Remote Monitoring of Inflammatory Bowel Disease: What Kind of Patient-Reported Questionnaires Should We Use?

Abstract Background Immunomodulators and biologicals are cornerstones in the current management of Inflammatory Bowel Disease (IBD), but are associated with increased risk of infections. Post-marketing surveillance studies are important to assess the risk for infectious side effects in real-world populations, yet mainly focus on severe infections. Data on mild and moderate infections in IBD patients are scarce, primarily since self-limiting infections and infections treated by the general practitioner are not systematically captured in surveillance registries. Mild and moderate infections take longer to clear in immunosuppressed patients, have a large impact on (work) disability and quality of life, and potentially precede severe infections. In the current study, we aimed to develop and implement a remote monitoring tool for real-world assessment of infections in IBD patients. Methods Through a structured iterative process with input from IBD specialists, nurse practitioners, and a comprehensive literature review, a 7-item Questionnaire comprising 15 different types of infections (covering e.g. upper/lower respiratory tract; urinary tract; eye; and skin infections) was developed to measure Patient-Reported Infections (PRIQ) with a recall period of 3 months. Infection severity was defined as either mild (self-limiting or requiring topical/local treatment), moderate (requiring oral antibiotic, antiviral or antifungal drugs) or severe (requiring hospitalization and/or IV treatment). To ascertain comprehensiveness and comprehensibility in the intended study population prior to implementation, in three rounds a total of 36 randomly selected IBD patients visiting the outpatient clinic were interviewed individually until saturation was reached. Results Overall, patient understanding of the PRIQ was good and cognitive interviews did not result in reduction of questionnaire-items. Analysis of feedback from interviews resulted in addition of definitions to certain response options (e.g. definition for antivirals) and minor linguistic adjustments to further improve patient understanding. A total of three patients (8.3%) raised concerns on the recall period of 3 months, which after expert consensus, did not result in alteration of the recall period. Next, the PRIQ was digitized and implemented in myIBDcoach, an established telemedicine platform for management of IBD. Conclusion We developed a remote monitoring tool (PRIQ) to assess patient-reported infections in IBD and ascertained patient understanding through cognitive interviewing. A prospective multicentre study using the myIBDcoach platform is ongoing to validate the PRIQ and subsequently report the risk of mild and moderate infections across different treatment regimens in IBD patients (NCT04151420).

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The Inflammatory Bowel Disease Symptom Inventory: A Patient-report Scale for Research and Clinical Application

Inflammatory Bowel Diseases ◽

10.1093/ibd/izz038 ◽

2019 ◽

Vol 25 (8) ◽

pp. 1277-1290 ◽

Cited By ~ 7

Author(s):

Kathryn A Sexton ◽

John R Walker ◽

Laura E Targownik ◽

Lesley A Graff ◽

Clove Haviva ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Factor Analysis ◽

Bowel Disease ◽

Convergent Validity ◽

Short Form ◽

Self Report ◽

Measurement Properties ◽

Systemic Complications ◽

Patient Reported ◽

Inflammatory Bowel

Abstract Objectives Existing measures of inflammatory bowel disease (IBD) symptoms are not well suited to self-report, inadequate in measurement properties, insufficiently specific, or burdensome for brief or repeated administration. We aimed to develop a patient-reported outcome measure to assess a broader range of IBD symptoms. Methods The IBD Symptoms Inventory (IBDSI) was developed by adapting symptom items from existing clinician-rated or diary-format inventories; after factor analysis, 38 items were retained on 5 subscales: bowel symptoms, abdominal discomfort, fatigue, bowel complications, and systemic complications. Participants completed the IBDSI and other self-report measures during a clinic visit. A nurse administered the Harvey Bradshaw Index (HBI) for Crohn’s disease (CD) or the Powell-Tuck Index (PTI) for ulcerative colitis (UC), and a gastroenterologist completed a global assessment of disease severity (PGA). Results The 267 participants with CD (n = 142) or UC (n = 125), ages 18 to 81 (M = 43.4, SD = 14.6) were 58.1% female, with a mean disease duration of 13.9 (SD = 10.5) years. Confirmatory factor analysis supported the 5 subscales. The total scale and subscales showed good reliability and significant correlations with self-report symptom and IBD quality of life measures, the HBI, PTI, and PGA. Conclusions The IBDSI showed strong measurement properties: a supported factor structure, very good internal consistency, convergent validity, and excellent sensitivity and specificity to clinician-rated active disease. Self-report HBI and PTI items, when extracted from this measure, produced scores comparable to clinician-administered versions. The 38-item IBDSI, or 26-item short form, can be used as a brief survey of common IBD symptoms in clinic or research settings.

