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
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 231 participants or records.
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