An instrument to assess the education needs of nursing assistants within a palliative approach in residential aged care facilities.

BACKGROUND: Providing quality palliative care in residential aged care facilities (RACFs) (aged care homes) is a high priority for ageing populations worldwide. Older people admitted to these facilities have palliative care needs. Nursing assistants (however termed) are the least qualified staff and provide most of the direct care. They have an important role at the frontline of care spending more time with residents than any other care provider but have been found to lack the necessary knowledge and skills to provide palliative care. The level of competence of this workforce to provide palliative care requires evaluation using a valid and reliable instrument designed for nursing assistants' level of education and the responsibilities and practices of their role. METHOD: The overall study purpose was to develop and test an instrument capable of evaluating the knowledge, skills and attitudes of nursing assistants within a palliative approach in RACFs. Development consisted of a four-phase mixed-methods sequential design. In this paper, the results and key findings following psychometric testing of the instrument in Phase 4 is reported using data collected from a random sample of 17 RACFs and 348 nursing assistants in the Greater Sydney region. Study hypotheses were tested to confirm discriminative validity and establish the utility of the instrument in both research and training assessment. RESULTS: Individual item properties were analysed for difficulty, discrimination and item-total correlations. Discriminative and structural validity, and internal consistency and test-retest reliability were demonstrated. Three separate questionnaires comprising 40 items were finalised: The Palliative Approach for Nursing Assistants (PANA)_Knowledge Questionnaire (17 items), the PANA_Skills Questionnaire (13 items) and the PANA_Attitudes Questionnaire (10 items). CONCLUSIONS: This study provides preliminary evidence for the validity and reliability of three new questionnaires that demonstrate sensitivity for nursing assistants' level of education and required knowledge, skills and attitudes for providing a palliative approach. Implications for practice include the development of palliative care competencies through structured education and training across this workforce, and ongoing professional development opportunities for nursing assistants, especially for those with the longest tenure.

Odontoid/Dens Fractures.

Odontoid fractures remain the most common C2 fracture and of those individuals older than 65 years. The type of optimal management remains in question given comorbidities, risk of nonunion, and limitations in mobility when surgical fusion is the treatment selected. These fractures are of particular importance, given the high incident of morbidity and mortality following an odontoid fracture. Overall quality of life remains a significant consideration when selecting the best intervention following careful examination and confirmation with radiographic imaging. The literature continues with controversies in the best treatment interventions for these fractures, resulting in a case-by-case decision-making process.

Perilunate and Lunate Dislocations.

Lunate and perilunate dislocations, although somewhat uncommon, are serious injuries and can be easily missed. The mechanism of injury is hyperextension of the wrist, often associated with a fall on the outstretched hand (FOOSH) injury, falls from height, or motor vehicle crash with a high-energy traumatic injury to the wrist. Perilunate dislocations typically present with pain and swelling over both the dorsal and volar aspects of the wrist and limited range of motion of the wrist. Perilunate dislocations result in disruption of the relationship between the lunate and the capitate, whereas lunate dislocations result in a disruption of the lunate bone, both from the radius and the capitate, primarily diagnosed on the lateral view of the wrist radiograph. These injuries require emergent reduction and stabilization either via a closed or open surgical reduction by an orthopedic specialist. Lunate dislocations can lead to long-term pain and disability if overlooked in their initial assessments.

Development of the B cell cancer vaccine HER-vaxx for the treatment of her-2 expressing cancers.

Her-2/neu is a tumor-associated protein that is overexpressed in a number of malignancies, including advanced cancer of the stomach, and has been proposed as a human cancer vaccine target. Overexpression of Her-2/neu in human breast and gastric carcinomas correlates with a more aggressive course of disease that results in poorer overall survival rates and shorter times to disease progression than in patients with tumors without overexpression of Her-2/neu. Cancer vaccines have the ability to stimulate the native immune system and in particular engineered B cell epitopes can elicit high affinity polyclonal antibodies with similar efficacy to Her-2 monoclonal antibodies such as trastuzumab (Roche). HER-Vaxx is under development as a therapeutic B cell vaccine for the treatment of gastric cancer in patients with Her-2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction, referred to as advanced cancer of the stomach. P467-CRM197, the vaccine's immunogenic component, contains a single peptide antigen composed of 3 individual linear B cell epitope peptide sequences selected from the oncoprotein Her-2/neu that induce the patient's own B cells to produce endogenous anti-Her-2/neu antibodies. This review provides results from comprehensive preclinical studies encompassing primary and secondary pharmacodynamics, biodistribution and safety studies. These studies were performed to support clinical development of HER-Vaxx. Results from the GLP toxicology study in rodents showed that the vaccine did not produce any observable adverse effects suggesting that the doses proposed for the clinical trial should be well tolerated in patients.

