Inflammatory Bowel Disease-related Behaviours [IBD-Bx] Questionnaire: Development, Validation and Prospective Associations with Fatigue.

BACKGROUND AND AIMS: Disease-related behaviours that may maintain or worsen symptom burden remain largely unexplored in inflammatory bowel disease [IBD]. In this study, we developed and validated an instrument assessing IBD-related, modifiable behaviours and explored which behaviours prospectively correlate with fatigue, a debilitating and common symptom in IBD. METHODS: Initially, 72 items reflecting IBD-related behaviours were generated based on literature review and input from clinicians and people diagnosed with IBD. During wave 1, 495 IBD patients rated to what extent each behaviour was applicable to them. Additionally, disease activity, fatigue, IBD-related concerns and psychological variables were assessed. During a follow-up visit 4-12 weeks later [wave 2], a random selection of 92 patients from wave 1 completed the measures assessing the IBD-related behaviours, disease activity and fatigue once more. RESULTS: A principal component analysis with oblique rotation revealed seven components in the 72 IBD behaviours, which could be interpreted as: [1] Avoiding food and activities, [2] Access to toilets, [3] Avoidance of sex, [4] Cognitive avoidance, [5] Not sharing with others, [6] Alternative treatments and [7] Disease management. Each component was reduced to three to five representative items, resulting in a final, 25-item IBD-Bx questionnaire showing good concurrent validity [alphas > 0.63] and reliability. Almost all components were cross-sectionally related to levels of fatigue. Avoiding food and activities and Access to toilets significantly predicted fatigue at wave 2 when controlling for baseline fatigue. CONCLUSIONS: The IBD-Bx is a valid and reliable questionnaire of IBD-related behaviours, some of which predict future fatigue burden.

Kinetics of peripheral blood neutrophils in severe coronavirus disease 2019.

OBJECTIVES: Emerging evidence of dysregulation of the myeloid cell compartment urges investigations on neutrophil characteristics in coronavirus disease 2019 (COVID-19). We isolated neutrophils from the blood of COVID-19 patients receiving general ward care and from patients hospitalised at intensive care units (ICUs) to explore the kinetics of circulating neutrophils and factors important for neutrophil migration and activation. METHODS: Multicolour flow cytometry was exploited for the analysis of neutrophil differentiation and activation markers. Multiplex and ELISA technologies were used for the quantification of protease, protease inhibitor, chemokine and cytokine concentrations in plasma. Neutrophil polarisation responses were evaluated microscopically. Gelatinolytic and metalloproteinase activity in plasma was determined using a fluorogenic substrate. Co-culturing healthy donor neutrophils with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) allowed us to investigate viral replication in neutrophils. RESULTS: Upon ICU admission, patients displayed high plasma concentrations of granulocyte-colony-stimulating factor (G-CSF) and the chemokine CXCL8, accompanied by emergency myelopoiesis as illustrated by high levels of circulating CD10-, immature neutrophils with reduced CXCR2 and C5aR expression. Neutrophil elastase and non-metalloproteinase-derived gelatinolytic activity were increased in plasma from ICU patients. Significantly higher levels of circulating tissue inhibitor of metalloproteinase 1 (TIMP-1) in patients at ICU admission yielded decreased total MMP proteolytic activity in blood. COVID-19 neutrophils were hyper-responsive to CXCL8 and CXCL12 in shape change assays. Finally, SARS-CoV-2 failed to replicate inside human neutrophils. CONCLUSION: Our study provides detailed insights into the kinetics of neutrophil phenotype and function in severe COVID-19 patients, and supports the concept of an increased neutrophil activation state in the circulation.

Worries and concerns of inflammatory bowel disease (IBD) patients in Belgium - a validation of the Dutch rating form.

