A Multidisciplinary Approach to Biopsychosocial Care for Adults With Inflammatory Bowel Disease: A Pilot Study

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.

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Increased genomic damage and vitamin B status in inflammatory bowel disease patients: A case-control, prospective, pilot study

Mutation Research/Genetic Toxicology and Environmental Mutagenesis ◽

10.1016/j.mrgentox.2018.10.002 ◽

2019 ◽

Vol 837 ◽

pp. 42-47 ◽

Cited By ~ 3

Author(s):

Su Young Kim ◽

Eun Chan Mun ◽

Jun-Won Chung ◽

Minsu Ha ◽

Sung-Min Ahn ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Pilot Study ◽

Bowel Disease ◽

Case Control ◽

Vitamin B ◽

Prospective Pilot Study ◽

Genomic Damage ◽

Inflammatory Bowel

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Effects of short-term oral administration of dietary marine oils in patients with inflammatory bowel disease and joint pain: A pilot study comparing seal oil and cod liver oil

Clinical Nutrition ◽

10.1016/j.clnu.2008.01.017 ◽

2008 ◽

Vol 27 (4) ◽

pp. 614-622 ◽

Cited By ~ 20

Author(s):

Linn A. Brunborg ◽

Tor M. Madland ◽

Ragna A. Lind ◽

Gülen Arslan ◽

Arnold Berstad ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Pilot Study ◽

Oral Administration ◽

Bowel Disease ◽

Joint Pain ◽

Cod Liver Oil ◽

Marine Oils ◽

Short Term ◽

Seal Oil ◽

Inflammatory Bowel

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P126 Low reproductive knowledge and fertility in patients with inflammatory bowel disease in Serbia—results of pilot study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjy222.250 ◽

2019 ◽

Vol 13 (Supplement_1) ◽

pp. S151-S151

Author(s):

T Glisic ◽

A Sokic-Milutinovic ◽

S Zgradic ◽

I Jovicic

Keyword(s):

Inflammatory Bowel Disease ◽

Pilot Study ◽

Bowel Disease ◽

Inflammatory Bowel

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P490 A pilot study of the electronic patient portal “Patient Knows Best” for monitoring biologic therapy in inflammatory bowel disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjx002.614 ◽

2017 ◽

Vol 11 (suppl_1) ◽

pp. S328-S328

Author(s):

N. Kamperidis ◽

M. O'Connor ◽

K. Crook ◽

N. Arebi

Keyword(s):

Inflammatory Bowel Disease ◽

Pilot Study ◽

Bowel Disease ◽

Biologic Therapy ◽

Patient Portal ◽

Inflammatory Bowel

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P114 A screening tool for the early diagnosis of extraintestinal manifestations in inflammatory bowel disease: the EMAIL questionnaire

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.243 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S192-S193

Author(s):

A Busacca ◽

G Ingrassia Strano ◽

E Giuffrida ◽

L Guida ◽

B Scrivo ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Early Diagnosis ◽

Bowel Disease ◽

Multidisciplinary Approach ◽

Screening Tool ◽

Erythema Nodosum ◽

Demographic Data ◽

Extraintestinal Manifestations ◽

History Of ◽

Inflammatory Bowel

Abstract Background Data on prevalence of extraintestinal manifestations (EIMs) in inflammatory bowel disease (IBD) range from 6% up to 47%. Recently, several red flags and questionnaires have been proposed for early diagnosis of articular manifestations. Our aim was to analyse the prevalence of EIMs in a single-centre prospective cohort, using a comprehensive questionnaire developed by our group to detect all EIMs (EMAIL questionnaire). Methods Patients with IBD attending our Clinic from November 2017 to January 2019 were interviewed using a two-part questionnaire, the first part for clinical-demographic data and the second part for EIMs. Patients positive to screening were referred for multidisciplinary approach. Results Two hundred and six IBD patients were interviewed, 114 (55.3%) Crohn’s disease (CD) and 92 (44.7%) ulcerative colitis (UC), 52.4% male, mean age 46.7 years (SD ± 15,2). Sixty (53%) CD patients and 48 (52%) UC patients, in total 108, had history of at least one EIM. Articular EIMs were found in 49 patients (24%); peripheral arthritis was found in 14% (29/206), axial arthritis in 9.7% (20 patients): seven patients (3.4%) had ankylosing spondylitis, 13 (6.3%) sacroiliitis. Cutaneous EIMs were detected in 39 patients (19%), erythema nodosum in 15 patients (7.3%), pyoderma gangrenosum in 9 (4.4%), psoriasis in 15 (7.3%) and folliculitis in 7 (3.4%). Ocular EIMs were observed in 35 patients (17%): uveitis in 7 patients (3.4%), conjunctivitis in 8 (3.9%), optic neuritis in 2, glaucoma in 2 patients, cataract in 13 (6,3%), dry eye in 4 (1.9%), central serous chorioretinopathy in 1. Hepatobiliary EIMs were observed in 31 patients (15%): 26 steatosis (12.6%), 5 (2.4%) primary sclerosing cholangitis. Four (2%) patients had DVT. Articular EIMs were more frequent in CD patients (p = 0.001). Skin manifestations were more frequent in female (p = 0.002) in CD (p = 0,032) and related with IBD activity (<0.001). Hepatobiliary manifestations were more frequent in male (p = 0,017) and in UC (p = 0,044). There was a significant correlation between DVT and IBD activity (p = 0,016). Conclusion The questionnaire developed by our group proved to be a sensitive screening tool. Articular and cutaneous EIMs are more frequent in CD, hepatobiliary EIMs are more frequent in UC. A gender difference has been found since cutaneous EIMs are more frequent in females, hepatobiliary more in males. Cutaneous EIMs and DVT are related with IBD activity.

