Sex-based Differences in the Use of Best Practices in Mechanically Ventilated Adults in the Intensive Care Unit: An Analysis of the Toronto Multi-center iCORE Database.

Rationale Patients who are critically ill and require admission to an Intensive Care Unit (ICU) should receive the same quality of care regardless of their sex. Objectives To determine, using population data from a multicenter database in Ontario, Canada, whether sex is associated with differences in the use of 8 best practices and other interventions during the ICU care of mechanically ventilated women and men. Methods Using a cohort of patients receiving mechanical ventilation in 8 intensive care units, our co-primary outcomes were differences in compliance with 8 evidence-based practices between women and men (opioid administration, use of continuous sedation or opioids, sedation minimization; spontaneous breathing trials; stress ulcer prophylaxis; deep venous thrombosis prophylaxis; physical restraint; and mobilization). All analyses were adjusted for confounders using logistic regression and restricted to patients eligible for each best practice. Measurements and Main Results We included 19070 (11910 men, 7160 women) patients who were mechanically ventilated for more than 4 hours. Men and women had similar opioid administration, sedation minimization, stress ulcer prophylaxis, DVT prophylaxis, and mobilization. Women were less likely to receive continuous infusions of sedation or opioids than men (adjusted OR 0.86, 95% CI 0.78, 0.95), and less likely to be physically restrained (adjusted OR 0.82, 95% CI 0.74, 0.89). Conclusions: In this cohort of mechanically ventilated patients, the use of evidence-based practices was similar between women and men, except for a higher utilization of continuous sedative or opioid infusions and physical restraints in men.

Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to the Staphylococcus aureus Network Adaptive Platform trial: study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial).

INTRODUCTION: Informed consent forms (ICFs) for randomised clinical trials (RCTs) can be onerous and lengthy. The process has the potential to overwhelm patients with information, leading them to miss elements of the study that are critical for an informed decision. Specifically, overly long and complicated ICFs have the potential to increase barriers to trial participation for patients with mild cognitive impairment, those who do not speak English as a first language or among those with lower medical literacy. In turn, this can influence trial recruitment, completion and external validity. METHODS AND ANALYSIS: SIMPLY-SNAP is a pragmatic, multicentre, open-label, two-arm parallel-group superiority RCT, nested within a larger trial, the Staphylococcus aureus Network Adaptive Platform (SNAP) trial. We will randomise potentially eligible participants of the SNAP trial 1:1 to a full-length ICF or a SIMPlified LaYered (SIMPLY) consent process where basic information is summarised with embedded hyperlinks to supplemental information and videos. The primary outcome is recruitment into the SNAP trial. Secondary outcomes include patient understanding of the clinical trial, patient and research staff satisfaction with the consent process, and time taken for consent. As an exploratory outcome, we will also compare measures of diversity (eg, gender, ethnicity), according to the consent process randomised to. The planned sample size will be 346 participants. ETHICS AND DISSEMINATION: The study has been approved by the ethics review board (Sunnybrook Health Sciences Research Ethics Board) at sites in Ontario. We will disseminate study results via the SNAP trial group and other collaborating clinical trial networks. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT06168474; www. CLINICALTRIALS: gov).

Recombinant factor VIIa is associated with an improved 24-hour survival without an improvement in inpatient survival in massively transfused civilian trauma patients

OBJECTIVE: To determine whether recombinant factor VIIa (rFVIIa) is associated with increased survival and/or thromboembolic complications. INTRODUCTION: Uncontrollable hemorrhage is the main cause of early mortality in trauma. rFVIIa has been suggested for the management of refractory hemorrhage. However, there is conflicting evidence about the survival benefit of rFVIIa in trauma. Furthermore, recent reports have raised concerns about increased thromboembolic events with rFVIIa use. METHODS: Consecutive massively transfused (> 8 units of red blood cells within 12 h) trauma patients were studied. Data on demographics, injury severity scores, baseline laboratory values and use of rFVIIa were collected. Rate of transfusion in the first 6 h was used as surrogate for bleeding. Study outcomes included 24-hour and in-hospital survival, and thromboembolic events. A multivariable logistic regression analysis was used to determine the impact of rFVIIa on 24-hour and in-hospital survival. RESULTS: Three-hundred and twenty-eight patients were massively transfused. Of these, 72 patients received rFVIIa. As expected, patients administered rFVIIa had a greater degree of shock than the non-rFVIIa group. Using logistic regression to adjust for predictors of death in the regression analysis, rFVIIa was a significant predictor of 24-hour survival (odds ratio (OR) = 2.65; confidence interval 1.26-5.59; p = 0.01) but not of in-hospital survival (OR = 1.63; confidence interval 0.79-3.37; p = 0.19). No differences were seen in clinically relevant thromboembolic events. CONCLUSIONS: Despite being associated with improved 24-hour survival, rFVIIa is not associated with a late survival to discharge in massively transfused civilian trauma patients.