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Exploring the feasibility of home-delivered capsule endoscopy with 5G support: innovations and carbon footprint insights. 探索在 5G 支持下进行上门胶囊内窥镜检查的可行性:创新和碳足迹见解。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-31 DOI: 10.1136/bmjgast-2024-001500
Gohar Jalayeri Nia, Cassie Conway, Frances Ward, Sheena Dungey, Linda Streames, Bei Bei Liu, Ian Lo Lei, James Cameron, Hagen Wenzek, Chander Shekhar, Sally Eason, Ramesh P Arasaradnam

Introduction: Colorectal cancer (CRC) poses a significant global health threat, necessitating early detection. Traditional diagnostic tools like optical colonoscopy have limitations prompting our '5G-SUCCEEDS' initiative to explore a novel approach involving remote colon capsule endoscopy (CCE).

Methods: This prospective feasibility study was conducted at a single hospital in England. Between December 2022 and September 2023, we introduced a remote CCE service within the 5G-SUCCEEDS framework. We undertook a feasibility study of CCE in patients with low-risk/moderate-risk CRC stratified by faecal haemoglobin. Outcomes included carbon footprint analysis (outlined through three potential clinical pathways) and patient-reported outcomes through structured questionnaires and interviews.

Results: Among 25 participants, 88% expressed satisfaction with remote CCE. 82% were willing to have remote CCE if clinically indicated in future. CCE findings included adenomatous polyps (58%), normal results (17%) and diverticulosis (21%), with no cancers identified in this pilot. Notably, we found that the carbon footprint associated with delivery of CCE at home (pathway 3) was lower compared with CCE delivered in a clinical setting (pathway 2). A fully optimised, automated scaled-up pathway would combine the delivery and collection of CCE equipment within a local area to reduce the carbon footprint of the travel element by 75%. Moreover, the conversion rate into a colonoscopy pathway is not static and clinicians acknowledge that this could be as low as 28%. Carbon footprint is more favourable for home-delivered CCE in the optimised scenario, while less so when considering the need for additional procedures (colonoscopy conversion).

Conclusion: The 5G-SUCCEEDS initiative highlights the feasibility and advantages of home-based diagnostics using CCE.

简介结肠直肠癌(CRC)对全球健康构成重大威胁,必须及早发现。光学结肠镜等传统诊断工具存在局限性,这促使我们的 "5G-SUCCEEDS "计划探索一种涉及远程结肠胶囊内镜(CCE)的新方法:这项前瞻性可行性研究在英国一家医院进行。2022 年 12 月至 2023 年 9 月期间,我们在 5G-SUCCEEDS 框架内引入了远程 CCE 服务。我们对按粪便血红蛋白分层的低风险/中度风险 CRC 患者进行了 CCE 可行性研究。研究结果包括碳足迹分析(通过三种可能的临床路径进行概述)以及通过结构化问卷和访谈进行的患者报告结果:结果:在 25 名参与者中,88% 的人对远程 CCE 表示满意。结果:在 25 名参与者中,88% 的人对远程 CCE 表示满意,82% 的人愿意在将来有临床需要时进行远程 CCE。CCE 结果包括腺瘤性息肉(58%)、正常结果(17%)和憩室(21%),本次试验未发现癌症。值得注意的是,我们发现在家进行 CCE(路径 3)与在临床环境中进行 CCE(路径 2)相比,碳足迹更低。经过全面优化的自动化扩大路径将把在当地提供和收集 CCE 设备结合起来,从而将旅行环节的碳足迹减少 75%。此外,结肠镜检查路径的转换率并不是一成不变的,临床医生承认转换率可能低至 28%。在优化方案中,碳足迹更有利于家庭交付的 CCE,而在考虑到需要额外程序(结肠镜检查转换)时,碳足迹就不那么有利了:5G-SUCCEEDS计划凸显了使用CCE进行家庭诊断的可行性和优势。
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引用次数: 0
Mixed-method Irish study exploring the role of diet in IBD based on an online questionnaire and a patient panel opinion. 基于在线问卷和患者小组意见的爱尔兰混合方法研究,探讨饮食在 IBD 中的作用。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-29 DOI: 10.1136/bmjgast-2023-001251
Naomi Hanrahan, Victoria Spillane, Kevin Moore, Mick Dineen, Aoife Murphy, Ana Velikonja, Margot Hurley, Majella O'Keeffe, Silvia Melgar

Objective: Diet is a risk factor in inflammatory bowel diseases (IBD) pathogenesis. This study aims to examine the dietary patterns and beliefs of Irish patients living with IBD through an online questionnaire and subsequent open discussions with an IBD patient collaborator panel (PCP). All data presented here are selected and presented following the PCP's suggestions and views.

Design: This mixed-method study included an online questionnaire using a short food frequency questionnaire examining dietary patterns, dietary opinions, beliefs and behaviours (phase I). Six in-person PCP sessions were conducted, where findings from the online questionnaire, diet and lifestyle in the context of IBD were discussed in depth (phase II).

Results: The questionnaire revealed that respondents with active IBD are associated with the consumption of high-sugar, processed and meat-based foods while reducing their consumption of high-fibre foods. Individuals with active Crohn's disease have a decrease in overall daily energy consumption and a significant reduction in intake of fibre, non-starch polysaccharides, micronutrients [B vitamins (B1, B2, and B9), vitamin C, calcium] and trace elements (iron, zinc, copper and manganese). The PCP reported that food tolerability is limited during relapse, leading patients to prefer simple carbohydrates for energy, consistent with the dietary intake data. The PCP reported that most dietary advice was received during hospitalisation (relapse), focused on food avoidance, with little follow-up during remission. The consensus among the PCP was that factors, such as disease type, psychological aspects, dietary understanding and support, can influence peoples' dietary choices.

Conclusion: In summary, we show that dietary intake in people with IBD varies and may depend on several factors, not just the disease itself. This PCP desires more dietary information and professional support outside of hospitalisation to assist with disease management.

