Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2025
Psychometric analysis of the Neuro-QoL Fatigue in generalized Myasthenia Gravis (gMG) using data from a phase 3 trial.
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 NCT04951622 (Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis), which is not on this map. Cited by 1 paper.
What it found
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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.
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.
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the psychometric properties of the Neuro-QoL Fatigue patient-reported outcome measure and its short form when used to assess fatigue in adults living with generalized Myasthenia Gravis (gMG).
methodsData from Vivacity-MG3 (ClinicalTrials.gov Identifier: NCT04951622), a double-blind placebo-controlled phase 3 study of nipocalimab enrolled 196 participants living with gMG were analyzed. Psychometric analyses of Neuro-QoL Fatigue scores (19-item version and short-form version) focused on data from Baseline and the 24-week double-blind interventional phase of the trial. Factor analytic and classical test theory (CTT) analyses were performed to investigate support for intended Neuro-QoL Fatigue score use, along with convergent and discriminant relationships, known groups analyses, and sensitivity to change analyses. Thresholds to define meaningful within-person change (improvement) over time were also investigated.
resultsThe full form factor analytic analyses showed evidence that a unidimensional model adequately fits the data (TLI = 0.99, RMSEA = 0.07), CTT analyses showed high internal consistency (alpha = 0.95), and high test-retest reliability for stable participants (r = 0.92); similar results were observed for the short form. Both versions' scores were correlated with a variety of reference variables at expected levels, demonstrated the ability to differentiate between clinically meaningfully distinct groups, and were significantly correlated with changes in other reference variables. Analyses suggested 19-item and short-form score changes of 6.7 and 7.6, respectively, as showing meaningful improvement over time.
conclusionsResults provided robust psychometric evidence that supports the use of Neuro-QoL Fatigue scores for assessing fatigue in adults living with gMG.
Indexed as
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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.