The perceptions of palliative care medical practitioners towards oral health: A descriptive qualitative study.

BACKGROUND: Oral health problems are common, but often overlooked, among people receiving palliative care. AIM: To better understand how oral health can be addressed in this population, this study aimed to explore the perceptions of oral health care among medical practitioners who provide palliative care to inform the development of a palliative oral health care program. DESIGN: A descriptive qualitative design was adopted. SETTING/PARTICIPANTS: A single focus group was conducted with 18 medical practitioners at a palliative care facility in Sydney, Australia. All participants had experience providing palliative care services to clients. The focus group was audio recorded, transcribed and thematically analysed. RESULTS: The results from the inductive thematic analysis identified four themes. The themes highlighted that participants were aware of the oral health needs of people receiving palliative care; however, they also reflected on the complexity in delivering oral health care across the healthcare settings, as well as the challenges around cost, lack of appropriate dental referral pathways, time constraints and limited awareness. Participants also provided recommendations to improve the delivery of oral health care to individuals receiving palliative care. CONCLUSIONS: To improve the provision of oral health care in this population, this study highlighted the need for oral health training across the multidisciplinary team, standardised screening assessments and referrals, a collective responsibility across the board and exploring the potential for teledentistry to support oral health care provision.

Oral health knowledge, attitudes and practices of dietitians in Australia: A national survey.

AIM: Dietitians are a well-placed profession to be providing pre-emptive oral health promotion. Despite recommendations that oral health promotion should be routinely part of dietetic practice, there is limited data informing the current practices of clinical dietitians in this area across Australia. Hence, the aim of this study was to investigate the knowledge and practices of Australian dietitians and oral health promotion. METHODS: A cross-sectional survey was undertaken involving registered clinical dietitians in Australia using purposive and snowballing sampling (social media/dietetic organisations/public databases). Data were analysed using descriptive and inferential statistics. RESULTS: A total of 149 dietitians participated in the national survey. Overall, dietitians were knowledgeable about oral health risk factors and preventative measures across general health domains. Majority of dietitians agreed that oral health can affect nutrition interventions (95.5%) and dietitians should be discussing oral health (88.0%). However, nearly half were not confident in providing counselling or education and felt that undergraduate training for oral health promotion was inadequate (78.2%). A small proportion (6.0%) of dietitians were already providing oral health promotion regularly. Key barriers included a lack of clear guidelines for practice, limited training opportunities and indistinct referral pathways. CONCLUSION: Dietitians have acknowledged that oral health promotion should be incorporated into their practice. However, they are challenged by a lack of resources and training to support this in clinical practice. SO WHAT?: Capacity building dietitians to promote oral health allows opportunity for improvement in the oral health, nutritional status and quality of life of priority population groups.

Long-term effectiveness of the midwifery initiated oral health-dental service program on maternal oral health knowledge, preventative dental behaviours and the oral health status of children in Australia.

BACKGROUND: The Midwifery Initiated Oral Health-Dental Service was developed to train midwives to promote maternal oral health, and a large trial showed it substantially improved the oral health, knowledge and behaviours of pregnant women. AIM: Evaluate the long-term effectiveness of the program (post-trial) on maternal oral health knowledge, dental behaviours, and early childhood caries in offspring. METHODS: A prospective cohort study involving 204 women and children 3-4 years (followed after trial) was conducted in Sydney, Australia from 2017 to 2019. RESULTS: The program did not have a significant impact on the study measures. Mothers who received the program did have comparatively better knowledge around preventative behaviours to reduce early childhood caries and significantly more mothers were engaging in a key behaviour of using a cup to feed their child. Overall maternal oral health knowledge and level of education did have a protective effect on the dental decay of children. Higher knowledge and levels of education reduced the odds of having a dmft of one or more by over half (OR 0.473), and almost 80% (OR 0.212) respectively. CONCLUSIONS: Although the MIOH-DS program was not effective, there is still value in exploring other complementary interventions to improve maternal oral health, especially for disadvantaged families. Future research should focus on co-designing an antenatal and postnatal oral health intervention and exploring its long-term impact on the oral health of children.

MASCC/ISOO expert opinion on the management of oral problems in patients with advanced cancer.

