Multi-dimensional patient-reported outcomes and quality of life at diagnosis of IBD: A population-based inception cohort study.

BACKGROUND AND AIMS: Patient-reported outcomes (PROs) are pivotal in assessing treatment efficacy and estimating the burden of inflammatory bowel diseases (IBD). We investigated PROs at the time of IBD diagnosis. METHODS: The Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD-Disability Index (IBD-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and disease activity-related PROs were assessed in the Copenhagen IBD Inception Cohort, a prospective, population-based cohort of patients newly diagnosed with IBD between May 2021 and May 2023. RESULTS: A total of 203 UC and 116 CD patients were recruited. At diagnosis, 160 (78.8%) and 99 (85.3%) patients with UC and CD, respectively, reported moderate-to-severe impairment in at least one PRO (p=0.18), with 89 (43.8%) and 74 (63.8%), respectively, reporting moderate-to-severe impairment in at least two PROs (p<0.01). Being female, the disease extent of UC, and extraintestinal manifestations were associated with impaired PROs. There were no differences found according to CD phenotype. FACIT-F, IBD-DI, and SIBDQ scores showed weak, but significant, correlations with the Mayo Endoscopic Score in UC, and the FACIT-F score with C-reactive protein (CRP). In CD, SIBDQ, IBD-DI, and FACIT-F correlated moderately with CRP and fecal calprotectin, but not with the endoscopic severity of CD. None of the PROs correlated with iron, ferritin, or vitamin D levels. Among the most prevalent symptoms reported were fatigue, abdominal pain, urgency, and passing of blood in both CD and UC. CONCLUSION: We found a substantial patient-reported disease burden in newly diagnosed IBD, underscoring the importance of vigilant PRO monitoring in clinical practice. FUNDING: This study was funded by an unrestricted grant from the Novo Nordisk Fonden.

Classifying Inflammation on Intestinal Ultrasound Images and Cineloops - A Learning Curve Study.

BACKGROUND AND AIMS: Intestinal ultrasound has become a crucial tool for assessing inflammation in patients with inflammatory bowel disease, prompting a surge in demand for trained sonographers. While educational programs exist, the length of training needed to reach proficiency in correctly classifying inflammation remains unclear. Our study addresses this gap partly by exploring the learning curves associated with the deliberate practice of sonographic disease assessment, focusing on the key disease activity parameters of bowel wall thickness, bowel wall stratification, color Doppler signal, and inflammatory fat. METHODS: Twenty-one novices and six certified intestinal ultrasound practitioners engaged in an 80-case deliberate practice online training program. A panel of three experts independently graded ultrasound images representing various degrees of disease activity and agreed upon a consensus score. We used statistical analyses, including mixed-effects regression models, to evaluate learning trajectories. Pass/fail thresholds distinguishing novices from certified practitioners were determined through contrasting-groups analyses. RESULTS: Novices showed significant improvement in interpreting bowel wall thickness, surpassing the pass/fail threshold, and reached mastery level by case 80. For color Doppler signal and inflammatory fat, novices surpassed the pass/fail threshold but did not achieve mastery. Novices did not improve in assessing bowel wall stratification. CONCLUSIONS: We found considerable individual and group-level differences in learning curves supporting the concept of competency-based training for assessing bowel wall thickness, color Doppler signal and inflammatory fat. However, despite practice over 80 cases, novices did not improve in their interpretation of bowel wall stratification, suggesting that a different approach is needed for this parameter.

The Impact of Periodontitis on Inflammatory Bowel Disease Activity.

