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Auricular Point Acupressure Self-Management (APA-SM) program for chronic musculoskeletal pain among rural populations: a protocol for a pragmatic, randomized controlled trial

Por: Kawi · J. · Bolin · J. · Wu · H. · Min · J. · Bora · R. · Pace · S. · Akpan · I. N. · Lockman · A. · Nnaka · T.
Introduction

Chronic musculoskeletal pain (CMP) is a leading cause of incurred personal healthcare costs and disability in the USA. It disproportionately affects rural populations, who are more likely to be uninsured, lack access to a regular healthcare provider and experience a higher prevalence of CMP. As a result of reduced access to non-pharmacological care, there is greater reliance on opioids. The Auricular Point Acupressure – Self-Management (APA-SM) program is a simple, needleless, evidence-based therapy that empowers individuals to self-manage their pain. Preliminary studies, including a recent UG3 pilot testing, demonstrated feasibility, safety and significant improvements in pain and function. Guided by Bandura’s self-efficacy model and informed by stakeholder input, APA-SM integrates a smartphone application, ecological momentary assessment and personalized motivational messaging to enhance adherence and behavior change. This study protocol describes the design of a real-world, hybrid effectiveness-implementation, randomized controlled trial to evaluate the clinical impact and sustainability of APA-SM in rural settings.

Methods and analysis

We will conduct a pragmatic, three-arm randomized controlled trial in Texas and South Carolina, enrolling 693 adults with CMP (231 per group). Participants will be randomized to: (1) APA-SM with remote training, (2) APA-SM with in-person training or (3) education control. The primary outcome is pain impact measured by the PEG (composite score of pain intensity, interference on enjoyment of life, and general activity) scale at immediate post-intervention (4 weeks), with follow-up at 1, 3 and 6 months. Secondary outcomes include National Institutes of Health Helping to End Addiction Long-Term Clinical Pain Core common data elements (eg, psychological functioning, disability, sleep, quality of life), opioid use and patient-reported adherence and satisfaction. Implementation outcomes will be assessed at both the patient and provider levels, guided by the RE-AIM framework. Cost-effectiveness will be estimated using implementation costs and incremental cost-effectiveness ratios, and predictive factors for APA-SM treatment response will be identified using statistical machine learning approaches and historical electronic health record data. The target sample size (231 per group) provides 90% power to detect a moderate effect size (Cohen’s d=0.35), accounting for 25% attrition. Randomization occurs at the participant level to reflect real-world delivery and minimize contamination.

Ethics and dissemination

This study, sponsored under grant number 4UH3AT012728, has single Institutional Review Board (IRB) approval at UTHealth Houston, Texas, USA (HSC-SN-25-0443). A Data Safety Monitoring Board will oversee adverse event reporting and trial conduct. Dissemination will occur through peer-reviewed publications, conference presentations, stakeholder workshops and community-based reports tailored for rural health systems and policymakers.

Discussion

This trial will provide the first large-scale evaluation of APA-SM in rural U.S. populations, integrating digital health tools and implementation science methods to help address disparities in pain management. By assessing clinical effectiveness, implementation outcomes, cost-effectiveness and predictive response factors, study results will inform scalable strategies for integrating APA-SM further into rural communities and healthcare systems. If successful, APA-SM has the potential to improve pain care access, reduce opioid reliance and provide a sustainable, patient-centered model for chronic pain management.

Trial registration number

NCT07179016.

WeCare intervention to improve breast cancer screening and research preparedness in rural and low-socioeconomic women: study protocol for a community-engaged feasibility trial

Por: Sharma · P. · Imsande · K. G. · Vitriago · A. · Seibel · M. · Pritchett · J. C. · Rudder · B. · Watson · D. · Beenken · M. J. · Tran · L. T. · Larson · S. L. · Flock · C. · Murphy · C. M. · Puljas · T. L. · Patten · C. A. · Asiedu · G. B. · Odedina · F. T. · Lynch · B. A. · Haddad · T. C.
Introduction

Women residing in rural areas or belonging to lower socioeconomic status (SES) strata experience disproportionately low rates of breast cancer screening, contributing to delayed diagnoses and poorer prognoses. In addition, their participation in clinical trials remains markedly limited, reducing opportunities to access preventive and screening interventions. Promoting research preparedness among women before disease onset may empower them to make informed decisions regarding their health and willingness to participate in clinical research with fewer emotional and logistical barriers.

