No Place Like Home: Improving the Transition From NICU to Home Through the NICU to Nursery Program.

BACKGROUND: Boston Children's Hospital's Level IV Neonatal Intensive Care Unit (NICU) discharges about a third of its medically complex infants home. Parental feedback indicated a need for more education and training in discharge preparation. PURPOSE: The NICU to Nursery (N2N) program was created to better prepare parents to care for their medically complex infants following Level IV NICU discharge. The goals were to (1) mitigate safety risks, (2) assess parent satisfaction, (3) assess pediatric primary care providers' (PCPs') satisfaction, (4) assess community visiting nurses' and PCPs' knowledge deficits, and (5) develop educational materials. METHODS: The N2N program provided parents with pre- and postdischarge assessments with an experienced nurse. Parents completed a survey following assessments to measure satisfaction. To enhance PCPs' knowledge, they were sent summary reports and asked for feedback. PCP feedback, along with a needs assessment of community visiting nurses, guided the development of free Web-based educational videos. RESULTS: One hundred and fifty-five parents participated in the N2N program. Parents' educational needs included medication education, safe sleep, and well-infant care, with some requiring significant nursing interventions for safety risk mitigation. Most PCPs found the home visit reports helpful. Knowledge deficits identified among PCPs and community visiting nurses included management of tubes and drains, growth and nutrition, and emergency response. More than 100,000 providers viewed the 3 Web-based educational videos developed. IMPLICATIONS FOR PRACTICE AND RESEARCH: The N2N program fills a crucial gap in the transition of medically complex infants discharged home. The next steps are developing best practices for virtual in-home assessments.

An examination of characteristics, social supports, caregiver resilience and hospital readmissions of children with medical complexity.

BACKGROUND: Children with medical complexity (CMC) account for 1% of children in the United States. These children experience frequent hospital readmissions, high healthcare costs and poor health outcomes. A link between CMC caregiver social support, resilience and hospital readmissions has never been fully investigated. This study examines the feasibility of a prospective, descriptive, repeated measures research design to characterize CMC and their caregivers, social supports, caregiver resilience and hospital readmissions to inform a larger prospective investigation. METHODS: Caregivers of CMC with unplanned hospitalizations completed surveys at the index hospitalization and 30 and 60 days after discharge. CMC caregiver and child characteristics, social supports and hospital readmissions were examined using an investigator-developed survey. Resilience was measured using the Resilience Scale-14© (7-Point Likert Scale, score range 14-98), and feasibility was measured by calculating enrolment, attrition, survey completion and item response. Analysis included descriptive statistics and qualitative data visualization. RESULTS: Of caregivers who were approached for participation, 81.1% consented  and completed 76 surveys. Attrition was 31%. Item response rates were ≥ 90% for all but one item. A total of 62.1% of children had hospital readmissions within 90 days and 37.9% within 30 days. Additionally, 70% of caregivers had home care nursing, but the approved hours were only partially filled. More than 70% of caregiver resilience scores were moderate to high (score range 74-98) and were stable across repeated measures and hospital readmissions. Open-ended question responses revealed the following five categories: All-consuming, Family Reliance, Impact of Covid, Taking Action and Broken System. CONCLUSIONS: Studying CMC caregiver social supports and resilience using repeated measures is feasible. CMC caregivers reported stressors including coordinating their child's substantial healthcare needs and managing partially filled home care nursing hours. Caregiver resilience remained stable over time, amidst frequent CMC hospital readmissions. Findings can inform future research priorities and power analyses for CMC caregiver resilience.

Safety, Pharmacokinetics and Preliminary Efficacy of IL4-Rα Monoclonal Antibody AK120 in Both Healthy and Atopic Dermatitis Subjects: A Phase I, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, First-In-Human Clinical Study.

