Patient-Reported Quality of Life in the BENEFIT Trial (P4.180)
Bibliographic record
Abstract
OBJECTIVE: To describe long-term QoL in BENEFIT BACKGROUND: In BENEFIT, patients with clinically isolated syndrome (CIS) randomized to early treatment with interferon beta-1b (IFNB-1b) had a longer time to reach clinically-definite multiple sclerosis (CDMS) and a lower annualized relapse rate than patients who received delayed treatment. Patient-reported outcomes (PROs) can provide valuable assessments of long-term quality of life (QoL). DESIGN/METHODS: Of the 468 patients with CIS (initially randomized to either IFNB-1b [early treatment] or placebo [delayed treatment]), 284 entered into the extension study and were followed for up to 8.7 years. QoL was assessed by the FAMS, EQ-5D, and EQ-VAS at screening and every 6 months thereafter. RESULTS: 195, 265, and 263 patients had FAMS, EQ-5D, and EQ-VAS scores respectively at baseline, with 111, 156, and 156 at Year 8. Baseline PRO scores (FAMS, EQ-5D, EQ-VAS) were relatively high and remained so for most patients for all 3 measures. At baseline mean [SD] FAMS-Trial Outcome Index (TOI) was for IFNB-1b: 122.73 [19.0], placebo: 127.79 [15.7] with only a slight decrease over time (mean [SD] change from baseline scores: early: -6.94 [21.45], delayed: -5.34 [23.12]). FAMS total scores showed a similar course, mainly driven by the family/social well-being and additional concerns subscales. Differences between treatment groups in FAMS-TOI or FAMS total score over the 8.7 years were not significant. For the early treatment group, EQ-5D scores tended to remain constant with a favorable trend compared with delayed treatment. No differences were observed on the EQ-VAS. CONCLUSIONS: PRO scores were comparable across early and delayed treatment groups and remained at high levels with only a slight decline over time in both groups. Although a bias due to only partial ascertainment of PROs and selective drop out cannot be excluded, these findings indicate an overall beneficial effect of IFNB-1b on PRO reported QoL. Study Supported by: Bayer HealthCare Pharmaceuticals
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 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".