Methods and analysis

This project applies a community-based participatory research approach to develop and refine the WeCARE (Women’s Engagement for Cancer Awareness, Resources and Education) intervention for women aged 50–74 years who have either never undergone breast cancer screening or have not received screening in the past 5 years and who reside in rural areas or belong to low SES groups. The intervention consists of two components. Component 1 is a single-day, in-person community forum that includes (a) an educational seminar led by an oncologist to address breast cancer risk and screening guidelines, (b) survivor storytelling to enhance emotional engagement and cultural resonance and (c) facilitated navigation to breast cancer screening and future research participation. Component 2 involves structured post-forum follow-up through multiple touchpoints (phone calls and mailed boosters) to reinforce knowledge, address barriers and support screening completion and research enrolment. Quantitative data (eg, screening completion, satisfaction and follow-up engagement) will be summarised using descriptive statistics to assess feasibility and reach on 50 participants. Qualitative feedback from participants will undergo thematic analysis to identify barriers, facilitators and perceived cultural relevance. Integrated mixed-method interpretation will inform iterative refinement of the WeCARE intervention and guide design of subsequent larger trials.

Ethics and dissemination

Approved by the Mayo Clinic Institutional Review Board (IRB #25–008934). All participants will provide informed consent. Procedures ensure confidentiality, cultural sensitivity and participant safety. Data will be stored in REDCap and disseminated through publications, conferences, local town halls and community reports.

Accessing and Administering Anticipatory Medications for Community End‐of‐Life Symptom Control: A Qualitative Focus Group Study

ABSTRACT

Aim

To understand healthcare professionals' perspectives of what works well and what can be improved in the supply and administration of anticipatory medications at the end of life in the community.

Design

Qualitative interpretive study using focus groups.

Methods

Semi-structured focus groups included healthcare professionals with experience of using anticipatory medications, and public contributors with lived experiences of relatives' end-of-life care. Participants' demographic information was elicited in a brief questionnaire. Transcripts were analysed inductively using thematic analysis. Data were collected in September 2022.

Setting and Participants

Eight focus groups involved 58 UK-based participants. Each group included people with a variety of professional roles from diverse geographical areas, and public contributors with relevant lived experiences.

Results

The administration of anticipatory prescriptions was widely perceived to be a valuable intervention, but extensive operational challenges were identified, with three interconnected themes arising from the data: (a) Communication between healthcare teams; (b) Intuitive documentation; (c) Accessibility of medications. Addressing these challenges was perceived to be onerous, particularly for nurses and families.

Conclusions

Operational barriers to the timely and appropriate administration of anticipatory medications risk were perceived as adversely affecting patient care and patients' and families' experiences.

Implications for the Profession and/or Patient Care

System-level improvements are needed to streamline care processes and ensure equitable, appropriate, and timely access to end-of-life symptom control medications in the community.

Reporting Method

This study adheres to relevant EQUATOR guidelines and follows the appropriate Standards for Reporting Qualitative Research (SRQR).

Patient or Public Contribution

Our Public and Clinician Advisory Group helped shape questions and commented on findings. Focus groups included public participants with lived experience of end-of-life care in the community.

