International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER): Study protocol for a multicenter, batched, parallel, cluster-randomized trial with a baseline period
Bibliographic record
Abstract
RATIONALE: A care bundle approach to the management of spontaneous intracerebral hemorrhage (ICH) has been shown to benefit patients in low- and middle-income countries (LMIC), but uncertainty persists over the specific components and its applicability in high-income countries (HICs). AIMS: An international collaborative initiative aimed at determining whether implementation of a care bundle improves functional outcome for patients with ICH in HIC. METHODS: An international, multicenter, batched, parallel, cluster-randomized clinical trial focused on implementation and quality improvement for adults with spontaneous ICH ⩽ 24 h of symptom onset. The care bundle includes time- and target-based interventions: early intensive blood pressure lowering, hyperglycemia and pyrexia management, anticoagulation reversal, avoidance of do-not-resuscitate orders, repeat imaging, and referral pathways for intensive care and neurosurgery. An embedded process evaluation will assess the effectiveness and implementation of the care bundle. SAMPLE SIZE: A total of 110 hospitals with 3500 ICH participants is estimated to provide 90% power (α = 0.05) to detect a plausible treatment effect of 0.20 improvement in utility-weighted modified Rankin scale (UW-mRS) scores. OUTCOMES: The primary outcome is UW-mRS at 6 months. Secondary outcomes include death, functional status, and health-related quality of life. Implementation outcomes include adoption, fidelity, acceptability, sustainability, and integration. DISCUSSION: We aim to provide reliable evidence to accelerate practice change for integration of a multifaceted ICH care bundle as a critical component of acute stroke care worldwide. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT06429332.
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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 | 0.039 | 0.039 |
| Meta-epidemiology (narrow) | 0.009 | 0.004 |
| Meta-epidemiology (broad) | 0.013 | 0.006 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.005 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.007 | 0.009 |
| Insufficient payload (model declined to judge) | 0.059 | 0.012 |
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".