Meng-Tzu Weng, Kuan-Lin Lin, Ya-Ling Huang, Chitra Karki, Jin-Liern Hong, Dimitri Bennett, K Arnold Chan, Shu-Chen Wei
Background: Population-based data on the course of perianal disease in East Asian populations with Crohn's disease (CD) are limited. This study examined the prevalence, clinical course, and compared the outcomes of CD patients with perianal CD (pCD) versus without pCD in Taiwan.
Methods: A nationwide population-based study was implemented from 2000 to 2017 by using the Taiwan National Health Insurance Research Database.
Results: Of 2424 patients with CD, 358 (14.8%) patients with pCD were identified. Most patients with CD and pCD were men (79.3%). The mean age at CD diagnosis was lower in patients with pCD (33.7 years) than in those without pCD (44.9 years). Approximately half the patients with pCD received the pCD diagnosis at least 6 months before receiving a CD diagnosis. Approximately one-third (121/358) of patients with pCD had recurrent fistula; the median recurrence interval was 239 days. Compared with patients without pCD, patients with pCD had higher mean incidences of hospitalization (7.0 vs 3.8, P < .01), outpatient visits (13 vs 2.9, P < .01), and emergency room visits (10.3 vs 4.4, P < .01) over a 15-year period. Although patients with pCD had higher rates of healthcare utilization, their 15-year mortality rate was lower than that of those without pCD (6.1% vs 17.3%, P < .01).
Conclusions: The period prevalence of pCD in Taiwanese patients with CD was 14.8%. Although patients with pCD required more intensive care and had greater healthcare utilization, they did not have inferior survival outcomes compared with those without pCD.
背景:东亚克罗恩病(CD)人群肛周疾病病程的基于人群的数据是有限的。本研究调查台湾有肛周CD (pCD)与无pCD的患者的患病率、临床病程,并比较其预后。方法:利用台湾全民健康保险研究数据库,于2000年至2017年在全国范围内开展基于人群的研究。结果:在2424例CD患者中,358例(14.8%)患者被确诊为pCD。大多数CD和pCD患者为男性(79.3%)。确诊时pCD患者的平均年龄(33.7岁)低于非pCD患者(44.9岁)。大约一半的pCD患者在接受CD诊断前至少6个月接受pCD诊断。大约三分之一(121/358)的pCD患者有复发性瘘管;中位复发间隔为239天。与无pCD患者相比,pCD患者的平均住院率更高(7.0 vs 3.8, P P P P P P)。结论:台湾CD患者的pCD期患病率为14.8%。尽管pCD患者需要更多的重症监护和更多的医疗保健利用,但与没有pCD的患者相比,他们的生存结果并不差。
{"title":"Epidemiology, Disease Course, and Clinical Outcomes of Perianal Fistulas and Fissures Crohn's Disease: A Nationwide Population-Based Study in Taiwan.","authors":"Meng-Tzu Weng, Kuan-Lin Lin, Ya-Ling Huang, Chitra Karki, Jin-Liern Hong, Dimitri Bennett, K Arnold Chan, Shu-Chen Wei","doi":"10.1093/crocol/otad035","DOIUrl":"https://doi.org/10.1093/crocol/otad035","url":null,"abstract":"<p><strong>Background: </strong>Population-based data on the course of perianal disease in East Asian populations with Crohn's disease (CD) are limited. This study examined the prevalence, clinical course, and compared the outcomes of CD patients with perianal CD (pCD) versus without pCD in Taiwan.</p><p><strong>Methods: </strong>A nationwide population-based study was implemented from 2000 to 2017 by using the Taiwan National Health Insurance Research Database.</p><p><strong>Results: </strong>Of 2424 patients with CD, 358 (14.8%) patients with pCD were identified. Most patients with CD and pCD were men (79.3%). The mean age at CD diagnosis was lower in patients with pCD (33.7 years) than in those without pCD (44.9 years). Approximately half the patients with pCD received the pCD diagnosis at least 6 months before receiving a CD diagnosis. Approximately one-third (121/358) of patients with pCD had recurrent fistula; the median recurrence interval was 239 days. Compared with patients without pCD, patients with pCD had higher mean incidences of hospitalization (7.0 vs 3.8, <i>P</i> < .01), outpatient visits (13 vs 2.9, <i>P</i> < .01), and emergency room visits (10.3 vs 4.4, <i>P</i> < .01) over a 15-year period. Although patients with pCD had higher rates of healthcare utilization, their 15-year mortality rate was lower than that of those without pCD (6.1% vs 17.3%, <i>P</i> < .01).</p><p><strong>Conclusions: </strong>The period prevalence of pCD in Taiwanese patients with CD was 14.8%. Although patients with pCD required more intensive care and had greater healthcare utilization, they did not have inferior survival outcomes compared with those without pCD.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10368329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10258852","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}
Michael D Kappelman, Millie D Long, Xian Zhang, Feng-Chang Lin, Laura Weisbein, Wenli Chen, Jessica Burris, Jennifer E Dorand, Lauren E Parlett, Tara Fehlmann, Colleen M Brensinger, Kevin Haynes, Vinit Nair, Alan F Kaul, Angela Dobes, James D Lewis
Background: Primary and secondary nonresponse to anti-tumor necrosis factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy.
