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3.  Alcohol Abuse Enhances Pulmonary Edema in Acute Respiratory Distress Syndrome 
Background
Pulmonary edema is a cardinal feature of the life-threatening condition known as Acute Respiratory Distress Syndrome (ARDS). Patients with chronic alcohol abuse are known to be at increased risk of developing and dying from ARDS. Based upon preclinical data, we hypothesized that a history of chronic alcohol abuse in ARDS patients is associated with greater quantities and slower resolution of pulmonary edema compared to ARDS patients without a history of alcohol abuse.
Methods
A PiCCO™ transpulmonary thermodilution catheter was inserted into 35 patients within 72 hours of meeting American European Consensus Criteria definition of ARDS. Pulmonary edema was quantified as extravascular lung water (EVLW) and measured for up to 7 days in 13 patients with a history of chronic alcohol abuse and 22 patients without a history of chronic alcohol abuse.
Results
Mean EVLW was higher in patients with a history of chronic alcohol abuse (16.6mL/kg vs. 10.5mL/kg, p<0.0001). Patients with alcohol abuse had significantly greater EVLW over the duration of the study (RM-ANOVA p=0.003). There was a trend towards slower resolution of EVLW in patients with a history of alcohol abuse (a decrease of 0.5mL/kg vs. 2.4mL/kg, p=0.17) over the study period. A history of alcohol abuse conferred a greater than three-fold increased risk of elevated EVLW [OR 3.16, (1.26-7.93)] using multivariate logistic regression analysis.
Conclusions
In patients who develop ARDS, alcohol abuse is associated with greater levels EVLW and a trend towards slower resolution of EVLW. Combined with mechanistic and preclinical evidence linking chronic alcohol consumption and ARDS, targeted therapies should be developed for these patients.
doi:10.1111/j.1530-0277.2009.01005.x
PMCID: PMC4241570  PMID: 19572988
alcoholism; sepsis; respiratory distress syndrome (adult); pulmonary edema; extravascular lung water
4.  Impact of Older Age and Nursing Home Residence on Clinical Outcomes of U.S. Emergency Department Visits for Severe Sepsis 
Journal of critical care  2013;28(5):606-611.
Purpose
To compare the impact of older age and nursing home residence on the incidence and morbidity of severe sepsis.
Materials and Methods
This was a retrospective analysis of 19,460 emergency department (ED) visits from the 2005–2009 National Ambulatory Medical Care Surveys with diagnosis of infection with or without severe sepsis (acute organ dysfunction). Clinical outcomes included intensive care unit (ICU) admission, hospital length of stay (LOS), and in-hospital mortality.
Results
Older adults (age ≥65 years) were five-fold more likely to have infections classified as severe sepsis than younger adults (6.5% vs. 1.3%), and nursing home residents were seven-fold more likely to have a severe sepsis diagnosis compared to non-nursing home residents (14% vs. 1.9%). Among visits for severe sepsis, older adults, compared to younger adults, had modestly higher rates of ICU admission (27% vs. 21%), hospital LOS (median 6 vs. 5 days), and in-hospital mortality (24% vs. 16%). Nursing home residents with severe sepsis, compared to non-nursing home residents, had significantly higher rates of ICU admission (40% vs. 21%), hospital LOS (median 7 vs. 5 days) and in-hospital mortality (37% vs. 15%).
Conclusions
Older adults, and particularly nursing home residents, have a disproportionately high incidence of and morbidity from severe sepsis.
doi:10.1016/j.jcrc.2013.03.018
PMCID: PMC3770757  PMID: 23683561
sepsis; infection; organ failure; critical care; emergency medicine; geriatrics; nursing home; epidemiology
5.  Facilitators and Barriers to Initiating Change in Medical Intensive Care Unit Survivors with Alcohol Use Disorders: A qualitative study 
Journal of critical care  2013;28(5):849-856.
Purpose
Alcohol abuse and dependence are collectively referred to as alcohol use disorders (AUD). An AUD is present in up to one third of patients admitted to an intensive care unit (ICU). We sought to understand the barriers and facilitators to change in ICU survivors with an AUD in order to provide a foundation upon which to tailor alcohol-related interventions.
Methods
We utilized a qualitative approach with a broad constructivist framework, conducting semistructured interviews in medical ICU survivors with an AUD. Patients were included if they were admitted to one of two medical ICUs and were excluded if they refused participation, were unable to participate, or did not speak English. Digitally recorded and professionally transcribed interviews were analyzed using a general inductive approach and grouped into themes.
Results
Nineteen patients were included with an average age of 51 [interquartile range (IQR) 36–51] years and an average APACHE II score of 9 [IQR 5–13]; 68% were Caucasian, 74% were male, and the most common reason for admission was alcohol withdrawal (n = 8). We identified five facilitators of change: empathy of the inpatient healthcare environment, recognition of accumulating problems, religion, pressure from others to stop drinking, and trigger events. We identified 3 barriers to change: missed opportunities, psychiatric comorbidity, and cognitive dysfunction. Social networks were identified as either a barrier or facilitator to change depending on the specific context.
