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Cognitive and physical exercise to improve outcomes after surgery (COPE-iOS) study: protocol for a randomised, controlled trial in the USA examining the efficacy of a combined cognitive and physical exercise programme performed before and after major surg

Por: Rengel · K. F. · Archer · K. R. · Jackson · J. C. · Raman · R. · Orun · O. M. · Ellison · T. · Vanston · S. W. · Ervin · H. · Lauck · A. · Provin · M. · Pandharipande · P. P. · Hughes · C. G.
Introduction

Surgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.

Methods and analysis

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.

Ethics and dissemination

Trial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.

Trial registration number

ClinicalTrials.gov Registry NCT04889417.

Geriatric Models of Surgical Care: A Scoping Review

ABSTRACT

Aim

To synthesise literature on hospital-based geriatric models of care for older adults undergoing surgery, examining structures, team composition, governance and nursing contributions.

Design

Scoping review.

Methods

Following JBI methodology, two reviewers independently screened articles against eligibility criteria (Population: adults ≥ 65 years, Concept: multidisciplinary geriatric surgical care model; Context: acute hospital settings), with conflicts resolved by a third reviewer. Data were extracted and charted for descriptive synthesis.

Data Sources

Six databases (CINAHL, MEDLINE, Embase, Scopus, AgeLine, Cochrane Library) searched for studies published between January 2015 and February 2025.

Results

Of 2753 records identified, 81 studies were included. Models were commonly co-managed between surgical and geriatric teams, implemented at varying surgical pathway points. Orthopaedics represented 57% of studies. Geriatricians were involved in 90% of models; 38% included advanced practice nurses or specialist gerontological nurses. Comprehensive Geriatric Assessment was used in nearly half the studies, typically preoperatively. Considerable heterogeneity existed in model design, professional roles and care settings.

Conclusion

Integrated geriatric perioperative care is expanding globally but remains limited outside orthopaedics. Research should shift from improvement projects to rigorous implementation for sustainable transformation, including nurse-led models. Critical examination is needed of whether current outcomes address comprehensive needs of older surgical patients or primarily optimise hospital flow.

Implications for the Profession and/or Patient Care

Findings highlight opportunities to expand geriatric models beyond orthopaedics and enhance nursing roles, particularly advanced practice nurses, in delivering comprehensive perioperative care for older adults.

Impact

Addressed the gap in understanding how geriatric models of surgical care are operationalised. Identified underutilisation of nursing expertise and limited expansion beyond orthopaedics. Will impact service design, policy development and clinical implementation for older surgical patients.

Reporting Method

Adhered to PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines.

Patient or Public Contribution

No patient or public involvement.

Protocol Registration

Open Science Framework Registries Network.

Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions

Por: Logan · V. · Hughes · D. · Turner · A. · Carter · N. · Jordan · S.
Objectives

We aimed to investigate the feasibility of a cluster randomised controlled trial (RCT) of the ADRe Profile in UK primary care. The ADRe Profile is a patient monitoring system to identify and address adverse drug reactions (ADR) and ADR-related issues to pre-empt clinical deterioration.

Design

A preliminary study to test the feasibility of an RCT.

Setting

General practices (GPs) in South-West Wales, UK.

Participants

20 patients aged >64 and prescribed >4 long-term medicines.

Interventions

Participants reported their health-related problems using the ADRe-Profile. Participants completed the profile independently initially, then with researcher support, capturing vital signs, clinical observations and patient-reported symptoms.

Main outcome measures

Feasibility was assessed based on recruitment, retention, adherence to protocols, potential for clinical impact and staff costs.

Results

We recruited two GP practices (0.94% of 213 contacted), and 20 patients aged >64 (51.3% of those approached). Retention was 100%. ADRe Profiles had a 98.29% completion rate, identifying 289 clinical problems, including pain (16 of 20 patients), dyspnoea (10/20), dizziness (8/20), bleeding/bruising (7/20) and falls (4/20). Most problems (90%) and vital signs (78%) recorded on ADRe Profiles were absent from existing patient records. Researchers recommended further investigations (164 instances) and interventions (126 suggestions). Despite the potential for clinical benefits, engagement from clinicians was limited. Cost estimates for ADRe administration ranged from £40 to £73, within the funding available from Health and Care Research Wales.

Conclusions

An RCT of the ADRe Profile was feasible, despite gatekeeping by clinicians. Recruitment of GP practices was challenging, with

Trial registration number

NCT04663360; Pre-Results.

Assessing uptake of the macular degeneration core outcome set in clinical trials: a cross-sectional study

Por: Oldham · E. · Hall · R. H. · Jones · G. · Modi · J. · Ward · S. · Magee · T. · Fitzgerald · K. · Magana · K. · Hughes · G. · Ford · A. I. · Vassar · M.
Purpose

Establishing comparability between measured outcomes in clinical trials poses a significant obstacle for systematic reviewers. Core outcome sets (COSs) were developed to address this issue. The macular degeneration (MD) COS is designed to standardise outcome measurement across clinical trials for MD. This study investigates the uptake of the MD COS in standardising outcome measurement across clinical trials.