Objective: We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient-reported outcomes (PROs).
Methods: We conducted a prospective cohort study nested within the Crohn's & Colitis Foundation's IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or tofacitinib and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO2, treatment persistence, and need for colectomy.
Results: We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (P = .04), but not Fatigue (P = .53) was lower among tofacitinib initiators. A trend toward higher Social Role Satisfaction was not significant. The remainder of secondary outcomes (PRO2, treatment persistence, colectomy) did not differ between treatment groups.
Conclusions: Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared with vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.
{"title":"Comparing Patient-Reported Outcomes Among Anti-TNF Experienced Patients With Ulcerative Colitis Initiating Vedolizumab Versus Tofacitinib.","authors":"Michael D Kappelman, Millie D Long, Xian Zhang, Feng-Chang Lin, Laura Weisbein, Wenli Chen, Jessica Burris, Jennifer E Dorand, Lauren E Parlett, Tara Fehlmann, Colleen M Brensinger, Kevin Haynes, Vinit Nair, Alan F Kaul, Angela Dobes, James D Lewis","doi":"10.1093/crocol/otad031","DOIUrl":"https://doi.org/10.1093/crocol/otad031","url":null,"abstract":"<p><strong>Background: </strong>Primary and secondary nonresponse to anti-tumor necrosis factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy.</p><p><strong>Objective: </strong>We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient-reported outcomes (PROs).</p><p><strong>Methods: </strong>We conducted a prospective cohort study nested within the Crohn's & Colitis Foundation's IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or tofacitinib and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO2, treatment persistence, and need for colectomy.</p><p><strong>Results: </strong>We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (<i>P</i> = .04), but not Fatigue (<i>P</i> = .53) was lower among tofacitinib initiators. A trend toward higher Social Role Satisfaction was not significant. The remainder of secondary outcomes (PRO2, treatment persistence, colectomy) did not differ between treatment groups.</p><p><strong>Conclusions: </strong>Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared with vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d4/23/otad031.PMC10284045.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9766689","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}
Ronaldo Paolo Panganiban, Alyssa Tuan, Maxwell Hart, Mathew Pelton, Daniella Mikhail, Sarah Akhtar, Kaleb Bogale, Susan Deiling, Shouhao Zhou, Mathew D Coates, Gregory S Yochum, Walter Koltun
Background: Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis that is a well-established extraintestinal manifestation (EIM) of inflammatory bowel disease. The clinical implications of developing PG in patients with ulcerative colitis (UC) who undergo total proctocolectomy colectomy and ileal pouch anal anastomosis (TPC-IPAA) surgery remain unknown.
Methods: Study participants were selected from patients enrolled in the Carlino Family Inflammatory Bowel and Colorectal Disease Biobank between 1998 and 2021 with a pre-colectomy diagnosis of UC and who underwent TPC-IPAA surgery. A retrospective study comparing patients with PG and those without PG was performed. The outcomes measured included the development of pouchitis, pouchitis classification, presence of pouch fistula, anal fistula, anal stenosis, and pouch failure.
Results: In this study, 357 IPAA patients were included, 10 of whom suffered PG. Patients with PG and without PG had similar demographics and clinical characteristics. Both groups had similar rates of pouchitis (80% in PG patients and 64% in patients without PG, P = .504). However, IPAA patients with PG had a higher risk of developing pouch fistula (50% vs 10%, P = .002), anal fistula (40% vs 12%, P = .031), and Crohn's-like disease of the pouch (70% vs 15%, P = .003) compared to patients without PG. Patients who developed PG prior to their first episode of pouchitis were more likely to eventually experience pouch failure (odds ratio: 20.7, 95% confidence interval: 3.9, 110.7, q = 0.003 after false discovery rate adjustment).
Conclusions: Among UC patients who undergo TPC-IPAA surgery, the development of PG portends poor pouch outcomes and is predictive of pouch failure.
