A randomised controlled trial comparing epinephrine and dexamethasone to placebo in the treatment of infants with bronchiolitis (BIPED study): a statistical analysis plan
Bibliographic record
Abstract
BACKGROUND: Bronchiolitis is a common lung infection that affects infants and young children. While most children can be treated at home, some require hospitalisation where supportive care, such as fluids and oxygen, is the suggested treatment. Bronchiolitis is the leading cause of infant hospitalisation in developed countries and exerts a significant burden on the healthcare system. The aim of the Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone (BIPED) study is to evaluate the effects of a combination of epinephrine and dexamethasone, given during initial presentation at the emergency department, on hospitalisation for bronchiolitis. This article outlines the statistical analysis plan (SAP) for the BIPED study. The BIPED study is a Phase III, multi-centre, randomised, controlled, double-blinded superiority, placebo-controlled trial to determine whether the combination of epinephrine and dexamethasone is successful in reducing hospitalisation for bronchiolitis up to 7 days following presentation at an emergency department with bronchiolitis. The secondary outcomes include hospital admissions for bronchiolitis at the emergency department enrolment visit, and all-cause hospital admissions, health care provider visits and health care-related costs in the 21 days following enrolment. The safety outcomes are gastrointestinal bleeding, serious bacterial infection, severe varicella and death. DISCUSSION: The BIPED study will provide evidence on whether a combination of epinephrine and dexamethasone reduces hospitalisation in infants following presentation to the emergency department with bronchiolitis. These data will be analyzed using this SAP, submitted before the data became available for analysis, to reduce the risk of bias in our reported outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03567473. Registered on June 25, 2018.
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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 | 0.019 | 0.028 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.008 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.013 | 0.001 |
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".