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Patient and Public Involvement in Inflammatory Bowel Disease Research-A Scoping Review. 患者和公众参与炎症性肠病研究--范围界定综述》。
Pub Date : 2023-12-14 eCollection Date: 2024-04-01 DOI: 10.1093/jcag/gwad054
Karam Elsolh, Amy Li, Malini Hu, Samir Seleq, Emma Neary, Nikko Gimpaya, Michael A Scaffidi, Teruko Kishibe, Rishad Khan, Samir C Grover

Background: Interest in patient and public involvement in research has grown. Medical, health, and social care research has demonstrated several benefits of patient and public engagement, such as empowering user input and reducing attrition rates in clinical trials. To date, no study has reviewed patient engagement in inflammatory bowel disease (IBD). We aimed to describe the benefits, challenges, and best practices of patient engagement in IBD research.

Methods: We performed a systematic search on MEDLINE, EMBASE, and Cochrane for all clinical IBD research studies in which patients were involved in the research process (1946- 2023). Patient input was considered in: (1) study design, (2) study execution, (3) research dissemination, and/or (4) other domains not specified here. Two authors independently screened and extracted data on type of engaged person(s), format of engagement, author-reported benefits, recommendations, and challenges. For each study, we reported the level of patient engagement and study adherence to standardized reporting guidelines.

Results: After screening 9,355 articles, we included 51 for final analysis. IBD patients were most frequently engaged in study design. Patient engagement in IBD research improved recruitment rates and promoted the creation of user-friendly quality-of-life tools. Selection bias and recruitment difficulties were common challenges in the application of patient engagement. Authors recommended continuous patient involvement to address emerging priorities and cognitive interviewing to improve questionnaire clarity.

Conclusions: Patient engagement represents an important step in promoting patient-centred care. According to study authors, implementing cognitive interviewing techniques, continuous patient involvement, and standardized reporting guidelines may improve future iterations of engagement in IBD.

背景:患者和公众参与研究的兴趣与日俱增。医疗、健康和社会护理研究已经证明了患者和公众参与的多种益处,如增强用户输入能力和降低临床试验中的自然减员率。迄今为止,还没有研究对患者参与炎症性肠病(IBD)的情况进行过回顾。我们旨在描述患者参与 IBD 研究的益处、挑战和最佳实践:我们在 MEDLINE、EMBASE 和 Cochrane 上对患者参与研究过程的所有临床 IBD 研究进行了系统检索(1946-2023 年)。患者的参与包括(1) 研究设计,(2) 研究执行,(3) 研究传播,和/或 (4) 其他未说明的领域。两位作者独立筛选并提取了有关参与人员类型、参与形式、作者报告的益处、建议和挑战的数据。对于每项研究,我们都报告了患者参与的程度以及研究对标准化报告指南的遵守情况:在筛选了 9,355 篇文章后,我们纳入了 51 篇文章进行最终分析。IBD患者最常参与研究设计。IBD研究中患者的参与提高了招募率,并促进了用户友好型生活质量工具的开发。选择偏差和招募困难是应用患者参与的常见挑战。作者建议让患者持续参与,以解决新出现的优先事项,并通过认知访谈提高问卷的清晰度:患者参与是促进以患者为中心的护理的重要一步。该研究的作者认为,实施认知访谈技术、持续的患者参与和标准化报告指南可能会改善 IBD 患者参与的未来迭代。
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引用次数: 0
Adaptation and Validation of a Questionnaire to Measure Satisfaction With Telephone Care Among Individuals Living With Inflammatory Bowel Disease 改编并验证用于衡量炎症性肠病患者对电话护理满意度的调查问卷
Pub Date : 2023-12-13 DOI: 10.1093/jcag/gwad053
Jermia Nehwa Foncham, N. Rohatinsky, S. Fowler, Sanchit Bhasin, Shannon Boklaschuk, Tomasz Guzowski, Kendall Wicks, Mike Wicks, J. Peña-Sánchez
