Safety and immunogenicity of a multivalent pneumococcal conjugate vaccine given with 13-valent pneumococcal conjugate vaccine in healthy infants: A phase 2 randomized trial.

Use of pneumococcal conjugate vaccines (PCVs) has led to substantial reductions in the global burden of pediatric pneumococcal disease. Expansion of serotype coverage has been achieved by increasing PCV valency, but this may carry the potential risk of antibody interference. A complementary 7-valent PCV (cPCV7) including polysaccharide conjugates from 7 non-13-valent (PCV13) serotypes was developed to potentially complement PCV13-mediated protection and expand serotype coverage. This study evaluated cPCV7 and PCV13 coadministered in separate limbs or separated in time in infants. This phase 2, multicenter, open-label study included 512 infants randomized 1:1:1 to receive cPCV7 coadministered with PCV13 at ages 2, 4, 6, and 12 months (cPCV7 Coadministered); cPCV7 given at ages 3, 5, 7, and 13 months, 3‒5 weeks after PCV13 (cPCV7 Separated); or PCV13 at ages 2, 4, 6, and 12 months followed by a single supplemental dose of cPCV7 at 13 months (PCV13 Control). Safety evaluations included local reactions, systemic events, and adverse events. Serotype-specific immunoglobulin G concentrations and opsonophagocytic activity titers were assessed. The safety profile of cPCV7 was similar to that of PCV13. cPCV7 was well-tolerated in infants when coadministered with or given separately from PCV13. Robust and functional immune responses for all cPCV7 serotypes were observed in both cPCV7 groups. No immunologic interference was observed for either the cPCV7 or PCV13 serotypes with coadministration. A single cPCV7 dose induced immune responses in toddlers. These findings support potential coadministration of a complementary PCV to supplement protection provided by existing PCVs.Trial registration: ClinicalTrials.gov, NCT03550313.

A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age.

INTRODUCTION: Introduction of pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), has considerably reduced pneumococcal disease burden. However, additional serotypes not in PCV13 continue to present a substantial disease burden. The 20-valent PCV (PCV20) was developed to expand protection against pneumococcal disease beyond PCV13. As part of the phase 3 clinical development program, the current study assessed consistency of immune responses across 3 lots of PCV20 and described the safety profile of PCV20. METHODS: This phase 3, randomized, multicenter, double-blind study of pneumococcal vaccine-naive adults 18-49 years of age randomized 1710 participants in a 2:2:2:1 ratio to receive 1 of 3 lots of PCV20 or PCV13. Immunogenicity was assessed through serotype-specific opsonophagocytic activity (OPA) titers before and approximately 1 month (28-42 days) after vaccination. Reported local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 30 days, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination were evaluated. RESULTS: Equivalence in immune responses (OPA geometric mean titers) for all 20 vaccine serotypes was demonstrated across the 3 PCV20 lots. Robust responses, assessed by OPA geometric mean fold rises, percentage of participants achieving ≥4-fold rises, and percentage of participants with OPA titers ≥lower limit of quantitation, were observed after PCV20. Reported rates of local reactions, systemic events, and AEs were similar between the pooled PCV20 lots and PCV13; most events were mild or moderate. Reported rates of SAEs and NDCMCs were low and similar between the PCV20 and PCV13 groups. CONCLUSIONS: Three different lots of PCV20 demonstrated robust and consistent immunogenicity. The safety and tolerability of PCV20 was acceptable and similar to that of PCV13. (Clinicaltrials.gov: NCT03828617).

Simulation versus live tissue training randomised trial for ECMO proficiency: is one better than the other?

Introduction: Extracorporeal membrane oxygenation (ECMO) is a classic low-volume high-risk procedure that requires just in time and/or refresher training through animal or simulation modalities. This manuscript evaluated the performance of ECMO personnel trained with both modalities to determine which is better suited for ECMO skills training. Methods: Participants (physicians, nurses and respiratory/medical technicians) completed a series of ECMO scenarios with synthetic tissue cannulation task trainer as well as a live tissue model. Objective performance quality was based on task completion using a validated ECMO skills assessment tool. Results: Thirty-eight individuals completed this study. Participants completed individual scenario tasks 3 min faster using the simulator (26 min vs 29 min; p=0.03). No differences were seen in percentage of individual tasks completed. In the group scenarios, participants completed a higher percentage of critical tasks using the simulator (97%) versus the animal model (91%; p=0.05), but no differences were seen in task completion times. Additionally, no differences were seen in either lab-based or participants' prelab cognitive scores. Conclusions: Regardless of their self-assessment or experience, participants' objective performances were similar among both animal and simulation labs. Task completion times were quicker with simulation model. The distinction between simulation versus animal model may be less important as both demonstrate benefit in development of and/or maintaining skill competency. In the era of questioning the need for and costs of live tissue training, expanding the role of simulation may achieve similar training goals.

