Neurodegenerative disorders (NDDs) represent an unprecedented public health burden. These disorders are clinically heterogeneous and therapeutically challenging, but advances in discovery science and trial methodology offer hope for translation to new treatments. Against this background, there is an urgent unmet need for biomarkers to aid with early and accurate diagnosis, prognosis and monitoring throughout the care pathway and in clinical trials.

Investigations routinely used in clinical care and trials are often invasive, expensive, time-consuming, subjective and ordinal. Speech data represent a potentially scalable, non-invasive, objective and quantifiable digital biomarker that can be acquired remotely and cost-efficiently using mobile devices, and analysed using state-of-the-art speech signal processing and machine learning approaches. This prospective case–control observational study of multiple NDDs aims to deliver a deeply clinically phenotyped longitudinal speech dataset to facilitate development and evaluation of speech biomarkers.

People living with dementia, motor neuron disease, multiple sclerosis and Parkinson’s disease are eligible to participate. Healthy individuals (including relatives or carers of participants with neurological disease) are also eligible to participate as controls. Participants complete a study app with standardised speech recording tasks (including reading, free speech, picture description and verbal fluency tasks) and patient-reported outcome measures of quality of life and mood (EuroQol-5 Dimension-5 Level, Patient Health Questionnaire 2) every 2 months at home or in clinic. Participants also complete disease severity scales, cognitive screening tests and provide optional samples for blood-based biomarkers at baseline and then 6-monthly. Follow-up is scheduled for up to 24 months. Initially, 30 participants will be recruited to each group. Speech recordings and contemporaneous clinical data will be used to create a dataset for development and evaluation of novel speech-based diagnosis and monitoring algorithms.

Digital App for Speech and Health Monitoring Study was approved by the South Central—Hampshire B Ethics Committee (REC ref. 24/SC/0067), NHS Lothian (R&D ref. 2024/0034) and NHS Forth Valley (R&D ref. FV1494). Results of the study will be submitted for publication in peer-reviewed journals and conferences. Data from the study will be shared with other researchers and used to facilitate speech processing challenges for neurological disorders. Regular updates will be provided on the Anne Rowling Regenerative Neurology Clinic web page and social media platforms.

ClinicalTrials.gov NCT06450418 (pre-results).

The Core Outcome Measures for Improving Dementia Care (COM-IC) project aims to develop a core outcome set for measuring the quality of care provided to people living with dementia in routine care settings. In a previous stage of the project, 17 core outcomes were identified. This study is the next step, aiming to review the literature to identify existing or recommended, validated scales for measuring the identified core outcomes.

A rapid review

Six electronic databases (PubMed, Embase (Elsevier), CINAHL Complete (EBSCOhost), APA PsycINFO (EBSCOhost), Web of Science (Clarivate) and Scopus (Elsevier) were searched. Searches were completed on 12 July 2024.

Peer-reviewed systematic reviews or original validation studies of scales measuring dignity; engagement in advance care planning; pain; quality of life; feeling safe and secure; emotional well-being; diagnosis of dementia; behavioural and psychological symptoms of dementia; the importance of relationships; meaningful activities; hygiene and comfort; resource utilisation and safety incidents for people living with dementia were included. Peer-reviewed systematic reviews or original validation studies of the scales to measure informal carers’ quality of life, their educational opportunities, formal carers’ morale and dementia-specific qualifications were also included. All studies were required to have been conducted among people living with dementia or carers, as appropriate, and to have full texts available in English.

Data on the scale’s name, the number of subscales, subscales’ names, the number of items, response options, scoring, estimated time to complete the scale, recommended frequency of data collection and the setting where the scale was first validated were extracted. Findings are presented in figures, tables and narrative texts.

A total of 88 validated scales were identified. No scales measuring dignity, engagement in advance care planning, feeling safe and secure, hygiene or safety incidents were validated for people living with dementia. No scale was identified to measure the importance of relationships for people living with dementia, the formal carers’ dementia-specific qualifications or the educational opportunities for informal carers. The review also describes the 50 recommended or validated scales.