目的:饮食是炎症性肠病(IBD)发病机制中的一个风险因素。本研究旨在通过在线问卷调查以及随后与 IBD 患者合作小组(PCP)的公开讨论,研究爱尔兰 IBD 患者的饮食模式和饮食观念。本文所展示的所有数据均根据 PCP 的建议和意见进行选择和展示:这项混合方法研究包括一份在线问卷,使用简短的食物频率问卷调查饮食模式、饮食观点、信仰和行为(第一阶段)。研究人员还与初级保健医生进行了六次面对面交流,深入讨论了在线问卷调查的结果、IBD 背景下的饮食和生活方式(第二阶段):调查问卷显示,患有活动性 IBD 的受访者与食用高糖、加工食品和肉类食品有关,同时减少了对高纤维食品的食用。活动性克罗恩病患者的每日总能量消耗减少,纤维、非淀粉多糖、微量营养素[B 族维生素(B1、B2 和 B9)、维生素 C、钙]和微量元素(铁、锌、铜和锰)的摄入量显著减少。初级保健医生报告说,复发期间患者对食物的耐受性受到限制,导致他们更喜欢简单的碳水化合物作为能量,这与饮食摄入数据一致。初级保健医生报告说,大多数饮食建议都是在住院(复发)期间接受的,重点是避免进食,而在缓解期很少进行跟踪。初级保健医生一致认为,疾病类型、心理因素、对饮食的理解和支持等因素都会影响患者的饮食选择:总之,我们的研究表明,IBD 患者的饮食摄入量各不相同,可能取决于多种因素,而不仅仅是疾病本身。这位初级保健医生希望在住院期间获得更多的饮食信息和专业支持,以协助疾病管理。
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引用次数: 0
Patients and clinicians have different priorities when discussing pain in the IBD clinic. 在 IBD 诊所讨论疼痛问题时,患者和临床医生有不同的侧重点。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-29 DOI: 10.1136/bmjgast-2024-001540
Danielle Huisman, Esther Andrews, Amanda C de C Williams, Miles Parkes, Christine Norton

Objective: Pain in inflammatory bowel disease (IBD) is frequently neglected/overlooked, particularly in ulcerative colitis, and communication about pain can be suboptimal. The current study juxtaposes clinicians' conceptualisations of patients' pain with patient narratives. The aim was to inform the development of a pain reporting tool and provide guidance for better communication about IBD pain.

Methods: In-depth semistructured interviews with 13 IBD clinicians in the UK: gastroenterologists (n=5), colorectal surgeons (n=2), specialist nurses (n=4) and psychologists (n=2). Primary analysis of these data and secondary analysis of earlier interviews about pain in IBD with clinicians (n=12) and patients (n=71) followed principles of reflexive thematic analysis. Themes were compared across participant groups.

Results: Clinicians state that they regularly ask about pain in Crohn's disease, but not ulcerative colitis. Patients, however, report inconsistent attention to pain in either condition, with power dynamics constraining their pain report. Some clinicians acknowledged that they assume that patients manage their pain independently, leading to insufficient follow-up (Theme 1: Contradictions and ambiguities when discussing pain in IBD). Inadequate acknowledgement of pain by clinicians was attributed to time constraints and systemic issues. Where inflammatory or structural causes were lacking, some clinicians default to attributing pain to irritable bowel syndrome, contributing to patients feeling uncared for (Theme 2: Consequences of limited tools and time for pain). Addressing pain was further complicated by the reluctance of some patients to express discomfort or pain and others who avoided activities that might lead to pain (Theme 3: Addressing pain in patients who do not complain).

Conclusion: The study emphasises the importance of consistent pain evaluation and management, advocating for more open dialogues between clinicians and patients.

目的:炎症性肠病(IBD)中的疼痛经常被忽视/忽视,尤其是溃疡性结肠炎患者,而且有关疼痛的交流可能不够理想。本研究将临床医生对患者疼痛的概念与患者的叙述并列起来。目的是为疼痛报告工具的开发提供信息,并为更好地交流 IBD 疼痛提供指导:对英国 13 名 IBD 临床医生进行了深入的半结构式访谈,其中包括胃肠病学家(5 人)、结直肠外科医生(2 人)、专科护士(4 人)和心理学家(2 人)。根据反思性主题分析的原则,对这些数据进行了初步分析,并对临床医生(人数=12)和患者(人数=71)就 IBD 疼痛问题进行的早期访谈进行了二次分析。对不同参与群体的主题进行了比较:结果:临床医生表示,他们会定期询问克罗恩病患者的疼痛情况,但不会询问溃疡性结肠炎患者的疼痛情况。然而,患者对两种疾病中疼痛的关注程度不一致,他们的疼痛报告受到权力的制约。一些临床医生承认,他们认为患者能够独立处理自己的疼痛,从而导致随访不足(主题 1:讨论 IBD 患者疼痛时的矛盾和模糊之处)。临床医生对疼痛认识不足的原因是时间限制和系统性问题。在缺乏炎症或结构性病因的情况下,一些临床医生默认将疼痛归咎于肠易激综合征,从而导致患者感到无人关心(主题 2:治疗疼痛的工具和时间有限的后果)。一些患者不愿表达不适或疼痛,另一些患者则回避可能导致疼痛的活动,这使得疼痛问题的解决变得更加复杂(主题 3:解决无主诉患者的疼痛问题):本研究强调了持续进行疼痛评估和管理的重要性,提倡临床医生和患者之间进行更开放的对话。
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引用次数: 0
Multicentre study to assess the performance of an artificial intelligence instrument to support qualitative diagnosis of colorectal polyps. 多中心研究,评估人工智能仪器在支持结直肠息肉定性诊断方面的性能。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-22 DOI: 10.1136/bmjgast-2024-001553
Keigo Sato, Mizuki Kuramochi, Akihiko Tsuchiya, Akihiro Yamaguchi, Yasuo Hosoda, Norio Yamaguchi, Naohiro Nakamura, Yuki Itoi, Yu Hashimoto, Kengo Kasuga, Hirohito Tanaka, Shiko Kuribayashi, Yoji Takeuchi, Toshio Uraoka

Objective: Computer-aided diagnosis (CAD) using artificial intelligence (AI) is expected to support the characterisation of colorectal lesions, which is clinically relevant for efficient colorectal cancer prevention. We conducted this study to assess the diagnostic performance of commercially available CAD systems.