PURPOSE: The Palliative Care Study Group in conjunction with the Oral Care Study Group of the Multinational Association for Supportive Care in Cancer (MASCC) formed a sub-group to develop evidence-based guidance on the management of common oral problems in patients with advanced cancer. METHODS: This guidance was developed in accordance with the MASCC Guidelines Policy. A search strategy for Medline was developed, and the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials were explored for relevant reviews and trials, respectively. Guidance was categorised by the level of evidence, and "category of guideline" (i.e., "recommendation", "suggestion" or "no guideline possible"). RESULTS: Twelve generic suggestions (level of evidence - 5), three problem-specific recommendations and 14 problem-specific suggestions were generated. The generic suggestions relate to oral hygiene measures, assessment of problems, principles of management, re-assessment of problems and the role of dental/oral medicine professionals. CONCLUSIONS: This guidance provides a framework for the management of common oral problems in patients with advanced cancer, although every patient requires individualised management.

Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study.

BACKGROUND: Paracentesis is commonly undertaken in patients with cancer-related ascites. AIM: To systematically investigate the symptomatic benefits and harms experienced by patients with cancer undergoing paracentesis using real-world data in the palliative care setting. DESIGN: Prospective, multisite, observational, consecutive cohort study. Benefits and harms of paracentesis were assessed between 01/07/2018 and 31/02/2021 as part of routine clinical assessments by treating clinicians at four timepoints: (T0) before paracentesis; (T1) once drainage ceased; (T2) 24 h after T1 and (T3) 28 days after T1 or next paracentesis, if sooner. SETTING/PARTICIPANTS: Data were collected from 11 participating sites across five countries (Australia, England, Hong Kong, Malaysia and New Zealand) on 111 patients undergoing paracentesis via a temporary (73%) or indwelling (21%) catheter: 51% male, median age 69 years, Australia-modified Karnofsky Performance Score 50. RESULTS: At T1 (n = 100), symptoms had improved for most patients (81%), specifically abdominal distension (61%), abdominal pain (49%) and nausea (27%), with two-thirds experiencing improvement in ⩾2 symptoms. In the remaining patients, symptoms were unchanged (7%) or worse (12%). At least one harm occurred in 32% of patients, the most common being an ascitic leak (n = 14). By T3, 89% of patients had experienced some benefit and 36% some harm, including four patients who experienced serious harm, one of which was a fatal bowel perforation. CONCLUSION: Most patients obtained rapid benefits from paracentesis. Harms were less frequent and generally mild, but occasionally serious and fatal. Our findings help inform clinician-patient discussions about the potential outcomes of paracentesis in this frail population.

The community nurse in Australia. Who are they? A rapid systematic review.

AIM: This study aimed to profile the community nurse in Australia. BACKGROUND: The need for nurses in the community health care sector is increasing in response to shorter hospital stays, an aging population and chronic disease. The increase in demand has not been followed by appropriate workforce planning, leading to structural issues and lack of qualified nursing workforce in the community sector. EVALUATION: MEDLINE and ProQuest Public Health and grey literature were searched for records published between 2010 and 2020 relative to the profile of the community nurse in Australia. Twenty-five records (21 publications, 2 databases and 2 reports) were included in the review. Abstracted data followed the principles of workforce planning and included demographics, qualifications and roles. KEY ISSUES: Inconsistent definitions, self-reported data and a focus on practice nurses have contributed to data irregularities. Little is known about the specific aspects of community nursing work. CONCLUSION: A lack of concrete data has overshadowed a community nursing workforce crisis with implications for patients' health and safety across the lifespan. IMPLICATIONS FOR NURSING MANAGEMENT: There is urgent need for nurse managers globally to refocus nursing recruitment to the community sector to maintain quality and ensure sustainability of the nursing workforce.

"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.

Effectiveness of preventive dental programs offered to mothers by non-dental professionals to control early childhood dental caries: a review.

