The Nonclinical Assessment of Trans-1,3,3,3-tetrafluoropropene (HFO-1234ze (E)), a Near Zero Global Warming Potential Propellant for Use in Metered Dose Inhalation Products.

HFO-1234ze (E) is proposed as a near zero global warming propellant for use in metered dose inhaled (MDI) products. This paper describes the non-clinical safety assessment in mice, rats, and dogs and supplements previously reported data (genetic toxicology, short-term toxicology, and reproductive toxicology). In all species, HFO-1234ze (E) was only detectable in blood for a short period after dosing with no evidence of accumulation. HFO-1234ze (E) was without any toxicological effects at very high doses in subchronic (13-week mouse) and chronic (39-week dog) studies. Chronic (26-week) administration to rats at very high doses was associated with an exacerbation of rodent progressive cardiomyopathy, a well-documented background finding in rodents. In a 2-generation study, extremely high doses were associated with the early euthanasia of some lactating female rats. This finding was considered to be significantly influenced by a state of negative energy balance, reflecting the specific vulnerability of rats during lactation. These findings are considered to not pose a risk to humans with typical MDI use given they occurred at doses which far exceed those expected in patients. Overall, the nonclinical safety data for HFO-1234ze (E) support its further development as an MDI propellant.

Longitudinal Study Transformed Onboarding Nurse Graduates.

The outcomes of a longitudinal research study on a nurse residency program indicated improvement in the onboarding experience for new graduate nurses. Practice changes and implications for nursing professional development practitioners resulting from the study include the number and orientation of preceptors, program length standardization, and improvement of emergency clinical response education. Additional research studies were implemented to further explore issues novice nurses and their proficient registered nurse colleagues experience throughout the organization.

Signal management in pharmacovigilance and human risk assessment of CpG 7909, integrating embryo-fetal and post-natal developmental toxicity studies in rats and rabbits.

The potential reproductive and developmental toxicity of the synthetic oligodeoxynucleotide (ODN) CpG 7909, a component of GSK's AS15 immunostimulant, was examined in rat and rabbit studies following intermittent intramuscular injections. Previous studies using subcutaneous and intraperitoneal injections in mice, rats and rabbits revealed that CpG ODNs induced developmental effects. To analyze the safety signal, GSK conducted additional animal studies using the intended clinical route of administration. CpG 7909 injections were administered intramuscularly to rats or rabbits 28 and 14days before pairing, on 4 or 5 occasions during gestation, and on lactation day 7. The No Observed Adverse Effect Level for female fertility, embryo-fetal and pre- and post-natal development was 4.2mg/kg in both species, approximately 500-fold higher than the anticipated human dose. In conclusion, the anticipated risk to humans is considered low for sporadic intramuscular exposure to CpG 7909.

Intramuscularly administered herpes zoster subunit vaccine has no effects on fertility, pre- and post-natal development in Sprague-Dawley rats.

The herpes zoster subunit vaccine (HZ/su) is an investigational vaccine for the prevention of shingles, a disease caused by the varicella zoster virus (VZV). It is composed of recombinant VZV glycoprotein E (gE) and AS01. We assessed the potential toxic effects of gE/AS01 and AS01 alone on female and male fertility, and on embryo-fetal, pre- and post-natal development in Sprague-Dawley rats. Females were immunized before pairing and during gestation. Half of the pregnant rats were used for embryo-fetal investigations. The ones that gave birth were immunized during lactation and offspring were analysed. In a male fertility study, rats were immunized before pairing. After mating, the untreated females were sacrificed and the fetuses examined. In addition, male fertility parameters were evaluated. Results indicated that female mating performance and fertility, pre- and post-natal survival and offspring development, male mating performance and fertility were unaffected by intramuscular administration of the zoster candidate vaccine gE/AS01.

CE: Original Research: An Investigation into the Health-Promoting Lifestyle Practices of RNs.

PURPOSE: The purpose of this study was to gather baseline data on the health-promoting lifestyle practices of RNs working in six major health care and educational institutions in a southeast Pennsylvania community. METHODS: A descriptive correlational study design was used. The 52-item Health-Promoting Lifestyle Profile II instrument was used to explore participants' self-reported health-promoting behaviors and measure the dimensions of health responsibility, physical activity, nutrition, interpersonal relations, spiritual growth, and stress management. RESULTS: Findings revealed that physical activity and stress management scores were low for the entire group of RNs. There were statistically significant differences between nurses 50 years of age and older and those 30 to 39 years of age for the subscales of health responsibility, nutrition, and stress management, suggesting that older nurses are more concerned about their health. There were also statistically significant differences between nurses 50 years of age and older and those 29 years of age and younger for the subscale of health responsibility. Sixty-seven percent of participants reported having too many competing priorities and had significantly lower subscale scores for spiritual growth, interpersonal relations, and stress management, as well as significantly lower total scores. CONCLUSION: This study's findings provided baseline data that will be useful in planning health-promoting lifestyle interventions for participants specific to their institutions, and may help guide future research and educational initiatives related to numerous issues common to the RN workforce. The failure of many nurses to take adequate care of themselves needs to be better understood and addressed, by both individual nurses and their employers.

The role of lumboperitoneal shunts in the treatment of syringomyelia.

OBJECT The role of thecoperitoneal shunts in the management of syringomyelia is not well defined. In this study, the authors analyze the outcome of lumboperitoneal shunt procedures carried out to treat syringomyelia in their institution. METHODS The authors retrospectively reviewed the medical records of 19 patients who underwent lumboperitoneal shunt procedures for syringomyelia. RESULTS The mean follow-up duration was 25 months (range 3-51 months). Of 16 cases followed up, only 5 patients reported clinical improvement in their preoperative symptoms, but of these, 2 had clear radiological evidence of improvement. Three of 6 patients with syringomyelia due to spinal arachnoiditis improved. CONCLUSIONS Lumboperitoneal shunts may lead to useful improvement in the symptoms of a patient with syringomyelia while avoiding the risk of neurological deterioration inherent in myelotomies required for syrinx shunting procedures.

Family presence in final moments: a precious gift.

The experience of a family and nurse who shared the acute illness of a teenager illustrates advocacy for family presence in the ICU and during resuscitation as well as integration of spiritual care in complex nursing practice. Family participation supports physical, emotional, and spiritual needs, allowing for open communication and the comfort of knowing that a loved one is receiving care. Although critical care, heart, and emergency nursing associations support family presence and holistic care, family presence remains controversial.

Nurses' advocacy behaviors in end-of-life nursing care.

Nursing professionals are in key positions to support end-of-life decisions and to advocate for patients and families across all health care settings. Advocacy has been identified as the common thread of quality end-of-life nursing care. The purpose of this comparative descriptive study was to reveal acute care nurses' perceptions of advocacy behaviors in end-of-life nursing practice. The 317 participating nurses reported frequent contact with dying patients despite modest exposure to end-of-life education. This study did not confirm an overall difference in advocacy behaviors among novice, experienced and expert nurses; however, it offered insight into the supports and barriers nurses at different skill levels experienced in their practice of advocacy.

Academic-community partnerships: opening the doors to a nursing career.

With the belief that diversity is strength, the community of Reading, Pennsylvania, set forth an effort to meet the challenges of the disparity within the local nursing workforce with a comprehensive, long-term approach for the recruitment and retention of an underrepresented group. An academic-community partnership was formed to develop multifaceted programs and support across school and community agency systems. The Alvernia College Nursing Department has taken a leadership role to coordinate many community and health care agencies with the goal of increasing the number of baccalaureate-prepared Hispanic and bilingual nurses to provide culturally competent and sensitive care to the community.