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What are the characteristics and impacts of a patient-led conference? A qualitative study

Por: Magel · T. · Strain · K. · Samson · A. · Richards · D. P. · Mulhall · H. · Khan · K. M. · Lingard · L.
Background

Patient engagement is the practice of "meaningful and active collaboration [of patient partners] in governance, priority setting, conducting research and knowledge translation." Patient engagement has been implemented in various settings including clinical, research, and quality improvement, with varying levels of patient contributions and decision-making responsibility. However, little is known about the experiences of patient partners who are in leadership roles in patient-led events. For Patients, By Patients (PxP) is an annual, virtual, patient-led conference that focuses on topics important to patient partners in research. Each year’s PxP steering committee is comprised of those with patient experiences and consequently, offers an opportunity for our research team to explore patient leadership within a conference setting. Understanding more about the intricacies of patient-led events is necessary if we wish to support patient leadership as a valuable form of patient engagement.

Objectives

The aim of this study was to explore (1) the benefits and challenges experienced by PxP steering committee members in a patient-led event and (2) how to better support patient leadership.

Design

We conducted a qualitative descriptive study of semi-structured virtual interviews with PxP conference steering committee members. Thematic analysis was used to identify core themes that were salient to the data.

Setting

The Canadian Institutes of Health Research-Institute of Musculoskeletal Health and Arthritis in Vancouver, Canada, and an international virtual setting via Zoom from January 2025 to April 2025.

Participants

Purposive sampling was used to conduct interviews with thirteen PxP patient partner steering committee members.

Results

Four core themes were identified in the data: (1) institutional support: how institutions can support patient leadership, (2) steering committee environmental characteristics: what characteristics are conducive to patient leadership, (3) personal growth: how patient leadership promotes growth among patient partners and (4) new possibilities: how patient-led events foster future expansion and opportunities. Power dynamics, intersectionality, and accessibility were also identified as central to supporting patient leadership and building safe and supportive environments.

Conclusions

Patient partners are capable of leading events which promote interpersonal relationships and advance patient engagement practices and governance. Important facilitators include institutional support and governance that considers power dynamics, accessibility and intersectionality.

Gender Justice in the Triple Planetary Crisis: A Scoping Review

ABSTRACT

Aim

To identify and report how gender justice is conceptualised and discussed in contemporary health literature in relation to the Triple Planetary Crisis of climate change, pollution and biodiversity loss, with a particular focus on the experiences of women and gender-diverse populations, and the representation of nurses and other healthcare professionals dominated by women.

Design

Scoping review.

Data Sources

Searches were conducted across MEDLINE (Ovid), Scopus, CINHAL, Embase and ProQuest, focusing on studies published from January 1 2000–23 September 2024.

Review Methods

The review was conducted in accordance with the JBI methodology for scoping reviews and reported against the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Data were extracted according to a pre-specified extraction framework, developed a priori, encompassing components of gender justice and intersectionality.

Results

A total of 39 studies were included: 17 (43.6%) qualitative, 17 (43.6%) quantitative and 5 (12.8%) mixed methods. The focus of the studies included gendered experiences of climate change (30.8%), decision-making and governance (20.5%), health and wellbeing (17.9%), women's economic participation (15.4%), cultural and spiritual connections to land (7.7%), and intersectionality and human rights (7.7%). Gender-diverse populations, nurses and other healthcare professions dominated by women were not represented in the literature.

Conclusion

The literature reported that women experienced differentiated exposure to the Triple Planetary Crisis. The underrepresentation of gender diverse people and nurses in recent studies remains a significant barrier to advancing understanding of gender justice. Integrating gender justice into health systems is increasingly important to prevent women from being disproportionately impacted by the Triple Planetary Crisis.

Impact

More attention to inclusion of frontline healthcare professionals, including nurses, in governance, policy discussions and leadership roles could strengthen the response to systemic environmental threats.

Patient or Public Contribution

No patient or public involvement.

Role of psychosocial factors in muscle performance and response to outpatient supervised exercise-based physical therapy in individuals with chronic low back pain: a prospective cohort analysis

Por: Lebens · R. · Havandjian · L. · Zavareh · A. · Taitano · L. · Richards · C. · Raiszadeh · K. · Shahidi · B.
Objective

The purpose of this study is to evaluate the relationship between psychosocial factors, muscle performance and treatment response in individuals undergoing an exercise-based physical therapy (EBPT) programme for chronic low back pain (CLBP).

