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Associations between self-reported upper limb motor ability, life satisfaction and life problems in people with cervical spinal cord injury from the community in the United States: a cross-sectional study

Por: Lewis · A. F. · Cao · Y. · Dellenbach · B. H. · Thompson · A. K. · Krause · J. S.
Objective

This study aims to evaluate relationships between self-reported fine motor ability and quality of life (assessed by life satisfaction and life problems) from people with spinal cord injury (SCI) at T1 and above.

Study design

Observational cohort study (current analysis from a cross section)

Participants

279 individuals with SCI at T1 or above

Setting

Community members sampled from records from two Midwestern hospitals and a speciality hospital in the Southeast United States

Main outcome measures

Fine motor ability was assessed via the Spinal Cord Injury Functional Index-Short Form 9A, while two facets of quality of life, life satisfaction and life problems, were assessed by the Life Situation Questionnaire-Revised version (LSQ-R). Pearson correlations and multivariate analysis were utilised to identify cross-sectional relationships between fine motor ability, life satisfaction and life problems.

Results

Fine motor ability was positively correlated with total life satisfaction score (r=0.16; p=0.02) and was negatively correlated with the total life problems score (r=–0.18; p=0.01), health problems factor (r=–0.24; pβ=0.25; p=0.02), fewer life problems (β=–0.40; pβ=–0.11; pβ=–0.10; p

Conclusion

The results identified significant, modest associations between self-reported outcomes, as better fine motor ability was related to less social isolation, fewer health problems and higher life satisfaction. Further investigation into the relationship between fine motor ability, life satisfaction and life problems is warranted.

Impact of physical activity on sleep in adults recovering from substance use disorders: a protocol for an N-of-1 observational study

Por: Thal · S. · Richardson · C. · McVeigh · J. · Thompson · C. · Wan · P. · Pang · B. · Riddell · H. · Bright · S. · Clarke · J. · Myers · B.
Introduction

Sleep impairments are prevalent among individuals recovering from substance use disorders (SUDs) and are associated with poorer treatment outcomes and increased relapse risk. Physical activity (PA) is known to enhance sleep in general populations, but its day-to-day effects on sleep during SUD recovery remain underexplored, especially across different recovery stages.

Methods and Analysis

In this observational n-of-1 study, we aim to examine within-person associations between daily PA and sleep quality in three groups of individuals at varying stages of substance use recovery (early treatment, continuing care and long-term recovery). A substudy will validate the agreement between two wearable sleep-monitoring devices. A total of 90 participants (30 per recovery group) from Western Australia will complete daily ecological momentary assessments and wear the SENS Motion sensor and/or Withings Sleep Analyzer over a 30-day period. Outcomes include device-derived sleep and PA measures, self-reported affect, craving, well-being and recovery outcomes. Multilevel models will explore within-person and between-person associations. This study will generate individualised evidence on associations between PA and sleep to inform tailored SUD care. It will also assess the feasibility of using wearable sleep monitors in real-world SUD recovery settings. Results may support the future development of just-in-time adaptive intervention procedures.

Ethics and Dissemination

The study was approved by the Human Research Ethics Committee of Curtin University (HRE2025-0379). Findings will be shared through peer-reviewed publications and conference presentations, with lay summaries provided to treatment facilities and interested participants to support translation into community and service settings.

Trial registration number

ACTRN12625000835448.

Exploring the role of symptom monitoring in self-management of chronic physical health conditions experienced by women: protocol for a scoping review

Por: Thompson · H. · Boivin · J. · Csontos · J. K. · Jackowich · R.
Introduction

Self-management is essential for girls, women and individuals assigned female at birth (AFAB) living with chronic physical health conditions. Evidence suggests that symptom monitoring can support self-management and empower individuals, yet limited research has explored how symptom monitoring is conceptualised, implemented and integrated within self-management frameworks considering the unique needs of biological, gendered and social factors affecting women and people AFAB. This scoping review aims to explore the role of symptom monitoring in self-management for girls, women and individuals AFAB. To achieve this, this review aims to define and conceptualise symptom monitoring and self-management, map existing symptom monitoring interventions and mechanisms linked to self-management and identify how sex, gender and systemic influences are considered in the context of chronic physical health conditions.