OBJECTIVES: Worry is the most common psychological complaint among patients with Inflammatory Bowel Disease (IBD). This study aimed to translate and test the psychometric properties the Rating Form of IBD Patient Concerns (RFIPC) among Dutch-speaking patients with IBD in Belgium. It also aimed to describe worries and concerns, and to examine possible differences in worry patterns between patients with different disease types and disease activities. METHODS: The RFIPC was translated into Dutch following the guidelines of the Rome Foundation and was completed by patients with Crohn's disease (CD, n = 336) and ulcerative colitis (UC, n = 160). To test concurrent validity, the Depression Anxiety Stress Scales (DASS-21) were used. Factor structure was examined with confirmatory factor analysis. RESULTS: The four-factor structure including subscales 'impact of the disease', 'sexual intimacy', 'complications of the disease' and 'body stigma' was confirmed in the Dutch sample. All factors had high internal consistency (>.70). Correlations with DASS-21 suggest good concurrent validity, all rs>.30, ps<.001. No differences in the RFIPC scores were observed between patients with CD and UC. Patients with active disease (53%) had higher scores than patients in remission (47%). Across all groups, the order of top concerns was consistent and included worries about energy level, side effects of medication, having an ostomy bag/surgery, and uncertain nature of the disease. CONCLUSIONS: The Dutch version of the RFIPC is a valid and reliable measure of IBD-specific worries and concerns which can be used in both research and clinical settings.

Development and feasibility of a telemonitoring tool with full integration in the electronic medical record: a proof of concept study for patients with inflammatory bowel disease in remission on biological therapy.

Objectives: Telemonitoring can be implemented to enhance disease monitoring and ultimately reduce the number of outpatient visits and associated costs. We developed an in house IBD mobile app and established a proof of concept study to demonstrate the effectiveness and accuracy of the telemonitoring tool for monitoring of disease activity.Methods: An IBD mobile app was designed through close collaboration between the Information Technology and Gastroenterology department of University Hospitals of Leuven. The study was proposed to all patients in remission under stable biological therapy visiting the outpatient clinic. During one-year follow-up, patients completed weekly and monthly questionnaires on their mobile device or on a website. Entered data were directly sent to the electronic medical record. Predefined red flags or alerts, generated by the answers to the questionnaires, were monitored daily.Results: The pilot study in 45 patients demonstrated accurate monitoring of disease activity with fast intervention during flares. During the 12-months follow-up period, an alert for disease activity was generated for 9 different patients out of 1296 completions of the questionnaire. Symptoms resolved spontaneously in 8 patients. One patient reported consecutive PRO-2 increase, endoscopy confirmed an IBD flare and therapy was switched. For the remaining 36 included patients, no alerts indicating disease activity increase were reported. Median compliance to all weekly and monthly questionnaires during 1 year was 52% (IQR: 24-91).Conclusions: We developed the mynexuzhealth IBD app with full integration in the electronic medical record. The app enabled continuous remote monitoring and showed accurate detection of flares.

Quality of Care Standards in Inflammatory Bowel Diseases: a European Crohn's and Colitis Organisation [ECCO] Position Paper.

The management of inflammatory bowel disease [IBD] is complex, and requires tight control of disease activity, close monitoring to avoid treatment side effects, health care professionals with expertise in IBD, and an interdisciplinary, holistic approach. Despite various efforts to standardise structures, processes, and outcomes,1-8 and due to the high variability at the local, national, and international levels, there are still no clear definitions or outcome measures available to establish quality of care standards for IBD patients which are applicable in all contexts and all countries. For this reason, the European Crohn's and Colitis Organisation [ECCO] supported the construction of a list of criteria summarising current standards of care in IBD. The list comprises 111 quality standard points grouped into three main domains [structure n = 31, process n = 42, outcomes n = 38] and is based on scientific evidence, interdisciplinary expert consensus, and patient-oriented perspectives. The list of proposed criteria is intended to represent the position of ECCO regarding the optimum quality of care that should be available to patients. Since health care systems and regulations vary considerably between countries, this list may require adaptation at local and national levels. It is recognised that not all these criteria that have been identified as optimal will be available in every unit. However, ECCO will continue its efforts to develop and coordinate projects and initiatives that will help to guarantee optimal quality of care for all IBD patients.

Short Health Scale: a valid and reliable measure of quality of life in Dutch speaking patients with inflammatory bowel disease.

