Pub Date : 2024-11-01Epub Date: 2024-01-25DOI: 10.1097/MCG.0000000000001976
Anika Varma, Jennifer Weinstein, Jamison Seabury, Spencer Rosero, Ellen Wagner, Christine Zizzi, Aaron Kaat, Elizabeth Luebbe, Nuran Dilek, John Heatwole, Lawrence Saubermann, Larissa Temple, Scott Rogoff, Chad Heatwole
Objective: We sought to develop and validate the Crohn's Disease-Health Index (CD-HI), a disease-specific, patient-reported outcome measure that serially measures Crohn's disease (CD) symptomatic burden in adults with CD.
Background: As therapeutic interventions are tested among patients with CD, responsive outcome measures are needed to track disease progression and therapeutic gain during clinical trials.
Patients and methods: We conducted a national cross-sectional study of individuals with CD to identify the most prevalent and impactful symptoms of CD. The most relevant symptoms were included in the CD-HI. We used factor analysis, qualitative patient interviews, test-retest reliability evaluation, and known group validity testing to evaluate and optimize the CD-HI.
Results: The CD-HI contains 12 subscales that comprehensively measure CD burden using the patient's perspective. Fifteen adults with CD beta tested the CD-HI and found the instrument to be clear, easy to use, and relevant to them. Twenty-three adults with CD participated in an assessment of test-retest reliability, which indicated high reliability of individual questions, subscales, and the full instrument (intraclass correlation coefficient = 0.84 for the full instrument). The CD-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.98 for the full instrument). The CD-HI distinguished between groups of individuals with CD known to differ in disease severity.
Conclusions: This research supports the use of the CD-HI as a valid, sensitive, reliable, and relevant patient-reported outcome to determine the multifactorial disease burden of those with CD, assess the relevance and merit of future CD therapies, and support drug labeling claims.
目的:我们试图开发并验证克罗恩病健康指数(CD-HI):我们试图开发并验证克罗恩病健康指数(CD-HI),这是一种疾病特异性、患者报告的结果测量方法,可连续测量成人克罗恩病(CD)患者的症状负担:背景:在对克罗恩病患者进行治疗干预试验时,需要采用反应性结果测量法来跟踪临床试验期间的疾病进展和治疗效果:我们对 CD 患者进行了一项全国性横断面研究,以确定 CD 最普遍和影响最大的症状。最相关的症状被纳入 CD-HI 中。我们使用因子分析、定性患者访谈、重测可靠性评估和已知群体有效性测试来评估和优化 CD-HI :CD-HI包含12个分量表,从患者的角度全面衡量了CD负担。15 名成年 CD 患者对 CD-HI 进行了 beta 测试,认为该工具清晰、易于使用,而且与他们息息相关。23 名成人 CD 患者参与了测试-再测试可靠性评估,结果表明单个问题、子量表和整个工具的可靠性都很高(整个工具的类内相关系数 = 0.84)。CD-HI 及其子量表显示出较高的内部一致性(完整工具的 Cronbach α = 0.98)。CD-HI 可以区分疾病严重程度不同的 CD 患者群体:这项研究支持使用 CD-HI 作为一种有效、敏感、可靠和相关的患者报告结果,以确定 CD 患者的多因素疾病负担,评估未来 CD 疗法的相关性和优点,并支持药物标签声明。
{"title":"The Crohn's Disease-Health Index: Development and Evaluation of a Novel Outcome Measure.","authors":"Anika Varma, Jennifer Weinstein, Jamison Seabury, Spencer Rosero, Ellen Wagner, Christine Zizzi, Aaron Kaat, Elizabeth Luebbe, Nuran Dilek, John Heatwole, Lawrence Saubermann, Larissa Temple, Scott Rogoff, Chad Heatwole","doi":"10.1097/MCG.0000000000001976","DOIUrl":"10.1097/MCG.0000000000001976","url":null,"abstract":"<p><strong>Objective: </strong>We sought to develop and validate the Crohn's Disease-Health Index (CD-HI), a disease-specific, patient-reported outcome measure that serially measures Crohn's disease (CD) symptomatic burden in adults with CD.</p><p><strong>Background: </strong>As therapeutic interventions are tested among patients with CD, responsive outcome measures are needed to track disease progression and therapeutic gain during clinical trials.</p><p><strong>Patients and methods: </strong>We conducted a national cross-sectional study of individuals with CD to identify the most prevalent and impactful symptoms of CD. The most relevant symptoms were included in the CD-HI. We used factor analysis, qualitative patient interviews, test-retest reliability evaluation, and known group validity testing to evaluate and optimize the CD-HI.</p><p><strong>Results: </strong>The CD-HI contains 12 subscales that comprehensively measure CD burden using the patient's perspective. Fifteen adults with CD beta tested the CD-HI and found the instrument to be clear, easy to use, and relevant to them. Twenty-three adults with CD participated in an assessment of test-retest reliability, which indicated high reliability of individual questions, subscales, and the full instrument (intraclass correlation coefficient = 0.84 for the full instrument). The CD-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.98 for the full instrument). The CD-HI distinguished between groups of individuals with CD known to differ in disease severity.</p><p><strong>Conclusions: </strong>This research supports the use of the CD-HI as a valid, sensitive, reliable, and relevant patient-reported outcome to determine the multifactorial disease burden of those with CD, assess the relevance and merit of future CD therapies, and support drug labeling claims.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"1043-1051"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11465757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139567042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-07-16DOI: 10.1097/MCG.0000000000001975