BACKGROUND: Early childhood caries is a common chronic childhood disease and maternal oral health is a risk factor. Improving the oral health behaviours of pregnant women/young mothers can positively influence the oral health of children and reduce their caries risk. Such preventative strategies have been undertaken by non-dental professionals producing mixed results encompassing various interventions across the perinatal period. However, no comprehensive review of these studies has been undertaken. The aim of this review was to assess the effectiveness of maternal oral health programs undertaken during the antenatal and/or postnatal period by non-dental health professionals to reduce early childhood caries. METHODS: A systematic search of five databases was undertaken using key search terms. Studies were included if they (a) involved quantitative study designs with a control; (b) were published in English; (c) reported on interventions delivered by non-dental professionals (d) delivered the intervention to expectant mothers or mothers with young infants up to 24 months; (e) measured outcomes when the child was under 5 years; (f) measured changes in oral health outcomes of children clinically and oral health behaviours of mothers or children. No restrictions were placed on the study quality and setting. RESULTS: Nine studies met the inclusion criteria and involved interventions delivered by diverse non-dental professionals across the antenatal (n = 1), postnatal (n = 6) and perinatal period (n = 2). Most studies were of low methodological quality (n = 6). The interventions focussed on oral health education (n = 8), dental referrals (n = 3) and oral health assessments (n = 1). Interventions conducted in either the postnatal or antenatal periods showed meaningful improvements in children's clinical and mother's behavioural oral health outcomes. The outcomes appear to be sustained when a suite of interventions were used along with referral reminders. There were mixed results from interventions across the perinatal period. CONCLUSIONS: Non-dental professionals can promote maternal oral health by providing oral health education, risk assessment and referrals. Combining these interventions could provide a sustained improvement in oral health outcomes for children although current evidence is weak. More high-quality studies are needed to confirm these findings and determine whether the antenatal and/or postnatal period is best suited to deliver these interventions.

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.

Improving women's knowledge about prenatal screening in the era of non-invasive prenatal testing for Down syndrome - development and acceptability of a low literacy decision aid.

BACKGROUND: Access to information about prenatal screening is important particularly in light of new techniques such as non-invasive prenatal testing (NIPT). This study aimed to develop and examine the acceptability of a low literacy decision aid (DA) about Down syndrome screening among pregnant women with varying education levels and GPs. METHODS: We developed a DA booklet providing information about first-trimester combined testing, maternal serum screening, and NIPT. GPs and women participated in a telephone interview to examine the acceptability of the DA and measure screening knowledge before and after reading the DA. The knowledge measure was designed to assess whether women had understood the gist of the information presented in the decision aid. It comprised conceptual questions (e.g. screening tells you the chance of having a baby with Down syndrome) and numeric questions (e.g. the accuracy of different screening tests). RESULTS: Twenty-nine women and 18 GPs participated. Regardless of education level, most women found the booklet 'very' clearly presented (n = 22, 76%), and 'very' informative (n = 23, 80%). Overall, women's conceptual and numeric knowledge improved after exposure to the DA, from 4% having adequate knowledge to 69%. Women's knowledge of NIPT also improved after receiving the decision aid, irrespective of education. Most GPs found it 'very' clearly presented (n = 13, 72%), and that it would 'very much' facilitate decision-making (n = 16, 89%). CONCLUSIONS: The DA was found to be acceptable to women as well as GPs. A comprehensive evaluation of the efficacy of the decision aid compared to standard information is an important next step. Strategies are needed on how to implement the tool in practice.

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.

Socioeconomic Differences in Informed Decisions About Down Syndrome Screening: A Systematic Review and Research Agenda.

Supporting pregnant women to make informed choices about Down syndrome screening is widely endorsed. We reviewed the literature on: (a) the association between socioeconomic position and informed choices and decision-making about Down syndrome screening, and (b) the possible mediating variables (e.g., health literacy, numeracy skills, behavioral and communication variables) that might explain the relationship. EMBASE, MEDLINE, PubMed, CINAHL, and PsycINFO were searched from January 1999 to September 2014. The methodological quality of studies was determined by predefined criteria regarding the research aims, study design, study population and setting, measurement tools, and statistical analysis. A total of 33 studies met the inclusion criteria. Women from lower socioeconomic groups experience greater difficulties making informed choices about Down syndrome screening compared to women from higher socioeconomic groups. Most studies focus on individual dimensions of informed decision-making rather than assessing elements in conjunction with one another. Few studies have explored why there are socioeconomic differences in women's ability to make informed screening decisions. Future work is needed to identify mediating variables in this pathway. Systematic evidence-based intervention development to improve communication, understanding, and decision-making about Down syndrome screening is needed to ensure that women have an equal opportunity to make an informed choice about screening regardless of their socioeconomic position.

Biomarker endpoints in cancer cachexia clinical trials: Systematic Review 5 of the cachexia endpoint series.

