Methods of Analysis in Randomized Noninferiority Trials: Methodological Survey Review Protocol
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Background: Noninferiority (NI) trial designs that investigate whether an experimental intervention is no worse than the standard of care have been used increasingly in recent years. The robustness of the conclusions depends in part on the analysis population set used. In NI settings, the intention-to-treat (ITT) and per-protocol (PP) analysis sets are most common. The ITT analysis has been considered anticonservative compared with the PP analysis. Objective: This study aimed to conduct a methodological review assessing the analysis population sets used in contemporary NI trials. Methods: A comprehensive electronic search strategy will be conducted to identify studies indexed in MEDLINE, Embase, Emcare, and Cochrane CENTRAL. Studies will be included if they are NI trials published in 2024. The primary outcome is the analysis population used for the primary analysis of the trial (ITT, PP, or as-treated). Secondary outcomes include the NI margin, effect estimates, point estimates, and corresponding CIs. Analyses will be performed using descriptive statistics. Results: The comprehensive search initially identified 1209 studies, of which 403 trials were eligible for data extraction. Data extraction began in January 2025 and is expected to be completed in January 2026. Conclusions: This methodological survey of NI trials will describe the analysis population used in the primary analysis and assess factors that may be associated with each analysis method.
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Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | Metaresearch Domain: Methods · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Not applicable | low |
| gpt | Metaresearch Domain: Methods · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Theoretical or conceptual | medium |
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 | 0.641 | 0.865 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.010 | 0.001 |
| Bibliometrics | 0.001 | 0.007 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| 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 it