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Management of inflammatory bowel disease with Clostridium difficile infection 被引量:16
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作者 Julie D’Aoust Robert Battat talat bessissow 《World Journal of Gastroenterology》 SCIE CAS 2017年第27期4986-5003,共18页
AIM To address the management of Clostridium difficile(C. difficile) infection(CDI) in the setting of suspected inflammatory bowel disease(IBD)-flare.METHODS A systematic search of the Ovid MEDLINE and EMBASE database... AIM To address the management of Clostridium difficile(C. difficile) infection(CDI) in the setting of suspected inflammatory bowel disease(IBD)-flare.METHODS A systematic search of the Ovid MEDLINE and EMBASE databases by independent reviewers identified 70 articles including a total of 932141 IBD patients or IBDrelated hospitalizations. RESULTS In those with IBD,CDI is associated with increased morbidity,including subsequent escalation in IBD medical therapy,urgent colectomy and increased hospitalization,as well as excess mortality. Vancomycincontaining regimens are effective first-line therapies for CDI in IBD inpatients. No prospective data exists with regards to the safety or efficacy of initiating or maintaining corticosteroid,immunomodulator,or biologic therapy to treat IBD in the setting of CDI. Corticosteroid use is a risk factor for the development of CDI,while immunomodulators and biologics are not. CONCLUSION Strong recommendations regarding when to initiate IBD specific therapy in those with CDI are precluded by a lack of evidence. However,based on expert opinion and observational data,initiation or resumption of immunosuppressive therapy after 48-72 h of targeted antibiotic treatment for CDI may be considered. 展开更多
关键词 生物学的治疗 Clostridium 顽固 煽动性的肠疾病 Ulcerative 大肠炎 Crohns 疾病 CORTICOSTEROIDS
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Systematic review and meta-analysis of colon cleansing preparations in patients with inflammatory bowel disease 被引量:16
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作者 Sophie Restellini Omar Kherad +5 位作者 talat bessissow Charles Ménard Myriam Martel Maryam Taheri Tanjani Peter L Lakatos Alan N Barkun 《World Journal of Gastroenterology》 SCIE CAS 2017年第32期5994-6002,共9页
AIM To performed a systematic review and meta-analysis to determine any possible differences in terms of effectiveness, safety and tolerability between existing colon-cleansing products in patients with inflammatory b... AIM To performed a systematic review and meta-analysis to determine any possible differences in terms of effectiveness, safety and tolerability between existing colon-cleansing products in patients with inflammatory bowel disease.METHODS Systematic searches were performed( January 1980-September 2016) using MEDLINE, EMBASE, Scopus, CENTRAL and ISI Web of knowledge for randomized trials assessing preparations with or without adjuvants, given in split and non-split dosing, and in high(> 3 L) or low-volume(2 L or less) regimens. Bowel cleansing quality was the primary outcome. Secondary outcomes included patient willingness-torepeat the procedure and side effects/complications.RESULTS Out of 439 citations, 4 trials fulfilled our inclusion criteria(n = 449 patients). One trial assessed the impact of adding simethicone to polyethylene glycol(PEG) 4 L with no effect on bowel cleansing quality, but a better tolerance. Another trial compared senna to castor oil, again without any differences in term of bowel cleansing. Two trials compared the efficacy of PEG high-volume vs PEG low-volume associated to an adjuvant in split-dose regimens: PEG low-dose efficacy was not different to PEG high-dose; OR = 0.84(0.37-1.92). A higher proportion of patients were willing to repeat low-volume preparations vs high-volume; OR = 5.11(1.31-20.0). CONCLUSION In inflammatory bowel disease population, PEG lowvolume regimen seems not inferior to PEG high-volume to clean the colon, and yields improved willingness-torepeat. Further additional research is urgently required to compare contemporary products in this population. 展开更多
关键词 煽动性的肠疾病 聚乙烯乙二醇 COLONOSCOPY 元分析
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Endoscopic management of Crohn's strictures 被引量:10
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作者 talat bessissow Jason Reinglas +2 位作者 Achuthan Aruljothy Peter L Lakatos Gert Van Assche 《World Journal of Gastroenterology》 SCIE CAS 2018年第17期1859-1867,共9页
