Music-based training programmes, such as learning how to play an instrument or sing in a choir, have been suggested as potential interventions for promoting healthy brain ageing in older adults at risk of cognitive decline because of their ability to enhance cognitive functions and potentially promote neuroplasticity. However, there is limited empirical evidence in older adults at risk of dementia, especially that evaluates both piano and singing interventions and their effects on cognition and neuroplasticity. In this protocol, we outline a study to assess the efficacy of keyboard and singing music training programmes on reducing cognitive decline and other outcomes in older adults with Mild Cognitive Impairment (MCI).
This randomised, single-blind, controlled, parallel-group trial aims to enrol 432 individuals with MCI from the community in Sydney, Australia. Participants are randomly allocated to participate in either keyboard lessons, singing lessons or a film discussion control group once a week for 3 months. The primary objective is to assess the effectiveness of two music training programmes (keyboard and choral singing) for enhancing verbal memory after 3 months compared with control. Additionally, we will examine how these music-based interventions affect other aspects of cognition, mood, sleep, overall well-being, markers of brain plasticity and blood biomarkers of Alzheimer’s disease and neurodegeneration. Tertiary objectives are to identify factors that impact the success of the interventions, such as participation rates, engagement levels and key demographic and clinical features. Outcomes are collected at baseline and at 3 and 9 months. The primary endpoint analysis will include all randomised participants to estimate the treatment effect using intention-to-treat principles. Primary and secondary outcomes will be analysed using linear mixed models and effect size measures will be calculated.
This study will be the first robust, randomised controlled trial to assess the potential and relative value of music engagement for cognitive decline in high-risk MCI individuals, as well as broader effects on other markers of mental health, well-being and neurodegeneration. Co-designed with implementation in mind, the music interventions can potentially be delivered within memory clinic or community settings.
The Sydney University Human Research Ethics Committee (2023-026) has approved this protocol. The trial findings will be shared through conferences, publications and media.
Australian and New Zealand Clinical Trials Registry (ACTRN12623000407695), Registered 21/04/2023 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385552
2.02 29/11/2024.
The HOPSCOTCH study ‘Helping Optimise Primary Care Support During Transition From Children’s Hospice Care’ aims to develop a toolbox to enable engagement of primary care services in the care of young people with life-limiting conditions (LLC) with a specific focus on the point of transition from children’s hospice services.
Individual interviews will be held with young people with LLC, their families and healthcare professionals (HCPs). In alignment with Experience Based Co-Design (EBCD) methodology, extracts of film and audio from young people and family interviews will be combined to professionally produce a ‘catalyst film’ highlighting key points and experiences before, during and after the transition from children’s hospice care. Role-specific workshops will be held with young people with LLC, their families and HCPs working in primary care, children’s hospices and adult hospice services. The catalyst film will be used in feedback workshops to prompt prioritisation of key issues to take forward into toolbox development in a shared young people, family and HCP workshop. A documentary analysis of resources currently used to support transition and communication between care settings will support contextual understanding of the transition process. Young people, parents and professionals have shaped and continue to have influence over the study delivery as advisors alongside a multidisciplinary steering committee.
The study design has been guided by the UK Medical Research Council complex intervention framework. Intervention development draws on the principles of EBCD and is theoretically driven by the Behaviour Change Wheel.
The study is registered with the UK’s Clinical Study Registry (ISCTRN75964234).
Ethical approval was obtained from Wales 3 ethics board on 2 July 2025 (IRAS ID 334486). This study will include ongoing dissemination and knowledge transfer to key audiences (young people, parents, service providers, commissioners) via publications, national bodies, knowledge exchange events, web-based platforms, social media and clinical/academic forums.
To determine the use, frequency and factors linked to the use of any electronic point of care resources (ePOC resources) used by early-career general practitioners (GPs in training, otherwise known as GP residents or registrars) during consultations; and the frequency, and factors linked to the use of evidence-based clinical summaries.
Cross-sectional analysis of data collected as part of the Registrar Clinical Encounters in Training (ReCEnT) project from 2018 to 2022. Every 6 months, GP trainees record 60 consecutive consultations, including information about their use of resources.
Australian training general practices.
3024 GP trainees in community-based vocational training.
The primary outcome was the use of ePOC resources, and the secondary outcome was the use of evidence-based ePOC summaries.
A total of 3024 GP trainees accessed electronic resources during patient encounters for 67 651/628 855 (10.8%) of diagnoses/problems. Use of ePOC resources increased 4% per year over the study period. Therapeutic Guidelines was accessed most often (27 435/79 536, 34.7% of all ePOC use) followed by Australian Medicines Handbook (7507, 9.4%) and HealthPathways (6965, 8.7%). Various factors were associated with increased use of ePOC resources, including increasing patient age, diagnosis/problem type, increasing years of experience prior to GP training and stage of training. GP trainees rarely accessed dedicated evidence-based clinical summaries.