Conclusions
Alcohol-related interventions to motivate and sustain behavior change could be tailored to ICU survivors by accounting for unique barriers and facilitators.
doi:10.1016/j.jcrc.2013.06.011
PMCID: PMC4117201  PMID: 23876701
Intensive care unit; critical illness; alcohol use disorder; brief intervention; motivational interviewing
6.  Healthcare Utilization in Medical Intensive Care Unit Survivors with Alcohol Withdrawal 
Background
Rehospitalization is an important and costly outcome that occurs commonly in several diseases encountered in the medical intensive care unit (ICU). Although alcohol use disorders are present in 40% of ICU survivors and alcohol withdrawal is the most common alcohol-related reason for admission to an ICU, rates and predictors of rehospitalization have not been previously reported in this population.
Methods
We conducted a retrospective cohort study of medical ICU survivors with a primary or secondary discharge diagnosis of alcohol withdrawal using two administrative databases. The primary outcome was time to rehospitalization or death. Secondary outcomes included time to first emergency department or urgent care clinic visit in the subset of ICU survivors who were not rehospitalized. Cox proportional hazard models were adjusted for age, gender, race, homelessness, smoking, and payer source.
Results
Of 1,178 patients discharged from the medical ICU over the study period, 468 (40%) were readmitted to the hospital and 54 (4%) died within 1 year. Schizophrenia (HR 2.23, 95% CI 1.57, 3.34, p < 0.001), anxiety disorder (HR 2.04, 95% CI 1.30, 3.32, p < 0.01), depression (HR 1.62, 95% CI 1.05, 2.40, p = 0.03), and Deyo comorbidity score ≥ 3 (HR 1.43, 95% CI 1.09, 1.1.89, p = 0.01) were significant predictors of time to death or first rehospitalization. Bipolar disorder was associated with time to first emergency department or urgent care clinic visit (HR 2.03, 95% CI 1.24, 3.62, p < 0.01) in the 656 patients who were alive and not rehospitalized within one year.
Conclusion
The presence of a psychiatric comorbidity is a significant predictor of multiple measures of unplanned healthcare utilization in medical ICU survivors with a primary or secondary discharge diagnosis of alcohol withdrawal. This finding highlights the potential importance of targeting longitudinal multidisciplinary care to patients with a dual diagnosis.
doi:10.1111/acer.12124
PMCID: PMC4045620  PMID: 23647435
alcohol withdrawal; alcohol use disorder; intensive care unit; rehospitalization; dual diagnosis
7.  Bronchoalveolar lavage neuregulin-1 is elevated in acute lung injury and correlates with inflammation 
The European respiratory journal  2012;41(2):396-401.
Shedding of neuregulin (NRG)-1 from the pulmonary epithelium leads to activation of the epithelial human epidermal growth factor receptor (HER)2 receptor, increased pulmonary epithelial permeability and acute lung injury (ALI). We sought to determine whether NRG-1 was detectable and elevated in bronchoalveolar lavage (BAL) and plasma from patients with ALI compared with controls and to determine whether a correlation exists between NRG-1 and inflammation and outcome in ALI.
Matched BAL and plasma samples were obtained from 23 ALI patients requiring intubation and mechanical ventilation. Control patients (n=5) included healthy volunteers. NRG-1 and indices of inflammation were measured in BAL and plasma via ELISA.
The mean±sd BAL NRG-1 concentration in ALI patients was 187.0±21.35 pg·mL−1 compared with 85.50±9.2 pg·mL−1 in controls (p=0.001). Increased BAL NRG-1 was associated with markers of inflammation, and inversely correlated with ventilator-free days (VFDs; r= −0.51, p=0.015). Plasma NRG-1 was elevated in ALI patients compared with controls (611.7±354.2 versus 25.17±19.33 pg·mL−1, p<0.001) and inversely correlated with VFDs (r= −0.51, p=0.04).
These results confirm shedding of NRG-1 in ALI and suggest that the NRG-1–HER2 pathway is active in patients with ALI.
doi:10.1183/09031936.00004912
PMCID: PMC4140244  PMID: 22599357
Acute respiratory failure; alveolar epithelium; biomarkers; inflammatory mediators
8.  Alcohol Screening Scores and 90 Day Outcomes in Patients with Acute Lung Injury 
Critical care medicine  2013;41(6):1518-1525.
Objective
The effects of excess alcohol consumption (alcohol misuse) on outcomes in patients with acute lung injury (ALI) have been inconsistent, and there are no studies examining this association in the era of low tidal volume ventilation and a fluid conservative strategy. We sought to determine whether validated scores on the Alcohol Use Disorders Identification Test (AUDIT) that correspond to past year abstinence (zone 1), low-risk drinking (zone 2), mild to moderate alcohol misuse (zone 3), and severe alcohol misuse (zone 4) are associated with poor outcomes in patients with ALI.
