Stress Ulcer Prophylaxis Prescribing Options for Critically Ill Patients in Hospitals Participating in a Randomized Controlled Trial: A Protocol and Statistical Analysis Plan
Bibliographic record
Abstract
Abstract Background Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) predominate as stress ulcer prophylaxis (SUP) agents in intensive care units (ICUs). Prescribing patterns may change over time as randomized controlled trials evaluate SUP in critically ill patients. Objective This study aims to compare site-specific, self-reported SUP prescribing practices before and after the REVISE trial in participating ICUs. Methods This is a pre-planned study as part of the REVISE trial ( NCT03374800 ), which compared intravenous pantoprazole with placebo in mechanically ventilated patients. The REVISE trial showed that intravenous pantoprazole reduced the risk of clinically important upper gastrointestinal bleeding (GIB) and patient-important upper GIB, without a significant effect on mortality or other clinical outcomes. We conducted a survey of all research teams (paired research coordinators and site physicians) in 68 participating trial centers, both before they enrolled patients and after the completion of the trial to record their self-reported SUP practice patterns. Results We will report ICU-level data on the typical SUP agent prescribed, the presence and content of preprinted orders or electronic admission order sets, and SUP discontinuation practices. We will apply descriptive statistics to summarize these patterns and compare them between the pre- and post-trial phases. Conclusions This study will describe contemporary data on SUP prescribing and discontinuation patterns before and after an international randomized controlled trial in participating trial centers.
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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 | 0.097 | 0.116 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.008 | 0.007 |
| Bibliometrics | 0.005 | 0.006 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.038 | 0.005 |
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".