Hydroxyurea to prevent brain injury in children with sickle cell disease (HU Prevent)-A randomized, placebo-controlled phase II feasibility/pilot study.

Central nervous system (CNS) injury is common in sickle cell disease (SCD) and occurs early in life. Hydroxyurea is safe and efficacious for treatment of SCD, but high-quality evidence from randomized trials to estimate its neuroprotective effect is scant. HU Prevent was a randomized (1:1), double-blind, phase II feasibility/pilot trial of dose-escalated hydroxyurea vs. placebo for the primary prevention of CNS injury in children with HbSS or HbS-ß0-thalassemia subtypes of SCD age 12-48 months with normal neurological examination, MRI of the brain, and cerebral blood flow velocity. We hypothesized that hydroxyurea would reduce by 50% the incidence of CNS injury. Two outcomes were compared: primary-a composite of silent cerebral infarction, elevated cerebral blood flow velocity, transient ischemic attack, or stroke; secondary-a weighted score estimating the risk of suffering the consequences of stroke (the Stroke Consequences Risk Score-SCRS), based on the same outcome events. Six participants were randomized to each group. One participant in the hydroxyurea group had a primary outcome vs. four in the placebo group (incidence rate ratio [90% CI] 0.216 [0.009, 1.66], p = .2914) (~80% reduction in the hydroxyurea group). The mean SCRS score was 0.078 (SD 0.174) in the hydroxyurea group, 0.312 (SD 0.174) in the placebo group, p = .072, below the p-value of .10 often used to justify subsequent phase III investigations. Serious adverse events related to study procedures occurred in 3/41 MRIs performed, all related to sedation. These results suggest that hydroxyurea may have profound neuroprotective effect in children with SCD and support a definitive phase III study to encourage the early use of hydroxyurea in all infants with SCD.

The Current State of Combined Pediatric Anesthesiology-Critical Care Practice: A Survey of Dual-Trained Practitioners in the United States.

BACKGROUND: Combined practice in pediatric anesthesiology (PA) and pediatric critical care medicine (PCCM) was historically common but has declined markedly with time. The reasons for this temporal shift are unclear, but existing evidence suggests that length of training is a barrier to contemporary trainees. Among current practitioners, restriction in dual-specialty practice also occurs, for reasons that are unknown at present. We sought to describe the demographics of this population, investigate their perceptions about the field, and consider factors that lead to attrition. METHODS: We conducted a cross-sectional, observational study of physicians in the United States with a combined practice in PA and PCCM. The survey was distributed electronically and anonymously to the distribution list of the Pediatric Anesthesia Leadership Council (PALC) of the Society for Pediatric Anesthesia (SPA), directing the recipients to forward the link to their faculty meeting our inclusion criteria. Attending-level respondents (n = 62) completed an anonymous, 40-question multidomain survey. RESULTS: Forty-seven men and 15 women, with a median age of 51, completed the survey. Major leadership positions are held by 44%, and 55% are externally funded investigators. A minority (26%) have given up one or both specialties, citing time constraints and politics as the dominant reasons. Duration of training was cited as the major barrier to entry by 77%. Increasing age and faculty rank and lack of a comparably trained institutional colleague were associated with attrition from dual-specialty practice. The majority (88%) reported that they would do it all again. CONCLUSIONS: The current cohort of pediatric anesthesiologist-intensivists in the United States is a small but accomplished group of physicians. Efforts to train, recruit, and retain such providers must address systematic barriers to completion of the requisite training and continued practice.

The Simulation-Based Assessment of Pediatric Rapid Response Teams.