How can a remotely delivered, personalised physical activity intervention for people with high risk of breast, lung and bowel cancer recurrence be implemented in England? Protocol for a mixed-methods process evaluation embedded in a feasibility basket tri

Por: Jackson · G. · Pearson · M. · Bullock · A. F. · Cohen · J. · Huang · C. · Lind · M. · Saxton · J. · Wilson · C. · Twiddy · M. · Forbes · C. C.
Introduction

Randomised controlled trials (RCTs) are essential to determine intervention effectiveness yet they often fail to capture how and why interventions succeed or fail in different contexts. Embedding a process evaluation alongside a clinical trial allows exploration of implementation processes, intervention fidelity and contextual influences. The CANFit trial is a basket-design RCT evaluating a personalised, remotely delivered exercise intervention for people diagnosed with breast, lung and bowel cancer with increased risk of recurrence. This embedded process evaluation aims to understand how individual, team and organisational factors influence intervention delivery and uptake.

Methods and analysis

A concurrent, mixed-methods process evaluation will be conducted using a hybrid type 1 design. Data will be collected from multiple sources, including participant and trainer questionnaires, semi-structured interviews, intervention adherence logs, trainer diaries and observations. Five core implementation outcomes, guided by Proctor’s framework—acceptability, appropriateness, fidelity, penetration and sustainability—will structure the evaluation. Quantitative data will be analysed descriptively and qualitative data will undergo framework analysis using both deductive and inductive coding. Data integration will occur through a convergent mixed-methods approach, using context-mechanism-outcome (CMO) configurations to refine programme theory.

Ethics and dissemination

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and the UK NHS Health Research Authority (ID: 327663). All participants will provide informed consent before taking part. Data will be handled according to General Data Protection Regulation and University of Hull data management policies. Findings will be disseminated through peer-reviewed publications, conference presentations, stakeholder reports and lay summaries for participants and the public.

Trial registration number

ISRCTN97662203.

The impacts of high-fidelity and virtual reality simulation on the development of non-technical skills in healthcare students and professionals: protocol for a systematic review

Por: Hunt · W. · Lock · S. · Bonfield · A. · Howick · J.
Introduction

Deficiencies in non-technical skills—including communication and leadership—are well-established causes of clinical errors in healthcare. Healthcare students and professionals increasingly use high-fidelity and virtual reality (VR) simulation to replicate clinical practice, through immersive and realistic scenarios in a risk-free teaching setting. However, there is no up-to-date, high-quality synthesis of the effects of high-fidelity and VR simulation on non-technical skills for healthcare students and professionals. A systematic review and meta-analysis of this literature is required to enhance the current knowledge.

Methods

This protocol has been reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement. We will include randomised trials and other controlled studies that report differences in non-technical skills between high-fidelity and VR simulation. We will search MEDLINE, Scopus, EMBASE, ERIC and CINAHL, from database inception. We will also search reference lists and contact experts to identify additional studies. Two independent reviewers will screen titles and abstracts, review full texts, and extract data. Discrepancies will be resolved through discussion, with a third reviewer if necessary. For randomised trials, we will use the Cochrane Risk-of-Bias 2.0 (RoB2) tool to evaluate the risk of bias in the included studies. For non-randomised studies, we will use the Risk Of Bias In Non-randomized Studies (ROBINS-1) assessment tool. If appropriate, meta-analysis will be performed. We will analyse continuous outcomes using weighted mean differences (with 95% CIs) or standardised mean differences (with 95% CIs) if different measurement scales are used. We will use subgroup and sensitivity analyses to explore heterogeneity. The overall certainty of evidence will be assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) tool.

Ethics and dissemination

Ethical approval is not applicable for this study because no primary data have been collected. This review will be disseminated through peer-reviewed publication and presented at conferences to inform ongoing educational practises.

PROSPERO registration number

CRD420251136479.