Methods and analysis

This scoping review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist. Six bibliographic databases (Cochrane Library, Scopus, PsycINFO (Ovid), MEDLINE (Ovid), EMBASE (Ovid) and CINAHL (EBSCO)) were searched from inception to 13 May 2025. Eligible studies will include primary research from Organisation for Economic Co-operation and Development countries, published in English, involving girls, women and individuals AFAB with chronic physical health conditions that involve symptom-monitoring tools linked to self-management. Studies focusing solely on obesity without reference to chronic conditions, acute illnesses or mental health conditions will be excluded. Screening will be undertaken independently by two reviewers in Rayyan, and citation management will be supported through reference software. Data extraction will follow Joanna Briggs Institute (JBI) guidance, capturing study characteristics, participant demographics and definitions related to symptom monitoring and self-management. Both inductive and deductive qualitative content analyses will be used: deductively, data will be organised according to the population, concept and context framework and research objectives. Inductively, descriptive categories will be developed from the data. Two complementary approaches will guide coding such as direct extraction of data and content coding of structured textual information, and thematic coding of interpretive data, supported by Microsoft Excel and SPSS. A small subset (5%–10%) will be double-coded to ensure consistency. Key outputs will include descriptive tables showing representation of girls, women and people AFAB by condition and context, following a synthesis of symptom monitoring and self-management (through theory/models). Tables summarising symptom-monitoring tools, mechanisms and a table outlining moderating factors influencing symptom monitoring and self-management experiences will be presented. Results will be presented through narrative summaries and visual diagrams to illustrate key relationships and concepts.

Ethics and dissemination

Formal ethical approval is not required for this study, as no primary data will be collected. The results of this scoping review will be shared with a wide range of audiences, including healthcare professionals, researchers, the public, policymakers, charities and patient advocacy groups. In the efforts of dissemination, this work strives to promote inclusive, evidence-based and equitable approaches to symptom monitoring and self-management among girls, women and people AFAB living with chronic physical health conditions.

Study registration

This protocol has been registered on the Open Science Framework, .

How can qualitative research enhance and strengthen randomised controlled trials undertaken with children and young people?

Por: Thompson · J. · Smith · J. · Evans · J.

Health research aims to improve people’s health by understanding the best ways to diagnose and treat conditions, and understand people’s responses to health problems and health promotion initiatives. Quantitative research, and more specifically randomised controlled trials (RCTs), aims to establish if an intervention works, for example testing the effectiveness of a new drug, using statistical analysis. In contrast, qualitative research focuses on understanding a situation, for example people’s experiences, perspectives and behaviours. Qualitative research can enhance RCTs by ensuring a more complete understanding of the factors that influence the acceptability of a new intervention and how it might be implemented in practice. A previous article in this series outlined how process evaluation embedded within RCTs can help understand how and why an intervention works.1 While process evaluation is important, we will outline the reasons qualitative research can enhance the design and procedures associated with RCTs, and the...

Digital App for Speech and Health Monitoring Study (DASH): protocol for a prospective longitudinal case-control observational study for developing speech datasets in neurodegenerative disorders and dementia

Por: Tam · J. · Weaver · C. · Ihenacho · A. · Newton · J. · Virgo · B. · Barrett · S. · Neale · J. · Perry · D. · Smith · A. · Chandran · S. · Watts · O. · Pal · S. · DASH Consortium · Ali · Baxter · Bozkhurt · Burr · Chandran · Chau · Clancy · Coupland · Devon · Entwistle-Thompson · Gardiner
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration

ClinicalTrials.gov NCT06450418 (pre-results).

Scales to measure core outcomes for the quality of dementia care in home or residential aged care facilities: a rapid review

Por: Dao-Tran · T.-H. · Kenny · D. · Welch · A. · Brittain · D. · Lendich · K. · Thompson · J. · Parkin · B. · Nunn · J. S. · Vos · G. · Comans · T.
Background

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.

Design

A rapid review

Data sources

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.

Eligibility criteria

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 extraction and synthesis

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.

Results

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.

Conclusions

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.

Implementation of an Australian helpline for low back pain: protocol of a type 2 hybrid effectiveness-implementation trial

Por: Zouch · J. · Roberts · K. · Bauman · A. · Jentz · H. · Ho · E. K. · Hodges · P. · Maher · C. · Baysari · M. T. · Thompson · J. · Calder · R. · Luscombe · G. · Ceprnja · D. · Maka · K. · Tian · Y. · Chen · Y. · Chen · M. · Mork · P. J. · Li · Q. · Wise · S. · Gilbert · M. · Hall · M. · Ferreira
Introduction

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.

