Psychometric properties of the Arabic version of the confusion assessment method for the intensive care unit (CAM-ICU).

BACKGROUND: It is recommended that critically ill patients undergo routine delirium monitoring with a valid and reliable tool such as the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). However, the validity and reliability of the Arabic version of the CAM-ICU has not been investigated. Here, we test the validity and reliability of the Arabic CAM-ICU. METHODS: We conducted a psychometric study at ICUs in a tertiary-care hospital in Saudi Arabia. We recruited consecutive adult Arabic-speaking patients, who had stayed in the ICU for at least 24 hours, and had a Richmond Agitation-Sedation Scale (RASS) score ≥ - 2 at examination. Two well-trained examiners (ICU nurse and intensivist) independently assessed delirium in eligible patients with the Arabic CAM-ICU. Evaluations by the two examiners were compared with psychiatrist blind clinical assessment of delirium according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Subgroup analyses were conducted for age, invasive mechanical ventilation, and gender. RESULTS: We included 108 patients (mean age: 62.6 ± 17.6; male: 51.9%), of whom 37% were on invasive mechanical ventilation. Delirium was diagnosed in 63% of enrolled patients as per the psychiatrist clinical assessment. The Arabic CAM-ICU sensitivity was 74% (95% confidence interval [CI] = 0.63-0.84) and 56% (95%CI = 0.44-0.68) for the ICU nurse and intensivist, respectively. Specificity was 98% (95%CI = 0.93-1.0) and 92% (95%CI = 0.84-1.0), respectively. Sensitivity was greater for mechanically-ventilated patients, women, and those aged ≥65 years. Specificity was greater for those aged < 65 years, non-mechanically-ventilated patients and men. The median duration to complete the Arabic CAM-ICU was 2 min (interquartile range, 2-3) and 4.5 min (IQR, 3-5) for the ICU nurse and intensivist, respectively. Inter-rater reliability (kappa) was 0.66. CONCLUSIONS: The Arabic CAM-ICU demonstrated acceptable reliability and validity to assess delirium in Arabic-speaking ICU patients.

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

BACKGROUND: The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. METHODS/DESIGN: In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. DISCUSSION: Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

BACKGROUND: Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE. METHODS/DESIGN: The PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %. DISCUSSION: The first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).