Methods: This was a multicentre, prospective performance evaluation study. The endoscopist diagnosed polyps using white light imaging, followed by non-magnified blue light imaging (non-mBLI) and mBLI. AI subsequently assessed the lesions using non-mBLI (non-mAI), followed by mBLI (mAI). Eventually, endoscopists made the final diagnosis by integrating the AI diagnosis (AI+endoscopist). The primary endpoint was the accuracy of the AI diagnosis of neoplastic lesions. The diagnostic performance of each modality (sensitivity, specificity and accuracy) and confidence levels were also assessed.

Results: Overall, 380 lesions from 139 patients were included in the analysis. The accuracy of non-mAI was 83%, 95% CI (79% to 87%), which was inferior to that of mBLI (89%, 95% CI (85% to 92%)) and mAI (89%, 95% CI (85% to 92%)). The accuracy (95% CI) of diagnosis by expert endoscopists using mAI (91%, 95% CI (87% to 94%)) was comparable to that of expert endoscopists using mBLI (91%, 95% CI (87% to 94%)) but better than that of non-expert endoscopists using mAI (83%, 95% CI (75% to 90%)). The level of confidence in making a correct diagnosis was increased when using magnification and AI.

Conclusions: The diagnostic performance of mAI for differentiating colonic lesions is comparable to that of endoscopists, regardless of their experience. However, it can be affected by the use of magnification as well as the endoscopists' level of experience.

目的:使用人工智能(AI)的计算机辅助诊断(CAD)有望支持结直肠病变的特征描述,这对有效预防结直肠癌具有临床意义。我们开展了这项研究,以评估市售计算机辅助诊断系统的诊断性能:这是一项多中心、前瞻性的性能评估研究。内镜医师使用白光成像诊断息肉,然后进行非放大蓝光成像(non-mBLI)和 mBLI。随后,人工智能使用非放大蓝光成像(non-mAI)评估病变,再使用放大蓝光成像(mBLI)评估病变。最后,内镜医师综合人工智能诊断(人工智能+内镜医师)做出最终诊断。主要终点是人工智能诊断肿瘤病变的准确性。此外,还评估了每种方法的诊断性能(敏感性、特异性和准确性)和置信度:共有 139 名患者的 380 个病灶被纳入分析。非 mAI 的准确率为 83%,95% CI(79% 至 87%),低于 mBLI(89%,95% CI(85% 至 92%))和 mAI(89%,95% CI(85% 至 92%))。使用 mAI 的内镜专家诊断的准确率(95% CI)(91%,95% CI(87% 至 94%))与使用 mBLI 的内镜专家诊断的准确率(91%,95% CI(87% 至 94%))相当,但优于使用 mAI 的非专业内镜专家诊断的准确率(83%,95% CI(75% 至 90%))。使用放大镜和人工智能时,做出正确诊断的信心水平会提高:结论:无论内镜医师的经验如何,mAI 在区分结肠病变方面的诊断性能都与内镜医师相当。然而,放大镜的使用以及内镜医师的经验水平都会影响诊断效果。
{"title":"Multicentre study to assess the performance of an artificial intelligence instrument to support qualitative diagnosis of colorectal polyps.","authors":"Keigo Sato, Mizuki Kuramochi, Akihiko Tsuchiya, Akihiro Yamaguchi, Yasuo Hosoda, Norio Yamaguchi, Naohiro Nakamura, Yuki Itoi, Yu Hashimoto, Kengo Kasuga, Hirohito Tanaka, Shiko Kuribayashi, Yoji Takeuchi, Toshio Uraoka","doi":"10.1136/bmjgast-2024-001553","DOIUrl":"10.1136/bmjgast-2024-001553","url":null,"abstract":"<p><strong>Objective: </strong>Computer-aided diagnosis (CAD) using artificial intelligence (AI) is expected to support the characterisation of colorectal lesions, which is clinically relevant for efficient colorectal cancer prevention. We conducted this study to assess the diagnostic performance of commercially available CAD systems.</p><p><strong>Methods: </strong>This was a multicentre, prospective performance evaluation study. The endoscopist diagnosed polyps using white light imaging, followed by non-magnified blue light imaging (non-mBLI) and mBLI. AI subsequently assessed the lesions using non-mBLI (non-mAI), followed by mBLI (mAI). Eventually, endoscopists made the final diagnosis by integrating the AI diagnosis (AI+endoscopist). The primary endpoint was the accuracy of the AI diagnosis of neoplastic lesions. The diagnostic performance of each modality (sensitivity, specificity and accuracy) and confidence levels were also assessed.</p><p><strong>Results: </strong>Overall, 380 lesions from 139 patients were included in the analysis. The accuracy of non-mAI was 83%, 95% CI (79% to 87%), which was inferior to that of mBLI (89%, 95% CI (85% to 92%)) and mAI (89%, 95% CI (85% to 92%)). The accuracy (95% CI) of diagnosis by expert endoscopists using mAI (91%, 95% CI (87% to 94%)) was comparable to that of expert endoscopists using mBLI (91%, 95% CI (87% to 94%)) but better than that of non-expert endoscopists using mAI (83%, 95% CI (75% to 90%)). The level of confidence in making a correct diagnosis was increased when using magnification and AI.</p><p><strong>Conclusions: </strong>The diagnostic performance of mAI for differentiating colonic lesions is comparable to that of endoscopists, regardless of their experience. However, it can be affected by the use of magnification as well as the endoscopists' level of experience.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11499753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495457","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}
引用次数: 0
The LIVERAID (LIVER And Infectious Diseases)-ICU score predicts in-hospital mortality in liver cirrhosis patients with infections in the intensive care unit. LIVERAID(肝脏和感染性疾病)-ICU评分可预测在重症监护病房感染的肝硬化患者的院内死亡率。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-08 DOI: 10.1136/bmjgast-2024-001482
Hauke Hoppmann, Florian Zeman, Daniela Wittmann, Petra Stöckert, Sophie Schlosser-Hupf, Alexander Mehrl, Vlad Pavel, Martina Müller, Stephan Schmid

