Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Gastroenterology
Published in: BMC Gastroenterology 1/2020

Open Access 01-12-2020 | Chronic Inflammatory Bowel Disease | Study protocol

Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study

Authors: C. Le Berre, A. Bourreille, M. Flamant, G. Bouguen, L. Siproudhis, M. Dewitte, N. Dib, E. Cesbron-Metivier, T. Goronflot, M. Hanf, P.-A. Gourraud, E. Kerdreux, A. Poinas, C. Trang-Poisson

Published in: BMC Gastroenterology | Issue 1/2020

Login to get access

Abstract

Background

Inflammatory Bowel Diseases (IBD) affect psychological, family, social and professional dimensions of patients’ life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess disability, but it is not appropriate for use in clinical practice. The IBD Disk was developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study are to validate this tool in a large population of IBD patients and to compare it to the already validated IBD-DI.

Methods

The VALIDate study is an ongoing multicentric prospective cohort study launched in April 2018 in 3 French University Hospitals (Nantes, Rennes, Angers), with an objective to reach a sample of 400 patients over a period inclusion of 6 months. Each patient will fill in the two questionnaires IBD Disk and IBD-DI at baseline, then between 3 and 12 months later, during a follow-up visit. Clinical and socio-demographic data will also be collected. During these two consultations, gastroenterologists and patients will evaluate disease activity thanks to a semi-quantitative 4-grade scale, named respectively PGA (Physician Global Assessment) and PtGA (Patient Global Assessment). This cohort will allow to evaluate the validity of the IBD Disk with respect to the IBD-DI in order to generalize its use for clinical practice. Other psychometric criteria of the IBD Disk will also be analysed as its reliability or its discriminant capacity. Close attention will nonetheless be needed to minimize the number of lost to follow-up patients between baseline and follow-up.

Discussion

The VALIDate study is the study designed to validate the IBD Disk, a visual tool easily useable in daily practice to assess disability in IBD patients. The results of this trial should enable the diffusion of this tool.

