Evidence map›Paper›PMID 37296268›Full record

ArticlePharmacoEconomics - open2023

Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis.

Edward V Loftus, Ashwin N Ananthakrishnan, Wan-Ju Lee, Yuri Sanchez Gonzalez, Kristina A Fitzgerald, Kori Wallace, Wen Zhou, Leighann Litcher-Kelly, Sarah B Ollis, Sylvia Su and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in PharmacoEconomics - open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 3% 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.

NCT02819635 phase2 / phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorAbbVieRan2016 to 2021Enrolled1,302ConditionsUlcerative Colitis (UC)ArmsPlacebo, Upadacitinib
NCT03105128 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

TypeinterventionalSponsorAbbVieRan2017 to 2021Enrolled931ConditionsCrohn's DiseaseArmsplacebo for risankizumab, risankizumab IV, risankizumab SC
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Trial
  5. Trial
  6. Fatigue in inflammatory bowel disease: Mechanisms, assessment, and management strategies.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
    Article
  7. Observational
  8. Article
  9. Review
  10. Article
  11. Management of Fatigue in Inflammatory Bowel Disease: A Narrative Review.International journal of general medicine · 2025
    Review
  12. Article
  13. 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

11 authors at 5 institutions in 2 countries.

Edward V LoftusMayo Clinic College of Medicine and Science, Rochester, MN, USA. loftus.edward@mayo.edu.ORCID http://orcid.org/0000-0001-7199-6851
Ashwin N AnanthakrishnanMassachusetts General Hospital, Boston, MA, USA.
Wan-Ju LeeAbbVie Inc, Chicago, IL, USA.
Yuri Sanchez GonzalezAbbVie Inc, Chicago, IL, USA.
Kristina A FitzgeraldAbbVie Inc, Chicago, IL, USA.
Kori WallaceAbbVie Inc, Chicago, IL, USA.
Wen ZhouAbbVie Inc, Chicago, IL, USA.
Leighann Litcher-KellyAdelphi Values, Boston, MA, USA.
Sarah B OllisAdelphi Values, Boston, MA, USA.
Sylvia SuAdelphi Values, Boston, MA, USA.
Silvio DaneseHumanitas University, Milan, Italy.
AbbVie (United States) · USAdelphi Laboratory Center · USHumanitas University · ITMassachusetts General Hospital · USMayo Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with Crohn's disease (CD) or ulcerative colitis (UC) frequently experience fatigue, although it is often overlooked in medical research and practice.

aimsTo explore patients' experience of fatigue and evaluate content validity, psychometric properties, and score interpretability of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in patients with CD or UC.

methodsConcept elicitation and cognitive interviews were conducted with participants aged ≥ 15 years with moderately-to-severely active CD (N = 30) or UC (N = 33). To evaluate psychometric properties (reliability and construct validity) and interpretation of FACIT-Fatigue scores, data from two clinical trials were analyzed [ADVANCE (CD): N = 850; U-ACHIEVE (UC): 248]. Meaningful within-person change was estimated using anchor-based methods.

resultsAlmost all interview participants reported experiencing fatigue. Over 30 unique fatigue-related impacts were reported per condition. The FACIT-Fatigue was interpretable for most patients. FACIT-Fatigue items had good internal consistency (Cronbach's α 0.86-0.88 for CD and 0.94-0.96 for UC); the total score displayed acceptable test-retest reliability (intraclass correlation coefficients > 0.60 for CD and > 0.90 for UC). FACIT-Fatigue scores had acceptable convergent validity with similar measures. A 7-10 point improvement for CD and 4-9 point improvement for UC on the FACIT-Fatigue total score may represent meaningful improvements.

conclusionsThese results highlight the importance of fatigue among adolescents and adults with CD or UC and provide evidence that the FACIT-Fatigue is content valid and produces reliable, valid, and interpretable scores in these populations. Care should be taken if using the questionnaire with adolescents who may be less familiar with the word "fatigue." Clinical trial registration numbers NCT03105128 (date of registration: 4 April 2017) and NCT02819635 (date of registration: 28 June 2016).

Identifiers

PMID37296268
PMCPMC10471538
OpenAlexW4379983914

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.