Benjamin R. Saville

Standardized postoperative handover process improves outcomes in the intensive care unit: a model for operational sustainability and improved team performance*.

Objective:To determine whether structured handover tool from operating room to pediatric cardiac intensive care unit following cardiac surgery is associated with a reduction in the loss of information transfer and an improvement in the quality of communication exchange. In addition, whether this tool is associated with a decrease in postoperative complications and an improvement in patient outcomes in the first 24 hrs of pediatric cardiac intensive care unit stay. Design:Prospective observational clinical study. Setting:Pediatric cardiac intensive care unit of an academic medical center. Patients:Pediatric cardiac surgery patients over a 3-yr period. Evaluation of communication and patients studied for two time periods: verbal handover (July 2007–June 2009) and structured handover (July 2009–June 2010). Interventions:None. Measurements and Main Results:Two anonymous surveys administered to the entire clinical team of the pediatric cardiac intensive care unit evaluated loss of information transfer for each of the two handover processes. Quality of structured handover tool was evaluated by Likert scale (1–5) responses in the second survey. Patient complications including cardiopulmonary resuscitation, mediastinal reexploration, placement on extracorporeal membrane oxygenation, development of severe metabolic acidosis, and number of early extubations in the first 24-hr pediatric cardiac intensive care unit stay were compared for the two time periods. Survey results showed the general opinion that the structured handover tool was of excellent quality to enhance communication (Likert scale: 4.4 ± 0.7). In addition, the tool was associated with a significant reduction (p < .001) in loss of information for every category of patient clinical care including patient, preoperative, anesthesia, operative, and postoperative details and laboratory values. Patient data revealed significant decrease (p < .05) for three of the four major complications studied and a significant increase (p < .04) in the number of early extubations following introduction of our standardized handover tool. Conclusions:In this setting, a standardized handover tool is associated with a decrease in the loss of patient information, an improvement in the quality of communication during postoperative transfer, a decrease in postoperative complications, and an improvement in 24-hr patient outcomes.

Fructose‐Fed Rhesus Monkeys: A Nonhuman Primate Model of Insulin Resistance, Metabolic Syndrome, and Type 2 Diabetes

The incidence of insulin resistance has increased dramatically over the past several years, and we and others have proposed that this increase may at least in part be attributable to increased dietary fructose consumption. However, a major limitation to the study of diet‐induced insulin resistance is the lack of relevant animal models. Numerous studies, mostly in rodents, have demonstrated that diets high in fructose induce insulin resistance; however, important metabolic differences exist between rodents and primates. Thus, the results of metabolic studies performed in primates are substantively more translatable to human physiology, underscoring the importance of establishing nonhuman primate models of common metabolic conditions. In this report, we demonstrate that a high‐fructose diet in rhesus monkeys produces insulin resistance and many features of the metabolic syndrome, including central obesity, dyslipidemia, and inflammation within a short period of time; moreover, a subset of monkeys developed type 2 diabetes. Given the rapidity with which the metabolic changes occur, and the ability to control for many factors that cannot be controlled for in humans, fructose feeding in rhesus monkeys represents a practical and efficient model system in which to investigate the pathogenesis, prevention, and treatment of diet‐induced insulin resistance and its related comorbidities. Clin Trans Sci 2011; Volume 4: 243–252

Preventability of Early Readmissions at a Children’s Hospital

OBJECTIVE: To determine whether pediatric readmissions within 15 days of discharge were considered preventable. METHODS: Retrospective chart review of 200 randomly selected readmissions (8% of all readmissions) occurring within 15 days of discharge from a freestanding children’s hospital between January 1, 2007, and December 31, 2008. The degree of preventability was assessed independently for each case by 4 pediatricians using a 5-point Likert scale and was correlated with chronic conditions and reason for index admission with 3M’s Clinical Risk Groups and All Patient-Refined Diagnostic-Related Groups, respectively. RESULTS: The rate of 15-day readmissions considered more likely preventable by the discharging hospital was 20.0% (1.7% of total admissions, 95% confidence interval 14.8%–26.4%). Reviewers failed to reach initial consensus in 62.5% of cases, although final consensus was achieved after the panel reviewed cases together. Consensus ratings served as the standard for the remainder of the study. Readmissions in children with malignancies were considered less preventable than those in children with other chronic illnesses (5.8% vs 25.8%, P = .003). Readmissions following surgical admissions were considered more likely preventable than those following medical admissions (38.9% vs 15.9%, P = .002). Central venous catheter infections and ventricular shunt malfunctions accounted for 8.5% of all readmissions reviewed. CONCLUSIONS: Although initial consensus about which readmissions were more likely preventable was difficult to achieve, the overall rate of preventable pediatric 15-day readmissions was low. Pediatric readmissions are unlikely to serve as a highly productive focus for cost savings or quality measurement.