Symptomatic intestinal strictures develop in more than one third of patients with Crohn's disease(CD) within 10 years of disease onset. Strictures can be inflammatory, fibrotic or mixed and result in a significant... Symptomatic intestinal strictures develop in more than one third of patients with Crohn's disease(CD) within 10 years of disease onset. Strictures can be inflammatory, fibrotic or mixed and result in a significant decline in quality of life, frequently requiring surgery for palliation of symptoms. Patients under the age of 40 with perianal disease are more likely to suffer from disabling ileocolonic disease thus may have a greater risk for fibrostenotic strictures. Treatment options for fibrostenotic strictures are limited to endoscopic and surgical therapy. Endoscopic balloon dilatation(EBD) appears to be a safe, less invasive and effective alternative modality to replace or defer surgery. Serious complications are rare and occur in less than 3% of procedures. For non-complex strictures without adjacent fistulizaation or perforation that are less than 5 cm in length, EBD should be considered as first-line therapy. The aim of this review is to present the current literature on the endoscopic management of small bowel and colonic strictures in CD, which includes balloon dilatation, adjuvant techniques of intralesional injection of steroids and anti-tumor necrosis factor, and metal stent insertion. Short and long-term outcomes, complications and safety of EBD will be discussed. 展开更多
关键词 Endoscopy Crohn’s DISEASE STRICTURE STENOSIS Inflammatory bowel DISEASE Endoscopic balloon DILATION
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Co-existence of non-alcoholic fatty liver disease and inflammatory bowel disease: a review article 被引量:7
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作者 Che-yung Chao Robert Battat +3 位作者 Alex Al Khoury Sophie Restellini Giada Sebastiani talat bessissow 《World Journal of Gastroenterology》 SCIE CAS 2016年第34期7727-7734,共8页
Emerging data have highlighted the co-existence of nonalcoholic fatty liver disease(NAFLD) and inflammatory bowel disease; both of which are increasingly prevalent disorders with significant complications and impact o... Emerging data have highlighted the co-existence of nonalcoholic fatty liver disease(NAFLD) and inflammatory bowel disease; both of which are increasingly prevalent disorders with significant complications and impact on future health burden. Cross-section observational studies have shown widely variable prevalence rates of co-existing disease,largely due to differences in disease definition and diagnostic tools utilised in the studies. Age,obesity,insulin resistance and other metabolic conditions are common risks factors in observational studies. However,other studies have also suggested a more dominant role of inflammatory bowel disease related factors such as disease activity,duration,steroid use and prior surgical intervention,in the development of NAFLD. This suggests a potentially more complex pathogenesis and relationship between the two diseases which may be contributed by factors including altered intestinal permeability,gut dysbiosis and chronic inflammatory response. Commonly used immunomodulation agents pose potential hepatic toxicity,however no definitive evidence exist linking them to the development of hepatic steatosis,nor are there any data on the impact of therapy and prognosis in patient with co-existent diseases. Further studies are required to assess the impact and establish appropriate screening and management strategies in order to allow early identification,intervention and improve patient outcomes. 展开更多
关键词 Crohn’s DISEASE Non-alcoholic fatty liver DISEASE Non-alcoholic STEATOHEPATITIS ulcerative colitis Metabolic syndrome
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Disease monitoring strategies in inflammatory bowel diseases: What do we mean by “tight control”? 被引量:4
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作者 Lorant Gonczi talat bessissow Peter Laszlo Lakatos 《World Journal of Gastroenterology》 SCIE CAS 2019年第41期6172-6189,共18页
In recent years,there has been a critical change in treatment paradigms in inflammatory bowel diseases(IBD)triggered by the arrival of new effective treatments aiming to prevent disease progression,bowel damage and di... In recent years,there has been a critical change in treatment paradigms in inflammatory bowel diseases(IBD)triggered by the arrival of new effective treatments aiming to prevent disease progression,bowel damage and disability.The insufficiency of symptomatic disease control and the well-known discordance between symptoms and objective measures of disease activity lead to the need of reviewing conventional treatment algorithms and developing new concepts of optimal therapeutic strategy.The treat-to-target strategies,defined by the selecting therapeutic targets in inflammatory bowel disease consensus recommendation,move away from only symptomatic disease control and support targeting composite therapeutic endpoints(clinical and endoscopical remission)and timely assessment.Emerging data suggest that early therapy using a treat-to-target approach and an algorithmic therapy escalation using regular disease monitoring by clinical and biochemical markers(fecal calprotectin and C-reactive protein)leads to improved outcomes.This review aims to present the emerging strategies and supporting evidence in the current therapeutic paradigm of IBD including the concepts of“early intervention”,“treat-to-target”and“tight control”strategies.We also discuss the real-word experience and applicability of these new strategies and give an overview on the future perspectives and areas in need of further research and potential improvement regarding treatment targets and(“tight”)disease monitoring strategies. 展开更多