Younghee Choe, Jae Myung Park, Joon Sung Kim, Yu Kyung Cho, Byung-Wook Kim, Myung-Gyu Choi, Na Jin Kim
Objective: The frequency of small bowel (SB) injuries has increased due to the increased use of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin. This study was a systematic review and meta-analysis to compare drugs effective for SB injuries caused by NSAIDs or aspirin use.
Methods: We searched MEDLINE, Embase, and Cochrane registries for randomized controlled trials through February 2023. The extracted data included changes in the number of erosions or ulcers in the jejunum or ileum observed through capsule endoscopy in patients taking NSAIDs or aspirin and administration of various mucoprotectants. We investigated the therapeutic or preventive efficacy of these drugs. The methodological bias was evaluated using Risk of Bias 2.0.
Results: Eighteen randomized controlled trials of drugs effective for NSAIDs or aspirin-induced SB injuries were included and analyzed. The agents used to treat or prevent SB injuries were rebamipide, misoprostol, geranylgeranylacetone, and probiotics. In the meta-analysis, the mucoprotectants that showed a significant effect in treating NSAID users, who developed SB injuries, were misoprostol (mean difference: -9.88; 95% CI: -13.26 to -6.50). Meanwhile, the mucoprotectant that can prevent SB injuries caused by NSAIDs or aspirin in the general population was rebamipide (mean difference: -1.85; 95% CI: -2.74 to -0.96).
Conclusions: Misoprostol was effective in treating SB injuries caused by NSAIDs or aspirin (CRD42023410946).
{"title":"Drugs Effective for Nonsteroidal Anti-inflammatory Drugs or Aspirin-induced Small Bowel Injuries: A Systematic Review and Meta-analysis of Randomized Controlled Trials.","authors":"Younghee Choe, Jae Myung Park, Joon Sung Kim, Yu Kyung Cho, Byung-Wook Kim, Myung-Gyu Choi, Na Jin Kim","doi":"10.1097/MCG.0000000000001975","DOIUrl":"10.1097/MCG.0000000000001975","url":null,"abstract":"<p><strong>Objective: </strong>The frequency of small bowel (SB) injuries has increased due to the increased use of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin. This study was a systematic review and meta-analysis to compare drugs effective for SB injuries caused by NSAIDs or aspirin use.</p><p><strong>Methods: </strong>We searched MEDLINE, Embase, and Cochrane registries for randomized controlled trials through February 2023. The extracted data included changes in the number of erosions or ulcers in the jejunum or ileum observed through capsule endoscopy in patients taking NSAIDs or aspirin and administration of various mucoprotectants. We investigated the therapeutic or preventive efficacy of these drugs. The methodological bias was evaluated using Risk of Bias 2.0.</p><p><strong>Results: </strong>Eighteen randomized controlled trials of drugs effective for NSAIDs or aspirin-induced SB injuries were included and analyzed. The agents used to treat or prevent SB injuries were rebamipide, misoprostol, geranylgeranylacetone, and probiotics. In the meta-analysis, the mucoprotectants that showed a significant effect in treating NSAID users, who developed SB injuries, were misoprostol (mean difference: -9.88; 95% CI: -13.26 to -6.50). Meanwhile, the mucoprotectant that can prevent SB injuries caused by NSAIDs or aspirin in the general population was rebamipide (mean difference: -1.85; 95% CI: -2.74 to -0.96).</p><p><strong>Conclusions: </strong>Misoprostol was effective in treating SB injuries caused by NSAIDs or aspirin (CRD42023410946).</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"1003-1010"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141620095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-01-15DOI: 10.1097/MCG.0000000000001963
Afrin N Kamal, Priya Kathpalia, David A Leiman, Albert J Bredenoord, John O Clarke, C Prakash Gyawali, David A Katzka, Adriana Lazarescu, John E Pandolfino, Roberto Penagini, Sabine Roman, Edoardo Savarino, Marcelo F Vela, Fouad Otaki
Goals: Develop quality indicators for ineffective esophageal motility (IEM).