{"title":"Pyoderma Gangrenosum Is Associated With Increased Risk of Inflammatory Pouch-Related Complications: A Retrospective Cohort Study.","authors":"Ronaldo Paolo Panganiban, Alyssa Tuan, Maxwell Hart, Mathew Pelton, Daniella Mikhail, Sarah Akhtar, Kaleb Bogale, Susan Deiling, Shouhao Zhou, Mathew D Coates, Gregory S Yochum, Walter Koltun","doi":"10.1093/crocol/otad024","DOIUrl":"https://doi.org/10.1093/crocol/otad024","url":null,"abstract":"<p><strong>Background: </strong>Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis that is a well-established extraintestinal manifestation (EIM) of inflammatory bowel disease. The clinical implications of developing PG in patients with ulcerative colitis (UC) who undergo total proctocolectomy colectomy and ileal pouch anal anastomosis (TPC-IPAA) surgery remain unknown.</p><p><strong>Methods: </strong>Study participants were selected from patients enrolled in the Carlino Family Inflammatory Bowel and Colorectal Disease Biobank between 1998 and 2021 with a pre-colectomy diagnosis of UC and who underwent TPC-IPAA surgery. A retrospective study comparing patients with PG and those without PG was performed. The outcomes measured included the development of pouchitis, pouchitis classification, presence of pouch fistula, anal fistula, anal stenosis, and pouch failure.</p><p><strong>Results: </strong>In this study, 357 IPAA patients were included, 10 of whom suffered PG. Patients with PG and without PG had similar demographics and clinical characteristics. Both groups had similar rates of pouchitis (80% in PG patients and 64% in patients without PG, <i>P</i> = .504). However, IPAA patients with PG had a higher risk of developing pouch fistula (50% vs 10%, <i>P</i> = .002), anal fistula (40% vs 12%, <i>P</i> = .031), and Crohn's-like disease of the pouch (70% vs 15%, <i>P</i> = .003) compared to patients without PG. Patients who developed PG prior to their first episode of pouchitis were more likely to eventually experience pouch failure (odds ratio: 20.7, 95% confidence interval: 3.9, 110.7, <i>q</i> = 0.003 after false discovery rate adjustment).</p><p><strong>Conclusions: </strong>Among UC patients who undergo TPC-IPAA surgery, the development of PG portends poor pouch outcomes and is predictive of pouch failure.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10474334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10150403","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}
Namita Singh, Steven J Steiner, Rebecca Fauth, Danyel Moosmann, Janis Arnold, Abdul Elkadri, Daniel Marinoni, Laurel Molloy, Becky Johnson Rescola, Jeanne Tung, Elizabeth C Utterson
Background: Camp Oasis is an annual week-long camp serving children with inflammatory bowel disease (IBD) and hosted by the Crohn's and Colitis Foundation. Youth with IBD are at increased risk for mental health challenges, with Camp Oasis potentially mitigating these risks. The aim of this study is to measure change in and predictors of social-emotional well-being and protective factors of self-worth as a result of attending Camp Oasis.
Methods: Between 2012 and 2019, a voluntary survey was administered to participants and their caregivers to reflect on their perceptions of social/emotional well-being and protective factors related to chronic disease. T-tests compared change in participants' and caregivers' perceptions before and after camp; path analyses examined the key predictors of social-emotional well-being.
Results: A total of 6011 online surveys were analyzed. Participants and caregivers reported consistently positive perceptions of participants' experiences during and after camp. Significant improvements in confidence, independence, activity, comfort around others, being more open about disease, and taking medication as expected were observed. Being new to Camp Oasis was one of the strongest predictors of both disease-related self-efficacy and social connections after camp.
Conclusions: The uniformly high rates of participants' perceptions during camp suggest camp is a life-changing experience for youth with IBD, reduces disease-related stigma, and enhances confidence and social skills. Participants' positive experiences appear to foster notable benefits after camp in terms of openness, their sense of belonging, connections, and confidence.