Several validated or recommended scales exist to measure core outcomes identified as important for assessing the quality of care provided to people living with dementia in routine care settings. This review offers COM-IC stakeholders and other potential users with information on the validated/recommended scales to measure these core outcomes.

Low back pain (LBP) is the leading contributor to disability globally. It has a substantial impact on the lives of those who experience it, and places considerable economic burden on healthcare systems. Despite these impacts, and the consistency of guideline recommendations, many individuals do not receive recommended LBP management. Structural barriers to accessing timely, evidence-based care, as well as public uncertainty about where to seek appropriate management, can influence the care individuals receive. Telephone and digitally based helplines assist to overcome many traditional barriers to accessing care and offer a scalable platform to improve the delivery of guideline recommended management for LBP. However, uptake of such services can be limited without targeted promotion and patient-centred design. This project aims to codesign, implement and evaluate an upgraded component of an existing Australian helpline service, tailored for people with back pain and supported by a media awareness campaign. This protocol outlines the codesign process, implementation and planned evaluation of the helpline.

This protocol uses three complementary frameworks—an iterative codesign process, the Practical Robust Implementation Sustainability Model, and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework—to guide the codesign and development, implementation and evaluation of an upgraded helpline for people with LBP. The codesign process involves key stakeholders, including consumers and clinicians, to inform the development and implementation of both the upgraded helpline service and the media campaign to raise awareness and uptake of the helpline. Data sources will include a pre–post cohort of helpline service users, routinely collected service data (eg, monthly call rate) and health system data to evaluate the broader population level impact (eg, rates of emergency department presentations for LBP in the Australian region targeted by the media campaign). Implementation evaluation will include Reach, Effectiveness, Adoption, Implementation and Maintenance as well as internal and external environmental factors that influence the success of these outcome measures.

The project was approved by the University of Sydney’s Human Research Ethics Committee (HE001081). This project involves collaboration with consumers, clinicians and other stakeholders to interpret, translate and disseminate research findings to relevant audiences.

Many people with long-term conditions such as pain and arthritis struggle with their health and well-being. To support better self-management, a new peer-delivered coaching intervention (Health Connect Coaching) was set up at a National Health Service integrated care organisation in Southwest England. Based on principles of personalised care and supported goal setting, the one-to-one coaching programme, targeting patients with low activation, delivered coaching sessions in a step-down approach over 6 months. A randomised controlled feasibility trial (fRCT) of Health Connect Coaching was conducted to inform the design of a definitive randomised controlled trial. This article reports the embedded qualitative component of the fRCT, describing the experiences of coaches, peers and staff of implementing and participating in the intervention and trial that ultimately struggled to recruit sufficient peers.

Semi-structured online interviews were conducted with coaches (n=16) and peers (n=6), and informal discussions held with staff (n=7). Interviews were recorded and transcribed verbatim, and summaries of informal discussions were made. Data were analysed using thematic framework analysis.

Four themes were identified from the interview and discussion data: (1) motivation for participation, (2) balance, (3) flexibility and (4) connection and building relationships.

One-to-one peer coaching demonstrates potential as an intervention to enable people to better manage their chronic health condition. However, in people with low activation, programmes and effectiveness studies need to pay close attention in their design to the motivation of peers, flexible delivery models that enable connection but can accommodate fluctuating needs and facilitating links between coaching services and clinical teams.

ISRCTN12623577.

Black and Asian women experience significantly higher rates of mortality and morbidity perinatally compared with white women and are more likely to lose their babies. These groups are also under-represented in clinical research, resulting in evidence that may not be generalisable. Tools have been developed to facilitate the inclusion of ethnic minority groups, but it is unknown to what extent representation and inclusion are considered in maternity trials.

To provide an overview of how ethnically diverse recruitment is considered and reported in maternity trials in the UK.

A scoping review was conducted, undertaking a systematic search to identify published trial protocols and their subsequent results papers, conducted within the UK, recruiting women during pregnancy or within 6 weeks postnatally between 2004 and 2024.