Background: IEM is identified in up to 20% of patients undergoing esophageal high-resolution manometry (HRM) based on the Chicago Classification. The clinical significance of this pattern is not established and management remains challenging.
Study: Using RAND/University of California, Los Angeles Appropriateness Methods, we employed a modified-Delphi approach for quality indicator statement development. Quality indicators were proposed based on prior literature. Experts independently and blindly scored proposed quality statements on importance, scientific acceptability, usability, and feasibility in a 3-round iterative process.
Results: All 10 of the invited esophageal experts in the management of esophageal diseases invited to participate rated 12 proposed quality indicator statements. In round 1, 7 quality indicators were rated with mixed agreement, on the majority of categories. Statements were modified based on panel suggestion, modified further following round 2's virtual discussion, and in round 3 voting identified 2 quality indicators with comprehensive agreement, 4 with partial agreement, and 1 without any agreement. The panel agreed on the concept of determining if IEM is clinically relevant to the patient's presentation and managing gastroesophageal reflux disease rather than the IEM pattern; they disagreed in all 4 domains on the use of promotility agents in IEM; and had mixed agreement on the value of a finding of IEM during anti-reflux surgical planning.
Conclusion: Using a robust methodology, 2 IEM quality indicators were identified. These quality indicators can track performance when physicians identify this manometric pattern on HRM. This study further highlights the challenges met with IEM and the need for additional research to better understand the clinical importance of this manometric pattern.
{"title":"Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study.","authors":"Afrin N Kamal, Priya Kathpalia, David A Leiman, Albert J Bredenoord, John O Clarke, C Prakash Gyawali, David A Katzka, Adriana Lazarescu, John E Pandolfino, Roberto Penagini, Sabine Roman, Edoardo Savarino, Marcelo F Vela, Fouad Otaki","doi":"10.1097/MCG.0000000000001963","DOIUrl":"10.1097/MCG.0000000000001963","url":null,"abstract":"<p><strong>Goals: </strong>Develop quality indicators for ineffective esophageal motility (IEM).</p><p><strong>Background: </strong>IEM is identified in up to 20% of patients undergoing esophageal high-resolution manometry (HRM) based on the Chicago Classification. The clinical significance of this pattern is not established and management remains challenging.</p><p><strong>Study: </strong>Using RAND/University of California, Los Angeles Appropriateness Methods, we employed a modified-Delphi approach for quality indicator statement development. Quality indicators were proposed based on prior literature. Experts independently and blindly scored proposed quality statements on importance, scientific acceptability, usability, and feasibility in a 3-round iterative process.</p><p><strong>Results: </strong>All 10 of the invited esophageal experts in the management of esophageal diseases invited to participate rated 12 proposed quality indicator statements. In round 1, 7 quality indicators were rated with mixed agreement, on the majority of categories. Statements were modified based on panel suggestion, modified further following round 2's virtual discussion, and in round 3 voting identified 2 quality indicators with comprehensive agreement, 4 with partial agreement, and 1 without any agreement. The panel agreed on the concept of determining if IEM is clinically relevant to the patient's presentation and managing gastroesophageal reflux disease rather than the IEM pattern; they disagreed in all 4 domains on the use of promotility agents in IEM; and had mixed agreement on the value of a finding of IEM during anti-reflux surgical planning.</p><p><strong>Conclusion: </strong>Using a robust methodology, 2 IEM quality indicators were identified. These quality indicators can track performance when physicians identify this manometric pattern on HRM. This study further highlights the challenges met with IEM and the need for additional research to better understand the clinical importance of this manometric pattern.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"975-980"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11534068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139477645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-03-15DOI: 10.1097/MCG.0000000000001988
Sunil V Patel, David Yu, Connie Taylor, Jackie McKay, Lawrence Hookey
Objective: To compare smartphone application (Colonoscopic Preparation) instructions versus paper instructions for bowel preparation for colonoscopy.
Background: Adhering to bowel preparation instructions is important to ensure a high-quality colonoscopy.