关键词 Crohn’s disease ULCERATIVE COLITIS Treat-to-target TIGHT control Monitorting BIOMARKER
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Positioning of old and new biologicals and small molecules in the treatment of inflammatory bowel diseases 被引量:3
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作者 Jason Reinglas Lorant Gonczi +2 位作者 Zsuzsanna Kurt talat bessissow Peter L Lakatos 《World Journal of Gastroenterology》 SCIE CAS 2018年第32期3567-3582,共16页
The past decade has brought substantial advances in the management of inflammatory bowel diseases(IBD). The introduction of tumor necrosis factor(TNF) antagonists, evidence for the value of combination therapy, the re... The past decade has brought substantial advances in the management of inflammatory bowel diseases(IBD). The introduction of tumor necrosis factor(TNF) antagonists, evidence for the value of combination therapy, the recog-nition of targeting lymphocyte trafficking and activation as a viable treatment, and the need for early treatment of high-risk patients are all fundamental concepts for current modern IBD treatment algorithms. In this article, authors review the existing data on approved biologicals and small molecules as well as provide insight on the current positioning of approved therapies. Patient stratification for the selection of specific therapies, therapeutic targets and patient monitoring will be discussed as well. The thera-peutic armamentarium for IBD is expanding as novel and more targeted therapies become available. In the absence of comparative trials, positioning these agents is becoming difficult. Emerging concepts for the future will include an emphasis on the development of algorithms which will facilitate a greater understanding of the positioning of novel biological drugs and small molecules in order to best tailor therapy to the patient. In the interim, anti-TNF therapy remains an important component of IBD therapy with the most real-life evidence and should be considered as first-line therapy in patients with complicated Crohn's disease and in acute-severe ulcerative colitis. The safety and efficacy of these ‘older' anti-TNF therapies can be optimized by adhering to therapeutic algorithms which combine clinical and objective markers of disease severityand response to therapy. 展开更多
关键词 Inflammatory BOWEL disease Small MOLECULE POSITIONING BIOLOGIC THERAPEUTIC
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Quality of care in inflammatory bowel diseases: What is the best way to better outcomes? 被引量:2
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作者 Matthew Strohl Lorant Gonczi +2 位作者 Zsuzsanna Kurt talat bessissow Peter L Lakatos 《World Journal of Gastroenterology》 SCIE CAS 2018年第22期2363-2372,共10页
Inflammatory bowel disease(IBD) is a lifelong, progres-sive disease that has disabling impacts on patient's lives. Given the complex nature of the diagnosis of IBD and its management there is consequently a large ... Inflammatory bowel disease(IBD) is a lifelong, progres-sive disease that has disabling impacts on patient's lives. Given the complex nature of the diagnosis of IBD and its management there is consequently a large economic burden seen across all health care systems. Quality in-dicators(QI) have been created to assess the different fa?ades of disease management including structure, process and outcome components. Their development serves to provide a means to target and measure quality of care(Qo C). Multiple different QI sets have been published in IBD, but all serve the same purpose of trying to achieve a standard of care that can be attained on a national and international level, since there is still a major variation in clinical practice. There have been many recent innovative developments that aim to improve Qo C in IBD including telemedicine, home biomarker assessment and rapid access clinics. These are some of the novel advancements that have been shown to have great potential at improving Qo C, while offloading some of the burden that IBD can have vis-a-vis emergency room visits and hospital admissions. The aim of the current review is to summarize and discuss available QI sets and recent developments in IBD care including telemedicine, and to give insight into how the utilization of these tools could benefit the Qo C of IBD patients. Additionally, a treating-to-target structure as well as evidence surrounding aggressive management directed at tighter disease control will be presented. 展开更多
关键词 INFLAMMATORY BOWEL disease TELEMEDICINE QUALITY INDICATORS QUALITY of care Treat-to-target
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Elderly patients with inflammatory bowel disease: Updated review of the therapeutic landscape 被引量:1