{"title":"IBD Camp Oasis: A look at Participants' Social-Emotional Well-Being and Protective Factors During Camp and Beyond.","authors":"Namita Singh, Steven J Steiner, Rebecca Fauth, Danyel Moosmann, Janis Arnold, Abdul Elkadri, Daniel Marinoni, Laurel Molloy, Becky Johnson Rescola, Jeanne Tung, Elizabeth C Utterson","doi":"10.1093/crocol/otad042","DOIUrl":"https://doi.org/10.1093/crocol/otad042","url":null,"abstract":"<p><strong>Background: </strong>Camp Oasis is an annual week-long camp serving children with inflammatory bowel disease (IBD) and hosted by the Crohn's and Colitis Foundation. Youth with IBD are at increased risk for mental health challenges, with Camp Oasis potentially mitigating these risks. The aim of this study is to measure change in and predictors of social-emotional well-being and protective factors of self-worth as a result of attending Camp Oasis.</p><p><strong>Methods: </strong>Between 2012 and 2019, a voluntary survey was administered to participants and their caregivers to reflect on their perceptions of social/emotional well-being and protective factors related to chronic disease. <i>T</i>-tests compared change in participants' and caregivers' perceptions before and after camp; path analyses examined the key predictors of social-emotional well-being.</p><p><strong>Results: </strong>A total of 6011 online surveys were analyzed. Participants and caregivers reported consistently positive perceptions of participants' experiences during and after camp. Significant improvements in confidence, independence, activity, comfort around others, being more open about disease, and taking medication as expected were observed. Being new to Camp Oasis was one of the strongest predictors of both disease-related self-efficacy and social connections after camp.</p><p><strong>Conclusions: </strong>The uniformly high rates of participants' perceptions during camp suggest camp is a life-changing experience for youth with IBD, reduces disease-related stigma, and enhances confidence and social skills. Participants' positive experiences appear to foster notable benefits after camp in terms of openness, their sense of belonging, connections, and confidence.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10486186/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10221764","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":"Golimumab for Ulcerative Colitis: One More Option to SAVE the Colon.","authors":"Sang Hyoung Park","doi":"10.1093/crocol/otad046","DOIUrl":"https://doi.org/10.1093/crocol/otad046","url":null,"abstract":"","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10492443/pdf/otad046.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10221766","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}
Suman Gupta, Sneh Lata Gupta, Aashima Singh, Neelam Oswal, Vineeta Bal, Satyajit Rath, Anna George, Srijani Basu
Background: Classically, IgA in the gut prevents the invasion of microorganisms to systemic organs through the process of neutralization and immune exclusion. Interestingly, recent reports suggest that IgA might help in biofilm formation and promote bacterial growth inside the intestine.
Methods: In this study, we used flow cytometry, ELISA, and chemical models of colitis to test whether the quality and quantity of IgA can select for bacterial persistence in the gut.
Results: We found that members of Proteobacteria, such as γ-Proteobacteria and SFB, are preferentially coated by IgA in WT mice. In the partial absence of either T-dependent or -independent IgA responses, there are no significant differences in the frequency of bacteria coated with IgA in mice. However, Rag-/- mice that lack all antibodies had a severe reduction in Proteobacteria and were resistant to DSS-induced colitis, suggesting that secretory IgA might be essential for differential retention of these taxa in the mouse gut. Rag-/- littermates in the F2 generation generated from (B6 × Rag-/-) F1 mice acquired the underrepresented bacteria taxa such as γ-Proteobacteria through vertical transmission of flora. They died soon after weaning, possibly due to the acquired flora. Additionally, continued exposure of Rag-/- mice to B6 flora by cohousing mice led to the acquisition of γ-Proteobacteria and mortality.
Conclusions: Together, our results indicate that host survival in the complete absence of an IgA response necessitates the exclusion of specific bacterial taxa from the gut microbiome.
{"title":"IgA Determines Bacterial Composition in the Gut.","authors":"Suman Gupta, Sneh Lata Gupta, Aashima Singh, Neelam Oswal, Vineeta Bal, Satyajit Rath, Anna George, Srijani Basu","doi":"10.1093/crocol/otad030","DOIUrl":"https://doi.org/10.1093/crocol/otad030","url":null,"abstract":"<p><strong>Background: </strong>Classically, IgA in the gut prevents the invasion of microorganisms to systemic organs through the process of neutralization and immune exclusion. Interestingly, recent reports suggest that IgA might help in biofilm formation and promote bacterial growth inside the intestine.</p><p><strong>Methods: </strong>In this study, we used flow cytometry, ELISA, and chemical models of colitis to test whether the quality and quantity of IgA can select for bacterial persistence in the gut.</p><p><strong>Results: </strong>We found that members of Proteobacteria, such as γ-Proteobacteria and SFB, are preferentially coated by IgA in WT mice. In the partial absence of either T-dependent or -independent IgA responses, there are no significant differences in the frequency of bacteria coated with IgA in mice. However, Rag-/- mice that lack all antibodies had a severe reduction in Proteobacteria and were resistant to DSS-induced colitis, suggesting that secretory IgA might be essential for differential retention of these taxa in the mouse gut. Rag-/- littermates in the F2 generation generated from (B6 × Rag-/-) F1 mice acquired the underrepresented bacteria taxa such as γ-Proteobacteria through vertical transmission of flora. They died soon after weaning, possibly due to the acquired flora. Additionally, continued exposure of Rag-/- mice to B6 flora by cohousing mice led to the acquisition of γ-Proteobacteria and mortality.</p><p><strong>Conclusions: </strong>Together, our results indicate that host survival in the complete absence of an IgA response necessitates the exclusion of specific bacterial taxa from the gut microbiome.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6c/97/otad030.PMC10244000.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9972189","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}
Ria Kanazaki, Ben Smith, Afaf Girgis, Susan J Connor
Background: With the evolving inflammatory bowel disease (IBD) management landscape, it is critical that gastroenterologists keep up to date with the clinical practice guidelines (CPGs). Several studies in IBD have documented suboptimal adherence to CPGs. We aimed to gain an in-depth understanding of guideline adherence barriers reported by gastroenterologists and determine how evidence-based education can best be delivered.