INTRODUCTION: Interleukin-4 (IL-4) and interleukin-13 (IL-13) are two essential cytokines involved in the T helper 2 (Th2)-mediated inflammatory response to diseases, such as atopic dermatitis (AD). AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. This mAb inhibits the signaling of the IL-4 and IL-13 cytokines. METHODS: The study consisted of two parts. Part 1 was a single ascending dose (SAD) study with five cohorts (receiving 15, 50, 150, 300 or 600 mg of AK120, respectively) of healthy subjects; part 2 was a multiple ascending dose (MAD) study with four cohorts (receiving AK120 at doses of 300 mg once every 2 weeks [Q2W], 300 mg once weekly [QW], 150 mg QW or 75 mg QW) of subjects with AD. A total of 81 subjects (40 in part 1, 41 in part 2) were enrolled in the study. RESULTS: The compound was safe and well tolerated in both a SAD up to 600 mg in healthy subjects and in a MAD from 75 to 600 mg in subjects with AD. The exposure of AK120 increased in an approximately dose-dependent manner upon subcutaneous dosing. The levels of the biomarkers serum thymus and activation-regulated chemokine ligand 17 (TARC/CCL17) and immunoglobulin E decreased from baseline after AK120 administration, indicating the inhibition of the IL-4/IL-13 signaling pathways. AK120 showed improved Eczema Area and Severity Index (EASI) scores, and the proportion of subjects with Investigator Global Assessment (IGA) score 0/1 increased after AK120 treatment. CONCLUSIONS: AK120 exhibited an acceptable safety profile in healthy and AD subjects, and showed preliminary efficacy. These findings support the continued investigation of AK120 for treating AD. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identification number: NCT04256174.

Transferring With TACT: A Novel Tool to Standardize Transfer Decisions From a Level IV NICU.

BACKGROUND: Neonatal patients who no longer require level IV neonatal intensive care unit care are transferred to less acute levels of care. Standardized assessment tools have been shown to be beneficial in the transfer of patient care. However, no standardized tools were available to assist neonatal providers in the assessment and communication of the infants needs at transfer. PURPOSE: The purpose was to develop a Transfer Assessment and Communication Tool (TACT) that guides provider decision making in the transfer of infants from a level IV neonatal intensive care unit to a less acute level of care within a regionalized healthcare system. METHODS: Phase 1 included developing the first draft of the TACT using retrospective data, known variables from published literature, and study team expertise. In phase 2, the final draft of the TACT was created through feedback from expert neonatal providers in the regionalized care system using e-Delphi methodology. RESULTS: The first draft of the TACT, developed in phase 1, included 36 characteristics. In phase 2, nurses, nurse practitioners, and physician experts representing all levels of newborn care participated in 4 e-Delphi surveys to develop the final draft of the TACT, which included 74 weighted characteristics. IMPLICATIONS FOR PRACTICE AND RESEARCH: Potential benefits of the TACT include improved communication across healthcare teams, reduced risk for readmission, and increased caregiver visitation. The next steps are to validate the TACT for use either retrospectively or in real time, including characteristic weights, before implementation of this tool in the clinical setting.

Evidence-based review of chlorhexidine gluconate and iodine in the preoperative skin preparation of young infants.

PURPOSE: The preoperative preparation of young infants' skin requires special considerations. Commonly used solutions for preparing the skin preoperatively include chlorhexidine (CHG) and iodine. The Centers for Disease Control and Prevention (CDC) has recommendations for preparing skin for surgery and other invasive procedures for adults, but they do not have recommendations for young infants' skin. The purpose of this evidence-based literature review is to synthesize the literature, compare, and inform healthcare providers about the safety and efficacy of CHG and iodine as preoperative preparation solutions for young infants' skin. For this project young infants is defined as infants less than 48 weeks' postmenstrual age and those born prematurely and less than 28 days old. CONCLUSIONS: We analyze 19 articles that met the inclusion criteria. Three discussion themes emerge: systemic absorption, dermatologic burns, and CHG and iodine efficacy. PRACTICE IMPLICATIONS: We need more research regarding the safety and efficacy of CHG and iodine solutions for preoperative preparation of young infants' skin. Findings suggest the cautious use of CHG and iodine solutions on patients born at or before 28 weeks' postmenstrual age, especially those less than 28 days postnatal age.

Child Life Specialists Decrease Procedure Time, Improve Experience, and Reduce Fear in an Outpatient Blood Drawing Lab (CLS Decrease Procedure Time).