Methodologies and methods for the development, evaluation and implementation of psychosocial interventions for dementia: protocol for a scoping review

Por: DAndrea · F. · Bartels · S. L. · Markaryan · M. · Masterson-Algar · P. · Bernal · A. N. · De Bruin · S. R. · Chirico · I. · Flynn · A. · Garcia · L. · Gebhard · D. · Handley · M. · Janssen · N. · Roes · M. · Stephens · N. · Teesing · G. · Van den Block · L. · Windle · K. · Moniz-Cook · E.
Introduction

Research on psychosocial interventions for dementia demonstrates increased rigour and robustness. However, if we are to influence practice, beyond results from randomised controlled trials, a variety of types and sources of evidence is needed. The Medical Research Council (MRC) framework offers a valuable guide for developing, evaluating and implementing complex interventions, to facilitate integration of research into practice. There is limited knowledge of how researchers design, evaluate and implement psychosocial intervention studies in dementia, using the MRC framework. This scoping review aims to: (1) identify the methodological and methods trends, use and gaps in the development, evaluation and implementation of psychosocial interventions for dementia, and (2) determine if and how the MRC six core elements were considered and applied in studies.

Methods and analysis

Six databases (Ovid MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, Cochrane Library) will be searched for studies published from 2015 (when MRC process guidance was published) to 2025. Identified deduplicated citations will be imported into Covidence software, where up to 40% of title/abstracts will be double screened by independent reviewers. ASReview will be used to rank articles by relevance, with a stopping criterion of 250 consecutive irrelevant articles. Full texts will be reviewed by a single reviewer and those excluded will be checked by a second reviewer. Data extraction will include study aim/objective (ie, to develop/adapt; test feasibility/pilot; evaluate; implement); methodology and methods applied; information on which MRC six core elements were considered (yes/no), and if so, how they were addressed (ie, qualitative details). A narrative synthesis, alongside graphical representations (eg, table/bar charts/histograms), will be used to synthesise findings on methodologies and methods mapped onto the MRC framework.

Ethics and dissemination

This secondary analysis scoping review does not require ethics approval. Results will be disseminated through peer-reviewed publication(s), seminars, webinars, conferences, postgraduate dementia programmes, blogs, commissioner briefings and social media. The findings will provide a state-of-the-art overview of current practices; advance methods/methodology such as informing a Delphi consensus study on appropriate research approaches; and guide researchers in application of the MRC framework to widen the scope of dementia care evidence for practice improvements.

Registration

Submitted to Open Science Framework https://doi.org/10.17605/OSF.IO/S56NQ.

Self‐Care Experiences and Support Needs of Community‐Dwelling Older Adults With Multimorbidity: A Qualitative Study Informed by the Caring Life‐Course Theory

ABSTRACT

Aim

To explore how community-dwelling older adults with multimorbidity experience, enact and navigate daily self-care using the Caring Life-Course Theory to identify opportunities for strengthening self-care and self-management support.

Design

Qualitative descriptive study.

Methods

Semi-structured interviews were conducted with community-dwelling older adults aged ≥ 50 years living with two or more chronic conditions across three Australian states and territories. Data were analysed inductively and deductively using qualitative content analysis. Inductive coding was followed by theory-informed analysis to interpret self-care capability, capacity, care networks and system supports.

Results

Eighteen participants (mean age = 70.9 years) described self-care as an adaptive, experience-based process influenced by lived experience, health transitions, informal care networks and system responsiveness. Participants generally demonstrated agency and resourcefulness in managing complex and changing care needs, often learning through trial and error. Psychosocial and relational needs were frequently under-recognised in healthcare encounters, requiring individuals and informal carers to compensate for fragmented, inconsistent support. Self-care capability and capacity were shaped by experiential learning, health and self-care literacy and access to informal and online resources, particularly where formal education was limited or unavailable.

Conclusion

Self-care for older adults with multimorbidity is shaped by dynamic interactions between personal capability, relational support and system-level factors across the life-course. The Caring Life-Course Theory provides a comprehensive approach for understanding these interdependencies and identifying opportunities for intervention.

Implications for the Profession and/or Patient Care

Findings highlight the need to strengthen coordinated, person-centred and relationally grounded approaches to self-care and self-management in primary and community care, including improved access to evidence-informed resources and anticipatory support.

Reporting Method

This study is reported in accordance with the Consolidated Criteria for Reporting Qualitative Studies.