Design
Secondary analysis.
Setting
The Acute Respiratory Distress Syndrome (ARDS) network, a consortium of 12 university centers (44 hospitals) dedicated to the conduct of multi-center clinical trials in patients with acute lung injury.
Subjects
Patients meeting consensus criteria for ALI enrolled in one of three recent ARDS network clinical trials.
Interventions
None
Measurements and Main Results
Of 1,133 patients enrolled in one of three ARDS network studies, 1,037 patients had an AUDIT score available for analysis. Alcohol misuse was common with 70 (7%) of patients having AUDIT scores in zone 3 and 129 (12%) patients in zone 4. There was a u-shaped association between validated AUDIT zones and death or persistent hospitalization at 90 days (34% in zone 1, 26% in zone 2, 27% in zone 3, 36% in zone 4; p < 0.05 for comparison of zone 1 to zone 2 and zone 4 to zone 2). In a multiple logistic regression model, there was a significantly higher odds of death or persistent hospitalization in patients in AUDIT zone 4 when compared to those in zone 2 (adjusted OR 1.70; 95% CI 1.00, 2.87; p = 0.048).
Conclusions
Severe, but not mild to moderate alcohol misuse is independently associated with an increased risk of death or persistent hospitalization at 90 days in ALI patients.
doi:10.1097/CCM.0b013e318287f1bb
PMCID: PMC4048714  PMID: 23538449
alcohol use disorders identification test; acute lung injury; alcohol use disorder; alcohol misuse; unhealthy alcohol use
9.  The fibroproliferative response in acute respiratory distress syndrome: mechanisms and clinical significance 
The European respiratory journal  2013;43(1):276-285.
Acute respiratory distress syndrome (ARDS) continues to be a major healthcare problem, affecting >190 000 people in the USA annually, with a mortality of 27–45%, depending on the severity of the illness and comorbidities. Despite advances in clinical care, particularly lung protective strategies of mechanical ventilation, most survivors experience impaired health-related quality of life for years after the acute illness. While most patients survive the acute illness, a subset of ARDS survivors develops a fibroproliferative response characterised by fibroblast accumulation and deposition of collagen and other extracellular matrix components in the lung.
Historically, the development of severe fibroproliferative lung disease has been associated with a poor prognosis with high mortality and/or prolonged ventilator dependence. More recent studies also support a relationship between the magnitude of the fibroproliferative response and long-term health-related quality of life. The factors that determine which patients develop fibroproliferative ARDS and the cellular mechanisms responsible for this pathological response are not well understood.
This article reviews our current understanding of the contribution of pulmonary dysfunction to mortality and to quality of life in survivors of ARDS, the mechanisms driving pathological fibroproliferation and potential therapeutic approaches to prevent or attenuate fibroproliferative lung disease.
doi:10.1183/09031936.00196412
PMCID: PMC4015132  PMID: 23520315
10.  The role of infection and comorbidity: Factors that influence disparities in sepsis 
Critical care medicine  2006;34(10):2576-2582.
Objective
Large healthcare disparities exist in the incidence of sepsis based on both race and gender. We sought to determine factors that may influence the occurrence of these healthcare disparities, with respect to the source of infection, causal organisms, and chronic comorbid medical conditions.
Design
Historical cohort study.
Setting
U.S. acute care hospitals from 1979 to 2003.
Patients
Hospitalized patients with a diagnosis of sepsis were identified from the National Hospital Discharge Survey per codes of the International Statistical Classification of Diseases, Ninth Revision (ICD-9CM). Chronic comorbid medical conditions and the source and type of infection were characterized by corresponding ICD-9CM diagnoses.
Interventions
None.
Measurements and Main Results
Sepsis incidence rates are mean cases per 100,000 after age adjustment to the 2000 U.S. Census. Males and nonwhite races were confirmed at increased risk for sepsis. Both proportional source distribution and incidence rates favored respiratory sources of sepsis in males (36% vs. 29%, p < .01) and genitourinary sources in females (35% vs. 27%, p < .01). Incidence rates for all common sources of sepsis were greater in nonwhite races, but proportional source distribution was approximately equal. After stratification by the source of infection, males (proportionate ratio 1.16, 95% confidence interval 1.04–1.29) and black persons (proportionate ratio 1.25, 95% confidence interval 1.18–1.32) remained more likely to have Gram-positive infections. Chronic comorbid conditions that alter immune function (chronic renal failure, diabetes mellitus, HIV, alcohol abuse) were more common in nonwhite sepsis patients, and cumulative comorbidities were associated with greater acute organ dysfunction. Compared with white sepsis patients, non-white sepsis patients had longer hospital length of stay (2.0 days, 95% confidence interval 1.9–2.1) and were less likely to be discharged to another medical facility (30% whites, 25% blacks, 18% other races). Case-fatality rates were not significantly different across racial and gender groups.