Individuals with inflammatory bowel disease (IBD) require routine medical follow-up. The usage of telephone care (TC) appointments increased because of the coronavirus disease 2019 (COVID-19) pandemic. We aimed to adapt a questionnaire to evaluate satisfaction with TC use and validate it among IBD individuals. A committee of experts adapted the Telehealth Usability Questionnaire to the TC context and validated its use in individuals with IBD. This committee included three IBD gastroenterology care providers (GCPs), two IBD-patient partners, and two healthcare researchers. The committee evaluated the content validity of the adapted items to measure TC satisfaction. A pilot study assessed the readability and usability of the questionnaire. Individuals with IBD in Saskatchewan completed an online survey with the adapted questionnaire between December 2021 and April 2022. Data were analyzed using descriptive and correlational techniques. Psychometric analyses were conducted to examine the reliability and validity of the questionnaire. The committee of experts developed the Telephone Care Satisfaction Questionnaire (TCSQ patient), with 16 items and one overall item for TC satisfaction. After the pilot, 87 IBD individuals participated in the online survey. A strong correlation was observed between the 16-item standardized level of TC satisfaction and the overall item, r = 0.85 (95%CI 0.78–0.90, p < 0.001). The TCSQ patient had optimal internal reliability (α = 0.96). Two dimensions were identified in the exploratory factor analysis (i.e., TC usefulness and convenience). The TCSQ patient is a valid and reliable measure of TC satisfaction among individuals with IBD. This questionnaire demonstrated excellent psychometric properties and we recommend its use.
炎症性肠病(IBD)患者需要常规医疗随访。由于 2019 年冠状病毒病(COVID-19)的流行,电话护理(TC)预约的使用率有所增加。我们旨在改编一份调查问卷,以评估 IBD 患者对电话护理预约的满意度,并对其进行验证。 一个专家委员会对远程保健可用性问卷进行了改编,使其适用于 TC 环境,并对其在 IBD 患者中的使用进行了验证。该委员会包括三名 IBD 胃肠病护理提供者 (GCP)、两名 IBD 患者伙伴和两名医疗保健研究人员。委员会评估了改编项目的内容有效性,以衡量 TC 满意度。一项试点研究评估了问卷的可读性和可用性。2021 年 12 月至 2022 年 4 月期间,萨斯喀彻温省的 IBD 患者使用改编问卷完成了在线调查。数据采用描述性和相关性技术进行分析。对问卷的可靠性和有效性进行了心理测量分析。 专家委员会制定了电话护理满意度问卷(TCSQ 患者),其中包括 16 个项目和一个 TC 满意度总项目。经过试点,87 名 IBD 患者参与了在线调查。在 16 个项目的标准化 TC 满意度水平和总项目之间观察到了很强的相关性,r = 0.85 (95%CI 0.78-0.90, p < 0.001)。TCSQ患者具有最佳的内部信度(α = 0.96)。探索性因子分析确定了两个维度(即 TC 实用性和便利性)。 TCSQ患者问卷是对IBD患者TC满意度的有效而可靠的测量。该问卷具有出色的心理测量特性,我们推荐使用。
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引用次数: 0
Unified Magnifying Endoscopic Classification (UMEC) of Gastrointestinal Lesions: A North American Validation Study 胃肠道病变的统一放大内镜分类 (UMEC):北美验证研究
Pub Date : 2023-12-09 DOI: 10.1093/jcag/gwad055
M. R. Fujiyoshi, Y. Fujiyoshi, N. Gimpaya, R. Bechara, T. Jeyalingam, N. Calo, Nauzer Forbes, Katarzyna M. Pawlak, Kareem Khalaf, R. Khan, M. Atalla, Akiko Toshimori, Y. Shimamura, M. Tanabe, Christopher Teshima, J. Mosko, Gary May, Haruhiro Inoue, S. Grover
Magnifying endoscopy enables the diagnosis of advanced neoplasia throughout the gastrointestinal tract. The unified magnifying endoscopic classification (UMEC) framework unifies optical diagnosis criteria in the esophagus, stomach, and colon, dividing lesions into three categories: non-neoplastic, intramucosal neoplasia, and deep submucosal invasive cancer. This study aims to ascertain the performance of North American endoscopists when using the UMEC. In this retrospective cohort study, five North American endoscopists without prior training in magnifying endoscopy independently diagnosed images of gastrointestinal tract lesions using UMEC. All endoscopists were blinded to endoscopic findings and histopathological diagnosis. Using histopathology as the gold standard, the endoscopists’ diagnostic performances using UMEC were evaluated. A total of 299 lesions (77 esophagus, 92 stomach, and 130 colon) were assessed. For esophageal squamous cell carcinoma, the sensitivity, specificity, and accuracy ranged from 65.2% (95%CI: 50.9–77.9) to 