Data was extracted from protocols on whether representation of participants was considered in the study design and if specific recruitment and retention strategies were planned for ethnic minority groups.

Data extracted from results papers identified whether representation of participants was discussed and if recruitment strategies were discussed; these were compared against the protocol.

A total of 96 published protocols met the inclusion criteria; 8 mentioned specific recruitment strategies and 5 mentioned specific retention strategies. Only two included both recruitment and retention strategies. The most common strategies included providing different types of language support and adapting interventions to be culturally appropriate. Strategies were not evaluated.

67 results papers were available. Ethnicity was reported in 57 papers, with heterogeneity of categories between papers. Only 32 papers discussed representativeness of participants.

Few maternity trials report considerations on how they ensure they are recruiting and retaining ethnically representative participants. Minimal discussion is undertaken around the extent to which trial participants reflect the population to which findings will be applied.

Further work is needed to support implementation and evaluation of inclusive research guidance. Failing to ensure those from ethnic minority groups are included in research can exacerbate inequalities.

Risk of cognitive decline following epilepsy surgery can be a significant barrier for patients pursuing surgery, and post-surgical cognitive changes can impact quality of life (QOL), surgical satisfaction and functional independence. Readiness Brain Operation Optimization Training (ReBOOT) is a virtual cognitive prehabilitation intervention that provides patients with psychoeducation and cognitive strategies prior to surgery to increase pre-surgical preparedness and post-surgical functional independence in the circumstance that a patient experiences cognitive decline after surgery. The primary aim of this feasibility trial is to evaluate the acceptability, adherence and procedural feasibility of implementing ReBOOT in patients being evaluated for epilepsy surgery. Secondary, explorative objectives include examining preliminary trends in QOL, compensatory strategy use, cognitive function and psychosocial outcomes to inform a future definitive trial.

This is a single-centre, parallel-group, feasibility randomised controlled trial of a standardised cognitive prehabilitation programme for patients who are considering epilepsy surgery. Participants are randomly assigned to intervention (n=32) or control groups (n=32). The intervention group is enrolled in ReBOOT, a virtual programme that includes two 1-hour individual sessions and four 1-hour group sessions. Feasibility outcomes include attendance, homework adherence, attrition and participant satisfaction for participants randomised to the intervention group. Exploratory analyses will use longitudinal linear mixed-effects models to describe trends in exploratory outcomes over time. Data will be used to refine procedures and estimate parameters (eg, effect sizes and variance) for a future fully powered trial.

Cleveland Clinic Institutional Review Board approved the study protocol, which is publicly available and registered on the National Institutes of Health ClinicalTrials.gov (NCT05992402) site. Results will be disseminated through conference presentations and academic publications, as well as shared with outside study sponsors (Society for Clinical Neuropsychology—Division 40 of the American Psychological Association; American Epilepsy Society).

NCT05992402.

Effective community-based disease management is essential for public health. In low- and middle-income countries, sustainable strategies for timely diagnosis and treatment are a research priority. This study aims to assess the feasibility of a non-invasive saliva self-sampling method, paired with digitally linked molecular point-of-care diagnostics, for detecting respiratory infections among paediatric patients in the Tshwane District, South Africa.

A field study will be conducted at Steve Biko Academic Hospital to compare saliva collection using the CandyCollect lollipop device and standard mouth swabs. The spiral groove of the lollipop device captures pathogens, which are stored in DNA/RNA preservation media and later analysed using quantitative PCR and commercially available rapid antigen tests. The multiplex respiratory pathogen panel, based on TaqMan real-time PCR technology, targets key paediatric pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, respiratory syncytial virus (RSV) and influenza A/B. Nucleic acids will be extracted using standard viral extraction kits and analysed following manufacturer protocols. Internal controls will be included in each qPCR run, and samples with CT values below defined thresholds will be considered positive. Rapid antigen tests will detect common pathogens such as influenza A/B, RSV and SARS-CoV-2 for comparative analysis. User experience and acceptability will be assessed via child-friendly and caregiver surveys following sample collection. The study will be implemented in two phases: diagnostic performance evaluation and user feedback assessment. The protocol is aligned with the Standard Protocol Items: Recommendations for Interventional Trials 2013 checklist.

