Study protocol for DICE trial: Video-assisted thoracoscopic surgery decortication versus interventional radiology guided chest tube insertion for the management of empyema
Bibliographic record
Abstract
BACKGROUND: Empyema is a common thoracic surgery presentation, defined as pus in the pleural space. Despite the commonality of empyema, consensus on initial management remains ambiguous. Two standard of care treatment options include inserting a chest tube (thoracostomy) and the administration of intrapleural fibrinolytics, or an initial surgical approach, surgical decortication. Due to the complexity of this pleural space infection, often repeat interventions are required after initial management in order to achieve source control and resolution of clinical symptoms. This study aims to identify the most effective initial management option for empyema. STUDY DESIGN: We present a study protocol for a randomized control trial (RCT) comparing adult individuals with empyema to one of two standard of care initial management options. Participants will be randomized into either interventional radiology guided chest tube insertion with intrapleural fibrinolytics (Dornase 5 mg and Alteplase 10 mg intrapleural twice daily for three days) or video-assisted thoracoscopic surgery (VATS) decortication. METHODS: All adults with empyema meeting inclusion criteria will be invited to participate. They will be randomized into one of two intervention groups; interventional radiology guided chest tube insertion with fibrinolytics or initial VATS decortication. Each intervention will take place within 48 hours of randomization. The primary outcome will be the rate of re-intervention within 30 days. Re-intervention is defined as repeat chest tube insertion, VATS decortication, or decortication via thoracotomy. Secondary outcomes include a change in the size of empyema, length of stay, morbidity, as well as 30-day and 90-day mortality, as well as quality of life measurements. ANTICIPATED IMPACT: This study is aimed at identifying the most effective initial management option for individuals with empyema.
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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 | 0.027 | 0.058 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.007 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.010 | 0.009 |
| Insufficient payload (model declined to judge) | 0.097 | 0.014 |
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".