Phase II, double blind, placebo controlled, multi-site study to evaluate the safety, feasibility and desirability of conducting a phase III study of anamorelin for anorexia in people with small cell lung cancer: A study protocol (LUANA trial).

Anorexia is experienced by most people with lung cancer during the course of their disease and treatment. Anorexia reduces response to chemotherapy and the ability of patients to cope with, and complete their treatment leading to greater morbidity, poorer prognosis and outcomes. Despite the significant importance of cancer-related anorexia, current therapies are limited, have marginal benefits and unwarranted side effects. In this multi-site, randomised, double blind, placebo controlled, phase II trial, participants will be randomly assigned (1:1) to receive once-daily oral dosing of 100mg of anamorelin HCl or matched placebo for 12 weeks. Participants can then opt into an extension phase to receive blinded intervention for another 12 weeks (weeks 13-24) at the same dose and frequency. Adults (≥18 years) with small cell lung cancer (SCLC); newly diagnosed with planned systemic therapy OR with first recurrence of disease following a documented disease-free interval ≥6 months, AND with anorexia (i.e., ≤ 37 points on the 12-item Functional Assessment of Anorexia Cachexia Treatment (FAACT A/CS) scale) will be invited to participate. Primary outcomes are safety, desirability and feasibility outcomes related to participant recruitment, adherence to interventions, and completion of study tools to inform the design of a robust Phase III effectiveness trial. Secondary outcomes are the effects of study interventions on body weight and composition, functional status, nutritional intake, biochemistry, fatigue, harms, survival and quality of life. Primary and secondary efficacy analysis will be conducted at 12 weeks. Additional exploratory efficacy and safety analyses will also be conducted at 24 weeks to collect data over longer treatment duration. The feasibility of economic evaluations in Phase III trial will be assessed, including the indicative costs and benefits of anamorelin for SCLC to the healthcare system and society, the choice of methods for data collection and the future evaluation design. Trial registration. The trial has been registered with the Australian New Zealand Clinical Trials Registry [ACTRN12622000129785] and approved by the South Western Sydney Local Health District Human Research Ethics Committee [2021/ETH11339]. https://clin.larvol.com/trial-detail/ACTRN12622000129785.

Aboriginal Health Workers Promoting Oral Health among Aboriginal and Torres Strait Islander Women during Pregnancy: Development and Pilot Testing of the Grinnin' Up Mums & Bubs Program.

BACKGROUND: this study aimed to develop and pilot test the model of care, Grinnin' Up Mums & Bubs, to train Aboriginal Health Workers to promote oral health among Aboriginal and Torres Strait Islander pregnant women. METHODS: Participatory Action Research was employed to develop the different components of the model (oral health promotion resources, training workshop, and a culturally safe referral pathway to dental services). The model was piloted (pre-post), using an embedded mixed-methods design, to determine the acceptability, satisfaction, and any recommendations made by seven Aboriginal Health Workers at an antenatal service in Western Sydney, Australia. RESULTS: there was a high level of satisfaction with the components of the model of care among the participants, who believed that the model could be integrated into practice. The training showed some improvement in oral health knowledge and confidence. The participants recommended strategies for discussing oral health with Aboriginal and Torres Strait Islander pregnant women, and changes in public health dental policy to ensure that all women would be able to access affordable dental services through the referral pathway. CONCLUSION: the findings suggest a high level of satisfaction with the model of care among the Aboriginal Health Workers. Further evaluation is needed to confirm the short and long-term impact of the model.

A Qualitative Study Exploring the Experiences and Perspectives of Australian Aboriginal Women on Oral Health during Pregnancy.

The aim of this study was to explore whether oral health was an important consideration for Aboriginal and Torres Strait Islander women during pregnancy, whether oral health could be promoted by Aboriginal health staff, and strategies that would be appropriate to use in a new model of care. A qualitative descriptive methodology underpinned the study. All participants in this study identified as Aboriginal, with no Torres Strait Islander participants, and were from New South Wales, Australia. The interviews were analysed using inductive thematic analysis. From the data, two themes were constructed. The first theme identified that oral health was not always the first priority for participants as poor accessibility alongside other competing commitments were challenges to accessing oral health services. The second theme highlighted how relationships with personal networks and healthcare providers were essential and could be used to support maternal oral health during pregnancy. Effective strategies to promote oral health during pregnancy for Aboriginal and Torres Strait Islander women should involve key stakeholders and health care providers, like Aboriginal Health Workers, to facilitate culturally safe support and tailored oral health advice.