CE: Trauma-Related Hemorrhagic Shock: A Clinical Review.

Optimal management of trauma-related hemorrhagic shock begins at the point of injury and continues throughout all hospital settings. Several procedures developed on the battlefield to treat this condition have been adopted by civilian health care systems and are now used in a number of nonmilitary hospitals. Despite the important role nurses play in caring for patients with trauma-related hemorrhagic shock, much of the literature on this condition is directed toward paramedics and physicians. This article discusses the general principles underlying the pathophysiology and clinical management of trauma-related hemorrhagic shock and updates readers on nursing practices used in its management.

Challenges Associated with Managing a Multicenter Clinical Trial in Severe Burns.

Managing multicenter clinical trials (MCTs) is demanding and complex. The Randomized controlled Evaluation of high-volume hemofiltration in adult burn patients with Septic shoCk and acUte kidnEy injury (RESCUE) trial was a prospective, MCT involving the impact of high-volume hemofiltration continuous renal replacement therapy on patients experiencing acute kidney injury and septic shock. Ten clinical burn centers from across the United States were recruited to enroll a target sample size of 120 subjects. This manuscripts reviews some of the obstacles and knowledge gained while coordinating the RESCUE trial. The first subject was enrolled in February 2012, 22 months after initial IRB approval and 29 months from the time the grant was awarded. The RESCUE team consisted of personnel at each site, including the lead site, a data coordination center, data safety monitoring board, steering committees, and the sponsor. Seven clinical sites had enrolled 37 subjects when enrollment stopped in February 2016. Obstacles included changes in institutional review boards, multiple layers of review, staffing changes, creation and amendment of study documents and procedures, and finalization of contracts. Successful completion of a MCT requires a highly functional research team with sufficient patient population, expertise, and research infrastructure. Additionally, realistic timelines must be established with strategies to overcome challenges. Inevitable obstacles should be discussed in the pretrial phase and continuous correspondence must be maintained with all relevant research parties throughout all phases of study.

An Evidence-Based Approach to Precepting New Nurses.

While developing a standardized approach to orient new staff in the U.S. Army Institute of Surgical Research Burn Center at Fort Sam Houston in Texas, nurse leaders identified the need to also standardize preceptor selection and instruction. A multidisciplinary research team conducted a two-year pilot project based on the evidence-based Vermont Nurses in Partnership Clinical Transition Framework, which provides a structured method for preceptor selection, development, and evaluation. Minimum preceptor qualifications; preceptor validation processes; and modifiable, unit-specific coaching tools were established. The authors previously published a description of the preceptor program implementation process and their findings. In this article, they discuss lessons learned during the project, highlighting the challenges and obstacles encountered when implementing this preceptorship program.

Bridging burn care education with modern technology, an integration with high fidelity human patient simulation.

OBJECTIVE: The Advanced Burn Life Support (ABLS) program is a burn-education curriculum nearly 30 years in the making, focusing on the unique challenges of the first 24h of care after burn injury. Our team applied high fidelity human patient simulation (HFHPS) to the established ABLS curriculum. Our hypothesis was that HFHPS would be a feasible, easily replicable, and valuable adjunct to the current curriculum that would enhance learner experience. METHODS: This prospective, evidenced-based practice project was conducted in a single simulation center employing the American Burn Association's ABLS curriculum using HFHPS. Participants managed 7 separate simulated polytrauma and burn scenarios with resultant clinical complications. After training, participants completed written and practical examinations as well as satisfaction surveys. RESULTS: From 2012 to 2013, 71 students participated in this training. Simulation (ABLS-Sim) participants demonstrated a 2.5% increase in written post-test scores compared to traditional ABLS Provider Course (ABLS Live) (p=0.0016). There was no difference in the practical examination when comparing ABLS-Sim versus ABLS Live. Subjectively, 60 (85%) participants completed surveys. The Educational Practice Questionnaire showed best practices rating of 4.5±0.7; with importance of learning rated at 4.4±0.8. The Simulation Design Scale rating for design was 4.6±0.6 with an importance rating of 4.4±0.8. Overall Satisfaction and Self-Confidence with Learning were 4.4±0.7 and 4.5±0.7, respectfully. CONCLUSIONS: Integrating HFHPS with the current ABLS curriculum led to higher written exam scores, high levels of confidence, satisfaction, and active learning, and presented an evidenced-based model for education that is easily employable for other facilities nationwide.

