Biomedical subjects

Andrew G Day

Publications and source records attributed to Andrew G Day.

3 recordsLinked to original sources

PubMed2026

High-Dose Intravenous Vitamin C and Mortality and Organ Dysfunction in Severe Burn Injury: The VICTORY Randomized Clinical Trial.

IMPORTANCE: Severe burn injury triggers systemic inflammation that can lead to multiple organ dysfunctions and death. High-dose intravenous vitamin C has been proposed to mitigate these effects, but strong evidence in patients with burn injury is lacking. OBJECTIVE: To evaluate the efficacy of high-dose intravenous vitamin C in patients with severe burn injury. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled phase 3 trial conducted across 24 burn centers in North, Central, and South America; Europe; and Asia. Adults (≥18 years) with deep second- and/or third-degree burns covering 20% or more of total body surface area and requiring skin grafting were enrolled between August 18, 2020, and September 12, 2025. Final follow-up was completed in March 2026. The trial was stopped early after the first prespecified interim analysis for futility/harm. INTERVENTIONS: Patients were randomly assigned (1:1) to receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours) or matched placebo. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of 28-day mortality and persistent organ dysfunction (defined as dependence on mechanical ventilation, kidney replacement therapy, or vasopressor/inotrope support at day 28). The main secondary outcome was time to discharge alive from hospital within 90 days. RESULTS: Among 238 patients enrolled (mean age, 48.9 [SD, 19.1] years; 79% male; mean total body surface area, 37.0% [SD, 14.6%]), 120 were assigned to vitamin C and 118 to placebo. The primary composite outcome occurred in 49 patients (40.8%) in the vitamin C group and 35 patients (29.7%) in the placebo group (adjusted risk ratio [RR], 1.28 [95% CI, 0.99-1.65]; P = .06), crossing the prespecified futility/harm threshold and prompting early trial termination. Time to discharge alive from hospital within 90 days was not improved (adjusted subdistribution hazard ratio, 0.85 [95% CI, 0.62-1.16]; P = .31). Twenty-eight-day mortality was higher in the vitamin C group (15.0% vs 7.6%; adjusted RR, 1.96 [95% CI, 1.32-2.90]; P = .001), as was hospital mortality (23.3% vs 16.1%; adjusted RR, 1.44 [95% CI, 1.03-2.00]; P = .03). CONCLUSIONS AND RELEVANCE: Among patients with severe burn injury, high-dose intravenous vitamin C did not reduce 28-day mortality and persistent organ dysfunction and is possibly harmful. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04138394.

Humans↗

PubMed2003

Can patients with obstructive sleep apnea titrate their own continuous positive airway pressure?

Manual continuous positive airway pressure (CPAP) titration in a sleep laboratory is costly and limits access for diagnostic studies. Many factors affect CPAP compliance, but education and support, rather than in-laboratory CPAP titration, appear to be pivotal. Self-adjustment of CPAP at home will provide equal or superior efficacy in the treatment of obstructive sleep apnea (OSA) as compared with in-laboratory titration. A randomized, single-blind, two-period crossover trial of CPAP treatment at the in-laboratory-determined optimal pressure versus at-home self-adjustment of CPAP (starting pressure based on prediction equation). Eighteen CPAP-naive patients (16 males, 50 +/- 15 years old, apnea hypopnea index 40 +/- 20) with a new diagnosis of OSA were tested. Testing was performed before and after CPAP treatment in each of two 5-week study limbs. CPAP, compliance with CPAP treatment, the Sleep Apnea Quality of Life Index, the Functional Outcomes of Sleep Questionnaire score, the Epworth sleepiness scale score, sleep architecture, sleep apnea severity, and maintenance of wakefulness tests were performed. Both modes of CPAP treatment significantly improved objective and subjective measures of OSA, but they did not differ in efficacy. Home self-titration of CPAP is as effective as in-laboratory manual titration in the management of patients with OSA.

Adult↗

PubMed2002

Proficiency testing performance: a case study with modeling.

OBJECTIVES: Previous literature has approached proficiency testing (PT) performance by defining the minimum levels, and combinations of imprecision and bias, necessary to meet PT requirements. In this case report, current PT performance was assessed and modeling performed to prioritize our quality improvement efforts. METHODS: A total of 1,006 chemistry challenge results from Ontario's Laboratory Proficiency Testing Program (LPTP, now QMPLS) performed on 69 tests during 1999 and 2000 were used for this retrospective analysis. Peer group means, all method means and results from reference labs were used for comparison. QMPLS flagging and recommended performance criteria were compiled, and modeling performed to predict different levels of performance. RESULTS: Our internal imprecision is <5% for 72% of our 69 tests; however, only 20% of our tests had a CV/PT <25%. Of the 1,006 challenges performed, 136 (13.5%) results were outside PT limits, 55 (5.5%) results were flagged, and 12 requests were received from QMPLS seeking clarification on 24 (2.4%) results. Follow-up identified 9 (38%) nonanalytical errors, 8 (33%) method bias errors, 4 (17%) random errors, 2 poor methods, and one with no error identified. Modeling predicted flagging rates of 2.4% using QMPLS recommended precision performance, 1.6% using our current internal imprecision, 2.2% or 7.0% if we included an overall 20% or 50% relative bias rate with our current imprecision levels, or 15.0% when an estimate of our actual bias for each analyte was considered along with our current imprecision levels. CONCLUSIONS: If imprecision were the only cause of PT errors, our flagging rate for this study period would be 1.6%, and we would need to formally investigate 8 results a year. In practice, strict application of the QMPLS PT criteria would result in 68 investigations annually; however, judicial review of the results before request for clarification significantly reduced this number to 12 investigations (of which 38% were nonanalytical errors). At the present time bias is a significant cause of poor PT performance in a variety of assays. Individual laboratories need to address the problem of bias, and ultimately so do manufacturers. It would be helpful if PT programs also acknowledged this necessary evolution in both their criteria and processes.

Chemistry, Clinical↗