Trial registration

The trial is registered in ClinicalTrials.Gov with registration number NCT03590639. First posted: July 18, 2018.
Appendix
Available only for authorised users
Literature
1.
Peyrin-Biroulet L, Loftus EV, Colombel J-F, Sandborn WJ. Long-term complications, extraintestinal manifestations, and mortality in adult Crohn’s disease in population-based cohorts. Inflamm Bowel Dis. 2011;17:471–8.PubMedCrossRef
2.
Peyrin-Biroulet L, Loftus EV, Colombel J-F, Sandborn WJ. The natural history of adult Crohn’s disease in population-based cohorts. Am J Gastroenterol. 2010;105:289–97.PubMedCrossRef
3.
Pariente B, Mary J-Y, Danese S, Chowers Y, De Cruz P, D’Haens G, et al. Development of the Lémann index to assess digestive tract damage in patients with Crohn’s disease. Gastroenterology. 2015;148:52–63.e3.PubMedCrossRef
4.
Casellas F, López-Vivancos J, Vergara M, Malagelada J. Impact of inflammatory bowel disease on health-related quality of life. Dig Dis. 1999;17:208–18.PubMedCrossRef
5.
Peyrin-Biroulet L, Cieza A, Sandborn WJ, Kostanjsek N, Kamm MA, Hibi T, et al. Disability in inflammatory bowel diseases: developing ICF Core sets for patients with inflammatory bowel diseases based on the international classification of functioning, disability, and health. Inflamm Bowel Dis. 2010;16:15–22.PubMedCrossRef
6.
Lönnfors S, Vermeire S, Greco M, Hommes D, Bell C, Avedano L. IBD and health-related quality of life -- discovering the true impact. J Crohns Colitis. 2014;8:1281–6.PubMedCrossRef
7.
Purc-Stephenson R, Bowlby D, Qaqish ST. “A gift wrapped in barbed wire” positive and negative life changes after being diagnosed with inflammatory bowel disease. Qual Life Res. 2015;24:1197–205.PubMedCrossRef
8.
Norton C, Dibley LB, Bassett P. Faecal incontinence in inflammatory bowel disease: associations and effect on quality of life. J Crohns Colitis. 2013;7:e302–11.PubMedCrossRef
9.
Dibley L, Norton C. Experiences of fecal incontinence in people with inflammatory bowel disease: self-reported experiences among a community sample. Inflamm Bowel Dis. 2013;19:1450–62.PubMedCrossRef
10.
Wojtowicz AA, Greenley RN, Gumidyala AP, Rosen A, Williams SE. Pain severity and pain catastrophizing predict functional disability in youth with inflammatory bowel disease. J Crohns Colitis. 2014;8:1118–24.PubMedCrossRef
11.
McDermott E, Mullen G, Moloney J, Keegan D, Byrne K, Doherty GA, et al. Body image dissatisfaction: clinical features, and psychosocial disability in inflammatory bowel disease. Inflamm Bowel Dis. 2015;21:353–60.PubMedCrossRef
12.
Cohen BL, Zoëga H, Shah SA, Leleiko N, Lidofsky S, Bright R, et al. Fatigue is highly associated with poor health-related quality of life, disability and depression in newly-diagnosed patients with inflammatory bowel disease, independent of disease activity. Aliment Pharmacol Ther. 2014;39:811–22.PubMedPubMedCentralCrossRef
13.
Marín L, Mañosa M, Garcia-Planella E, Gordillo J, Zabana Y, Cabré E, et al. Sexual function and patients’ perceptions in inflammatory bowel disease: a case-control survey. J Gastroenterol. 2013;48:713–20.PubMedCrossRef
14.
Floyd DN, Langham S, Séverac HC, Levesque BG. The economic and quality-of-life burden of Crohn’s disease in Europe and the United States, 2000 to 2013: a systematic review. Dig Dis Sci. 2015;60:299–312.PubMedCrossRef
15.
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006;4:79.PubMedCentralCrossRef
16.
Williet N, Sandborn WJ, Peyrin-Biroulet L. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2014;12:1246–1256.e6.PubMedCrossRef
17.
Bojic D, Bodger K, Travis S. Patient Reported Outcome Measures (PROMs) in Inflammatory Bowel Disease: New Data. J Crohns Colitis. 2017;11(suppl_2):S576–85.PubMed
18.
Peyrin-Biroulet L. What is the patient’s perspective: how important are patient-reported outcomes, quality of life and disability? Dig Dis. 2010;28:463–71.PubMedCrossRef
19.
US Food and Drug Administration (FDA). Department of Health and Human Services (US) FDA CfDEaRC. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. 2009.
20.
Peyrin-Biroulet L, Sandborn W, Sands BE, Reinisch W, Bemelman W, Bryant RV, et al. Selecting therapeutic targets in inflammatory bowel disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol. 2015;110:1324–38.PubMedCrossRef
21.
Levesque BG, Sandborn WJ, Ruel J, Feagan BG, Sands BE, Colombel J-F. Converging goals of treatment of inflammatory bowel disease from clinical trials and practice. Gastroenterology. 2015;148:37–51.e1.PubMedCrossRef
22.
Warsame R, D’Souza A. Patient reported outcomes have arrived: a practical overview for clinicians in using patient reported outcomes in oncology. Mayo Clin Proc. 2019;94:2291–301.PubMedCrossRef
23.
Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989;96:804–10.PubMedCrossRef
24.
Love JR, Irvine EJ, Fedorak RN. Quality of life in inflammatory bowel disease. J Clin Gastroenterol. 1992;14:15–9.PubMedCrossRef
25.
Irvine EJ, Zhou Q, Thompson AK. The short inflammatory bowel disease questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT investigators. Canadian Crohn’s relapse prevention trial. Am J Gastroenterol. 1996;91:1571–8.PubMed
26.
Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the functional assessment of Cancer therapy (FACT) measurement system. J Pain Symptom Manag. 1997;13:63–74.CrossRef
27.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4:353–65.PubMedCrossRef
28.
Reilly MC, Gerlier L, Brabant Y, Brown M. Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn’s disease. Clin Ther. 2008;30:393–404.PubMedCrossRef
29.
Vergara M, Montserrat A, Casellas F, Maudsley M, Gallardo O, Ricart E, et al. Validation of the Spanish work productivity and activity impairment questionnaire: Crohn’s disease version. Eur J Gastroenterol Hepatol. 2009;21:809–15.PubMedCrossRef
30.
Zung WW. The depression status inventory: an adjunct to the self-rating depression scale. J Clin Psychol. 1972;28:539–43.PubMedCrossRef
31.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.PubMedCrossRef
32.
Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561–71.PubMedCrossRef
33.
Bernstein CN, Zhang L, Lix LM, Graff LA, Walker JR, Fisk JD, et al. The validity and reliability of screening measures for depression and anxiety disorders in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24:1867–75.
34.
Navabi S, Gorrepati VS, Yadav S, Chintanaboina J, Maher S, Demuth P, et al. Influences and impact of anxiety and depression in the setting of inflammatory bowel Disease. Inflamm Bowel Dis. 2018;24:2303–8.
35.
Dibley L, Czuber-Dochan W, Woodward S, Wade T, Bassett P, Sturt J, et al. Development and psychometric properties of the Inflammatory Bowel Disease Distress Scale (IBD-DS): a new tool to measure disease-specific distress. Inflamm Bowel Dis. 2018;24:2068–77.
36.
Williet N, Sarter H, Gower-Rousseau C, Adrianjafy C, Olympie A, Buisson A, et al. Patient-reported outcomes in a French Nationwide survey of inflammatory bowel disease patients. J Crohns Colitis. 2017;11:165–74.PubMedCrossRef
37.
de Dombal FT, Burton I, Goligher JC. The early and late results of surgical treatment for Crohn’s disease. Br J Surg. 1971;58:805–16.PubMedCrossRef
38.
Rubin DT, Siegel CA, Kane SV, Binion DG, Panaccione R, Dubinsky MC, et al. Impact of ulcerative colitis from patients’ and physicians’ perspectives: results from the UC: NORMAL survey. Inflamm Bowel Dis. 2009;15:581–8.PubMedCrossRef
39.
Peyrin-Biroulet L, Van Assche G, Sturm A, Gisbert JP, Gaya DR, Bokemeyer B, et al. Treatment satisfaction, preferences and perception gaps between patients and physicians in the ulcerative colitis CARES study: a real world-based study. Dig Liver Dis. 2016;48:601–7.PubMedCrossRef
40.
Marín-Jiménez I, Gobbo Montoya M, Panadero A, Cañas M, Modino Y. Romero de Santos C, et al. Management of the Psychological Impact of inflammatory bowel disease: perspective of doctors and patients-the ENMENTE project. Inflamm Bowel Dis. 2017;23:1492–8.PubMedCrossRef
41.
Chiricozzi A, Bianchi L, Zangrilli A, Bavetta M, Giunta A, Chimenti S, et al. Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk. Eur J Dermatol. 2015;25:64–9.PubMedCrossRef
42.
Mercuri SR, Gregorio G, Brianti P. Quality of life of psoriasis patients measured by the PSOdisk: a new visual method for assessing the impact of the disease. G Ital Dermatol Venereol. 2017;152:424–31.PubMed
43.
Goekoop-Ruiterman YPM, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJSM, Hazes JMW, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum. 2005;52:3381–90.PubMedCrossRef
44.
Thompson PW, Pegley FS. A comparison of disability measured by the Stanford health assessment questionnaire disability scales (HAQ) in male and female rheumatoid outpatients. Br J Rheumatol. 1991;30:298–300.PubMedCrossRef
45.
Noseworthy JH, Vandervoort MK, Wong CJ, Ebers GC. Interrater variability with the expanded disability status scale (EDSS) and functional systems (FS) in a multiple sclerosis clinical trial. The Canadian cooperation MS study group. Neurology. 1990;40:971–5.PubMedCrossRef
46.
Ebers GC, Heigenhauser L, Daumer M, Lederer C, Noseworthy JH. Disability as an outcome in MS clinical trials. Neurology. 2008;71:624–31.PubMedCrossRef
47.
Schreiber S, Panés J, Louis E, Holley D, Buch M, Paridaens K. Perception gaps between patients with ulcerative colitis and healthcare professionals: an online survey. BMC Gastroenterol. 2012;12:108.PubMedPubMedCentralCrossRef
48.
