Evidence map›Paper›PMID 37470874›Full record

Observational studyJournal of patient-reported outcomes2023

Experience and measurement of fatigue in adults with Crohn's disease: results from qualitative interviews and a longitudinal 2-week daily diary pilot study.

Miguel Regueiro, Laure Delbecque, Theresa Hunter, Larissa Stassek, Gale Harding, James Lewis

Abstract readObservational Study
In one paragraph

Observational study in Journal of patient-reported outcomes, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. 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
  3. Review
  4. Article
  5. 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

6 authors.

Miguel RegueiroCleveland Clinic, Cleveland, OH, USA.
Laure DelbecqueEli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA.
Theresa HunterEli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA. hunter_theresa_marie@lilly.com.ORCID 0000-0001-8412-9175
Larissa StassekEvidera, Bethesda, MD, USA.
Gale HardingEvidera, Bethesda, MD, USA.
James LewisPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFatigue has a detrimental impact on health-related quality of life and functioning in patients with Crohn's disease (CD). We aimed to confirm the relevance and importance of fatigue, establish the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), qualitatively explore meaningful change in fatigue experience, and assess the measurement properties of the FACIT-F in patients with moderate-to-severe CD.

methodsThis was a mixed-methods observational study consisting of a cross-sectional qualitative interview (Part A) and a longitudinal 2-week daily diary pilot study (Part B) in participants aged ≥ 18 years with a clinical diagnosis of moderate-to-severe CD. Part A included open-ended questions related to the participant's overall experiences with CD, fatigue, and impact on daily activities and a cognitive debriefing of several patient-reported outcomes (PROs), including the FACIT-F. Part B consisted of participants completing an electronic daily diary that included the FACIT-F and other PROs for 14 days. Item performance, test-retest reliability, and construct validity were assessed at baseline (Day 1), Day 7, and Day 14.

resultsThirty-five participants (mean age 45.1 years; 65.7% female) completed an interview (Part A). Ninety-one percent of the interview participants reported fatigue as a symptom attributed to CD. Participants indicated that fatigue had a major impact on their daily activities (e.g., recreation/ hobbies, work/school, yard work and housework), social activities, and emotional health. The FACIT-F was well understood by the interview participants. Seventy-six participants (mean age 41.9 years; 66% female) completed at least the Day 1 diary entry (Part B). Potential floor and ceiling effects were observed for several FACIT-F items, but test-retest reliability and construct validity were all strong and within the ranges hypothesized a priori.

conclusionsThe interviews indicate that fatigue is a frequent and bothersome symptom experienced by most patients with moderate-to-severe CD and support the content validity of the FACIT-F in this population. Daily diary study results indicate that the FACIT-F scale demonstrates adequate reliability and validity among patients with CD. These study findings suggest that the FACIT-F would be a reliable, valid, and useful measure of fatigue in patients with moderate-to-severe CD.

Indexed as

Crohn DiseaseAdultCross-Sectional StudiesFatigueFemaleHumansMaleMiddle AgedPilot ProjectsQuality of LifeReproducibility of ResultsConstruct validityFunctional Assessment of Chronic Illness Therapy–FatiguePatient-reported outcomePsychometric properties

Identifiers

PMID37470874
PMCPMC10359232

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Registered trials

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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.