Inflammatory Bowel Disease-related Behaviours [IBD-Bx] questionnaire: Development, validation, and prospective associations with fatigue

Author(s):  
Marta Walentynowicz ◽  
Iris van de Pavert ◽  
Liselotte Fierens ◽  
Sofie Coenen ◽  
Johan W S Vlaeyen ◽  
...  

Abstract 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 3-5 representative items, resulting in a final, 25-item IBD-Bx questionnaire showing good concurrent validity (alphas > .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.

1988 ◽  
Vol 27 (03) ◽  
pp. 83-86 ◽  
Author(s):  
B. Briele ◽  
F. Wolf ◽  
H. J. Biersack ◽  
F. F. Knapp ◽  
A. Hotze

A prospective study was initiated to compare the clinically proven results concerning localization/extent and activity of inflammatory bowel diseases with those of 111ln-oxine leukocyte imaging. All patients studied were completely examined with barium enema x-ray, clinical and laboratory investigations, and endoscopy with histopathology. A total of 31 leukocyte scans were performed in 15 patients (12 with Crohn’s disease, 3 with ulcerative colitis). The scans were graded by comparing the cell uptake of a lesion (when present) and a bone marrow area providing a count ratio (CR). The inflammatory lesions were correctly localized on 26 leukocyte scans, and in 21 scans the scintigraphically estimated extent of disease was identical to endoscopy. In 5 cases the disease extent was underestimated, 4 scans in patients with relapse of Crohn’s disease were falsely negative, and in one patient with remission truly negative. The scintigraphically assessed disease activity was also in a good agreement with clinical disease activity based on histopathology in all cases. We conclude that leukocyte imaging provides valuable information about localization and activity of inflammatory bowel disease.


2021 ◽  
Vol 28 (1) ◽  
pp. e100337
Author(s):  
Vivek Ashok Rudrapatna ◽  
Benjamin Scott Glicksberg ◽  
Atul Janardhan Butte

ObjectivesElectronic health records (EHR) are receiving growing attention from regulators, biopharmaceuticals and payors as a potential source of real-world evidence. However, their suitability for the study of diseases with complex activity measures is unclear. We sought to evaluate the use of EHR data for estimating treatment effectiveness in inflammatory bowel disease (IBD), using tofacitinib as a use case.MethodsRecords from the University of California, San Francisco (6/2012 to 4/2019) were queried to identify tofacitinib-treated IBD patients. Disease activity variables at baseline and follow-up were manually abstracted according to a preregistered protocol. The proportion of patients meeting the endpoints of recent randomised trials in ulcerative colitis (UC) and Crohn’s disease (CD) was assessed.Results86 patients initiated tofacitinib. Baseline characteristics of the real-world and trial cohorts were similar, except for universal failure of tumour necrosis factor inhibitors in the former. 54% (UC) and 62% (CD) of patients had complete capture of disease activity at baseline (month −6 to 0), while only 32% (UC) and 69% (CD) of patients had complete follow-up data (month 2 to 8). Using data imputation, we estimated the proportion achieving the trial primary endpoints as being similar to the published estimates for both UC (16%, p value=0.5) and CD (38%, p-value=0.8).Discussion/ConclusionThis pilot study reproduced trial-based estimates of tofacitinib efficacy despite its use in a different cohort but revealed substantial missingness in routinely collected data. Future work is needed to strengthen EHR data and enable real-world evidence in complex diseases like IBD.


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 77-79
Author(s):  
Y Hanna ◽  
P Tandon ◽  
V W Huang