OBJECTIVE: To create scenarios of simulated decompensating pediatric patients to train pediatric rapid response teams (RRTs) and to determine whether the scenario scores provide a valid assessment of RRT performance with the hypothesis that RRTs led by intensivists-in-training would be better prepared to manage the scenarios than teams led by nurse practitioners. STUDY DESIGN: A set of 10 simulated scenarios was designed for the training and assessment of pediatric RRTs. Pediatric RRTs, comprising a pediatric intensive care unit (PICU) registered nurse and respiratory therapist, led by a PICU intensivist-in-training or a pediatric nurse practitioner, managed 7 simulated acutely decompensating patients. Two raters evaluated the scenario performances and psychometric analyses of the scenarios were performed. RESULTS: The teams readily managed scenarios such as supraventricular tachycardia and opioid overdose but had difficulty with more complicated scenarios such as aortic coarctation or head injury. The management of any particular scenario was reasonably predictive of overall team performance. The teams led by the PICU intensivists-in-training outperformed the teams led by the pediatric nurse practitioners. CONCLUSIONS: Simulation provides a method for RRTs to develop decision-making skills in managing decompensating pediatric patients. The multiple scenario assessment provided a moderately reliable team score. The greater scores achieved by PICU intensivist-in-training-led teams provides some evidence to support the validity of the assessment.

The important role of simulation in sedation.

PURPOSE OF REVIEW: This article reviews the development of simulation-based training strategies to educate sedation providers. RECENT FINDINGS: Medical simulation has been utilized to train and evaluate providers in numerous domains related to sedation. Sedation providers come to the patient with a wide range of clinical training and experience and simulation can serve as a platform for achieving a baseline skill level and for periodic retraining. Although widely accepted by participants in simulation training, data demonstrating simulation's efficacy in improving sedation-related clinical outcomes are lacking. SUMMARY: Simulation provides an opportunity for sedation providers to develop deliberative practice, to consider rare or challenging clinical conditions, and to benefit from directed feedback, in a manner that does not put patients in harm's way.

Acute care of pediatric patients with sickle cell disease: a simulation performance assessment.

BACKGROUND: Sickle cell disease (SCD) is a rare disorder with cardinal features including hospitalization for vaso-occlusive pain episodes, acute pulmonary injury, and increased infection rates. For physician-trainees, learning optimal SCD management is challenging because of limited exposure to life threatening complications requiring timely interventions. PROCEDURE: To create, demonstrate reliability, and validate simulation-based, acute care SCD scenarios for physician-trainees, seven scenarios were derived from SCD patient cases. For each scenario, participants had 5 minutes to complete diagnostic and treatment interventions. Participants were divided into two groups based on clinical experience: interns or residents/fellows. Two raters scored performances using diagnostic and therapeutic checklists--indicating whether specific actions were performed and a global, 1 (poor) to 9 (excellent), rating. Scenario scores were calculated by averaging rater scores on each metric. Reliability was defined through uniformity in rater scoring and consistency of participant performance over scenarios. Validity was demonstrated by the performance gradient where the more experienced trainees outperform those early in training. RESULTS: Twenty-eight pediatric residents and hematology fellows took part in the study. Reliability for assessment scores overall was moderate. Performance on all but one scenario was moderately predictive of overall performance. Senior resident/fellows performed significantly better than interns. Positive associations existed between overall performance scores (P < 0.01) and months of postgraduate training (P < 0.01). CONCLUSIONS: Mannequin-based simulation is a novel method for teaching pediatric residents SCD-specific acute care skills. The assessment provided reliable and valid measures of trainees' performance. Further studies are needed to determine simulation's utility in education and evaluation.

Simulation in pediatric anesthesiology.

Simulation-based training, research and quality initiatives are expanding in pediatric anesthesiology just as in other medical specialties. Various modalities are available, from task trainers to standardized patients, and from computer-based simulations to mannequins. Computer-controlled mannequins can simulate pediatric vital signs with reasonable reliability; however the fidelity of skin temperature and color change, airway reflexes and breath and heart sounds remains rudimentary. Current pediatric mannequins are utilized in simulation centers, throughout hospitals in-situ, at national meetings for continuing medical education and in research into individual and team performance. Ongoing efforts by pediatric anesthesiologists dedicated to using simulation to improve patient care and educational delivery will result in further dissemination of this technology. Health care professionals who provide complex, subspecialty care to children require a curriculum supported by an active learning environment where skills directly relevant to pediatric care can be developed. The approach is not only the most effective method to educate adult learners, but meets calls for education reform and offers the potential to guide efforts toward evaluating competence. Simulation addresses patient safety imperatives by providing a method for trainees to develop skills and experience in various management strategies, without risk to the health and life of a child. A curriculum that provides pediatric anesthesiologists with the range of skills required in clinical practice settings must include a relatively broad range of task-training devises and electromechanical mannequins. Challenges remain in defining the best integration of this modality into training and clinical practice to meet the needs of pediatric patients.