Objectives: The admission of patients with liver cirrhosis to the intensive care unit (ICU) due to infections is a frequent occurrence, often leading to complications such as hepatic encephalopathy, renal failure and circulatory collapse, significantly elevating mortality risks. Accurate and timely diagnosis and intervention are critical for improving therapeutic outcomes. In this context, medical scoring systems in ICUs are essential for precise diagnosis, severity assessment and appropriate therapeutic strategies. There are no specific models for the prediction of mortality in ICU patients with liver cirrhosis-associated infections. This study aims to develop an improved prognostic scoring system for predicting in-hospital mortality among liver cirrhosis patients with infections in the ICU. This scoring system is designed to enhance the predictive accuracy of in-hospital mortality complementing existing sepsis and liver-specific prognostic models.

Methods: A retrospective analysis was conducted in 620 patients with liver cirrhosis, treated for infections in the ICU of a German university hospital during 2017-19. Advanced statistical techniques were employed to develop and validate the LIVERAID (LIVER And Infectious Diseases)-ICU score, a novel scoring system specifically tailored for liver cirrhosis patients in the ICU with infections. The development of the multivariable logistic regression model involved selecting variables with the highest prognostic efficacy, and its predictive performance was assessed using calibration plots and the concordance statistic (c-index) to evaluate both calibration and discrimination.

Results: The LIVERAID-ICU score integrates Child-Pugh class, serum urea levels and respiratory metrics. It is designed for bedside calculation using basic clinical and laboratory data, with no need for additional tools. In the validation cohort, the LIVERAID-ICU score exhibited enhanced sensitivity and specificity (AUC=0.83) in forecasting in-hospital mortality of patients with liver cirrhosis-associated infections when compared with established scores like Sequential Organ Failure Assessment (SOFA) (p=0.045), Model for End-Stage Liver Disease (MELD) (p=0.097), Child (p<0.001) and CLIF consortium acute-on-chronic liver failure (CLIF-C ACLF) (p<0.001).

Conclusion: The newly developed LIVERAID-ICU score represents a robust, streamlined and easy tool for predicting in-hospital mortality in liver cirrhosis patients with infections, surpassing the predictive capabilities of established liver or sepsis scores like SOFA, MELD, Child and CLIF-C ACLF. The reliance of the LIVERAID-ICU score on fundamental clinical and laboratory data facilitates its global application in ICUs, enabling immediate application at the bedside for patients with liver cirrhosis during episodes of suspected or confirmed infections.

目的:肝硬化患者因感染入住重症监护室(ICU)的情况屡见不鲜,往往会导致肝性脑病、肾功能衰竭和循环衰竭等并发症,大大增加了死亡风险。准确及时的诊断和干预对于改善治疗效果至关重要。在这种情况下,重症监护室的医疗评分系统对精确诊断、严重程度评估和适当的治疗策略至关重要。目前还没有专门的模型来预测 ICU 中肝硬化相关感染患者的死亡率。本研究旨在开发一种改进的预后评分系统,用于预测重症监护病房肝硬化感染患者的院内死亡率。该评分系统旨在提高院内死亡率预测的准确性,补充现有的败血症和肝脏特异性预后模型:对2017-19年间在德国一所大学医院重症监护室接受感染治疗的620名肝硬化患者进行了回顾性分析。采用先进的统计技术开发并验证了LIVERAID(肝脏和感染性疾病)-ICU评分,这是一种专为ICU感染的肝硬化患者量身定制的新型评分系统。在建立多变量逻辑回归模型时,我们选择了预后效果最好的变量,并使用校准图和一致性统计量(c-index)对其预测性能进行了评估,以评价其校准性和区分度:LIVERAID-ICU评分综合了Child-Pugh分级、血清尿素水平和呼吸指标。它的设计目的是利用基本的临床和实验室数据进行床旁计算,无需其他工具。在验证队列中,LIVERAID-ICU 评分在预测肝硬化相关感染患者的院内死亡率方面显示出更高的灵敏度和特异性(AUC=0.83),与已建立的评分如器官功能衰竭序列评估(SOFA)(p=0.045)、终末期肝病模型(MELD)(p=0.097)、Child(pConclusion)等相比均有所提高:新开发的 LIVERAID-ICU 评分是预测肝硬化合并感染患者院内死亡率的可靠、简便、易用的工具,其预测能力超过了 SOFA、MELD、Child 和 CLIF-C ACLF 等既有的肝脏或败血症评分。LIVERAID-ICU 评分依赖于基本的临床和实验室数据,这为其在重症监护病房的全面应用提供了便利,使其能够在疑似或确诊感染发作期间立即应用于肝硬化患者的床边治疗。
{"title":"The LIVERAID (LIVER And Infectious Diseases)-ICU score predicts in-hospital mortality in liver cirrhosis patients with infections in the intensive care unit.","authors":"Hauke Hoppmann, Florian Zeman, Daniela Wittmann, Petra Stöckert, Sophie Schlosser-Hupf, Alexander Mehrl, Vlad Pavel, Martina Müller, Stephan Schmid","doi":"10.1136/bmjgast-2024-001482","DOIUrl":"10.1136/bmjgast-2024-001482","url":null,"abstract":"<p><strong>Objectives: </strong>The admission of patients with liver cirrhosis to the intensive care unit (ICU) due to infections is a frequent occurrence, often leading to complications such as hepatic encephalopathy, renal failure and circulatory collapse, significantly elevating mortality risks. Accurate and timely diagnosis and intervention are critical for improving therapeutic outcomes. In this context, medical scoring systems in ICUs are essential for precise diagnosis, severity assessment and appropriate therapeutic strategies. There are no specific models for the prediction of mortality in ICU patients with liver cirrhosis-associated infections. This study aims to develop an improved prognostic scoring system for predicting in-hospital mortality among liver cirrhosis patients with infections in the ICU. This scoring system is designed to enhance the predictive accuracy of in-hospital mortality complementing existing sepsis and liver-specific prognostic models.</p><p><strong>Methods: </strong>A retrospective analysis was conducted in 620 patients with liver cirrhosis, treated for infections in the ICU of a German university hospital during 2017-19. Advanced statistical techniques were employed to develop and validate the LIVERAID (LIVER And Infectious Diseases)-ICU score, a novel scoring system specifically tailored for liver cirrhosis patients in the ICU with infections. The development of the multivariable logistic regression model involved selecting variables with the highest prognostic efficacy, and its predictive performance was assessed using calibration plots and the concordance statistic (c-index) to evaluate both calibration and discrimination.</p><p><strong>Results: </strong>The LIVERAID-ICU score integrates Child-Pugh class, serum urea levels and respiratory metrics. It is designed for bedside calculation using basic clinical and laboratory data, with no need for additional tools. In the validation cohort, the LIVERAID-ICU score exhibited enhanced sensitivity and specificity (AUC=0.83) in forecasting in-hospital mortality of patients with liver cirrhosis-associated infections when compared with established scores like Sequential Organ Failure Assessment (SOFA) (p=0.045), Model for End-Stage Liver Disease (MELD) (p=0.097), Child (p<0.001) and CLIF consortium acute-on-chronic liver failure (CLIF-C ACLF) (p<0.001).</p><p><strong>Conclusion: </strong>The newly developed LIVERAID-ICU score represents a robust, streamlined and easy tool for predicting in-hospital mortality in liver cirrhosis patients with infections, surpassing the predictive capabilities of established liver or sepsis scores like SOFA, MELD, Child and CLIF-C ACLF. The reliance of the LIVERAID-ICU score on fundamental clinical and laboratory data facilitates its global application in ICUs, enabling immediate application at the bedside for patients with liver cirrhosis during episodes of suspected or confirmed infections.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388208","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}
引用次数: 0
Adverse events after colonoscopy in a randomised colorectal cancer screening trial. 随机大肠癌筛查试验中结肠镜检查后的不良事件。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-07 DOI: 10.1136/bmjgast-2024-001471
Øyvind Bakken Rognstad, Edoardo Botteri, Geir Hoff, Michael Bretthauer, Elisabeth Gulichsen, Svein Oskar Frigstad, Øyvind Holme, Kristin Ranheim Randel

