Surrogate consent for research involving adults with impaired decision making: survey of Institutional Review Board practices.

OBJECTIVES: Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research. DESIGN, SETTINGS, AND PARTICIPANTS: A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008. INTERVENTIONS: None. MEASUREMENTS: Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults. MAIN RESULTS: Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives. CONCLUSIONS: Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

Adding emotional stressors to training in simulated cardiopulmonary arrest enhances participant performance.

OBJECTIVES: Advanced cardiac life support (ACLS) skills tend to degrade over time. There is mounting evidence that high-fidelity simulation (HFS) is advantageous to teaching ACLS. The aspects of HFS that enhance learning are not entirely clear, but the anxiety generated by a scenario may enhance retention through well-established learning pathways. We sought to determine whether an HFS with added emotional stress could provoke anxiety and, if so, whether or not participants learning ACLS would demonstrate better written and applied knowledge retention 6 months after their initial course. METHODS: Twenty-five student volunteers from Year 1 and 2 at Mount Sinai School of Medicine were randomly assigned to a control group or an emotional content (EC) group for a sudden cardiac death management course. All subjects were monitored for heart rate and were assessed using the State-Trait Anxiety Inventory. Control group participants experienced an HFS in which actors were not scripted to add stress, whereas EC group participants were exposed to an emotionally charged environment using the same actors. RESULTS: Participants across the two groups were well matched by resting heart rates, baseline anxiety and prior ACLS knowledge. The EC group participants experienced greater anxiety than controls (mean state anxiety score: 35.0 versus 28.2 [p<0.05]; average heart rate [HR]: 94.6 bpm versus 72.9 bpm [p<0.05]; maximum HR: 120.8 bpm versus 95.3 bpm [p<0.05]). Six months later, written test scores were similar, but the EC group participants achieved higher practical competency examination ('mega code') scores than controls (32.5 versus 25.0; p<0.05). Independent t-tests and Spearman rank coefficients were employed where applicable. CONCLUSIONS: Simulation with added emotional stressors led to greater anxiety during ACLS instruction but correlated with enhanced performance of ACLS skills after this course. The quantitative and qualitative values of added stressors need further exploration, but these values represent important variables in simulation-based education.

Consensus statement: First International Workshop on Anesthetics and Alzheimer's disease.

In order to review the current status of the potential relationship between anesthesia and Alzheimer's disease, a group of scientists recently met in Philadelphia for a full day of presentations and discussions. This special article represents a consensus view on the possible link between Alzheimer's disease and anesthesia and the steps required to test this more definitively.

Addiction and substance abuse in anesthesiology.

Despite substantial advances in our understanding of addiction and the technology and therapeutic approaches used to fight this disease, addiction still remains a major issue in the anesthesia workplace, and outcomes have not appreciably changed. Although alcoholism and other forms of impairment, such as addiction to other substances and mental illness, impact anesthesiologists at rates similar to those in other professions, as recently as 2005, the drug of choice for anesthesiologists entering treatment was still an opioid. There exists a considerable association between chemical dependence and other psychopathology, and successful treatment for addiction is less likely when comorbid psychopathology is not treated. Individuals under evaluation or treatment for substance abuse should have an evaluation with subsequent management of comorbid psychiatric conditions. Participation in self-help groups is still considered a vital component in the therapy of the impaired physician, along with regular monitoring if the anesthesiologist wishes to attempt reentry into clinical practice.

Hypnosis decreases presurgical distress in excisional breast biopsy patients.