Australian GP trainees use a range of resources to answer their clinical questions, mostly from Therapeutic Guidelines and prescribing compendiums, but also system specific resources that are free to access.
To estimate condition-specific patient travel distances and associated carbon emissions across common chronic diseases in routine National Health Service (NHS) care, and to assess the potential carbon savings of modal shifts in transportation.
Retrospective population-based cohort study.
NHS Greater Glasgow and Clyde, Scotland.
6599 patients aged 50–55 years at diagnosis, including cardiovascular disease (n=1711), epilepsy (n=1044), cancer (n=716), rheumatoid arthritis (RA; n=172) and a matched control group based on age, sex and area-level deprivation (n=2956).
Annual home-to-clinic distances and associated carbon emissions modelled under four transport modes (petrol car, electric car, bus, train) across five time points: 2-year prediagnosis, diagnosis year and 2-year postdiagnosis.
Mean annual travel distances to hospital varied by condition and peaked at diagnosis. Patients with cancer had the highest travel distances (161 km/patient/year for men; 139 km/patient/year for women), followed by RA (approximately 78 km/patient/year). The matched control group travelled 2/patient/year to 8.0 kg CO2/patient/year. Bus travel resulted in intermediate emissions, estimated between 10.5 and 8.0 kg CO2/patient. When travel was modelled using electric vehicles, emissions dropped between 3.5 and 2.7 kg for all conditions. Train travel produced similarly low emissions. Reducing petrol car travel from 100% to 60% lowered emissions up to 6.6 kg CO2/patient.
Condition-specific estimates of healthcare-related travel emissions provide baseline understanding of the opportunities and challenges for decarbonising healthcare. Emission reduction is most achievable through modal shift, yet such shifts depend on factors beyond NHS control—such as transport infrastructure, digital access and social equity. Multisectoral strategies, including targeted telemedicine and integrated transport and urban planning, are critical to achieving net-zero healthcare while maintaining equitable access to care.
The WHO Surgical Safety Checklist (SSC) can improve patient outcomes through checks and enhancing the safety climate, provided the team engage. Patients are central to that team and may be awake during part or all of many procedures. Their greater inclusion in the SSC process could enhance its checking objectives by using patient knowledge of details relevant to proposed procedures, and its objective of improving culture by emphasising patient identity, seeing patients as individuals rather than items on a production line. We aimed to evaluate SSC use, including clinicians’ and patients’ perspectives, in cardiothoracic operating rooms (CTORs) and cardiac catheterisation laboratories (CCLs), and to identify opportunities to refine its use in these spaces.
We undertook a multimethod study based on positivism and interpretivism, with evaluation of SSC administration and interviews. We evaluated SSC administration during 20 Sign Ins, 20 Time Outs and 20 Sign Outs in CTORs and 20 Time Outs in CCLs (11 coronary angiography and 9 electrophysiology cases) using the WHO Behaviourally Anchored Rating Scale (WHOBARS, 1–7, where higher scores indicate better practice). We additionally interviewed 10 clinicians and 17 patients about their experiences and perceptions of safety and SSC use. We undertook thematic analysis of interview data.
CTORs and CCLs in an Auckland public hospital.
We observed 171 clinicians during 20 cases. We interviewed 10 clinicians (Pakeha/New Zealand/European n=6; male n=5; doctor n=5). We interviewed 17 patients (Pakeha/New Zealand/European n=12; male n=10; age range 45–81 years).
In CTORs, the SSC was used in full: median (IQR) WHOBARS score was 5.9 (5.2, 6.5). In CCLs, its use differed between electrophysiology and angiography CCLs: median (IQR) WHOBARS score was 4.50 (3.2, 5.6). In both CTORs and CCLs, high levels of carefulness and respect between team members were observed. Clinicians described the SSC as valuable and identified context-related reasons for variations in its use. Patients wanted to feel cared for and respected (including culturally). The SSC contributed positively to this. Clinicians expressed reservations about increasing patients’ involvement with the SSC. However, patients’ comments supported their increased engagement in the SSC process (including establishing their preferred names).
The SSC is used at Auckland City Hospital with some variation between services and with high levels of carefulness and respect. The SSC increased patients’ sense of being cared for. With modification (eg, by verifying their preferred name during the Sign In phase), the SSC could enhance patients’ perception of being seen as individuals, their cultural safety and the safety climate in operating and procedure rooms, and hence potentially improve patient outcomes. Our findings reinforce the value of regular evaluation and context-relevant modification of SSC for its effective use.