Objective: Colonoscopy-related adverse events increase the burden of colorectal cancer (CRC) screening. This cross-sectional study evaluates adverse events during and after colonoscopy in a large, randomised CRC screening trial in Norway comparing sigmoidoscopy to immunochemical testing for faecal blood.

Methods: We included all individuals who underwent colonoscopy at two screening centres between 2012 and 2020. From medical records, we retrieved data on adverse events during and within 30 days after colonoscopy and classified them according to the American Society for Gastrointestinal Endoscopy lexicon for endoscopic adverse events. Multivariable logistic regression models were fitted to identify risk factors for adverse events.

Results: Of the 10 244 included individuals, 242 (2.4%) had at least one adverse event that was possibly, probably, or definitively related to the colonoscopy. 188 (1.8%) had mild adverse events, 50 (0.49%) had moderate, 3 (0.03%) had severe, and 1 had a fatal adverse event. The most frequent adverse events were lower gastrointestinal bleeding (0.86%), abdominal pain (0.48%), vasovagal reaction (0.39%), postpolypectomy syndrome (0.20%), and perforation (0.08%). 23 (0.22%) individuals had non-gastrointestinal adverse events. Risk factors associated with adverse events were older age, female sex, screening centre, anticoagulant therapy, number of polypectomies, size of lesion removed, presence of proximal lesion, and adenocarcinoma. Adverse event rates per endoscopist ranged from 0% to 4.9%.

Conclusion: Adverse events after colonoscopy of screening positives occurred in about 2 out of 100 procedures. Three-quarters of events were mild. Awareness of risk factors may help endoscopists to mitigate the risk.

Trial registration number: NCT01538550.