BACKGROUND: Excisional breast biopsy is associated with presurgical psychological distress. Such distress is emotionally taxing, and may have negative implications for postsurgical side effects and satisfaction with anesthesia. We investigated the ability of a brief hypnosis session to reduce presurgical psychological distress in excisional breast biopsy patients. METHODS: Ninety patients presenting for excisional breast biopsy were randomly assigned to receive either a 15-minute presurgery hypnosis session (n = 49, mean age: 46.4 (95% CI: 42.3-50.4)) or a 15-minute presurgery attention control session (n = 41, mean age: 45.0 (95% CI: 40.8-49.2)). The hypnosis session involved suggestions for increased relaxation and decreased distress. The attention control session involved nondirective empathic listening. Presurgery distress was measured using visual analog scales (VAS) and the short version of the Profile of Mood States (SV-POMS). Data were analyzed using analysis of variance and chi2 procedures. RESULTS: Groups did not differ in terms of the following: demographics (age, education, ethnicity, marital status, all P's > 0.28); medical variables (presurgery diagnosis, previous excisional biopsy, previous breast cancer, all P's > 0.11); or preintervention distress (SV-POMS P > 0.74) assessed on the day of surgery. Postintervention, and before surgery, patients in the hypnosis group had significantly lower mean values for presurgery VAS emotional upset (16.5 vs 38.2, P < 0.0001, d = .85), VAS depressed mood (6.6 vs 19.9, P < 0.02, d = .67), and SV-POMS anxiety (10.0 vs 5.0, P < 0.0001, d = 0.85); and significantly higher levels for VAS relaxation (75.7 vs 54.2, P < 0.001, d = -0.76) than attention controls. CONCLUSIONS: The study results indicate that a brief presurgery hypnosis intervention can be an effective means of controlling presurgical distress in women awaiting diagnostic breast cancer surgery.

Neuropsychiatric consequences of coronary artery bypass grafting and noncardiovascular surgery.

This paper reviews findings regarding short- and long-term neuropsychiatric consequences of coronary artery bypass grafting (CABG) and noncardiac surgery. Stroke is one of the potentially most serious complications of CABG; studies have identified some demographic and medical risk factors. Short-term neuropsychological deficits are common after CABG, but have been similarly documented in noncardiac surgery patients, and may therefore not be specific to this procedure. Neuropsychological deficits in some cognitive areas may persist over time. Patients with depression before surgery are likely to have persistent depression afterwards. Also, depression does not account for the cognitive decline after CABG. Conflicting findings, and the possible methodological limitations of current published studies, are presented and discussed.

Predictors of expectancies for post-surgical pain and fatigue in breast cancer surgical patients.

Expectancies for post-surgical pain and fatigue have previously been found to predict pain and fatigue among breast cancer surgery patients. However, the study of predictors of these expectancies has been neglected. The present study was designed to investigate predictors of expectancies for post-surgical pain and fatigue among breast cancer surgery patients.Four hundred and eighteen women (M = 48.3 years, SD = 13.66 years) scheduled to undergo excisional breast biopsy or lumpectomy completed questionnaires assessing demographics/medical history, pre-surgical distress, stable personality characteristics, pre-surgical pain and fatigue, and expectancies for post-surgical pain and fatigue.Path analysis revealed: expectancies for post-surgical pain were significantly predicted by trait anxiety, acute pre-surgical distress, and age; and expectancies for post-surgical fatigue were significantly predicted by acute pre-surgical distress, acute pre-surgical fatigue, previous experience with the same surgical procedure, and education (all ps < .05). Examination of an alternative model revealed that the effects of the aforementioned predictors on expectancies were not mediated by acute pre-surgical distress, clarifying the directionality of the distress-expectancy relationship.Expectancies for post-surgical pain and fatigue are influenced by distress, treatment history, stable personality characteristics, extant symptoms, and demographic factors. These variables should be considered in designing clinical interventions to manipulate expectancies for patient benefit.

Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial.

OBJECTIVES: To compared outcomes of regional nerve blocks with those of standard analgesics after hip fracture. DESIGN: Multisite randomized controlled trial from April 2009 to March 2013. SETTING: Three New York hospitals. PARTICIPANTS: Individuals with hip fracture (N = 161). INTERVENTION: Participants were randomized to receive an ultrasound-guided, single-injection, femoral nerve block administered by emergency physicians at emergency department (ED) admission followed by placement of a continuous fascia iliaca block by anesthesiologists within 24 hours (n = 79) or conventional analgesics (n = 82). MEASUREMENTS: Pain (0-10 scale), distance walked on Postoperative Day (POD) 3, walking ability 6 weeks after discharge, opioid side effects. RESULTS: Pain scores 2 hours after ED presentation favored the intervention group over controls (3.5 vs 5.3, P = .002). Pain scores on POD 3 were significantly better for the intervention than the control group for pain at rest (2.9 vs 3.8, P = .005), with transfers out of bed (4.7 vs 5.9, P = .005), and with walking (4.1 vs 4.8, P = .002). Intervention participants walked significantly further than controls in 2 minutes on POD 3 (170.6 feet, 95% confidence interval (CI) = 109.3-232 vs 100.0 feet, 95% CI = 65.1-134.9; P = .04). At 6 weeks, intervention participants reported better walking and stair climbing ability (mean Functional Independence Measure locomotion score of 10.3 (95% CI = 9.6-11.0) vs 9.1 (95% CI = 8.2-10.0), P = .04). Intervention participants were significantly less likely to report opioid side effects (3% vs 12.4%, P = .03) and required 33% to 40% fewer parenteral morphine sulfate equivalents. CONCLUSION: Femoral nerve blocks performed by emergency physicians followed by continuous fascia iliaca blocks placed by anesthesiologists are feasible and result in superior outcomes.