Design

A secondary analysis of a prospectively collected clinical registry involving participants with CLBP enrolled in an 8–10-week EBPT programme. Participants completed psychosocial questionnaires before starting EBPT for CLBP. Lumbar extensor muscle performance was assessed using an isokinetic dynamometer, which recorded absolute and age and sex adjusted torque. Differences in muscle performance (absolute and adjusted) were calculated and regressed against psychosocial factors and clinical outcomes.

Results

Absolute and adjusted torque increased with treatment (33.33% and 82.84% respectively, p0.20).

Conclusion

Individuals with CLBP demonstrated improved muscle performance and clinical outcomes after EBPT, though these improvements were independent of each other. Better absolute lumbar extensor muscle performance correlated with higher pain self-efficacy, and greater treatment response corresponded with lower fear-avoidance. These data suggest that pain coping strategies and addressing fear avoidance through educational and exposure-based interventions may be a target for modifying muscle performance in CLBP.

Blood Cancer Clinical Trials Long-term Follow-up Using Integrated Healthcare Systems Data (BLISS): protocol for a data-linkage study integrating randomised clinical trials with national healthcare systems data

Por: Smith · L. · Hoang · J. · Gillson · S. · Richards · J. · Cook · G. · Brown · S. · Royle · K.-L. · Roberts · S. · Olivier · C. · Parish · C. · Spencer · K. · Thompson · S. · Cairns · D. A.
Introduction

Randomised clinical trials (RCTs) are gold standard in evidence-based medicine, but follow-up typically relies on clinic visits and trial-specific data collection. Much of this information overlaps with routinely collected healthcare systems data (HSD), such as electronic health records and national registries. Leveraging HSD for trial follow-up has the potential to reduce cost, time and resource burden. However, concerns remain about data quality and evidence is needed to show that HSD-based outcomes are reported to an equivalent standard to trial-specific data.

The Blood Cancer Clinical Trials Long-term Follow-up Using Integrated Healthcare Systems platform will link data collected from multiple myeloma clinical trials with HSD to create a research database supporting extended follow-up and further methodological and clinical research.

Methods and analysis

This data-linkage study includes participants from multiple myeloma RCTs conducted by the University of Leeds between 2008 and 2021. NHS (National Health Service) England will link these participants to HSD, including deaths and cancer registrations, systemic anticancer therapy, radiotherapy and Hospital Episode Statistics.

We will compare trial-collected outcomes with those derived from HSD, including mortality, treatment, second cancer incidence and major adverse events. Long-term overall survival will be estimated using national mortality data. HSD-derived demographic and clinical variables will be used to assess population representativeness relative to the wider myeloma population. Time to next treatment will be derived and evaluated as a surrogate for progression-free survival. HSD-derived frailty measures will be examined for prognostic utility, and radiotherapy and hospital records will be analysed to characterise bone-related treatments and skeletal complications.

Ethics and dissemination

Ethical approval has been obtained from the East of England–Cambridge Central Research Ethics Committee, with Section251 support from the Health Research Authority on advice from the Confidentiality Advisory Group. Findings will be disseminated through publications, conference presentations and engagement with stakeholders and patient groups.

Trial registration

ISRCTN60123120, ISRCTN49407852, ISRCTN90889843, ISRCTN24989786, ISRCTN08577602, ISRCTN17354232,ISRCTN59395590, ISRCTN24593488, ISRCTN58227268, ISRCTN15028850.

Patient engagement, shared decision-making and equity, diversity and inclusion considerations in research ethics board application forms and templates in Canada: a mixed methods study

Por: Morgan · T. L. · Carroll · K. · Mosa · M. · Hudek · N. · Richards · D. P. · Marlin · S. · Meeking · K. · Etherington · C. · Presseau · J. · Brehaut · J. C.
Objectives

Equity, diversity and inclusion (EDI), patient engagement and shared decision-making are important considerations throughout clinical trials, including the research ethics review stage. Meaningfully integrating these considerations can enhance the relevance and generalisability of trial results and reduce participation barriers among equity-deserving populations. Presently, it is unclear to what extent such guidance is provided at the ethics application stage for clinical trials. This study aimed to report the degree of guidance on EDI, patient engagement and shared decision-making in clinical trial research ethics documents.

Design

This was an embedded mixed methods study conducted in collaboration with Clinical Trials Ontario.

