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Psychometric validation of the PROMIS Fatigue-Short Form 7a in adults with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease: the ARISE and ENCORE studies

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Title: Psychometric validation of the PROMIS Fatigue-Short Form 7a in adults with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease: the ARISE and ENCORE studies
Authors: Kevin C. Mange, Daniel Serrano, Mariam Hassan, Marie-Laure Nevoret, Dayton W. Yuen, Shauna McManus, Lauren Podger, Bryant Barnes, Charles L. Daley
Source: Journal of Patient-Reported Outcomes, Vol 9, Iss 1, Pp 1-13 (2025)
Publisher Information: SpringerOpen, 2025.
Publication Year: 2025
Collection: LCC:Public aspects of medicine
Subject Terms: Fatigue, Lung disease, Mycobacterium avium complex, Patient-reported outcome, Psychometric validation, Public aspects of medicine, RA1-1270
Description: Abstract Background Fatigue symptoms contribute to the burden of Mycobacterium avium complex (MAC) lung disease. This study evaluated the psychometric properties of the Patient Reported Outcomes Measurement Information System Short Form v1.0 – Fatigue 7a (PROMIS-F SF-7a) in adults with a new or recurrent diagnosis of MAC lung disease. Methods Data from the ARISE (NCT04677543) and ENCORE (NCT04677569) phase 3 trials were analyzed. Modern psychometric methods were employed to confirm the structural validity of the PROMIS-F SF-7a within this context of use. Classical methods were used to confirm the reliability and validity of the PROMIS-F SF-7a within this context of use. Internal consistency (McDonald’s omega, Cronbach’s alpha), test-retest reliability (two-way mixed effects intraclass correlation coefficient [ICC(2,1)]), and known-groups validity across Patient Global Impression of Severity (PGI-S) Fatigue groups were estimated. Convergent validity (Pearson correlations) was assessed by correlating PROMIS-F SF-7a scores with scores on the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), EXACT Respiratory Symptoms (E-RS), St. George Respiratory Questionnaire (SGRQ), and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. Meaningful within-patient change (MWPC) thresholds were determined using anchor-based methods. Results The baseline sample included 231 patients (99 ARISE, 132 ENCORE). The cross-sectional validation sample comprised 230 patients (excluding 1 ARISE patient with missing item-level PROMIS-F SF-7a data). The longitudinal validation analysis sample comprised all 99 ARISE patients. Modern psychometric methods supported the relevance of all items and a unidimensional unit-weighted sum score for the PROMIS-F SF-7a. The PROMIS-F SF-7a demonstrated strong internal consistency (Cronbach’s alpha: 0.86), test-retest reliability (ICC[2, 1]: 0.76), and convergent validity (FACIT-Fatigue: −0.80, EXACT: 0.56, E-RS: 0.52, SGRQ: 0.66). Known-groups validity was demonstrated across PGI-S Fatigue groups. The MWPC analyses supported a −4.00-point median change from baseline (95% CI: −3.00 to −6.00 points) as the estimated threshold of clinically meaningful within-patient improvement for the PROMIS-F SF-7a. Conclusions The PROMIS-F SF-7a is a robust, sensitive, and responsive measure of fatigue in adult patients with a new or recurrent diagnosis of MAC lung disease. It is content and psychometrically valid and appears to have interpretability to assess a threshold of MWPC for fatigue symptoms in this population. Trial registration ClinicalTrials.gov. NCT04677543, registered 16 December 2020, https://clinicaltrials.gov/study/NCT04677543 . NCT04677569, registered 16 December 2020, https://www.clinicaltrials.gov/study/NCT04677569 .
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2509-8020
Relation: https://doaj.org/toc/2509-8020
DOI: 10.1186/s41687-025-00944-8
Access URL: https://doaj.org/article/c6c9a4de9aaa4aec8dfd336f29611599
Accession Number: edsdoj.6c9a4de9aaa4aec8dfd336f29611599
Database: Directory of Open Access Journals
Description
Abstract:Abstract Background Fatigue symptoms contribute to the burden of Mycobacterium avium complex (MAC) lung disease. This study evaluated the psychometric properties of the Patient Reported Outcomes Measurement Information System Short Form v1.0 – Fatigue 7a (PROMIS-F SF-7a) in adults with a new or recurrent diagnosis of MAC lung disease. Methods Data from the ARISE (NCT04677543) and ENCORE (NCT04677569) phase 3 trials were analyzed. Modern psychometric methods were employed to confirm the structural validity of the PROMIS-F SF-7a within this context of use. Classical methods were used to confirm the reliability and validity of the PROMIS-F SF-7a within this context of use. Internal consistency (McDonald’s omega, Cronbach’s alpha), test-retest reliability (two-way mixed effects intraclass correlation coefficient [ICC(2,1)]), and known-groups validity across Patient Global Impression of Severity (PGI-S) Fatigue groups were estimated. Convergent validity (Pearson correlations) was assessed by correlating PROMIS-F SF-7a scores with scores on the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), EXACT Respiratory Symptoms (E-RS), St. George Respiratory Questionnaire (SGRQ), and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. Meaningful within-patient change (MWPC) thresholds were determined using anchor-based methods. Results The baseline sample included 231 patients (99 ARISE, 132 ENCORE). The cross-sectional validation sample comprised 230 patients (excluding 1 ARISE patient with missing item-level PROMIS-F SF-7a data). The longitudinal validation analysis sample comprised all 99 ARISE patients. Modern psychometric methods supported the relevance of all items and a unidimensional unit-weighted sum score for the PROMIS-F SF-7a. The PROMIS-F SF-7a demonstrated strong internal consistency (Cronbach’s alpha: 0.86), test-retest reliability (ICC[2, 1]: 0.76), and convergent validity (FACIT-Fatigue: −0.80, EXACT: 0.56, E-RS: 0.52, SGRQ: 0.66). Known-groups validity was demonstrated across PGI-S Fatigue groups. The MWPC analyses supported a −4.00-point median change from baseline (95% CI: −3.00 to −6.00 points) as the estimated threshold of clinically meaningful within-patient improvement for the PROMIS-F SF-7a. Conclusions The PROMIS-F SF-7a is a robust, sensitive, and responsive measure of fatigue in adult patients with a new or recurrent diagnosis of MAC lung disease. It is content and psychometrically valid and appears to have interpretability to assess a threshold of MWPC for fatigue symptoms in this population. Trial registration ClinicalTrials.gov. NCT04677543, registered 16 December 2020, https://clinicaltrials.gov/study/NCT04677543 . NCT04677569, registered 16 December 2020, https://www.clinicaltrials.gov/study/NCT04677569 .
ISSN:25098020
DOI:10.1186/s41687-025-00944-8