Can Intraoperative Processed EEG Predict Postoperative Cognitive Dysfunction in the Elderly?

PURPOSE: Postoperative cognitive dysfunction (POCD) is a serious and costly complication of the elderly; even mild impairment has the potential to impact overall well being. Anesthesiologists continue to search for ways to manipulate intraoperative technique to optimize postoperative cognition in the elderly. Depth of anesthesia during surgery is an area that has shown some promise for short-term outcomes, such as delirium. However, excessive depth has both positive and negative associations with longer-term POCD. We hypothesize that this uncertainty is due to the inability of median depth to capture the amount of burst suppression or electrical silence. In this study, our purpose was to identify the intraoperative processed EEG parameters that are most closely correlated with POCD. METHODS: To explore the association of several processed EEG parameters with POCD, we performed a retrospective analysis of a cohort of 105 patients aged >68 years scheduled for major surgery under general anesthesia. Intraoperative medications, hemodynamics, processed EEG and cerebral oxygen saturation were recorded. All patients had a cognitive battery before surgery and repeated at 3 months afterward. FINDINGS: One hundred and five patients enrolled and 77 (73.3%) patients completed the 3-month cognitive testing. The incidence of POCD was 27%; the median Bispectral Index value for patients who developed POCD was similar to patients who did not (46 vs 42 minutes). However, patients who developed POCD spent less time with Bispectral Index <45 minutes (82.8 vs 122.5 minutes, P = 0.01) and burst suppression (35 vs 96 minutes, P = 0.04). Hypotension, cerebral desaturation, and use of total intravenous anesthesia were similar between patients with and without POCD. IMPLICATIONS: Patients who developed POCD spent less time in EEG burst suppression and less time in deep states. Burst suppression may be protective for POCD. Further work is needed to definitively identify the role of burst suppression in the context of other patient and intraoperative variables to prevent POCD.

Role of glucocorticoids in mediating effects of fasting and diabetes on hypothalamic gene expression.

BACKGROUND: Fasting and diabetes are characterized by elevated glucocorticoids and reduced insulin, leptin, elevated hypothalamic AGRP and NPY mRNA, and reduced hypothalamic POMC mRNA. Although leptin replacement can reverse changes in hypothalamic gene expression associated with fasting and diabetes, leptin also normalizes corticosterone; therefore the extent to which the elevated corticosterone contributes to the regulation of hypothalamic gene expression in fasting and diabetes remains unclear. To address if elevated corticosterone is necessary for hypothalamic responses to fasting and diabetes, we assessed the effects of adrenalectomy on hypothalamic gene expression in 48-hour-fasted or diabetic mice. To assess if elevated corticosterone is sufficient for the hypothalamic responses to fasting and diabetes, we assessed the effect of corticosterone pellets implanted for 48 hours on hypothalamic gene expression. RESULTS: Fasting and streptozotocin-induced diabetes elevated plasma glucocorticoid levels and reduced serum insulin and leptin levels. Adrenalectomy prevented the rise in plasma glucocorticoids associated with fasting and diabetes, but not the associated reductions in insulin or leptin. Adrenalectomy blocked the effects of fasting and diabetes on hypothalamic AGRP, NPY, and POMC expression. Conversely, corticosterone implants induced both AGRP and POMC mRNA (with a non-significant trend toward induction of NPY mRNA), accompanied by elevated insulin and leptin (with no change in food intake or body weight). CONCLUSION: These data suggest that elevated plasma corticosterone mediate some effects of fasting and diabetes on hypothalamic gene expression. Specifically, elevated plasma corticosterone is necessary for the induction of NPY mRNA with fasting and diabetes; since corticosterone implants only produced a non-significant trend in NPY mRNA, it remains uncertain if a rise in corticosterone may be sufficient to induce NPY mRNA. A rise in corticosterone is necessary to reduce hypothalamic POMC mRNA with fasting and diabetes, but not sufficient for the reduction of hypothalamic POMC mRNA. Finally, elevated plasma corticosterone is both necessary and sufficient for the induction of hypothalamic AGRP mRNA with fasting and diabetes.