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Crohn’s disease and ulcerative colitis patient-reported outcomes signs and symptoms for the remote management of inflammatory bowel disease during the COVID-19 pandemic

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-021-00323-z ◽

2021 ◽

Vol 5 (1) ◽

Author(s):

Sergio Pinto ◽

Erica Loddo ◽

Salvatore Paba ◽

Agnese Favale ◽

Fabio Chicco ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Crohn’S Disease ◽

Bowel Disease ◽

Patient Reported Outcomes ◽

Signs And Symptoms ◽

Patient Reported ◽

Inflammatory Bowel ◽

Active Patients ◽

Active Disease

Abstract Background and aims The COVID-19 pandemic has led to a deep reorganization of hospital services including inflammatory bowel disease (IBD) units. In this situation, conversion of in-person routine follow-up visits into phone consultations might be necessary. Here we explored the feasibility of using the validated Crohn’s Disease (CD) or Ulcerative Colitis (UC) Patient-Reported Outcomes Signs and Symptoms (CD- and UC-PRO/SS) to collect data about abdominal symptoms (abdominal/S) and bowel signs and symptoms (bowel/SS) remotely. Methods CD- and UC-PRO/SS were collected during phone consultations and compared among patients with active and inactive disease. The effectiveness of therapeutic intervention in patients with active disease was assessed by PRO/SS variation. Results Twenty-one CD and 56 UC patients were evaluated by phone. Six (28.6%) CD and 15 (26.8%) UC patients were considered to have active disease. In CD the bowel/SS but not the abdominal/S module was significantly higher in active patients (mean bowel/SS 2.50 [SE ± 0.44] active vs 0.76 [SE ± 0.18] remission, p = 0.008, AUC 0.87; mean abdominal/S 1.11 [SE ± 0.38] active vs 0.24 [SE ± 0.13] remission, p = 0.066). UC-PRO/SS measures were significantly higher in active patients as compared to patients in remission (median bowel/SS 1.63 [SE ± 0.24] active vs 0.33 [SE ± 0.04] remission; p < 0.0001, AUC 0.91; mean abdominal/S 1.03 [SE ± 0.24] vs 0.37 [SE ± 0.12]; p = 0.009, AUC 0.71). Therapy was escalated in 12 patients (3 CD and 9 UC) due to disease relapse. Therapy escalation resulted in the reduction of PRO/SS as evaluated at the subsequent phone consultation. Conclusions PRO/SS might represent a feasible tool to evaluate disease activity and therapy outcome in IBD patients during periods of limited access to outpatient clinics.

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Patient-Reported Outcomes in Inflammatory Bowel Disease: A Measurement of Effect in Research and Clinical Care

Gastroenterology Insights ◽

10.3390/gastroent12020020 ◽

2021 ◽

Vol 12 (2) ◽

pp. 225-237

Author(s):

Jane Fletcher ◽

Sheldon C. Cooper ◽

Amelia Swift

Keyword(s):

Inflammatory Bowel Disease ◽

Systematic Reviews ◽

Bowel Disease ◽

Core Outcome Set ◽

Core Outcome ◽

Health Measurement ◽

Outcome Set ◽

Patient Reported ◽

Inflammatory Bowel ◽

Selection Of

The measurement of outcomes is key in evaluating healthcare or research interventions in inflammatory bowel disease (IBD). In patient-centred care, patient-reported outcome measures (PROMs) are central to this evaluation. In this review, we provide an overview of validated, adult disease-specific PROMs developed for use in IBD. Our aim is to assist clinicians and researchers in selection of PROMs to measure outcomes in their patient cohort. The Consensus-based Standards for the Selection of Health Measurement Instruments database of systematic reviews was the primary resource used to identify PROMs used in IBD. Search terms were ‘Crohn’s disease’, ‘ulcerative colitis’, and ‘IBD’. Seven systematic reviews were identified from this search. In addition, the publication by the IBD Core Outcome Set Working Group was used to identify further PROMs. Three systematic reviews were excluded as they did not meet the inclusion criteria. From the five included systematic reviews, we identified 21 PROMs and their shortened versions. In conclusion, it does not appear that any one PROM is entirely suitable for both research and clinical practice. Overall, the IBDQ-32 is most widely used in research but has the limitation of cost, whereas the IBD-Control has been recommended in the clinical core outcome set.