Methods and analyses

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.

Ethics and dissemination

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.

The BrainWaves study of adolescent wellbeing and mental health: Methods development and pilot data

by Ryan D. Parsons, Sarah Bauermeister, Julian Turner, Natalie Coles, Simon Thompson, Emma Squires, Tracey Riseborough, Joshua Bauermeister, Abbie Simpkin, Naomi French, Shankly Cragg, Hazel Lockhart-Jones, Olly Robertson, Abhaya Adlakha, Ian Thompson, John Gallacher

Adolescent mental health and wellbeing are of growing concern globally with increased incidence of mental health disorders in young people. BrainWaves provides a framework for relevant and diverse research programmes into adolescent mental health and wellbeing that can translate into practice and policy. The research programme is a partnership with schools centred on establishing a large (n > 50,000) cohort and trials platform. Reported here is the BrainWaves cohort pilot study. This was designed as proof-of-concept for our recruitment and data capture pipelines, and for cost-modelling. A network of research schools was recruited and a computer-driven questionnaire administered. The eligible population was 16 + year olds who were attending the research schools. Of 41 research schools, 36 (88%) participated over one three-week and one four-week data collection period. From an eligible population of 33,531 young people, 16,010 (48%) attended the study lesson and created an account. Of the 16,010 (100%) who created an account, 15,444 (96%) consented to participate, 9,321 (60%) consented to linkage of research data with educational records, and 6,069 (39%) consented to linkage of research with school/college attendance data. Participants were aged 16–19 years, 59% female, and 76% White. Higher levels of anxiety and depression were found in females than males. Higher levels of media-based social networking were found in females, whereas higher levels of media-based gaming were found in males. Females were more likely to report insufficient sleep whilst males were more likely to report high levels of exercise. This study confirmed an ability to recruit at pace and scale. Whilst the response-rate does not indicate a representative sample, the demographics describe an inclusive and diverse sample. Data collected confirmed findings from previous studies indicating that the electronic data collection methods did not materially bias the findings. Initial cost-modelling suggests these data were collected for around £20 per participant.

PEER CONNECT: an embedded qualitative study of the experiences of a peer well-being coaching intervention for people living with a long-term health condition

Por: Dennett · R. · Elston · J. · Thompson · T. P. · Clyne · W. · Hosking · J. · Bones · K. · Davies-Cox · H. · Straukiene · A.
Introduction

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.

Methods

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.

Results

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

Conclusion

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.

Trial registration number

ISRCTN12623577.

Recruitment, retention and reporting of ethnic representativeness in maternity trials: a scoping review

Por: Lovell · H. · Wicks · E. · Thompson · H. · Brace · L. · Stacey · T. · Rayment-Jones · H. · Harding · S.
Introduction

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.

Aim

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

Methods

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.

Results

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.

Conclusion

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.

Beyond Amount: Parent Perceptions of Feeding Success for Their Developmentally At‐Risk Infants in the First 2 Years

ABSTRACT

Aim

Examine the meaning of ‘successful feeding’ for parents of infants at risk for feeding difficulties and how this meaning evolved from 1 to 24 months post-term age.

Design

Secondary analysis of responses to an open-ended question from a U.S. longitudinal mixed methods study.

Methods

At 1-, 6-, 12-, 18-, and 24-months post-term, parents completed surveys which included the question: What is ‘successful feeding’ to you? Using conventional content analysis, 864 responses from parents of 254 infants were coded into the following categories: Child Behaviour, Positive Response, Intake, and Time. Themes characterizing each category were identified.

Results

Child Behaviour, Positive Response, and Intake were common at all time points. Responses related to Time (e.g., eating in a timely manner) were least frequent at 1, 6, and 12 months and were no longer mentioned thereafter. Demonstrating feeding skill/ability and satiety were common themes at all time points. Adequate quantity of food and no adverse response (e.g., emesis, choking) were common themes at 1 month; both decreased thereafter. The perception that the child was engaged in eating and eating nutritionally adequate food increased as children aged.

Conclusion

Parents' perspectives of successful feeding focused on indicators of their child's development and emotional and physical well-being. As their children aged, ate increasingly complex foods, and developed physiologic stability, the meaning of success focused less on the amount of intake and avoidance of an adverse response and more on child well-being.

Implications for the Profession and/or Patient Care

Nurses and feeding specialists can incorporate parents' views of success as they provide feeding support.