Methods: Interviews were conducted with a purposive sample of gastroenterologists' representative of the current workforce. Questions focused on previously identified problematic areas and shaped by the theoretical domains framework, a theory-informed approach to understanding clinician behavior, to assess all determinants of behavior. Questions explored perceived barriers to adherence and clinicians' preferred content and modes of delivery for an educational intervention. Interviews were conducted by a single interviewer and qualitative analysis performed.
Results: A total of 20 interviews were conducted before data saturation was achieved (male = 12, work in a metropolitan area = 17). Five dominant subthemes for barriers to adherence emerged: negative experiences impacting future decisions, time constraints, long guidelines are impractical, unfamiliar with guideline specifics and prescribing restrictions. Adherence enablers were identified including features that improved the usability of CPGs. Computer- or smart phone-based educational interventions were preferred.
Conclusions: This study identified several barriers and enablers for IBD guideline adherence and gained insight into how gastroenterologists prefer to receive evidence-based education. These results will inform the development of a targeted intervention to improve IBD guideline adherence. Improving guideline adherence is expected to facilitate standardized IBD care, ultimately leading to improved patient outcomes.
{"title":"Clinician Adherence to Inflammatory Bowel Disease Guidelines: Results of a Qualitative Study of Barriers and Enablers.","authors":"Ria Kanazaki, Ben Smith, Afaf Girgis, Susan J Connor","doi":"10.1093/crocol/otac018","DOIUrl":"https://doi.org/10.1093/crocol/otac018","url":null,"abstract":"<p><strong>Background: </strong>With the evolving inflammatory bowel disease (IBD) management landscape, it is critical that gastroenterologists keep up to date with the clinical practice guidelines (CPGs). Several studies in IBD have documented suboptimal adherence to CPGs. We aimed to gain an in-depth understanding of guideline adherence barriers reported by gastroenterologists and determine how evidence-based education can best be delivered.</p><p><strong>Methods: </strong>Interviews were conducted with a purposive sample of gastroenterologists' representative of the current workforce. Questions focused on previously identified problematic areas and shaped by the theoretical domains framework, a theory-informed approach to understanding clinician behavior, to assess all determinants of behavior. Questions explored perceived barriers to adherence and clinicians' preferred content and modes of delivery for an educational intervention. Interviews were conducted by a single interviewer and qualitative analysis performed.</p><p><strong>Results: </strong>A total of 20 interviews were conducted before data saturation was achieved (male = 12, work in a metropolitan area = 17). Five dominant subthemes for barriers to adherence emerged: negative experiences impacting future decisions, time constraints, long guidelines are impractical, unfamiliar with guideline specifics and prescribing restrictions. Adherence enablers were identified including features that improved the usability of CPGs. Computer- or smart phone-based educational interventions were preferred.</p><p><strong>Conclusions: </strong>This study identified several barriers and enablers for IBD guideline adherence and gained insight into how gastroenterologists prefer to receive evidence-based education. These results will inform the development of a targeted intervention to improve IBD guideline adherence. Improving guideline adherence is expected to facilitate standardized IBD care, ultimately leading to improved patient outcomes.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/30/c6/otac018.PMC10174629.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9469850","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}
Suha Abushamma, Ted Walker, Kevin Garza, Ling Chen, Darren Nix, Chien-Huan Chen
Background and aim: Infliximab is typically given over an infusion time of 2 hours, leading to a significant burden in inflammatory bowel disease (IBD) patients. We aimed to determine the safety and cost-effectiveness of an accelerated infliximab infusion of 1 hour, compared with the standard 2-hour infusion.