"Got to build that trust": the perspectives and experiences of Aboriginal health staff on maternal oral health.

BACKGROUND: In Australia, models of care have been developed to train antenatal care providers to promote oral health among pregnant women. However, these models are underpinned by Western values of maternity care that do not consider the cultural needs of Aboriginal and Torres Strait Islander women. This study aimed to explore the perceptions and experiences of Aboriginal health staff towards oral health care during pregnancy. It is part of a larger program of research to develop a new, culturally safe model of oral health care for Aboriginal women during pregnancy. METHODS: A descriptive qualitative methodology informed the study. Focus groups were convened to yarn with Aboriginal Health Workers, Family Partnership Workers and Aboriginal management staff at two antenatal health services in Sydney, Australia. RESULTS: A total of 14 people participated in the focus groups. There were four themes that were constructed. These focused on Aboriginal Health Workers and Family Partnership Workers identifying their role in promoting maternal oral health, where adequate training is provided and where trust has been developed with clients. Yet, because the Aboriginal health staff work in a system fundamentally driven by the legacy of colonisation, it has significantly contributed to the systemic barriers Aboriginal pregnant women continue to face in accessing health services, including dental care. The participants recommended that a priority dental referral pathway, that supported continuity of care, could provide increased accessibility to dental care. CONCLUSIONS: The Aboriginal health staff identified the potential role of Aboriginal Health Workers and Family Partnership Workers promoting oral health among Aboriginal pregnant women. To develop an effective oral health model of care among Aboriginal women during pregnancy, there is the need for training of Aboriginal Health Workers and Family Partnership Workers in oral health. Including Aboriginal staff at every stage of a dental referral pathway could reduce the fear of accessing mainstream health institutions and also promote continuity of care. Although broader oral health policies still need to be changed, this model could mitigate some of the barriers between Aboriginal women and both dental care providers and healthcare systems.

The oral health of Indigenous pregnant women: A mixed-methods systematic review.

BACKGROUND: Western models of care to improve the oral health of pregnant women have been successfully implemented in the healthcare setting across various developed countries. Even though Indigenous women experience poorer pregnancy and birth outcomes compared to other women, these models have not been developed with Indigenous communities to address the oral health needs of Indigenous pregnant women. This review aimed to understand the oral health knowledge, practices, attitudes and challenges of Indigenous pregnant women globally. METHODS: A comprehensive search including six electronic databases and grey literature up to September 2018 was undertaken (PROSPERO Registration Number: 111402). Quantitative and qualitative evidence exploring at least one of the four oral health domains relating to Indigenous pregnant women worldwide, including women pregnant with an Indigenous child, were retrieved. RESULTS: Eleven publications related to nine studies were included. Indigenous pregnant women's attitudes, practices and challenges relating to their oral health were influenced by socioeconomic and psychosocial factors, and their healthcare context. Availability of dental services varied depending on the healthcare model, whether services were public or private, and whether services met their needs. Although there was little evidence related to oral health knowledge, the literature suggests some misconceptions within this population. CONCLUSIONS: The availability of culturally appropriate dental services that fulfilled the needs of Indigenous pregnant women varied between developed countries. This review highlighted the need for community-tailored dental services and a care coordinator to provide both education and assistance to those navigating services.

Nursing assessment and management of incontinence among medical and surgical adult patients in a tertiary hospital: a best practice implementation project.

OBJECTIVES: The objectives of this implementation project were to review the nursing assessment and management of adult patients with urinary and fecal incontinence, and to develop local guidelines and ward-based continence assessment tools to assist nursing staff in assessing and managing incontinence. INTRODUCTION: Urinary or fecal incontinence in acute care hospitals is a growing issue that can lead to constipation, depression, breakdown of skin integrity, increased nursing home placement of older patients, increased length of hospital stay, and escalated healthcare costs. In many cases, incontinence can be treated and managed effectively; however, it is poorly understood and under-prioritized in many hospital settings. METHODS: A pre-post intervention chart audit was conducted to review compliance with 10 best-practice criteria for incontinence assessment and management. Following baseline data analysis, barriers to compliance with the criteria were identified and subsequently addressed using targeted strategies. The project utilized the JBI Practical Application of Clinical Evidence System (PACES) and the Getting Research into Practice (GRiP) tools. RESULTS: Education on continence strategies was delivered to nursing staff, which resulted in improved compliance for all audit criteria. There were notable improvements in the nursing documentation, and assessment and management of patients with urinary and/or fecal incontinence in the post-intervention analysis. CONCLUSIONS: The results demonstrate that nursing education and formalized assessment pathways in an acute setting can improve nursing compliance with the assessment and management of patients with either urinary or fecal incontinence to ensure safe, compassionate and person-centered care.

Process evaluation of the midwifery initiated oral health-dental service program: Perceptions of dental professionals.

ISSUE ADDRESSED: All pregnant women should have a comprehensive oral health evaluation. Unfortunately, many pregnant women seldom seek dental care and some dentists are hesitant to treat during pregnancy. To address these issues, the Midwifery Initiated Oral Health Dental Service (MIOH-DS) program was developed in Australia. The aim of this study was to undertake a process evaluation and explore the perceptions of dental professionals involved in the program to determine the acceptability, feasibility and effectiveness of the program if it were to be upscaled. METHODS: A qualitative approach using content analysis was conducted on data from two focus groups involving 12 dental professionals. RESULTS: All participants were supportive of the MIOH-DS program. They thought pregnant women were receptive to their care, and reported markedly improved oral health. The provision of free dental care and the involvement of midwives were cited as major factors that improved the uptake of the program. Some of the challenges encountered were the prevailing misconceptions about the safety of dental treatment and pregnancy-related impairments. CONCLUSIONS: Dental professionals found the MIOH-DS to be acceptable, feasible and effective in improving oral health of pregnant women and their uptake of dental services. However, some challenges need to be addressed as the MIOH-DS program is upscaled into a cost-effective model. SO WHAT?: Dental professionals are important stakeholders in the MIOH-DS model. The process evaluation of the successful dental intervention is necessary to understand how and why such interventions work, and is an important step in scaling up to a population-wide intervention.

The role of indigenous health workers in promoting oral health during pregnancy: a scoping review.

BACKGROUND: Early childhood caries is the most common chronic childhood disease worldwide. Australian Aboriginal and Torres Strait Islander children are twice more likely to develop dental decay, and contributing factors include poor maternal oral health and underutilisation of dental services. Globally, Indigenous health workers are in a unique position to deliver culturally competent oral healthcare because they have a contextual understanding of the needs of the community. METHODS: This scoping review aimed to identify the role of Indigenous health workers in promoting maternal oral health globally. A systematic search was undertaken of six electronic databases for relevant published literature and grey literature, and expanded to include non-dental health professionals and other Indigenous populations across the lifespan when limited studies were identified. RESULTS: Twenty-two papers met the inclusion criteria, focussing on the role of Indigenous health workers in maternal oral healthcare, types of oral health training programs and screening tools to evaluate program effectiveness. There was a paucity of peer-reviewed evidence on the role of Indigenous health workers in promoting maternal oral health, with most studies focusing on other non-dental health professionals. Nevertheless, there were reports of Indigenous health workers supporting oral health in early childhood. Although some oral health screening tools and training programs were identified for non-dental health professionals during the antenatal period, no specific screening tool has been developed for use by Indigenous health workers. CONCLUSIONS: While the role of health workers from Indigenous communities in promoting maternal oral health is yet to be clearly defined, they have the potential to play a crucial role in 'driving' screening and education of maternal oral health especially when there is adequate organisational support, warranting further research.

Health professionals' evaluation of delivering treatment-focused genetic testing to women newly diagnosed with breast cancer.

Increasingly, women are offered genetic testing shortly after diagnosis of breast cancer to facilitate decision-making about treatment, often referred to as 'treatment-focused genetic testing' (TFGT). As understanding the attitudes of health professionals is likely to inform its integration into clinical care we surveyed professionals who participated in our TFGT randomized control study. Thirty-six completed surveys were received (response rate 59%), 15 (42%) health professionals classified as genetic and 21 (58%) as non-genetic. Mainly positive experiences with participating in the TFGT trial were reported. The high cost of testing and who could best deliver information about TGFT to the patient were raised as key constraints to implementation of TFGT in usual care. More non-genetic than genetic health professionals (44 vs 8%) preferred that the surgeon provide the information for decision-making about TFGT. While costs of TFGT itself and the time and effort of staff involved were perceived barriers, as testing costs become lower, it is expected that TFGT will become a routine part of standard clinical care for patients at high genetic risk in the near future.