Conclusions
Healthcare disparities exist in the incidence of sepsis within all major sources of infection, and males and blacks have greater frequency of Gram-positive infections independent of the infection source. The differential distribution of specific chronic comorbid medical conditions may contribute to these disparities. Large cohort and administrative studies are required to confirm discrete root causes of sepsis disparities.
doi:10.1097/01.CCM.0000239114.50519.0E
PMCID: PMC3926300  PMID: 16915108
sepsis; healthcare disparities; comorbidities; infection
11.  Chest Computed Tomography Features are Associated with Poorer Quality of Life in Acute Lung Injury Survivors 
Critical care medicine  2013;41(2):445-456.
Objectives
Despite decreasing mortality rates in acute lung injury (ALI), studies of long term physical function in ALI survivors have consistently reported poorer quality of life persisting years into recovery for reasons that are not completely understood. We sought to determine if pulmonary dysfunction is independently associated with functional impairment among ALI survivors, and to determine if high resolution computed tomography could be used to predict its development.
Design
Secondary analysis of data from a randomized controlled trial in ALI.
Setting
Intensive care units at three academic medical centers.
Patients
Patients diagnosed with ALI who had high resolution computed tomography scans performed at 14 and/or 180 days after diagnosis.
Interventions
None.
Measurements and main results
An objective radiologic scoring system was used to quantify patterns present on chest high resolution computed tomography obtained at 14 and 180 days in patients with ALI. These scores were correlated in univariable and multivariable analyses with pulmonary function testing and quality of life survey data obtained at 180 days. Eighty-nine patients had evaluable data at day 14, and 47 at 180 days. At 180 days, increased radiologic scores for reticulation were associated with a decreased total lung capacity, forced vital capacity, and diffusing capacity for carbon monoxide (p values all <0.002). Decrements in quality of life attributable to pulmonary dysfunction were most strongly associated with higher radiologic scores. Additionally, radiologic scores at 14 days independently predicted poorer quality of life at 180 days, accounting for age, severity of illness, pneumonia as the ALI risk factor, and length of time on mechanical ventilation.
Conclusions
Among survivors of ALI, increasing chest high resolution computed tomography involvement correlated with restrictive physiology and poorer health related quality of life, implicating pulmonary dysfunction as a potential contributor to activity limitation in these patients.
doi:10.1097/CCM.0b013e31826a5062
PMCID: PMC3671861  PMID: 23263616
reticulation; biomarker; restriction; fibroproliferation; radiologic; pulmonary function
12.  Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study 
PLoS ONE  2013;8(12):e81890.
Objective
Barriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV) via remote electronic monitoring is feasible.
Methods
Five hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected.
Results
Thirty-two study subjects were randomized to either remote SDV (N=16) or traditional on-site SDV (N=16). Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47%) could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12%) required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD): Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11); Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37) and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10); Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10) using remote SDV.
Conclusions
Because each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study monitoring.
doi:10.1371/journal.pone.0081890
PMCID: PMC3857788  PMID: 24349149
13.  Diagnosis and treatment of post-extubation dysphagia: Results from a National Survey 
Journal of critical care  2012;27(6):578-586.
Purpose
This study sought to determine the utilization of speech-language pathologist (SLPs) for the diagnosis and treatment of post-extubation dysphagia in survivors of mechanical ventilation.
Methods
We designed, validated, and mailed a survey to 1,966 inpatient SLPs who routinely evaluate patients for post-extubation dysphagia.
Results
The majority of SLP diagnostic evaluations (60%; 95% CI = 59–62%) were performed using clinical techniques with uncertain accuracy. Instrumental diagnostic tests (such as fluoroscopy and endoscopy) are more likely to be available at university than community hospitals. After adjusting for hospital size and academic affiliation, instrumental test use varied significantly by geographical region. Treatments for post-extubation dysphagia usually involved dietary adjustment (76%; 95% CI = 73–79%) and postural changes/compensatory maneuvers (86%; 95% CI = 84–88%), rather than on interventions aimed to improve swallowing function (24%; 95% CI = 21–27%).
Conclusions
SLPs frequently evaluate acute respiratory failure survivors. However, diagnostic evaluations rely mainly upon bedside techniques with uncertain accuracy. The use of instrumental tests varies by geographic location and university affiliation. Current diagnostic practices and feeding decisions for critically ill patients should be viewed with caution until further studies determine the accuracy of bedside detection methods.
doi:10.1016/j.jcrc.2012.07.016
PMCID: PMC3518658  PMID: 23084136
Mechanical Ventilation; Intratracheal Intubation; Respiratory Aspiration; Dysphagia; Swallowing Disorders
14.  Simple Frailty Score Predicts Post-Operative Complications Across Surgical Specialties 
American journal of surgery  2013;206(4):544-550.