Relationship Between Maternal and Neonatal Staphylococcus aureus Colonization

OBJECTIVE: The study aimed to assess whether maternal colonization with Staphylococcus aureus during pregnancy or at delivery was associated with infant staphylococcal colonization. METHODS: For this prospective cohort study, women were enrolled at 34 to 37 weeks of gestation between 2007 and 2009. Nasal and vaginal swabs for culture were obtained at enrollment; nasal swabs were obtained from women and their infants at delivery and 2- and 4-month postbirth visits. Logistic regression was used to determine whether maternal colonization affected infant colonization. RESULTS: Overall, 476 and 471 mother-infant dyads had complete data for analysis at enrollment and delivery, respectively. Maternal methicillin-resistant S aureus (MRSA) colonization occurred in 10% to 17% of mothers, with the highest prevalence at enrollment. Infant MRSA colonization peaked at 2 months of age, with 20.9% of infants colonized. Maternal staphylococcal colonization at enrollment increased the odds of infant staphylococcal colonization at birth (odds ratio; 95% confidence interval: 4.8; 2.4–9.5), hospital discharge (2.6; 1.3–5.0), at 2 months of life (2.7; 1.6–4.3), and at 4 months of life (2.0; 1.1–3.5). Similar results were observed for maternal staphylococcal colonization at delivery. Fifty maternal-infant dyads had concurrent MRSA colonization: 76% shared isolates of the same pulsed-field type, and 30% shared USA300 isolates. Only 2 infants developed staphylococcal disease. CONCLUSIONS: S aureus colonization (including MRSA) was extremely common in this cohort of maternal-infant pairs. Infants born to mothers with staphylococcal colonization were more likely to be colonized, and early postnatal acquisition appeared to be the primary mechanism.

Epidemiology of 15-Day Readmissions to a Children's Hospital

OBJECTIVE: To describe the population of pediatric patients readmitted to a childrens hospital within 15 days of discharge. PATIENTS AND METHODS: Medical records were reviewed to identify characteristics of patients and their hospitalizations for all children hospitalized during calendar years 2007–2008 who were readmitted up to and including 15 days after a previous discharge. RESULTS: Of 30 188 total hospital admissions during the study period, 2546 (8.4%) were followed by a readmission within 15 days of discharge. The age groups with the greatest number of readmissions were infants (aged 31–364 days, 20.8% of readmissions) and patients aged >10 years (31.3% of readmissions). Most readmitted patients (78.0%) had an underlying chronic illness, and patients with malignancies were most likely to be readmitted, followed by newborns and patients with neurologic conditions. Patients with malignancies also experienced the greatest number of readmissions per patient (4.1). Most patients who were readmitted had only 1 readmission (71.5%), but the small subset of patients with 3 or more readmissions accounted for 43.7% of all 15-day readmissions. Disease recurrence and natural course of the original diagnosis were the most common reasons for readmission (44.9%), followed by planned readmissions (20.6%) and readmissions for a new, unrelated illness (7.7%). CONCLUSIONS: This report is the first description of the epidemiology of all 15-day pediatric readmissions at a childrens hospital. The results of this study serve as a basis for additional analysis to determine the extent to which readmissions in the pediatric population may or may not be preventable.

Decision curve analysis.

Decision curve analysis (DCA) is a method for evaluating the benefits of a diagnostic test across a range of patient preferences for accepting risk of undertreatment and overtreatment to facilitate decisions about test selection and use.1 In this issue of JAMA, Siddiqui and colleagues2 used DCA to evaluate 3 prostate biopsy strategies: targeted magnetic resonance/ultrasound fusion biopsy, standard extended-sextant biopsy, or a combination, for establishing the diagnosis of intermediateto high-risk prostate cancer. Their goal was to identify the best biopsy strategy to ensure prostatectomy is offered to patients with intermediateand highrisk tumors and avoided for patients with low-risk tumors.

Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design

BACKGROUND Pulmonary vein antrum isolation (PVI) as a treatment of paroxysmal atrial fibrillation (AF) is associated with a high rate of success; however, outcomes for treating persistent and long-standing persistent AF with PVI alone are substantially lower and often require multiple procedures to maintain long-term freedom from atrial arrhythmias. Foci and/or substrate outside the pulmonary veins, particularly in the left atrial appendage (LAA), has been identified as a key mechanism in the maintenance of persistent AF and long-standing persistent AF. OBJECTIVE The goals of the study are to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the LAA and to determine if LAA ligation as adjunctive therapy to PVI improves maintenance of sinus rhythm in patients with persistent and long-standing persistent AF. STUDY DESIGN The trial is a prospective, multicenter, randomized controlled study. The trial design incorporates a Bayesian adaptive design that will randomize a maximum of 600 patients with persistent or long-standing persistent AF to LAA ligation and PVI vs PVI alone in a 2:1 randomization. The primary end points include 30-day safety of the LARIAT procedure and freedom from documented AF, atrial flutter, or atrial tachycardia of more than 30 seconds at 12 months after the PVI off antiarrhythmic drugs. Key secondary outcomes include a composite of cardiovascular death and stroke, as well as quality of life. CONCLUSION The aMAZE trial will determine if LAA ligation as adjunctive therapy to PVI increases the efficacy of maintaining sinus rhythm in patients with persistent and long-standing persistent AF.