Analysis of Pediatric Trauma in Combat Zone to Inform High-Fidelity Simulation Predeployment Training.

OBJECTIVES: The military uses "just-in-time" training to refresh deploying medical personnel on skills necessary for medical and surgical care in the theater of operations. The burden of pediatric care at Role 2 facilities has yet to be characterized; pediatric predeployment training has been extremely limited and primarily informed by anecdotal experience. The goal of this analysis was to describe pediatric care at Role 2 facilities to enable data-driven development of high-fidelity simulation training and core knowledge concepts specific to the combat zone. SETTING AND PATIENTS: A retrospective review of the Role 2 Database was conducted on all pediatric patients (< 18 yr) admitted to Role 2 in Afghanistan from 2008-2014. INTERVENTIONS: Three cohorts were determined based on commercially available simulation models: Group 1: less than 1 year, Group 2: 1-8 years, Group 3: more than 8 years. The groups were sub-stratified by point of injury care, pre-hospital management, and Role 2 facility medical/surgical management. MEASUREMENTS AND MAIN RESULTS: Appropriate descriptive statistics (chi square and Student t test) were utilized to define demographic and epidemiologic characteristics of this population. Of 15,404 patients in the Role 2 Database, 1,318 pediatric subjects (8.5%) were identified. The majority of patients were male (80.0%) with a mean age of 9.5 years (± SD, 4.5). Injury types included: penetrating (56%), blunt (33%), and burns (7%). Mean transport time from point of injury to Role 2 was 198 minutes (±24.5 min). Mean Glasgow Coma Scale and Revised Trauma Score were 14 (± 0.1) and 7.0 (± 1.4), respectively. Role 2 surgical procedures occurred for 424 patients (32%). Overall mortality was 4% (n = 58). CONCLUSIONS: We have described the epidemiology of pediatric trauma admitted to Role 2 facilities, characterizing the spectrum of pediatric injuries that deploying providers should be equipped to manage. This analysis will function as a needs assessment to facilitate high-fidelity simulation training and the development of "pediatric trauma core knowledge concepts" for deploying providers.

Follow-Up Evaluation of the U.S. Army Institute of Surgical Research Burn Flow Sheet for En Route Care Documentation of Burned Combat Casualties.

INTRODUCTION: In 2006, burn clinical practice guidelines were developed to provide recommendations for optimal care of U.S. military and local national burn casualties. As part of that effort, a paper-based Burn Flow Sheet (BFS) was included to document the burn resuscitation of combat casualties with ≥20% total body surface area burns. The purpose of this study was to evaluate the BFS in terms of ongoing utilization, resuscitation management, and outcomes of patients transported. MATERIALS AND METHODS: A retrospective review was performed of hard-copy BFSs received from January 2007 to December 2013. En route injury and treatment data from these flowsheets were manually transcribed into the research database. Outcomes and complications of BFS subjects were extracted from the Burn Center Registry and added to the research database. RESULTS: A total of 73 BFSs were collected from the study period. On average, BFSs were 61 ± 30% complete with a total of 14.7 ± 7 hours documented per patient in the first 24-hours postburn. Patients received nearly 7 L more fluid than estimated by traditional formulas. Sixteen patients (26%) received greater than 250 mL/kg of fluid, half of whom had concomitant traumatic injuries. Fifteen patients received a fasciotomy (21%), 4 received a laparotomy (5%), and 8 (11%) received both. No patients developed abdominal compartment syndrome associated with fluid resuscitation. Overall mortality was 21%. CONCLUSIONS: Although the majority of providers did initiate a BFS, it was not always used as intended; problems included missing data and miscalculations. Although there was a clear improvement with decline in the incidence of abdominal compartment syndrome, mortality did not change for severely burned patients. Simplification of the recommendations, additional built-in prompts, and automated tools such as computerized decision support software may help standardize practice and improve outcomes.