87.0% (95%CI: 75.3–94.6), 77.4% (95%CI: 60.9–89.6) to 96.8% (95%CI: 86.8–99.8), and 75.3% to 87.0%, respectively. For gastric adenocarcinoma, the sensitivity, specificity, and accuracy ranged from 94.9% (95%CI: 85.0–99.1) to 100%, 52.9% (95%CI: 39.4–66.2) to 92.2% (95%CI: 82.7–97.5), and 73.3% to 93.3%. For colorectal adenocarcinoma, the sensitivity, specificity, and accuracy ranged from 76.2% (95%CI: 62.0–87.3) to 83.3% (95%CI: 70.3–92.5), 89.7% (95%CI: 82.1–94.9) to 97.7% (95%CI: 93.1–99.6), and 86.8% to 90.7%. Intraclass correlation coefficients indicated good to excellent reliability. UMEC is a simple classification that may be used to introduce endoscopists to magnifying narrow-band imaging and optical diagnosis, yielding satisfactory diagnostic accuracy.
放大内窥镜可以诊断整个胃肠道的晚期肿瘤。统一放大内镜分类(UMEC)框架统一了食道、胃和结肠的光学诊断标准,将病变分为非肿瘤性、粘膜内瘤变和深部粘膜下浸润性癌三大类。本研究旨在确定北美内窥镜医师在使用UMEC时的表现。在这项回顾性队列研究中,五名未经放大内镜培训的北美内窥镜医师使用UMEC独立诊断胃肠道病变图像。所有内窥镜检查人员对内窥镜检查结果和组织病理学诊断均不知情。以组织病理学为金标准,评估内镜医师使用UMEC的诊断性能。总共评估了299个病变(77个食道,92个胃,130个结肠)。对于食管鳞状细胞癌,其敏感性、特异性和准确性分别为65.2% (95%CI: 50.9 ~ 77.9) ~ 87.0% (95%CI: 75.3 ~ 94.6)、77.4% (95%CI: 60.9 ~ 89.6) ~ 96.8% (95%CI: 85.8 ~ 99.8)和75.3% ~ 87.0%。对于胃腺癌,其敏感性、特异性和准确性分别为94.9% (95%CI: 85.0 ~ 99.1) ~ 100%、52.9% (95%CI: 39.4 ~ 66.2) ~ 92.2% (95%CI: 82.7 ~ 97.5)和73.3% ~ 93.3%。对于结直肠腺癌,其敏感性、特异性和准确性分别为76.2% (95%CI: 62.0 ~ 87.3) ~ 83.3% (95%CI: 70.3 ~ 92.5)、89.7% (95%CI: 82.1 ~ 94.9) ~ 97.7% (95%CI: 93.1 ~ 99.6)和86.8% ~ 90.7%。类内相关系数表明信度良好至优异。UMEC是一个简单的分类,可用于介绍内窥镜医师放大窄带成像和光学诊断,产生令人满意的诊断准确性。
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引用次数: 0
Measuring the Impact of Patient Engagement in Health Research: An Exploratory Study Using Multiple Survey Tools 衡量患者参与健康研究的影响:使用多种调查工具的探索性研究
Pub Date : 2023-12-02 DOI: 10.1093/jcag/gwad045
D. Marshall, Nitya Suryaprakash, Stirling Bryan, K. Barker, Gail Mackean, S. Zelinsky, Tamara L. McCarron, Maria J. Santana, Paul Moayyedi, Danielle C Lavallee
Studies report various ways in which patients are involved in research design and conduct. Limited studies explore the influence of patient engagement (PE) at each research stage in qualitative research from the perspectives of all stakeholders. We established two small research groups, a Patient Researcher-Led Group and an Academic Researcher-Led Group. We recruited patient research partners (PRP; n = 5), researchers (n = 5), and clinicians (n = 4) to design and conduct qualitative research aimed at identifying candidate attributes related to patient preferences for tapering biologic treatments in inflammatory bowel disease. We administered surveys before starting, two months into, and post-project work. The surveys contained items from three PE evaluation tools. We assessed the two groups regarding the influence and impact each stakeholder had during the different research stages. PRPs had a moderate or a great deal of influence on the critical research activities across the research stages. They indicated moderate/very/extremely meaningful engagement and agreed/strongly agreed impact of PE. PRPs helped operationalize the research question; design the study and approach; develop study materials; recruit participants; and collect and interpret the data. The three tools together provide deeper insight into the influence of PE at each research stage. Lessons learnt from this study suggest that PE can impact many aspects of research including the design, process, and approach in the context of qualitative research, increasing the patient-centeredness of the study. More comprehensive validated tools are required that work with a more diverse subject pool and in other contexts.