Simulation-based assessment of pediatric anesthesia skills.

BACKGROUND: Assessment of pediatric anesthesia trainees is complicated by the random nature of adverse patient events and the vagaries of clinical exposure. However, assessment is critical to improve patient safety. In previous studies, a multiple scenario assessment provided reliable and valid measures of the abilities of anesthesia residents. The purpose of this study was to develop a set of relevant simulated pediatric perioperative scenarios and to determine their effectiveness in the assessment of anesthesia residents and pediatric anesthesia fellows. METHODS: Ten simulation scenarios were designed to reflect situations encountered in perioperative pediatric anesthesia care. Anesthesiology residents and fellows consented to participate and were debriefed after each scenario. Two pediatric anesthesiologists scored each scenario by key action checklist. The psychometric properties (reliability, validity) of the scores were studied. RESULTS: Thirty-five anesthesiology residents and pediatric anesthesia fellows participated. The participants with greater experience administering pediatric anesthetics generally outperformed those with less experience. Score variance attributable to raters was low, yielding a high interrater reliability. CONCLUSIONS: A multiple-scenario, simulation-based assessment of pediatric perioperative care was designed and administered to residents and fellows. The scores obtained from the assessment indicated the content was relevant and that raters could reliably score the scenarios. Participants with more training achieved higher scores, but there was a wide range of ability among subjects. This method has the potential to contribute to pediatric anesthesia performance assessment, but additional measures of validity including correlations with more direct measures of clinical performance are needed to establish the utility of this approach.

Massive Fetal Transfusion During an Emergency Ex Utero Intrapartum Treatment for a Congenital Infantile Fibrosarcoma: A Case Report.

Although originally described to assist airway management of fetal congenital malformations with life-threatening airway obstruction, the indications for an ex utero intrapartum treatment (EXIT) have expanded to include surgical resection of lesions that are potentially incompatible with life in the absence of uteroplacental circulatory support. We describe the case of an infantile fibrosarcoma (IFS) that presented with fetal hydrops and was successfully managed with an emergency EXIT that necessitated the initiation of a massive fetal blood transfusion both with and without the support of uteroplacental circulation.

Pediatric-Oncology Simulation Training for Resident Education.

INTRODUCTION: We sought to evaluate pediatric oncology simulations intended to improve pediatric residents' skills and comfort in caring for children with cancer. METHOD: In a non-randomized trial, controls (the first three rotations) received a standard set of lectures, and the intervention arm received these lectures plus five simulation-training scenarios-fever/neutropenia, a new leukemia diagnosis, end-of-life care discussion, tumor lysis syndrome, and a mediastinal mass. All residents were tested after the rotation on the first three scenarios; management skills were evaluated independently by two raters. Before and after training, all residents completed an emotional-appraisal questionnaire evaluating each scenario as a perceived challenge or threat. Analysis of variance (ANOVA) measured differences by study arm in skills-checklist assessments and appraisals; repeated-measures ANOVA measured changes in emotional-appraisal scores. RESULTS: Forty-two residents (9 control, 33 intervention) participated. Inter-rater agreement for skills-checklist scores using average-measures intraclass correlation was high (0.847), and overall mean scores were significantly higher for the intervention than control group across both raters (P = 0.005). For all residents, perceived challenge increased in the end-of-life simulation, and perceived threat decreased in all three test scenarios. The intervention group, regardless of training year, evaluated the teaching scenarios favorably and felt that challenging oncology situations were addressed, skills were enhanced, and the simulations should be offered to other residents. CONCLUSIONS: It was feasible to introduce residents to difficult pediatric oncology scenarios using simulation. The intervention group performed more skills than controls when tested, and perceive threat declined in all residents after their pediatric oncology rotation.

Clinical Practice Guideline: Maintenance Intravenous Fluids in Children.