Implementation and outcomes of an evidence-based precepting program for burn nurses.

INTRODUCTION: There is significant nationwide interest in transitioning new and new-to-specialty nurses into practice, especially in burn care. Lack of a structured transition program in our Burn Center was recognized as a contributing factor for nursing dissatisfaction and increased turnover compared to other hospital units. Employee evaluations exposed a need for more didactic instruction, hands-on learning, and preceptor support. The goal of this project was to implement an evidence-based transition to practice program specific to the burn specialty. MATERIAL AND METHODS: The Iowa Model of Evidence-based Practice served as the model for this project. A working group was formed consisting of nurse scientists, clinical nurse leaders, clinical nurse specialists, lead preceptors, staff nurse preceptors and wound care coordinators. A systematic review of the literature was conducted focusing on nurse transition; preceptor development and transitioning nurse training programs with competency assessment, ongoing multifaceted evaluation and retention strategies were created. The evidence-based Vermont Nurses in Partnership (VNIP) Clinical Transition Framework was selected and subsequent education was provided to all Burn Center leaders and staff. Benchmarks for basic knowledge assessment (BKAT) and burn wound care were established among current staff by work site and education level to help evaluate transitioning nurses. Policies were modified to count each preceptor/transitioning nurse dyad as half an employee on the schedule. Multiple high-fidelity simulation scenarios were created to expand hands-on opportunities. RESULTS: From September 2012-December 2013, 110 (57% acute care nursing) Burn Center staff attended the VNIP Clinical Coaching Course, to include 34 interdisciplinary staff (rehabilitation, education, respiratory therapy, and outpatient clinic staff) and 100% of identified preceptors (n=33). A total of 30 new nurses participated in the transition program: 26 (87%) completed, 3 (10%) did not complete, and 1 (3%) received exception (no patient care). Transitioning nurses achieved passing BKAT scores (n=22; 76%) and WC scores (n=24; 93%); individual remediation was provided for those failing to achieve unit benchmarks and transition training was modified to improve areas of weakness. Transitioning nurses' weekly competency progression average initial ratings on a 10 point scale (10 most competent) were 5±2; final ratings averaged 9±1 (n=25) (p<0.0001). CONCLUSIONS: An evidence-based team practice approach toward preceptorship created a standardized, comprehensive and flexible precepting program to assist and support transition to specialty burn practice for experienced nurses. Use of objective metrics enabled ongoing assessment and made training adaptable, individualized, and cost effective. Application of this standardized approach across our organization may improve consistency for all transitions in practice specialty.

Improving Teamwork and Resiliency of Burn Center Nurses Through a Standardized Staff Development Program.

For many acute care nursing units, such as the Burn Progressive Care Unit (BPCU) at the U.S. Army Burn center, staff stress and burnout is always a concern for leaders. Job stress not only contributes to nursing turnover, but can have a negative impact on patient care. The purpose of this project was to develop a training platform for nursing staff education and teambuilding with the intent of improving nurse satisfaction, increasing resiliency, building unit cohesion, enhancing morale, and increasing staff awareness of unit performance. All nursing staff were given an 8-hour training day, half of which was focused on education and the other half on teambuilding and resiliency. At the end of the staff development day (SDD), participants were encouraged to complete an evaluation; all activities were scored on a 10-point scale, with 10 representing the most informative. In total, 46 of 48 staff (96%) participated in the first two SDDs. During the first iteration (Spring 2015), participants scored all activities very high, with a total average score of 9.15 ± 0.26 (n = 246). In the Fall of 2015, the SDD program was again rated well, with an average score of 9.36 ± 0.13 (n = 276). The SDD program has been successful in supporting teamwork and resiliency among BPCU staff. Staff feedback supported success in meeting the objectives of building unit cohesion and increasing satisfaction and morale.

Bacterial Contamination of Burn Unit Employee Identity Cards.