Introduction
Our purpose was to determine the relationship between pre-operative frailty and the occurrence of postoperative complications following colorectal and cardiac operations.
Study Design
Patients ≥65 years undergoing elective colorectal or cardiac surgery were enrolled. Seven baseline frailty traits were measured pre-operatively: Katz Score ≤5, Timed Up-and-Go ≥15 seconds, Charlson Index ≥3, anemia<35%, Mini-Cog score ≤3, albumin<3.4gm/dL and ≥1 fall within six-months. Patients were categorized by the number of positive traits: non-frail: 0–1 trait, pre-frail: 2–3 traits and frail: ≥4 traits.
Results
201 subjects (age 74±6 years) were studied. Preoperative frailty was associated with increased postoperative complications following colorectal (non-frail 21%, pre-frail 40% and frail 58%; p=0.016) and cardiac operations (non-frail 17%, pre-frail 28% and frail 56%; p<0.001). This finding in both groups was independent of advancing age. Frail individuals in both groups had longer hospital stays and higher 30-day readmission rates. Receiver operating characteristic curves examining frailty’s ability to forecast complications were: colorectal (0.702; p=0.004) and cardiac (0.711; p<0.001).
Conclusion
A simple pre-operative frailty score defines older adults at higher risk for postoperative complications across surgical specialties.
doi:10.1016/j.amjsurg.2013.03.012
PMCID: PMC3788864  PMID: 23880071
15.  Slower Walking Speed Forecasts Increased Postoperative Morbidity and One-Year Mortality Across Surgical Specialties 
Annals of surgery  2013;258(4):582-590.
Objective
The purpose of this study was to determine the relationship between the timed up-and-go test and postoperative morbidity and one-year mortality, and to compare the timed up-and-go to the standard-of-care surgical risk calculators for prediction of postoperative complications.
Methods
In this prospective cohort study, patients 65 years and older undergoing elective colorectal and cardiac operations with a minimum of one-year follow-up were included. The timed up-and-go test was performed preoperatively. This timed test starts with the subject standing from a chair, walking ten feet, returning to the chair, and ends after the subject sits. Timed up-and-go results were grouped: Fast≤10 sec, Intermediate=11-14 sec, Slow≥15 sec. Receiver operating characteristic curves were used to compare the three timed-up-and-go groups to current standard-of-care surgical risk calculators at forecasting postoperative complications.
Results
This study included 272 subjects (mean age of 74±6 years). Slower timed up-and-go was associated with an increased postoperative complications following colorectal (fast-13%, intermediate-29% and slow-77%;p<0.001) and cardiac (fast-11%, intermediate-26% and slow-52%;p<0.001) operations. Slower timed up-and-go was associated with increased one-year mortality following both colorectal (fast-3%, intermediate-10% and slow-31%;p=0.006) and cardiac (fast-2%, intermediate-3% and slow-12%;p=0.039) operations. Receiver operating characteristic area under curve of the timed up-and-go and the risk calculators for the colorectal group was 0.775 (95% CI:0.670,0.880) and 0.554 (95% CI:0.499,0.609), and for the cardiac group was 0.684 (95% CI:0.603,0.766) and 0.552 (95% CI:0.477,0.626).
Conclusions
Slower timed up-and-go forecasted increased postoperative complications and one-year mortality across surgical specialties. Regardless of operation performed, the timed up-and-go compared favorably to the more complex risk calculators at forecasting postoperative complications.
doi:10.1097/SLA.0b013e3182a4e96c
PMCID: PMC3771691  PMID: 23979272
16.  Surrogate and Patient Discrepancy Regarding Consent for Critical Care Research 
Critical care medicine  2012;40(9):2590-2594.
Objective
Critically ill patients frequently display impaired decision making capacity due to their underlying illness and the use of sedating medications. Health care providers often rely on surrogates to make decisions for medical care and participation in clinical research. However, the accuracy of surrogate decisions for a variety of critical care research studies is poorly understood.
Design
Cross-sectional observational study
Setting
Academic medical center
Patients
Medical ICU patients and their designated surrogates
Intervention
Patients were asked if they would consent to participate in hypothetical research studies of increasing complexity, and surrogates independently indicated whether they would consent to enroll the patient in the same scenarios.
Results
Overall, 69 MICU patients were enrolled into the study. The majority of surrogates were either the spouse (58%) or parent (22%) of the patient. The percentage of patients that would agree to participate in a research study and the percentage of surrogates that would agree to have the patient enrolled into a research study both declined as the risk of the study increased (P < 0.001 for both analyses). In addition, the overall discrepancy, the false negative rates, and the false positive rates between patient and surrogates were greater as the risk of the study increased (P <0.001, P < 0.001, and P = 0.049 respectively). Kappa values for all seven scenarios demonstrated less than moderate agreement (range 0.03–0.41).
