Purpose: To provide further evidence on the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in moderately to severely active Crohn's disease (CD), and to determine thresholds for meaningful improvement in fatigue.
Methods: The FACIT-Fatigue is a 13-item patient-reported outcome measure (range, 0-52) assessing fatigue over the previous week. Using pooled data from the Phase 3 VIVID-1 study of moderately to severely active CD, psychometric properties of FACIT-Fatigue were evaluated up to Week 52. The Patient Global Rating of Severity (PGRS) and Patient Global Impression of Change (PGIC) were used as primary anchors to estimate the FACIT-Fatigue score change representing meaningful improvement.
Results: Psychometric analyses included 1065 adults. The FACIT-Fatigue demonstrated good internal consistency, and correlations between individual items and the total score were moderate to strong. The FACIT-Fatigue score showed moderate to strong correlations with other patient-reported assessments and weak correlations with endoscopic/laboratory assessments. The FACIT-Fatigue differentiated between distinct groups of participants varying in disease severity, quality of life, and fatigue based on PGRS and other assessments. FACIT-Fatigue improvements during the study differed significantly between most PGRS change and PGIC categories. Anchor-based estimates suggested a 6-9-point increase in the FACIT-Fatigue total score as meaningful improvement.
Conclusions: The FACIT-Fatigue demonstrated strong psychometric properties in the VIVID-1 population of adults with moderately to severely active CD and determined a FACIT-Fatigue score change threshold representing meaningful improvement.
Trial registration: NCT03926130. Registered 23 April 2019, https://clinicaltrials.gov/study/NCT03926130 .
Keywords: Crohn’s disease; Fatigue; Functional Assessment of Chronic Illness therapy–fatigue; Patient-reported outcome; Psychometric evaluation.
Fatigue, a state of extreme tiredness, exhaustion, or lack of energy that does not get better after sleeping, is one of the symptoms of Crohn’s disease that has the most impact on patients’ lives. People can use the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue), a survey of 13 questions, to rate their own fatigue from the previous week. This study explored how well the FACIT-Fatigue assessed fatigue in people with Crohn’s disease who took part in a clinical trial. People in the trial completed the FACIT-Fatigue as well as other surveys at different times. FACIT-Fatigue scores related to scores on other surveys about their Crohn’s disease. FACIT-Fatigue was able to tell apart groups of people expected to have different levels of fatigue based on their scores on other surveys. FACIT-Fatigue scores improved when people improved based on other surveys, confirming that the FACIT-Fatigue was responsive to changes in health. Finally, we estimated how much of a change in the FACIT-Fatigue score would represent a meaningful improvement in fatigue to people such as those in the trial. These findings show that the FACIT-Fatigue survey can be used to measure fatigue in people with Crohn’s disease, and to tell us whether their experience of fatigue has improved over time (for example, when they take a medicine).
© 2024. The Author(s).