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"Sousa, Mariana S."
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Oral health and individuals with a lived experience of an eating disorder: a qualitative study
by
George, Ajesh
,
Patterson-Norrie, Tiffany
,
Ramjan, Lucie
in
Analysis
,
Behavioral Science and Psychology
,
Clinical Psychology
2023
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.
Plain English summary
The link between eating disorders of any sub-type and poor oral health such as dental caries and enamel wear has been well established in the literature, but barriers such as embarrassment and dental fear can often deter individuals from seeking dental care. Non-dental health professionals such as general practitioners, nurses and allied health professionals including dietitians who work closely with individuals with an eating disorder may be able to play an active role in promoting oral health. The findings of this study provided insight into the experiences of individuals with an eating disorder and the impact this had on their oral health. Barriers to accessing oral health care included shame and embarrassment as well as the cost of dental services. However, many participants felt that having a trusted non-dental health professional such as their dietitian to provide education and referral to dental services would have been beneficial. Further research is needed to understand the requirements for dietitians and other non-dental health professionals to provide oral health promotion in eating disorder clinical areas.
Journal Article
Effectiveness of preventive dental programs offered to mothers by non-dental professionals to control early childhood dental caries: a review
2019
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.
Journal Article
Physical function endpoints in cancer cachexia clinical trials: Systematic Review 1 of the cachexia endpoints series
by
Sayers, Judith
,
Philips, Iain
,
Balstad, Trude Rakel
in
cachexia
,
Cachexia - complications
,
Cachexia - therapy
2023
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.
Journal Article
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)
by
Lee, Jessica T.
,
Morgan, Deidre
,
Johnson, Miriam J.
in
Adult
,
Anorexia
,
Anorexia - drug therapy
2023
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 .
Journal Article
A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy
2017
There is increasing attention and concern about managing the adverse effects of adjuvant endocrine therapy for women with early breast cancer as the side effects of therapy influence compliance and can impair quality of life (QoL). Most side effects associated with tamoxifen (TAM) and aromatase inhibitors (AIs) are directly related to estrogen deprivation, and the symptoms are similar to those experienced during natural menopause but appear to be more severe than that seen in the general population. Prolonged estrogen deprivation may lead to atrophy of the vulva, vagina, lower urinary tract and supporting pelvic structures, resulting in a range of genitourinary symptoms that can in turn lead to pain, discomfort, impairment of sexual function and negatively impact on multiple domains of QoL. The genitourinary side effects may be prevented, reduced and managed in most cases but this requires early recognition and appropriate treatment. We provide an overview of practical clinical approaches to understanding the pathophysiology and the management of genitourinary symptoms in postmenopausal women receiving adjuvant endocrine therapy for breast cancer.
Journal Article
Oncological and Survival Endpoints in Cancer Cachexia Clinical Trials: Systematic Review 6 of the Cachexia Endpoints Series
by
Philips, Iain
,
Sayers, Judith
,
Simpson, Melanie
in
adverse events
,
Appetite
,
Binomial distribution
2025
Background In patients receiving anti‐cancer treatment, cachexia results in poorer oncological outcomes. However, there is limited understanding and no systematic review of oncological endpoints in cancer cachexia (CC) trials. This review examines oncological endpoints in CC clinical trials. Methods An electronic literature search of MEDLINE, Embase and Cochrane databases (1990–2023) was performed. Eligibility criteria comprised participants ≥ 18 years old; controlled design; ≥ 40 participants; and a cachexia intervention for > 14 days. Trials reporting at least one oncological endpoint were selected for analysis. Data extraction was performed using Covidence and followed PRISMA guidelines and the review was registered (PROSPERO CRD42022276710). Results Fifty‐seven trials were eligible, totalling 9743 patients (median: 107, IQR: 173). Twenty‐six (46%) trials focussed on a single tumour site: eight in lung, six in pancreatic, six in head and neck and six in GI cancers. Forty‐two (74%) studies included patients with Stage III/IV disease, and 41 (70%) included patients receiving palliative anti‐cancer treatment. Ten studies (18%) involved patients on curative treatment. Twenty‐eight (49%) studies used pharmacological interventions, 29 (50%) used oral nutrition, and two (4%) used enteral or parenteral nutrition. Reported oncological endpoints included overall survival (OS, n = 46 trials), progression‐free survival (PFS, n = 7), duration of response (DR, n = 1), response rate (RR, n = 9), completion of treatment (TC, n = 11) and toxicity/adverse events (AE, n = 42). Median OS differed widely from 60 to 3468 days. Of the 46 studies, only three reported a significant positive effect on survival. Seven trials showed a difference in AE, four in TC, one in PFS and one in RR. Reported significances were unreliable due to missing adjustments for extensive multiple testing. Only three of the six trials using OS as the primary endpoint reported pre‐trial sample size calculations, but only one recruited the planned number of patients. Conclusion In CC trials, oncological endpoints were mostly secondary and only few significant findings have been reported. Due to heterogeneity in oncological settings, nutritional and metabolic status and interventions, firm conclusions about CC treatment are not possible. OS and AE are relevant endpoints, but future trials targeting clinically meaningful hazard ratios will required more homogeneous patient cohorts, adequate pre‐trial power analyses and adherence to statistical testing standards.
Journal Article
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
by
Halliday, Jane
,
Welsh, Alec
,
Lewis, Sharon
in
Access to information
,
Clinical decision making
,
Decision aid
2018
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.
Journal Article
Body weight and composition endpoints in cancer cachexia clinical trials: Systematic Review 4 of the cachexia endpoints series
2024
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.
Journal Article
“Got to build that trust”: the perspectives and experiences of Aboriginal health staff on maternal oral health
2020
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.
Journal Article
The role of indigenous health workers in promoting oral health during pregnancy: a scoping review
2018
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.
Journal Article