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作者 Jean-Frédéric LeBlanc Daniel Wiseman +1 位作者 Peter L Lakatos talat bessissow 《World Journal of Gastroenterology》 SCIE CAS 2019年第30期4158-4171,共14页
High-quality data remains scarce in terms of optimal management strategies in the elderly inflammatory bowel disease(IBD)population.Indeed,available trials have been mostly retrospective,of small sample size,likely ow... High-quality data remains scarce in terms of optimal management strategies in the elderly inflammatory bowel disease(IBD)population.Indeed,available trials have been mostly retrospective,of small sample size,likely owing to underrepresentation of such a population in the major randomized controlled trials.However,in the last five years,there has been a steady increase in the number of published trials,helping clarify the estimated benefits and toxicity of the existing IBD armamentarium.In the Everhov trial,prescription strategies were recorded over an average follow-up of 4.2 years.A minority of elderly IBD patients(1%-3%)were treated with biologics within the five years following diagnosis,whilst almost a quarter of these patients were receiving corticosteroid therapy at year five of follow-up,despite its multiple toxicities.The low use of biologic agents in real-life settings likely stems from limited data suggesting lower efficacy and higher toxicity.This minireview will aim to highlight current outcome measurements as it portends the elderly IBD patient,as well as summarize the available therapeutic strategies in view of a growing body of evidence. 展开更多
关键词 INFLAMMATORY BOWEL disease ELDERLY OUTCOMES GLUCOCORTICOIDS Biological therapy Surgery
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Effectiveness, safety, and drug sustainability of biologics in elderly patients with inflammatory bowel disease: A retrospective study 被引量:1
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作者 Gustavo Drugg Hahn Jean-Frederic LeBlanc +11 位作者 Petra Anna Golovics Panu Wetwittayakhlang Abdulrahman Qatomah Anna Wang Levon Boodaghians Jeremy Liu Chen Kiow Maryam Al Ali Gary Wild Waqqas Afif Alain Bitton Peter Laszlo Lakatos talat bessissow 《World Journal of Gastroenterology》 SCIE CAS 2022年第33期4823-4833,共11页
BACKGROUND Biologic therapy resulted in a significant positive impact on the management of inflammatory bowel disease(IBD) however data on the efficacy and side effects of these therapies in the elderly is scant.AIM T... BACKGROUND Biologic therapy resulted in a significant positive impact on the management of inflammatory bowel disease(IBD) however data on the efficacy and side effects of these therapies in the elderly is scant.AIM To evaluate retrospectively the drug sustainability, effectiveness, and safety of the biologic therapies in the elderly IBD population.METHODS Consecutive elderly(≥ 60 years old) IBD patients, treated with biologics [infliximab(IFX), adalimumab(ADAL), vedolizumab(VDZ), ustekinumab(UST)] followed at the McGill University Inflammatory Bowel Diseases Center were included between January 2000 and 2020.Efficacy was measured by clinical scores at 3, 6-9 and 12-18 mo after initiation of the biologic therapy. Patients completing induction therapy were included. Adverse events(AEs) or serious AE were collected during and within three months of stopping of the biologic therapy.RESULTS We identified a total of 147 elderly patients with IBD treated with biologicals during the study period, including 109 with Crohn’s disease and 38 with ulcerative colitis. Patients received the following biologicals: IFX(28.5%), ADAL(38.7%), VDZ(15.6%), UST(17%). The mean duration of biologic treatment was 157.5(SD = 148) wk. Parallel steroid therapy was given in 34% at baseline,19% at 3 mo, 16.3% at 6-9 mo and 6.5% at 12-18 mo. The remission rates at 3, 6-9 and 12-18 mo were not significantly different among biological therapies. Kaplan-Meyer analysis did not show statistical difference for drug sustainability(P = 0.195), time to adverse event(P = 0.158) or infection rates(P = 0.973) between the four biologics studied. The most common AEs that led to drug discontinuation were loss of response, infusion/injection reaction and infection.CONCLUSION Current biologics were not different regarding drug sustainability, effectiveness, and safety in the elderly IBD population. Therefore, we are not able to suggest a preferred sequencing order among biologicals. 展开更多
关键词 Inflammatory bowel disease BIOLOGICS ELDERLY Efficacy SAFETY Adverse events
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Therapeutic drug monitoring in inflammatory bowel disease:The dawn of reactive monitoring 被引量:1
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作者 Farah Albader Petra Anna Golovics +3 位作者 Lorant Gonczi talat bessissow Waqqas Afif Peter Laszlo Lakatos 《World Journal of Gastroenterology》 SCIE CAS 2021年第37期6231-6247,共17页