Setting

This study analysed research ethics board (REB) forms and templates from 17 institutions across seven provinces in Canada.

Participants and methods

15 REB application forms, 9 protocol templates and 17 informed consent document (ICD) templates were assessed for guidance related to EDI, patient engagement and shared decision-making. The Place of residence, Race, ethnicity, culture and language, Occupation, Gender and sex, Religion, Education, Socio-economic status, Social capital (PROGRESS)-Plus framework, International Association for Public Participation Spectrum of Public Participation, Patient-Oriented Research Level of Engagement Tool, Indigenous Research Level of Engagement Tool and shared decision-making standards guided our coding. We engaged with patients and persons with lived experience to inform interpretation, reporting and dissemination.

Results

EDI guidance from 15 ethics application forms and 9 protocol templates predominantly covered the ‘Race, ethnicity, culture, language’ (n=14; 93.3%), ‘Age’ (n=13; 86.7%) and ‘Gender and sex’ (n=12; 80%) categories of PROGRESS-Plus but lacked nuance on diverse gender identities (n=1; 6.7%). Patient engagement guidance mostly covered the ‘inform’ level (n=7; 46.7%) and applying ‘knowledge in practice’ with non-Indigenous (n=7; 46.7%) or Indigenous communities (n=13; 86.7%). All 17 (100%) ICD templates included guidance on information about options, disclosures, key elements, ethical issues and study design. No guidance was available on time-dependent relationships, empowering patients and communities in co-leading trials or providing structured guidance in making trial participation decisions (all n=0; 0%).

Conclusions

We provided a comprehensive view of EDI, patient engagement and shared decision-making guidance in trial ethics applications in Canada. REB guidance may be strengthened in several areas to support the inclusion of equity-deserving populations in trials, meaningful engagement with patients and Indigenous communities and evidence-informed, values-aligned decisions about trial participation.

Cancer survival and its social determinants among children with a migrant background: systematic review protocol

Por: Rajabzadeh · V. · Sami · A. · Harila · A. H. · Richards · D. A. · Woodford · J. · von Essen · L.
Introduction

Childhood cancer survival rates are not equal for all, with disparities existing both between and within low- and middle-income countries and high-income countries, particularly among ethnic minorities and children with migrant backgrounds. Factors such as cultural misunderstandings, language barriers and limited support networks can lead to delays in diagnosis and treatment challenges, which can result in poor health outcomes. Social determinants of health (SDoH), such as housing insecurity and poverty, may worsen these disparities. This protocol outlines a systematic review to examine childhood cancer survival in children with migrant backgrounds compared with non-migrants and to explore the SDoH associated with these survival outcomes.

Methods and analysis

We will search MEDLINE (PubMed), Scopus, Web of Science, and Embase for relevant studies, with secondary searches of grey literature. Two reviewers will screen for observational studies, including longitudinal cohort, case–control, cross-sectional and registry-based studies, that report childhood cancer survival outcomes (eg, survival rates, HRs) for both migrant and non-migrant populations. A narrative synthesis will explore SDoH and their association with survival outcomes. If data allow, we will perform random-effects meta-analyses to estimate pooled survival outcomes. Subgroup analyses will examine factors such as geographic region, migration status and type of cancer.

Discussion

Understanding factors contributing to childhood cancer survival disparities in migrant populations is critical for informing the development of targeted strategies to address them, ensuring all children, regardless of their migration status, have an equitable opportunity for effective care and improved outcomes.

Ethics and dissemination

Ethical approval is not required for this study as it is based on previously published data and does not involve primary data collection. We will publish the results in peer-reviewed journals and present at academic conferences.

PROSPERO registration number

CRD42024547239.

Rehabilitation intervention to improve Recovery after an Episode of Delirium in adults over 65 years (RecoverED): a multicentre, single-arm feasibility study in NHS acute hospitals in the UK

Por: Allan · L. · Um · J. · OConnell · A. · Raghuraman · S. · Bingham · A. · Laberick · A. · Chandler · K. · Connors · J. · Mahmoud · A. · Hawton · A. · Goodwin · E. · Morgan-Trimmer · S. · Goodwin · V. A. · Ukoumunne · O. C. · Jackson · T. A. · Richardson · S. J. · Collier · L. · Glasby · J.
Objectives

To test a theory-informed, person-centred rehabilitation intervention for older adults following a hospital admission complicated by delirium, developed in line with the Medical Research Council framework for complex interventions, to determine whether: (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible.

