scholarly journals P178 Variation in assessment of outcomes for inflammatory bowel disease in routine clinical practice: a mixed-methods study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S227-S227
Author(s):  
V Razanskaite ◽  
P Williamson ◽  
B Young ◽  
K Bodger
Keyword(s):  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Activity Index ◽  
Clinical Disease ◽  
Routine Practice ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel ◽  
Activity Indices

Abstract Background A number of global initiatives have sought to standardise the assessment of outcomes for inflammatory bowel disease (IBD), both for clinical trials (Core Outcome Sets1) and routine practice (ICHOM2). Our aim was to explore variability in the assessment and recording of clinical IBD outcomes during routine practice in England, evaluating the range of individual outcomes elicited and the extent of objective quantification of symptoms. Methods We performed ethnographic observations of 102 IBD clinic consultations conducted by 24 IBD clinicians (10 consultants, 10 IBD nurses and 4 trainees) in six acute hospitals in the North West region of England. We analysed 909 retrospective clinic records from outpatient IBD clinic visits recorded for observed patients in routine electronic patient records (EPRs). Audio-recordings of observed consultations and clinic records were analysed for pre-defined IBD outcomes, including those items required for Crohn’s Disease Activity Index (CDAI), Harvey–Bradshaw Index (HBI), Mayo Clinic Score (MCS) and Simple Clinical Colitis Activity Index (SCCAI). In addition, we performed 24 semi-structured interviews with IBD clinicians to explore the barriers and facilitators to capturing structured IBD outcomes in EPRs. Results The most commonly elicited and recorded outcomes were general well-being (95% consultations [C] and 61% clinic records [R]), stool frequency [SF] (87% C, 68% R), abdominal pain [AP] (79% C, 46% R), blood in stool [BS] (71% C, 57% R) and loose stool (64% C, 51% R). Clinical disease activity indices (HBI and SCCAI) were collected in only 15 (14.7%) observed consultations and recorded in 51 (5.6%) clinic letters. There was marked variation in the quantification of individual symptom items of MCS, SCCAI, CDAI and HBI in analysed consultations and records. Both PRO2 Crohn’s disease outcomes [AP and SF] were collected in 29/50 (58%) observed consultations and recorded in 169/484 (35%) records. Both PRO2 ulcerative colitis outcomes [SF and BS] were collected in 42/52 (81%) consultations and 253/425 (60%) records. Selected outcomes were recorded significantly more frequently by IBD nurses compared with doctors. Clinicians reported a range of IT barriers and issues with psychometric properties of currently available clinical disease activity indices in practice. Conclusion There is significant variability in the breadth, depth and quantification of IBD clinical outcomes during routine clinical assessments. Although most domains of clinical disease activity indices were elicited in consultations, formal scoring and assessment over fixed time periods was rare. There is an urgent need for practical alternatives to clinician reported disease activity indices in routine care.

Validation of the “German Inflammatory Bowel Disease Activity Index (GIBDI)”: An Instrument for Patient-Based Disease Activity Assessment in Crohn’s Disease and Ulcerative Colitis

2018 ◽  
Vol 56 (10) ◽  
pp. 1267-1275 ◽  
Author(s):  
Angelika Hüppe ◽  
Jana Langbrandtner ◽  
Winfried Häuser ◽  
Heiner Raspe ◽  
Bernd Bokemeyer
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Activity Index ◽  
Disease Activity Index ◽  
Inflammatory Bowel ◽  
Activity Indices

Abstract Introduction Assessment of disease activity in Crohn’s disease (CD) and ulcerative colitis (UC) is usually based on the physician’s evaluation of clinical symptoms, endoscopic findings, and biomarker analysis. The German Inflammatory Bowel Disease Activity Index for CD (GIBDICD) and UC (GIBDIUC) uses data from patient-reported questionnaires. It is unclear to what extent the GIBDI agrees with the physicians’ documented activity indices. Methods Data from 2 studies were reanalyzed. In both, gastroenterologists had documented disease activity in UC with the partial Mayo Score (pMS) and in CD with the Harvey Bradshaw Index (HBI). Patient-completed GIBDI questionnaires had also been assessed. The analysis sample consisted of 151 UC and 150 CD patients. Kappa coefficients were determined as agreement measurements. Results Rank correlations were 0.56 (pMS, GIBDIUC) and 0.57 (HBI, GIBDICD), with p < 0.001. The absolute agreement for 2 categories of disease activity (remission yes/no) was 74.2 % (UC) and 76.6 % (CD), and for 4 categories (none/mild/moderate/severe) 60.3 % (UC) and 61.9 % (CD). The kappa values ranged between 0.47 for UC (2 categories) and 0.58 for CD (4 categories). Discussion There is satisfactory agreement of GIBDI with the physician-documented disease activity indices. GIBDI can be used in health care research without access to assessments of medical practitioners. In clinical practice, the index offers a supplementary source of information.

