Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.

Water Cultures Are More Sensitive Than Swab Cultures for the Detection of Environmental Legionella.

Water cultures were significantly more sensitive than concurrently collected swab cultures (n=2,147 each) in detecting Legionella pneumophila within a Veterans Affairs healthcare system. Sensitivity for water versus swab cultures was 90% versus 30% overall, 83% versus 48% during a nosocomial Legionnaires' disease outbreak, and 93% versus 22% post outbreak. Infect Control Hosp Epidemiol 2018;39:108-110.

Improving the Diagnosis of Legionella Pneumonia within a Healthcare System through a Systematic Consultation and Testing Program.

Rationale: Legionella testing is not recommended for all patients with pneumonia, but rather for particular patient subgroups. As a result, the overall incidence of Legionella pneumonia may be underestimated.

Objectives: To determine the incidence of Legionella pneumonia in a veteran population in an endemic area after introduction of a systematic infectious diseases consultation and testing program.

Inflammatory Mediators and Clinical Outcome in Patients With Advanced Heart Failure Receiving Cardiac Resynchronization Therapy.

Expression of different cytokines and growth factors after myocardial injury has been associated with fibroplasia and dilatation versus reverse remodeling and myocardial repair. Specifically, the proinflammatory/fibrotic mediators: interleukin (IL)-6, epidermal growth factor, and fibroblast growth factor (FGF)-2 cause fibroplasia, whereas reparative cytokines including: IL-1α, IL-1β, IL-4, and IL-13 can limit fibrosis. In appropriate patients, cardiac resynchronization therapy (CRT) reverses cardiomyopathy and improves outcome.

The importance of clinical surveillance in detecting legionnaires' disease outbreaks: a large outbreak in a hospital with a Legionella disinfection system-Pennsylvania, 2011-2012.

Background: Healthcare-associated Legionnaires' disease (LD) is a preventable pneumonia with a 30% case fatality rate. The Centers for Disease Control and Prevention guidelines recommend a high index of suspicion for the diagnosis of healthcare-associated LD. We characterized an outbreak and evaluated contributing factors in a hospital using copper-silver ionization for prevention of Legionella growth in water.

Association of BNP and Troponin Levels with Outcome among Cardiac Resynchronization Therapy Recipients.

Background: We conducted a prospective multicenter study to assess the prognostic value of combined baseline preimplant plasma levels of the biomarkers cardiac troponin T (TnT) and B-type natriuretic peptide (BNP) among cardiac resynchronization therapy (CRT) with or without defibrillator capability (CRT-D) recipients.

Methods: At CRT-D implant, patients were stratified based on detectable TnT (≥0.01 ng/mL) and elevated BNP (predefined as >440 pg/mL) levels.

2-octyl-cyanoacrylate glue for fixation of STSG in genitourinary tissue defects due to Fournier gangrene: a preliminary trial.

Background: In these reported cases, we observed the outcomes of skin take and wound healing using 2-octyl-cyanoacrylate glue, which was used as tissue glue in the reconstruction of complex genital skin loss due to fournier gangrene.

Methods: Fifteen patients with Fournier's gangrene were treated in this study. After initial surgical debridement, all defects were repaired using STSG.

Impact of endoscopic versus open saphenous vein harvest technique on late coronary artery bypass grafting patient outcomes in the ROOBY (Randomized On/Off Bypass) Trial.

Objective: In the Randomized On/Off Bypass (ROOBY) Trial, the efficacy of on-pump versus off-pump coronary artery bypass grafting was evaluated. This ROOBY Trial planned subanalysis compared the effects on postbypass patient clinical outcomes and graft patency of endoscopic vein harvesting and open vein harvesting.

Methods: From April 2003 to April 2007, the technique used for saphenous vein graft harvesting was recorded in 1471 cases.

Frequency of major noncardiac surgery and subsequent adverse events in the year after drug-eluting stent placement results from the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) Registry.

Objectives: This study sought to determine the frequency of noncardiac surgery and adverse post-operative events among patients who recently received a drug-eluting stent (DES) following noncardiac surgery.

Background: Little is known about frequency of and risks associated with noncardiac surgery after DES implantation.

Methods: In the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) registry, consecutive patients who underwent attempted stent placement at 42 hospitals between July 2004 and September 2005 were enrolled and followed for 1 year.

Hypercholesterolemia paradox in relation to mortality in acute coronary syndrome.

Background: Hypercholesterolemia is a risk factor for coronary artery disease, yet is associated with lower risk of adverse outcomes in patients with acute coronary syndromes (ACS).

Hypothesis: We explored this paradox in 84,429 patients with non-ST-segment elevation ACS in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines registry.

Methods: We examined the association between a history of hypercholesterolemia and in-hospital mortality after adjusting for clinical covariates.

Clinical significance of borderline elevated troponin I levels across different assays in patients with suspected acute coronary syndrome.

We aimed to elucidate the clinical significance of borderline troponin I (TnI) increases and see if such increases are of similar significance across different assays. Markedly increased TnI is a strong predictor of adverse cardiac events. It is not clear if borderline increases with different commercially available TnI assays provide similar prognostic information.

Factors associated with the use of preventive care for contrast-induced acute kidney injury.

Background: The factors that affect the implementation of preventive care for contrast-induced acute kidney injury (CIAKI) are unknown.

Objective: To assess patient and provider factors associated with the use of preventive care for CIAKI.

Design: Prospective cohort study.

Veterans' decision-making preferences and perceived involvement in care for chronic heart failure.

Background: Patients with heart failure require a great deal of information about their disease, but it is also important to know about their preferences for involvement in medical decision making and about factors that may influence their preferences so that patients' needs, values, and preferences can be met by clinicians.

