A randomised investigation of film-forming silicone gel in superficial partial thickness face and neck burn patients: Indication of improved early scar pigmentation outcomes.

INTRODUCTION: Burns to the face and neck are a source of considerable distress and a challenge to manage with dressings. Further, these often superficial injuries pose a risk of scarring and altered pigmentation. Silicone gels have emerged as a potential solution to the challenges of conservative management for face and neck burn injuries. The aims of this study were to explore the effect of topical silicone compared to routine treatment of conservatively managed burns to the face and neck. METHODS: This single-blind, randomised, controlled trial compared topical silicone film-forming dressing to standard of care for superficial partial thickness burns to the face and neck. Time to healing was the primary outcome and secondary outcomes included: 1) scar assessments (modified Vancouver Scar Scale, Dermalab Combo and Patient and Observer Scar Assessment Scale) at six weeks and three months; and 2) pain intensity scale at wound review appointments. RESULTS: Of the 55 participants in the face/neck study, 34 were male and 21 were female. Median age was 36 years (range from 25 to 47 years). The median time to healing for the silicone group was 9 days (CI 7.6 -10.4) and the control group was 7 days (CI 5.3- 8.7), p = 0.056. Analysis demonstrated significantly reduced pigmentation at six weeks in mVSS scores for the silicone group (Md = 0, IQR = 0) compared to the control group (Md = 0, IQR = 0 - 3), p = 0.043. We found no evidence of differences in reported pain between the groups (Silicone - Md = 1.15, IQR 0.3 - 4.5 vs control group - Md = 1.5, IQR 0.6 - 3.8, z = -0.63, p = 0.53). No other differences were observed, and no adverse events were associated with the topical silicone in the study whereas an infection and a reaction were experienced in the control group. CONCLUSION: Film-forming silicone gel had comparable effects to standard of care emollient on wound healing of superficial partial thickness burns of the face and neck. Silicone treated wounds were associated with a significant improvement in scar pigmentation outcome at six weeks post-burn.

Outcomes of completed quality activities in an Australian tertiary hospital, 2015-2019.

Quality activities including quality assurance and quality improvement are an integral part of safety and quality governance for hospitals. Previous studies identified that (i) majority are for quality assurance and knowledge-acquiring purposes and (ii) adherence to the quality cycle as well as impact on patient-related outcomes at the hospital level are unclear, neither associated with costs. This study aims to (i) assess adherence to the quality cycle for quality activities in a large Australian tertiary hospital; (ii) report outcomes of quality activities at the hospital level, including impact on patient-related outcomes measured by the occurrence of hospital-acquired complications; and (iii) estimate time and costs for data collection. This quantitative study utilized three data sources. First is the hospital's electronic quality management system, Governance, Evidence, Knowledge and Outcome that identifies completed quality activities over a 5-year period; second is Tableau dashboards for hospital-acquired complication performance; third is Microsoft Teams Forms used to capture time of data collection for bedside observations and retrospective notes reviews. Median sample size and median hourly rates in 2018 were used for calculations. A total of 1768 quality activities were completed over a 5-year period representing an average of 353 quality activities per year, of which 87.8% were initiated by clinicians and 12.2% planned and coordinated by safety and quality or equivalent. The activity reports indicated that less than a fifth (17.1%) brought about improvement in process measures and only 7.1% improved outcome measures. Two-thirds of the quality activities (66.3%) provided recommendations based on their findings, but evidence of action plan was available in 14.1% of the reports only. No association was found between the number of activities completed and overall hospital-acquired complication performance. Retrospective data collection (64.7%) was common. The estimated time and cost for data collection averaged at 3490 h/year, equivalent to 1.8 full-time employees, for a cost of $171 000 at the nursing rate (A$49.0), $280 000 at the medical rate (A$79.5), and $200 000 at the Health Service Union rate (A$58.9). Most quality activities were clinician-initiated. Implementing change and achieving and sustaining improvement were the two challenging stages in the quality cycle. No clear association was observed between activities completed and improvement in patient-related outcomes although some improvement in processes. A paradigm shift may be needed to engineer quality activities in hospitals to be more outcome-oriented. Opportunities exist for hospitals to consider how quality activities can be organized to maximize returns from investment.