Design

Multicentre, single-arm feasibility study.

Participants

19 patient (aged >65 years old) and carer pairs were recruited from six National Health Service acute hospitals across the UK.

Intervention

Home-based rehabilitation programme designed to support recovery after hospital discharge, addressing cognitive, physical, physiological and psychosocial needs. Delivered by a trained team of occupational therapists, physiotherapists and rehabilitation support workers, the intervention included a comprehensive home assessment, collaborative goal setting, up to 10 personalised sessions over 12 weeks and the use of a recovery record to guide progress, education and psychosocial support.

Outcome measures

Examined aspects of feasibility including eligibility, recruitment, data collection, attrition, acceptability of the rehabilitation intervention and potential to calculate cost-effectiveness.

Results

In total, 419 patients were identified as having delirium and 36 met the full eligibility. 19 patient and carer pairs agreed to participate in the study (consent rate 53%; 95% CI 35% to 70%) with 13 participants going on to start the intervention (68%; 95% CI 43% to 87%) and 10 participants completing final follow-up (53%; 95% CI 29% to 76%). Baseline assessments were conducted either during hospitalisation or postdischarge, with initial assessments occurring a mean of 18 days (SD=13.0) postdischarge, and 77% completed within 14 days. Participants completed a mean of eight sessions (SD=2.9). 19 participants completed the primary outcome at baseline, while 10 participants completed it at 6-month follow-up. The economic evaluation indicated a total cost of £1249.29 per participant, covering assessments, intervention sessions and training costs.

Conclusions

The intervention showed feasibility among older adults recovering from delirium, as evidenced by the trial processes for participants who entered the study. However, recruitment challenges indicate a need for better strategies and further research through a definitive randomised controlled trial to demonstrate the effectiveness and cost-effectiveness of the intervention.

Trial registration number

ISRCTN15676570

Supported implementation of tailored hospital fall prevention interventions: a protocol for the PROTECT stepped wedge type I hybrid effectiveness-implementation trial

Por: McLennan · C. · Hassett · L. · Tilden · W. · Naganathan · V. · Haynes · A. · Jennings · M. · Ni Chroinin · D. · Richards · B. · Hallahan · A. · Biswas · R. K. · Kwok · W. · McVeigh · T. · Heppleston · E. · Jackson · D. · Nayak · V. · Delaney · S. · Howard · K. · Pinheiro · M. · Macpherson
Introduction

Patient falls in hospitals lead to patient harm, staff distress and economic burden on health systems. There are few strategies with robust evidence demonstrating benefit for the prevention of falls, especially in acute hospital settings. Education and multicomponent fall prevention approaches are promising. Rigorous systematic measurement of implementation has been lacking in most hospital fall prevention trials. This paper describes the protocol for a trial that will evaluate the impact of supported implementation of tailored multicomponent fall prevention interventions on patient falls in hospital.

Methods and analysis

A stepped-wedge hybrid type I effectiveness implementation cluster randomised trial will be conducted. Twelve inpatient wards across four metropolitan hospitals will be enrolled in the trial, clustered into groups of four and randomised to commence the intervention at one of three time periods. Patients and ward staff will be recruited to complete pre-implementation surveys, which, combined with analysis of routinely collected local falls data and staff brainstorming, will inform tailored multicomponent fall prevention interventions for each ward. Wards will receive quality improvement training, clinical facilitation and staff education for at least 4 months to support implementation of their fall prevention interventions. The primary outcome—rate of falls—will be measured using routinely collected hospital falls data from the incident management system and medical records. Pre-implementation and post-implementation patient and staff surveys, qualitative interviews and bedside audits will measure secondary effectiveness and implementation outcomes. Healthcare utilisation from hospital data will inform the cost-effectiveness analysis.

Ethics and dissemination

The Sydney Local Health District Human Research Ethics Committee (RPAH Zone) approved this trial (protocol number X24-0087 and 2024/ETH00583). The trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572). Data collection commenced in October 2024, due for completion in May 2026. Results will be published in reputable international journals and presented at relevant conferences.

Trial registration number

Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572).

Black Women as Superwomen; Health Disparities and the Cost of Strength: A Discursive Paper

ABSTRACT

Aim

Historically, Black women have been positioned as primary caretakers and problem-solvers, often expected to bear disproportionate responsibility during times of crisis. There is an enduring image of Black women possessing exceptional strength handed down through generations, captured in the sociocultural phenomenon known as the superwoman schema, or SWS. The aim of this discursive review is to explore health disparities among Black women related to the SWS.