Ethical approval has been granted by the University of Pretoria (509/2023) and the Gauteng Department of Health (GP_202406_032). The study is registered in the Pan African Clinical Trial Registry (PACTR202411743094783). Findings will be disseminated through peer-reviewed journals, conferences and stakeholder briefings. The study complies with South Africa’s Protection of Personal Information Act. Data collection is scheduled from November 2024 to February 2025, with project completion expected within 1 year.

Pan African Clinical Trial Registry (PACTR202411743094783).

Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.

This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.

This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.

Glaucoma is the second leading cause of moderate to severe visual impairment worldwide, primarily affecting peripheral vision and increasing the risk of falls due to impaired balance and mobility. While traditional physical training (PT) is used for fall prevention, its effectiveness may be limited by low patient engagement. Action video games (AVGs) may offer a more engaging alternative for improving balance and mobility in individuals with glaucoma.

This prospective, two-arm, single-blind, active-control trial will involve 56 patients with glaucoma with moderate to severe peripheral field loss and intact cognitive function, who have not previously undergone balance training. Participants will be randomly assigned in a 1:1 ratio to either a physically interactive action video-game training (AVG) group or a conventional PT group. The AVG group will use a Nintendo Switch gaming station for 20 sessions of 45 min each, conducted two to three sessions per week over 8 weeks. These sessions will involve standing game exercises using game controllers or body sensors, focusing on muscle stretching and strengthening, balance improvement and fitness. The PT group will engage in traditional PT for the same duration and frequency. The primary outcome is the change in mobility function after 20 sessions, measured by the narrow path walking test. Secondary outcomes include balance function (modified Clinical Test of Sensory Interaction and Balance, motor control test, landing balance test, five-time sit-to-stand test and time up and go test), visual cognition (reaction time test and useful field of view test) and patient-reported outcomes (validated questionnaires). Exploratory outcomes include fall frequency, fear of falling, visual function and serum brain-derived neurotrophic factor levels (one of the biomarkers related to exercise). Assessments will occur at seven time points: baseline (T1), after 10 sessions (T2), after 20 sessions (T3), 1-month post-training (T4) and 3, 6 and 9 months after all training sessions (T5–T7).

The human ethics approval was obtained from the respective ethics board of the Hong Kong Polytechnic University (ID: HSEARS20210722001). The study protocol will conform to the principles of the Declaration of Helsinki. Results will be disseminated through peer-reviewed journals and conferences.

NCT06000865.

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide, associated with significant morbidity, mortality and healthcare utilisation. AF rhythm control strategies demonstrate attrition with time. A number of modifiable AF risk factors contribute to an atrial cardiomyopathy culminating in incident AF but importantly also recurrence. We propose that a novel multidisciplinary lifestyle intervention (Super Rehab, SR) may improve symptoms and AF burden.

This is a single-centre, randomised controlled study. Patients aged ≥18 years with a body mass index ≥27 kg/m² with paroxysmal or persistent AF will be randomised 1:1 to National Health Service (NHS) usual care (UC) or to SR (together with NHS UC). SR incorporates high-intensity exercise, personalised dietary advice and AF risk factor modification. SR will be undertaken over 12 months. In addition to baseline assessments, follow-up assessments will occur at the 6, 12 and 15-month time points. The primary outcome will be the difference in AF symptom burden at 12 months between groups. Secondary outcomes include AF burden (assessed by an implantable cardiac monitor), changes to cardiac structure and function and computed tomography-based assessment of epicardial adipose tissue.

Ethics approval was granted by London-Chelsea Research Ethics Committee (reference: 22/LO/0479 22/08/2022). All participants will provide written informed consent prior to enrolment. Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. A summary will also be communicated to the participants.

ClinicalTrials.gov ID NCT05596175.

The emergency department (ED) often serves as a crucial pathway for cancer diagnosis. However, little is known about the management of patients with new suspected cancer diagnoses in the ED. The objective of this study was to explore emergency physicians’ experiences in managing patients with a newly suspected cancer diagnosis in the ED.

