Evidence map›Paper›PMID 37962770›Full record

ArticleJournal of patient-reported outcomes2023

Qualitative and psychometric evaluation of the PROMIS®-Fatigue SF-7a scale to assess fatigue in patients with moderately to severely active inflammatory bowel disease.

Brian G Feagan, William J Sandborn, Bruce E Sands, Yan Liu, Marion Vetter, Susan D Mathias, Kuan-Hsiang Gary Huang, Jewel Johanns, Matthew Germinaro, Chenglong Han

Open access · goldAbstract read
In one paragraph

Article 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 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
4.7field-weighted citation impact, top 5% 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.

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

15 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
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  9. Management of Fatigue in Inflammatory Bowel Disease: A Narrative Review.International journal of general medicine · 2025
    Review
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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

10 authors at 6 institutions in 2 countries.

Brian G FeaganWestern University and Alimentiv Inc, London, ON, Canada.
William J SandbornUniversity of California San Diego, La Jolla, CA, USA.
Bruce E SandsIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Yan LiuJanssen Research & Development, LLC, Spring House, PA, USA.
Marion VetterJanssen Research & Development, LLC, Spring House, PA, USA.
Susan D MathiasHealth Outcomes Solutions, Winter Park, FL, USA.
Kuan-Hsiang Gary HuangJanssen Research & Development, LLC, Spring House, PA, USA.
Jewel JohannsJanssen Research & Development, LLC, Spring House, PA, USA.
Matthew GerminaroJanssen Research & Development, LLC, Spring House, PA, USA.
Chenglong HanJanssen Research & Development, LLC, Spring House, PA, USA. CHan3@its.jnj.com.ORCID 0000-0001-7175-7834
Janssen (United States) · USHealth Outcomes Solutions (United States) · USIcahn School of Medicine at Mount Sinai · USSpringhouse · USUniversity of California San Diego · USWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the content validity and psychometric properties of the Patient-Reported Outcomes Measurement Information System® (PROMIS)-Fatigue Short Form 7a (SF-7a) v1.0 scale to determine its suitability in clinical trials to assess fatigue in patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC).

methodsA qualitative interview assessed patients' experience living with CD (N = 20) and UC (N = 19). The contents of the SF-7a scale were cognitively debriefed to evaluate content validity. A psychometric evaluation was performed using data from clinical trials of patients with CD (N = 360) and UC (N = 214). Correlations with Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Activity Index (CDAI; CD only), and Mayo score (UC only) determined validity. The Patient Global Impression of Change (PGIC) was used to evaluate reliability and responsiveness to change. Using PGIC as an anchor, a preliminary threshold for clinically meaningful change was identified to define fatigue response in both CD and UC patients.

resultsAll patients reported fatigue as a common symptom. Patients confirmed SF-7a items were relevant to assessing fatigue, instructions and response options were clear, and its 7-day recall period was appropriate. Higher SF-7a scores were associated with higher disease activity (CDAI and Mayo score) and lower health-related quality of life (IBDQ), confirming known groups validity. The correlation of the SF-7a scale was higher with fatigue-related items. (r

conclusionThe SF-7a scale is a valid, reliable, and sensitive measure of fatigue in patients with moderately to severely active IBD and can be used to evaluate treatment response.

Indexed as

Colitis, UlcerativeCrohn DiseaseFabaceaeInflammatory Bowel DiseasesHumansPsychometricsQuality of LifeReproducibility of ResultsCrohn’s diseaseDisease activityFatiguePatient-reported outcomes Measurement Information System® (PROMIS)-Fatigue Short Form 7a (SF-7a) scaleUlcerative colitis

Identifiers

PMID37962770
PMCPMC10645698
OpenAlexW4388657268

What OpenQuestion holds

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LicenceCC BY
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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.