Search

Background and Aims: Standardising health outcome measurements supports delivery of care and enables data-driven learning systems and secondary data use for research. As part of the Health Outcomes Observatory [H2O] initiative, and building on existing knowledge, a core outcome set [COS] for inflammatory bowel diseases [IBD] was defined through an international modified Delphi method., Methods: Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by ≥80% of the participants, or based on consensus meeting agreement, were included in the final set., Results: In total, 136 stakeholders (45 IBD patients [advocates], 74 health care professionals/researchers, 13 industry representatives, and four regulators) from 20 different countries participated. The final set includes 18 case-mix variables, three biomarkers [haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation] for completeness, and 28 outcomes (including 16 patient-reported outcomes [PROs] and one patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form, to collect generic PROs annually., Conclusions: A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven, and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide., (© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)

Background: Anemia is a common complication of inflammatory bowel disease (IBD) and contributes to the deterioration of health-related quality of life (HRQOL). Iron deficiency (ID) is a prevalent underlying factor, present in up to 90% of patients. In the absence of anemia, it is unclear as to what extent ID can affect HRQOL in patients with IBD. Our aim was to determine whether ID without anemia negatively affects normal perception of HRQOL in patients with IBD in remission., Methods: We conducted a prospective, cross-sectional study in patients with IBD in remission without anemia. Blood samples were obtained to determine iron status, and patients completed the Inflammatory Bowel Disease Questionnaire-36. ID was defined on serum ferritin <30 ng/mL and transferrin saturation <16%. Restoration of HRQOL was defined as ≥209 on the Inflammatory Bowel Disease Questionnaire-36., Results: One hundred-four patients with IBD in clinical remission were included; 45 patients were iron deficient and 59 had normal iron status. All patients were in clinical remission, with a median Harvey-Bradshaw Index ≤0 and Simple Clinical Colitis Activity Index ≤0. Median hemoglobin was 12.8 g/dL in the ID group and 13.9 g/dL in the normal iron status group (P < 0.05). Prevalence of female patients was higher in the ID group (odds ratio, 4.45; 95% CI, 1.7-11.7; P < 0.01). The median global value of Inflammatory Bowel Disease Questionnaire-36 was not different between the groups (219 in the ID group versus 230 in the normal iron status group, P = not significant), but restoration of health was significantly less frequent in patients with ID (odds ratio, 2.83; 95% CI, 1.22-6.6; P < 0.05)., Conclusions: ID in absence of anemia negatively impacts normal perception of HRQOL in patients with IBD in remission. Correction of ID may be a new target in the treatment of these patients.