Conclusions
There are significant discrepancies in the willingness to participate in various types of clinical research proposals between critically ill patients and their surrogate decision makers. The results of this study raise concerns about the use of surrogate consent for inclusion of critically ill patients into research protocols.
doi:10.1097/CCM.0b013e318258ff19
PMCID: PMC3674768  PMID: 22732283
critical care; informed consent; surrogate; medical ethics; research design
17.  Symptoms of Post-traumatic Stress Disorder Among Pediatric Acute Care Nurses 
Journal of Pediatric Nursing  2011;27(4):357-365.
doi:10.1016/j.pedn.2011.04.024
PMCID: PMC3381608  PMID: 22703683
18.  Transfusion-related acute lung injury in ICU patients admitted with gastrointestinal bleeding 
Intensive care medicine  2010;36(10):1710-1717.
Purpose
Transfusion of blood components is common in patients admitted to the intensive care unit (ICU) for gastrointestinal (GI) bleeding, yet the incidence and risk factors for development of transfusion-related acute lung injury (TRALI) in these patients are unknown.
Methods
Patients admitted to a medical ICU for GI bleeding (n = 225) were analyzed for patient-and transfusion-specific risk factors for development of TRALI.
Results
In transfused patients (n = 150), the incidence of TRALI was 15% [95% confidence interval (CI), 10–21%] and accounted for 76% (22/29) of all acute lung injury (ALI) cases. Transfused patients with end-stage liver disease (ESLD) (n = 72) developed TRALI more frequently than those without ESLD (29% versus 1%, p < 0.01). Fresh frozen plasma (FFP) was temporally associated with TRALI in 86% of cases. Transfusion-specific risk factors for development of TRALI included number of transfused units of FFP and nonleukoreduced red blood cells. Patient-specific risk factors included Model for End-Stage Liver Disease (MELD) score, admission serum albumin level, and presence of ALI risk factors.
Conclusions
TRALI is common in critically ill ESLD patients with gastrointestinal bleeding. Nonleukoreduced red blood cells and FFP are significant transfusion-specific risk factors and their use should be re-evaluated in bleeding patients with ESLD.
doi:10.1007/s00134-010-1954-x
PMCID: PMC3727900  PMID: 20658125
Transfusion-related acute lung injury; Transfusion complications; Acute respiratory distress syndrome; Variceal bleeding; Chronic liver disease; Plasma transfusion
19.  Preoperative Cognitive Dysfunction Is Related to Adverse Postoperative Outcomes in the Elderly 
Background
Pre-operative risk stratification is commonly performed by assessing end organ function (such as cardiac and pulmonary) to define post-operative risk. Little is known about impaired pre-operative cognition and outcomes. The purpose of this study was to evaluate the impact of baseline impaired cognition on post-operative outcomes in geriatric surgery patients.
Study Design
Prospectively, subjects 65 years and older undergoing a planned elective operation requiring post-operative ICU admission were recruited. Pre-operative baseline cognition was assessed using the validated Mini-Cog test. Impaired cognition was defined as a Mini-Cog score of ≤3. Delirium was assessed using the Confusion Assessment Method-ICU by a trained research team. Adverse outcomes were defined using the Veterans Affairs Surgical Quality Improvement Program definitions.
Results
186 subjects were included with an average age of 73±6 years. Eighty-two subjects (44%) had baseline impaired cognition. The impaired cognition group had the unadjusted outcomes: increased incidence of ≥1 post-operative complication (41% versus 24%; p=.011), higher incidence of delirium (78% versus 37%; p<.001), longer hospital stays (15±14 versus 9±9 days; p=.008), higher rate of discharge institutionalization (42% versus 18%; p=.001) and higher six-month mortality (13% versus 5%; p=.040). Adjusting for potential confounders determined by univariate analysis, logistic regression found impaired cognition was still associated to the occurrence of one or more post-operative complications (odds ratio 2.401; 95% confidence interval 1.185, 4.865; p=0.015). Kaplan-Meier survival analysis revealed higher mortality in the impaired cognition group (Log-Rank p =.008).
Conclusions
Baseline cognitive impairment in older adults undergoing major elective operations is related to adverse post-operative outcomes including increased complications, length of stay and long-term mortality. Improved understanding of baseline cognition and surgical outcomes may aid surgical decision-making in older adults.
doi:10.1016/j.jamcollsurg.2012.02.007
PMCID: PMC3383613  PMID: 22626912
20.  Post-extubation dysphagia is associated with longer hospitalization in survivors of critical illness with neurologic impairment 
Critical Care  2013;17(3):R119.
Introduction
Critically ill patients can develop acute respiratory failure requiring endotracheal intubation. Swallowing dysfunction after liberation from mechanical ventilation, also known as post-extubation dysphagia, is common and deleterious among patients without neurologic disease. However, the risk factors associated with the development of post-extubation dysphagia and its effect on hospital lengthofstay in critically ill patients with neurologic disorders remains relatively unexplored.