研究报告了患者参与研究设计和实施的各种方式。有限的研究从所有利益相关者的角度探讨了定性研究中每个研究阶段患者参与(PE)的影响。我们建立了两个小型研究小组,一个由患者研究人员领导的小组和一个由学术研究人员领导的小组。我们招募了患者研究伙伴(PRP;N = 5)、研究人员(N = 5)和临床医生(N = 4)设计并开展定性研究,旨在确定与炎症性肠病患者偏好逐渐减少生物治疗相关的候选属性。我们在项目开始前、开始两个月后和项目结束后进行了调查。调查包含三个体育评估工具的项目。我们评估了两组在不同研究阶段每个利益相关者的影响和影响。PRPs对各研究阶段的关键研究活动具有中等或较大的影响。他们表示适度/非常/非常有意义的参与和同意/强烈同意体育的影响。PRPs帮助实现了研究问题;设计研究和方法;制定学习材料;招募参与者;收集并解释数据。这三个工具一起提供了更深入地了解PE在每个研究阶段的影响。本研究的经验教训表明,在定性研究的背景下,体育可以影响研究的许多方面,包括设计、过程和方法,增加了研究的以患者为中心。需要更全面的经过验证的工具来处理更多样化的主题池和其他环境。
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引用次数: 0
Beyond Eosinophilic Esophagitis: Eosinophils in Gastrointestinal Disease-New Insights, "New" Diseases. 超越嗜酸性粒细胞食管炎:胃肠道疾病中的嗜酸性粒细胞--新见解、"新 "疾病。
Pub Date : 2023-11-24 eCollection Date: 2023-12-01 DOI: 10.1093/jcag/gwad046
Nicholas J Talley, Grace L Burns, Emily C Hoedt, Kerith Duncanson, Simon Keely

Functional dyspepsia (FD) is a highly prevalent disorder. Upper endoscopy is normal, and according to the Rome IV criteria, there is no established pathology. Data accumulated over the last 15 years has challenged the notion FD is free of relevant pathology, and in particular, increased duodenal eosinophils have been observed. Intestinal eosinophils play important roles in microbial defence, immune regulation, tissue regeneration and remodelling, and maintaining tissue homeostasis and metabolism; degranulation of eosinophils releases toxic granule products (e.g., major basic protein, eosinophil-derived neurotoxin) which can damage nerves. Normal cut-offs for eosinophil infiltration into the duodenum histologically are less than five eosinophils per high power field (<25 per five high power fields). In clinical practice there is evidence that pathologically increased intestinal eosinophils may often be overlooked. In a meta-analysis duodenal eosinophils were significantly increased in FD although there was substantial heterogeneity; degranulation of duodenal eosinophils was also significantly higher in FD without significant heterogeneity. In addition, increased duodenal permeability, systemic immune activation, and an altered mucosa-associated duodenal microbiome have been identified that may help explain why symptoms arise, often occur after food with exposure to food antigens, and typically fluctuate. Several potentially reversible risk factors for FD have now been identified. We evaluate the current evidence linking duodenal microinflammation and immune activation with FD and disorders of gut-brain interactions that overlap with FD. We propose a two-hit disease model for eosinophilic functional dyspepsia (EoFD) with management implications.

