SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)
Bibliographic record
Abstract
The SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials) contains guidance for authors of protocols for randomized and nonrandomized clinical trials. Funding agencies, institutional review boards (IRB), journals, and regulators can also use SPIRIT as their standard guidance for the content of submitted protocols. The SPIRIT initiative also includes a comprehensive Explanation and Elaboration (E&E) paper. This document provides information to promote a more complete understanding of the checklist recommendations. The author recommends that the E&E paper be used in conjunction with the SPIRIT 2013 Statement. SPIRIT 2013 can be used by investigators developing any type of clinical trial protocol, regardless of topic, intervention type, or study design. This chapter includes five items enshrining several important administrative elements of trial protocol development and conduct, including the title, protocol version, trial registration, funding, and the roles and responsibilities of the sponsor and key members of the protocol development team.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.248 | 0.507 |
| Meta-epidemiology (narrow) | 0.004 | 0.008 |
| Meta-epidemiology (broad) | 0.006 | 0.011 |
| Bibliometrics | 0.013 | 0.016 |
| Science and technology studies | 0.003 | 0.005 |
| Scholarly communication | 0.010 | 0.006 |
| Open science | 0.008 | 0.006 |
| Research integrity | 0.012 | 0.022 |
| Insufficient payload (model declined to judge) | 0.123 | 0.085 |
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".