A guide to the reporting of protocols of pilot and feasibility trials
Bibliographic record
Abstract
Publishing protocols of trials including protocols of pilot and feasibility trials—designed to inform the designs of main trials—has been advocated as an important strategy towards improving transparency in the conduct and reporting of main trials and pilot/feasibility trials. This editorial aims to provide some general guidance on how to report protocols of pilot and feasibility trials, drawing upon two available resources—the CONSORT extension to pilot trials and the SPIRIT guideline for main trials. We describe how these might be adapted for the reporting of protocol manuscripts of pilot and feasibility trials for submission in Pilot and Feasibility Studies journal.
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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 | 0.218 | 0.448 |
| Meta-epidemiology (narrow) | 0.003 | 0.004 |
| Meta-epidemiology (broad) | 0.005 | 0.004 |
| Bibliometrics | 0.012 | 0.007 |
| Science and technology studies | 0.003 | 0.007 |
| Scholarly communication | 0.010 | 0.008 |
| Open science | 0.007 | 0.005 |
| Research integrity | 0.012 | 0.029 |
| Insufficient payload (model declined to judge) | 0.026 | 0.052 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".