Patient or Public Contribution

Participants contributed through semi-structured interviews and provided feedback on study findings.

Impact

What problem did the study address? Community-dwelling older adults living with multimorbidity are expected to engage in self-care, yet little is known about how they experience, enact and sustain daily self-care, particularly when psychosocial and relational needs are inconsistently recognised within health and social care systems. What were the main findings? Self-care was characterised as an adaptive, experiential process shaped by life experience, informal support networks and system responsiveness. Participants frequently compensated for under-recognised psychosocial and relational needs through informal and online supports and resources. Where and on whom will the research have an impact? Findings can inform clinicians, service providers and policymakers in primary, community and aged care settings by identifying opportunities to strengthen coordinated, person-centred and relational self-care and self-management support for older people with multimorbidity.

Hospitalizations associated with endemic and non-endemic mosquito-borne arboviruses in Canada, 2002–2023

by Maria Elizabeth Mitri, Antoinette Ludwig, Joanne Tataryn, Salima Gasmi, Mandy Whitlock, Peter A. Buck, Annie-Claude Bourgeois

Mosquito-borne arboviruses pose a growing public health concern in Canada, particularly in the context of climate change and increased global travel. This study aimed to quantify the burden of endemic and non-endemic mosquito-transmitted arboviral diseases in Canada by examining hospitalization trends from 2002 to 2023. Using administrative hospital data from the Canadian Institute for Health Information (CIHI) and national West Nile virus (WNV) surveillance data, we analyzed patient demographics, temporal and spatial patterns, and disease classification. Hospitalizations were classified as endemic (e.g., WNV) or non-endemic (e.g., dengue, chikungunya, Zika, yellow fever) based on historical presence and vector establishment in Canada. A total of 2,470 unique hospitalizations were identified, with 56.4% attributed to endemic diseases and 39.7% to non-endemic diseases. WNV accounted for over 99% of endemic-related hospitalizations, with peaks in 2003, 2007, and 2012 aligning with national surveillance data. Hospitalizations were highest among males aged 75–79 years, particularly in the southern regions of Saskatchewan, Manitoba, and Ontario. Non-endemic disease hospitalizations, primarily due to dengue and chikungunya, increased after 2010 and were more evenly distributed throughout the year, reflecting travel patterns. Younger adults (20–49 years) were most affected. The study highlights limitations in diagnostic coding and surveillance coverage, particularly the exclusion of Quebec data and underreporting of emerging arboviruses. These findings underscore the utility of hospital administrative data in complementing traditional surveillance systems and identifying populations at risk for severe outcomes. As climate change and travel continue to influence arboviral disease dynamics, integrated data sources are essential for guiding public health planning and response.

Investigating the effects of cannabinoids for the reduction of inflammation and sickle cell disease pain (CRISP); A protocol for a randomized double-blind placebo-controlled study

by Jordan Bellis, Lydia Monk, Ritika Jhawar, Galia Pollock, Angela Liu, Charleen Jacobs-McFarlane, Brittany McCrary, Jeffrey Glassberg, Susanna Curtis

Sickle Cell Disease (SCD) is a hemoglobinopathy affecting millions of people globally. Pain, both acute and chronic, affects over half of those living with SCD, but treatment of chronic pain is an ongoing challenge. While opioid treatments are widely used for chronic pain, it’s efficacy is limited, so alternatives must be explored. This protocol outlines a procedure for investigation of dronabinol, an FDA-approved synthetic tetrahydrocannabinol (THC), for the treatment of pain in patients living with SCD and chronic pain. The study is an 8-week, randomized, double-blind placebo-controlled study which aims to assess both the efficacy and safety of this opioid alternative to pain treatment. The study will also track biomarkers of inflammation as THC has demonstrated anti-inflammatory properties, and inflammation is a driver of SCD pain and disease severity. Results from this study have the potential to further clinical understanding of cannabinoids for pain management in Sickle Cell Disease treatment and spark new questions for research.