Patients and methods: This randomized controlled trial included individuals undergoing colonoscopy at a tertiary care hospital. Individuals were randomized (1:1) to receive instructions through a smartphone application or traditional paper instructions. The primary outcome was the quality of the bowel preparation as measured by the Boston Bowel Preparation Score. Secondary outcomes included cecal intubation and polyp detection. Patient satisfaction was assessed using a previously developed questionnaire.
Results: A total of 238 individuals were randomized (n = 119 in each group), with 202 available for the intention-to-treat analysis (N = 97 in the app group and 105 in the paper group). The groups had similar demographics, indications for colonoscopy, and type of bowel preparation. The primary outcome (Boston Bowel Preparation Score) demonstrated no difference between groups (Colonoscopic Preparation app mean: 7.26 vs paper mean: 7.28, P = 0.91). There was no difference in cecal intubation ( P = 0.37), at least one polyp detected ( P = 0.43), or the mean number of polyps removed ( P = 0.11). A higher proportion strongly agreed or agreed that they would use the smartphone app compared with paper instructions (89.4% vs 70.1%, P = 0.001).
Conclusions: Smartphone instructions performed similarly to traditional paper instructions for those willing to use the application. Local patient preferences need to be considered before making changes in the method of delivery of medical instructions.
{"title":"Smartphone Application Versus Standard Instruction for Colonoscopic Preparation: A Randomized Controlled Trial.","authors":"Sunil V Patel, David Yu, Connie Taylor, Jackie McKay, Lawrence Hookey","doi":"10.1097/MCG.0000000000001988","DOIUrl":"10.1097/MCG.0000000000001988","url":null,"abstract":"<p><strong>Objective: </strong>To compare smartphone application (Colonoscopic Preparation) instructions versus paper instructions for bowel preparation for colonoscopy.</p><p><strong>Background: </strong>Adhering to bowel preparation instructions is important to ensure a high-quality colonoscopy.</p><p><strong>Patients and methods: </strong>This randomized controlled trial included individuals undergoing colonoscopy at a tertiary care hospital. Individuals were randomized (1:1) to receive instructions through a smartphone application or traditional paper instructions. The primary outcome was the quality of the bowel preparation as measured by the Boston Bowel Preparation Score. Secondary outcomes included cecal intubation and polyp detection. Patient satisfaction was assessed using a previously developed questionnaire.</p><p><strong>Results: </strong>A total of 238 individuals were randomized (n = 119 in each group), with 202 available for the intention-to-treat analysis (N = 97 in the app group and 105 in the paper group). The groups had similar demographics, indications for colonoscopy, and type of bowel preparation. The primary outcome (Boston Bowel Preparation Score) demonstrated no difference between groups (Colonoscopic Preparation app mean: 7.26 vs paper mean: 7.28, P = 0.91). There was no difference in cecal intubation ( P = 0.37), at least one polyp detected ( P = 0.43), or the mean number of polyps removed ( P = 0.11). A higher proportion strongly agreed or agreed that they would use the smartphone app compared with paper instructions (89.4% vs 70.1%, P = 0.001).</p><p><strong>Conclusions: </strong>Smartphone instructions performed similarly to traditional paper instructions for those willing to use the application. Local patient preferences need to be considered before making changes in the method of delivery of medical instructions.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"1028-1033"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140136870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-01-15DOI: 10.1097/MCG.0000000000001966
James D Miller, Brendan P Kemple, Joni K Evans, Steven B Clayton
Objective: The aims of this study are to determine the functional luminal imaging probe's (FLIP) diagnostic utility by comparing FLIP measurements with results from other esophageal evaluation standards.
Background: The FLIP is an esophageal evaluation technique performed at the time of endoscopy. Few studies have evaluated FLIP diagnostic capabilities compared with the established testing techniques, including high-resolution manometry (HRIM), time barium esophagram (TBE), and 24-hour impedance-pH monitoring.
Patients and methods: A retrospective review was performed for 413 preintervention patients who underwent FLIP testing during endoscopy. Data from HRIM, 24-hour pH monitoring, and TBE were compared.
Results: Abnormal Distensibility Index (DI) was associated with abnormal integrated relaxation pressure (IRP; P = 0.003). Average DI was higher in patients with abnormal IRP (>15 mm Hg) when a hiatal hernia was present ( P = 0.025). The total agreement between correlated diagnoses from FLIP and HRIM was 33.5%. DI was not associated with acid exposure time on pH monitoring. Agreement between FLIP and TBE was 49% with a sensitivity of 98.1% and a specificity of 36.5%. A 60 mL distension had a significantly lower detection rate than 40 mL and 50 mL for active peristalsis and was unaffected by pressure ( P < 0.05).