Design

A discursive paper.

Methods

A literature search was conducted in PubMed, Scopus and Google Scholar to identify relevant papers published from 2016 to 2025 that addressed health disparities among Black women.

Discussion

Through literature review, we identified three critical areas of health disparities associated with mental health disorders, maternal mortality and breast cancer, reflecting the influence of inequitable practices embedded within healthcare systems and society. Nurses, advanced practice nurses and other healthcare providers must prioritise identifying and addressing barriers that hinder access to quality healthcare for Black women. Many providers remain unaware of how depressive symptoms, chronic stress and social determinants impact maternal, mental and breast health outcomes. Encouraging Black women to prioritise mental health, engage in routine prenatal care and seek early breast cancer screening is critical to improving health outcomes. By understanding the historical, societal, and personal contexts of the SWS, nurses can clarify both its benefits and challenges for Black women.

Feasibility of an adjunctive INtervention for Debilitating symptom complexes attributed to ticks (FIND): study protocol for a randomised, waitlist-controlled feasibility trial

Por: Kanaan · R. A. A. · Macdonell · R. · Long · M. · Richardson · R. J. · Rogers · C. · Mcmanus · M. · Braat · S. · Zaloumis · S. · Mihalopoulos · C. · Chatterton · M. L. · Gibney · K. B. · Oliver · G. · Wilson · S. J. · Chalder · T.
Background

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.

Methods

We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.

Ethics and dissemination

The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.

Trial registration number

ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.

Exploring patient navigation services in physical activity for people with chronic conditions in Canada: a rapid review protocol

Por: Cheung · L. · Tseung · V. · Abreu · J. · Park · J. · McKenney · S. · Pinili · K. · Bello · C. · Singh · H. · Smith-Turchyn · J. · Richardson · J. · Tang · A.
Introduction

Adults living with chronic conditions may need to access health programmes to mitigate health-related challenges that persist long after discharge from the hospital. Community physical activity programmes represent critical opportunities for health promotion and chronic disease self-management that can extend beyond hospital-based services. However, navigating the healthcare system and connecting to much-needed physical activity programmes can be challenging due to fragmentation of the health and social care system, especially for those who are transitioning between different healthcare providers, settings, stages of recovery and funding sources (eg, public, private). Patient navigation services can assist with this fragmentation by providing tailored support to individuals with chronic conditions. However, our understanding of patient navigation services in Canada is limited. This rapid review seeks to explore the landscape of patient navigation services supporting Canadians with chronic conditions in connecting to physical activity programmes in the community.

Methods and analysis

The rapid review will follow the recommendations published by Garritty et al in 2024. Integrated Knowledge Translation will be employed to facilitate meaningful engagement of people with lived experience of chronic conditions throughout the entire research process. Studies published in English that examine patient navigation services in physical activity for community-dwelling Canadians with chronic conditions will be included. Ovid MEDLINE, Embase, Emcare, CINAHL and Google Canada will be searched for articles published from 1990 to May 2025 to identify the characteristics, strengths and limitations, and prioritised features of patient navigation services for community physical activity programmes. The Mixed Methods Appraisal Tool will be used to assess the quality of included studies.

Ethics and dissemination

This protocol is a rapid review of published literature and does not require ethical approval. Review findings will be disseminated to various key interest groups through publications, presentations, infographics, social media posts and/or videos.

Registration

https://osf.io/gd2zm.

Identifying innovative models of urgent care in rural coastal areas in England: the Elevate study - a mixed-methods protocol

Por: Lampard · P. · Adamson · J. · Anderson · H. · Ballantine · L. · Bell · F. · Benger · J. R. · Blakey · R. L. · Dickinson · P. · Dykes · S. · Gaughan · J. · Maitland-Knibb · S. · Mensah · D. · Ransome · Z. A. · Richardson · G. · Santos · R. · Sheridan · R. · Sivey · P. · Smith · E. · Song · W
Introduction

Urgent and emergency care (UEC) systems in England face unprecedented pressures, with record accident and emergency attendances, persistent breaches of ambulance response targets and poorer outcomes for time-sensitive conditions. National UEC recovery plans have introduced multiple innovations—such as same-day emergency care, virtual wards and specialty hubs—to manage these pressures and improve patient flow. Rural coastal areas are particularly vulnerable to excessive demand due to higher levels of deprivation, older populations with complex health needs, seasonal surges that generate unpredictable demand and challenges in attracting and retaining staff. Following the Chief Medical Officer’s 2021 Annual Report, funding research and developing bespoke solutions to manage UEC demand and address geographical disparities has been recognised as a national priority. The Elevate study responds to this priority by identifying and evaluating innovative models of UEC in rural coastal communities in England.