Abstract Background Women with active inflammatory bowel disease (IBD) are at increased risk of adverse pregnancy outcomes such as preeclampsia. Though aspirin prophylaxis is prescribed in the general population (prior to 16 weeks’ gestation) for those at high-risk of preeclampsia, its use in patients with IBD has not been established. Aims To determine the frequency of and risk factors for adverse pregnancy outcomes in women with IBD, and to evaluate the risk for preeclampsia and the use of aspirin for primary prevention. Methods All pregnant women with IBD (Crohns disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBDU)) seen at Mount Sinai Hospital from 2016–2020 were retrospectively identified. Demographics, reproductive history, and IBD characteristics including therapy and activity during pregnancy were recorded. Adverse pregnancy outcomes were also identified. Active disease during pregnancy was defined as a fecal calprotectin > 250 ug/g and/or using clinical disease activity scores. Categorical variables were compared using the Chi-square (x2) test and continuous variables using the Mann-Whitney test. A two-sided p-value less than 0.05 was considered statistically significant. Results 127 patients (66 with CD, 60 with UC, 1 with IBDU) were included with a median age of 32 years at conception. The majority were Caucasian (70.9%), married (82.7%), completed post-secondary education (69.3%), had no prior or current smoking (78.7%) or alcohol use history (67.7%), and had no other comorbidities (81.9%). 50.4% of women had a prior pregnancy. 3 had a history of preeclampsia and 15/127 were prescribed aspirin prophylaxis. 73.2% of women were in clinical remission at conception. Compared to women with CD, women with UC were more likely to have infants with low birth weight (LBW) (p=0.031), small for gestational age (SGA) (p=0.002) and had higher rates of active IBD during pregnancy (p=0.005). 13 women with IBD developed preeclampsia (6 with UC and 7 with CD). IBD type (p=0.844) and disease activity (p=0.308) were not associated with preeclampsia. Married women (p=0.001) while those who had a preconception consultation (50/127) (p=0.009) had lower rates of preeclampsia while those with a prior history of preeclampsia had higher rates (p=0.002). Among women who developed preeclampsia, pregnancy outcomes were comparable to those who did not. Women on aspirin prophylaxis (5/13) had a higher rate of preeclampsia (p=0.012), although they were also more likely to have a history of preeclampsia (p=0.002). Aspirin use was not associated with subsequent disease activity in pregnancy (p=0.830). Conclusions Women receiving aspirin prophylaxis had higher rates of preeclampsia, likely owing to a higher baseline risk. Preeclampsia prevention with aspirin prophylaxis does not appear to result in disease flares but larger studies are needed to confirm this finding. Funding Agencies None


Author(s):  
Shinichiro Shinzaki ◽  
Katsuyoshi Matsuoka ◽  
Hiroki Tanaka ◽  
Fuminao Takeshima ◽  
Shingo Kato ◽  
...  

Abstract Background This multicenter prospective study (UMIN000019958) aimed to evaluate the usefulness of serum leucin-rich alpha-2 glycoprotein (LRG) levels in monitoring disease activity in inflammatory bowel disease (IBD). Methods Patients with moderate-to-severe IBD initiated on adalimumab therapy were enrolled herein. Serum LRG, C-reactive protein (CRP), and fecal calprotectin (fCal) levels were measured at week 0, 12, 24, and 52. Colonoscopy was performed at week 0, 12, and 52 for ulcerative colitis (UC), and at week 0, 24, and 52 for Crohn’s disease (CD). Endoscopic activity was assessed using the Simple Endoscopic Score for Crohn’s Disease (SES-CD) for CD and the Mayo endoscopic subscore (MES) for UC. Results A total of 81 patients was enrolled. Serum LRG levels decreased along with improvements in clinical and endoscopic outcomes upon adalimumab treatment (27.4 ± 12.6 μg/ml at week 0, 15.5 ± 7.7 μg/ml at week 12, 15.7 ± 9.6 μg/ml at week 24, and 14.5 ± 6.8 μg/ml at week 52), being correlated with endoscopic activity at each time point (SES-CD: r = 0.391 at week 0, r = 0.563 at week 24, r = 0.697 at week 52; MES: r = 0.534 at week 0, r = 0.429 at week 12, r = 0.335 at week 52). Endoscopic activity better correlated with LRG compared to CRP and fCal on pooled analysis at all time points (SES-CD: LRG: r = 0.636, CRP: r = 0.402, fCal: r = 0.435; MES: LRG: r = 0.568, CRP: 0.389, fCal: r = 0.426). Conclusions Serum LRG is a useful biomarker of endoscopic activity both in CD and UC during the adalimumab treatment.


Author(s):  
Vera E.R. Asscher ◽  
Sanne N. Waars ◽  
Andrea E. van der Meulen-de Jong ◽  
Rogier J.L. Stuyt ◽  
A. Martine C. Baven-Pronk ◽  
...  

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