2010 Clinical Trial/Clinical Science Abstracts
Bibliographic record
Abstract
The role of cardiac resynchronization therapy (CRT) in patients with mild to moderate heart failure (HF) symptoms requiring an implantable cardioverter-defibrillator therapy (ICD) remains uncertain.We hypothesized that the addition of CRT to optimal medical therapy and ICD reduces mortality and HF hospitalization in patients with mild to moderate HF symptoms, LV dysfunction (EF less than or equal to 30%) and wide QRS duration.Design: This study is a prospective multicenter (34 sites in Canada, Europe, Australia, and Turkey) randomized double-blinded controlled clinical trial.Patients were randomized to receive an ICD (control) or ICD with CRT in a 1:1 ratio in addition to optimal heart failure medical therapy.The primary endpoint is a composite of all cause mortality and adjudicated HF hospitalization (defined as an admission to hospital for Ͼ24 hrs with a diagnosis of worsening HF) whichever comes first.Secondary endpoints include all cause mortality at anytime during the study, HF hospitalization, quality of life and cost effectiveness of therapy.Sample size: A total of 1798 patients satisfying the inclusion/exclusion criteria were enrolled between January 2003 and February 2009.The study was designed to achieve 85% power to detect a 25% relative risk reduction in the primary end-point with a minimum follow-up of 18 months accounting for a projected loss to follow-up of 2%, crossover of 5% and 7% and a projected annual event rate of 11% in the control group.Study population: At baseline, the mean age was 66 years; 82% were male; mean LVEF was 23%; 67% had ischemic cardiomyopathy; 13% had permanent atrial fibrillation; conducted QRS duration was 158 ms and paced QRS duration was 209 ms.Results: We anticipate that the primary endpoint will have been reached in Ͼ580 patients with Ͼ390 patient deaths at any time during a mean follow-up of ϳ36 months; Ͼ 330 patients had at least one adjudicated HF hospitalization.The final data analysis with the intention-to-treat principle of primary and major secondary endpoints will be completed in September and will be available for the AHA presentation.
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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 | 0.005 | 0.015 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.006 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.005 | 0.006 |
| Insufficient payload (model declined to judge) | 0.331 | 0.176 |
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".