目的:结肠镜检查相关不良事件增加了结肠直肠癌(CRC)筛查的负担。这项横断面研究评估了挪威一项大型随机 CRC 筛查试验中结肠镜检查期间和之后发生的不良事件,该试验比较了乙状结肠镜检查和粪血免疫化学检测:我们纳入了 2012 年至 2020 年期间在两个筛查中心接受结肠镜检查的所有患者。我们从医疗记录中检索了结肠镜检查期间和检查后 30 天内的不良事件数据,并根据美国消化内镜学会的内镜不良事件词典进行了分类。多变量逻辑回归模型用于确定不良事件的风险因素:在纳入的 10 244 人中,242 人(2.4%)至少有一次不良事件可能、可能或确定与结肠镜检查有关。188人(1.8%)有轻度不良反应,50人(0.49%)有中度不良反应,3人(0.03%)有重度不良反应,1人有致命不良反应。最常见的不良事件是下消化道出血(0.86%)、腹痛(0.48%)、血管迷走神经反应(0.39%)、息肉切除术后综合征(0.20%)和穿孔(0.08%)。23人(0.22%)发生了非胃肠道不良反应。与不良事件相关的风险因素有:年龄较大、女性、筛查中心、抗凝治疗、息肉切除次数、切除病灶的大小、近端病灶的存在以及腺癌。每位内镜医师的不良事件发生率从 0% 到 4.9% 不等:结肠镜检查筛查阳性患者后的不良事件发生率约为 2/100。四分之三的事件是轻微的。对风险因素的认识有助于内镜医师降低风险:NCT01538550.
{"title":"Adverse events after colonoscopy in a randomised colorectal cancer screening trial.","authors":"Øyvind Bakken Rognstad, Edoardo Botteri, Geir Hoff, Michael Bretthauer, Elisabeth Gulichsen, Svein Oskar Frigstad, Øyvind Holme, Kristin Ranheim Randel","doi":"10.1136/bmjgast-2024-001471","DOIUrl":"10.1136/bmjgast-2024-001471","url":null,"abstract":"<p><strong>Objective: </strong>Colonoscopy-related adverse events increase the burden of colorectal cancer (CRC) screening. This cross-sectional study evaluates adverse events during and after colonoscopy in a large, randomised CRC screening trial in Norway comparing sigmoidoscopy to immunochemical testing for faecal blood.</p><p><strong>Methods: </strong>We included all individuals who underwent colonoscopy at two screening centres between 2012 and 2020. From medical records, we retrieved data on adverse events during and within 30 days after colonoscopy and classified them according to the American Society for Gastrointestinal Endoscopy lexicon for endoscopic adverse events. Multivariable logistic regression models were fitted to identify risk factors for adverse events.</p><p><strong>Results: </strong>Of the 10 244 included individuals, 242 (2.4%) had at least one adverse event that was possibly, probably, or definitively related to the colonoscopy. 188 (1.8%) had mild adverse events, 50 (0.49%) had moderate, 3 (0.03%) had severe, and 1 had a fatal adverse event. The most frequent adverse events were lower gastrointestinal bleeding (0.86%), abdominal pain (0.48%), vasovagal reaction (0.39%), postpolypectomy syndrome (0.20%), and perforation (0.08%). 23 (0.22%) individuals had non-gastrointestinal adverse events. Risk factors associated with adverse events were older age, female sex, screening centre, anticoagulant therapy, number of polypectomies, size of lesion removed, presence of proximal lesion, and adenocarcinoma. Adverse event rates per endoscopist ranged from 0% to 4.9%.</p><p><strong>Conclusion: </strong>Adverse events after colonoscopy of screening positives occurred in about 2 out of 100 procedures. Three-quarters of events were mild. Awareness of risk factors may help endoscopists to mitigate the risk.</p><p><strong>Trial registration number: </strong>NCT01538550.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388207","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}
引用次数: 0
Health literacy and cumulative social disadvantage are associated with survival and transplant in patients with hepatocellular carcinoma: a prospective study. 肝细胞癌患者的健康素养和累积性社会劣势与生存和移植相关:一项前瞻性研究。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-02 DOI: 10.1136/bmjgast-2024-001537
Lauren D Nephew, Susan M Rawl, Allie Carter, Nicole Garcia, Patrick O Monahan, John Holden, Marwan Ghabril, Eleazar Montalvan-Sanchez, Kavish Patidar, Archita P Desai, Eric Orman, Naga Chalasani

Objective: To investigate how individual social determinants of health (SDOH) and cumulative social disadvantage (CSD) affect survival and receipt of liver transplant (LT) in patients with hepatocellular carcinoma (HCC).

Methods: We enrolled 139 adult patients from two Indianapolis hospital systems between June 2019 and April 2022. Structured questionnaires collected SDOH and social risk factor data. We compared SDOH and CSD by race, gender and disease aetiology, assigning one point per adverse SDOH. Multivariable competing risk survival analysis assessed associations between SDOH, CSD, survival and LT receipt.

Results: Black patients experienced higher CSD than white patients in the cohort (5.4±2.5 vs 3.2±2.1, p<0.001). Black patients were significantly more likely to have household incomes

Conclusions: There are significant racial and aetiology-related differences in SDOH burden. Low health literacy and high CSD are linked to worse outcomes in HCC patients. Health literacy screening and targeted interventions for those with high CSD could improve LT access and survival rates.

目的研究个人健康社会决定因素(SDOH)和累积性社会不利条件(CSD)如何影响肝细胞癌(HCC)患者的生存和接受肝移植(LT):我们在 2019 年 6 月至 2022 年 4 月期间从印第安纳波利斯的两家医院系统招募了 139 名成年患者。结构化问卷收集了 SDOH 和社会风险因素数据。我们按种族、性别和疾病病因对 SDOH 和 CSD 进行了比较,对每个不利的 SDOH 给予一个点。多变量竞争风险生存分析评估了SDOH、CSD、生存和接受LT之间的关联:结果:在队列中,黑人患者的CSD高于白人患者(5.4±2.5 vs 3.2±2.1,p结论:黑人患者的CSD高于白人患者(5.4±2.5 vs 3.2±2.1,p结论):SDOH负担存在明显的种族和病因差异。低健康素养和高 CSD 与 HCC 患者较差的预后有关。对高 CSD 患者进行健康素养筛查并采取有针对性的干预措施,可提高接受长期治疗的机会和存活率。
{"title":"Health literacy and cumulative social disadvantage are associated with survival and transplant in patients with hepatocellular carcinoma: a prospective study.","authors":"Lauren D Nephew, Susan M Rawl, Allie Carter, Nicole Garcia, Patrick O Monahan, John Holden, Marwan Ghabril, Eleazar Montalvan-Sanchez, Kavish Patidar, Archita P Desai, Eric Orman, Naga Chalasani","doi":"10.1136/bmjgast-2024-001537","DOIUrl":"10.1136/bmjgast-2024-001537","url":null,"abstract":"<p><strong>Objective: </strong>To investigate how individual social determinants of health (SDOH) and cumulative social disadvantage (CSD) affect survival and receipt of liver transplant (LT) in patients with hepatocellular carcinoma (HCC).</p><p><strong>Methods: </strong>We enrolled 139 adult patients from two Indianapolis hospital systems between June 2019 and April 2022. Structured questionnaires collected SDOH and social risk factor data. We compared SDOH and CSD by race, gender and disease aetiology, assigning one point per adverse SDOH. Multivariable competing risk survival analysis assessed associations between SDOH, CSD, survival and LT receipt.</p><p><strong>Results: </strong>Black patients experienced higher CSD than white patients in the cohort (5.4±2.5 vs 3.2±2.1, p<0.001). Black patients were significantly more likely to have household incomes <US$15 000 per year (52.6% vs 18.3%, p=0.003), to be insured by Medicaid (57.9% vs 33.0%, p=0.04), and to live in high Social Deprivation Index areas (68.4% vs 17.5%, p<0.001) than white patients. Patients with hepatitis C virus and alcohol-related liver disease had more adverse SDOH than those with metabolic dysfunction-associated steatotic liver disease, while there were no significant differences by gender. On multivariable analysis, a higher health literacy score was a significant predictor of survival (HR 2.54, 95% CI 1.19 to 5.43 CI, p=0.02) and higher CSD was associated with a lower probability of receipt of LT (HR 0.80, 95% CI 0.68 to 0.95, p=0.01).</p><p><strong>Conclusions: </strong>There are significant racial and aetiology-related differences in SDOH burden. Low health literacy and high CSD are linked to worse outcomes in HCC patients. Health literacy screening and targeted interventions for those with high CSD could improve LT access and survival rates.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364439","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}
引用次数: 0
Sex disparities in gallstone disease: insights from the MAUCO prospective population-based cohort study. 胆石症的性别差异:MAUCO 前瞻性人群队列研究的启示。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-28 DOI: 10.1136/bmjgast-2024-001457
Danae Rodriguez Gatta, Laura Huidobro, Fanny Petermann-Rocha, Vanessa Van de Wyngard, Franco Godoy, Vicente Cid, Macarena Garrido, Paz Cook, Juan Carlos Roa, Claudio Vargas, Juan Carlos Araya, Sandra Cortes, Francisco Cruz, Jill Koshiol, Marco Arrese, Catterina Ferreccio