Inflammatory bowel disease(IBD)is a chronic condition that significantly affects the quality of life of its patients.Biologic drugs have been the mainstay treatment in the management of IBD patients but despite their ... Inflammatory bowel disease(IBD)is a chronic condition that significantly affects the quality of life of its patients.Biologic drugs have been the mainstay treatment in the management of IBD patients but despite their significant contribution,there remains a proportion of patients that do not respond or lose response to treatment.Therapeutic drug monitoring(TDM)involves measuring levels of serum drug concentrations and anti-drug antibodies.TDM of biologic drugs initially emerged to understand treatment failure in other immune mediated inflammatory diseases.This was then introduced in IBD to rationalize primary non-response or secondary loss of response,given that low serum drug concentrations or the formation of anti-drug antibodies are variably associated with treatment failure.The aim of this narrative review is to provide an overview regarding the current use of TDM in clinical practice and to present the evidence available regarding its use in both proactive and reactive clinical settings in preventing and managing treatment failure.This review also presents the existing evidence regarding the association of various clinical outcomes with specific thresholds of drug concentrations,in everyday practice.A narrative review of published articles and conference abstracts regarding the use of TDM in IBD management,through an electronic search using PubMed and ScienceDirect.TDM has proven to be superior and more cost effective in guiding management of patients with treatment failure compared to empiric dose escalation or change in treatment.Despite a trend towards an association between clinical outcomes and drug concentrations,proactive TDM based strategies have not been shown to achieve clear benefit in long-term outcomes.In the clinical setting,TDM has proven to be useful in managing IBD patients,and its use in the reactive setting,as an additional tool to help manage patients with treatment failure,is being promoted as newer guidelines and consensus groups implement TDM as part of the management plan. 展开更多
关键词 Therapeutic drug monitoring Inflammatory bowel disease Biologic therapies Loss of response REACTIVE PROACTIVE
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Benefits of implementing a rapid access clinic in a high-volume inflammatory bowel disease center:Access, resource utilization and outcomes 被引量:1
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作者 Sofia Nene Lorant Gonczi +11 位作者 Zsuzsanna Kurti Isabelle Morin Kelly Chavez Christine Verdon Jason Reinglas Rita Kohen talat bessissow Waqqas Afif Gary Wild Ernest Seidman Alain Bitton Peter Laszlo Lakatos 《World Journal of Gastroenterology》 SCIE CAS 2020年第7期759-769,共11页
BACKGROUND Emergency situations in inflammatory bowel diseases(IBD)put significant burden on both the patient and the healthcare system.AIM To prospectively measure Quality-of-Care indicators and resource utilization ... BACKGROUND Emergency situations in inflammatory bowel diseases(IBD)put significant burden on both the patient and the healthcare system.AIM To prospectively measure Quality-of-Care indicators and resource utilization after the implementation of the new rapid access clinic service(RAC)at a tertiary IBD center.METHODS Patient access,resource utilization and outcome parameters were collected from consecutive patients contacting the RAC between July 2017 and March 2019 in this observational study.For comparing resource utilization and healthcare costs,emergency department(ED)visits of IBD patients with no access to RAC services were evaluated between January 2018 and January 2019.Time to appointment,diagnostic methods,change in medical therapy,unplanned ED visits,hospitalizations and surgical admissions were calculated and compared.RESULTS 488 patients(Crohn’s disease:68.4%/ulcerative colitis:31.6%)contacted the RAC with a valid medical reason.Median time to visit with an IBD specialist following the index contact was 2 d.Patients had objective clinical and laboratory assessment(C-reactive protein and fecal calprotectin in 91%and 73%).Fast-track colonoscopy/sigmoidoscopy was performed in 24.6%of the patients,while computed tomography/magnetic resonance imaging in only 8.1%.Medical therapy was changed in 54.4%.ED visits within 30 d following the RAC visit occurred in 8.8%(unplanned ED visit rate:5.9%).Diagnostic procedures and resource utilization at the ED(n=135 patients)were substantially different compared to RAC users:Abdominal computed tomography was more frequent(65.7%,P<0.001),coupled with multiple specialist consults,more frequent hospital admission(P<0.001),higher steroid initiation(P<0.001).Average medical cost estimates of diagnostic procedures and services per patient was$403 CAD vs$1885 CAD comparing all RAC and ED visits.CONCLUSION Implementation of a RAC improved patient care by facilitating easier access to IBD specific medical care,optimized resource utilization and helped avoiding ED visits and subsequent hospitalizations. 展开更多