Preclinical Studies of a Novel Human PD-1 B-Cell Peptide Cancer Vaccine PD1-Vaxx From BALB/c Mice to Beagle Dogs and to Non-Human Primates (Cynomolgus Monkeys).

Immunotherapy with monoclonal antibodies to checkpoint inhibitors against the PD-1/PD-L1 signaling pathway is a landmark achievement in cancer therapy. Some anti-PD-1 inhibitors such as nivolumab and pembrolizumab have shown clinical success, in a percentage of patients with prolonged survival rates. However, adverse effects accompany these benefits. In this case, strategies with lower toxicity and increased specificity are urgently required. Cancer vaccines have the ability to stimulate the native immune system and in particular, an engineered B-cell epitope can elicit high-affinity polyclonal antibodies with similar efficacy to PD-1 monoclonal antibodies in murine animal models. We have previously designed and synthesized a unique B-cell vaccine, PD1-Vaxx [MVF-PD-1(92-110)], and we have tested the immunogenicity and antitumor properties in CT26 colon cancer BALB/c syngeneic mice model. This manuscript provides results from comprehensive preclinical pharmacology studies encompassing primary and secondary pharmacodynamics, biodistribution, and safety studies. The results from these preclinical studies support the use of PD1-Vaxx in a first-in-human clinical trial in patients with non-small cell lung cancer (NSCLC). A phase I trial in patients with NSCLC has commenced.

Clinical and Immunologic Responses to a B-Cell Epitope Vaccine in Patients with HER2/neu-Overexpressing Advanced Gastric Cancer-Results from Phase Ib Trial IMU.ACS.001.

PURPOSE: HER2/neu is overexpressed in up to 30% of gastroesophageal adenocarcinomas (GEA) and linked to poor prognosis. Recombinant mAbs to treat HER2/neu-overexpressing cancers are effective with limitations, including resistance and toxicity. Therefore, we developed a therapeutic B-cell epitope vaccine (IMU-131/HER-Vaxx) consisting of three fused B-cell epitopes from the HER2/neu extracellular domain coupled to CRM197 and adjuvanted with Montanide. This phase Ib study aimed to evaluate the optimal/safe dose leading to immunogenicity and clinical responses (https//clinicaltrials.gov/ct2/show/NCT02795988). PATIENTS AND METHODS: A total of 14 patients with HER2/neu-overexpressing GEA were enrolled, and dose escalation (10, 30, 50 µg) was performed in three cohorts (C). Immunogenicity was evaluated by HER2-specific Abs and cellular responses, clinical responses by CT scans according to RECIST version 1.1. RESULTS: IMU-131 was safe without vaccine-related significant local/systemic reactions or serious adverse events. A total of 11 of 14 patients were evaluable for changes in tumor size and vaccine-specific immune responses. One patient showed complete, 5 partial responses, and 4 stable diseases as their best response. HER2-specific IgG levels were dose dependent. In contrast to patients in C1 and C2, all patients in C3 mounted substantial HER2-specific Ab levels. In addition, cellular vaccine responses, such as Th1-biased cytokine ratios and reduced regulatory T cell numbers, were generated. Progression-free survival was prolonged in C3, correlating with the vaccine-specific humoral and cellular responses. CONCLUSIONS: IMU-131 was well tolerated and safe. The induced HER2-specific Abs and cellular responses were dose dependent and correlated with clinical responses. The highest dose (50 µg) was recommended for further evaluation in a phase II trial, with chemotherapy + IMU-131 or chemotherapy alone, which is currently ongoing.

A randomised controlled trial of Lavender (Lavandula Angustifolia) and Lemon Balm (Melissa Officinalis) essential oils for the treatment of agitated behaviour in older people with and without dementia.

OBJECTIVE: Lavender and Lemon Balm essential oils are popular in the management of older person agitation due to their ease of application, minimal side effects and low interaction with concurrent medications. This study addressed limitations in the literature to evaluate and compare effectiveness of Lavender and Lemon Balm essential oils on the agitated behaviour of older people with and without dementia living in residential aged care facilities [RACFs]. METHODS: Forty-nine nursing home residents with dementia (n=39) and without dementia (n=10) exhibiting agitation participated in this study. Participants were randomised to a counterbalanced, repeated measures design experiment that tests the treatments Lavender, Lemon Balm, and Placebo (Sunflower oil). Treatments were administered once daily for two-weeks followed by a two-week washout period before commencing the subsequent treatment. All participants trialed all three treatments over a 10-week period. Data were collected on the Neuropsychiatric Inventory (NPI) and Cohen-Mansfield Agitation Inventory (CMAI). RESULTS: A significant difference was shown when essential oils effect were compared between the cognitive groups. Post hoc analysis reports Lemon Balm more effective in reducing NPI agitation (p = .04) and CMAI physical non-aggressive behaviour (PNAB) (p = .02) in residents without dementia. Lemon Balm less effective in reducing NPI irritability (p = 0.01) and Lavender more effective in reducing CMAI PNAB (p = 0.04) in dementia. CONCLUSION: The findings support an opposing effect of Lemon Balm and Lavender in reducing agitated behaviour between the participant cognitive groups. There was no reduction in agitation with treatments when compared to placebo independent of cognitive groups.

