Design and participant baseline characteristics of ‘A <scp>C</scp>linical <scp>T</scp>rial of <scp>IntensiVE D</scp>ialysis’: The <scp>ACTIVE D</scp>ialysis <scp>S</scp>tudy
Bibliographic record
Abstract
AIMS: Observational reports suggest extended dialysis hours are associated with improved outcomes. These findings are confounded by better prognostic characteristics among people practising extended hours. The aim of this article is to provide an overview of the methods and baseline characteristics for ACTIVE Dialysis Study participants. METHODS: This multicentre, randomized, open-label, blinded endpoint-assessment trial randomized participants receiving maintenance haemodialysis therapy to either extended (≥24 h) or standard (12-18 h) weekly haemodialysis for 12 months. A web-based randomization system used minimization to ensure balanced allocation across regions, dialysis setting and dialysis vintage. The primary outcome is the change in quality of life over 12 months of study treatment assessed by EQ-5D. Secondary outcomes include change in left ventricular mass index assessed by magnetic resonance imaging and safety outcomes including dialysis access events. RESULTS: A total of 200 participants were recruited between 2009 and 2013 from Australia (29.0%), China (62.0%), Canada (5.5%) and New Zealand (3.5%). Participants had a mean age of 52 (± 12) years and 11.5% were dialysing at home, with a mean duration of 13.9 h per week over a median of three sessions. At baseline, 32.5% had a history of cardiovascular disease and 36.5% had diabetes. CONCLUSION: The ACTIVE Dialysis Study has met its planned recruitment target. The participant population are drawn from a range of health service settings in a global context. The study will contribute important evidence on the benefits and harms of extending weekly dialysis hours. The trial is registered at clinicaltrials.gov (NCT00649298).
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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 | 0.012 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.020 | 0.004 |
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".