Methods
We conducted a retrospective, observational cohort study from 2008 to 2010 of patients with neurologic impairment who required mechanical ventilation and subsequently received a bedside swallow evaluation (BSE) by a speech-language pathologist.
Results
A BSE was performed after mechanical ventilation in 25% (630/2,484) of all patients. In the 184 patients with neurologic impairment, post-extubation dysphagia was present in 93% (171/184), and was classified as mild, moderate, or severe in 34% (62/184), 26% (48/184), and 33% (61/184), respectively. In univariate analyses, statistically significant risk factors for moderate/severe dysphagia included longer durations of mechanical ventilation and the presence of a tracheostomy. In multivariate analysis, adjusting for age, tracheostomy, cerebrovascular disease, and severity of illness, mechanical ventilation for >7 days remained independently associated with moderate/severe dysphagia (adjusted odds ratio = 4.48 (95%confidence interval = 2.14 to 9.81), P<0.01). The presence of moderate/severe dysphagia was also significantly associated with prolonged hospital lengthofstay, discharge status, and surgical placement of feeding tubes. When adjusting for age, severity of illness, and tracheostomy, patients with moderate/severe dysphagia stayed in the hospital 4.32 days longer after their initial BSE than patients with none/mild dysphagia (95% confidence interval = 3.04 to 5.60 days, P <0.01).
Conclusion
In a cohort of critically ill patients with neurologic impairment, longer duration of mechanical ventilation is independently associated with post-extubation dysphagia, and the development of post-extubation dysphagia is independently associated with a longer hospital length of stay after the initial BSE.
doi:10.1186/cc12791
PMCID: PMC4057203  PMID: 23786755
mechanical ventilation; intubation; intratracheal; swallowing disorders; dysphagia; aspiration; respiratory
21.  Growth differentiation factor-15 and prognosis in acute respiratory distress syndrome: a retrospective cohort study 
Critical Care  2013;17(3):R92.
Introduction
We sought to determine whether higher levels of the novel biomarker growth differentiation factor-15 (GDF-15) are associated with poor outcomes and the presence of pulmonary vascular dysfunction (PVD) in patients with acute respiratory distress syndrome (ARDS).
Methods
We conducted a retrospective cohort study in patients enrolled in the Acute Respiratory Distress Syndrome Network Fluid and Catheter Treatment (FACT) Trial. Patients enrolled in the FACT Trial who received a pulmonary artery catheter (PAC), had plasma available from the same study day and sufficient hemodynamic data to determine the presence of PVD were included. Logistic regression was used to determine the association between GDF-15 level and 60-day mortality.
Results
Of the 513 patients enrolled in the FACT Trial assigned to receive a PAC, 400 were included in this analysis. Mortality at 60 days was significantly higher in patients whose GDF-15 levels were in the third (28%) or fourth (49%) quartile when compared to patients with GDF-15 levels in the first quartile (12%) (P <0.001). Adjusting for severity of illness measured by APACHE III score, the odds of death for patients with GDF-15 levels in the fourth quartile when compared to the first quartile was 4.26 (95% CI 2.18, 10.92, P <0.001). When added to APACHE III alone for prediction of 60-day mortality, GDF-15 levels increased the area under the receiver operating characteristic curve from 0.72 to 0.77. At an optimal cutoff of 8,103 pg/mL, the sensitivity and specificity of GDF-15 for predicting 60-day mortality were 62% (95% CI 53%, 71%) and 76% (95% CI 71%, 81%), respectively. Levels of GDF-15 were not useful in identifying the presence of PVD, as defined by hemodynamic measurements obtained by a PAC.
Conclusions
In patients with ARDS, higher levels of GDF-15 are significantly associated with poor outcome but not PVD.
doi:10.1186/cc12737
PMCID: PMC3706804  PMID: 23706007
Acute respiratory distress syndrome; pulmonary vascular dysfunction; risk prediction; growth differentiation factor-15
22.  Severity of Acute Illness is Associated with Baseline Readiness to Change in Medical Intensive Care Unit Patients with Unhealthy Alcohol Use 
Introduction
Unhealthy alcohol use predisposes to multiple conditions that frequently result in critical illness and is present in up to one-third of patients admitted to a medical intensive care unit (ICU). We sought to determine the baseline readiness to change in medical ICU patients with unhealthy alcohol use and hypothesized that the severity of acute illness would be independently associated with higher scores on readiness to change scales. We further sought to determine whether this effect is modified by the severity of unhealthy alcohol use.
Materials and Methods
We performed a cross-sectional observational study of current regular drinkers in three medical ICUs. The Alcohol Use Disorders Identification Test was used to differentiate low risk and unhealthy alcohol use and further categorize patients into risky alcohol use or an alcohol use disorder. The severity of a patient’s acute illness was assessed by calculating the Acute Physiology and Chronic Healthy Evaluation II score at the time of admission to the medical ICU. Readiness to change was assessed using standardized questionnaires.