BACKGROUND: Inflammatory bowel disease (IBD) and periodontitis are chronic, progressive, inflammatory diseases with similarly complex pathogeneses that involve an interplay between dysbiotic microbiota and dysregulated immune-inflammatory responses. However, whether the presence of periodontitis is associated with IBD activity and/or its severity remains unknown. METHODS: An online, questionnaire-based study was answered by 1093 patients with IBD, comprising 527 patients with Crohn's disease and 566 patients with ulcerative colitis. The survey included questions on social demographics; oral health, including the Periodontal Screening Score (PESS); and IBD-related characteristics, including validated disease indices. RESULTS: Irrespective of disease subtype, patients with a reduced number of teeth and those with self-reported severe periodontitis scored significantly higher on the IBD disability index (number of teeth: coefficient, 4.93 [95% confidence interval {CI}, 1.21-8.66; P = .010]; periodontitis: coefficient, 3.54 [95% CI, 0.27-6.80; P = .034]) and reported increased disease activity in the preceding 12 months (number of teeth: odds ratio [OR], 1.91 [95% CI, 1.36-2.69; P < .001]; periodontitis: OR, 1.71 [95% CI, 1.27-2.31; P < .001]). There was also evidence of a weak association between self-reported severe periodontitis and current disease activity (OR, 1.33; 95% CI, 0.95-1.86; P = .099). However, IBD severity, as a composite parameter of a history of surgery due to IBD and/or treatment with biological therapy, was not associated with possessing a reduced number of teeth (OR, 1.18; 95% CI, 0.77-1.80; P = .451), nor with self-reported severe periodontitis (OR, 1.15; 95% CI, 0.79-1.66; P = .467). CONCLUSIONS: Periodontitis and tooth loss were significantly associated with increased IBD-related disability and more disease activity in the preceding 12 months. Our results suggest that greater attention should be paid to IBD patients' oral health.

In this questionnaire-based study among 1093 patients with inflammatory bowel disease (IBD), we demonstrated a significant association between the presence of periodontitis and more IBD disease activity in the last 12 months, as well as increased IBD disability.

Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease - a systematic review with meta-analysis.

BACKGROUND: The efficacy and safety of vedolizumab in bio-naïve patients with ulcerative colitis (UC) and Crohn's disease (CD) remain unknown. AIMS: To perform a meta-analysis regarding vedolizumab as first line of biological therapy for UC or CD. METHODS: A systematic review of Medline, EMBASE, and Cochrane databases per December 2020 was undertaken. Meta-analysis was conducted using random-effects models. RESULTS: This systematic review identified 79 eligible studies with 4,520 and 3,494 bio-naïve patients with UC and CD, respectively, and 8,105 and 11,140 bio-exposed patients. Among bio-naïve patients with UC, a total of 40.0% (95%CI 27.0-54.0, I2=86%) and 63.9% (95%CI 47.0-79.2, I2=36%) achieved clinical remission at weeks 14 and 52, respectively. The corresponding rates in CD were 54.0% (95%CI 42.0-66.0, I2=23%), and 61.7% (95%CI 55.2-68.1, I2=0%). Bio-naïvety was associated with a higher probability of clinical remission at week 52 in UC (relative risk (RR)=1.32 (95%CI 1.14-1.53)), while this was only apparent until week 26 in CD (RR=1.60 (95%CI 1.30-1.95)). Finally, bio-naïve UC patients had a lower risk of serious adverse events (RR=0.29 (95%CI 0.09-0.95)). CONCLUSION: Vedolizumab was found to have a favorable efficacy and safety profile in bio-naïve patients with UC and CD. The findings have implications in the management of IBD.

The knowledge and skills needed to perform intestinal ultrasound for inflammatory bowel diseases-an international Delphi consensus survey.

BACKGROUND: Intestinal ultrasound (IUS) is a non-invasive modality for monitoring disease activity in inflammatory bowel diseases (IBD). IUS training currently lacks well-defined standards and international consensus on competency criteria. AIM: To achieve international consensus on what competencies should be expected from a newly certified IUS practitioner. METHODS: A three-round, iterative Delphi process was conducted among 54 IUS experts from 17 countries. Round 1 was a brainstorming phase with an open-ended question to identify the knowledge and skills that experts believe a newly certified IUS practitioner should possess. The experts' suggestions were then organised into statements by a Steering Committee. In round 2, the experts commented upon and rated the statements, which were revised accordingly. In round 3, the experts rated the revised statements. Statements meeting the pre-defined consensus criterion of at least 70% agreement were included in the final list of statements. RESULTS: In total, 858 items were suggested by the experts in the first round. Based on these suggestions, 55 statements were organised into three categories: knowledge, technical skills and interpretation skills. After the second round, 53 revised statements remained. After the final round, a total of 41 statements had achieved consensus. CONCLUSIONS: We established international, expert consensus on the knowledge and skills that should be expected from newly certified IUS practitioners. These consensus statements are the first step towards mastery learning for IUS training. Educators can utilise these statements to design training programmes and evaluate the competencies of trainees before they engage in independent practice.