Objectives: Patient reported outcomes are widely used in today's clinical practice. The Short Health Scale has been proven to be an easy-to-use and reliable measure to evaluate quality of life in patients with inflammatory bowel disease. We aimed to validate this Short Health Scale in Dutch speaking patients. Methods: A total of 157 Crohn's disease and ulcerative colitis patients (46% male, median age 39 years) completed the Short Health Scale on a tablet during the outpatient clinic. Validity was assessed by correlating both individual and total Short Health Scale scores with short Inflammatory Bowel Disease Questionnaire dimensions and clinical disease activity. Test-retest reliability was assessed in eight patients in stable remission who completed the Short Health Scale a second time after 4-8 weeks. Results: All Short Health Scale items correlated with corresponding short Inflammatory Bowel Disease Questionnaire dimensions (correlation coefficients ranging from -0.403 to -0.833, all p < .01). Short Health Scale scores increased stepwise with increasing clinical disease activity (all p < .001). The results of the Short Health Scale questionnaire remained stable on repeated measurements in patients in remission (rs between 0.699 and 0.994, all p < .01 except for well-being). Conclusions: The Short health Scale is a rapid and valid instrument for measuring quality of life in Dutch speaking patients with Inflammatory Bowel Disease. Its simplicity and usability make it a good candidate for routine care and suitable for home-monitoring of patients.

'Quality of Care' Standards in Inflammatory Bowel Disease: A Systematic Review.

BACKGROUND: Inflammatory bowel disease [IBD] includes chronic, disabling and progressive conditions that need a complex approach and management. Although several attempts have been made to standardize the care of IBD patients, no clear definitions of a global 'standard of care' are currently available. METHODS: We performed a systematic review of the available literature, searching for all relevant data concerning three main domains of standards of quality of care in IBD patients: structure, process and outcomes. From the literature search, 2394 abstracts were retrieved, and 62 relevant papers were included in the final review. RESULTS: Standards of quality of care in IBD include several aspects that can be summarized in three identified domains: structure, process and outcomes. The suggested structure of an IBD Unit includes a multi-disciplinary approach, effective referral processes, improved access using helplines, and departmental guidelines/pathways with identification of measurable quality indicators. Coordinated care models which incorporate a multi-disciplinary approach, structured clinical pathways or processes for the diagnosis, monitoring and treatment of IBD, fast-track recovery from IBD surgery, designated IBD clinics, virtual clinics and telemanagement are currently considered the main standards for process, although supporting data are limited. Several consensus statements on outcomes and quality indicators have been reported, focusing on outcomes in symptoms, function and quality of life restoration, survival and disease control, in addition to effective healthcare utilization. CONCLUSIONS: The results of this systematic review can provide the basis for general recommendations for standards of quality of care in IBD.

Investing in workability of patients with inflammatory bowel disease: results of a pilot project Activ84worK (Activate for work).

OBJECTIVES: Inflammatory bowel diseases (IBD) are chronic gastrointestinal conditions mainly affecting young people. Disease symptoms often make it difficult to actively participate in the workplace. The aim of Activ84worK was to stimulate professional activity and reduce absenteeism by removing work-related stress factors and providing patients with more flexible working conditions. PATIENTS AND METHODS: Activ84worK was a collaboration between Abbvie, Mensura, Proximus, SD Worx, and University Hospitals Leuven (UZ Leuven) with the support of the patient association 'Crohn-en Colitis Ulcerosa Vereniging (CCV vzw)' in Flanders, Belgium. Since March 2015, IBD patients whose employer was also willing to participate, were recruited. Informed consent was signed and both the employee and the employer were followed for 6 months. RESULTS: Between March 2015 and October 2016, 70 patients showed interest in the Activ84worK program, 18 were eligible to participate, and 14 completed the program (29% male, 29% private companies). The case studies, based on interviews conducted with participating employees, indicated that removing work-related stress factors resulted in employees feeling much more at ease. Concretely, this led to absence of sick leave for more than 50% of the included patients. A higher degree of workability and focus of employees was achieved, and a decrease in costs of absenteeism was associated with this. CONCLUSION: This pilot project shows that teleworking and flexible working conditions improve labor participation of IBD patients. The results of this project are now used to inspire policy-makers and employers. This initiative should be extended to a larger cohort and tested in other chronic diseases.

Effects of Education and Information on Vaccination Behavior in Patients with Inflammatory Bowel Disease.

