669 The Validation of a Novel Outcome Measure in Severe Burns- the Persistent Organ Dysfunction (POD)+Death: Results from a Multicentre Evaluation
Bibliographic record
Abstract
Abstract Introduction Very few burn care interventions have been rigorously evaluated with adequately powered randomized clinical trials (RCTs) focusing on long-term clinically relevant outcomes. There is a need to improve the efficiency of RCTs in burn care so that more definitive high quality RCTs can be completed with the available resources. Persistent Organ Dysfunction (POD) plus death is a novel endpoint that has been previously validated in general ICU patients. The objective of this study was to validate and demonstrate the utility of POD+death for clinical trials of burn patients. Methods We performed a secondary analysis of a dataset from a RCT of enteral glutamine (the RE-ENERGIZE Trial) involving 60 Intensive Care Units (ICUs) around the world. Enrolled patients were followed for 6 months documenting hospital and 6 months outcomes including quality of life. For the purposes of this analysis, we restricted inclusion to patients with >20% burn size. We define POD as requiring supportive technologies during critical illness and is present when a patient has ongoing requirement for vasopressors, dialysis, or mechanical ventilation at the outcome assessments time points. We evaluated the data for the prevalence of POD and its association with outcome. We hypothesized that patients alive with POD, compared to those alive without POD, would have worse clinical outcomes and that by combining POD+death, we would gain statistical efficiencies. Results Five hundred thirty-nine patients were involved in this analysis. At 28 days, 4.6% of patients were estimated to have circulatory failure, 6.3% had renal failure, 17.1% had respiratory failure, and 8.9% had died, for an overall prevalence of POD+death=27%. Of survivors at day 28, those with POD, compared to those without POD, had a higher mortality rate in the follow up period, had longer ICU and hospital stays, and a reduced quality of life on many of the domains at 6 months (see Tables). Using our observed 28 day rates, to achieve 80% power at a two-sided alpha=0.05 to determine a 25% RRR in mortality, we would require 2246 patient per group to detect a 25% RRR in mortality from 9% to 6.75%, but only 573 patients per group to detect a 25% RRR in mortality+POD from 27% to 20% Conclusions POD+death may be a valid composite outcome measure and compared to historically used endpoints, POD may reduce the sample size requirements of clinical trials of severe burns patients. Further validation in larger clinical trials is required. Applicability of Research to Practice To improve the efficiency of RCTs in burn settings.
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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 | 0.065 | 0.067 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.007 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".