Methods and analysis

The Elevate study is a 30-month, mixed-methods evaluation that comprises three interlinked work packages: (1) National service mapping—outlining provision of innovative models of UEC in rural coastal areas of England. This will be developed through document review and interviews with regional and national service leaders. (2) Quantitative analysis—quasiexperimental and longitudinal approaches will use National Health Service (NHS) England’s Emergency Care Data Set and linked routine NHS datasets to evaluate the impact of UEC models on health and process outcomes. Standard and bespoke metrics will be developed and used to assess performance. (3) Qualitative case studies—up to 12 case studies of UEC models in rural coastal communities. Interviews with patients and staff and non-participant observation will explore how and why different UEC models influence patient experience, clinical outcomes, resource use and the workforce. Findings will be integrated using the Consolidated Framework for Implementation Research to identify components of UEC models that are effective, scalable and sensitive to local context,

Ethics and dissemination

Ethical approval for qualitative components was granted by the North of Scotland Research Ethics Committee (25/NS/0099). Dissemination will include peer-reviewed publications, policy briefs, creative media and community engagement activities to ensure findings are communicated inclusively and effectively to policymakers, health and social care practitioners and the public.

Trial registration number

Research Registry (researchregistry11126).

Cost-utility analysis of the Circle of Security-Parenting programme to reduce perinatal psychopathology in birthing parents in England

Por: Wang · J. · Rosan · C. · Alyousefi-van Dijk · K. · Darwin · Z. · Babalis · D. · Cornelius · V. · Waddingham · E. · Richards · L. · Pilling · S. · Fearon · P. · Fonagy · P. · Pizzo · E.
Objectives

The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.

Design

A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.

Setting

Secondary care NHS perinatal health services across multiple centres in England.

Participants

A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.

Interventions

Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.

Primary and secondary outcome measures

The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.

Results

Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.

Conclusions

On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.

Trial registration number

SRCTN18308962.

Nursing Students' Perceptions of Acceptable Use of Smartphones During Clinical Placement: A Cross‐Sectional Study

ABSTRACT

Background

The rise in smartphone use presents opportunities and challenges in clinical settings. Despite guidelines restricting mobile phone use, nurses frequently rely on them for various purposes. While beneficial, smartphone use poses risks to information security, patient safety, and care quality, prompting the need for monitoring.

Objective

This study examined smartphone usage among nursing students and their perspectives on acceptable and unacceptable use during clinical placements.

Design

This cross-sectional study used convenience sampling to recruit undergraduate nursing students from five universities in Australia and New Zealand. Participants completed the Attitude Towards Digital Device Use during Clinical Placement (Adduct) Scale online between September 2021 and August 2022. The survey included closed and open-ended questions. Descriptive and inferential analyses were conducted using SPSS. Exploratory factor analysis identified attitudinal dimensions, while group comparisons assessed demographic variations. Qualitative responses were thematically analysed. Reporting followed the Consensus-Based Checklist for Reporting of Survey Studies (CROSS).

Results

Among 279 respondents, drawn from an eligible population of 2682 students, the response rate was 10.4%. Age significantly influenced perceptions of unacceptable smartphone use. Younger students (mean age = 25.0, SD = 9.8) were more likely to view such use as acceptable, with those up to 21 years reporting higher scores on the Unacceptable Use sub-scale compared to older peers (p = 0.024). Most respondents found smartphone use beneficial for accessing information and learning, though concerns included distractions and confidentiality breaches. Younger students were at greater risk of non-adherence to guidelines.

Conclusion

Smartphones can enhance learning and efficiency, but clear guidelines and education are needed to balance benefits with risks, particularly for younger students.

Relevance to Clinical Practice

This study highlights the need for clear guidelines and structured training to balance educational benefits of smartphone use with the risks of distraction and breaches of patient confidentiality in clinical practice.

Patient or Public Contribution

No patient or public pontribution.