Adrenalectomy stimulates hypothalamic proopiomelanocortin expression but does not correct diet-induced obesity.

BACKGROUND: Elevated glucocorticoid production and reduced hypothalamic POMC mRNA can cause obese phenotypes. Conversely, adrenalectomy can reverse obese phenotypes caused by the absence of leptin, a model in which glucocorticoid production is elevated. Adrenalectomy also increases hypothalamic POMC mRNA in leptin-deficient mice. However most forms of human obesity do not appear to entail elevated plasma glucocorticoids. It is therefore not clear if reducing glucocorticoid production would be useful to treat these forms of obesity. We hypothesized that adrenalectomy would increase hypothalamic POMC mRNA and reverse obese phenotypes in obesity due to a high-fat diet as it does in obesity due to leptin deficiency. RESULTS: Retired breeder male mice were placed on a high-fat diet or a low-fat diet for two weeks, then adrenalectomized or sham-adrenalectomized. The high-fat diet increased body weight, adiposity, and plasma leptin, led to impaired glucose tolerance, and slightly stimulated hypothalamic proopiomelanocortin (POMC) expression. Adrenalectomy of mice on the high-fat diet significantly reduced plasma corticosterone and strikingly increased both pituitary and hypothalamic POMC mRNA, but failed to reduce body weight, adiposity or leptin, although slight improvements in glucose tolerance and metabolic rate were observed. CONCLUSION: These data suggest that neither reduction of plasma glucocorticoid levels nor elevation of hypothalamic POMC expression is effective to significantly reverse diet-induced obesity.

Interleukin balance and early recovery from anesthesia in elderly surgical patients exposed to beta-adrenergic antagonism.

STUDY OBJECTIVE: To determine whether proinflammatory and antiinflammatory cytokines, as measured in blood specimens, would correlate with improved SF-36 physical composite scores observed in elderly surgical patients who were administered perioperative atenolol. DESIGN: Post hoc analysis of data from a randomized clinical study. SETTING: Department of Anesthesiology, Mount Sinai Medical School, New York. PATIENTS: 59 ASA physical status II, III, and IV patients > or =65 years of age, who were scheduled for major elective noncardiac surgery. INTERVENTIONS: Patients were randomized to one of three anesthetic regimens to receive 1) perioperative management without beta-adrenergic antagonism, 2) preoperative and postoperative administration of atenolol, or 3) intraoperative atenolol as a major component of the anesthetic regimen. MEASUREMENTS AND MAIN RESULTS: Blood samples were drawn perioperatively at seven different time points. Interleukin-1 beta, interleukin-6, interleukin-1ra, and interleukin-10 were measured using enzyme-linked immunosorbent assay (ELISA) kits. Also, recovery from anesthesia and physical/mental well-being (SF-36 questionnaire) were determined perioperatively. Compared with control patients, atenolol-treated patients experienced improved postoperative physical well-being, which paralleled the previously reported faster recovery from anesthesia and a decreased need for perioperative analgesics. Improved postoperative physical well-being of atenolol-treated patients was specifically caused by an ameliorated bodily pain score, a major component of the physical composite score of the SF-36 questionnaire. The cytokine response of these elderly surgical patients was similar to that of younger patients, and the perioperative profile of proinflammatory and antiinflammatory cytokines was not affected by atenolol. CONCLUSIONS: Perioperative administration of atenolol to elderly surgical patients markedly improves physical sense of well-being, which coincides with improved postoperative pain control and decreased analgesic requirements. This improvement experienced by patients receiving atenolol is not related to alterations in perioperative cytokine response.