Fish Oil Supplementation Ameliorates Fructose-Induced Hypertriglyceridemia and Insulin Resistance in Adult Male Rhesus Macaques

Fish oil (FO) is a commonly used supplemental source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), 2 n-3 (ω-3) polyunsaturated fatty acids (PUFAs) that have been shown to have a variety of health benefits considered to be protective against cardiometabolic diseases. Although the effects of EPA and DHA on lipid metabolism have been extensively studied, not all of the metabolic effects of FO-derived n-3 PUFAs have been characterized. Our laboratory recently showed that a high-fructose diet in rhesus monkeys induces the features of metabolic syndrome (MetS) similar to those observed in humans. Thus, we specifically wanted to evaluate the effects of FO in rhesus monkeys fed a high-fructose diet and hypothesized that FO supplementation would mitigate the development of fructose-induced insulin resistance, dyslipidemia, and other cardiometabolic risk factors. In this study, adult monkeys (aged 12-20 y) received either a standard unpurified diet plus 75 g fructose/d (control group; n = 9) or a standard unpurified diet, 75 g fructose/d, and 4 g FO (16% EPA + 11% DHA)/d (treatment group; n = 10) for 6 mo. Importantly, our results showed that daily FO supplementation in the monkeys prevented fructose-induced hypertriglyceridemia and insulin resistance as assessed by intravenous-glucose-tolerance testing (P ≤ 0.05). Moreover, FO administration in the monkeys prevented fructose-induced increases in plasma apolipoprotein (Apo)C3, ApoE, and leptin concentrations and attenuated decreases in circulating adropin concentrations (P ≤ 0.05). No differences between the control and FO-treated monkeys were observed in body weight, lean mass, fat mass, or fasting glucose, insulin, and adiponectin concentrations. In conclusion, FO administration in a nonhuman primate model of diet-induced MetS ameliorates many of the adverse changes in lipid and glucose metabolism induced by chronic fructose consumption.

Efficiencies of platform clinical trials: A vision of the future:

Background: A “platform trial” is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. Adaptive platform designs offer flexible features such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during the course of a trial. Methods: A simulation study explores the efficiencies of various platform trial designs relative to a traditional two-arm strategy. Results: Platform trials can find beneficial treatments with fewer patients, fewer patient failures, less time, and with greater probability of success than a traditional two-arm strategy. Conclusion: In an era of personalized medicine, platform trials provide the innovation needed to efficiently evaluate modern treatments.

Predicting Persistence of Functional Abdominal Pain From Childhood Into Young Adulthood

BACKGROUND & AIMS Pediatric functional abdominal pain has been linked to functional gastrointestinal disorders (FGIDs) in adulthood, but little is known about patient characteristics in childhood that increase the risk for FGID in young adulthood. We investigated the contribution of gastrointestinal symptoms, extraintestinal somatic symptoms, and depressive symptoms in pediatric patients with functional abdominal pain and whether these predicted FGIDs later in life. METHODS In a longitudinal study, consecutive new pediatric patients, diagnosed with functional abdominal pain in a subspecialty clinic, completed a comprehensive baseline evaluation of the severity of their physical and emotional symptoms. They were contacted 5 to 15 years later and evaluated, based on Rome III symptom criteria, for abdominal pain-related FGIDs, including irritable bowel syndrome, functional dyspepsia, functional abdominal pain syndrome, and abdominal migraine. Controlling for age, sex, baseline severity of abdominal pain, and time to follow-up evaluation, multivariable logistic regression was used to evaluate the association of baseline gastrointestinal, extraintestinal somatic, and depressive symptoms in childhood with FGID in adolescence and young adulthood. RESULTS Of 392 patients interviewed an average of 9.2 years after their initial evaluation, 41% (n = 162) met symptom criteria for FGID; most met the criteria for irritable bowel syndrome. Extraintestinal somatic and depressive symptoms at the initial pediatric evaluation were significant predictors of FGID later in life, after controlling for initial levels of GI symptoms. Age, sex, and abdominal pain severity at initial presentation were not significant predictors of FGID later in life. CONCLUSIONS In pediatric patients with functional abdominal pain, assessment of extraintestinal and depressive symptoms may be useful in identifying those at risk for FGID in adolescence and young adulthood.