Evidence map›Paper›PMID 40728672›Full record

Observational studyJournal of patient-reported outcomes2025

Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients.

Sheryl Pease, Rikki Mangrum, Karolina Schantz, Christina Slota, Lindsey Rubin, Susan Martin, Cathye Shu, Kayla Scippa

Abstract readObservational Study
In one paragraph

Observational study in Journal of patient-reported outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Observational
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

8 authors.

Sheryl PeaseJohnson & Johnson, Patient Reported Outcomes, Raritan, NJ, USA.
Rikki MangrumVector Psychometric Group, LLC, Chapel Hill, NC, USA. rikki.mangrum@vpgcentral.com.ORCID http://orcid.org/0000-0001-6231-5890
Karolina SchantzVector Psychometric Group, LLC, Chapel Hill, NC, USA.
Christina SlotaRTI Health Solutions, Patient-Centered Outcomes Assessment, Research Triangle Park, NC, USA.
Lindsey RubinVector Psychometric Group, LLC, Chapel Hill, NC, USA.
Susan MartinRTI Health Solutions, Patient-Centered Outcomes Assessment, Research Triangle Park, NC, USA.
Cathye ShuJohnson & Johnson, Immunology, Spring House, PA, USA.
Kayla ScippaJohnson & Johnson, Patient Reported Outcomes, Raritan, NJ, USA.

Funding

Johnson and Johnson NA
6 · The paper itself

Abstract

purposeWarm autoimmune hemolytic anemia (wAIHA) is a rare disorder characterized by premature destruction of red blood cells (hemolysis) and fatigue that affects patients' health-related quality of life. This study aimed to identify fatigue concepts important to patients and evaluate the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) in the wAIHA patient population. METHODOLOGY: Two observational studies collected data via 60-minute, individual interviews. Eligible participants were English-speaking, US-resident adults diagnosed with wAIHA by a physician. Both studies gathered data regarding fatigue experiences that mattered to patients and comprehension and relevance of the FACIT-Fatigue; one study also gathered data about patient perspectives on meaningful change in item-level response selection.

resultsEach study enrolled 10 individuals with wAIHA (n = 20). All participants described fatigue as the most prominent or most bothersome symptom, with substantial impacts on daily functioning, family and social life, and emotional well-being. The FACIT-Fatigue was well understood, comprehensive, and relevant to participants' experiences with wAIHA. Data analysis indicated that at least a 3-point change in total score likely reflects a meaningful change in fatigue.

conclusionsFatigue is the primary patient-reported wAIHA symptom and important to measure from the patient perspective. Findings demonstrated that wAIHA patients found the FACIT-Fatigue understandable, comprehensive, and relevant, and the data indicated that the instrument can detect a meaningful change in fatigue symptoms and impacts. Study findings support the content validity of the FACIT-Fatigue and contribute to the evidence that the FACIT-Fatigue is fit-for-purpose to evaluate fatigue in adults with wAIHA.

Indexed as

Anemia, Hemolytic, AutoimmuneFatigueQuality of LifeAdultAgedFemaleHumansInterviews as TopicMaleMiddle AgedQualitative ResearchReproducibility of ResultsSurveys and QuestionnairesCognitive debriefingConcept elicitationFACIT-FatiguePatient-reported outcomesRare diseaseWarm autoimmune hemolytic anemia

Identifiers

PMID40728672
PMCPMC12307827

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.