Assessing nursing assistants' competency in palliative care: An evaluation tool.

Nursing assistants are the largest aged care workforce providing direct care to older people in residential aged care facilities (RACF) in Australia and internationally. A palliative approach is a large component of this direct care that necessitates nursing assistants possess requisite knowledge, skills and attitudes. While training needs have been identified to enhance their practices, preservice education is variable, educational interventions have been adhoc and professional development found to be inadequate to the demands of the workplace. In addition, evaluation of nursing assistants' knowledge, skills and attitudes has lacked an instrument specifically tailored to nursing assistants' level of education and role responsibilities when providing a palliative approach. This paper reports on Phase 3 of a research study to develop such an instrument capable of assessing nursing assistants' knowledge of, skills in, and attitudes within a palliative approach. This phase assesses the usability and performance capabilities of the new instrument on a purposive sample of nursing assistants in two RACFs using the survey method. Results showed that the instrument was able to discriminate between groups of nursing assistants based on experience in role. Usability results indicated that the instrument is user friendly and time efficient.

Measuring nursing assistants' knowledge, skills and attitudes in a palliative approach: A literature review.

BACKGROUND: Nursing assistants are the largest aged care workforce providing care to older people in residential aged care facilities. Although studies have focused on their training and development needs when providing a palliative approach, a valid and reliable instrument to evaluate their knowledge, skills and attitudes is required. AIMS: To examine what instruments have been used to evaluate nursing assistants' knowledge of, skills in and attitudes towards a palliative approach in residential aged care facilities, critically evaluate development processes, and discuss the strengths and limitations of existing instruments for this population. METHODS: CINAHL, the Cochrane Library, ERIC, MEDLINE, PubMed, Scopus and Web of Science were searched using key words. Selected articles were published in English in the period 2004-2014 and included instruments which evaluated nursing assistants and a palliative approach. RESULTS: Ten studies using seven instruments met the inclusion criteria. One of these instruments measured nursing assistants' level of comfort in providing end-of-life care. The six remaining instruments measured palliative care knowledge, palliative care practice, self-efficacy, knowledge and attitudes towards people with advanced dementia, beliefs and attitudes to death, dying, palliative and interdisciplinary care across the aged care workforce. CONCLUSION: Seven instruments have been used to evaluate nursing assistants' knowledge, skills and attitudes in a palliative approach. Instrument design and recommended psychometric processes for development limit specificity and usefulness of these instruments for nursing assistants' scope of practice. Adhering to recommended psychometric processes will increase the validity and reliability of an instrument tailored to this population and a palliative approach.

Predictive validity of the post-enrolment English language assessment tool for commencing undergraduate nursing students.

BACKGROUND: Nursing students with English as an additional language (EAL) may underperform academically. The post-enrolment English language assessment (PELA) is used in literacy support, but its predictive validity in identifying those at risk of underperformance remains unknown. OBJECTIVES: To validate a PELA, as a predictor of academic performance. DESIGN: Prospective survey design. SETTING: The study was conducted at a university located in culturally and linguistically diverse areas of western Sydney, Australia. PARTICIPANTS: Commencing undergraduate nursing students who were Australian-born (n=1323, 49.6%) and born outside of Australia (n=1346, 50.4%) were recruited for this study. The 2669 (67% of 3957) participants provided consent and completed a first year nursing unit that focussed on developing literacy skills. METHOD: Between 2010 and 2013, commencing students completed the PELA and English language acculturation scale (ELAS), a previously validated instrument. The grading levels of the PELA tool were: Level 1 (proficient), Level 2 (borderline), and Level 3 (poor, and requiring additional support). RESULTS: Participants with a PELA Level 2 or 3 were more likely to be: a) non-Australian-born (χ(2): 520.6, df: 2, p<0.001); b) spoke a language other than English at home (χ(2): 490.2, df: 2, p<0.001); and c) an international student (χ(2): 225.6, df: 2, p<0.001). There was an inverse relationship between participants' ELAS scores and PELA levels (r=-0.52, p<0.001), and those graded as 'proficient' with a PELA Level 1 were more likely to obtain higher scores in their: i) unit essay assessment (χ(2): 40.2, df: 2, p<0.001); ii) final unit mark (χ(2): 218.6, df: 2, p<0.001), and attain a higher GPA (χ(2): 100.8, df: 2, p<0.001). CONCLUSION: The PELA is a useful screening tool in identifying commencing nursing students who are at risk of academic underachievement.