti-TNF compared with no therapy on surgical resection rates. Baseline factors were used to balance groups by propensity scores, with inverse probability of treatment weighting (IPTW) methodology and removing immortal time bias. Crohn's disease (CD) and ulcerative colitis (UC) with IBD unclassified (IBD-U) (excluding those with proctitis) were analysed.</p><p><strong>Results: </strong>1250 patients were studied. For CD, early sustained anti-TNF therapy was associated with a reduced likelihood of resection compared with no treatment (IPTW HR 0.29 (95% CI 0.13 to 0.65), p=0.003). In UC including IBD-U (excluding proctitis), there was an increase in the risk of colectomy for the early sustained anti-TNF group compared with no treatment (IPTW HR 4.6 (95% CI 1.9 to 10), p=0.001).</p><p><strong>Conclusions: </strong>Early sustained use of anti-TNF therapy is associated with reduced surgical resection rates in CD, but not in UC where there was a paradoxical increased surgery rate. This was because baseline clinical factors were less predictive of colectomy than anti-TNF usage. These data support the use of early introduction of anti-TNF therapy in CD whereas benefit in UC cannot be assessed by this methodology.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11116861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141080417","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":"Population-level impact of the BMJ Rapid Recommendation for colorectal cancer screening: a microsimulation analysis.","authors":"Luuk A van Duuren, Jean-Luc Bulliard, Ella Mohr, Rosita van den Puttelaar, Ekaterina Plys, Karen Brändle, Douglas A Corley, Florian Froehlich, Kevin Selby, Iris Lansdorp-Vogelaar","doi":"10.1136/bmjgast-2024-001344","DOIUrl":"10.1136/bmjgast-2024-001344","url":null,"abstract":"<p><strong>Objective: </strong>In 2019, a BMJ Rapid Recommendation advised against colorectal cancer (CRC) screening for adults with a predicted 15-year CRC risk below 3%. Using Switzerland as a case study, we estimated the population-level impact of this recommendation.</p><p><strong>Design: </strong>We predicted the CRC risk of all respondents to the population-based Swiss Health Survey. We derived the distribution of risk-based screening start age, assuming predicted risk was calculated every 5 years between ages 25 and 70 and screening started when this risk exceeded 3%. Next, the MISCAN-Colon microsimulation model evaluated biennial faecal immunochemical test (FIT) screening with this risk-based start age. As a comparison, we simulated screening initiation based on age and sex.</p><p><strong>Results: </strong>Starting screening only when predicted risk exceeded 3% meant 82% of women and 90% of men would not start screening before age 65 and 60, respectively. This would require 43%-57% fewer tests, result in 8%-16% fewer CRC deaths prevented and yield 19%-33% fewer lifeyears gained compared with screening from age 50. Screening women from age 65 and men from age 60 had a similar impact as screening only when predicted risk exceeded 3%.</p><p><strong>Conclusion: </strong>With the recommended risk prediction tool, the population impact of the BMJ Rapid Recommendation would be similar to screening initiation based on age and sex only. It would delay screening initiation by 10-15 years. Although halving the screening burdens, screening benefits would be reduced substantially compared with screening initiation at age 50. This suggests that the 3% risk threshold to start CRC screening might be too high.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11085988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140897434","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":"Effects of prednisolone tapering on effectiveness of infliximab in patients with ulcerative colitis: data from a retrospective cohort","authors":"Pernille Dige Ovesen, Mohamed Attauabi, Johan F K F Ilvemark, Mads Damsgaard Wewer, David J Warren, Johan Burisch, Rolf A Klaasen, Nils Bolstad, Casper Steenholdt, Jakob Benedict Seidelin","doi":"10.1136/bmjgast-2024-001343","DOIUrl":"https://doi.org/10.1136/bmjgast-2024-001343","url":null,"abstract":"Background and objective The influence of concomitant prednisolone on clinical outcomes and safety in infliximab-treated ulcerative colitis (UC) patients is unknown. Design, setting, participants and outcome measures A retrospective cohort study was performed, including 147 UC patients treated with infliximab at a tertiary inflammatory bowel disease (IBD) centre. Primary outcome was corticosteroid-free clinical remission (CFCR) at week 14 and week 52. Patients were grouped according to prednisolone tapering regimens: standard (≤5 mg/week), fast (>5 mg/week), direct discontinuation or no prednisolone. Patients intolerant to corticosteroids and patients stopping corticosteroids in preparation for surgery including colectomy during their initial admission were excluded. Results There was no overall association between prednisolone exposure or no exposure and CFCR at weeks 14 or 52 of infliximab. The proportion of patients with C reactive protein ≤5 mg/L was higher in the standard tapering at week 14 as compared with faster regimens or no prednisolone. In subgroup analyses, the standard tapering was associated with a higher rate of CFCR at week 14 compared with the fast-tapering regimen in patients receiving ≥40 mg prednisolone at initiation of infliximab (64.3% vs 26.3%, p=0.04) and among patients admitted with acute severe UC (66.6% vs 23.5%, p<0.05). Similar data were seen at week 52. Prednisolone did not affect infliximab trough levels but increased infection rates (10/77 vs 2/70, p=0.03), in particular C. difficile infection. Conclusion In UC patients with limited disease burden, prednisolone did not affect effectiveness of infliximab. However, patients with increased disease burden seem to benefit from corticosteroid combination therapy. Data are available upon reasonable request. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"28 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140883213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Increased rate of pancreatitis in gender diverse and transgender patients on hormone therapy: a case series study","authors":"Alexander Podboy, Catherine Casey, Ross C D Buerlein, Daniel S Strand, Vanessa M Shami, Andrew Y Wang","doi":"10.1136/bmjgast-2023-001312","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001312","url":null,"abstract":"Background There is limited data on the incidence of gastrointestinal-specific pathology in gender non-conforming (GNC) populations. Methods Retrospective analysis of pancreatitis incidence rates in transgender and GNC persons exposed and not exposed to gender-affirming hormone therapy (GAHT). Results 7 of the 1333 patients on hormone therapy had an incidence of pancreatitis. 0 of the 615 patients with no history of GAHT use developed pancreatitis. Representing a 6.96 (95% CI 2.76 to 848.78) for the development of pancreatitis in patients with exposure to GAHT therapy. Conclusion Clinicians working with GNC individuals should be aware of this possible association Data are available upon reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"96 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140636853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of hepatorenal syndrome and associated outcomes: a systematic reviews","authors":"Jamshid Roozbeh, Shahrokh Ezzatzadegan Jahromi, Mohamad Hossein Rezazadeh, Anahid Hamidianjahromi, Leila Malekmakan","doi":"10.1136/bmjgast-2023-001319","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001319","url":null,"abstract":"Background Hepatorenal syndrome (HRS), a multiorgan condition of acute kidney injury, is seen in advanced liver disease. This study aims to evaluate the current treatment for HRS. Methods The authors searched PubMed, Scopus and Google Scholar literature. After quality assessment, 31 studies were included in this review. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology and the population, intervention, comparison and outcome scheme were used. We included human-controlled trials that evaluate the current treatment for HRS. Two authors independently screened articles for inclusion, extracted data and assessed the quality of included studies. Results This study investigated the studies conducted on the effects of different treatments on follow-up of HRS patients. We gathered 440 articles, so 31 articles remained in our study. Of which 24 articles were conducted on terlipressin versus placebo or other treatments (midodrine/octreotide, norepinephrine, etc) that showed the higher rate of HRS reversal was detected for terlipressin in 17 studies (10 of them were significant), 2 studies achieved an insignificant lower rate of the model for end-stage liver disease score for terlipressin, 15 studies showed a decreased mortality rate in the terlipressin group (4 of them were significant). Conclusion This review showed that terlipressin has a significantly higher reversal rate of HRS than the other treatments. Even the results showed that terlipressin is more efficient than midodrine/octreotide and norepinephrine as a previous medication, in reverse HRS, increasing patient survival. All data relevant to the study are included in the article or uploaded as online supplemental information.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"5 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140612340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What is the role of out of programme clinical fellowships in the era of Shape of Training? A single-centre cohort study","authors":"Suneil A Raju, Freya J Bowker-Howell, Imran Aziz, Mo Thoufeeq, Alan J Lobo, Dermot C Gleeson, Amer Al-Joudeh, Mark E McAlindon, Andrew D Hopper, Sampath Kumar, Reena Sidhu, David S Sanders","doi":"10.1136/bmjgast-2023-001311","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001311","url":null,"abstract":"Background The updated Shape of Training curriculum has shortened the duration of specialty training. We present the potential role of out of programme clinical fellowships. Method An electronic online survey was sent to all current fellows to understand their experiences, training opportunities and motivations. Data were collected on fellows’ endoscopic experiences and publications using PubMed for all previous doctors who have completed the Sheffield Fellowship Programme. Results Since 2004, 39 doctors have completed the Sheffield Fellowship. Endoscopic experience: current fellows completed a median average of 350 (IQR 150–500) gastroscopies and 150 (IQR 106–251) colonoscopies per year. Fellows with special interests completed either 428 hepato-pancreato-biliary procedures or 70 endoscopic mucosal resections per year. Medline publications: Median average 9 publications(IQR 4–17). They have also received multiple national or international awards and 91% achieved a doctoral degree. The seven current fellows in the new Shape of Training era (57% male, 29% Caucasian, aged 31–40 years) report high levels of enjoyment due to their research