功能性消化不良(FD)是一种高发疾病。上消化道内镜检查正常,根据罗马IV标准,没有确定的病理变化。过去 15 年积累的数据对功能性消化不良没有相关病理的说法提出了质疑,特别是观察到十二指肠嗜酸性粒细胞增多。肠道嗜酸性粒细胞在微生物防御、免疫调节、组织再生和重塑、维持组织稳态和新陈代谢等方面发挥着重要作用;嗜酸性粒细胞脱颗粒后会释放出有毒的颗粒产物(如主要碱性蛋白、嗜酸性粒细胞衍生神经毒素),可损害神经。组织学上嗜酸性粒细胞浸润十二指肠的正常临界值是每个高倍视野少于 5 个嗜酸性粒细胞((......))。
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引用次数: 0
Correction to: The 2023 Impact of Inflammatory Bowel Disease in Canada: Executive Summary 更正:2023年加拿大炎症性肠病的影响:执行摘要
Pub Date : 2023-11-13 DOI: 10.1093/jcag/gwad038
{"title":"Correction to: The 2023 Impact of Inflammatory Bowel Disease in Canada: Executive Summary","authors":"","doi":"10.1093/jcag/gwad038","DOIUrl":"https://doi.org/10.1093/jcag/gwad038","url":null,"abstract":"","PeriodicalId":17263,"journal":{"name":"Journal of the Canadian Association of Gastroenterology","volume":"25 6","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136282273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Impact of COVID-19 on Health Anxiety and Perceived Stress Among Persons with IBD: A Population-representative Study COVID-19对IBD患者健康焦虑和感知压力的影响:一项具有人群代表性的研究
Pub Date : 2023-11-12 DOI: 10.1093/jcag/gwad047
Seth R Shaffer, Gia L Jackson, Sydney Chochinov, Casandra Dolovich, Lesley A Graff, Renée El-Gabalawy, Souradet Yuh-Nan Shaw, Harminder Singh, Charles N Bernstein
Abstract Background The Corona Virus Immune Disease-2019 (COVID-19) pandemic has broadly impacted the mental health of individuals worldwide, especially with restrictions including social distancing and quarantining. Persons with IBD are at increased risk of mental health disorders. The aim was to understand how the COVID-19 pandemic affected adults with a chronic health issue, inflammatory bowel disease (IBD), using a population-based sample. Methods A survey study in Manitoba was conducted during the second COVID-19 wave in autumn 2020. We assessed proportions of health anxiety and perceived stress using validated measures, as well as stressors during the COVID-19 pandemic. We used univariable and multivariable logistic regression analysis to assess predictors of perceived stress and health anxiety. Results A total of 1,384 (47.1%) persons responded, with a mean age of 58.0, and 46.9% had Crohn’s disease. Almost three quarters (73.7%) had increased stress, with 37.7% having increased stress about their IBD, and 33.6% worried about their IBD worsening. 46.0% felt increased stress about accessing their doctor or nurse, and 56.5% felt they had good access to their gastroenterologist. Elevated stress and health anxiety were seen in 63.5% and 17.2% of respondents, respectively. Younger age and being on immune-modifying therapy (IMT) was predictive of increased health anxiety and stress. Longer IBD duration was associated with decreased stress, including those on IMT. Conclusion Persons with IBD reported high rates of stress and health anxiety early in the COVID-19 pandemic, especially among those on IMT. It will be important to determine how this evolved over time and to what extent this impacted on disease course.