Background: Inflammatory bowel disease impairs patients' health related quality of life (HRQOL). AntiTNFα agents control disease activity effectively. An ambitious goal of treatment is to achieve the normalization of health. This can be assessed by using a cut-off scoring threshold of the IBDQ-36 questionnaire. It has not been established if antiTNFα treatment is able to restore to normal patients' HRQOL., Aims: To determine whether patients with Crohn's disease (CD) and ulcerative colitis (UC) in clinical remission after one year treatment with antiTNFα agents achieve normalization of their HRQOL., Methods: Observational and cross-sectional study in patients treated with antiTNFα for one year and in sustained clinical remission. Patients completed the specific questionnaire IBDQ-36. Complete restoration of health was considered achieved when global score of IBDQ-36 was higher than 209 points., Results: 54 patients (43 with CD and 11 with UC) were included. Thirty patients received adalimumab and 24 infliximab. Median global score of the IBDQ-36 was 231, without differences between CD and UC (228 vs 235 respectively, p=ns). Normalization of HRQOL was achieved in all 11 UC patients and in 29 out of 43 CD patients (67%). In our sample population, restoration of health was significantly more frequent in UC than in CD (p<0.05)., Conclusions: One-year clinical remission induced by antiTNFα treatment restores perception of health to normal in most patients with IBD., (Copyright © 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Unlabelled: One of the objectives in the treatment of the inflammatory bowel disease (IBD) is improving the patient's quality of life. However, we do not dispose of validated criteria to determine the questionnaire's scoring threshold that has to be reached in order to be able to assert that the patients' quality of life has normalized., Objective: To determine the normality punctuation cutoff in the IBD specific quality of life questionnaire IBDQ-36., Method: Cross-sectional study in a random sample of IBD patients, who have completed the questionnaires IBDQ-36 and EuroQol-5D. The IBDQ-36 normality was calculated according to its equivalence with the EuroQol-5D tariff ≥ 0.90, which corresponds to the 95% CI of the average obtained in a Spanish general population., Results: 218 patients were included. According to the EuroQol-5D tariff, 70 patients were considered to have a normal quality of life and 148 a quality of life poorer than the general population. The IBDQ-36 scoring was significantly higher in the normal quality of life group (222.9 ± 22.8 vs. 171.4 ± 44.8 in the bad quality of life group, p<0.001). According to the linear regression between IBDQ-36 and EuroQol-5D, the cutoff point is 209, with a sensitivity and specificity to predict normality of 0.74 and 0.71 respectively., Conclusions: Scores of the IBDQ-36 equal or superior to 209 suggest quality of life comparable to that perceived by the general population. This study allowed to set a threshold of normality in the management of the inflammatory bowel diseases., (Copyright © 2010 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Background: Crohn's disease (CD) and ulcerative colitis (UC) are chronic immunoinflammatory diseases that place a considerable burden on patients, their families, and society. Quality of care plays an important role for patients. A questionnaire to measure quality of care through the eyes of patients with inflammatory bowel disease (QUOTE-IBD) has been designed and validated specifically for the English language and culture. The objective was to translate the QUOTE-IBD into Spanish and to determine its validity in patients with IBD., Methods: This is a prospective study in 2 phases: first, translation and validation of the Spanish QUOTE-IBD. Translation was based on the validated QUOTE-IBD. Second, once the complete translation was finished, comprehension of the items was assessed with a specific questionnaire in a reduced number of patients. Criterion validity was assessed with the Pearson's correlation coefficient between scores of the QUOTE-IBD and visual analog scales (VAS). In order to analyze the reproducibility of the Spanish QUOTE-IBD, the questionnaire was completed by stable patients twice, with a span of time of at least 4 weeks., Results: A total of 103 patients (CD: 61, UC: 42) were included in the study. Pearson's correlation coefficient between total care Spanish QUOTE-IBD and VAS of health care items was 0.34 (P < 0.001). Correlations among all 6 care dimensions score of Spanish QUOTE-IBD and VAS were statistically significant (P < 0.01). Results of first and second administration of total care and dimensional care scores of Spanish QUOTE-IBD in 46 stable patients were not different., Conclusions: The Spanish QUOTE-IBD has proved to be a valid instrument to measure the quality of health care for patients with CD and UC.

Background: The interaction of commensal bacteria with the intestinal immune system is an essential factor in the development of inflammatory bowel disease (IBD). The study of isolated commensal bacteria's effects on the mucosal immune response might be relevant for a better understanding of pathophysiological mechanisms in IBD., Methods: We investigated the immune responses to signals from the commensal Escherichia coli ATCC 35345 and the probiotic Lactobacillus casei DN-114 001 in Crohn's disease (CD) mucosa. Ileal specimens were obtained during surgery from CD patients. Mucosal explants were incubated with L. casei or its genomic DNA; TNF-alpha, IFN-gamma, IL-2, IL-6, IL-8, and CXCL1 were measured in the supernatant. Second, tissue expression of key proinflammatory cytokines (IL-6, TGF-beta, IL-23p19, IL-12p35, IL-17F), and chemokines (IL-8, CXCL1, CXCL2) was evaluated after incubation with L. casei or E. coli. Finally, combination experiments were carried out by incubating both strains with mucosal explants at different timepoints., Results: Live L. casei significantly decreased secretion of TNF-alpha, IFN-gamma, IL-2, IL-6, IL-8, and CXCL1 by CD mucosa, but the effect was not reproduced by L. casei DNA. Second, live L. casei downregulated expression of IL-8, IL-6, and CXCL1 and did not modify expression of IL-23p19, IL-12p35, and IL-17F. In contrast, E. coli significantly upregulated expression of all these cytokines. Interestingly, combination experiments revealed the ability of L. casei to prevent and counteract the proinflammatory effects of E. coli., Conclusions: Live L. casei can counteract the proinflammatory effects of E. coli on CD inflamed mucosa by specific downregulation of key proinflammatory mediators.