Bouncing back from COVID-19: a Western Australian community perspective.

Introduction: This study explored the behavioral profiles of residing Western Australians during a COVID-19 lockdown period and transitions in behavior post-lockdown. Methods: A total of 313 participants (76% female, age: M = 50.1, SD = 15.7 years) completed behavioral and mental health questionnaire items ~2 months after a 3-month COVID-19 lockdown in October 2020, using a retrospective recall to assess their experience during the lockdown period. Latent transition analysis (LTA) was used to identify behavioral profiles and transitions. Indicators were identified by assessing during-post-lockdown group differences (Kruskal-Wallis, chi-square tests) and profiles described using qualitative open-ended questions. Results: Significant indicators included changes in physical activity, leisure screen time, alcohol intake, psychological distress, and loneliness, but not fast food consumption. The significant indicators were used to form LTA models. The five latent class model showed the best model fit (Log-likelihood = -1301.66, AIC = 426.12, BIC = 609.68). Approximately one in four participants reported a change in their behavior profiles after the lockdown ceased. Key differences between the profiles were age, household income, education, resilience, sense of control, existing mental health issues, and social relations. Washing hands and social distancing were the most recalled and effective health campaigns across the classes, with health campaigns encompassing physical activity/alcohol consumption, or domestic violence having the least attention. Discussion: Overall, while most participants recovered relatively well after the lockdown period, LTA did identify subgroups such as those who were inactive and lonely experienced more difficulties than other groups, and engagement with public health campaigns differed. The results provide important insights for future public health campaigns on how these campaigns might be diversified to effectively target more people and particular groups to maximize engagement for maintaining people's mental health with additional focus on physical activity, alcohol consumption, and domestic violence.

Examining the use of cannabidiol and delta-9-tetrahydrocannabinol-based medicine among individuals diagnosed with dementia living within residential aged care facilities: Results of a double-blind randomised crossover trial.

OBJECTIVE: Dementia affects individuals older than 65 years. Currently, residential aged care facilities (RACF) use psychotropic medications to manage behavioural and neuropsychiatric symptoms of dementia (BPSD), which are recommended for short-term use and have substantial side effects, including increased mortality. Cannabinoid-based medicines (CBM) have some benefits that inhibit BPSD and cause minimal adverse effects (AEs), yet limited research has been considered with this population. The study aimed to determine a tolerable CBM dose (3:2 delta-9-tetrahydrocannabinol:cannabidiol), and assessed its effect on BPSD, quality of life (QoL) and perceived pain. METHODS: An 18-week randomised, double-blinded, crossover trial was conducted. Four surveys, collected on seven occasions, were used to measure changes in BPSD, QoL and pain. Qualitative data helped to understand attitudes towards CBM. General linear mixed models were used in the analysis, and the qualitative data were synthesised. RESULTS: Twenty-one participants (77% female participants, mean age 85) took part in the trial. No significant differences were seen between the placebo and CBM for behaviour, QOL or pain, except a decrease in agitation at the end of treatment in favour of CBM. The qualitative findings suggested improved relaxation and sleep among some individuals. Post hoc estimates on the data collected suggested that 50 cases would draw stronger conclusions on the Neuropsychiatric Inventory. CONCLUSIONS: The study design was robust, rigorous and informed by RACF. The medication appeared safe, with minimal AEs experienced with CBM. Further studies incorporating larger samples when considering CBM would allow researchers to investigate the sensitivity of detecting BPSD changes within the complexity of the disease and concomitant with medications.

Life in a time of COVID: retrospective examination of the association between physical activity and mental well-being in western Australians during and after lockdown.