背景冠状病毒免疫疾病-2019 (COVID-19)大流行广泛影响了全世界个人的心理健康,特别是在社交距离和隔离等限制措施的情况下。IBD患者患精神健康障碍的风险增加。目的是通过基于人群的样本,了解COVID-19大流行如何影响患有慢性健康问题,炎症性肠病(IBD)的成年人。方法在2020年秋季第二波COVID-19流行期间对马尼托巴省进行调查研究。我们使用有效的测量方法评估了健康焦虑和感知压力的比例,以及COVID-19大流行期间的压力源。我们使用单变量和多变量逻辑回归分析来评估感知压力和健康焦虑的预测因子。结果共有1384人(47.1%)回复,平均年龄为58.0岁,其中46.9%患有克罗恩病。近四分之三(73.7%)的人压力增加,37.7%的人对他们的IBD感到压力增加,33.6%的人担心他们的IBD恶化。46.0%的人觉得去看医生或护士的压力增加了,56.5%的人觉得去看肠胃科医生的机会更大。63.5%和17.2%的受访者分别出现压力升高和健康焦虑。年龄较小和接受免疫修饰治疗(IMT)可预测健康焦虑和压力的增加。较长的IBD持续时间与压力减少有关,包括IMT组。结论在COVID-19大流行早期,IBD患者报告的压力和健康焦虑率很高,特别是在IMT患者中。重要的是要确定这是如何随着时间的推移而演变的,以及这在多大程度上影响了疾病的进程。
{"title":"The Impact of COVID-19 on Health Anxiety and Perceived Stress Among Persons with IBD: A Population-representative Study","authors":"Seth R Shaffer, Gia L Jackson, Sydney Chochinov, Casandra Dolovich, Lesley A Graff, Renée El-Gabalawy, Souradet Yuh-Nan Shaw, Harminder Singh, Charles N Bernstein","doi":"10.1093/jcag/gwad047","DOIUrl":"https://doi.org/10.1093/jcag/gwad047","url":null,"abstract":"Abstract Background The Corona Virus Immune Disease-2019 (COVID-19) pandemic has broadly impacted the mental health of individuals worldwide, especially with restrictions including social distancing and quarantining. Persons with IBD are at increased risk of mental health disorders. The aim was to understand how the COVID-19 pandemic affected adults with a chronic health issue, inflammatory bowel disease (IBD), using a population-based sample. Methods A survey study in Manitoba was conducted during the second COVID-19 wave in autumn 2020. We assessed proportions of health anxiety and perceived stress using validated measures, as well as stressors during the COVID-19 pandemic. We used univariable and multivariable logistic regression analysis to assess predictors of perceived stress and health anxiety. Results A total of 1,384 (47.1%) persons responded, with a mean age of 58.0, and 46.9% had Crohn’s disease. Almost three quarters (73.7%) had increased stress, with 37.7% having increased stress about their IBD, and 33.6% worried about their IBD worsening. 46.0% felt increased stress about accessing their doctor or nurse, and 56.5% felt they had good access to their gastroenterologist. Elevated stress and health anxiety were seen in 63.5% and 17.2% of respondents, respectively. Younger age and being on immune-modifying therapy (IMT) was predictive of increased health anxiety and stress. Longer IBD duration was associated with decreased stress, including those on IMT. Conclusion Persons with IBD reported high rates of stress and health anxiety early in the COVID-19 pandemic, especially among those on IMT. It will be important to determine how this evolved over time and to what extent this impacted on disease course.","PeriodicalId":17263,"journal":{"name":"Journal of the Canadian Association of Gastroenterology","volume":"20 9","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135037974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Role of Tofacitinib in the Treatment of Acute Severe Colitis in Children 托法替尼在治疗儿童急性严重结肠炎中的作用
Pub Date : 2023-11-06 DOI: 10.1093/jcag/gwad042
Guillermo Alejandro Costaguta, Chloé Girard, Véronique Groleau, Kelly Grzywacz, Martha Heather Dirks, Colette Deslandres
Abstract Objectives Acute severe colitis (ASC) occurs in up to 15 percent of children with ulcerative colitis, with a high index of morbidity and mortality. Treatment includes high-dose steroids, infliximab, and salvage therapies. Unfortunately, up to 20 percent of patients may need an urgent colectomy due to treatment failure. We report our experience using tofacitinib for the treatment of six patients. Methods A retrospective review of our medical electronic records was conducted. We included every patient with ASC and treatment failure, in whom tofacitinib was used as a salvage therapy. Response, complications, and disease course were noted. Results Six patients were included with Pediatric Ulcerative Colitis Activity Index (PUCAI) scores ranging from 65 to 85 on admission, and 35 to 85 before tofacitinib was started (P 0.07). Median response time was 72 h. A median decrease of 40 points in PUCAI was noted (P 0.00001). Mean length of stay was 18 days with discharge 9 days after tofacitinib introduction. Haemoglobin, albumin, fecal calprotectin, and CRP improved after tofacitinib (P 0.02, P 0.02, P 0.025, and P 0.01, respectively). The mean follow-up was 8.5 months, four patients achieved complete remission and only one had a recrudescence of symptoms (P 0.01). One patient had a systemic Epstein-Barr virus infection prior to tofacitinib therapy, which resolved with rituximab treatment. No other complications were noted. Conclusions Tofacitinib response is rapid and impressive in children suffering from ASC, and the safety profile appears comparable to or better than other available treatments. In the future, tofacitinib should be integrated into pediatric protocols.