Overweight and obesity impacts approximately 50% of pregnant women. Professional medical colleges worldwide recommend women with a higher body mass index (BMI) lose weight before conception. While diet and lifestyle interventions before pregnancy are associated with improvements in diet and modest weight loss, subsequent clinical pregnancy outcomes are poorly reported.
Our aim is to conduct a randomised controlled trial of a comprehensive lifestyle intervention for women with overweight or obesity who are planning pregnancy. We will evaluate the impact of this intervention on maternal health and well-being prior to conception; and pregnancy, birth and newborn health outcomes in a subsequent pregnancy.
Women with a BMI ≥25.0 kg/m2 who plan to conceive within 2 years will be recruited.
Women randomised to the ‘Educational Control Group’ will attend a pre-conception health consultation with a research midwife, providing limited information about obesity and associated risks in pregnancy, nutrition, exercise and weight management.
Women randomised to the ‘Pre-pregnancy Lifestyle Intervention Group’ will attend a pre-conception health consultation with a research midwife, as above, and additionally consult with a research dietitian and trained health coaches throughout the 6-month intervention period. Women will also have access to a specifically designed mHealth application providing tailored content and interactive tasks delivered bi-weekly during this time.
Secondary outcomes will include a range of maternal pre-conception health outcomes; maternal and infant pregnancy and birth outcomes; diet and physical activity changes; and quality of life.
We estimate a mean birth weight z-score of 0.43 (SD 1.09) and will recruit 800 women to detect 0.4 SD difference (alpha 0.05 (two-tailed); power 80%). Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.
The study protocol was approved by the Human Research and Ethics Committee of the Women’s and Children’s Hospital, Adelaide, South Australia (HREC/17/WCHN/177; 2020/HRE01445) on 17 August 2018. The first participant was recruited in June 2021, with recruitment anticipated through 2025. The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.
ACTRN 12621000128897. This study has been registered at (https://www.anzctr.org.au/).
To examine health and social service use pre- and post-cochlear implant in adults.
A retrospective cohort study.
All public and private hospitals in Australia.
A total of 3033 adults aged ≥18 years who received a cochlear implant in Australia between 1 January 2014 and 31 December 2018 were included. Participants were followed for 3 years pre-implant date and 3 years post-implant date or until death. Data were sourced from the Person Level Integrated Data Asset.
The study examined the (i) number of visits to general practitioners (GPs), specialists and audiologists; (ii) fee charged, benefit paid and out-of-pocket (OOP) expenses for health services; (iii) personal income; (iv) completion of higher education and post-high school vocational education and training and (v) number of government benefits and concession cards received.
The mean age of adults at cochlear implantation was 63.3 years (SD 16.1). Over the 3 years period before and after implantation, the mean number of GP visits remained stable (24.5 pre-implant vs 24.7 post-implant), specialist visits decreased (6.4 pre-implant vs 5.3 post-implant) and audiologist visits increased (1.7 pre-implant vs 6.6 post-implant). Higher GP visit rates were observed both pre- and post-implantation among females (RR 1.13 vs 1.14), older adults (RR 1.06 vs 1.15), individuals needing assistance with daily activities (RR 1.11 vs 1.12), individuals with chronic health conditions (RR 1.25 vs 1.34), with ≥6 RxRisk comorbidities (RR 2.35 vs 2.22) and adults residing in socio-economically disadvantaged areas (RR 1.64 vs 1.19). Mental health conditions were associated with increased specialist visits pre- and post-implantation (RR 2.57 vs 2.53), while employed individuals had higher specialist visit rates post-implantation (RR 1.58). Average OOP costs for health services decreased by 31.4% post-implant. Government benefits were higher pre-implant (55.6%) than post-implant (44.4%). Females and adults needing assistance with activities of daily living were more likely to seek government benefits.
These findings highlight the need for tailored healthcare and social support services to address the diverse needs of cochlear implant users, ensuring comprehensive care and support throughout their healthcare journey.
Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.
The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.
This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.
To assess atrial fibrillation (AF) burden, symptoms and quality of life (QoL) in endurance athletes with paroxysmal AF.
Prospective cohort study.
Otherwise healthy endurance athletes with paroxysmal AF in Norway, Australia and Belgium. The current study presents baseline measurements collected before the intervention of a randomised controlled trial on effects of individually tailored training adaptation.
