Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Survival advantage and PaO2 threshold in severe traumatic brain injury.

BACKGROUND: Hypoxemia can adversely affect outcome after traumatic brain injury (TBI). However, the effect of high PaO2 on TBI outcomes is controversial. The primary aim of this study was to identify the optimal PaO2 range early after severe TBI. METHODS: In this single-center retrospective study conducted at a level-1 trauma center, patients with severe TBI (head Abbreviated Injury Scale score >3, admission Glasgow Coma Scale score ≤8) were included. The crude and adjusted (including chest injuries and acute respiratory distress syndrome) effects of 50 mm Hg incremental PaO2 thresholds during the first 72 hours on discharge survival were examined. RESULTS: Data from 193 patients (44±18 y; 77% male; admission Glasgow Coma Scale score 4±2) were reviewed. Overall survival was 57%. PaO2 thresholds in increments of 50 mm Hg between 250 and 486 mm Hg (68%) were associated with discharge survival in patients with severe TBI compared with PaO2 60 mm Hg

Prevalence and risk factors for intraoperative hypotension during craniotomy for traumatic brain injury.

BACKGROUND: Hypotension after traumatic brain injury (TBI) is associated with poor outcomes. However, data on intraoperative hypotension (IH) are scarce and the effect of anesthetic agents on IH is unknown. We examined the prevalence and risk factors for IH, including the effect of anesthetic agents during emergent craniotomy for isolated TBI. METHODS: This is a retrospective cohort study of patients 18 years and above, who underwent emergent craniotomy for TBI at Harborview Medical Center (level 1 trauma center) between October 2007 and January 2010. Demographic, clinical, and radiographic characteristics and hemodynamic and anesthetic data were abstracted from medical and electronic anesthesia records. Hypotension was defined as systolic blood pressure <90 mm Hg. Univariate analyses were performed to compare the clinical characteristics of patients with and without IH, and multiple logistic regression analysis was used to determine independent risk factors for IH. RESULTS: Data abstracted from 113 eligible patients aged 48±19 years were analyzed. IH was common (n=73, 65%) but not affected by the choice of anesthetic agent. Independent risk factors for IH were multiple computed tomographic (CT) lesions [adjusted odds ratios (AOR) 19.1; 95% confidence interval (CI), 2.08-175.99; P=0.009], subdural hematoma (AOR 17.9; 95% CI, 2.97-108.10; P=0.002), maximum CT lesion thickness (AOR 1.1; 95% CI, 1.01-1.13; P=0.016), and anesthesia duration (AOR 1.1; 95% CI, 1.01-1.30; P=0.009). CONCLUSIONS: IH was common in adult patients with isolated TBI undergoing emergent craniotomy. The presence of multiple CT lesions, subdural hematoma, maximum thickness of CT lesion, and longer duration of anesthesia increase the risk for IH.

Perioperative management of traumatic brain injury.

Traumatic brain injury (TBI) is a major public health problem and the leading cause of death and disability worldwide. Despite the modern diagnosis and treatment, the prognosis for patients with TBI remains poor. While severity of primary injury is the major factor determining the outcomes, the secondary injury caused by physiological insults such as hypotension, hypoxemia, hypercarbia, hypocarbia, hyperglycemia and hypoglycemia, etc. that develop over time after the onset of the initial injury, causes further damage to brain tissue, worsening the outcome in TBI. Perioperative period may be particularly important in the course of TBI management. While surgery and anesthesia may predispose the patients to new onset secondary injuries which may contribute adversely to outcomes, the perioperative period is also an opportunity to detect and correct the undiagnosed pre-existing secondary insults, to prevent against new secondary insults and is a potential window to initiate interventions that may improve outcome of TBI. For this review, extensive Pubmed and Medline search on various aspects of perioperative management of TBI was performed, followed by review of research focusing on intraoperative and perioperative period. While the research focusing specifically on the intraoperative and immediate perioperative TBI management is limited, clinical management continues to be based largely on physiological optimization and recommendations of Brain Trauma Foundation guidelines. This review is focused on the perioperative management of TBI, with particular emphasis on recent developments.

Current trends and update on injury prevention.