Methods: Open-label randomized trial where IBD patients receiving maintenance infliximab infusions were randomly assigned to 1- and 2-hour infusion groups, corresponding to study and control groups, respectively. The primary outcome was the rate of infusion reactions. Secondary outcomes were assessment of the effect of premedications and immunomodulators on the rate of infusion reactions, and cost-effectiveness analysis. The cost-effectiveness analysis was based on direct nursing costs for the infusion time, indirect infusion center costs, and cost of productivity loss for patients. This trial is registered with ClinicalTrials.gov, NCT05340764.
Results: From November 2020 to November 2021, 96 patients were randomly assigned: 51 (53%) to the 1-hour infusion group and 45 (47%) to the 2-hour infusion group. Over a median time of 1 year, 309 infusions were administered in the control group, and 376 in the study group. Fifty-seven (18%) infusions in the control group and 45 (12%) infusions in the study group experienced an infusion reaction. The only infusion reaction was asymptomatic hypotension not requiring infusion discontinuation. No other infusion reactions (mild or moderate/severe) were seen. Diphenhydramine was associated with an increased rate of infusion reactions (OR 2.04 [95% CI 1.18-3.52], P = .01). The average costs were estimated to reduce by 37% in the accelerated infusion group.
Conclusions: Accelerated 1-hour infusions are non-inferior in safety and superior in cost-effectiveness compared with standard 2-hour infusions in IBD patients receiving maintenance infliximab infusions.
Trial identification number: Registered with ClinicalTrials.gov, NCT05340764.
背景和目的:英夫利昔单抗通常在2小时输注时间内给予,导致炎症性肠病(IBD)患者的显著负担。我们的目的是确定英夫利昔单抗加速输注1小时与标准输注2小时相比的安全性和成本效益。方法:开放标签随机试验,接受维护性英夫利昔单抗输注的IBD患者随机分为1小时输注组和2小时输注组,分别对应于研究组和对照组。主要观察指标是输液反应的速率。次要结局是评估预用药和免疫调节剂对输液反应率的影响,并进行成本-效果分析。成本-效果分析基于输液时间的直接护理成本、间接输液中心成本和患者生产力损失成本。该试验已在ClinicalTrials.gov注册,编号NCT05340764。结果:2020年11月至2021年11月,96例患者随机分配:1小时输注组51例(53%),2小时输注组45例(47%)。在平均1年的时间内,对照组输注309次,研究组输注376次。对照组57例(18%)和研究组45例(12%)发生输液反应。唯一的输液反应是无症状性低血压,不需要停药。未见其他输液反应(轻度或中度/重度)。苯海拉明与输液反应发生率增加相关(OR 2.04 [95% CI 1.18-3.52], P = 0.01)。据估计,加速输注组的平均费用降低了37%。结论:与接受维持性英夫利昔单抗输注的IBD患者相比,加速1小时输注在安全性上不差,在成本效益上优于标准2小时输注。试验识别号:注册于ClinicalTrials.gov, NCT05340764。
{"title":"Accelerated Infliximab Infusion Safety and Tolerability Is Non-inferior to Standard Infusion Protocol in Inflammatory Bowel Disease Patients: A Randomized Controlled Study.","authors":"Suha Abushamma, Ted Walker, Kevin Garza, Ling Chen, Darren Nix, Chien-Huan Chen","doi":"10.1093/crocol/otad022","DOIUrl":"https://doi.org/10.1093/crocol/otad022","url":null,"abstract":"<p><strong>Background and aim: </strong>Infliximab is typically given over an infusion time of 2 hours, leading to a significant burden in inflammatory bowel disease (IBD) patients. We aimed to determine the safety and cost-effectiveness of an accelerated infliximab infusion of 1 hour, compared with the standard 2-hour infusion.</p><p><strong>Methods: </strong>Open-label randomized trial where IBD patients receiving maintenance infliximab infusions were randomly assigned to 1- and 2-hour infusion groups, corresponding to study and control groups, respectively. The primary outcome was the rate of infusion reactions. Secondary outcomes were assessment of the effect of premedications and immunomodulators on the rate of infusion reactions, and cost-effectiveness analysis. The cost-effectiveness analysis was based on direct nursing costs for the infusion time, indirect infusion center costs, and cost of productivity loss for patients. This trial is registered with ClinicalTrials.gov, NCT05340764.</p><p><strong>Results: </strong>From November 2020 to November 2021, 96 patients were randomly assigned: 51 (53%) to the 1-hour infusion group and 45 (47%) to the 2-hour infusion group. Over a median time of 1 year, 309 infusions were administered in the control group, and 376 in the study group. Fifty-seven (18%) infusions in the control group and 45 (12%) infusions in the study group experienced an infusion reaction. The only infusion reaction was asymptomatic hypotension not requiring infusion discontinuation. No other infusion reactions (mild or moderate/severe) were seen. Diphenhydramine was associated with an increased rate of infusion reactions (OR 2.04 [95% CI 1.18-3.52], <i>P</i> = .01). The average costs were estimated to reduce by 37% in the accelerated infusion group.</p><p><strong>Conclusions: </strong>Accelerated 1-hour infusions are non-inferior in safety and superior in cost-effectiveness compared with standard 2-hour infusions in IBD patients receiving maintenance infliximab infusions.</p><p><strong>Trial identification number: </strong>Registered with ClinicalTrials.gov, NCT05340764.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10243871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9972192","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}
David Singer, Philippe Thompson-Leduc, Deepshekhar Gupta, Sara Poston, Wendy Y Cheng, Siyu Ma, John E Pawlowski, Mei Sheng Duh, Francesca Devine, Azeem Banatwala, Emma Bernstein, Francis A Farraye
Background: Patients with ulcerative colitis (UC) or Crohn's disease (CD) are at increased risk of herpes zoster (HZ); however, relevant cost and healthcare resource utilization (HCRU) data are limited.