BACKGROUND: The aim of this study was to examine physical activity and sedentary behaviours during Western Australia's COVID-19 lockdown and their association with mental well-being. METHODS: Participants completed activity related questions approximately two months after a three-month lockdown (which formed part of a larger cross-sectional study from August to October 2020) as part of a 25-minute questionnaire adapted from the Western Australia Health and Well-being Surveillance system. Open-ended questions explored key issues relating to physical activity behaviours. RESULTS: During the lockdown period, 463 participants (female, n = 347; 75.3%) reported lower number of active days (W = 4.47 p < .001), higher non-work-related screen hours per week (W = 11.8 p < .001), and higher levels of sitting time (χ2=28.4 p < .001). Post lockdown body mass index was higher (U = 3.0 p = .003), with obese individuals reporting the highest non-work-related screen hours per week (Wald χ2= 8.9 p = .012). Inverse associations were found for mental well-being where higher lockdown scores of Kessler-10 (p = .011), Dass-21 anxiety (p = .027) and Dass-21 depression (p = .011) were associated with lower physical activity levels. A key qualitative message from participants was wanting to know how to stay healthy during lockdown. CONCLUSIONS: Lockdown was associated with lower physical activity, higher non-work-related screen time and more sitting time compared to post lockdown which also reported higher body mass index. Lower levels of mental well-being were associated with lower physical activity levels during lockdown. Given the known positive affect of physical activity on mental well-being and obesity, and the detrimental associations shown in this study, a key public health message should be considered in an attempt to maintain healthy activity behaviours in future lockdowns and similar emergency situations to promote and maintain positive well-being. Furthermore, consideration should be given to the isolation of a community due to infectious disease outbreaks and to recognise the important role physical activity plays in maintaining weight and supporting good mental health.

Encouraging Adults Aged 65 and over to Participate in Resistance Training by Linking Them with a Peer: A Pilot Study.

Resistance training (RT) is beneficial for older adults, particularly to support living independently in their home. However, fewer than 25% of older adults in Australia participate in the recommended, twice-weekly sessions. Reasons older adults do not participate in RT include not having anyone to go with or not knowing what to do. Our study linked older adults with a peer (i.e., older person already participating in RT) to help them overcome these barriers. The aim of our study was to determine whether peer support was suitable for older adults participating in RT for the first time in the home or gymnasium setting. Each group (home vs. gymnasium) received a 6 week, twice-weekly program. Twenty-one participants completed the 6 week intervention: 14 in the home group and seven in the gymnasium group. The home group completed significantly more sessions per week (2.7 vs. 1.8) than the gymnasium group. Although both groups significantly improved on many physical assessments, no between-group differences were found. However, it is suitable to link a peer for support with novice older people participating in a RT program for the first time in the home or gymnasium. It is recommended that future studies explore whether peer support improves sustainability.

Employing cognitive interviewing to evaluate, improve and validate items for measuring the health-related quality of life of women diagnosed with ovarian cancer.

BACKGROUND: Use of patient-reported outcome measures in clinical settings facilitate the delivery of better health care to improve patient health outcomes. Previously collected qualitative data indicated themes that could inform items for a health-related quality of life measure. This study investigated the content validity of items for inclusion in a new health-related quality of life measure suitable for patients with ovarian cancer. METHODS: Cognitive interviewing techniques were used with fourteen women diagnosed with ovarian cancer and at different times since diagnosis, to evaluate items derived from the previously collected qualitative dataset. A set of draft items was administered via telephone, Zoom and WhatsApp app together with questions on item meaning and wording. Interviews were transcribed and thematically analysed. RESULTS: Four broad themes emerged in relation to the questionnaire construction and comprehension of items: intent and clarity, wording, relevance and context, and overall questionnaire construct. All draft items were adjusted based on the interview findings. A final set of 38 health-related quality of life items comprised 7 items describing physical health and functioning, 21 describing emotional wellbeing and 10 items describing social wellbeing; each rated on a five-point frequency response scale. CONCLUSION: The items reflected a range of personal experiences associated with the patient clinical journey, creating a health-related quality of life tool specific to women diagnosed with ovarian cancer. The cognitive interviewing process established content validity for the tool, thereby, preparing it for field testing and evaluation of its psychometric properties. This study highlighted the fundamental role of cognitive interviewing during health-related quality of life questionnaire development to ensure that item content is grounded in patient feelings, functioning and meaning.