Are equity, diversity and inclusion considered in early-phase studies evaluating innovative and developing surgical procedures? Protocol for a scoping review

Por: Etemadi · M. · Macefield · R. · Avery · K. · Elliott · D. · Dawson · S. · Blencowe · N. S. · Coyle · M. · Richards · H. S. · Graham · B. · Jones · E. · Torkington · A. · Chatfield · K. · Malik · H. · Garlick · M. · Blazeby · J.
Introduction

Increased risks and concerns regarding patient safety in early-phase studies exist because knowledge about the new intervention is still accumulating. This means that narrow eligibility criteria are needed. However, if early-phase studies are narrow in their inclusion, for example, by not including diverse populations, there is a potential risk that new therapies have insufficient relevant efficacy and safety data. Existing research has explored equity, diversity and inclusion (EDI) factors in early-phase pharmaceutical studies, but it has not been possible to find studies that have systematically examined whether EDI factors have been considered in surgical studies reporting innovative procedures. We aim to examine how EDI factors are considered in early-phase surgical studies and surgical innovation reports to explore how this may impact on later-phase evaluation and inclusive intervention implementation.

Methods and analysis

A scoping review following the JBI (Joanna Briggs Institute) and Arksey and O’Malley’s five-step process is being conducted. We will search Scopus, PubMed and Web of Science for surgical early-phase studies. A two-step screening process for eligibility is being used. Independent double screening will take place for 20% of the papers. Eligible articles will report early evaluation of an innovative surgical/invasive procedure. Excluded will be comparative and later-phase studies and early evaluations of pharmaceutical products even in a surgical setting. Data on article details, patient eligibility and whether protected characteristics are reported and considered will be extracted. Information about EDI considerations reported in the introduction or discussion of the papers will also be extracted. Findings will be discussed with a patient advisory group. A content synthesis approach will be undertaken and descriptive summaries presented.

Ethics and dissemination

This study does not require ethical approval being a secondary analysis. The findings will be disseminated through academic journal publications and oral presentations.

Adult survivors of sickle cell disease, transfusion-dependent beta-thalassaemia and childhood acute leukaemia in England: protocol for a mixed methods data linkage and health-related quality of life survey study

Por: Ahmed · K. · Holloway · I. · Absolom · K. · Mason · S. J. · Mujica-Mota · R. · Gkountouras · G. · Martin · A. · Flannery · T. · Richards · M. · Astwood · E. · Ackroyd · S. · Greystoke · B. · Greenfield · D. M. · Hill · Q. · James · B. · Kwok- Williams · M. · Murray · R. D. · Samuelson · C
Introduction

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

Methods and analysis

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

Ethics and dissemination

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.

User experience and safety of generative AI-based mental health chatbots: Scoping review protocol

by Lotenna Olisaeloka, Chris Richardson, Daniel Vigo

Introduction

Mental health problems constitute a significant global health challenge due to their rising prevalence and substantial treatment gap. Digital Mental Health Interventions (DMHIs) including mental health chatbots have emerged as promising solutions due to their effectiveness and scalability. Recent advances in Generative Artificial Intelligence (GenAI) have improved the conversational abilities of these chatbots, further amplifying their potential. However, despite instances of inadvertent harm stemming from the unpredictable nature of GenAI, little attention has been paid to user experience and safety of these chatbots.

Objective

This proposed review will explore existing research on GenAI-based mental health chatbots. Specifically, it aims to identify and describe current chatbots, focusing on user experience, safety and risk mitigation strategies.

Methods

The review will follow the Joanna Briggs Institute (JBI) guidelines for conducting scoping reviews. It will also adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review (PRISMA-ScR). A systematic database search of Medline (PubMed), Scopus, PsycINFO, ACM Digital Library, and IEEE Xplore will be conducted. The database search will be complimented by research-based search engines (Google Scholar and Consensus). Studies focusing on the development, evaluation or implementation of GenAI-based mental health chatbots will be included without limitations to specific disorders or population groups. Two independent reviewers will perform screening and data extraction. The analysis will include descriptive summary and thematic analysis, with results presented in tabular, graphical, and narrative formats.

Conclusion

This review will provide a comprehensive overview of GenAI-based mental health chatbots while identifying innovative practices and knowledge gaps relating to user experience and safety. Findings will inform the ethical development, evaluation and implementation of GenAI-based mental health interventions.

