Evidence map›Paper›PMID 32299390›Full record

ArticleBMC gastroenterology2020

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.

C Le Berre, A Bourreille, M Flamant, G Bouguen, L Siproudhis, M Dewitte, N Dib, E Cesbron-Metivier, T Goronflot, M Hanf and 4 more

Registry-linked trialOpen access · goldAbstract readComparative Study
In one paragraph

Article in BMC gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03590639 (IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03590639 completednot on this map

IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic

TypeobservationalSponsorNantes University HospitalRan2018 to 2020Enrolled400ConditionsInflammatory Bowel Diseases
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 1 country.

C Le BerreInstitut des Maladies de l'Appareil Digestif, Nantes University Hospital, Nantes, France. catherine@leberre.org.
A BourreilleInstitut des Maladies de l'Appareil Digestif, Nantes University Hospital, Nantes, France.
M FlamantInstitut des Maladies de l'Appareil Digestif, Nantes University Hospital, Nantes, France.
G BouguenService des Maladies de l'Appareil Digestif, Rennes University Hospital, Rennes, France.
L SiproudhisService des Maladies de l'Appareil Digestif, Rennes University Hospital, Rennes, France.
M DewitteService des Maladies de l'Appareil Digestif, Rennes University Hospital, Rennes, France.
N DibService de Gastroentérologie, Angers University Hospital, Angers, France.
E Cesbron-MetivierService de Gastroentérologie, Angers University Hospital, Angers, France.
T GoronflotClinique des Données, Nantes University Hospital, Nantes, France.
M HanfClinique des Données, Nantes University Hospital, Nantes, France.
P-A GourraudClinique des Données, Nantes University Hospital, Nantes, France.
E KerdreuxCentre d'Investigation Clinique, Nantes University Hospital, Nantes, France.
A PoinasDirection de la Recherche Clinique, Nantes University Hospital, Nantes, France.
C Trang-PoissonInstitut des Maladies de l'Appareil Digestif, Nantes University Hospital, Nantes, France.
Digestive Health Research Institute · FRCentre Hospitalier Universitaire de Nantes · FRCentre d'Investigation Clinique de Nantes · FRHôpital Pontchaillou · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Rennes · FRUniversité d'Angers · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 registrationThe trial is registered in ClinicalTrials.Gov with registration number NCT03590639. First posted: July 18, 2018.

Indexed as

Disability EvaluationInflammatory Bowel DiseasesPatient Reported Outcome MeasuresHumansMulticenter Studies as TopicProspective StudiesPsychometricsQuality of LifeReproducibility of ResultsResearch DesignSeverity of Illness IndexValidation Studies as TopicDisabilityIBD-disability indexIBD diskInflammatory bowel diseasesPatient-reported outcomesQuality of life

Identifiers

PMID32299390
PMCPMC7164208
OpenAlexW3016721788

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.