Conclusions: FLIP as an adjunct to HRIM is supported by strong metric correlation. FLIP was not correlated to pH monitoring findings, suggesting FLIP is not useful in reflux assessment. The agreement between FLIP and TBE was lower than in previous studies. Hiatal hernia impacted the normality between DI and IRP, not between FLIP and TBE. We suggest analyzing peristaltic patterns on panometry at all fill volumes to optimize detection.
{"title":"A Comparison of Functional Luminal Imaging Probe With High-resolution Manometry, Timed Barium Esophagram, and pH Impedance Testing to Evaluate Functional Luminal Imaging Probe's Diagnostic Capabilities.","authors":"James D Miller, Brendan P Kemple, Joni K Evans, Steven B Clayton","doi":"10.1097/MCG.0000000000001966","DOIUrl":"10.1097/MCG.0000000000001966","url":null,"abstract":"<p><strong>Objective: </strong>The aims of this study are to determine the functional luminal imaging probe's (FLIP) diagnostic utility by comparing FLIP measurements with results from other esophageal evaluation standards.</p><p><strong>Background: </strong>The FLIP is an esophageal evaluation technique performed at the time of endoscopy. Few studies have evaluated FLIP diagnostic capabilities compared with the established testing techniques, including high-resolution manometry (HRIM), time barium esophagram (TBE), and 24-hour impedance-pH monitoring.</p><p><strong>Patients and methods: </strong>A retrospective review was performed for 413 preintervention patients who underwent FLIP testing during endoscopy. Data from HRIM, 24-hour pH monitoring, and TBE were compared.</p><p><strong>Results: </strong>Abnormal Distensibility Index (DI) was associated with abnormal integrated relaxation pressure (IRP; P = 0.003). Average DI was higher in patients with abnormal IRP (>15 mm Hg) when a hiatal hernia was present ( P = 0.025). The total agreement between correlated diagnoses from FLIP and HRIM was 33.5%. DI was not associated with acid exposure time on pH monitoring. Agreement between FLIP and TBE was 49% with a sensitivity of 98.1% and a specificity of 36.5%. A 60 mL distension had a significantly lower detection rate than 40 mL and 50 mL for active peristalsis and was unaffected by pressure ( P < 0.05).</p><p><strong>Conclusions: </strong>FLIP as an adjunct to HRIM is supported by strong metric correlation. FLIP was not correlated to pH monitoring findings, suggesting FLIP is not useful in reflux assessment. The agreement between FLIP and TBE was lower than in previous studies. Hiatal hernia impacted the normality between DI and IRP, not between FLIP and TBE. We suggest analyzing peristaltic patterns on panometry at all fill volumes to optimize detection.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"981-988"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139477548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-07-24DOI: 10.1097/MCG.0000000000002047
Alejandra Vargas, Michael Saadeh, C Richard Boland, Ranjit K Goudar, David A Johnson
{"title":"Genetic Testing in Colorectal Cancer: Towards a Better Understanding and Utilization by Clinicians.","authors":"Alejandra Vargas, Michael Saadeh, C Richard Boland, Ranjit K Goudar, David A Johnson","doi":"10.1097/MCG.0000000000002047","DOIUrl":"10.1097/MCG.0000000000002047","url":null,"abstract":"","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"945-949"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Comparing direct oral anticoagulants (DOACs) and warfarin's efficacy and safety in patients with nonvalvular atrial fibrillation (AF) and liver cirrhosis (LC).
Background: Evidence of the pharmacodynamics of DOACs is limited in patients with AF and LC.
Methods: A retrospective cohort study was conducted in the largest hospital system in Taiwan, involving patients with AF and LC for the years 2012 to 2021. Hazards of thromboembolic events (ischemic stroke, transient ischemic attack, and systemic embolism), intracranial hemorrhage, gastrointestinal, major bleeding, and all-cause mortality were investigated with a new-user, active comparator design. Inverse probability of treatment weighting was applied to balance potential confounders between treatment groups.