The purpose of this study was to identify the presence or absence of pathogenic bacteria on burn intensive care unit employees' common access cards (CACs) and identity badges (IDs) and to identify possible variables that may increase risk for the presence of those bacteria. A prospective, cross-sectional study was conducted in our regional Burn Center in which bacterial swab specimens were collected from both the CAC and ID of 10 burn intensive care unit employees in each of five cohorts (nurses, respiratory therapists, physical therapists, physicians, and ancillary staff). Ten additional paired samples, collected from direct care staff in the outpatient burn clinic, served as control. Additional information described how the cards were worn and if/how they had been cleaned in the previous week. Fifty-eight CACs and 60 IDs were swabbed from participants. The overall contamination rate was 75%, with no trends identified based on how cards were worn. Bacteria were recovered from 86% (50/58) of CACs and 65% (39/60) of IDs, with CACs being significantly more contaminated overall than IDs (P < .01). In terms of potentially pathogenic bacteria, the overall rate was 3%, with 100% of those isolates coming from the outpatient clinic staff cohort (P < .001). When cleaned in the last week (n = 16), the contamination rate dropped to 50% overall (P = .003), indicating that even periodic cleaning appears to have a positive effect on bacterial contamination rates. The simple practice of routine identity card decontamination may reduce potential threats to patient safety as a result of nosocomial bacterial transmission.

Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines.

BACKGROUND: This study in 11- to 15-year-old boys and girls compared the immunogenicity and safety of GARDASIL 9 (9-valent human papillomavirus [9vHPV] vaccine) administered either concomitantly or nonconcomitantly with 2 vaccines routinely administered in this age group (Menactra [MCV4; Neisseria meningitidis serotypes A/C/Y/W-135] or Adacel [Tdap; diphtheria/tetanus/acellular pertussis]). METHODS: Participants received 9vHPV vaccine at day 1 and months 2 and 6; the concomitant group (n = 621) received MCV4/Tdap concomitantly with 9vHPV vaccine at day 1; the nonconcomitant group (n = 620) received MCV4/Tdap at month 1. Antibodies to HPV-, MCV4-, and Tdap-relevant antigens were determined. Injection-site and systemic adverse events (AEs) were monitored for 15 days after any vaccination; serious AEs were monitored throughout the study. RESULTS: The geometric mean titers for all HPV types in 9vHPV vaccine 4 weeks after dose 3, proportion of subjects with a fourfold rise or greater in titers for 4 N meningitidis serotypes 4 weeks after injection with MCV4, proportion of subjects with antibody titers to diphtheria and tetanus ≥0.1 IU/mL, and geometric mean titers for pertussis antigens 4 weeks after injection with Tdap were all noninferior in the concomitant group compared with the nonconcomitant group. Injection-site swelling occurred more frequently in the concomitant group. There were no vaccine-related serious AEs. CONCLUSIONS: Concomitant administration of 9vHPV vaccine with MCV4/Tdap was generally well tolerated and did not interfere with the antibody response to any of these vaccines. This strategy would minimize the number of visits required to deliver each vaccine individually.

Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study.

OBJECTIVES: Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgical site infections (SSIs) following elective colorectal surgery in Chinese adult patients. METHODS: Eligible Chinese adults aged 18-80 years scheduled to undergo elective colorectal surgery by laparotomy were randomized to receive a 30 min infusion of 1 g of ertapenem/metronidazole placebo or 2 g of ceftriaxone/500 mg of metronidazole within 2 h before initial incision. The study endpoint was the proportion of patients with successful prophylaxis at 4 weeks after treatment. The primary analysis was based on the evaluable population (PP population) and the pre-specified non-inferiority margin was set at -15%. ClinicalTrials.gov: NCT01254344. RESULTS: Of 599 patients randomized, 499 (251 ertapenem and 248 ceftriaxone) were eligible for inclusion in the PP population. The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxone groups were 90.4% (227/251) and 90.3% (224/248), respectively. The difference in the proportion of successful outcomes was 0.1% (95% CI -5.2%, 5.5%). Unexplained antibiotic use was the most frequent reason for prophylaxis failure in both groups [ertapenem 4.8% (12/251), ceftriaxone 4.4% (11/248); difference 0.3%; 95% CI -3.6, 4.3]. Pathogen species isolated from SSI sources were consistent with previously conducted studies and the product package insert. The incidence of adverse events (AEs) was similar between the groups, with the most common AE being pyrexia [ertapenem 7.6% (22/290), ceftriaxone 5.7% (17/297)]. CONCLUSIONS: Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoing elective colorectal surgery, and is well tolerated.