S786 Psychometric Evaluation of PROMIS-Fatigue Short Form Scales in Patients With Moderately to Severely Active Crohn’s Disease
Bibliographic record
Abstract
Introduction: Fatigue is common among patients (pts) with Crohn’s disease (CD). Accurate assessment of pt fatigue is critical and may be correlated with disease activity and negatively impact health-related quality of life. This study evaluated the psychometric properties of the Patient-Reported Outcomes Measurement Information System-Fatigue Short Form 7a (SF-7a) and 4a (SF-4a) scales, which assessed the frequency and severity of fatigue, respectively, in pts with CD. Methods: GALAXI-1, a Phase 2, dose-ranging, blinded, active- and placebo-controlled study, evaluated the efficacy and safety of guselkumab in pts with moderately to severely active CD. Pooled data from an interim database lock at Week 12 (N = 245) were used to assess SF-7a and SF-4a, Crohn’s Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), and Patient Global Impression of Disease Severity (PGIS) and Change (PGIC). Raw scores of SF-4a and SF-7a were converted into a standardized T-score, where a T-score >50 indicated fatigue. Results: At baseline, the mean±standard deviation values of SF-7a (fatigue frequency) and SF-4a (fatigue severity) were 58.8±8.29 and 56.9±9.26, respectively. At Week 12, mean values of SF-7a and SF-4a correlated with an increasing trend in disease severity at Week 12 with PGIS categories and CDAI quartiles (worse health) but a decreasing trend with IBDQ total score quartiles (better health). The scales were reliable (intraclass coefficient ≥0.77) and able to detect changes in disease severity assessed by the PGIS or PGIC at Week 12. A strong correlation (r = -0.81) with the IBDQ “feeling fatigue” item and a weak correlation (r = -0.25) with IBDQ “rectal bleeding” item were also observed, further confirming convergent and divergent validity. Using PGIC as an anchor variable for assessing clinically meaningful improvements from baseline to Week 12, a 1-level change (improvement) by feeling “a little better” was associated with a 4.2- and 3.4-point reduction in SF-7a and SF-4a, respectively. Similarly, a 2-level change by feeling “moderately better” was associated with a 5.5- and 6.2-point reduction in SF-7a and SF-4a, respectively. Conclusion: This psychometric analysis demonstrated that the SF-7a and SF-4a scales are valid, reliable, and sensitive assessments to measure fatigue in pts with moderately to severely active CD. A change in mean scale scores of 4 to 6 points indicated a clinically meaningful improvement in fatigue response.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.013 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".