Between January and April 2024, we conducted a qualitative descriptive study. Interviews were conducted by trained research personnel using a semistructured interview guide. Interviews were conducted until thematic saturation was achieved. The interview transcripts were coded and thematic analysis was used to uncover key themes.

Emergency physicians practising in Ontario, Canada.

20 emergency physicians were interviewed. Four themes around the management of patients with new suspected cancer diagnoses in the ED were identified: (1) healthcare system-level factors that impact suspected cancer diagnosis through the ED, (2) institutional and provider-level challenges associated with managing patients with a suspected cancer diagnosis in the ED, (3) patient-level characteristics and experiences of receiving a cancer diagnosis in the ED and (4) the need for care coordination for patients with suspected cancer in the ED.

Physicians experienced several unique challenges in managing patients with a suspected cancer diagnosis in the ED. Overall, the findings of this study suggest these challenges often make the ED a difficult environment in which to deliver a suspected cancer diagnosis.

The rapid growth in the cancer survivor population in Chile and Latin America raises new challenges in addressing their care needs. This study assesses the health status and compares the quality of care and quality of life in cancer survivors at a primary care network and a private cancer centre in Santiago, Chile.

Retrospective cohort study.

Three primary care clinics and one cancer centre in Chile.

All breast and colorectal cancer patients identified from a primary care retrospective cohort of 61 174 were followed from 2018 to 2023 and compared with an equivalent sample of patients from a university cancer centre identified during the same period.

Quality of care was assessed based on American Cancer Society standards, while quality of life was measured using the EuroQol 5 Dimensions-5 Levels survey instrument.

A total of 420 cancer survivors participated in the study; 208 from primary care and 212 from the cancer centre. All participants received substandard care. Patients in primary care had lower educational levels and higher rates of comorbidity. They reported a lower quality of life score (72.22 vs 78.43, p

Cancer survivors face a significant disease burden and receive substandard care in Chile. As the primary source of care for this population, primary care is challenged to better integrate with speciality care to develop an effective shared care model for cancer survivors.

To estimate the direction and magnitude of socioeconomic inequalities in outcome, experience and care among adults consulting for a musculoskeletal pain condition.

Multicentre, prospective observational cohort with repeated measures at three waves (baseline, 3 months and 6 months after index consultation).

30 general practices in North Staffordshire and Stoke-on-Trent, England.

1875 consecutive, eligible, consenting patients, aged 18 years and over, presenting with a relevant SNOMED CT-coded musculoskeletal pain condition between September 2021 and July 2022.

Standard care.

Primary outcome was patient-reported pain and function using the Musculoskeletal Health Questionnaire (MSK-HQ score, 0–56). Secondary outcomes were patient experience (overall dissatisfaction with consultation experience, dichotomised) and an indicator of care received (opioid prescription within 14 days of index consultation). Using multilevel models, we examined inequalities in primary and secondary outcomes by area deprivation (Index of Multiple Deprivation derived from patient residential postcode), before and after adjusting for sociodemographic and survey administration variables, clinical case-mix and selected practice-level covariates.

Compared with patients from the least deprived neighbourhoods, patients from the most deprived neighbourhoods had significantly poorer MSK-HQ scores at baseline (mean 22.6 (SD 10.4) vs 27.6 (10.1)). At 6 months, the inequality gap in MSK-HQ score widened (difference in mean score after adjustment for all covariates: 1.94; 95% CI: –0.70 to 4.58). Opioid prescription was more common for patients living in the most deprived neighbourhoods (30% vs 19%; fully adjusted OR: 0.69; 95% CI: 0.44 to 1.08). Only 6% of patients overall reported being dissatisfied with their consultation. Analysis of multiply imputed data produced a similar pattern of findings to complete-case analysis.

Substantial inequalities in the chronicity, severity and complexity of musculoskeletal pain problems are already present at the time of accessing care. Inequalities in pain and function do not reduce after accessing care and may even widen slightly.

ISRCTN18132064; Results.