Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): Rationale and protocol

Introduction Cachexia is common in malignant mesothelioma (MM); half of patients have malnutrition and low skeletal muscle mass. Malnourished patients have worse quality of life (QoL). Weight loss is strongly associated with poor survival. Anamorelin is an oral ghrelin receptor agonist that improves appetite, body weight and QoL in advanced cancer. The aim of this study is to examine the efficacy of anamorelin in improving appendicular skeletal muscle mass (ASM) and patient-reported outcomes in patients with MM with cachexia. Methods and analysis A single-centre, phase II, randomised, placebo-controlled cross-over pilot study with 28-day treatment periods and 3-day washout. Forty patients will be randomised. Primary outcome is change in ASM relative to height measured by dual energy X-ray absorptiometry at end of period 1. Secondary outcomes include cancer-specific and cachexia-related QoL, objective physical activity, dietary intake and adverse events. Eligible patients will have confirmed MM, Eastern Cooperative Oncology Group 0-2, expected survival \u3e 3 months and cachexia (defined as \u3e 5% weight loss in 6 months or body mass index \u3c 20 kg/m 2 with weight loss \u3e2%). Ethics and dissemination Ethical approval has been granted. Results will be reported in peer-reviewed publications. Trial registration number Australian New Zealand Clinical Trials Registry (U1111-1240-6828). © © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ

Proactive primary care of carers of people with cognitive impairment: A feasibility study

Background: Over 250 000 Australians live with dementia, and it is estimated that this number will more than double by 2030. Many people with dementia or cognitive impairment are cared for at home by family carers who may themselves be frail older adults or who may suffer from chronic conditions. There is evidence that caring has adverse impacts on carers; however, many do not seek or delay seeking appropriate health care. Aim: To explore the feasibility of a protocol to identify the unmet healthcare needs of carers of people with cognitive impairment. Method: This feasibility study used a mixed methods approach. Data were collected through a set of three wellbeing questionnaires, and interviews with carers and one general practitioner. Carers were recruited through government-funded adult day care centres in Perth, Western Australia. General practitioners were nominated by the carers. The sample included 15 carers and one general practitioner. Results: Carer participants in this study experienced varying degrees of care burden. Insomnia, fatigue and pain were the most prominent symptoms. Their overall health status was lower than that of the general population, with physical functioning and bodily pain obtaining the lowest scores. Carers found the protocol useful and the questionnaires easy to complete; they reported specific outcomes resulting from the implementation of the protocol aimed at addressing their healthcare needs. Conclusion: The study results demonstrate the feasibility of adopting a protocol to identify and address carers’ unmet healthcare issues, and warrant further research. In the context of an ageing population, the growing number of carers of people with cognitive impairment and dementia need to receive adequate support to enable them to continue to provide care

An antithrombin replacement strategy during asparaginase therapy for acute lymphoblastic leukemia is associated with a reduction in thrombotic events

Thrombosis is a well-recognized complication of asparaginase therapy for acute lymphoblastic leukemia (ALL), associated with the depletion of antithrombin (AT). Following a high incidence of thrombotic episodes during induction therapy for ALL in our tertiary referral center, we prospectively instituted a protocol of AT replacement. Forty-five consecutive adolescents and adults with ALL treated with asparaginase-containing phase I induction protocols were included in this observational study. Fifteen received standard therapy with no replacement; the subsequent 30 were managed with the protocol described. One or more low AT levels (<70 iu/dl) were recorded in 76% of patients in the cohort managed using the protocol, resulting them in receiving an AT replacement. There was a significant reduction in the incidence of thrombosis with this strategy (0/30 vs. 5/15, p < 0.001). We suggest that such a strategy should be studied in a prospective randomized sub-study within the context of a national ALL trial

An antithrombin replacement strategy during asparaginase therapy for acute lymphoblastic leukemia is associated with a reduction in thrombotic events