Regulatory agencies require evidence that endpoints correlate with clinical benefit before they can be used to approve drugs. Biomarkers are often considered surrogate endpoints. In cancer cachexia trials, the measurement of biomarkers features frequently. The aim of this systematic review was to assess the frequency and diversity of biomarker endpoints in cancer cachexia trials. A comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990-2023) was completed. Eligible trials met the following criteria: adults (≥18 years), prospective design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a biomarker(s) as an endpoint. Biomarkers were defined as any objective measure that was assayed from a body fluid, including scoring systems based on these assays. Routine haematology and biochemistry to monitor intervention toxicity were not considered. Data extraction was performed using Covidence, and reporting followed PRISMA guidance (PROSPERO: CRD42022276710). A total of 5975 studies were assessed, of which 52 trials (total participants = 6522) included biomarkers as endpoints. Most studies (n = 29, 55.7%) included a variety of cancer types. Pharmacological interventions (n = 27, 51.9%) were most evaluated, followed by nutritional interventions (n = 20, 38.4%). Ninety-nine different biomarkers were used across the trials, and of these, 96 were assayed from blood. Albumin (n = 29, 55.8%) was assessed most often, followed by C-reactive protein (n = 22, 42.3%), interleukin-6 (n = 16, 30.8%) and tumour necrosis factor-α (n = 14, 26.9%), the latter being the only biomarker that was used to guide sample size calculations. Biomarkers were explicitly listed as a primary outcome in six trials. In total, 12 biomarkers (12.1% of 99) were used in six trials or more. Insulin-like growth factor binding protein 3 (IGFBP-3) and insulin-like growth factor 1 (IGF-1) levels both increased significantly in all three trials in which they were both used. This corresponded with a primary outcome, lean body mass, and was related to the pharmacological mechanism. Biomarkers were predominately used as exploratory rather than primary endpoints. The most commonly used biomarker, albumin, was limited by its lack of responsiveness to nutritional intervention. For a biomarker to be responsive to change, it must be related to the mechanism of action of the intervention and/or the underlying cachexia process that is modified by the intervention, as seen with IGFBP-3, IGF-1 and anamorelin. To reach regulatory approval as an endpoint, the relationship between the biomarker and clinical benefit must be clarified.

Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series.

There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing interventions and their clinical value. The aim of this systematic review was to summarize and evaluate endpoints used to assess appetite and dietary intake in cancer cachexia clinical trials. A search for studies published from 1 January 1990 until 2 June 2021 was conducted using MEDLINE, Embase and Cochrane Central Register of Controlled Trials. Eligible studies examined cancer cachexia treatment versus a comparator in adults with assessments of appetite and/or dietary intake as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guidance, and a protocol was published in PROSPERO (2022 CRD42022276710). This review is part of a series of systematic reviews examining cachexia endpoints. Of the 5975 articles identified, 116 were eligible for the wider review series and 80 specifically examined endpoints of appetite (65 studies) and/or dietary intake (21 studies). Six trials assessed both appetite and dietary intake. Appetite was the primary outcome in 15 trials and dietary intake in 7 trials. Median sample size was 101 patients (range 40-628). Forty-nine studies included multiple primary tumour sites, while 31 studies involved single primary tumour sites (15 gastrointestinal, 7 lung, 7 head and neck and 2 female reproductive organs). The most frequently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appetite item from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30/C15 PAL (38%) and the appetite question from North Central Cancer Treatment Group anorexia questionnaire (17%) were also frequently applied. Of the studies that assessed dietary intake, 13 (62%) used food records (prospective registrations) and 10 (48%) used retrospective methods (24-h recall or dietary history). For VAS/NRS, a mean change of 1.3 corresponded to Hedge's g of 0.5 and can be considered a moderate change. For food records, a mean change of 231 kcal/day or 11 g of protein/day corresponded to a moderate change. Choice of endpoint in cachexia trials will depend on factors pertinent to the trial to be conducted. Nevertheless, from trials assessed and available literature, NRS or EORTC QLQ C30/C15 PAL seems suitable for appetite assessments. Appetite and dietary intake endpoints are rarely used as primary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not validated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.

Body weight and composition endpoints in cancer cachexia clinical trials: Systematic Review 4 of the cachexia endpoints series.

