Estimating meaningful change thresholds (MCTs) for selected scales from the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires in the phase 3 SERENA-6 trial in patients with hormone receptor-positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ABC).
Bibliographic record
Abstract
409 Background: Interpretation of patient-reported outcome (PRO) data from oncology clinical trials requires that MCTs are defined for within-participant change and between-group differences. This study aimed to estimate MCTs for selected EORTC quality of life (QoL) 30-item core questionnaire (QLQ-C30) scales and breast cancer-specific module (QLQ-BR23) scales using data from the SERENA-6 study in patients with ABC switching first-line endocrine therapy at emergence of ESR1 mutations ahead of clinical or radiologic progression; patients switched to camizestrant or continued to receive aromatase inhibitor, with CDK4/6 inhibitor maintained. Methods: Pre-specified analyses were performed to define MCTs in EORTC-QLQ-C30 Global Health Status/Quality of Life (GHS/QoL), functional (physical, role, emotional, cognitive, social) and symptom (pain and fatigue) scores as well as EORTC-QLQ-BR23 arm and breast symptom scores using pooled, blinded patient data from baseline, weeks 12 and 28. Patient Global Impression of Severity, Patient Global Impression of Change, and EORTC-QLQ-C30 item 29 were used as anchors. Anchor adequacy was assessed using correlation coefficients, with values ≥0.371 considered adequate. Within-participant thresholds for both improvement and deterioration were derived through a triangulation process that utilized anchor- and distribution-based methods. Within-participant MCT estimates were additionally evaluated against the possible amount of change observable on each scale. For scales where no appropriate anchor was identified, distribution-based methods were used. Between-group thresholds were also estimated. Results: In total, 124, 121, and 82 participants had scores from evaluable forms at baseline, week 12, and week 28, respectively, for all scales. Anchor correlations were appropriate (≥0.371) for at least one anchor for all scales except for emotional functioning and arm symptoms, where anchor correlations were lower (< 0.371). Within-participant threshold for deterioration was estimated as –16.7 points for GHS/QoL, role, emotional, cognitive and social functioning, +16.7 points for pain and breast symptoms, +22.2 points for fatigue and arm symptoms, and –13.3 points for physical functioning. The between-group MCT ranged from 2.5 to 10.8 across the selected scales. Conclusions: MCTs were determined for the selected EORTC scales for use in the PRO endpoint definition and data interpretation in SERENA-6 and another study with a similar population. Using MCTs estimated from blinded study data provides context-specific thresholds that may accurately reflect a meaningful change in PROs for patients in the targeted study population. Clinical trial information: NCT04964934 .
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 |
| 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".