Patient experience and preference while waiting for elective cardiac surgery: a mixed-methods cross-sectional survey across four major National Health Service hospitals in London

Por: Russo · M. · Richards · K. L. · Kumar · R. · Burridge · J. · Chaplin · H. · Chua · K.-C. · Hardy · D. · Avlonitis · V. S. · Baig · K. · Bhudia · S. · Noorani · A. · Khan · H. · Petrou · M.
Objectives

Waiting for cardiac surgery is a stressful life event for most patients. Exploring what people experience while waiting and understanding their preferences and views on how waiting time could be improved will help to inform new strategies for more efficacious waiting list management. In this study, we explored experiences and views of people waiting for elective cardiac surgery across four major London hospitals.

Design

Mixed-methods cross-sectional survey, with explanatory concurrent design.

Setting

Four cardiac surgery services across two National Health Service Trusts in London.

Participants

Patients on waiting lists for elective cardiac surgery at Royal Brompton, Harefield, St Thomas and King’s College hospitals between October 2023 and March 2024.

Outcome measures

Experience of waiting for surgery, and preferences about how waiting time could be improved.

Results

554 out of 1041 invited participants agreed to participate (recruitment rate 53.2%). Among them, 274 fully completed the survey (completion rate 49.5%). Most participants (from 52.2% to 70.9%) reported their daily and social activities were impacted by their cardiac condition, and worrying was an ubiquitous feeling (reported by 86%). Psychological distress was reported differently across women and men (higher in women). Eight themes were identified: worrying, daily activities, family/friends and social activities, sexual life, waiting list experience and feelings, communication, most important factors for surgery and suggested improvements. Communication with the surgeon and clinical team, and regular updates on waiting list progress are suggested as crucial factors to alleviate stress, thus potentially improving the experience of waiting for the surgery.

Conclusions

This study highlights the importance of emotional support, clear communication, regular updates on waiting list progress and building trust with the clinical team to improve patient-centred care while waiting for elective cardiac surgery. This finding can offer valuable insights for managing waiting lists in other surgery waiting list contexts.

Trial registration

NCT05996640.

Assessment of greenhouse gas emission of type 2 diabetes management in adults: a modelling study in the UK

Por: Lund · N. · Maslova · E. · Chen · J. · Giannini · J. · Soro · M. · Culligan · I. · Richards · G. · Taneja · L. · Varghese · S. · Li · Y. · Xu · W. · Gonzalez · J. · Valentim · J. · Tour · P. d. L. · Adshead · F. · Moore · K. · Puggina · A.
Background

The carbon footprint of end-to-end healthcare deliveries by the National Health Service in England totalled 25.0 megatons of carbon dioxide equivalent (CO2e) in 2019. Optimal and sustainable healthcare can lead to better health outcomes as well as a lower environmental footprint.

Objectives

To evaluate the potential impact of prevention and effective management of type 2 diabetes mellitus (T2DM) in adults on both the clinical outcomes and greenhouse gas (GHG) emissions in the UK healthcare setting.

Research design and methods

We incorporated an environmental module into the existing IQVIA core diabetes model to estimate the impact of improving clinical outcomes on GHG emissions over a lifetime horizon. We assessed two hypothetical scenarios: (1) preventing progression from pre-diabetes to T2DM through diet and exercise versus no intervention and natural disease progression to T2DM; and (2) well-controlled T2DM using interventions with clinical benefit on glycosylated haemoglobin (HbA1c), and renal and cardiovascular outcomes versus uncontrolled T2DM.

Results

Preventing progression to T2DM led to 6.357 additional undiscounted life years and 67% less kg CO2e emissions compared with subsequent natural progression to T2DM for a person with pre-diabetes over a lifetime (emissions of 9586 kg CO2e over 37.115 years vs 28 716 kg CO2e over 30.758 years, respectively). Well-controlled T2DM led to 1.947 additional undiscounted life years and 21% less kg CO2e emissions per patient over a lifetime compared with uncontrolled T2DM (emissions of 14 545 kg CO2e over 22.772 years vs 18 516 kg CO2e over 20.825 years, respectively). In both scenarios, the GHG emission savings were primarily due to reduced emissions related to avoidance of treating complications of T2DM including cardiovascular, renal and eye diseases.

Conclusion

Effective prevention and management of T2DM through implementation of evidence-based clinical guidelines can improve patient outcomes while reducing the healthcare-related environmental impacts.

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