Implementation and Short-term Adverse Events of Anti-SARS-CoV-2 Vaccines in Inflammatory Bowel Disease Patients: An International Web-based Survey.

INTRODUCTION: Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients' concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data. METHODS: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed. RESULTS: In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p < 0.001]. Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination. CONCLUSIONS: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.

Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study.

INTRODUCTION: Inflammatory bowel diseases (IBD), encompassing Crohn's disease and ulcerative colitis, are chronic, inflammatory diseases of the gastrointestinal tract. We have initiated a Danish population-based inception cohort study aiming to investigate the underlying mechanisms for the heterogeneous course of IBD, including need for, and response to, treatment. METHODS AND ANALYSIS: IBD Prognosis Study is a prospective, population-based inception cohort study of unselected, newly diagnosed adult, adolescent and paediatric patients with IBD within the uptake area of Hvidovre University Hospital and Herlev University Hospital, Denmark, which covers approximately 1 050 000 inhabitants (~20% of the Danish population). The diagnosis of IBD will be according to the Porto diagnostic criteria in paediatric and adolescent patients or the Copenhagen diagnostic criteria in adult patients. All patients will be followed prospectively with regular clinical examinations including ileocolonoscopies, MRI of the small intestine, validated patient-reported measures and objective examinations with intestinal ultrasound. In addition, intestinal biopsies from ileocolonoscopies, stool, rectal swabs, saliva samples, swabs of the oral cavity and blood samples will be collected systematically for the analysis of biomarkers, microbiome and genetic profiles. Environmental factors and quality of life will be assessed using questionnaires and, when available, automatic registration of purchase data. The occurrence and course of extraintestinal manifestations will be evaluated by rheumatologists, dermatologists and dentists, and assessed by MR cholangiopancreatography, MR of the spine and sacroiliac joints, ultrasonography of peripheral joints and entheses, clinical oral examination, as well as panoramic radiograph of the jaws. Fibroscans and dual-energy X-ray absorptiometry scans will be performed to monitor occurrence and course of chronic liver diseases, osteopenia and osteoporosis. ETHICS AND DISSEMINATION: This study has been approved by Ethics Committee of the Capital Region of Denmark (approval number: H-20065831). Study results will be disseminated through publication in international scientific journals and presentation at (inter)national conferences.

NBOMe hallucinogenic drug exposures reported to the Danish Poison Information Centre.

INTRODUCTION: N-benzylmethoxy (NBOMe) is a new class of hallucinogenic designer drugs sold on cheap blotter papers. They are potent 5-hydroxytryptamine-2A-receptor agonists, and since their recent entry into the drug market there have been worldwide reports of severe intoxications and even fatalities. This study reviews suspected NBOMe drug exposures reported to the Danish Poison Information Centre (DPIC). METHODS: Data from the DPIC database were extracted, including all enquiries with NBOMe exposures reported from 1 January 2013 to 30 June 2016. The following data were extracted: age, sex, date of exposure, risk assessment, co-exposures, geography and reported symptoms. RESULTS: A total of 43 cases were identified: one in 2013, five in 2014, 32 in 2015 and five in the first six months of 2016. The mean patient age was 21 years (range: 15-34 years) with 32 (74%) male and 11 (26%) female patients. The patients most frequently presented with hallucinations/psychosis (n = 18), tachycardia (n = 18) and agitation (n = 15). A total of 16 patients were admitted with co-exposures to other drugs such as alcohol (n = 9), cannabis (n = 7), amphetamine (n = 5) cocaine (n = 3), benzodiazepines (n = 1) and 3,4-methylenedioxymethamphetamine (n = 1). The cases were distributed evenly across the entire country with only ten cases having a postal address in one of the three major cities of Denmark. CONCLUSIONS: This study has shown a steep and sudden rise in reported NBOMe exposures in Denmark within 3-4 years. Geographical data demonstrate an even distribution throughout the country. However, our results also suggest that the use has started to decline. FUNDING: none. TRIAL REGISTRATION: This study was approved by the Danish Data Protection Agency. (BFH-2016-070/04985).