Injuries are a major and growing public health problem, a leading cause of death and disabilities among people aged 1-44 years around the world. Each year, 5.8 million people die from injuries, accounting for 10% of the world's deaths. Road traffic injuries (RTIs), self-inflicted injuries and violence are the top three leading causes of all injury deaths, while RTIs, falls and drowning are the top three leading causes of unintentional injury death. In many high-income countries, trends of injury death have been decreasing as a result of prevention measures. In contrast, trends in low- and middle-income countries have been rising. In this article, we review the prevention strategies for RTIs, violence, falls and drowning developed over decades to disseminate the knowledge and inform health care providers, especially acute care physicians, about the importance of injury prevention.

Hyperglycemia during craniotomy for adult traumatic brain injury.

BACKGROUND: Hyperglycemia after traumatic brain injury (TBI) is associated with poor outcome, but previous studies have not addressed intraoperative hyperglycemia in adult TBI. In this study, we examined glucose value variability and risk factors for hyperglycemia during craniotomy in adults with TBI. METHODS: A retrospective cohort study of patients ≥18 years who underwent urgent or emergent craniotomy for TBI at Harborview Medical Center (level 1 adult and pediatric trauma center) between October 2007 and May 2010 was performed. Preoperative (within 24 hours of anesthesia start) and intraoperative (during anesthesia) glucose values for each patient were retrieved. The prevalence of intraoperative hyperglycemia (glucose ≥200 mg/dL), hypoglycemia (glucose <60 mg/dL), and glycemic trends was determined. Generalized Estimating Equations was used to determine the independent predictors of intraoperative hyperglycemia. Data are presented as adjusted odds ratio (AOR) (95% confidence interval [CI]), and P < 0.05 reflects significance. RESULTS: Intraoperative hyperglycemia was common (26 [15%]) and intraoperative hypoglycemia was not observed. Independent risk factors of intraoperative hyperglycemia were age ≥65 years (AOR 3.9 [95% CI: 1.4-10.3]; P = 0.007), Glasgow Coma Scale score <9 (AOR 4.9 [95% CI: 1.6-15.1]; P = 0.006), preoperative hyperglycemia (AOR 4.4 [95% CI: 1.7-11.6]; P = 0.003), and subdural hematoma (AOR 5.6 [95% CI: 1.4-22.2]; P = 0.02). Mean intraoperative glucose was highest in severe TBI patients (P = 0.02). There was both between-patient (79.5% variance; P < 0.001) and within-patient (20.5% variance; P < 0.001) intraoperative glucose value variability. Patients with intraoperative hyperglycemia had higher in-hospital mortality (8 [31%] vs 20 [13%]; P < 0.02). CONCLUSION: Intraoperative hyperglycemia was common in adults undergoing urgent/emergent craniotomy for TBI and was predicted by severe TBI, the presence of subdural hematoma, preoperative hyperglycemia, and age ≥65 years. However, there was significant variability in intraoperative glucose values.

Change in mean transit time, apparent diffusion coefficient, and cerebral blood volume during pediatric diabetic ketoacidosis treatment.

OBJECTIVES: Cerebral edema is a devastating complication of pediatric diabetic ketoacidosis. We examined measures describing potential causes of whole brain and regional brain edema (mean transit time, apparent diffusion coefficient, and relative cerebral blood volume) during treatment of diabetic ketoacidosis in children. DESIGN: Prospective observational study. SETTING: Regional children's hospital. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: After Institutional Review Board approval, children admitted with diabetic ketoacidosis (pH <7.3, HCO3 <15 mEq/L, glucose >300 mg/dL, and ketosis) underwent two serial paired contrast-enhanced (gadolinium) and diffusion magnetic resonance imaging scans. Change in whole brain and regional (frontal lobe, occipital lobe, and basal ganglia) mean transit time, apparent diffusion coefficient, and relative cerebral blood volume between the two time periods (12-24 hrs) and (36-72 hrs) after start of insulin treatment (time 0) were determined. Thirteen children (median age, 10.3 ± 1.1 yrs; 7 female) with diabetic ketoacidosis were examined. Overall, whole brain and regional mean transit time decreased from time 1 (first magnetic resonance imaging after time 0) to time 2 (second magnetic resonance imaging after time 0) by 51% ± 59% (p = .01), without differences between the brain regions examined. Whole brain apparent diffusion coefficient increased by 4.7% ± 3.4% (p = .001), without differences between the brain regions examined. There was no change in relative cerebral blood volume for the whole brain and for the three brain regions examined. CONCLUSIONS: In this study, whole brain mean transit time decreased and apparent diffusion coefficient increased, suggesting a vasogenic process between the two study periods during diabetic ketoacidosis treatment.