Background: We have developed a technique for measuring fecal excretion of human DNA by assuming that luminal desquamation of epithelial and inflammatory cells increases in damaged colonic mucosa. However, the clinical usefulness of this technique in the follow-up of patients with ulcerative colitis has not been established. The aim of this study was to determine the stability of fecal DNA in inactive ulcerative colitis and its potential value as an indicator of relapse., Methods: The 54 patients with clinically quiescent ulcerative colitis in this prospective study were followed for 12 months or until clinical relapse (clinical activity index > 7). Fecal calprotectin concentration was determined by ELISA, and fecal DNA concentration was determined by quantitative PCR., Results: During the year of follow-up, 23 of the 54 patients relapsed, with a median increase in the colitis activity index from 1.0 to 8.0 (P < 0.01). Median fecal DNA remained unchanged in patients with stable, inactive colitis, ranging from 6.8 copies/microg at inclusion to 1.7 copies/microg at the end of follow-up. Fecal calprotectin level also was unchanged, ranging from 414.0 microg/g at inclusion to 128.9 microg/g at the end of follow-up. In contrast, fecal DNA concentration increased significantly in patients who relapsed (259.0 versus 3.9 copies/microg at entry; P < 0.01). Similar increases in relapsing patients were also observed with fecal calprotectin. ROC curve analysis to assess the accuracy of fecal DNA and calprotectin in detecting relapses during follow-up yielded similar results., Conclusions: Fecal DNA concentration remained stable in patients with inactive ulcerative colitis but increased significantly with relapses. Determining fecal DNA concentration may be a new objective instrument to use in the follow-up of patients.

Apoptosis of active T lymphocytes constitutes a major control mechanism of immune homeostasis and tolerance. In Crohn's disease, abnormal activation of mucosal T lymphocytes against enteric bacteria is the key event triggering intestinal inflammation. Resistance of lymphocytes to apoptosis has been proposed as the pathogenetic defect. We examined the influence of bacteria-mucosa interactions on apoptosis of mucosal T lymphocytes. Ileal specimens were obtained at surgery from 12 patients with Crohn's disease. Mucosal explants from each specimen were cultured with nonpathogenic Escherichia coli ATCC 35345, Lactobacillus casei DN-114 001, or no bacteria. Cytokine release was measured in supernatant, and mononuclear cells were isolated for phenotypic characterization and Bcl-2 family protein expression. Coculture of inflamed tissue with L. casei significantly reduced the release of interleukin (IL)-6 and tumor necrosis factor alpha (P < 0.05). In addition, coculture with L. casei significantly reduced the number of T cells displaying the IL-2 receptor in the lamina propria. Expression of the antiapoptotic protein Bcl-2 in lamina propria lymphocytes was also reduced after coculture with L. casei, and the percentage of deoxyuridine triphosphate nick-end labeling positive lymphocytes increased. The nonpathogenic E. coli strain had no significant effect. In conclusion, L. casei reduces the number of activated T lymphocytes in the lamina propria of Crohn's disease mucosa. A balanced, local microecology may restore immune homeostasis.

The inflammatory activity of colonic mucosal lesions may be stimulated by intraluminal bacteria. Our aim was to investigate whether administration of broad-spectrum antibiotics decreases inflammatory activity in ulcerative colitis. To this end, we performed a randomized, 5-day study with either oral enterically coated amoxicillin-clavulanic acid (1 g + 250 mg, t.i.d.); i.v. methylprednisolone (40 mg/day) and oral placebo (t.i.d.); or both i.v. methylprednisolone and oral amoxicillin-clavulanic acid as above, in 30 patients with clinically active ulcerative colitis. Before and after 5 days of treatment, intestinal inflammation was assessed by the quantification of mucosal release of eicosanoids and interleukin-8 by rectal dialysis in each patient. Breath H2 excretion after oral lactulose was determined as an index of metabolic activity of colonic flora. The total release of (IL-8) interleukin-8 and eicosanoids significantly decreased in patients treated with antibiotic or steroids and antibiotic. Antibiotic treatment, but not steroids, markedly inhibited breath H2 excretion. In conclusion, short-term treatment with enteric-coated amoxicillin-clavulanic acid decreases the intraluminal release of IL-8 and other inflammatory mediators.