Children can experience extreme fear when undergoing medical procedures, including blood draws. A growing body of evidence points to the benefits of Child Life Specialists supporting children throughout medical procedures in various medical settings. This prospective cohort study aimed to describe the impact of Child Life Specialist facilitated play on children's fear and caregiver satisfaction in an outpatient blood drawing lab. A nonrandomized convenience sample of 150 children and their caregivers were enrolled. Seventy-five patients received the Child Life Specialist intervention during their blood draw, while the remaining 75 patients were enrolled as controls. Children and caregivers in the intervention group spent less time in the procedure room, with a median time of 3 min (interquartile range: 2-5) as compared to 5 min (interquartile range: 5-6; P < .001) for the control group. Caregivers in the intervention group reported the atmosphere (P = .032) and experience (P < .001) more positively, and children reported lower fear scores (P = .007) as compared to the control group. The findings of this study suggest that Child Life Specialist interventions in pediatric outpatient blood drawing labs improve satisfaction and reduce fear.

Safety and feasibility of the paediatric post-cardiac catheterisation Wrap: a pilot study.

OBJECTIVE: The paediatric post-cardiac catheterisation Wrap (Wrap), an innovative medical safety device, swaddles young paediatric patients in a supine position aiding in immobilisation post-cardiac catheterisation. This pilot study investigated the feasibility and safety of using the Wrap on young paediatric patients during their bed rest period following cardiac catheterisation with femoral access. SETTING: Boston Children's Hospital Cardiac Catheterization Lab. PARTICIPANTS: 20 patients, ages 1-5 years and weighing 3-25 kg. METHODS: Investigator-developed tools used to collect data included the Demographic and Outcome Measures Data Tool, the Parent/Caregiver Satisfaction, and Provider Ease of Use tools. They measured:1.The feasibility of using the Wrap2.Wrap ease of use from the nurse providers' perspective3.Parent satisfaction related to the Wrap4.Frequency of Wrap non-bleeding-related adverse events5.Frequency of rebleeding at femoral groin access sites. RESULTS: The Wrap was feasible and safe; increased nurse provider satisfaction by allowing visualisation of the groin access sites while minimising the need for hands-on care; and increased parent satisfaction by allowing parents to hold and provide comfort while their child was on bed rest. IMPLICATIONS FOR RESEARCH: The Wrap is a safe alternative to the current practice of swaddling with a bath blanket. Further studies are warranted to assess the Wrap's effectiveness in reducing the incidence of rebleeding events in the post-cardiac catheterisation period and explore clinical use outside of the Cardiac Catheterization Lab.

Utilizing high-fidelity simulation to improve newly licensed pediatric intensive care unit nurses' experiences with end-of-life care.

PURPOSE: New pediatric intensive care unit (PICU) nurses face distinct challenges in transitioning from the protected world of academia to postlicensure clinical practice; one of their greatest challenges is how to support children and their caregivers at the end-of-life (EOL). The purpose of this quality improvement project was to create, implement, and assess the efficacy of a high-fidelity EOL simulation, utilizing the "Debriefing with Good Judgment" debriefing model. DESIGN AND METHODS: Participants were nurses with 4 years or less of PICU experience from a 404-bed quaternary care, free-standing children's hospital in the northeastern United States. Data were collected with the Simulation Effectiveness Tool-Modified (SET-M) and the PICU EOL Simulation Evaluation Survey. RESULTS: Twenty-four nurses participated; the majority (54%) were 25-29 years of age. The SET-M results indicate that the EOL simulation was beneficial to their learning and increased nurse confidence in delivering EOL care. Responding to the EOL Simulation Survey, participants rated high levels of confidence with tasks such as utilizing unit and hospital-based supports, self-care, ability to listen and support families, and medicating their patients at the EOL. PRACTICE IMPLICATIONS: This high-fidelity EOL simulation is a robust teaching tool that serves to support the unmet needs of the PICU nurses who care for dying children. Nurse participants had a unique opportunity to practice procedural and communication skills without risk for patient or family harm. Findings from this project can serve to guide curriculum changes at the undergraduate level as well as provide direction for new nurse orientation classes.

An online tool for improving biospecimen data element reporting.