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EXAMINATION OF THE EFFICACY OF A CHRONIC DISEASE SELF-MANAGEMENTRAMME (CDSMP) FOR PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD): A PILOT STUDY

Gut ◽

10.1136/gutjnl-2013-305143.65 ◽

2013 ◽

Vol 62 (Suppl 2) ◽

pp. A28.1-A28

Author(s):

M Forry ◽

E McDonnell ◽

J Wilson O'Raghallaigh ◽

O Kelly ◽

A O'Toole ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Chronic Disease ◽

Pilot Study ◽

Bowel Disease ◽

Inflammatory Bowel

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Monitoring biologics in inflammatory bowel disease (IBD) using the Patients Know Best electronic portal: pilot study of uptake, acceptability and outcomes

Gastrointestinal Nursing ◽

10.12968/gasn.2018.16.9.31 ◽

2018 ◽

Vol 16 (9) ◽

pp. 31-36

Author(s):

Nikolaos Kamperidis ◽

Marian O'Connor ◽

Naila Arebi

Keyword(s):

Inflammatory Bowel Disease ◽

Pilot Study ◽

Bowel Disease ◽

Inflammatory Bowel

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Breath Analysis Using eNose and Ion Mobility Technology to Diagnose Inflammatory Bowel Disease—A Pilot Study

Biosensors ◽

10.3390/bios9020055 ◽

2019 ◽

Vol 9 (2) ◽

pp. 55 ◽

Cited By ~ 11

Author(s):

Tiele ◽

Wicaksono ◽

Kansara ◽

Arasaradnam ◽

Covington

Keyword(s):

Inflammatory Bowel Disease ◽

Pilot Study ◽

Ion Mobility ◽

Bowel Disease ◽

Breath Analysis ◽

Diagnostic Tools ◽

Exhaled Breath ◽

Faecal Calprotectin ◽

Non Invasive ◽

Inflammatory Bowel

Early diagnosis of inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), remains a clinical challenge with current tests being invasive and costly. The analysis of volatile organic compounds (VOCs) in exhaled breath and biomarkers in stool (faecal calprotectin (FCP)) show increasing potential as non-invasive diagnostic tools. The aim of this pilot study is to evaluate the efficacy of breath analysis and determine if FCP can be used as an additional non-invasive parameter to supplement breath results, for the diagnosis of IBD. Thirty-nine subjects were recruited (14 CD, 16 UC, 9 controls). Breath samples were analysed using an in-house built electronic nose (Wolf eNose) and commercial gas chromatograph–ion mobility spectrometer (G.A.S. BreathSpec GC-IMS). Both technologies could consistently separate IBD and controls [AUC ± 95%, sensitivity, specificity], eNose: [0.81, 0.67, 0.89]; GC-IMS: [0.93, 0.87, 0.89]. Furthermore, we could separate CD from UC, eNose: [0.88, 0.71, 0.88]; GC-IMS: [0.71, 0.86, 0.62]. Including FCP did not improve distinction between CD vs UC; eNose: [0.74, 1.00, 0.56], but rather, improved separation of CD vs controls and UC vs controls; eNose: [0.77, 0.55, 1.00] and [0.72, 0.89, 0.67] without FCP, [0.81, 0.73, 0.78] and [0.90, 1.00, 0.78] with FCP, respectively. These results confirm the utility of breath analysis to distinguish between IBD-related diagnostic groups. FCP does not add significant diagnostic value to breath analysis within this study.

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