Results: In total, 478 DOAC users and 247 warfarin users were included. DOACs and warfarin demonstrated similar trends in preventing thromboembolic events, namely ischemic stroke [adjusted hazard ratio (aHR), 1.05 (95% CI: 0.42-2.61)], transient ischemic attack [aHR, 1.36 (95% CI: 0.18-10.31)], and systemic embolism [aHR, 0.49 (95% CI: 0.14-1.70)]. DOAC use was associated with a similar risk of intracranial hemorrhage [aHR, 0.65 (95% CI: 0.26-1.59)] and gastrointestinal bleeding [aHR, 0.64 (95% CI: 0.39-1.03)], a decreased risk of major bleeding [aHR, 0.64 (95% CI: 0.42-0.99)], and a reduction in mortality [aHR, 0.73 (95% CI: 0.54-0.99)]. DOAC users exhibited a significant reduction in major bleeding risk in patients with Child-Pugh class A (aHR, 0.48; 95% CI: 0.33-0.70).
Conclusions: DOACs showed potential safety advantages over warfarin for patients with nonvalvular AF and LC, particularly in reducing major bleeding risk in those with Child-Pugh class A.
{"title":"Efficacy and Safety of Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation and Liver Cirrhosis.","authors":"Tien-Shin Chou, Yuan Lin, Ming-Lung Tsai, Chin-Ju Tseng, Jhih-Wei Dai, Ning-I Yang, Chih-Lang Lin, Li-Wei Chen, Ming-Jui Hung, Tien-Hsing Chen","doi":"10.1097/MCG.0000000000002089","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002089","url":null,"abstract":"<p><strong>Objective: </strong>Comparing direct oral anticoagulants (DOACs) and warfarin's efficacy and safety in patients with nonvalvular atrial fibrillation (AF) and liver cirrhosis (LC).</p><p><strong>Background: </strong>Evidence of the pharmacodynamics of DOACs is limited in patients with AF and LC.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted in the largest hospital system in Taiwan, involving patients with AF and LC for the years 2012 to 2021. Hazards of thromboembolic events (ischemic stroke, transient ischemic attack, and systemic embolism), intracranial hemorrhage, gastrointestinal, major bleeding, and all-cause mortality were investigated with a new-user, active comparator design. Inverse probability of treatment weighting was applied to balance potential confounders between treatment groups.</p><p><strong>Results: </strong>In total, 478 DOAC users and 247 warfarin users were included. DOACs and warfarin demonstrated similar trends in preventing thromboembolic events, namely ischemic stroke [adjusted hazard ratio (aHR), 1.05 (95% CI: 0.42-2.61)], transient ischemic attack [aHR, 1.36 (95% CI: 0.18-10.31)], and systemic embolism [aHR, 0.49 (95% CI: 0.14-1.70)]. DOAC use was associated with a similar risk of intracranial hemorrhage [aHR, 0.65 (95% CI: 0.26-1.59)] and gastrointestinal bleeding [aHR, 0.64 (95% CI: 0.39-1.03)], a decreased risk of major bleeding [aHR, 0.64 (95% CI: 0.42-0.99)], and a reduction in mortality [aHR, 0.73 (95% CI: 0.54-0.99)]. DOAC users exhibited a significant reduction in major bleeding risk in patients with Child-Pugh class A (aHR, 0.48; 95% CI: 0.33-0.70).</p><p><strong>Conclusions: </strong>DOACs showed potential safety advantages over warfarin for patients with nonvalvular AF and LC, particularly in reducing major bleeding risk in those with Child-Pugh class A.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142576212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-01-17DOI: 10.1097/MCG.0000000000001968
Roberta Elisa Rossi, Angelo Zullo, Silvia Ferretti, Giulia Migliorisi, Luigi Gatta, Vincenzo De Francesco, Alessandro Del Forno, Giacomo Marcozzi, Benedetta Masoni, Gianluca Franchellucci, Cesare Hassan, Alessandro Repici
Background and aim: Gastrointestinal (GI) bleeding or malabsorption represents the most frequent aetiologies of iron deficiency anemia (IDA). The cause of IDA remains undetermined in ~10% to 20% of patients undergoing upper and lower GI endoscopies. In this scenario, a small bowel examination with videocapsule endoscopy (VCE) is recommended. We performed a systematic review with meta-analysis to evaluate the diagnostic yield of VCE in patients with IDA without overt bleeding, assessing the prevalence of either any lesion or lesions at high potential of bleeding.
Materials and methods: A computerized literature search was performed using relevant keywords to identify all the pertinent articles published until March 2023.
Results: Twelve studies with a total of 1703 IDA patients (Males: 47%; age range: 19-92 y) were included in this systematic review. The diagnostic yield of VCE for overall lesions in the small bowel was 61% (95% CI=44-77; 95 CI=97.2-98.1; I2 =97.7%). When analyzing only small bowel lesions likely responsible of IDA, the diagnostic yield was 40% (95% CI=27-53; 95% CI=95.3-97; I2 =96.3%).