Objectives: We assessed patients' preferred role and perceived level of involvement in medical decision making and tested the effects of patients' age and role preference on perceived involvement in medical decision making.

Methods: We conducted a telephone survey of 90 adults being treated for heart failure by a Veterans Affairs primary care provider or cardiologist.

"They diagnosed bad heart": a qualitative exploration of patients' knowledge about and experiences with heart failure.

Background: Patient education is central to the management of individuals with heart failure; therefore, it is important to know what these patients understand and experience both clinically and personally.

Objectives: This study qualitatively explored patients' knowledge regarding a heart failure diagnosis, their understanding of their cardiac care providers' treatment recommendations, and their views concerning the impact of heart failure on their daily lives and prognosis.

Methods: A qualitative study was conducted whereby data were collected through 25 telephone interviews with adults being followed for heart failure at a Veterans Affairs medical center.

Prevention, incidence, and outcomes of contrast-induced acute kidney injury.

Background: Little is known about whether health care providers (physicians) implement preventive care for contrast-induced acute kidney injury (CIAKI). The objectives of our prospective cohort study were (1) to assess provider use of preventive strategies for CIAKI, (2) to determine the incidence of CIAKI, and (3) to examine the association of CIAKI with adverse outcomes at 30 days, including death, need for dialysis, and hospital admission.

Methods: We prospectively identified patients with estimated glomerular filtration rates less than 60 mL/min/1.

The incidence of clinically significant contrast-induced nephropathy following non-emergent coronary angiography.

Objectives: The primary aim of this study was to assess the incidence of clinically significant contrast-induced nephropathy (CIN) among patients undergoing non-emergent coronary angiography.

Background: Although retrospective analyses have emphasized the association of CIN with adverse patient outcomes, the actual incidence of clinically significant CIN following non-emergent coronary angiography is not clear.

Methods: We prospectively identified patients with baseline estimated glomerular filtration rates (eGFR) < 60 ml/min/1.

Effect of hyponatremia (<135 mEq/L) on outcome in patients with non-ST-elevation acute coronary syndrome.

Hyponatremia is associated with adverse outcomes in patients with heart failure and ST-elevation myocardial infarction (STEMI). We evaluated the effect of hyponatremia on outcomes in patients with suspected acute coronary syndrome and non-STEMI. All patients had a sodium level determined at time of admission, at 24 and 48 hours, and at discharge.

Comparison of frequency of new-onset atrial fibrillation or flutter in patients on statins versus not on statins presenting with suspected acute coronary syndrome.

The effect of statins on the incidence of new-onset atrial fibrillation (AF) in patients presenting with suspicion of acute coronary syndrome (ACS) is unknown. Our study population consisted of patients admitted to a tertiary care Veterans Administration hospital with suspicion of ACS between November 2001 and January 2006. All patients had an electrocardiogram on admission that was compared with a previous electrocardiogram to confirm new-onset AF or atrial flutter.

Detectable troponin levels predict poor prognosis in patients with left ventricular dysfunction undergoing internal defibrillator implantation.

Introduction: Troponin levels have been demonstrated to predict mortality in patients with cardiomyopathy. Implantable cardiac defibrillator (ICD) devices have been demonstrated to improve survival. It is not clear if ICDs would mitigate the negative outcome predicted by elevated troponin levels.

Impact of blood transfusions in patients presenting with anemia and suspected acute coronary syndrome.

Anemia has been shown to predict adverse events in patients presenting with acute coronary syndromes and non-ST-elevation myocardial infarctions (MIs). Less is known about the value of blood transfusions in this setting. We sought to evaluate the impact of red blood cell transfusions on outcomes.

Patency outcomes of aortic connectors.

Objective: : Controlled outcome analysis of mechanical aortic connectors for proximal saphenous vein bypass graft anastomosis is lacking. We report the clinical and angiographic outcome of patients receiving the Symmetry aortic connector (St. Jude Medical, Inc St.

Racial disparities in outcomes following coronary artery bypass grafting.

More than 12 million people in the United States have coronary heart disease, the second leading cause of hospitalization in the United States. It is known that persons within racial minorities, specifically African Americans, have a higher prevalence of coronary heart disease, yet are much less likely to undergo invasive cardiac treatment interventions. An invasive intervention commonly used to treat coronary heart disease is coronary artery bypass grafting, with over 140,000 operations performed annually in the United States.

Clinical characteristics, process of care, and outcomes of Hispanic patients presenting with non-ST-segment elevation acute coronary syndromes: results from Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines (CRUSADE).

Background: Data regarding the management of non-ST-segment elevation acute coronary syndromes (NSTE ACS) in Hispanic patients, the largest and fastest-growing minority in the United States, are scarce.

Methods: We sought to describe the clinical characteristics, process of care, and outcomes of Hispanics presenting with NSTE ACS at US hospitals. We compared baseline characteristics, resource use, and inhospital mortality among 3936 Hispanics and 90280 non-Hispanic whites with NSTE ACS from the CRUSADE Quality Improvement Initiative.

Noncardiac surgery and the risk of death and other cardiovascular events in patients with hypertrophic cardiomyopathy.

Background: There is a paucity of reports evaluating the perioperative risk of noncardiac surgery in patients with hypertrophic cardiomyopathy (HCM).

Hypothesis: The study was undertaken to evaluate the incidence of acute myocardial infarction (MI) and all-cause inhospital mortality following noncardiac surgery in patients with HCM.

Methods: We searched the National Hospital Discharge Survey database for patients with a diagnosis of HCM who had undergone noncardiac surgery.