Results
Of 101 medical ICU patients who were enrolled, 65 met the criteria for unhealthy alcohol use. The association between the severity of acute illness and readiness to change depended on the instrument used. A higher severity of illness measured by APACHEII score was an independent predictor of readiness to change as assessed by the Stages of Change Readiness and Treatment Eagerness Scale (Taking Action scale) (p< 0.01). When a visual analog scale was used to assess readiness to change, there was a significant association with severity of acute illness (p < 0.01) that was modified by the severity of unhealthy alcohol use (p = 0.04 for interaction term).
Conclusion
Medical ICU patients represent a population where brief interventions require further study. Studies of brief intervention should account for the severity of acute illness and the severity of unhealthy alcohol use as potential effect modifiers.
doi:10.1111/j.1530-0277.2011.01648.x
PMCID: PMC3251713  PMID: 21950704
23.  The presence of resilience is associated with a healthier psychological profile in ICU nurses: Results of a national survey 
Objective
ICU nurses are repeatedly exposed to work related stresses resulting in the development of psychological disorders including posttraumatic stress disorder and burnout syndrome. Resilience is a learnable multidimensional characteristic enabling one to thrive in the face of adversity. In a national survey, we sought to determine whether resilience was associated with healthier psychological profiles in intensive care unit nurses.
Design
Surveys were mailed to 3500 randomly selected ICU nurses across the United States and included: demographic questions, the Posttraumatic Diagnostic Scale, Hospital Anxiety and Depression Scale, Maslach Burnout Inventory and the Connor-Davidson Resilience Scale.
Measurements and Main Results
Overall, 1239 of the mailed surveys were returned for a response rate of 35%, and complete data was available on a total of 744 nurses. Twenty-two percent of the intensive care unit nurses were categorized as being highly resilient. The presence of high resilience in these nurses was significantly associated with a lower prevalence of posttraumatic stress disorder, symptoms of anxiety or depression, and burnout syndrome (<0.001 for all comparisons). In independent multivariable analyses adjusting for five potential confounding variables, the presence of resilience was independently associated with a lower prevalence of posttraumatic stress disorder (p < 0.001), and a lower prevalence of burnout syndrome (p < 0.001).
Conclusions
The presence of psychological resilience was independently associated with a lower prevalence of posttraumatic stress disorder and burnout syndrome in intensive care unit nurses. Future research is needed to better understand coping mechanisms employed by highly resilient nurses and how they maintain a healthier psychological profile.
doi:10.1016/j.ijnurstu.2011.09.015
PMCID: PMC3276701  PMID: 21974793
Resilience; posttraumatic stress disorder; burnout syndrome; ICU nurses
25.  A randomized trial of recombinant human GM-CSF for patients with acute lung injury* 
Critical care medicine  2012;40(1):90-97.
Rationale
Despite recent advances in critical care and ventilator management, acute lung injury (ALI) and the Acute Respiratory Distress Syndrome (ARDS) continue to cause significant morbidity and mortality. Granulocyte-macrophage colony stimulating factor (GM-CSF) may be beneficial for patients with ARDS.
Objectives
To determine whether intravenous infusion of GM-CSF would improve clinical outcomes for patients with ALI/ARDS.
Design
A randomized, double-blind, placebo-controlled clinical trial of human recombinant GM-CSF vs. placebo. The primary outcome was days alive and breathing without mechanical ventilatory support within the first 28 days after randomization. Secondary outcomes included mortality and organ failure free days.
Setting
Medical and Surgical Intensive Care Units at three academic medical centers.
Patients
One hundred-thirty individuals with ALI of at least three days duration were enrolled, out of a planned cohort of 200 subjects.
Interventions
Patients were randomized to receive human recombinant GM-CSF (64 subjects, 250 μg/M2) or placebo (66 subjects) by intravenous infusion daily for 14 days. Patients received mechanical ventilation using a lung protective protocol.
Measurements and Main Results
There was no difference in ventilator-free days between groups (10.7 ± 10.3 days placebo vs. 10.8 ± 10.5 days GM-CSF, p=0.82). Differences in 28-day mortality (23% in placebo vs. 17% in patients receiving GM-CSF (p=0.31)) and organ failure free days (12.8 ± 11.3 days placebo vs. 15.7 ± 11.9 days GM-CSF, p=0.16) were not statistically significant. There were similar numbers of serious adverse events in each group.
Conclusions
In a randomized phase II trial, GM-CSF treatment did not increase the number of ventilator free days in patients with ALI/ARDS. A larger trial would be required to determine whether treatment with GM-CSF might alter important clinical outcomes such as mortality or multiorgan failure. (ClinicalTrials.gov number, NCT00201409 [ClinicalTrials.gov])
doi:10.1097/CCM.0b013e31822d7bf0
PMCID: PMC3242850  PMID: 21926600
Acute Respiratory Distress Syndrome; growth factors; sepsis; innate immunity

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