‘We've Taken on a More Advanced Clinical Role’: A Multimethod Study of Community Nurses' Extended Roles in Palliative Care

ABSTRACT

Aim

To explore community nurses' experiences of changes to their roles in palliative and end-of-life care.

Design

An e-survey was followed by focus groups.

Methods

Fifty-one community nurses with recent experience of delivering end-of-life care in the United Kingdom completed a survey about changes to their roles. A purposive sample of 35 respondents participated in focus groups exploring these changes in more depth; thematic analysis was used with constant comparison.

Results

As well as two new roles—prescribing and verifying death—many participants talked about a broader expansion of their role, increasing their leadership in making complex end-of-life care decisions with patients and families. Most nurses expressed pride in their new knowledge and skills, and satisfaction with the care they were providing. Yet many also expressed distress that heavy workloads impaired their capacity both to provide good clinical care and to train junior colleagues. The importance of General Practitioner support with complex cases was often highlighted, but accessing such support was sometimes difficult.

Conclusion

While welcoming the opportunity to extend their palliative care roles, many participants indicated experiencing moral distress.

Implications for the Profession and/or Patient Care

Excessive workloads and patchy medical support threaten the retention of the experienced nurses upon whom community palliative care depends.

Impact

Our findings suggest that new and extended palliative care roles are viewed positively by nurses. To be sustainable, these changes require better workload management and consistent medical back-up.

Reporting

We adhered to relevant EQUATOR guidelines, using the SRQR checklist.

Patient or Public Contribution

Our Public and Clinician Advisory Group helped shape questions and commented on findings.

Hemopurifier device in patients with solid tumours who have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab: protocol for an Australian safety, feasibility and dose-finding study

Por: Brown · M. P. · Matos · M. · Clarke · S. · Coates · P. T. · Pollock · C. · Kurtkoti · J. · Grau · G. · Edinburg · K. · Bloesch · A. · de Necochea Campion · R. · Khin · N. Y. · Shin · J. · LaRosa · S. P.
Background

Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.

Methods

This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.

The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.

Ethics and dissemination

The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Trial registration number

Australia New Zealand registration number ACTRN12624000732583.

Health literacy scale for English-speaking children: translation and validation of the HLS-Child-Q15-EN

Por: Drake-Brockman · T. F. E. · Locke · V. · Hauser · N. · Sommerfield · D. · Evans · D. · Sommefield · A. · Khan · N. · von Ungern-Sternberg · B. S.
Objective

To translate and validate the HLS-Child-Q15, a relatively short questionnaire for assessing health literacy in children originally validated in German, into English to make it accessible to a large population of English-speaking children.

Design

We translated the HLS-Child-Q15 into English following established methods, including forward and backward translation, using multiple translators. We incorporated clinician and consumer input into the translation process. We conducted a qualitative pre-test to assess comprehension and a validation to assess psychometric properties and test-retest reliability.

Setting

Perth Children’s Hospital, Perth, Western Australia

Patients

We recruited English-speaking children aged 8 to 15 years.

Main outcome measures

Qualitative analysis of pre-test interviews, Cronbach’s α coefficient for internal consistency and intraclass correlation coefficient for test-retest reliability.

Results

The translation process yielded an acceptable translation. A qualitative pre-test conducted with 10 children demonstrated good comprehension of questionnaire items and resulted in small changes to increase item clarity. Validation with 207 participants demonstrated that questionnaire output score increased with age, school year, self-efficacy score, parental educational level and home literacy environment score. Internal consistency was assessed, with a Cronbach’s α coefficient of 0.854 (95% CI 0.812 to 0.887). Test-retest reliability was moderate, with an intraclass correlation coefficient of 0.612 (95% CI 0.402 to 0.761).

Conclusions

The translated HLS-Child-Q15 was well understood by children. Validation of the translated questionnaire demonstrated adequate psychometric properties, consistent with the original German questionnaire. The translated HLS-Child-Q15 is suitable for use with English-speaking children.