Conclusion: VCE plays a relevant role in the diagnostic work-up of patients with IDA without overt bleeding with a satisfactory diagnostic yield.
背景和目的:胃肠道(GI)出血或吸收不良是缺铁性贫血(IDA)最常见的病因。在接受上消化道和下消化道内窥镜检查的患者中,约有 10% 至 20% 的患者仍无法确定 IDA 的病因。在这种情况下,建议使用视频胶囊内镜(VCE)进行小肠检查。我们进行了一项系统性综述和荟萃分析,评估了VCE对无明显出血的IDA患者的诊断率,评估了任何病变或出血可能性高的病变的发生率:使用相关关键词进行计算机文献检索,找出截至2023年3月发表的所有相关文章:本系统综述纳入了12项研究,共计1703名IDA患者(男性:47%;年龄范围:19-92岁)。VCE对小肠总体病变的诊断率为61% (95% CI=44-77; 95 CI=97.2-98.1; I2=97.7%)。当仅分析可能导致 IDA 的小肠病变时,诊断率为 40% (95% CI=27-53; 95% CI=95.3-97; I2=96.3%):VCE在无明显出血的IDA患者的诊断工作中发挥着重要作用,诊断率令人满意。
{"title":"Diagnostic Yield of Small Bowel Videocapsule Endoscopy in Patients with Iron Deficiency Anemia. A Systematic Review and meta-analysis.","authors":"Roberta Elisa Rossi, Angelo Zullo, Silvia Ferretti, Giulia Migliorisi, Luigi Gatta, Vincenzo De Francesco, Alessandro Del Forno, Giacomo Marcozzi, Benedetta Masoni, Gianluca Franchellucci, Cesare Hassan, Alessandro Repici","doi":"10.1097/MCG.0000000000001968","DOIUrl":"10.1097/MCG.0000000000001968","url":null,"abstract":"<p><strong>Background and aim: </strong>Gastrointestinal (GI) bleeding or malabsorption represents the most frequent aetiologies of iron deficiency anemia (IDA). The cause of IDA remains undetermined in ~10% to 20% of patients undergoing upper and lower GI endoscopies. In this scenario, a small bowel examination with videocapsule endoscopy (VCE) is recommended. We performed a systematic review with meta-analysis to evaluate the diagnostic yield of VCE in patients with IDA without overt bleeding, assessing the prevalence of either any lesion or lesions at high potential of bleeding.</p><p><strong>Materials and methods: </strong>A computerized literature search was performed using relevant keywords to identify all the pertinent articles published until March 2023.</p><p><strong>Results: </strong>Twelve studies with a total of 1703 IDA patients (Males: 47%; age range: 19-92 y) were included in this systematic review. The diagnostic yield of VCE for overall lesions in the small bowel was 61% (95% CI=44-77; 95 CI=97.2-98.1; I2 =97.7%). When analyzing only small bowel lesions likely responsible of IDA, the diagnostic yield was 40% (95% CI=27-53; 95% CI=95.3-97; I2 =96.3%).</p><p><strong>Conclusion: </strong>VCE plays a relevant role in the diagnostic work-up of patients with IDA without overt bleeding with a satisfactory diagnostic yield.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"998-1002"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139477561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-01-29DOI: 10.1097/MCG.0000000000001977
Andrew Canakis, Sanad Maher Dawod, Enad Dawod, Malorie Simons, Bianca Di Cocco, Donevan Richard Westerveld, Roberto Paolo Trasolini, Tyler M Berzin, Christopher A Marshall, Ahmed Maher Abdelfattah, Neil B Marya, George B Smallfield, Matthew Kaspar, Guilherme M Campos, Wasseem Skef, Prashant Kedia, Terrence A Smith, Hiroyuki Aihara, Matthew T Moyer, Kartik Sampath, Srihari Mahadev, David L Carr-Locke, Reem Z Sharaiha
Background and aims: The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure.
Methods: This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates.
Results: In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted.
Conclusion: This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.
