Evidence map›Paper›PMID 39537976›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2025

Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease.

Miguel Regueiro, Sylvia Su, Aisha Vadhariya, Xian Zhou, Frederick Durand, Larissa Stassek, Ariane K Kawata, Claudine Clucas, Vipul Jairath

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03926130 (A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT03926130 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2023Enrolled1,158ConditionsCrohn's DiseaseArmsMirikizumab, Ustekinumab, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Fatigue in inflammatory bowel disease: Mechanisms, assessment, and management strategies.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
    Article
  3. Article
  4. Review
  5. Observational
  6. Management of Fatigue in Inflammatory Bowel Disease: A Narrative Review.International journal of general medicine · 2025
    Review
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

9 authors.

Miguel RegueiroDepartment of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA.
Sylvia SuEli Lilly and Company, Indianapolis, IN, USA. su_sylvia@lilly.com.ORCID http://orcid.org/0009-0007-0666-9804
Aisha VadhariyaEli Lilly and Company, Indianapolis, IN, USA.
Xian ZhouSyneos Health, Morrisville, NC, USA.
Frederick DurandEli Lilly and Company, Indianapolis, IN, USA.
Larissa StassekEvidera, Wilmington, NC, USA.
Ariane K KawataEvidera, Wilmington, NC, USA.
Claudine ClucasEvidera, London, UK.
Vipul JairathDivision of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.

Funding

Eli Lilly and Company Eli Lilly and Company
6 · The paper itself

Abstract

purposeTo provide further evidence on the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in moderately to severely active Crohn's disease (CD), and to determine thresholds for meaningful improvement in fatigue.

methodsThe FACIT-Fatigue is a 13-item patient-reported outcome measure (range, 0-52) assessing fatigue over the previous week. Using pooled data from the Phase 3 VIVID-1 study of moderately to severely active CD, psychometric properties of FACIT-Fatigue were evaluated up to Week 52. The Patient Global Rating of Severity (PGRS) and Patient Global Impression of Change (PGIC) were used as primary anchors to estimate the FACIT-Fatigue score change representing meaningful improvement.

resultsPsychometric analyses included 1065 adults. The FACIT-Fatigue demonstrated good internal consistency, and correlations between individual items and the total score were moderate to strong. The FACIT-Fatigue score showed moderate to strong correlations with other patient-reported assessments and weak correlations with endoscopic/laboratory assessments. The FACIT-Fatigue differentiated between distinct groups of participants varying in disease severity, quality of life, and fatigue based on PGRS and other assessments. FACIT-Fatigue improvements during the study differed significantly between most PGRS change and PGIC categories. Anchor-based estimates suggested a 6-9-point increase in the FACIT-Fatigue total score as meaningful improvement.

conclusionsThe FACIT-Fatigue demonstrated strong psychometric properties in the VIVID-1 population of adults with moderately to severely active CD and determined a FACIT-Fatigue score change threshold representing meaningful improvement.

trial registrationNCT03926130. Registered 23 April 2019, https://clinicaltrials.gov/study/NCT03926130 .

Indexed as

Crohn DiseaseFatiguePatient Reported Outcome MeasuresPsychometricsQuality of LifeAdultAgedChronic DiseaseFemaleHumansMaleMiddle AgedReproducibility of ResultsSeverity of Illness IndexSurveys and QuestionnairesYoung AdultCrohn’s diseaseFatigueFunctional Assessment of Chronic Illness therapy–fatiguePatient-reported outcomePsychometric evaluation

Identifiers

PMID39537976
PMCPMC11865103

What OpenQuestion holds

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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.