Data availability statement

Data are available on reasonable request and in compliance with institutional ethics and governance requirements.

Trial registration number

ACTRN12622001499774

Prevention of Infections in Cardiac Surgery (PICS)-Prevena Study – A pilot/vanguard factorial cluster cross-over RCT

by Thomas C. Scheier, Richard Whitlock, Mark Loeb, Philip James Devereaux, Andre Lamy, Michael McGillion, MacKenzie Quantz, Ingrid Copland, Shun-Fu Lee, Dominik Mertz

Sternal surgical site infections after cardiac surgery can lead to significant morbidity, mortality, and cost. The effects of negative pressure wound management and adding vancomycin as perioperative antimicrobial prophylaxis are unknown. The PICS-PREVENA pilot/vanguard trial, a 2x2 factorial, open label, cluster-randomized crossover trial with 4 periods, was conducted at two major cardiac surgery hospitals in Ontario, Canada. Sites were randomized to one of eight sequences of the four study arms (Cefazolin or Cefazolin + Vancomycin (not analyzed) and standard wound dressing or a negative pressure 3M Prevena incision management system (Prevena). Only diabetic or obese patients were eligible for the latter comparison. This trial investigated feasability including adherence to protocol of each intervention (goal: > 90% each) and loss to follow-up (goal: 

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.

What is known about flexible assertive community treatment across populations and contexts? A scoping review protocol

Por: Tang · F. · Evans · C. · Bogdan · A. · Bullock · H. · Westen · K. · Kroon · H. · Delespaul · P.
Introduction

The objective of this scoping review is to elucidate contexts in which Flexible Assertive Community Treatment (FACT) has been utilised, which populations it has served, how it has been adapted and what outcomes it has achieved. FACT is a model of mental healthcare where patients are transitioned along a continuum of high-intensity outreach-based treatment and lower-intensity case management, according to need. Despite being adopted globally, a review of the evidence on the FACT model has not been conducted since 2014.

Methods and analysis

This study will follow the Joanna Briggs Institute’s (JBI) methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A structured search of several electronic databases (MedLine, CINAHL, PsycINFO, Psychology & Behavioural Sciences, Embase, Scopus, Sociological Abstracts and ASSIA Social Sciences Index Abstracts) will be conducted to locate relevant studies addressing models of care that adhere to the core components of the FACT model and that were published in English or Dutch from 2003 (model conception date) to the present day. To explore the range of populations served by FACT, we will not limit participant populations by age or diagnosis. With respect to FACT adaptations, we will include articles that explore modifications to the structure of FACT such as staffing complement, caseloads or interface with other health and social services. Articles identified from our structured searches will be screened independently by two reviewers. Data from included articles will be extracted, analysed and presented on tables and visual graphs, and summarised in a narrative report.

Ethics and dissemination

Our scoping review does not require ethics approval as it does not involve human subjects and will draw evidence from published peer-reviewed articles. Our findings will be disseminated through journal publication, presentations at relevant conferences and distribution across our networks and those of our partners, including healthcare providers, researchers and other key stakeholders.

Impacts of Global School Feeding Programmes on Childrens Health and Wellbeing Outcomes: A Scoping Review

Por: Locke · A. · James · M. · Jones · H. · Davies · R. · Williams · F. · Brophy · S.
Objectives

School feeding programmes (SFPs) are widely implemented to address child poverty, food insecurity and malnutrition, yet evidence on their influence on children’s health outcomes is limited. With ongoing debate around universal versus targeted provision, this scoping review aims to map global literature on SFPs, identify which health and well-being outcomes are reported, and explore how these outcomes vary by programme type (targeted vs universal).

Design

Scoping review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The protocol was pre-registered on the Open Science Framework.

Data sources

Four electronic databases—Medline, PubMed, Web of Science and Google Scholar—were searched in December 2023 and July 2025. Reference lists of included papers were also screened.

