External validity of a contemporaneous primary percutaneous coronary intervention trial in patients with acute ST-elevation myocardial infarction: insights from a single-centre investigation
Bibliographic record
Abstract
AIMS: Randomised controlled trials (RCTs) represent the most robust source of evidence-based medicine. However, the generalisability of RCTs is limited by the inclusion of selected populations. We sought to assess the external validity of a contemporary trial including patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). METHODS AND RESULTS: Patients presenting to Bern University Hospital during the inclusion period of the COMFORTABLE AMI trial were divided into three groups: RCT participants (41%), eligible not included (17.5%), and excluded patients (41.5%). Major adverse cardiac events (MACE) were defined as one-year death and myocardial infarction. RCT participants compared with RCT-eligible patients had comparable baseline characteristics and outcomes; however, excluded patients differed in risk and had higher rates of MACE (HR 3.63, 95% CI: 2.03-6.48, p<0.001), death (HR 6.23, 95% CI: 2.93-13.24, p<0,001) and definite/probable stent thrombosis (HR 3.63, 95% CI: 1.79-7.36, p<0.001). Inability to provide consent was the most frequent exclusion criterion and was independently associated with an increased risk for MACE (HR 6.85, 95% CI: 3.97-11.81, p<0.001). CONCLUSIONS: In this single-centre investigation, results from the COMFORTABLE AMI trial appeared applicable to a broad representation of RCT-eligible patients. However, patients excluded from the trial represented a higher-risk population with impaired clinical outcomes and a lower adherence to cardiovascular medication.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".