Crohn's & Colitis 360Pub Date : 2023-12-30eCollection Date: 2024-01-01DOI: 10.1093/crocol/otad082
Anastasia Naritsin, Neev Mehta, Randall Pellish
{"title":"Discordance Between Inflammatory Bowel Disease Specialists and Insurance Authorization Denials-A Survey of Specific Inflammatory Bowel Disease Treatment Scenarios.","authors":"Anastasia Naritsin, Neev Mehta, Randall Pellish","doi":"10.1093/crocol/otad082","DOIUrl":"10.1093/crocol/otad082","url":null,"abstract":"<p><strong>Background: </strong>Prior authorizations are generally required by insurers for gastroenterologists to prescribe biologics and small-molecule drugs to treat inflammatory bowel disease (IBD). Authorization denials occur in a wide variety of clinical scenarios, including denials of standard and nonstandard medication dosing.</p><p><strong>Methods: </strong>We performed a national cross-sectional survey on a broad variety of specific clinical scenarios to assess experience and opinions on whether or not insurance authorization denials are in accordance with clinical expertise.</p><p><strong>Results: </strong>Eighty-four gastroenterologists completed the survey. Denial experience was common for infliximab dose modifications, vedolizumab dose modifications, ustekinumab first-time therapy, and maintenance dosing. The bulk of disagreement with authorization denials involved scenarios of dose escalation and re-induction guided by both loss of clinical response and/or therapeutic drug monitoring, denial of re-authorizations of stable dosing, and use of non-anti-TNFs in specific patient populations including the elderly and patients with multiple comorbidities. Respondents unanimously agreed that insurance companies do not play an adequate role in helping patients obtain PA. Furthermore, most of the respondents agree that to decrease the burden of the PA process, peer-peer processes should be between other IBD-trained providers who understand these complex treatment strategies.</p><p><strong>Conclusions: </strong>Our cross-sectional survey highlights the degree of discordance in clinical decision-making between insurers and gastroenterologists. Further engagement between gastroenterologists and insurers is needed to foster common understanding on these discordant authorization denials in these real-world clinical IBD scenarios.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 1","pages":"otad082"},"PeriodicalIF":1.8,"publicationDate":"2023-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10805526/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139542050","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}
Crohn's & Colitis 360Pub Date : 2023-12-23eCollection Date: 2024-01-01DOI: 10.1093/crocol/otad080
Lawrence S Gaines, Michael D Kappelman, David A Schwartz, Sara N Horst, Dawn B Beaulieu, Elizabeth S Scoville, Robin L Dalal, Baldeep S Pabla, James C Slaughter
{"title":"The Comorbidity of Patient-Reported Crohn's Disease Activity and Depression: The Role of Health Behavior Mediators.","authors":"Lawrence S Gaines, Michael D Kappelman, David A Schwartz, Sara N Horst, Dawn B Beaulieu, Elizabeth S Scoville, Robin L Dalal, Baldeep S Pabla, James C Slaughter","doi":"10.1093/crocol/otad080","DOIUrl":"10.1093/crocol/otad080","url":null,"abstract":"<p><strong>Background: </strong>Longitudinal research reveals a unidirectional relationship between a nonsomatic symptom of depression, a negative view of the self, and later reported Crohn's disease (CD) activity. We evaluated whether health behaviors mediated this association using a longitudinal design.</p><p><strong>Methods: </strong>We studied 3304 adult volunteers with a self-reported diagnosis of CD who completed a baseline survey that included demographics, CD activity, a symptom-specific index of depression, and measures of physical activity, smoking, and sleep quality. Crohn's disease status and the cognitive index of depression were also measured 6 and 12 months after the baseline evaluation. We specified single-mediator and multiple-mediator models to elucidate the depression-disease activity relationship.</p><p><strong>Results: </strong>Among 2395 females and 909 males, we found a significant mediation effect for activity level (<i>P</i> < .001) after adjusting for age, sex, and body mass index. There was no evidence that sleep quality and smoking are significant single mediators. When we considered multiple mediation models, smoking and less activity partially mediate the depression-CD association.</p><p><strong>Conclusions: </strong>Smoking and lower levels of physical activity are potential mediators of the unidirectional association between a nonsomatic symptom of depression-a negative view of the self-and patient-reported CD activity. Evaluating and treating specific symptoms of depression may reduce the frequency of CD exacerbations.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 1","pages":"otad080"},"PeriodicalIF":1.4,"publicationDate":"2023-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10771267/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139377331","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}
Crohn's & Colitis 360Pub Date : 2023-12-18eCollection Date: 2024-01-01DOI: 10.1093/crocol/otad076
William J Sandborn, Bruce E Sands, Sharif Uddin, Rana M Qasim Khan, Richa Sagar Mukherjee