Older women's perceptions of the impact of homelessness on their health needs and their ability to access healthcare.

OBJECTIVE: This study explored the healthcare needs and barriers to health services in older homeless women in the Perth metropolitan area, Western Australia. METHODS: Twenty-two older women experiencing homelessness completed a questionnaire and semi-structured interview. Data were analysed using descriptive statistics and thematic analysis. RESULTS: The study highlighted that these women had complex and inter-related issues that affected their health. The nine major themes that emerged from the interview data consisted of: safe accommodation; financial insecurity; experience of trauma and abuse; stigma, embarrassment and fear of being judged; the health impact of not fulfilling their role as family nurturer; mental health; complex interaction of physical and mental health issues; healthcare costs; and the need for ongoing psychosocial and healthcare support once housed. CONCLUSION: Provision of safe and secure accommodation is pivotal to women's health, as is the need for greater understanding of the impact of poverty, women's traditional roles, social disconnection and domestic violence, and ongoing access to healthcare and support services. Implications for public health: A structural and systemic approach based on a social determinants of health framework is required to address the health needs of the increasing numbers of older women becoming homeless in this country.

Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer.

BACKGROUND: Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies. PRIMARY OBJECTIVES: To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment. STUDY HYPOTHESIS: We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective. TRIAL DESIGN: Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy. PRIMARY ENDPOINTS: Emotional wellbeing at 12 months. SAMPLE SIZE: 150 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: July 2023. Results expected in 2025, 24 months after the last participant is enrolled. TRIAL REGISTRATION: ACTRN12620000332921.

Prescribing tailored home exercise program to older adults in the community using a tailored self-modeled video: A pre-post study.

Background: Community rehabilitation for older people after hospital discharge is necessary to regain functional ability and independence. However, poor adherence to exercise programs continues to hinder achieving positive health outcomes in older people. This study aimed to evaluate the effectiveness of prescribing a tailored video self-modeled DVD-HEP for 6 weeks, on functional mobility, physical activity, exercise self-efficacy, and health-related quality of life, in a sample of frail older adults. Materials and methods: A pre- and post-test intervention study design was conducted, with each participant acting as their own control. A convergent, parallel, mixed-methods approach involving quantitative, and qualitative data collection was used. Participants received an individualized assessment at baseline and subsequently were provided with a 30-min tailored 6-week self-modeled DVD-HEP that showed the physiotherapist instructing the participant. The physiotherapist phoned participants fortnightly to encourage engagement in the program and explore responses to it. Outcomes evaluated included functional mobility, balance, gait speed, and exercise self-efficacy. Results: Participants (n = 15) showed clinically meaningful improvements at follow-up compared to baseline in functional mobility (TUGMCID = 3.4-3.5 s, 3-MWTMCID = 0.1-0.2 m/s) and gait speed (3-MWTMCID = 0.1-0.2 m/s). There were also significant improvements in balance and self-efficacy for exercise and a 2.5- and a 1.3-fold increase in moderate and light physical activity participation at follow-up compared to baseline. The deductive themes were: (i) Enjoyment, self-efficacy, and wellbeing; (ii) Achieving life goals; (iii) Background music as a motivator to adherence; and (iv) Enhanced motor performance and learning: Task goal mastery, multimodal feedback, autonomy to self-regulate learning. The new inductive theme was (v) Preference for in-person support for exercise. Conclusion: Future studies are warranted to compare a tailored self-modeled video HEP to face-to-face programs and other digital health modalities to evaluate older adults' adherence levels and functional improvement.

Life in a time of COVID: a mixed method study of the changes in lifestyle, mental and psychosocial health during and after lockdown in Western Australians.