急性严重结肠炎(ASC)发生在高达15%的儿童溃疡性结肠炎,具有很高的发病率和死亡率。治疗包括大剂量类固醇、英夫利昔单抗和挽救性治疗。不幸的是,多达20%的患者可能由于治疗失败而需要紧急结肠切除术。我们报告使用托法替尼治疗6例患者的经验。方法对我院电子病历资料进行回顾性分析。我们纳入了所有ASC和治疗失败的患者,在这些患者中,托法替尼被用作挽救性治疗。记录反应、并发症和病程。结果6例患者入院时儿童溃疡性结肠炎活动指数(PUCAI)评分为65 ~ 85分,托法替尼开始治疗前为35 ~ 85分(P < 0.07)。中位反应时间为72 h, PUCAI中位下降40分(P 0.00001)。使用托法替尼后平均住院时间为18天,出院时间为9天。托法替尼治疗后,血红蛋白、白蛋白、粪便钙保护蛋白和CRP均有改善(分别为P < 0.02、P < 0.02、P < 0.025和P < 0.01)。平均随访8.5个月,4例患者完全缓解,1例复发(p0.01)。1例患者在托法替尼治疗前出现系统性eb病毒感染,经利妥昔单抗治疗后消退。未发现其他并发症。结论:托法替尼对ASC患儿的反应迅速且令人印象深刻,其安全性似乎与其他可用治疗相当或更好。在未来,托法替尼应该整合到儿科方案中。
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引用次数: 0
Correction to: The 2023 Impact of Inflammatory Bowel Disease in Canada: Epidemiology of IBD 2023年加拿大炎症性肠病的影响:IBD的流行病学
Pub Date : 2023-11-01 DOI: 10.1093/jcag/gwad043
{"title":"Correction to: The 2023 Impact of Inflammatory Bowel Disease in Canada: Epidemiology of IBD","authors":"","doi":"10.1093/jcag/gwad043","DOIUrl":"https://doi.org/10.1093/jcag/gwad043","url":null,"abstract":"","PeriodicalId":17263,"journal":{"name":"Journal of the Canadian Association of Gastroenterology","volume":"39 7","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135455137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An Update On Anti-TNF Biosimilar Switching—Real-World Clinical Effectiveness and Safety 抗肿瘤坏死因子生物仿制药转换的最新进展-现实世界的临床有效性和安全性
Pub Date : 2023-10-25 DOI: 10.1093/jcag/gwad027
Susanna Meade, Elizabeth Squirell, Thomas Tam Hoang, James Chow, Gregory Rosenfeld
Abstract Background Biological medications for inflammatory bowel disease (IBD) account for a significant burden on provincial budgets. In an effort to curb these rising costs, nationwide switching to biosimilars is expected to be complete in Canada before the end of 2023. Biosimilar products do not require the same rigor for licensing as the originator and therefore there has been appropriate scepticism as to how biosimilars will perform in real-world practice. Methods We have performed a systematic review including real-world observational studies of adult patients with IBD. The primary outcome was clinical effectiveness and/or safety in patients who had switched from originator to biosimilar anti-TNF. Secondary outcomes included loss of response (LOR), treatment persistence or cessation and immunogenicity. Results We included 43 studies (7,462 patients [70 percent Crohn’s disease: 30 percent ulcerative colitis]; 32 infliximab studies, and 11 adalimumab studies). For infliximab, 75 percent patients were in clinical remission at the time of switch and 75 percent maintained clinical remission beyond 12 months, compared to 78 percent of patients who continued originator. For adalimumab, 86 percent patients were in remission at the time of switch with 82 percent maintaining remission at 6 months follow-up. Injection site pain was higher in patients who switched to a citrate containing adalimumab biosimilar, compared with those who continued originator. All other outcomes (LOR, treatment cessation or persistence and serious adverse events) were similar to patients who continued originator (in comparator cohorts or the available literature). Conclusion Whilst ongoing vigilance is required, these data are reassuring to both patients and clinicians and will significantly help to reduce health-care costs across Canada.