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Mo1771 - The Feasibility and Reliability of Patient-Reported Malnutrition Risk Screening in Inflammatory Bowel Disease

Gastroenterology ◽

10.1016/s0016-5085(18)32735-5 ◽

2018 ◽

Vol 154 (6) ◽

pp. S-796

Author(s):

Caroline Hwang ◽

Welmoed K. van Deen ◽

Swapna Reddy ◽

Kelly Issokson ◽

Catherine Giguere-Rich ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Risk Screening ◽

Patient Reported ◽

Inflammatory Bowel

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Limited Health Literacy Is Associated With Worse Patient-Reported Outcomes in Inflammatory Bowel Disease

Inflammatory Bowel Diseases ◽

10.1093/ibd/izy237 ◽

2018 ◽

Vol 25 (1) ◽

pp. 204-212 ◽

Cited By ~ 3

Author(s):

Lauren K Tormey ◽

Jason Reich ◽

Yu Sarah Chen ◽

Arush Singh ◽

Zachary Lipkin-Moore ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Health Literacy ◽

Bowel Disease ◽

Patient Reported Outcomes ◽

Limited Health Literacy ◽

Patient Reported ◽

Inflammatory Bowel ◽

Limited Health

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Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review

The American Journal of Gastroenterology ◽

10.14309/ajg.0000000000001545 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Nghia H. Nguyen ◽

Ivonne Martinez ◽

Ashish Atreja ◽

Amy M. Sitapati ◽

William J. Sandborn ◽

...

Keyword(s):

Systematic Review ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Remote Monitoring ◽

Digital Health ◽

Health Technologies ◽

Inflammatory Bowel

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The Development and Initial Findings of A Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD)

Inflammatory Bowel Diseases ◽

10.1093/ibd/izab071 ◽

2021 ◽

Author(s):

Laura E Raffals ◽

Sumona Saha ◽

Meenakshi Bewtra ◽

Cecile Norris ◽

Angela Dobes ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Data ◽

Bowel Disease ◽

Patient Reported Outcomes ◽

Data Entry ◽

The United States ◽

Predictors Of Response ◽

Patient Reported ◽

Inflammatory Bowel ◽

Reported Data

Abstract Background Clinical and molecular subcategories of inflammatory bowel disease (IBD) are needed to discover mechanisms of disease and predictors of response and disease relapse. We aimed to develop a study of a prospective adult research cohort with IBD (SPARC IBD) including longitudinal clinical and patient-reported data and biosamples. Methods We established a cohort of adults with IBD from a geographically diverse sample of patients across the United States with standardized data and biosample collection methods and sample processing techniques. At enrollment and at time of lower endoscopy, patient-reported outcomes (PRO), clinical data, and endoscopy scoring indices are captured. Patient-reported outcomes are collected quarterly. The quality of clinical data entry after the first year of the study was assessed. Results Through January 2020, 3029 patients were enrolled in SPARC, of whom 66.1% have Crohn’s disease (CD), 32.2% have ulcerative colitis (UC), and 1.7% have IBD-unclassified. Among patients enrolled, 990 underwent colonoscopy. Remission rates were 63.9% in the CD group and 80.6% in the UC group. In the quality study of the cohort, there was 96% agreement on year of diagnosis and 97% agreement on IBD subtype. There was 91% overall agreement describing UC extent as left-sided vs extensive or pancolitis. The overall agreement for CD behavior was 83%. Conclusion The SPARC IBD is an ongoing large prospective cohort with longitudinal standardized collection of clinical data, biosamples, and PROs representing a unique resource aimed to drive discovery of clinical and molecular markers that will meet the needs of precision medicine in IBD.

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