Objective: To investigate factors associated with the prevalence and incidence of gallstone disease (GSD) in women and men of the MAUCO population-based prospective cohort.

Design: 8948 MAUCO participants (aged 38-74 years) underwent abdominal ultrasound at baseline (2015-2019); 4385 received follow-up ultrasound at years 2 or 4. Factors associated with prevalent GSD were assessed using Poisson multiple regression and with incident GSD using Cox regression models.

Results: GSD prevalence was 40.4% in women (13.1% gallstones, 27.3% cholecystectomies) and 17.1% in men (8.9% gallstones, 8.2% cholecystectomies). In men, GSD prevalence rate ratio (PRR) by age in >64 years was 3.85 (95% CI 3.00 to 4.94), doubling that of women's PRR 1.78 (95% CI 1.57 to 2.01). In women, waist circumference and diabetes were stronger GSD factors; a higher number of children and worse metabolic and socioeconomic conditions were also highlighted. GSD men had higher cardiovascular disease and a family history of GSD and gallbladder cancer. 198 GSD cases developed during follow-up, with incidence increasing by 2% (95% CI 1.005% to 1.03%) per each centimetre above the ideal waist circumference, statistically significant only in women. In men, age was the strongest factor for incidence, followed by a family history of GSD and low high-density lipoprotein increased incidence risk.

Conclusions: GSD burden was high in this population; a third of women had their gallbladder removed, which may pose them at risk of other health problems. Abdominal obesity was the only preventable GSD risk factor, highlighting the need for effective public health policies promoting obesity reduction.

目的调查MAUCO人群前瞻性队列中女性和男性胆石症(GSD)患病率和发病率的相关因素。设计:8948名MAUCO参与者(38-74岁)在基线(2015-2019年)时接受了腹部超声检查;4385人在第2年或第4年接受了随访超声检查。使用泊松多元回归评估了与GSD患病率相关的因素,使用Cox回归模型评估了与GSD发病率相关的因素:女性的 GSD 患病率为 40.4%(13.1% 为胆结石,27.3% 为胆囊切除术),男性为 17.1%(8.9% 为胆结石,8.2% 为胆囊切除术)。在男性中,年龄大于 64 岁的 GSD 患病率比为 3.85(95% CI 3.00 至 4.94),是女性患病率比 1.78(95% CI 1.57 至 2.01)的两倍。在女性中,腰围和糖尿病是更强的 GSD 因素;子女人数较多、代谢和社会经济条件较差也是突出的因素。男性 GSD 患者的心血管疾病发病率较高,且有 GSD 和胆囊癌家族史。198 例 GSD 患者在随访期间发病,理想腰围每增加 1 厘米,发病率就增加 2%(95% CI 1.005% 至 1.03%),只有女性的发病率具有统计学意义。在男性中,年龄是最主要的发病因素,其次是 GSD 家族史和低高密度脂蛋白会增加发病风险:结论:该人群的 GSD 负担很高;三分之一的女性切除了胆囊,这可能使她们面临其他健康问题的风险。腹部肥胖是唯一可预防 GSD 的风险因素,这说明需要制定有效的公共卫生政策来促进减少肥胖。
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引用次数: 0
Multiancestry transferability of a polygenic risk score for diverticulitis. 憩室炎多基因风险评分的多种族可转移性。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-23 DOI: 10.1136/bmjgast-2024-001474
Thomas E Ueland, Jonathan D Mosley, Christopher Neylan, John P Shelley, Jamie Robinson, Eric R Gamazon, Lillias Maguire, Richard Peek, Alexander T Hawkins

Objective: Polygenic risk scores (PRS) for diverticular disease must be evaluated in diverse cohorts. We sought to explore shared genetic predisposition across the phenome and to assess risk stratification in individuals genetically similar to European, African and Admixed-American reference samples.