Methods: We estimated HCRU (hospitalization, emergency department [ED], and outpatient visits) and costs in patients with UC or CD, with and without HZ, using administrative claims data (October 2015-February 2020). HCRU and costs (2020 US dollars) were compared at 1 month, 1 quarter, and 1 year after the index date, using propensity score adjustment and generalized linear models.
Results: In total, 20 948 patients were included: UC+/HZ+ (n = 431), UC+/HZ- (n = 10 285), CD+/HZ+ (n = 435), and CD+/HZ- (n = 9797). Patients with HZ had higher all-cause HCRU rates and all-cause total healthcare costs relative to those without HZ. In the first month, adjusted incidence rate ratios (aIRRs) for hospitalizations and ED visits for patients with UC and HZ compared with UC alone were 2.87 (95% confidence interval [CI], 1.93-4.27) and 2.66 (95% CI,1.74-4.05), respectively; for those with CD and HZ, aIRRs were 3.34 (95% CI, 2.38-4.70) and 3.31 (95% CI, 2.32-4.71), respectively, compared with CD alone (all P < .001). Adjusted cost differences in UC and CD cohorts with HZ over the first month were $2189 and $3774, respectively, chiefly driven by higher inpatient costs. The incremental impact on HCRU and costs in cohorts with HZ predominantly occurred during the first quarter following diagnosis.
Conclusions: HZ is associated with increased HCRU and costs in patients with UC and CD, especially shortly after diagnosis.
{"title":"Economic and Clinical Burden of Herpes Zoster Among Patients With Inflammatory Bowel Disease in the United States.","authors":"David Singer, Philippe Thompson-Leduc, Deepshekhar Gupta, Sara Poston, Wendy Y Cheng, Siyu Ma, John E Pawlowski, Mei Sheng Duh, Francesca Devine, Azeem Banatwala, Emma Bernstein, Francis A Farraye","doi":"10.1093/crocol/otad033","DOIUrl":"https://doi.org/10.1093/crocol/otad033","url":null,"abstract":"<p><strong>Background: </strong>Patients with ulcerative colitis (UC) or Crohn's disease (CD) are at increased risk of herpes zoster (HZ); however, relevant cost and healthcare resource utilization (HCRU) data are limited.</p><p><strong>Methods: </strong>We estimated HCRU (hospitalization, emergency department [ED], and outpatient visits) and costs in patients with UC or CD, with and without HZ, using administrative claims data (October 2015-February 2020). HCRU and costs (2020 US dollars) were compared at 1 month, 1 quarter, and 1 year after the index date, using propensity score adjustment and generalized linear models.</p><p><strong>Results: </strong>In total, 20 948 patients were included: UC+/HZ+ (<i>n</i> = 431), UC+/HZ- (<i>n</i> = 10 285), CD+/HZ+ (<i>n</i> = 435), and CD+/HZ- (<i>n</i> = 9797). Patients with HZ had higher all-cause HCRU rates and all-cause total healthcare costs relative to those without HZ. In the first month, adjusted incidence rate ratios (aIRRs) for hospitalizations and ED visits for patients with UC and HZ compared with UC alone were 2.87 (95% confidence interval [CI], 1.93-4.27) and 2.66 (95% CI,1.74-4.05), respectively; for those with CD and HZ, aIRRs were 3.34 (95% CI, 2.38-4.70) and 3.31 (95% CI, 2.32-4.71), respectively, compared with CD alone (all <i>P</i> < .001). Adjusted cost differences in UC and CD cohorts with HZ over the first month were $2189 and $3774, respectively, chiefly driven by higher inpatient costs. The incremental impact on HCRU and costs in cohorts with HZ predominantly occurred during the first quarter following diagnosis.</p><p><strong>Conclusions: </strong>HZ is associated with increased HCRU and costs in patients with UC and CD, especially shortly after diagnosis.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10368335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10258851","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}
Background: The usefulness of leucine-rich alpha 2 glycoprotein (LRG) to evaluate Crohn's disease (CD) activity differs among various intestinal lesions. We aimed to evaluate the association between endoscopic disease activity based on the Simple Endoscopic Score for Crohn's disease (SES-CD) and LRG level separately for small intestinal and colonic lesions.