BACKGROUND: Since the beginning of the COVID-19 pandemic, the Western Australian government imposed multiple restrictions that impacted daily life activities and the social life. The aim of this study was to examine the effects of COVID-19 lockdown on the community's physical, mental and psychosocial health. METHODS: Approximately 2 months after a three-month lockdown, a cross-sectional study was opened to Western Australian adults for an 8-week period (25th August - 21 October 2020). Participants competed a 25-min questionnaire adapted from the Western Australia Health and Wellbeing Surveillance system. Participants provided information on their socio-demographic status, lifestyle behaviours, mental health, and psychosocial health during and post-lockdown. Open-ended questions explored key issues in greater detail. Changes between the lockdown and post-lockdown period were assessed using Wilcoxon signed rank test and One-Sample Kolmogorov-Smirnov Normal tests as appropriate. Sex differences were examined using the Mann-Whitney U test. A content analysis approach examined responses to the open-ended questions with frequencies and variations in responses determined using Chi-Square tests. RESULTS: A total of 547 complete responses were obtained. Compared to post-lockdown period, lockdown was associated with a significantly lower levels of physical activity, poorer mental well-being and sense of control over one's life, and a higher level of loneliness. Similarly, during lockdown, there was a significantly higher consumption of junk food, soft drinks and alcoholic drinks but no change in fruit and vegetable intake. Participants recalled health campaigns on hand washing and social distancing and there was a retrospective view that more timely and informative campaigns on physical activity, nutrition and mental well-being should have been available during lockdown. CONCLUSIONS: While advice on infection control measures were appropriately provided, there is a need for concurrent health promotional information to help combat the changes in physical, mental and psychosocial well-being observed during quarantine to prevent negative health consequences in the community even if there are minimal effects of the pandemic itself.

Characteristics of quality activities in a tertiary teaching hospital in Western Australia.

BACKGROUND: Despite all the resourcefulness and efforts in the last 30 years for quality in healthcare, safety and quality considerations are recognized with up to 17% of total hospital activity and expenditure related to adverse events. A knowledge gap is identified in the literature that few studies have reported from a whole hospital perspective on what and how quality activities are being performed, particularly in the Australian context. OBJECTIVE: This study aims to describe the characteristics of quality activities in a tertiary quaternary hospital in Western Australia. METHODS: Data from the study hospital's electronic quality management system Governance, Evidence, Knowledge and Outcome between 1 January 2015 and 31 December 2019 was analysed by using descriptive and thematic methods. RESULTS: Quality assurance (QA) accounted for 68.3% of all quality activities in the study hospital. Principal investigators of activities were mostly in clinical roles and relatively senior in their profession. Collaboration within the same profession and same team was common, but much less so across departments. The median quality cycle length measured by proposal submission to completion was 202 days, but 190 days when measured by proposal approval to completion. A majority (93.2%) of quality activities were undertaken as part of everyday business. Common issues outlined in activity reports were documentation and compliance 44.8% (n = 100), data and tool limitations 10.8% (n = 24), variation in care 9.9% (n = 22), process 9.4% (n = 21), and knowledge and awareness 9.0% (n = 20). Common recommendations to address the issues were communicating findings to relevant teams and governance committees 26.8% (n = 104), further data collection including re-audit 26.0% (n = 101), education and training 20.4% (n = 79), process review and/or development 13.9% (n = 54), and policy/guidelines review and/or development 4.4% (n = 17). CONCLUSION: Understanding the characteristics of quality activities from a whole hospital perspective provides insights and informs discussions relating to the efficiency and effectiveness of quality activities in hospitals. Embedding quality activities into everyday business is achievable for hospitals but considerations need to occur on how to sustain staff motivation and enthusiasm by helping individuals and teams reach the ultimate goals for improvement and keeping performance monitoring as close to the real time of care as possible. There is a need to transform QA into quality improvement, with the 90-day cycle being a feasible target for QA in hospitals.

Injuries in mothers hospitalised for domestic violence-related assault: a whole-population linked data study.