Maintenance intravenous fluids (IVFs) are used to provide critical supportive care for children who are acutely ill. IVFs are required if sufficient fluids cannot be provided by using enteral administration for reasons such as gastrointestinal illness, respiratory compromise, neurologic impairment, a perioperative state, or being moribund from an acute or chronic illness. Despite the common use of maintenance IVFs, there is high variability in fluid prescribing practices and a lack of guidelines for fluid composition administration and electrolyte monitoring. The administration of hypotonic IVFs has been the standard in pediatrics. Concerns have been raised that this approach results in a high incidence of hyponatremia and that isotonic IVFs could prevent the development of hyponatremia. Our goal in this guideline is to provide an evidence-based approach for choosing the tonicity of maintenance IVFs in most patients from 28 days to 18 years of age who require maintenance IVFs. This guideline applies to children in surgical (postoperative) and medical acute-care settings, including critical care and the general inpatient ward. Patients with neurosurgical disorders, congenital or acquired cardiac disease, hepatic disease, cancer, renal dysfunction, diabetes insipidus, voluminous watery diarrhea, or severe burns; neonates who are younger than 28 days old or in the NICU; and adolescents older than 18 years old are excluded. We specifically address the tonicity of maintenance IVFs in children.The Key Action Statement of the subcommittee is as follows:1A: The American Academy of Pediatrics recommends that patients 28 days to 18 years of age requiring maintenance IVFs should receive isotonic solutions with appropriate potassium chloride and dextrose because they significantly decrease the risk of developing hyponatremia (evidence quality: A; recommendation strength: strong).

Simulation and the diagnostic process: a pilot study of trauma and rapid response teams.

BACKGROUND: Simulation is frequently used to recreate many of the crises encountered in patient care settings. Teams learn to manage these crises in an environment that maximizes their learning experiences and eliminates the potential for patient harm. By designing simulation scenarios that include conditions associated with diagnostic errors, teams can experience how their decisions can lead to errors. The purpose of this study was to assess how trauma teams (TrT) and pediatric rapid response teams (RRT) managed scenarios that included a diagnostic error. METHODS: We developed four scenarios that would require TrT and pediatric RRT to manage an error in diagnosis. The two trauma scenarios (spinal cord injury and tracheobronchial tear) were designed to not respond to the heuristic management approach frequently used in trauma settings. The two pediatric scenarios (foreign body aspiration and coarctation of the aorta) had an incorrect diagnosis on admission. Two raters independently scored the scenarios using a rating system based on how teams managed the diagnostic process (search, establish and confirm a new diagnosis and initiate therapy based on the new diagnosis). RESULTS: Twenty-one TrT and 17 pediatric rapid response managed 51 scenarios. All of the teams questioned the initial diagnosis. The teams were able to establish and confirm a new diagnosis in 49% of the scenarios (25 of 51). Only 23 (45%) teams changed their management of the patient based on the new diagnosis. CONCLUSIONS: Simulation can be used to recreate conditions that engage teams in the diagnostic process. In contrast to most instruction about diagnostic error, teams learn through realistic experiences and receive timely feedback about their decision-making skills. Based on the findings in this pilot study, the majority of teams would benefit from an education intervention designed to improve their diagnostic skills.

ECMO for Pediatric Lung Transplantation.

Extracorporeal membrane oxygenation (ECMO) has been reported as an alternative to cardiopulmonary bypass during lung transplantation. The reports in the literature have been limited to adult practice and associated with decreased pulmonary and renal complications, lower mortality, and lower in-hospital mortality. We present four pediatric lung transplantations performed on ECMO and discuss relevant perfusion management.

Simulation-Based Assessment of ECMO Clinical Specialists.