BACKGROUND: Despite the existence of international guidelines, vaccination in patients with inflammatory bowel disease (IBD) has not been integrated optimally. We developed a thorough education program, and compared its influence on vaccination rates with routine clinical practice in a tertiary IBD center. METHODS: Between December 2014 and March 2015, we included 505 consecutive patients with IBD visiting our outpatient clinic (53% men, 72% Crohn's disease, median age 44 years). Vaccination data, including hepatitis B, influenza, pneumococcus, tetanus, and varicella zoster virus, as well as demographic data, were collected by a fellow in training or a certified gastroenterologist. Thereafter, patients were randomly assigned to group A receiving routine clinical practice or intervention group B receiving additional education by the IBD nurse with help of an information brochure and vaccination card. Vaccination status was reassessed 8 months later. RESULTS: At baseline, 32% of patients were vaccinated according to the guidelines. The remaining 346 patients were randomized to group A (n = 206) or intervention group B (n = 140). Eight months after randomization, 33% of intervention group B versus 6% of group A followed vaccination recommendations and differences were significant for each vaccine (all P < 0.001). A higher educational level was independently associated with better compliance to pneumococcal vaccination (P = 0.008) and to the guidelines overall (P < 0.001). However, the educational intervention was the only consistent factor independently associated with improved compliance to each individual vaccination recommendation (all P ≤ 0.023). CONCLUSIONS: Introduction of thorough vaccination education significantly increased compliance to vaccination guidelines. However, further education of patients and health care providers remains necessary.

Effects of introduction of an inflammatory bowel disease nurse position on the quality of delivered care.

BACKGROUND AND AIMS: Inflammatory bowel diseases (IBDs) are chronic gastrointestinal conditions requiring long-term outpatient follow-up, ideally by a dedicated, multidisciplinary team. In this team, the IBD nurse is the key point of access for education, advice, and support. We investigated the effect of the introduction of an IBD nurse on the quality of care delivered. METHODS: In September 2014, an IBD nurse position was instituted in our tertiary referral center. All contacts and outcomes were prospectively recorded over a 12-month period using a logbook kept by the nurse. RESULTS: Between September 2014 and August 2015, 1313 patient contacts were recorded (42% men, median age: 38 years, 72% Crohn's disease, 83% on immunosuppressive therapy). The contacts increased with time: Q1 (September-November 2014): 144, Q2: 322, Q3: 477, and Q4: 370. Most of the contacts were assigned to scheduling of follow-up (316/1420), start of new therapy (173/1420), therapy follow-up (313/1420), and providing disease information (227/1420). In addition, 134 patients contacted the IBD nurse for flare management and a smaller number for administrative support, psychosocial support, and questions about side effects. During the study period, 30 emergency room and 133 unscheduled outpatient visits could be avoided through the intervention of the IBD nurse. A faster access to procedures and other departments could be provided for 136 patients. CONCLUSION: The role of IBD nurses as the first point of contact and counseling is evident from a high volume of nurse-patient interactions. Avoidance of emergency room and unscheduled clinic visits are associated with these contacts.

Identifying predictors of low adherence in patients with inflammatory bowel disease.

BACKGROUND AND AIM: Inflammatory bowel diseases (IBDs) are chronic gastrointestinal conditions requiring medical therapy to maintain clinical remission. Low adherence to therapy leads to poorer disease outcome. Therefore, we aimed to identify predictors of low adherence in the Belgian IBD population. PATIENTS AND METHODS: Between November 2013 and March 2014, 570 ambulatory patients (471 patients with IBD and 99 non-IBD controls) visiting a tertiary IBD-referral centre were requested to complete the Morisky 8-Item Medication Adherence Scale (MMAS-8) questionnaire as well as a survey of sociodemographic data (smoking, educational level, marital status and occupation). On the basis of the self-reported MMAS questionnaire, adherence was categorized as low (MMAS-8 score: >2), medium (MMAS-8 score: 1-2) or high (MMAS-8 score: 0). RESULTS: The response rate in the IBD population was as high as 99%. Low adherence was reported less frequently in the IBD population than in the non-IBD controls (36 vs. 49%, P=0.021). In multivariate analysis, factors associated independently with low adherence in the IBD population were age younger than 40 [odds ratio: 1.589 (95% confidence interval: 1.057-2.389), P=0.026], higher educational level [1.961 (1.305-2.946), P=0.001], being single [1.641 (1.020-2.639), P=0.041] and the use of mesalamine [1.591 (1.018-2.487), P=0.041]. Self-employment was identified as a protective factor for low adherence [0.397 (0.167-0.946), P=0.041]. CONCLUSION: Approximately one-third of the IBD patients were low adherers. Predictors of low adherence were aged younger than 40 years, higher educational level, being single and mesalamine use, whereas being self-employed was a protective factor. On the basis of these data, personalized algorithms may be developed to improve patient education, empowerment and follow-up.