Detailed documentation of the experimental materials and methods is essential for the validation of scientific papers. Human biospecimens are increasingly utilized as materials in cancer research and information about the biospecimens used is a component of this documentation. We hypothesized that previously reported biospecimen data are inadequate for accurate replication and/or validation of a substantial proportion of studies. To examine this issue, we analyzed biospecimen reporting in a representative cross section of publications over the past 12 years (1998, 2004, 2010) in the journals, Cancer Research (CR, n=46) and Clinical Cancer Research (CCR, n=73). We assessed biospecimen data in relation to the standards outlined as the Tier 1 recommended data elements from the Biospecimen Reporting for Improved Study Quality (BRISQ), in addition to ethics criteria. These data elements encompass features of biospecimens influenced by the patient, medical procedure, and biospecimen acquisition, handling and storage processes. Analysis found that while there was a significant increase in the reporting of ethics board approval status (p<0.008) and name of the ethics board (p<0.0001), there were no significant differences between these journals or over this period in reporting other biospecimen-related data elements. Of the 15 Tier 1 data elements assessed in CR and CCR, the data elements commonly obtained from the "Clinical Chart" (8/15 elements) were significantly better reported than elements that would typically be obtained from the "Biobank" (p<0.0001). Our findings demonstrate that reporting of biospecimen-related data elements has been incomplete. As one part of the solution to this issue, we propose the use of an online data-elements reporting tool (www.biobanking.ca) by biobanks. This BRISQ Report tool aims to help biobanks provide the relevant biospecimen-related data as a structured report, and to promote its inclusion as supplementary material in publications to improve the quality of future research studies.

Biospecimen use correlates with emerging techniques in cancer research: impact on planning future biobanks.

The average cohort size for tissue biospecimens used in cancer research studies has increased significantly over the last 20 years. To understand some of the factors behind changes in biospecimen use, we examined cancer research publications to characterize the relationship between specific assay techniques and biospecimen formats and products. We assessed a representative cross section of 378 publications in the journal Cancer Research that used tissue biospecimens, selected from 6 intervals between 1988 and 2010. Publications were categorized by biospecimen utilization, format type (Frozen, Formalin-Fixed Paraffin-Embedded, and Fresh), product type (RNA, DNA, Protein, Cells, and Metabolites), and types of research techniques performed. There was an increase in average biospecimen cohort size (p=0.001); relative use of Formalin-Fixed Paraffin-Embedded biospecimens (24%-68%, p<0.0001); and the proportion of techniques assaying RNA products from biospecimens (Frozen and Fresh formats, p<0.05), from 1988 to 2008. However, these trends have not continued and there has been no further increase from 2008 to 2010. While specific techniques such as 'tissue microarray' analysis appear to have driven some changes in format requirements, there is an overall trend towards techniques requiring RNA products across all formats of biospecimens in basic cancer research. Since pre-analytical variables influence gene expression (RNA levels) more than gene structure (DNA sequence), recognition of these research trends is important for biobanks when deciding priorities for the optimal preservation format and annotation of biospecimens.

SHIP-deficient mice develop spontaneous intestinal inflammation and arginase-dependent fibrosis.

Intestinal fibrosis is a serious complication of Crohn's disease (CD) that can lead to stricture formation, which requires surgery. Mechanisms underlying intestinal fibrosis remain elusive because of a lack of suitable mouse models. Herein, we describe a spontaneous mouse model of intestinal inflammation with fibrosis and the profibrotic role of arginase I. The Src homology 2 domain-containing inositol polyphosphate 5'-phosphatase-deficient (SHIP(-/-)) mice developed spontaneous discontinuous intestinal inflammation restricted to the distal ileum starting at the age of 4 weeks. Mice developed several key features resembling CD, including inflammation and fibrosis. Inflammation was characterized by abundant infiltrating Gr-1-positive immune cells, granuloma-like immune cell aggregates that contained multinucleated giant cells, and a mixed type 2 and type 17 helper T-cell cytokine profile. Fibrosis was characterized by a thickened ileal muscle layer, collagen deposition, and increased fibroblasts at the sites of collagen deposition. SHIP(-/-) ilea had increased arginase activity and arginase I expression that was inversely proportional to nitrotyrosine staining. SHIP(-/-) mice were treated with the arginase inhibitor S-(2-boronoethyl)-l-cysteine, and changes in the disease phenotype were measured. Arginase inhibition did not affect the number of immune cell infiltrates in the SHIP(-/-) mouse ilea; rather, it reduced collagen deposition and muscle hyperplasia. These findings suggest that arginase activity is a potential target to limit intestinal fibrosis in patients with CD.

Completely aborted uterine leiomyosarcoma in the puerperium.

A patient passed a large tissue mass at home on postpartum day 1. Pathologic examination demonstrated leiomyosarcoma. A total abdominal hysterectomy was performed, which demonstrated residual disease. All tissue passed in the puerperium should be evaluated to ensure that significant pathologic conditions are not overlooked. Conservative management of leiomyosarcomas is controversial.