{"title":"Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience.","authors":"Andrew Canakis, Sanad Maher Dawod, Enad Dawod, Malorie Simons, Bianca Di Cocco, Donevan Richard Westerveld, Roberto Paolo Trasolini, Tyler M Berzin, Christopher A Marshall, Ahmed Maher Abdelfattah, Neil B Marya, George B Smallfield, Matthew Kaspar, Guilherme M Campos, Wasseem Skef, Prashant Kedia, Terrence A Smith, Hiroyuki Aihara, Matthew T Moyer, Kartik Sampath, Srihari Mahadev, David L Carr-Locke, Reem Z Sharaiha","doi":"10.1097/MCG.0000000000001977","DOIUrl":"10.1097/MCG.0000000000001977","url":null,"abstract":"<p><strong>Background and aims: </strong>The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure.</p><p><strong>Methods: </strong>This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates.</p><p><strong>Results: </strong>In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted.</p><p><strong>Conclusion: </strong>This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"1052-1057"},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139567036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1097/MCG.0000000000002097
Thong Duy Vo, Sang Hoai Mai, Huong Tu Lam
Introduction: Early diagnosis of hepatocellular carcinoma (HCC) is crucial but challenging, and late detection limits its treatment and prognosis. We aimed to evaluate the GALAD score as a novel yet highly accurate and promising diagnostic tool for HCC.
Methods: A prospective and retrospective cohort study was conducted in 196 adult patients with cirrhosis, including 102 with HCC and 94 without. The diagnostic performance of the GALAD score for HCC detection was compared with that of single biomarkers.
Results: In patients with cirrhosis with HCC, the GALAD score was 2.5 (95% CI: -2.43 to 11.09), which was significantly higher than the GALAD score of -2.46 (95% CI: -6.15 to 2.04) in patients with cirrhosis without HCC (P<0.001). Patients with multiple tumors had a significantly higher GALAD score than those with a single tumor (P=0.0081). There was a moderate correlation between the GALAD score and tumor size in patients with cirrhosis (r=0.44; P<0.001). The GALAD score had an area under the receiver operating characteristic curve of 0.91, higher than that of all single biomarkers used to diagnose HCC (all P<0.001). The optimal cutoff for diagnosing HCC using the GALAD score was -0.518, achieving a sensitivity of 87.25%, specificity of 82.98%, positive predictive value of 84.62%, and negative predictive value of 84.78%. At this cutoff, the GALAD score demonstrated superior sensitivity compared with single or combined biomarkers.
Conclusions: The GALAD score shows promise in detecting HCC in patients with cirrhosis. The GALAD score could be applied in clinical practice to diagnose HCC in patients with cirrhosis, and calculating the GALAD score in clinical settings may help predict tumor size and quantity before imaging results become available.
{"title":"Evaluating the GALAD Score for Detection of Hepatocellular Carcinoma in Patients With Cirrhosis.","authors":"Thong Duy Vo, Sang Hoai Mai, Huong Tu Lam","doi":"10.1097/MCG.0000000000002097","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002097","url":null,"abstract":"<p><strong>Introduction: </strong>Early diagnosis of hepatocellular carcinoma (HCC) is crucial but challenging, and late detection limits its treatment and prognosis. We aimed to evaluate the GALAD score as a novel yet highly accurate and promising diagnostic tool for HCC.</p><p><strong>Methods: </strong>A prospective and retrospective cohort study was conducted in 196 adult patients with cirrhosis, including 102 with HCC and 94 without. The diagnostic performance of the GALAD score for HCC detection was compared with that of single biomarkers.</p><p><strong>Results: </strong>In patients with cirrhosis with HCC, the GALAD score was 2.5 (95% CI: -2.43 to 11.09), which was significantly higher than the GALAD score of -2.46 (95% CI: -6.15 to 2.04) in patients with cirrhosis without HCC (P<0.001). Patients with multiple tumors had a significantly higher GALAD score than those with a single tumor (P=0.0081). There was a moderate correlation between the GALAD score and tumor size in patients with cirrhosis (r=0.44; P<0.001). The GALAD score had an area under the receiver operating characteristic curve of 0.91, higher than that of all single biomarkers used to diagnose HCC (all P<0.001). The optimal cutoff for diagnosing HCC using the GALAD score was -0.518, achieving a sensitivity of 87.25%, specificity of 82.98%, positive predictive value of 84.62%, and negative predictive value of 84.78%. At this cutoff, the GALAD score demonstrated superior sensitivity compared with single or combined biomarkers.</p><p><strong>Conclusions: </strong>The GALAD score shows promise in detecting HCC in patients with cirrhosis. The GALAD score could be applied in clinical practice to diagnose HCC in patients with cirrhosis, and calculating the GALAD score in clinical settings may help predict tumor size and quantity before imaging results become available.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}