S1383 Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Adults With Moderate to Severe Crohn’s Disease
Bibliographic record
Abstract
Introduction: This study provides evidence on the measurement properties of the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) and determines thresholds for meaningful improvement in patients with moderately to severely active Crohn's disease (CD). Methods: Pooled data from VIVID-1, a phase 3, multicenter, randomized, placebo- and active-controlled study of mirikizumab, were used to evaluate the reliability, validity, and responsiveness of the FACIT-Fatigue at Weeks 0 (Baseline), 12, and 52. Other assessments completed in the trial were used for these analyses, including the: Patient Global Rating of Severity (PGRS), Patient Global Impression of Change (PGIC), Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn’s Disease Activity Index (CDAI), and 36-Item Short Form Health Survey (SF-36). An anchor-based approach was used to estimate the FACIT-Fatigue total score that would constitute meaningful change. PGRS and PGIC were used as primary anchors. Results: Analyses included 1065 adults (mean age 36.2±13.0 years). The mean FACIT-Fatigue total score improved during the study (Baseline: 31.5; Week 12: 37.1; Week 52: 40.0). The measure demonstrated excellent internal consistency and reliability across visits (Cronbach’s alpha: 0.92–0.94); correlations between individual items and the total score were moderate (0.30≤ r < 0.70) to large (r ≥0.70). Across visits, the FACIT-Fatigue showed moderate-to-large correlations with the PGRS; IBDQ Bowel Function domain, item 2 (fatigue), and total score; CDAI score; and SF-36 Vitality domain score. Correlations with clinical measures were weak (r < 0.30), as hypothesized. FACIT-Fatigue could discriminate between participant groups known to differ based on PGRS, IBDQ total score, and IBDQ item 2. FACIT-Fatigue was able to detect change, as total score improvements from baseline to weeks 12 and 52 were statistically significantly different between most PGRS change groups and PGIC groups, and between groups based on IBDQ response/remission, IBDQ item 2, SF-36 Vitality domain, and clinical response/remission by CDAI. Anchor-based analyses suggested that a 6–9-point increase in the FACIT-Fatigue total score would represent meaningful improvement. Conclusion: The findings expand upon previous evidence supporting the use of the FACIT-Fatigue as a reliable and valid measure in adults with moderately to severely active CD, with a clinically meaningful improvement threshold range of 6-9 points.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".