OBJECTIVE: To retrospectively assess a cohort of mothers for characteristics of injuries that they have suffered as a result of family and domestic violence (FDV) and which have required admission to a hospital during both the intrapartum and postpartum periods. DESIGN AND SETTING: Retrospective, whole-population linked data study of FDV in Western Australia using the Western Australia birth registry from 1990 to 2009 and Hospital Morbidity Data System records from 1970 to 2013. MAIN OUTCOME MEASURES: Number of hospitalisations, and mode, location and type of injuries recorded, with particular focus on the head and neck area. RESULTS: There were 11 546 hospitalisations for mothers due to FDV. 8193 hospitalisations recorded an injury code to the head and/or neck region. The upper and middle thirds of the face and scalp were areas most likely to receive superficial injuries (58.7% or 4158 admissions), followed by the mouth and oral cavity (9.7% or 687 admissions). Fracture to the mandible accounted for 479 (4.2%) admissions and was almost equal to the sum of the next three most common facial fractures (nasal, maxillary and orbital floor). Mothers more likely to be hospitalised due to a head injury from FDV included those with more than one child (OR=1.17, 95% CI 1.03 to 1.30) and those with infants (<1 year old) (OR=1.40, 95% CI 1.04 to 1.90) and young children (<7 years old) (OR=1.15, 95% CI 1.01 to 1.30). CONCLUSIONS: FDV is a serious and ongoing problem and front-line clinicians are in need of evidence-based guidelines to recognise and assist victims of FDV. Mothers with children in their care are a particularly vulnerable group.

Change in ejection fraction and long-term mortality in adults referred for echocardiography.

AIMS: We investigated long-term mortality associated with changes in left ventricular ejection fraction (LVEF) in a large, real-world patient cohort. METHODS AND RESULTS: A total of 117 275 adults (63 ± 16 years, 46% women) had LVEF quantified by the same method ≥6 months apart. This included 17 343 cases (66 ± 15 years, 48% women) being initially investigated for heart failure (HF). During 3.3 [interquartile range (IQR) 1.7-6.0] years from first to last echocardiogram, median change in LVEF was -1 (IQR -8 to +5) units from a baseline of 62% (IQR 54-69%). During subsequent 7.6 (IQR 4.3-10.1) years of follow-up, 11 397 (9.7%) and 34 101 (29.1%) cases died from cardiovascular disease and all causes, respectively. Actual 5-year, all-cause mortality increased from 12% to 29% among those with the smallest to the largest decrease in LVEF (from <5 units to >30 units); the adjusted risk of cardiovascular-related mortality increased two- to eightfold beyond a >10-unit decline in LVEF (vs. minimal change; P < 0.001 for all comparisons). Among those initially investigated for HF (32% with initial LVEF <50%), the adjusted hazard ratio for cardiovascular-related mortality ranged from 0.35 [95% confidence interval (CI) 0.28-0.49] to 4.21 (95% CI 3.30-5.22) for a >30-unit increase to >30-unit decline in LVEF (vs. minimal change; P < 0.001 for both comparisons). A distinctive, bi-directional plateau of improved vs. worsening mortality was evident around a final LVEF of 50% to 55%. CONCLUSIONS: These data, derived from a large, heterogeneous cohort of adults being followed up with echocardiography, suggest that modest LVEF changes (particularly around an LVEF of 50-55%) may be of clinical significance.

Women Diagnosed with Ovarian Cancer: Patient and Carer Experiences and Perspectives.