projects, supervisory teams and social aspects. The most cited reasons for undertaking the fellowship were to develop a subspecialty interest, take time off the on-call rota and develop endoscopic skills. The most reported drawback was a reduced income. All current fellows feel that the fellowship has enhanced their clinical confidence and prepared them to become consultants. Conclusion Out of programme clinical fellowships offer the opportunity to develop the required training competencies, subspecialty expertise and research skills in a supportive environment. Data are available on reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"56 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140842002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study","authors":"Kiminori Kimura, Junko Tanuma, Masamichi Kimura, Jun Imamura, Mikio Yanase, Ichiro Ieiri, Masayuki Kurosaki, Tsunamasa Watanabe, Tomoyuki Endo, Hiroshi Yotsuyanagi, Hiroyuki Gatanaga","doi":"10.1136/bmjgast-2023-001341","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001341","url":null,"abstract":"Objective Patients with haemophilia and HIV who acquire hepatitis C virus (HCV) after receiving contaminated blood products can experience accelerated progression of liver fibrosis and a poor prognosis, making liver disease a prominent cause of mortality among these patients. In the current study, we aimed to evaluate the safety and tolerability of the potential antifibrotic agent OP-724—a CREB-binding protein/β-catenin inhibitor—in this patient subset. Design In this single-centre, open-label, non-randomised, phase I trial, we sequentially enrolled patients with cirrhosis following HIV/HCV coinfection classified as Child-Pugh (CP) class A or B. Five patients received an intravenous infusion of OP-724 at doses of 140 or 280 mg/m2 for 4 hours two times weekly over 12 weeks. The primary endpoint was the incidence of serious adverse events (SAEs). Secondary endpoints included the incidence of AEs and improved liver stiffness measure (LSM), as determined by vibration-controlled transient elastography. This study was registered at ClinicalTrials.gov ([NCT04688034][1]). Results Between 9 February 2021 and 5 July 2022, five patients (median age: 51 years) were enrolled. All five patients completed 12 cycles of treatment. SAEs were not observed. The most common AEs were fever (60%) and gastrointestinal symptoms (diarrhoea: 20%, enterocolitis: 20%). Improvements in LSM and serum albumin levels were also observed. Conclusion In this preliminary assessment, intravenous administration of 140 or 280 mg/m2/4 hours OP-724 over 12 weeks was well tolerated by patients with haemophilia combined with cirrhosis due to HIV/HCV coinfection. Hence, the antifibrotic effects of OP-724 warrant further assessment in patients with cirrhosis. Trial registration number [NCT04688034][1]. Data are available upon reasonable request. The anonymous data displayed in the manuscript will be made available on request from the corresponding author following the publication of this article. Data displayed in the manuscript or acquired during the clinical trial will be made available in a form that does not deviate from what is accepted by local regulatory authorities with respect to the handling of patient data and in adherence to the policies of the Tokyo Metropolitan Komagome Hospital. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04688034&atom=%2Fbmjgast%2F11%2F1%2Fe001341.atom","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"10 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140804872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality of reporting inflammatory bowel disease randomised controlled trials: a systematic review","authors":"Morris Gordon, Jamal Khudr, Vassiliki Sinopoulou, Svetlana Lakunina, Aditi Rane, Anthony Akobeng","doi":"10.1136/bmjgast-2023-001337","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001337","url":null,"abstract":"Objective Our objective was to perform a systemic evaluation of the risk of bias in randomised controlled trial (RCT) reports published on inflammatory bowel disease (IBD). Design We assessed the risk of bias using the Cochrane tool, as indicators of poor methodology or subsequently poor reporting. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings. Results 563 full texts were included after selection and review. No abstract publications were free of any source of bias. Full-text publications still fared badly, as only 103 full-text papers exhibited a low risk of bias in all reporting domains when excluding blinding. RCTs published in journals with higher impact factor (IF) were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an IF greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with a lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p=0.037). Conclusion These findings are consistent with those of other specialties in the literature. While this unclear risk of bias may represent poor reporting of methods instead of poor methodological quality, it leaves readers and future secondary researchers with significant questions regarding such key issues. Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The protocol for the review has been uploaded to a repository (Repository ID: 33117). Further methodological components and results are included in the appendix. Other data are available upon reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"62 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140611955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}