{"title":"Clinical Trial Design in Ulcerative Colitis: Interpreting Evolving Endpoints Based on Post Hoc Analyses of the Vedolizumab Phase 3 Trials GEMINI 1 and VISIBLE 1.","authors":"William J Sandborn, Bruce E Sands, Sharif Uddin, Rana M Qasim Khan, Richa Sagar Mukherjee","doi":"10.1093/crocol/otad076","DOIUrl":"10.1093/crocol/otad076","url":null,"abstract":"<p><strong>Background: </strong>The 12-point total Mayo score including a Physician's Global Assessment (PGA) of disease activity has been used to assess outcomes in clinical trials for ulcerative colitis (UC). In 2016, the US Food and Drug Administration (FDA) issued guidance advising the removal of the PGA in future trials. We examined how endpoints in UC trials have evolved and conducted a post hoc analysis of the GEMINI 1 and VISIBLE 1 trials to understand how the use of a 9-point modified Mayo score, excluding PGA, compares with the total Mayo score.</p><p><strong>Methods: </strong>Endpoint definitions of clinical remission in phase 3 trials were extracted from published literature and ClinicalTrials.gov. The difference (%Δ) between the proportions of patients in GEMINI 1 and VISIBLE 1 achieving clinical remission with vedolizumab versus placebo at week 52 was measured according to 4 endpoint definitions.</p><p><strong>Results: </strong>Trials completed up to the end of 2019 used the total Mayo score to assess clinical remission. Most trials that were completed or estimated to be completed by June 2020 or later used modified Mayo scores. Post hoc analysis revealed decreasing endpoint stringency was associated with increasing %Δ values. The modified Mayo score definition most like the definition recommended by the FDA produced %Δ values like those reported using the total Mayo score in GEMINI 1 and VISIBLE 1.</p><p><strong>Conclusions: </strong>Endpoint definitions for UC clinical trials have evolved following FDA guidance. The efficacy of vedolizumab, measured using modified Mayo scoring, was comparable to values reported using the total Mayo score.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 1","pages":"otad076"},"PeriodicalIF":1.4,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10782208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139424499","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}
Crohn's & Colitis 360Pub Date : 2023-12-14eCollection Date: 2023-10-01DOI: 10.1093/crocol/otad078
Poonam Beniwal-Patel, Gabrielle Waclawik, Keely Browning, Aijan Urmat, Trevor L Schell, Ryan Smith, Antonio Huerta, Lauren Hipp, Sonya Dave, Neemit Shah, Kayla E Dillon, Katelyn Reiter-Schreurs, Rachel K Russ, Miguel A Mailig, Fauzia Osman, Francis A Farraye, Jennifer Weiss, Mary S Hayney, Freddy Caldera
{"title":"Racial, Ethnic, and Geographic Disparities in Immunization Rates Among Patients With Inflammatory Bowel Disease.","authors":"Poonam Beniwal-Patel, Gabrielle Waclawik, Keely Browning, Aijan Urmat, Trevor L Schell, Ryan Smith, Antonio Huerta, Lauren Hipp, Sonya Dave, Neemit Shah, Kayla E Dillon, Katelyn Reiter-Schreurs, Rachel K Russ, Miguel A Mailig, Fauzia Osman, Francis A Farraye, Jennifer Weiss, Mary S Hayney, Freddy Caldera","doi":"10.1093/crocol/otad078","DOIUrl":"10.1093/crocol/otad078","url":null,"abstract":"<p><strong>Background and aims: </strong>Racial and ethnic disparities exist in the treatment of IBD. These disparities exist in adult vaccine uptake among the general population and may extend to patients with IBD. The primary aim of this study was to determine whether racial, ethnic, or geographic disparities existed in influenza vaccine uptake among patients with IBD.</p><p><strong>Methods: </strong>We performed a multicenter, retrospective cohort study evaluating adult vaccine uptake among patients with IBD seen at two tertiary referral centers between September 2019 and February 2020. The primary outcome was to determine if racial/ethnic and geographic disparities existed in influenza vaccine uptake for the two prior seasons. Our secondary outcomes were to determine if disparities existed for pneumococcal, zoster, or hepatitis B vaccines.</p><p><strong>Results: </strong>Among the 2453 patients who met the inclusion criteria, most identified as non-Hispanic White (89.9%), were on immunosuppressive therapy (74.5%), and received the influenza vaccine in both seasons (56.0%). Older age (prevalence ratio (PR) 0.98; 95% confidence interval (95%CI) 0.98-0.99; <i>P</i> < .001) and non-Hispanic White patients (PR 0.76, 95%CI 0.59-0.98, <i>P</i> < 0.03) were significantly more likely to be immunized. Black patients (PR 1.37; 95%CI 1.18-1.59; <i>P</i> < .001) and those living in underserved geographic areas (PR 1.35; 95%CI 1.17-1.56; <i>P</i> < 0.001) were less likely to be immunized. Racial/ethnic and geographic disparities were identified for pneumococcal, zoster, and hepatitis B vaccine uptake.</p><p><strong>Conclusions: </strong>Racial and ethnic vaccination uptake disparities exist among patients with IBD; patients from medically underserved areas are also vulnerable to these disparities Studies identifying patient, provider, and system-level opportunities to address these disparities are needed.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"5 4","pages":"otad078"},"PeriodicalIF":1.4,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10734681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138828659","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}
