Abstract
BackgroundInflammatory 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.MethodsThe 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.DiscussionThe 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 registrationThe trial is registered in ClinicalTrials.Gov with registration number NCT03590639. First posted: July 18, 2018.
Highlights
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
PROs have become an integral part of the endpoints evaluated in IBD clinical trials [16,17,18], strongly recommended by the United States Food and Drug Administration (FDA) [19], as PROs are considered as real therapeutic targets [20, 21]
The IBD-Disability Index (IBD-DI) has been validated in a French population based-cohort for use in clinical trials and epidemiological studies, and showed high internal consistency, interobserver reliability and construct validity, and a moderate intra-observer reliability [55]
Summary
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, between 3 and 12 months later, during a follow-up visit. Clinical and socio-demographic data will be collected. During these two consultations, gastroenterologists and patients will evaluate disease activity thanks to a semiquantitative 4-grade scale, named respectively PGA (Physician Global Assessment) and PtGA (Patient Global Assessment). Gastroenterologists and patients will evaluate disease activity thanks to a semiquantitative 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. Close attention will be needed to minimize the number of lost to follow-up patients between baseline and follow-up
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