Significant variation exists in the outcomes used in cancer cachexia trials, including measures of body composition, which are often selected as primary or secondary endpoints. To date, there has been no review of the most commonly selected measures or their potential sensitivity to detect changes resulting from the interventions being examined. The aim of this systematic review is to assess the frequency and diversity of body composition measures that have been used in cancer cachexia trials. MEDLINE, Embase and Cochrane Library databases were systematically searched between January 1990 and June 2021. Eligible trials examined adults (≥18 years) who had received an intervention aiming to treat or attenuate the effects of cancer cachexia for >14 days. Trials were also of a prospective controlled design and included body weight or at least one anthropometric, bioelectrical or radiological endpoint pertaining to body composition, irrespective of the modality of intervention (e.g., pharmacological, nutritional, physical exercise and behavioural) or comparator. Trials with a sample size of <40 patients were excluded. Data extraction used Covidence software, and reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. This review was prospectively registered (PROSPERO: CRD42022276710). A total of 84 clinical trials, comprising 13 016 patients, were eligible for inclusion. Non-small-cell lung cancer and pancreatic cancer were studied most frequently. The majority of trial interventions were pharmacological (52%) or nutritional (34%) in nature. The most frequently reported endpoints were assessments of body weight (68 trials, n = 11 561) followed by bioimpedance analysis (BIA)-based estimates (23 trials, n = 3140). Sixteen trials (n = 3052) included dual-energy X-ray absorptiometry (DEXA)-based endpoints, and computed tomography (CT) body composition was included in eight trials (n = 841). Discrepancies were evident when comparing the efficacy of interventions using BIA-based estimates of lean tissue mass against radiological assessment modalities. Body weight, BIA and DEXA-based endpoints have been most frequently used in cancer cachexia trials. Although the optimal endpoints cannot be determined from this review, body weight, alongside measurements from radiological body composition analysis, would seem appropriate. The choice of radiological modality is likely to be dependent on the trial setting, population and intervention in question. CT and magnetic resonance imaging, which have the ability to accurately discriminate tissue types, are likely to be more sensitive and provide greater detail. Endpoints are of particular importance when aligned with the intervention's mechanism of action and/or intended patient benefit.

Quality of life endpoints in cancer cachexia clinical trials: Systematic review 3 of the cachexia endpoints series.

The use of patient-reported outcomes (PROMs) of quality of life (QOL) is common in cachexia trials. Patients' self-report on health, functioning, wellbeing, and perceptions of care, represent important measures of efficacy. This review describes the frequency, variety, and reporting of QOL endpoints used in cancer cachexia clinical trials. Electronic literature searches were performed in Medline, Embase, and Cochrane (1990-2023). Seven thousand four hundred thirty-five papers were retained for evaluation. Eligibility criteria included QOL as a study endpoint using validated measures, controlled design, adults (>18 years), ≥40 participants randomized, and intervention exceeding 2 weeks. The Covidence software was used for review procedures and data extractions. Four independent authors screened all records for consensus. Papers were screened by titles and abstracts, prior to full-text reading. PRISMA guidance for systematic reviews was followed. The protocol was prospectively registered via PROSPERO (CRD42022276710). Fifty papers focused on QOL. Twenty-four (48%) were double-blind randomized controlled trials. Sample sizes varied considerably (n = 42 to 469). Thirty-nine trials (78%) included multiple cancer types. Twenty-seven trials (54%) featured multimodal interventions with various drugs and dietary supplements, 11 (22%) used nutritional interventions alone and 12 (24%) used a single pharmacological intervention only. The median duration of the interventions was 12 weeks (4-96). The most frequent QOL measure was the EORTC QLQ-C30 (60%), followed by different FACIT questionnaires (34%). QOL was a primary, secondary, or exploratory endpoint in 15, 31 and 4 trials respectively, being the single primary in six. Statistically significant results on one or more QOL items favouring the intervention group were found in 18 trials. Eleven of these used a complete multidimensional measure. Adjustments for multiple testing when using multicomponent QOL measures were not reported. Nine trials (18%) defined a statistically or clinically significant difference for QOL, five with QOL as a primary outcome, and four with QOL as a secondary outcome. Correlation statistics with other study outcomes were rarely performed. PROMs including QOL are important endpoints in cachexia trials. We recommend using well-validated QOL measures, including cachexia-specific items such as weight history, appetite loss, and nutritional intake. Appropriate statistical methods with definitions of clinical significance, adjustment for multiple testing and few co-primary endpoints are encouraged, as is an understanding of how interventions may relate to changes in QOL endpoints. A strategic and scientific-based approach to PROM research in cachexia trials is warranted, to improve the research base in this field and avoid the use of QOL as supplementary measures.

Exploring culture-specific differences in beliefs about causes, kinship and the heritability of major depressive disorder: the views of Anglo-Celtic and Chinese-Australians.