Methods: We examined the correlation between LRG level and SES-CD and performed receiver operating characteristic (ROC) analysis to determine the LRG cutoff value in 141 patients who underwent endoscopy (total 235 measurements). Furthermore, the LRG cutoff value was analyzed by comparing small intestinal and colonic lesions.
Results: LRG levels were significantly higher in patients without mucosal healing than in those with mucosal healing (15.9 μg/mL vs 10.5 μg/mL, P < .0001). The LRG cutoff value for mucosal healing was 14.3 μg/mL (area under the ROC curve [AUC]: 0.80; sensitivity: 0.89; specificity: 0.63). The LRG cutoff value for patients with type L1 was 14.3 μg/mL (sensitivity: 0.91; specificity: 0.53), and that for patients with type L2 was 14.0 μg/mL (sensitivity: 0.95; specificity: 0.73). The diagnostic performance (AUC) of LRG and C-reactive protein (CRP) for mucosal healing was, respectively, 0.75 and 0.60 (P = 0.01) in patients with type L1 and 0.80 and 0.85 (P = 0.90) in patients with type L2.
Conclusions: The optimal LRG cutoff value for evaluating mucosal healing in CD is 14.3 μg/mL. LRG is more useful than CRP for predicting mucosal healing in patients with type L1. The superiority of LRG to CRP differs between small intestinal and colonic lesions.
{"title":"Usefulness of Serum Leucine-rich Alpha 2 Glycoprotein in Crohn's Disease: Is There Any Difference between Small Intestine and Colonic Lesions?","authors":"Satohiro Matsumoto, Hirosato Mashima","doi":"10.1093/crocol/otad028","DOIUrl":"https://doi.org/10.1093/crocol/otad028","url":null,"abstract":"<p><strong>Background: </strong>The usefulness of leucine-rich alpha 2 glycoprotein (LRG) to evaluate Crohn's disease (CD) activity differs among various intestinal lesions. We aimed to evaluate the association between endoscopic disease activity based on the Simple Endoscopic Score for Crohn's disease (SES-CD) and LRG level separately for small intestinal and colonic lesions.</p><p><strong>Methods: </strong>We examined the correlation between LRG level and SES-CD and performed receiver operating characteristic (ROC) analysis to determine the LRG cutoff value in 141 patients who underwent endoscopy (total 235 measurements). Furthermore, the LRG cutoff value was analyzed by comparing small intestinal and colonic lesions.</p><p><strong>Results: </strong>LRG levels were significantly higher in patients without mucosal healing than in those with mucosal healing (15.9 μg/mL vs 10.5 μg/mL, <i>P</i> < .0001). The LRG cutoff value for mucosal healing was 14.3 μg/mL (area under the ROC curve [AUC]: 0.80; sensitivity: 0.89; specificity: 0.63). The LRG cutoff value for patients with type L1 was 14.3 μg/mL (sensitivity: 0.91; specificity: 0.53), and that for patients with type L2 was 14.0 μg/mL (sensitivity: 0.95; specificity: 0.73). The diagnostic performance (AUC) of LRG and C-reactive protein (CRP) for mucosal healing was, respectively, 0.75 and 0.60 (<i>P</i> = 0.01) in patients with type L1 and 0.80 and 0.85 (<i>P</i> = 0.90) in patients with type L2.</p><p><strong>Conclusions: </strong>The optimal LRG cutoff value for evaluating mucosal healing in CD is 14.3 μg/mL. LRG is more useful than CRP for predicting mucosal healing in patients with type L1. The superiority of LRG to CRP differs between small intestinal and colonic lesions.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10243872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9972190","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}