PURPOSE: By directly engaging with women diagnosed with ovarian cancer, this study aimed to explore and identify their view of the health symptoms and outcomes that matter most to them as they traverse their disease pathway. BACKGROUND: Patient-reported outcome measures in ovarian cancer have tended to focus on physical symptoms rather than the more complex psychosocial aspects of living with the disease. Using a "ground-up approach", this study sought to comprehensively understand the health concerns that matter most to women with ovarian cancer as a first step in generating items for development into an ovarian cancer-specific patient-reported outcome measure. PATIENTS AND METHODS: Following an extensive literature review, we sought to capture the "patient voice" through a qualitative descriptive approach including a community conversation with ovarian cancer patients, their carers and clinicians, and interviews and focus groups with women with ovarian cancer. Thirteen women were interviewed individually, and two focus groups were conducted. A template thematic analysis was used to analyze the data. RESULTS: Key themes included challenges related to clinical diagnosis, treatment phase, altered relationships with family/friends, financial issues, relationships with health professionals and coping strategies. Within each key theme, several sub-themes emerged that were identified as various challenges experienced by participants. Diagnostic delay, chemotherapy and surgery-related challenges, negative impact of sexual well-being on partner relationship, communicational challenges with health professionals were among the few issues identified. In addition, self-empowerment was identified as a coping mechanism among participants. CONCLUSION: By identifying priorities for women diagnosed with ovarian cancer we have highlighted the need for strategies to reduce diagnostic delays and improve quality of life for these women. Data will inform the development of an ovarian cancer-specific patient-reported outcome measure.

Ejection fraction and mortality: a nationwide register-based cohort study of 499 153 women and men.

AIMS: We investigated the sex-based risk of mortality across the spectrum of left ventricular ejection fraction (LVEF) in a large cohort of patients in Australia. METHODS AND RESULTS: Quantified levels of LVEF from 237 046 women (48.1%) and 256 109 men undergoing first-time, routine echocardiography (2000-2019) were linked to 119 232 deaths (median 5.6 years of follow-up). Overall, 17.6% of men vs. 8.3% of women had an LVEF <50%. An LVEF <40% was associated with the highest crude cardiovascular-related and all-cause mortality at 5 years (∼20-30% and ∼ 40-50%, respectively). Thereafter, actual cardiovascular-related and all-cause mortality at 5 years in both sexes steeply improved to a nadir LVEF of 65.0-69.9% (reference group). Below this LVEF level, the adjusted hazard ratio (HR) for cardiovascular-related mortality for a LVEF of 55.0-59.9% was 1.36 [95% confidence interval (CI) 1.16-1.59; P < 0.001] in women and 1.21 (95% CI 1.05-1.39; P = 0.008) in men. In women, an LVEF of 60.0-64.9% was also associated with a HR 1.33 (95% CI 1.16-1.52; P < 0.001) for cardiovascular-related mortality. These associations were most striking in women and men aged <65 years and were replicated in those with suspected heart failure (32 403 cases aged 65.2 ± 16.1 years, 57.0% women). For pre-existing heart failure (33 738 cases aged 67.6 ± 16.9 years, 46.5% women), the specific threshold of increased mortality was at and below 50.0-54.9%. CONCLUSIONS: Among patients investigated for suspected or established cardiovascular disease, we found clinically relevant sex-based differences in the distribution and mortality associated with an LVEF <65.0-69.9%. Specifically, they suggest a greater risk of mortality at higher LVEF levels among women.

Excisional treatment comparison for in situ endocervical adenocarcinoma (EXCISE): A phase 2 pilot randomized controlled trial to compare histopathological margin status, specimen size and fragmentation after loop electrosurgical excision procedure and cold knife cone biopsy.

OBJECTIVE: Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC). METHODS: The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and fragmentation. Analysis was by intention-to-treat. RESULTS: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. Margin status was evaluable in 36 cases. The proportion of patients with involved margins did not differ between groups. 25 of 26 LEEP and all 14 CKC biopsies were excised as single specimens (p = 1·00). There were no differences in specimen dimensions. Patients in the CKC group had more post-operative complications (64.3% compared to 15.4% for LEEP p = ·00). There were no differences in grade three complications (p = ·65). CONCLUSIONS: LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol. However, the study was not powered to establish non-inferiority of LEEP and a definitive phase 3 trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted.

Poor Survival with Impaired Valvular Hemodynamics After Aortic Valve Replacement: The National Echo Database Australia Study.