scholarly journals Correlating Gastrointestinal Histopathologic Changes to Clinical Disease Activity in Dogs With Idiopathic Inflammatory Bowel Disease

2018 ◽  
Vol 56 (3) ◽  
pp. 435-443 ◽  
Author(s):  
Karin A. Allenspach ◽  
Jonathan P. Mochel ◽  
Yingzhou Du ◽  
Simon L. Priestnall ◽  
Frances Moore ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Scoring System ◽  
Activity Index ◽  
Clinical Disease ◽  
Clinical Activity ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel ◽  
Histopathologic Changes

Prior studies have failed to detect a convincing association between histologic lesions of inflammation and clinical activity in dogs with inflammatory bowel disease (IBD). We hypothesized that use of a simplified histopathologic scoring system would improve the consistency of interpretation among pathologists when describing histologic lesions of gastrointestinal inflammation. Our aim was to evaluate the correlation of histopathologic changes to clinical activity in dogs with IBD using this new system. Forty-two dogs with IBD and 19 healthy control dogs were enrolled in this retrospective study. Endoscopic biopsies from the stomach, duodenum, ileum, and colon were independently scored by 8 pathologists. Clinical disease activity was scored using the Canine Inflammatory Bowel Disease Activity Index (CIBDAI) or the Canine Chronic Enteropathy Clinical Activity Index (CCECAI), depending on the individual study center. Summative histopathological scores and clinical activity were calculated for each tissue (stomach, duodenum, ileum, and colon) and each tissue histologic score (inflammatory/morphologic feature). The correlation between CCECAI/CIBDAI and summative histopathologic score was significant ( P < .05) for duodenum ( r = 0.42) and colon ( r = 0.33). In evaluating the relationship between histopathologic scores and clinical activity, significant ( P < .05) correlations were observed for crypt dilation ( r = 0.42), lamina propria (LP) lymphocytes ( r = 0.40), LP neutrophils ( r = 0.45), mucosal fibrosis ( r = 0.47), lacteal dilation ( r = 0.39), and villus stunting ( r = 0.43). Compared to earlier grading schemes, the simplified scoring system shows improved utility in correlating histopathologic features (both summative histology scores and select histologic scores) to IBD clinical activity.

scholarly journals P485 Switching infliximab biosimilar: No adverse impact on inflammatory bowel disease control or drug levels with the first or second switch

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S426-S427
Author(s):  
R Luber ◽  
R O’Neill ◽  
S Singh ◽  
Z Arkir ◽  
P Irving
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Disease Control ◽  
Bowel Disease ◽  
Trough Level ◽  
Clinical Disease ◽  
Drug Levels ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel ◽  
Activity Indices

Abstract Background Biological medicines account for a significant cost to healthcare systems. With the advent of anti-tumour necrosis factor biosimilars, switching from originator to biosimilar has enabled cost saving in inflammatory bowel disease (IBD) without compromising disease control. However, with more biosimilars entering the market, the effect on IBD activity and pharmacokinetics (PK) of a second switch to another biosimilar is uncertain. This study aims to assess the effect on disease activity and drug levels associated with switching from infliximab (IFX) biosimilar Remsima® (Celltrion, Hungary) to another biosimilar, Flixabi® (Samsung Bioepis, The Netherlands), and to compare those switching for the first and second time. Methods All IBD patients on IFX biosimilar Remsima® were prospectively followed during their switch to Flixabi® in a single centre. Baseline data including C-reactive protein (CRP), trough IFX level, and clinical disease activity indices were collected; Harvey Bradshaw Index for Crohn’s disease (CD) and Simple Clinical Colitis Activity Index for ulcerative colitis (UC). These indices were repeated after at least two infusions of Flixabi®. Results 221 patients (179 CD, 42 UC) on stable IFX treatment were included in the study. 174 (79%) were on a concomitant immunomodulator. 5 (2%) patients ceased IFX prior to follow-up due to sustained remission, and 3 (1%) patients discontinued due to factors not directly related to drug or disease. 112 patients had PK analysis performed pre and post switch. An increase in IFX trough level was observed after switching IFX biosimilars; baseline median (IQR) trough level of 4.5µg/ml (2.9–6.3) compared with post switch of 5.1µg/ml (3.4–7.0) (p = 0.02). There was no difference in clinical scores or CRP post switch, and no new anti-IFX antibodies were detected. 107 patients (48%) were switching IFX agent for the second time, of which 51 had PK analysis performed. A similar increase in median IFX trough level was observed post switch in those switching for the first (4.7 vs. 6.1 µg/ml, p = 0.03) and second (4.0 vs. 4.5µg/ml, p = 0.05) times (Figure 1). No change in clinical disease activity or CRP occurred in either group. Concomitant immunomodulator and disease classification had no impact on change in IFX level (p = 0.72 and 0.37, respectively, on univariate analysis). Conclusion In a cohort of IBD patients switching to a new IFX biosimilar either for the first or second time, an increase in IFX level was observed with no impact on clinical and biochemical disease activity indices. Switching IFX biosimilars in IBD appears safe in the short term with respect to maintaining drug pharmacokinetic profile and disease control whether switching for the first or second time.