Methods: A 44-variant PRS was applied to the All of Us Research Program. Phenome-wide association studies (PheWAS) identified conditions linked with heightened genetic susceptibility to diverticular disease. To evaluate the PRS in risk stratification, logistic regression models for symptomatic and for severe diverticulitis were compared with base models with covariates of age, sex, body mass index, smoking and principal components. Performance was assessed using area under the receiver operating characteristic curves (AUROC) and Nagelkerke's R2.

Results: The cohort comprised 181 719 individuals for PheWAS and 50 037 for risk modelling. PheWAS identified associations with diverticular disease, connective tissue disease and hernias. Across ancestry groups, one SD PRS increase was consistently associated with greater odds of severe (range of ORs (95% CI) 1.60 (1.27 to 2.02) to 1.86 (1.42 to 2.42)) and of symptomatic diverticulitis ((95% CI) 1.27 (1.10 to 1.46) to 1.66 (1.55 to 1.79)) relative to controls. European models achieved the highest AUROC and Nagelkerke's R2 (AUROC (95% CI) 0.78 (0.75 to 0.81); R2 0.25). The PRS provided a maximum R2 increase of 0.034 and modest AUROC improvement.

Conclusion: Associations between a diverticular disease PRS and severe presentations persisted in diverse cohorts when controlling for known risk factors. Relative improvements in model performance were observed, but absolute change magnitudes were modest.

目的:憩室疾病的多基因风险评分(PRS)必须在不同的队列中进行评估。我们试图探索整个表型组的共同遗传易感性,并评估与欧洲、非洲和美国混血参考样本基因相似的个体的风险分层:方法:在 "我们所有人研究计划 "中应用了 44 个变体的 PRS。全表型关联研究(Phenome-wide association studies,PheWAS)确定了与憩室疾病遗传易感性增高相关的条件。为了评估 PRS 在风险分层中的作用,将无症状憩室炎和严重憩室炎的逻辑回归模型与带有年龄、性别、体重指数、吸烟和主成分等协变量的基础模型进行了比较。使用接收者操作特征曲线下面积(AUROC)和纳格尔克R2对结果进行评估:结果:PheWAS 的队列由 181 719 人组成,风险建模的队列由 50 037 人组成。PheWAS确定了与憩室疾病、结缔组织疾病和疝气的关联。在不同血统群体中,相对于对照组,PRS 增加一个 SD 值与更高的严重几率(OR 值范围(95% CI)为 1.60(1.27 至 2.02)至 1.86(1.42 至 2.42))和症状性憩室炎几率((95% CI)为 1.27(1.10 至 1.46)至 1.66(1.55 至 1.79))相关。欧洲模型的AUROC和Nagelkerke's R2最高(AUROC (95% CI) 0.78 (0.75 to 0.81); R2 0.25)。PRS的R2最大增加了0.034,AUROC略有改善:结论:在控制已知风险因素的情况下,憩室疾病 PRS 与严重病症之间的关联在不同队列中持续存在。模型性能有了相对改善,但绝对变化幅度不大。
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引用次数: 0
Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT): study protocol for phase II two-centre, randomised controlled trial. 肝移植前后的家庭运动和激励计划(EXALT):第二阶段双中心随机对照试验的研究方案。
IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-03 DOI: 10.1136/bmjgast-2024-001410

Introduction: Physical frailty is associated with increased mortality and poor quality of life (QoL) before and after liver transplantation (LT). Evidence is lacking on how to tailor exercise and behavioural techniques in this patient population.

Methods and analysis: Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT) is a phase 2b, open-label, two-centre randomised controlled clinical trial designed to investigate whether a remotely monitored 'home-based exercise and theory-based motivation support programme (HBEP)' before and after LT improves QoL in LT recipients. Adult patients awaiting a primary LT will be assessed for eligibility at two LT centres (Birmingham, Royal Free London). Participants will be randomly assigned (1:1) to receive either an HBEP while on the LT waiting list through to 24 weeks after LT (Intervention) or a patient exercise advice leaflet (Control). Using a standard method of difference in means (two-sided significance level 0.05; power 0.90) and accounting for a 35% attrition/withdrawal rate, a minimum of 133 patients will be randomised to each treatment group. The primary outcome measure will be assessed using intention-to-treat analysis of the difference in the Physical Component Score of Short form-36 version 2.0 health-related QoL questionnaire between the groups at 24 weeks post-LT.

Ethics and dissemination: The protocol was approved by the South Central-Hampshire A National Research Ethics Committee. Recruitment into the EXALT trial started in May 2022 and is due to end in June 2024, with 217/266 patients randomised to date. The intervention follow-up is due to finish in May 2026. The findings of this trial will be disseminated through peer-reviewed publications, conferences and social media.

Trial registration number: ISRCTN13476586.

导言:身体虚弱与肝移植(LT)前后死亡率增加和生活质量(QoL)低下有关。方法与分析:肝移植前后的家庭锻炼和激励计划(EXALT)是一项2b期、开放标签、双中心随机对照临床试验,旨在研究肝移植前后远程监控的 "家庭锻炼和基于理论的激励支持计划(HBEP)"是否能改善肝移植受者的生活质量。将在两个LT中心(伯明翰和伦敦皇家自由医院)对等待接受初级LT的成年患者进行资格评估。参与者将被随机分配(1:1),在LT候诊期间至LT术后24周接受HBEP(干预)或患者运动建议宣传单(对照)。采用均值差异标准方法(双侧显著性水平 0.05;功率 0.90),并考虑到 35% 的自然减员/退出率,每个治疗组将随机分配至少 133 名患者。主要结局指标将采用意向治疗分析法进行评估,即在长程治疗后 24 周时,两组患者在 Short form-36 version 2.0 健康相关 QoL 问卷中的身体成分得分的差异:研究方案获得了中南部-汉普郡A国家研究伦理委员会的批准。EXALT试验的招募工作于2022年5月开始,将于2024年6月结束,迄今已有217/266名患者接受了随机治疗。干预随访将于 2026 年 5 月结束。该试验的结果将通过同行评议出版物、会议和社交媒体进行传播。试验注册号:ISRCTN13476586。
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引用次数: 0
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