关键词 Crohn’s disease Ulcerative colitis Rapid access Quality-of-care Emergency department
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Transition care in inflammatory bowel disease: A needs assessment survey of Quebec gastroenterologists and allied nurses 被引量:1
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作者 Matthew Strohl Xun Zhang +1 位作者 Dominique Lévesque talat bessissow 《World Journal of Gastrointestinal Pharmacology and Therapeutics》 CAS 2017年第3期186-192,共7页
AIM To determine the tools needed and problems encountered during the transition of inflammatory bowel disease(IBD) patients from pediatric to adult gastroenterologists(GIs) in Québec, Canada.METHODS We conducted... AIM To determine the tools needed and problems encountered during the transition of inflammatory bowel disease(IBD) patients from pediatric to adult gastroenterologists(GIs) in Québec, Canada.METHODS We conducted a needs assessment survey of Quebec health care professionals(HCPs). The survey was handed out to 136 Québec HCPs at a local conference in 2013. Additionally, it was emailed to any other HCPs in Quebec involved in caring for IBD patients. The completed surveys were compiled to derive descriptive data. Further specific subgroup analysis was then conducted. RESULTS Among the conference attendees and individuals emailed 77(28.2%) completed the questionnaire. Respondents included adult GIs(61.3%), pediatric GIs(20.8%) and IBD nurses(18.3%). The majority of respondents believed that a standardized structure is important for a successful transition. Adult and pediatric GIs equally felt that patients were inadequately prepared for the transition(P = 0.6). There were significant differences between adult and pediatric GIs when it came to resource availability(55.6% vs 90.9%, P = 0.002) and perceived need of a formal transition clinic(21.7% vs 68.8%, P = 0.0006). Both transition program and medical summaries were identified as the most valuable tools to improve transition. CONCLUSION As described in previous studies, our survey reinforces the importance of a transition program, education for young adult IBD patients and the need to improve communication between adult and pediatric GIs. 展开更多
关键词 煽动性的肠疾病 转变 儿科学 加拿大 工具 护理专业人员
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Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study
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作者 talat bessissow Geoffrey C Nguyen +4 位作者 Osman Tarabain Laurent Peyrin-Biroulet Nathalie Foucault Kevin McHugh Joannie Ruel 《World Journal of Gastroenterology》 SCIE CAS 2022年第34期5058-5075,共18页
BACKGROUND A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis(UC)patients treated in a real-world setting.The use of patient-reported outcomes(PROs)ha... BACKGROUND A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis(UC)patients treated in a real-world setting.The use of patient-reported outcomes(PROs)has been discussed as a primary endpoint in the context of the FDA PRO Guidance,for labelling purposes.Specifically,the efficacy and safety of adalimumab have been demonstrated in pivotal trials;however,data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients,such as symptoms,health-related quality of life(HRQoL),and disability.AIM To assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC.METHODS UCanADA was a single arm,prospective,1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed—with psychologic distress/depression symptoms as the primary endpoint—by patients with moderate-to-severe UC.Assessments were performed during patients’routine care visit schedule,which was at the initiation of adalimumab(baseline),after induction(approximately 8 wk),and 52 wk after baseline.Additional optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this period.Serious safety events and per-protocol adverse events were collected.RESULTS From 23 Canadian centres,100 patients were enrolled and 48 completed the study.Measured with the Patient Health Questionnaire–9 items at week 52,61.5%(40/65)[95%confidence interval(CI):49.7%-73.4%]of the patients improved in psychologic distress/depression symptoms,which was slightly higher in completers[65.9%(29/44);95%CI:51.9%-79.9%].At week 52,clinical response and clinical remission were achieved respectively by 65.7%(44/73)and 47.8%(32/73)of the patients.The odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinical remission(CI:1.42,44.41;P=0.018).Significant changes from baseline to weeks 8 and 52 were observed in disability,HRQoL,and fatigue.Meaningful improvement was reported in work impairment.CONCLUSION At week 52,over 60%of the UCanADA patients had depressive symptoms significantly reduced,as well as HRQoL,fatigue symptoms,and work impairment improved.No new safety signals were detected. 展开更多
关键词 Disease burden Patient-reported outcome Depressive symptoms Ulcerative colitis ADALIMUMAB Real-world data
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