Eligibility criteria

Included studies examined the impact of SFPs on physical, emotional, psychological and social health outcomes in children aged 5–16. Only English-language studies published between 2009 and 2025 were included.

Data extraction and synthesis

Data were extracted using a structured template and reviewed by multiple authors. Due to the heterogeneity in study designs and reported outcomes, a narrative synthesis approach was used to group findings thematically, following established guidance for narrative synthesis in systematic reviews.

Results

A total of 44 papers were included in the final review, spanning 13 countries and published between 2009 and 2025. SFPs were associated with healthier weight status, improved dietary intake, better social engagement and reductions in stigma. Targeted programmes addressed food insecurity but were more often linked to stigma and poorer mental health outcomes.

Conclusions

Universal SFP were effective at improving children’s health outcomes such as healthy weight, improved behaviour and social support. Overall, both targeted and universal SFP positively impact children’s health outcomes and address health disparities.

Phase II randomised controlled basket feasibility trial of a personalised, remotely delivered exercise programme on disease-free survival among early-stage, high-risk cancers: CANFit study protocol

Por: Bullock · A. F. · Cohen · J. · Huang · C. · Jackson · G. · Lind · M. · Pearson · M. · Richardson · G. · Saxton · J. · Twiddy · M. · Wilson · C. · Forbes · C.
Introduction

Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.

Methods and analysis

This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.

Ethics and dissemination

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.

Trial registration number

ISRCTN97662203.

Understanding why resident doctors leave the NHS and what can be done to retain them: protocol for a realist synthesis

Por: Klepacz · N. · Melvin · A. · Briscoe · S. · Carrieri · D. · Lock · F. K. · Patel · P. · Teoh · K. · Wong · G. · Mattick · K.
Introduction

The UK’s medical workforce is under increasing strain, and this is compounded by increasing numbers of resident doctors diverging from specialist training pathways, instead entering non-training roles, reducing clinical hours or leaving the profession or UK workforce entirely. These decisions are shaped by both individual motivations and wider structural conditions, including unsatisfactory working conditions, limited flexibility and a perceived lack of support or autonomy. While pursuing alternative career routes offers personal and professional benefits, they can also delay progression to senior clinical roles, contributing to workforce instability. There remains limited understanding of how best to support retention, particularly given the varied contexts, settings and career trajectories of resident doctors. This realist synthesis will examine how, why and in what contexts resident doctors leave the National Health Service, and what interventions might support their retention.

Methods and analysis

This realist synthesis will follow Realist And Meta-narrative Evidence Synthesis: Evolving Standards guidance and will be conducted in five iterative steps: (1) identifying existing theories to develop an initial programme theory; (2) undertaking formal and purposive searches to identify relevant UK-based literature; (3) selecting documents based on relevance and rigour; (4) extracting and coding data to support the development of explanatory insights; and (5) synthesising findings using a realist logic of analysis to develop and refine context-mechanism-outcome configurations. An advisory group will guide the review throughout. The final programme theory will inform the development of evidence-based recommendations and design principles to support resident doctor retention.

Ethics and dissemination

Ethical approval is not required for this synthesis of existing literature. Findings will be disseminated through academic publications, conference presentations and accessible formats, including infographics, plain English summaries and blog posts. Target audiences include resident doctors, medical educators, workforce planners and policymakers.

Study registration

PROSPERO, CRD420251004453.

Prioritising methodological research questions for scoping reviews, mapping reviews and evidence and gap maps for health research: a protocol for PROSPECT Delphi study

Por: Pollock · D. · Hasanoff · S. · McBride · G. · Kanukula · R. · Tricco · A. C. · Khalil · H. · Campbell · F. · Jia · R. M. · Alexander · L. · Peters · M. · Vieira · A. M. · Aromataris · E. · Nunn · J. · Saran · A. · Evans · C. · Godfrey · C. · Pieper · D. · de Moraes · E. B. · Biesty · L. · Co
Introduction

Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.

Methods and analysis

A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.

Ethics and dissemination

This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.

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