The aim of this study was to explore cultural differences in causal attributions and beliefs about heritability of major depressive disorder (MDD). Face-to-face interviews with Anglo-Celtic- and Chinese-Australians community members with a family history of MDD were conducted and subjected to a rigorous qualitative analysis, using the computer software NVivo. Sixteen Anglo-Celtic-Australians and 16 Chinese-Australians were interviewed. Both groups believed that a combination of genetic and environmental factors contributed to MDD, that stress was an important cause of MDD, and that coping factors were significant moderators of the impact of stress on MDD. Both cultural groups believed that the causes of MDD affecting multiple family members included a shared family environment and a "contagion effect", in addition to genetics. Unique to the Chinese-Australian group was the beliefs that parental pressures to exceed academically contributed to MDD; this cultural group also reported beliefs that depression was due to God's will or alternatively fate, which in turn was related to attributions to feng shui and auspicious dates. This study documented key culture-specific differences in beliefs about causes and inheritance of MDD; such differences have major implications for clinician-patient communication about genetic risk associated with having a family history of MDD.

Oral health and individuals with a lived experience of an eating disorder: a qualitative study.

BACKGROUND: Limited evidence exists describing the impact to oral health when living with an eating disorder and the availability of information or access to oral health services. This study investigated the perceptions of individuals with a lived experience of an eating disorder specifically to understand their needs and recommendations for improving access to early intervention and oral health promotion. METHODS: Using purposive sampling a total of 12 semi-structured interviews were conducted with participants across Australia who had a lived experience of an eating disorder. A hybrid inductive and deductive approach to thematic analysis was used to construct salient themes and subthemes. RESULTS: Most participants had experienced some oral health manifestation as part of their eating disorder hence, many felt quite knowledgeable on the topic. Following their eating disorder many participants felt confident in engaging with dental services, although, barriers including embarrassment, shame, and cost compromised access at times. Participants felt strongly that greater emphasis on oral health promotion during an eating disorder was important and this may be achieved by increasing the availability of resources and using trusted non-dental health professionals like dietitians. CONCLUSIONS: The need for oral health promotion while experiencing an eating disorder was evident, however, dentists can often be a costly option. Non-dental health professionals like dietitians working with clients with an eating disorder may be an acceptable alternative for closing this gap.

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.

Physical function endpoints in cancer cachexia clinical trials: Systematic Review 1 of the cachexia endpoints series.

In cancer cachexia trials, measures of physical function are commonly used as endpoints. For drug trials to obtain regulatory approval, efficacy in physical function endpoints may be needed alongside other measures. However, it is not clear which physical function endpoints should be used. The aim of this systematic review was to assess the frequency and diversity of physical function endpoints in cancer cachexia trials. Following a comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990-2021), records were retrieved. Eligible trials met the following criteria: adults (≥18 years), controlled design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a physical function endpoint. Physical function measures were classified as an objective measure (hand grip strength [HGS], stair climb power [SCP], timed up and go [TUG] test, 6-min walking test [6MWT] and short physical performance battery [SPPB]), clinician assessment of function (Karnofsky Performance Status [KPS] or Eastern Cooperative Oncology Group-Performance Status [ECOG-PS]) or patient-reported outcomes (physical function subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ-C30 or C15]). Data extraction was performed using Covidence and followed PRISMA guidance (PROSPERO registration: CRD42022276710). A total of 5975 potential studies were examined and 71 were eligible. Pharmacological interventions were assessed in 38 trials (54%). Of these, 11 (29%, n = 1184) examined megestrol and 5 (13%, n = 1928) examined anamorelin; nutritional interventions were assessed in 21 trials (30%); and exercise-based interventions were assessed in 6 trials (8%). The remaining six trials (8%) assessed multimodal interventions. Among the objective measures of physical function (assessed as primary or secondary endpoints), HGS was most commonly examined (33 trials, n = 5081) and demonstrated a statistically significant finding in 12 (36%) trials (n = 2091). The 6MWT was assessed in 12 trials (n = 1074) and was statistically significant in 4 (33%) trials (n = 403), whereas SCP, TUG and SPPB were each assessed in 3 trials. KPS was more commonly assessed than the newer ECOG-PS (16 vs. 9 trials), and patient-reported EORTC QLQ-C30 physical function was reported in 25 trials. HGS is the most commonly used physical function endpoint in cancer cachexia clinical trials. However, heterogeneity in study design, populations, intervention and endpoint selection make it difficult to comment on the optimal endpoint and how to measure this. We offer several recommendations/considerations to improve the design of future clinical trials in cancer cachexia.