OBJECTIVE: The aims of the study were (1) to create multiple scenarios that simulate a range of urgent and emergent extracorporeal membrane oxygenation (ECMO) events and (2) to determine whether these scenarios can provide reliable and valid measures of a specialist's advanced skill in managing ECMO emergencies. DESIGN: Multiscenario simulation-based performance assessment was performed. SETTING: The study was conducted in the Saigh Pediatric Simulation Center at St. Louis Children's Hospital. SUBJECTS: ECMO clinical specialists participated in the study. MEASUREMENTS AND MAIN RESULTS: Twenty-five ECMO specialists completed 8 scenarios presenting acute events in simulated ECMO patients. Participants were evaluated by 2 separate reviewers for completion of key actions and for global performance. The scores were highest for the hemodilution scenario, whereas the air entrainment scenario had the lowest scores. Psychometric analysis demonstrated that ECMO specialists with more than 1 year of experience outperformed the specialists with less than 1 year of experience. Participants endorsed these sessions as important and representative of events that might be encountered in practice. CONCLUSIONS: The scenarios could serve as a component of an ECMO education curriculum and be used to assess clinical specialists' readiness to manage ECMO emergencies.

Decision making in trauma settings: simulation to improve diagnostic skills.

INTRODUCTION: In the setting of acute injury, a wrong, missed, or delayed diagnosis can impact survival. Clinicians rely on pattern recognition and heuristics to rapidly assess injuries, but an overreliance on these approaches can result in a diagnostic error. Simulation has been advocated as a method for practitioners to learn how to recognize the limitations of heuristics and develop better diagnostic skills. The objective of this study was to determine whether simulation could be used to provide teams the experiences in managing scenarios that require the use of heuristic as well as analytic diagnostic skills to effectively recognize and treat potentially life-threatening injuries. METHODS: Ten scenarios were developed to assess the ability of trauma teams to provide initial care to a severely injured patient. Seven standard scenarios simulated severe injuries that once diagnosed could be effectively treated using standard Advanced Trauma Life Support algorithms. Because diagnostic error occurs more commonly in complex clinical settings, 3 complex scenarios required teams to use more advanced diagnostic skills to uncover a coexisting condition and treat the patient. Teams composed of 3 to 5 practitioners were evaluated in the performance of 7 (of 10) randomly selected scenarios (5 standard, 2 complex). Expert rates scored teams using standardized checklists and global scores. RESULTS: Eighty-three surgery, emergency medicine, and anesthesia residents constituted 21 teams. Expert raters were able to reliably score the scenarios. Teams accomplished fewer checklist actions and received lower global scores on the 3 analytic scenarios (73.8% [12.3%] and 5.9 [1.6], respectively) compared with the 7 heuristic scenarios (83.2% [11.7%] and 6.6 [1.3], respectively; P < 0.05 for both). Teams led by more junior residents received higher global scores on the analytic scenarios (6.4 [1.3]) than the more senior team leaders (5.3 [1.7]). CONCLUSIONS: This preliminary study indicates that teams led by more senior residents received higher scores when managing heuristic scenarios but were less effective when managing the scenarios that require a more analytic approach. Simulation can be used to provide teams with decision-making experiences in trauma settings and could be used to improve diagnostic skills as well as study the decision-making process.

Simulation in pediatrics: the reliability and validity of a multiscenario assessment.

OBJECTIVE: The goal of this study was to develop an inventory of simulated scenarios that mimic pediatric crises and determine if the resident scores could be used to establish the reliability and validity of a multiple-scenario assessment. The long-term objective is to provide pediatric residents with experiences in the recognition, diagnosis, and management of a range of simulated acute conditions. METHODS: Twenty scenarios were constructed. Each resident participated in 10 scenarios that were scored by 2 independent raters using an action-item checklist and a global score. Debriefing occurred after each scenario. Several analyses were performed to investigate the psychometric adequacy of the scores. RESULTS: Twenty-nine residents participated. The residents' scores in both sets of 10 scenarios were reliable when using either the checklist or global scoring method (>0.79). Generalizability analyses indicated that the major source of variance in scores was attributable to the scenario and scenario-resident interaction. The variance attributable to the rater was low, yielding high interrater reliability values. The more-experienced residents who participated in the study outperformed the less-experienced interns. CONCLUSIONS: An inventory of critical events was designed to assess pediatric residents' diagnostic and management skills. A reliable measure of ability could be obtained, provided the residents managed multiple scenarios. The residents outscored the interns, providing evidence to support the construct validity of the scores. Additional validity evidence is needed, including studies to determine if this type of training improves physicians' management of real-life critical events.