AF burden (percentage time in AF) was measured by insertable cardiac monitors (Confirm Rx, Abbott). AF-related symptoms and QoL were assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) with any score
43 athletes (age 57±10 (mean±SD), range 33–75 years, 3 women) were included. The athletes were monitored for 50±18 days. Median AF burden was 0.18% (IQR 0%–2.6%). Out of 29 athletes with at least one AF episode, 21 (72%) had AF episodes >60 min. 13 athletes (30%) had AFEQT overall score 60 min were associated with reduced QoL (mean AFEQT score 78 vs 90, p=0.001 and 78 vs 90, p=0.001, respectively). There were large individual variations between the athletes concerning AF burden, symptoms and QoL.
Although most athletes were still competing, more than half had troublesome symptoms. One-third had reduced QoL, which was associated with higher AF burden and longer duration of AF episodes. Variations between the athletes highlight the need for individually tailored AF management in athletes with paroxysmal AF.
Frequency of general practitioners’ (GPs’) antibiotic prescribing for acute, self-limiting respiratory tract infections (aRTIs) is high. The practice environment and culture influence the clinical behaviour, including prescribing behaviour, of GP specialist vocational trainees (registrars). We aimed to assess inter-practice variability in registrars’ antibiotic prescribing.
This was a cross-sectional analysis from the Registrar Clinical Encounters in Training (ReCEnT) cohort study, from 2010 to 2020.
ReCEnT documents registrars’ clinical experiences and behaviours. Before 2016, 5 of 17 Australian training regions participated in ReCEnT. From 2016, three of nine regions (~40% of Australian registrars) participated.
3210 registrars (response rate 91.8%) from 1286 training practices contributed to the analysis.
The outcomes were prescription of an antibiotic for new diagnoses of (1) all aRTIs and (2) acute bronchitis diagnoses specifically. Prescribing percentages were calculated at the training practice level. Intraclass correlation coefficients (ICCs) were used to measure the ratio of interpractice variation to total variance. Median ORs (MORs) were also estimated to quantify interpractice variability.
Practice-level antibiotic prescribing percentages ranged from 0% to 100% for both aRTIs and acute bronchitis diagnoses in the primary analysis. ICCs for aRTI prescribing were 0.08 (unadjusted) and 0.02 (adjusted). For acute bronchitis, ICCs were 0.10 (unadjusted) and 0.05 (adjusted). MORs were 1.66 (unadjusted) and 1.32 (adjusted) for aRTIs. MORs for acute bronchitis were 1.80 (unadjusted) and 1.53 (adjusted). This indicates a marked variation in the odds of a patient receiving antibiotics for an aRTI if randomly attending different practices.
There was considerable interpractice variation in registrars’ antibiotic prescribing frequencies. Further research is required to examine the factors accounting for this variation and to develop practice-level interventions to reduce antibiotic prescribing in high-prescribing practices.
Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).
There is a need for early, non-invasive and inexpensive biomarkers for Alzheimer’s disease (AD), which could serve as a proxy measure in prevention and intervention trials that might eventually be suitable for mass screening. People with Down syndrome (DS) are the largest patient group whose condition is associated with a genetically determined increased risk of AD. The REVEAL study aims to examine changes in the structure and function of the eye in individuals with DS compared with those with mild cognitive impairment (MCI) and cognitively healthy control (HC) individuals. REVEAL will also explore whether these changes are connected to inflammatory markers previously associated with AD.
The protocol describes a cross-sectional, non-interventional, single-centre study recruiting three cohorts, including (1) participants with DS (target n=50; age range, 6–60 years), (2) participants with MCI (target n=50; age range, 50–80 years) and (3) HC participants (target n=50; age range, 50–80 years). The primary research objective is to profile retinal, choroidal and lenticular status using a variety of eye imaging modalities and retinal functional testing to determine potential associations with cognitive status. The REVEAL study will also measure and compare established blood markers for AD and proteomic and transcriptomic marker profiles between DS, MCI and HC groups. Between-group differences will be assessed with an independent sample t-test and 2 tests for normally distributed or binary measures, respectively. Multivariate regression analysis will be used to analyse parameters across all three cohorts. Data collection began in October 2023 and is expected to end in October 2025.
The study gained a favourable opinion from Health and Social Care Research Ethics Committee A (REC reference 22/NI/0158; approved on 2 December 2022; Amendment 22/0064 Amend 1, 5 April 2023; Amendment 22/0064 Amend 2; 23 May 2024; Amendment 22/0064 Amend 3; 25 June 2024; Amendment 22/0064 Amend 4; 16 January 2025; Amendment 22.0064 Amend 5; 9 May 2025; Amendment 22.0064 Amend 6; 9 June 2025). The study has also been reviewed and approved by the School of Biomedical Sciences Research Ethics Filter Committee within Ulster University. Findings from the REVEAL study will be presented to academic audiences at international conferences and peer-reviewed publications in targeted high-impact journals after data collection and analysis are complete. Dissemination activities will also include presentations at public events.