Improvement in health related quality of life in infliximab-treated moderate-tosevere active ulcerative colitis patients: Improvement overall and by baseline disease activity
Bibliographic record
Abstract
To evaluate the long-term effect of IFX on health related quality of life (HRQL) in pts with moderate-to-severe active UC in ACT 1. The relationship between baseline disease activity (measured by the Mayo Clinic score) and the magnitude of improvement in HRQL (data from ACT 1 and ACT 2) was examined. Pts with moderate-to-severe active UC (baseline Mayo score between 6 and 12, inclusive) were enrolled in ACT 1 (n=364) and ACT 2 (n=364). Pts were randomized (1:1:1) to PBO, IFX 5, or 10 mg/kg at baseline, wks 2, 6, and q8 wks through wk 22 in ACT 2 and through wk46 in ACT 1. HRQL was assessed using the IBDQ and the SF-36,with Physical and Mental Component Summaries (PCS, MCS) at baseline, wks 8, and 30 (ACT 1 and ACT 2), and at wk 54 (ACT 1). Results at 1-yr are reported for ACT 1 and analyses using data from the combined trials were used to determine the improvement in HRQL by baseline disease severity [Mayo score (moderate UC: UC outpts with Mayo score<10; severe UC: UC outpts with Mayo score ≥10)]. Analysis of variance on van der Waerden scores was used to compare groups. In ACT 1, at wk 54, the IFX groups had > improvements from baseline than PBO (p<0.05 except for MCS in the 5 mg/kg group), with the following comparisons [mean (median)] between the combined IFX group vs PBO: Total IBDQ [32 (23) vs 13 (0.0)], PCS [6.0 (2.5) vs 2.7 (0.0)], and MCS [5.1 (0.0) vs 1.3 (0.0)]. All 4 IBDQ dimensions and all 8 scales of the SF-36 also showed > improvements in the combined IFX group vs PBO (p<0.05). Moderate UC pts had higher baseline scores in the IBDQ and PCS and MCS, than those with severe UC (Table). In both severity groups, there was a > improvement in all 3 HRQL scores in the combined IFX group vs PBO, at both wk 8 and 30. The magnitude of improvement in HRQL was similar regardless of baseline disease severity. Mean baseline score and mean improvement from baseline at wks 8 and 30 Pts with moderate-to-severe active UC had significant improvement in HRQL through 1-yr of IFX treatment. IFX treatment results in consistent improvement in HRQL in pts with UC, irrespective of baseline disease severity.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 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".