Crohn's & Colitis 360Pub Date : 2023-12-13eCollection Date: 2023-10-01DOI: 10.1093/crocol/otad074
Mohamed Attauabi, Ditlev Nytoft Rasmussen, Fredrik Olof Bergenheim, Johan Burisch, Jakob Benedict Seidelin
{"title":"Unraveling the Place of Small Molecules in the Treatment of Fistulizing Crohn's Disease-A Systematic Review and Network Meta-Analysis.","authors":"Mohamed Attauabi, Ditlev Nytoft Rasmussen, Fredrik Olof Bergenheim, Johan Burisch, Jakob Benedict Seidelin","doi":"10.1093/crocol/otad074","DOIUrl":"10.1093/crocol/otad074","url":null,"abstract":"","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"5 4","pages":"otad074"},"PeriodicalIF":1.4,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10734679/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138828660","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":"Authors' Reply to Unraveling the Place of Small Molecules in the Treatment of Fistulizing Crohn's Disease-A Systematic Review and Network Meta-analysis.","authors":"Arshdeep Singh, Vandana Midha, Gursimran Singh Kochhar, Bo Shen, Ajit Sood","doi":"10.1093/crocol/otad075","DOIUrl":"10.1093/crocol/otad075","url":null,"abstract":"","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"5 4","pages":"otad075"},"PeriodicalIF":1.4,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10734682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138828658","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}
Crohn's & Colitis 360Pub Date : 2023-12-09eCollection Date: 2024-01-01DOI: 10.1093/crocol/otad077
Scott Manski, Nicholas Noverati, Tatiana Policarpo, Emily Rubin, Raina Shivashankar
{"title":"Diet and Nutrition in Inflammatory Bowel Disease: A Review of the Literature.","authors":"Scott Manski, Nicholas Noverati, Tatiana Policarpo, Emily Rubin, Raina Shivashankar","doi":"10.1093/crocol/otad077","DOIUrl":"10.1093/crocol/otad077","url":null,"abstract":"<p><p>Diet is thought to contribute to the development of inflammatory bowel disease (IBD) and may act as a mediator of inflammation in patients with IBD. Patients commonly associate their diet with symptoms and inquire about dietary modifications to manage their IBD. Without clinical guidelines and well-established nutritional data, healthcare providers managing patients with IBD may find it difficult to provide recommendations. Strong evidence for enteral nutrition, particularly in the pediatric population, has been established in Crohn's disease (CD) as a therapeutic option. Enteral nutrition may also serve as an adjunct to an exclusion diet. Recent studies such as the randomized trial comparing the Specific Carbohydrate Diet to a Mediterranean Diet in CD patients provide additional insights in forming dietary plans. A low-fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet in quiescent IBD and an anti-inflammatory diet have also been explored as adjunctive therapies. In this review, we discuss the latest evidence for the role of diet in IBD both as a therapeutic modality and as an opportunity to provide patient-centered care.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 1","pages":"otad077"},"PeriodicalIF":1.4,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10782214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139424500","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}
Crohn's & Colitis 360Pub Date : 2023-12-09eCollection Date: 2024-01-01DOI: 10.1093/crocol/otad079
Dakota Rhys-Jones, Chu K Yao, Zaid S Ardalan
{"title":"Accurate Diet Assessment, Patient Selection, and Objective Clinical Outcome Are Critical in Untangling the Role of Diet on Pouchitis.","authors":"Dakota Rhys-Jones, Chu K Yao, Zaid S Ardalan","doi":"10.1093/crocol/otad079","DOIUrl":"10.1093/crocol/otad079","url":null,"abstract":"","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 1","pages":"otad079"},"PeriodicalIF":1.4,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10862651/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139729189","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}
Crohn's & Colitis 360Pub Date : 2023-12-08eCollection Date: 2023-10-01DOI: 10.1093/crocol/otad048
Andrew Ford, Vibhu Chittajallu, Jaime Abraham Perez, Scott Martin, Motasem Alkhayyat, Maneesh Dave, Edith Y Ho, Preetika Sinh, Vu Nguyen, Gregory Cooper, Jeffry Katz, Fabio Cominelli, Miguel Regueiro, Emad Mansoor
{"title":"Prevalence Rates of Pneumococcal Vaccination in IBD and 30-Day Clinical Outcomes in Patients With IBD and Pneumococcal Disease Stratified by Receipt of Pneumococcal Vaccination: A Multi-Network Study.","authors":"Andrew Ford, Vibhu Chittajallu, Jaime Abraham Perez, Scott Martin, Motasem Alkhayyat, Maneesh Dave, Edith Y Ho, Preetika Sinh, Vu Nguyen, Gregory Cooper, Jeffry Katz, Fabio Cominelli, Miguel Regueiro, Emad Mansoor","doi":"10.1093/crocol/otad048","DOIUrl":"10.1093/crocol/otad048","url":null,"abstract":"","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"5 4","pages":"otad048"},"PeriodicalIF":1.4,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10708920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138799739","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}