Impact

Children having a positive behavioural and affective response to eating, and adequate intake provide evidence to parents of their success in achieving feeding goals. Understanding issues of importance to parents is an essential component of family-centered care of children with feeding difficulties.

Patient or Public Contribution

No Patient or Public Contribution.

Reporting Method

The authors have adhered to the Standards for reporting qualitative research.

Readiness Brain Operation Optimization Training (ReBOOT) protocol: a feasibility randomised controlled trial for a cognitive prehabilitation programme for epilepsy surgery conducted at Cleveland Clinic, USA

Por: Arrotta · K. · Babiker · S. · Lake · J. · Thompson · N. · Lioi · A. · Najm · I. · Busch · R. M.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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).

Trial registration number

NCT05992402.

Feasibility of implementing a non-invasive self-sampling method for saliva specimens that can be used for the diagnosis of respiratory infections among paediatric patients in the Tshwane District, South Africa: a study protocol

Por: Nxele · S. · Dlangalala · T. · Gxekwa · N. V. · Ramatsokotla · S. · Musekiwa · A. · Kgatle · M. M. · Hatchett · D. B. · Shin · A. · Tu · W.-c. · Robertson · I. H. · Su · X. · Berthier · E. · Thongpang · S. · Theberge · A. B. · Mashamba-Thompson · T. P.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

Pan African Clinical Trial Registry (PACTR202411743094783).

Evaluating the health and well-being effects of increasing biodiversity within multiple small parks in Edinburgh, UK: a protocol for a mixed-methods, longitudinal, pre-post natural experiment

Por: Malden · S. · McDougall · C. W. · Ward Thompson · C. · Wendelboe-Nelson · C. · Ross-Perez · A. · Clemens · T. · Mason · S. · Villegas-Diaz · R. · Hoadley · A. · Hunter · A. · Jepson · R. · Williams · A. J.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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 rehabilitation with action video games and exercise: study protocol of an active-controlled trial (GRADE)

Por: Yihong · P. · Thompson · B. · Winser · S. · Lau · I. · Suen · V. · Cheung · M. · Cheong · A. M. Y.
Introduction

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.

Methods and analysis

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).

Ethics and dissemination

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.

Trial registration number

NCT06000865.

Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial

Por: Murphy · D. · Graby · J. · Smith · T. · Peacock · O. · Abramik · J. · Antoniades · C. · Rodrigues · J. C. L. · Thompson · D. · Khavandi · A.
Introduction

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.

Methods and analysis

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 and dissemination

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.

Trial registration number

ClinicalTrials.gov ID NCT05596175.

Emergency physicians experiences managing patients with a suspected cancer diagnosis in Ontario, Canada: a qualitative study

Por: Moore · C. · Petrovic · B. · Bender · J. L. · Thompson · C. · McLeod · S. L. · Savage · D. · Borgundvaag · B. · Ovens · H. · Irish · J. · Eskander · A. · Cheskes · S. · Krzyzanowska · M. · de Wit · K. · Mohindra · R. · Thiruganasambandamoorthy · V. · Grewal · K.
Objective

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.

Design

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.

Setting and participants

Emergency physicians practising in Ontario, Canada.

Results

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.

Conclusions

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.

Challenges of cancer survivorship care in Chile: a longitudinal study comparing the quality of care and quality of life for cancer survivors in a primary care network and a cancer centre in Chile

Por: Puschel · K. · Arancibia · V. · Rioseco · A. · Paz · S. · Soto · M. G. · Martinez · J. · Faundez · M. · Acevedo · F. · Di Biase · F. · Emery · J. · Leon · A. · Are · C. · Thompson · B.
Objective

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.

Design

Retrospective cohort study.

Setting

Three primary care clinics and one cancer centre in Chile.

Participants

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.

Outcome measures

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.

Results

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

Conclusion

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.

Socioeconomic inequalities in outcomes, experiences and treatment among adults consulting primary care for a musculoskeletal pain condition: a prospective cohort study

Por: Peat · G. M. · Hill · J. C. · Yu · D. · Wathall · S. · Parry · E. · Bailey · J. · Thompson · C. · Jordan · K. P. · The MIDAS Patient Advisory Group · Brown · Dent · Haines · Haines · Southam · Maddison · Sandhu
Objectives

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

Design

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

Setting

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

Participants

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.

Interventions

Standard care.

Primary and secondary outcome measures

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.

Results

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.

Conclusions

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.

Trial registration number

ISRCTN18132064; Results.

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