Nahon S, Lahmek P, Saas C, Durance C, Olympie A, Lesgourgues B, et al. Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: results of the ISSEO survey. Inflamm Bowel Dis. 2011;17:1270–6.PubMedCrossRef
49.
Panés J, O’Connor M, Peyrin-Biroulet L, Irving P, Petersson J, Colombel J-F. Improving quality of care in inflammatory bowel disease: what changes can be made today? J Crohns Colitis. 2014;8:919–26.PubMedCrossRef
50.
Kennedy AP, Nelson E, Reeves D, Richardson G, Roberts C, Robinson A, et al. A randomised controlled trial to assess the effectiveness and cost of a patient orientated self management approach to chronic inflammatory bowel disease. Gut. 2004;53:1639–45.PubMedPubMedCentralCrossRef
51.
Cousin G, Schmid Mast M, Roter DL, Hall JA. Concordance between physician communication style and patient attitudes predicts patient satisfaction. Patient Educ Couns. 2012;87:193–7.PubMedCrossRef
52.
Siegel CA, Lofland JH, Naim A, Gollins J, Walls DM, Rudder LE, et al. Novel statistical approach to determine inflammatory bowel disease: patients’ perspectives on shared decision making. Patient. 2016;9:79–89.PubMedCrossRef
53.
54.
Peyrin-Biroulet L, Cieza A, Sandborn WJ, Coenen M, Chowers Y, Hibi T, et al. Development of the first disability index for inflammatory bowel disease based on the international classification of functioning, disability and health. Gut. 2012;61:241–7.PubMedCrossRef
55.
Gower-Rousseau C, Sarter H, Savoye G, Tavernier N, Fumery M, Sandborn WJ, et al. Validation of the inflammatory bowel disease disability index in a population-based cohort. Gut. 2017;66:588–96.PubMedCrossRef
56.
Ghosh S, Louis E, Beaugerie L, Bossuyt P, Bouguen G, Bourreille A, et al. Development of the IBD disk: a visual self-administered tool for assessing disability in inflammatory bowel diseases. Inflamm Bowel Dis. 2017;23:333–40.PubMedCrossRef
57.
Linder D, Sampogna F, Torreggiani A, Balato N, Bianchi L, Cassano N, et al. Psodisk, a new visual method for assessing the burden of psoriasis on patients. J Eur Acad Dermatol Venereol. 2012;26:1163–6.PubMedCrossRef
58.
Sampogna F, Linder D, Romano GV, Gualberti G, Merolla R, di Luzio Paparatti U. Results of the validation study of the Psodisk instrument, and determination of the cut-off scores for varying degrees of impairment. J Eur Acad Dermatol Venereol. 2015;29:725–31.PubMedCrossRef
59.
Streiner D, Norman G. Health measurement scales. Oxford: Oxford University Press; 1989.
60.
Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25:3186–91.PubMedCrossRef
61.
Silverberg MS, Satsangi J, Ahmad T, Arnott IDR, Bernstein CN, Brant SR, et al. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can J Gastroenterol. 2005;19(Suppl A):5A–36A.PubMedCrossRef
62.
Bolarinwa OA. Principles and methods of validity and reliability testing of questionnaires used in social and health science researches. Niger Postgrad Med J. 2015;22:195–201.PubMedCrossRef
63.
Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998;17:101–10.PubMedCrossRef
64.
Bouguen G, Levesque BG, Feagan BG, Kavanaugh A, Peyrin-Biroulet L, Colombel J, et al. Treat to Target: A Proposed New Paradigm for the Management of Crohn’s Disease. Clin Gastroenterol Hepatol. 2015;13:1042–1050.e2.PubMedCrossRef
Metadata
Title
Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study
Authors
C. Le Berre
A. Bourreille
M. Flamant
G. Bouguen
L. Siproudhis
M. Dewitte
N. Dib
E. Cesbron-Metivier
T. Goronflot
M. Hanf
P.-A. Gourraud
E. Kerdreux
A. Poinas
C. Trang-Poisson
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Gastroenterology / Issue 1/2020
Electronic ISSN: 1471-230X
DOI
https://doi.org/10.1186/s12876-020-01246-7

Other articles of this Issue 1/2020

BMC Gastroenterology 1/2020 Go to the issue

Case report

Ischemic colitis induced by indigo naturalis in a patient with ulcerative colitis: a case report

Case report

Gastropathy associated with lanthanum phosphate deposition that was endoscopically tracked for 3 years. A case report

Research article

Association of Helicobacter pylori vacA genotypes and peptic ulcer in Iranian population: a systematic review and meta-analysis

Research article

Three-hour post-ERCP amylase level: a useful indicator for early prediction of post-ERCP pancreatitis

Research article

Transcriptomic analysis on the effects of melatonin in gastrointestinal carcinomas

Technical advance

Direct endoscopic full-thickness resection for submucosal tumors with an intraluminal growth pattern originating from the muscularis propria layer in the gastric fundus

ACC 2024 Congress Coverage

Heart Failure Video

Year in Review: Heart failure and cardiomyopathies

Watch now

Watch this official video from ACC.24. Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits