Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL) – Rationale and Study Protocol
Bibliographic record
Abstract
AIMS: The objective of the Randomized comparison of the Outcome of single vs. Multiple Arterial grafts: Quality of Life (ROMA:QOL) trial is to evaluate the impact of coronary artery bypass graft surgery (CABG) on quality of life (QOL). The primary hypothesis of ROMA:QOL is that participants in the multiple arterial graft (MAG) will report time-varying changes in QOL that will be lower in the post-operative recovery period and higher after 12 months compared to patients in the single arterial graft (SAG). The secondary hypotheses are that both groups will have improvements in symptoms at 12 months, and that compared to the SAG group, participants in the MAG group will experience better physical functioning and physical and mental health symptoms. METHODS AND RESULTS: An estimated 2111 participants will be enrolled from the parent ROMA trial from 13 countries. Outcome assessments include the Seattle Angina Questionnaire (SAQ) (primary outcome), Short Form-12v2, EuroQol-5D (EQ-5D)-5L, PROMIS-29, and PROMIS Neuropathic Pain measured at baseline, first post-operative visit, 6, 12, 24, 36, 48, and 60 months. The analysis for the primary outcome, the change in the SAQ from baseline to 12 months, will be compared across all time-points between the two treatment arms. CONCLUSION: The ROMA:QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.
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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 | 0.031 | 0.030 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.040 | 0.008 |
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".