scholarly journals The association between inflammatory potential of diet and disease activity: results from a cross-sectional study in patients with inflammatory bowel disease

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Carlijn R. Lamers ◽  
Nicole M. de Roos ◽  
Ben J. M. Witteman
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Activity Index ◽  
Statistical Significance ◽  
Inflammatory Bowel ◽  
Anti Inflammatory

Abstract Background Diet may play a role in disease status in patients with inflammatory bowel disease. We tested whether the inflammatory potential of diet, based on a summation of pro- and anti-inflammatory nutrients, is associated with disease activity in patients with Crohn’s disease and ulcerative colitis. Methods Participants completed a disease activity questionnaire (short Crohn’s Disease Activity (sCDAI) or Patient Simple Clinical Colitis Activity Index (P-SCCAI)) and a Food Frequency Questionnaire (FFQ). FFQ data were used to calculate the Dietary Inflammatory Index (DII) which enables categorization of individuals’ diets according to their inflammatory potential on a continuum from pro- to anti-inflammatory. Associations with disease activity were investigated by multiple linear regression. Results The analysis included 329 participants; 168 with Crohn’s disease (median sCDAI score 93 [IQR 47–156]), and 161 with ulcerative colitis (median P-SCCAI score 1 [IQR 1–3]). Mean DII was 0.71 ± 1.33, suggesting a slightly pro-inflammatory diet. In Crohn’s disease, the DII was positively associated with disease activity, even after adjustment for confounders (p = 0.008). The mean DII was significantly different between participants in remission and with mild and moderately active disease (0.64, 0.97 and 1.52 respectively, p = 0.027). In ulcerative colitis, the association was not significant. Conclusions Disease activity was higher in IBD participants with a more pro-inflammatory diet with statistical significance in Crohn’s disease. Although the direction of causality is not clear, this association strengthens the role for diet in medical treatment, which should be tested in an intervention study.

Su1345 Patterns of Antibiotic Exposure and Clinical Disease Activity in Inflammatory Bowel Disease: A 4 Year Prospective Study

2014 ◽  
Vol 146 (5) ◽  
pp. S-442
Author(s):  
Jana G. Hashash ◽  
Claudia M. Ramos Rivers ◽  
Miguel Regueiro ◽  
Arthur Barrie ◽  
Marc Schwartz ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Prospective Study ◽  
Disease Activity ◽  
Bowel Disease ◽  
Clinical Disease ◽  
Antibiotic Exposure ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel

Su1255 Fecal Calprotectin Is Elevated With Clinical Disease Activity During Pregnancy in Women With Inflammatory Bowel Disease

2015 ◽  
Vol 148 (4) ◽  
pp. S-452 ◽  
Author(s):  
Vivian Huang ◽  
Jasmin Bal ◽  
Rae R. Foshaug ◽  
Lindsy Ambrosio ◽  
Karen Kroeker ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Fecal Calprotectin ◽  
Clinical Disease ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel

Mo1830 - Sleep Fragmentation Measured by Wearable Device is an Indicator of Clinical Disease Activity in Inflammatory Bowel Disease

2018 ◽  
Vol 154 (6) ◽  
pp. S-817-S-818
Author(s):  
M. Anthony Sofia ◽  
Olivia Yvellez ◽  
Nada Zmeter ◽  
Katia El Jurdi ◽  
Jacob Ollech ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Sleep Fragmentation ◽  
Clinical Disease ◽  
Wearable Device ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel

scholarly journals The Crohn’s Disease Activity Index, Its Derivatives and the Inflammatory Bowel Disease Questionnaire: A Review of Instruments to Assess in Crohn’s Disease

1999 ◽  
Vol 13 (1) ◽  
pp. 65-73 ◽  
Author(s):  
Eric M Yoshida
Keyword(s):  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Activity Index ◽  
Disease Activity Index ◽  
Inflammatory Bowel Disease Questionnaire ◽  
Inflammatory Bowel ◽  
Disease Questionnaire

The Crohn’s Disease Activity Index (CDAI) has been used to measure Crohn’s activity for over a quarter of a century. The development of the CDAI is reviewed and its reliability and validity are examined. Instruments used to assess Crohn’s disease that were developed subsequent to the CDAI, including the Harvey-Bradshaw Index, the Cape Town Index and a three-variable version of the CDAI (modified for survey research), are similarly reviewed. The most recent instrument to assess Crohn’s disease, the Inflammatory Bowel Disease Questionnaire, which assesses patients in the domains of bowel, systemic, emotional and social function, is also discussed.

Sign in / Sign up

Export Citation Format

Share Document