BACKGROUND: There are limited data to describe the relationship between the transvalvular gradient and mortality among patients who undergo aortic valve replacement. METHODS: Using the National Echo Database Australia, valvular hemodynamics were characterized in 3,943 men (mean age, 62 ± 18 years) and 2,107 women (mean age, 62 ± 19 years) who underwent aortic valve replacement (median follow-up duration, 770 days; interquartile range, 381-1,584 days). The degree of impaired valvular hemodynamics (IVH) was categorized as mild (mean gradient 10.0-19.9 mm Hg, peak velocity 2.0-2.9 m/sec), moderate (mean gradient 20.0-39.9 mm Hg, peak velocity 3.0-3.9 m/sec), or severe (mean gradient ≥ 40.0 mm Hg, peak velocity ≥ 4 m/sec or effective orifice area < 0.8 cm2). RESULTS: Overall, 2,175 (36.0%), 2,598 (42.9%), 698 (11.5%), and 579 (9.6%) patients had no, mild, moderate, and severe IVH, respectively. Those with residual moderate or severe IVH had 5-year mortality of 45.5% and 57.3%, respectively, and higher adjusted long-term all-cause mortality (adjusted hazard ratios, 1.44 and 2.02; P < .001) compared with "no IVH." Patients with mild IVH had similar mortality rates to those without IVH. A mortality threshold was evident above a mean transvalvular gradient >22.5 mm Hg after adjusting for age, sex, stroke volume index, aortic regurgitation, and effective orifice area. CONCLUSIONS: After aortic valve replacement, most patients displayed an acceptable aortic valve hemodynamic profile. Moderate to severe IVH, however, was associated with poor long-term survival, with a threshold for increased mortality similar to that of native valvular aortic stenosis evident.

Do Peers Increase Older Adults' Participation in Strength Training? Pilot Randomized Trial.

Fewer than 20% of older adults participate in strength training (ST). Barriers to ST participation include not knowing where to go or not having someone to go with. To address these barriers, the authors provided older adults with a peer (older person already participating in ST) to support their engagement. The aim of this pilot randomized controlled trial was to determine whether older adults who were provided with a peer when participating in ST were more likely to be participating in ST 4 weeks postintervention, compared with those receiving ST alone. Fifty-one ST participants were recruited; 40 completed the intervention and postintervention data collection (78.4%). Providing peer support with ST did not significantly increase ST participation (p = .775). However, both groups made significant improvements over time in lower-limb strength and mobility. Participants in either group who continued the ST program (55%) had made additional significant improvements in lower-limb strength and mobility.

Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial.

BACKGROUND: Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65 years and above. More effective ways to manage dementia symptoms are needed because current treatment options (antidepressants and antipsychotics) can be ineffective and are associated with substantial side effects, including increased rate of mortality. Cannabinoid-based medicine (CBM) has shown an ability to inhibit some symptoms associated with dementia, and the adverse effects are often minimal; yet, little research has explored the use of CBM among this population. AIM: To monitor the safety of a purified dose of CBM oil (3:2 delta-9-tetrahydrocannabinol:cannabidiol) on behaviour symptoms, quality of life and discomfort caused by pain. METHODS/DESIGN: We will carry out an 18-week, randomised, double-blind crossover trial that consists of a 2-week eligibility period, two 6-week treatment cycles, and two 2-week washout periods (between both cycles and after the second treatment cycle). We aim to recruit 50 participants with dementia who are living in residential aged-care facilities. The participants will be randomised into two groups and will receive a dose of either CBM oil or placebo for the first treatment cycle and the opposite medication for the second. Data will be collected using the Neuropsychiatric Inventory Questionnaire, the Cohen-Mansfield Agitation Inventory, the Quality of Life in Alzheimer's Disease questionnaire, and the Abbey Pain Scale on seven occasions. These will be completed by the participants, aged-care staff, and nominated next of kin or family members. The participants' heart rate and blood pressure will be monitored weekly, and their body composition and weight will be monitored fortnightly by a research nurse, to assess individual dose response and frailty. In addition, pre- and post-surveys will be administered to aged-care staff and family members to understand their perceptions of CBM and to inform proposed focus groups consisting of the aged-care staff and next of kin. DISCUSSION: The study design has been informed by medical professionals and key stakeholders, including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619000474156. Registered on 21 March 2019.