Thrombosis is a well-recognized complication of asparaginase therapy for acute lymphoblastic leukemia (ALL), associated with the depletion of antithrombin (AT). Following a high incidence of thrombotic episodes during induction therapy for ALL in our tertiary referral center, we prospectively instituted a protocol of AT replacement. Forty-five consecutive adolescents and adults with ALL treated with asparaginase-containing phase I induction protocols were included in this observational study. Fifteen received standard therapy with no replacement; the subsequent 30 were managed with the protocol described. One or more low AT levels (<70 iu/dl) were recorded in 76% of patients in the cohort managed using the protocol, resulting them in receiving an AT replacement. There was a significant reduction in the incidence of thrombosis with this strategy (0/30 vs. 5/15, p < 0.001). We suggest that such a strategy should be studied in a prospective randomized sub-study within the context of a national ALL trial

Characterising Australian memory clinics: current practice and service needs informing national service guidelines

Abstract Background Memory clinics (MCs) play a key role in accurate and timely diagnoses and treatment of dementia and mild cognitive impairment. However, within Australia, there are little data available on current practices in MCs, which hinder international comparisons for best practice, harmonisation efforts and national coordination. Here, we aimed to characterise current service profiles of Australian MCs. Methods The ‘Australian Dementia Network Survey of Expert Opinion on Best Practice and the Current Clinical Landscape’ was conducted between August-September 2020 as part of a larger-scale Delphi process deployed to develop national MC guidelines. In this study, we report on the subset of questions pertaining to current practice including wait-times and post-diagnostic care. Results Responses were received from 100 health professionals representing 60 separate clinics (45 public, 11 private, and 4 university/research clinics). The majority of participants were from clinics in metropolitan areas (79%) and in general were from high socioeconomic areas. While wait-times varied, only 28.3% of clinics were able to offer an appointment within 1-2 weeks for urgent referrals, with significantly more private clinics (58.3%) compared to public clinics (19.5%) being able to do so. Wait-times were less than 8 weeks for 34.5% of non-urgent referrals. Only 20.0 and 30.9% of clinics provided cognitive interventions or post-diagnostic support respectively, with 7.3% offering home-based reablement programs, and only 12.7% offering access to group-based education. Metropolitan clinics utilised neuropsychological assessments for a broader range of cases and were more likely to offer clinical trials and access to research opportunities. Conclusions In comparison to similar countries with comprehensive government-funded public healthcare systems (i.e., United Kingdom, Ireland and Canada), wait-times for Australian MCs are long, and post-diagnostic support or evidence-based strategies targeting cognition are not common practice. The timely and important results of this study highlight a need for Australian MCs to adopt a more holistic service of multidisciplinary assessment and post-diagnostic support, as well as the need for the number of Australian MCs to be increased to match the rising number of dementia cases

A cross-sectional examination of the prevalence of psychotropic medications for people living with dementia in Australian long-term care facilities: issues of concern

Background: Behavioral and psychological symptoms of dementia (BPSD) are a common problem in long-term care facilities (LTC). Clinical guidelines dictate that first-line treatments for BPSD are psychosocial and behavioral interventions; if these are unsuccessful, psychotropic medications may be trialed at low doses and their effects can be monitored.Methods: There have previously been no studies with nationally representative samples to investigate psychotropic administration in LTCs in Australia. This study determines the prevalence of psychotropic administration in a representative stratified random sample of 446 residents living with dementia from 53 Australian LTCs. Questionnaire and medical chart data in this study is drawn from a larger cross-sectional, mixed methods study on quality of life in Australian LTCs.Results: It was found that 257 (58%) residents were prescribed psychotropic medications including: antipsychotics (n = 160, 36%), benzodiazepines (n = 136, 31%), antidepressants (n = 117, 26%), and anti-dementia medications (n = 9, 2%). BPSD were found to be very common in the sample, with 82% (n = 364) of participants experiencing at least one BPSD. The most prevalent BPSD were depression (n = 286, 70%) and agitation (n = 299, 67%).Conclusions: Although detailed background information was not collected on individual cases, the prevalence found is indicative of systematic industry-wide, over-prescription of psychotropic medications as a first-line treatment for BPSD. This study highlights a clear need for further research and interventions in this area