背景:炎症性肠病(IBD)的生物药物治疗占省级预算的重要负担。为了控制这些不断上涨的成本,加拿大预计将在2023年底之前完成全国范围内向生物仿制药的转变。生物仿制药产品不需要与发起人相同的严格许可,因此对生物仿制药在现实世界中的表现存在适当的怀疑。方法:我们进行了一项系统综述,包括对IBD成年患者的现实世界观察性研究。主要结局是从原药切换到抗tnf生物类似药的患者的临床有效性和/或安全性。次要结局包括反应丧失(LOR)、治疗持续或停止以及免疫原性。我们纳入了43项研究(7462例患者[70%克罗恩病:30%溃疡性结肠炎];32项英夫利昔单抗研究和11项阿达木单抗研究)。对于英夫利昔单抗,75%的患者在切换时处于临床缓解状态,75%的患者在12个月后保持临床缓解,而继续使用原药的患者为78%。对于阿达木单抗,86%的患者在切换时处于缓解状态,82%的患者在6个月的随访中保持缓解状态。与继续使用原药的患者相比,改用含有阿达木单抗的柠檬酸盐生物类似药的患者注射部位疼痛更高。所有其他结果(LOR、治疗停止或持续以及严重不良事件)与继续原药治疗的患者相似(在比较组队列或现有文献中)。结论:虽然需要保持警惕,但这些数据使患者和临床医生放心,并将大大有助于降低加拿大各地的医疗保健费用。
{"title":"An Update On Anti-TNF Biosimilar Switching—Real-World Clinical Effectiveness and Safety","authors":"Susanna Meade, Elizabeth Squirell, Thomas Tam Hoang, James Chow, Gregory Rosenfeld","doi":"10.1093/jcag/gwad027","DOIUrl":"https://doi.org/10.1093/jcag/gwad027","url":null,"abstract":"Abstract Background Biological medications for inflammatory bowel disease (IBD) account for a significant burden on provincial budgets. In an effort to curb these rising costs, nationwide switching to biosimilars is expected to be complete in Canada before the end of 2023. Biosimilar products do not require the same rigor for licensing as the originator and therefore there has been appropriate scepticism as to how biosimilars will perform in real-world practice. Methods We have performed a systematic review including real-world observational studies of adult patients with IBD. The primary outcome was clinical effectiveness and/or safety in patients who had switched from originator to biosimilar anti-TNF. Secondary outcomes included loss of response (LOR), treatment persistence or cessation and immunogenicity. Results We included 43 studies (7,462 patients [70 percent Crohn’s disease: 30 percent ulcerative colitis]; 32 infliximab studies, and 11 adalimumab studies). For infliximab, 75 percent patients were in clinical remission at the time of switch and 75 percent maintained clinical remission beyond 12 months, compared to 78 percent of patients who continued originator. For adalimumab, 86 percent patients were in remission at the time of switch with 82 percent maintaining remission at 6 months follow-up. Injection site pain was higher in patients who switched to a citrate containing adalimumab biosimilar, compared with those who continued originator. All other outcomes (LOR, treatment cessation or persistence and serious adverse events) were similar to patients who continued originator (in comparator cohorts or the available literature). Conclusion Whilst ongoing vigilance is required, these data are reassuring to both patients and clinicians and will significantly help to reduce health-care costs across Canada.","PeriodicalId":17263,"journal":{"name":"Journal of the Canadian Association of Gastroenterology","volume":"35 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134973491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of the Canadian Association of Gastroenterology
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