Design

Cross-sectional analysis

Methods

We conducted a search on ClinicalTrials.gov to locate MD clinical trials that were registered 5 years prior to COS publication through the search date of 26 June 2023 and obtained a pool of 2152 registered studies. After applying various inclusion and exclusion criteria, we analysed 159 trials. We then analysed the COS uptake using an interrupted time series analysis (ITSA) and performed performed analyses of variance (ANOVAs) and Pearson correlations to evaluate associations between trial characteristics and outcome measurement.

Results

ITSA showed no significant change in uptake following the MD COS (2016): mean percentage of completion of the COS increased by 0.24% per month before publication (p=0.27) and by 0.07% per month after publication (p=0.62), indicating no meaningful post-publication slope change in COS use. For context, visual acuity was most commonly measured, while several patient-reported and disutility domains were infrequently captured.

Conclusion

No discernible patterns in COS usage for MD trials were observed. We recommend further collaboration between regulators and COS developers to help with COS uptake. Additionally, we suggest that further studies analyse adherence to COSs in respect to regulatory recommendations.

International evaluation of the SEIZUre Risk in Encephalitis (SEIZURE) score for predicting acute seizure risk

Por: Hughes · T. · Venkatesan · A. · Hetherington · C. · Egbe · F. N. · Netravathi · M. · Thakur · K. T. · Baykan · B. · Hui Jan · T. · Arias · S. · Garcia-de Soto · J. · Kahwagi · J. · Vogrig · A. · Versace · S. · Habis · R. · Sowmitran · S. · Husari · K. S. · Probasco · J. · Hasbun · R. · Bea
Objective

Encephalitis is brain parenchyma inflammation, frequently resulting in seizures which worsens outcomes. Early anti-seizure medication could improve outcomes but requires identifying patients at greatest risk of acute seizures. The SEIZURE (SEIZUre Risk in Encephalitis) score was developed in UK cohorts to stratify patients by acute seizure risk. A ‘basic score’ used Glasgow Coma Scale (GCS), fever and age; the ‘advanced score’ added aetiology. This study aimed to evaluate the score internationally to determine its global applicability.

Design

Patients were retrospectively analysed regionally, and by country, in this international evaluation study. Univariate analysis was conducted between patients who did and did not have inpatient seizures, followed by multivariable logistic regression, hierarchical clustering and analysis of the area under the receiver operating curves (AUROC) with 95% CIs.

Participants and setting

2032 patients across 13 countries were identified, among whom 1324 were included in SEIZURE score calculations and 970 were included in regression modelling. The involved countries comprised 19 organisations spanning all WHO regions.

Outcome measures

The primary outcome was measuring inpatient seizure rates.

Results

Autoantibody-associated encephalitis, low GCS and presenting with a seizure were frequently associated with inpatient seizures; fever showed no association. Globally, the score had limited discriminatory ability (basic AUROC 0.58 (95% CI 0.55 to 0.62), advanced AUROC 0.63 (95% CI 0.60 to 0.66)). The scoring system performed acceptably in western Europe, excluding Spain, with the best performance in Portugal (basic AUROC 0.82 (95% CI 0.69 to 0.94), advanced AUROC 0.83 (95% CI 0.72 to 0.95)).

Conclusions

The SEIZURE score performed best in several countries in Western Europe but performed poorly elsewhere, partly due to differing and unknown aetiologies. In most regions, the score did not reach a threshold to be clinically useful. The Western European results could aid in designing clinical trials assessing primary anti-seizure prophylaxis in encephalitis following further prospective trials. Beyond Western Europe, there is a need for tailored, localised scoring systems and future large-scale prospective studies with optimised aetiological testing to accurately identify high-risk patients.

Barriers and strategies for pain management in non-verbal people with dementia in residential care facilities: protocol for an e-Delphi study

Por: Felix · I. B. · Ramos · C. · Guerreiro · R. · Hughes · J. D. · Hoti · K. · Andrade · T. · Guerreiro · M.
Introduction

Pain is a prevalent symptom in people living with dementia. Evidence shows that pain frequently remains unrecognised and untreated in this vulnerable population, leading to avoidable suffering. Effective pain management is hindered by multifactorial barriers at the individual, organisational and policy level. This study aims to achieve expert consensus on the key barriers to pain management in non-verbal people living with dementia and strategies to address these barriers within Portuguese residential care facilities.

Methods and analysis

An e-Delphi study will be conducted using two rounds of online questionnaires. The Behaviour Change Wheel (BCW) framework guided the development of e-Delphi statements by linking identified determinants (i.e., barriers and facilitators) to intervention functions. Barriers were extracted from the literature reviews and mapped into the capability, opportunity and motivation–behaviour model. Intervention functions were then selected using the BCW linkage matrices and operationalised into practical strategies. A purposive and snowball sampling approach will be used to recruit a heterogeneous panel of experts across national residential care facilities, including nurses, physicians, managers and policymakers with relevant experience in dementia. During the e-Delphi rounds, participants will be invited to rate the relevance of each barrier and associated strategy(ies) on a five-point Likert scale and provide comments or suggestions. Consensus will be defined as ≥75% agreement on each statement.

Ethics and dissemination

Ethical approval for this study was obtained from the Egas Moniz Ethics Committee (Ref. 1586), and all procedures will comply with the Declaration of Helsinki. Informed consent will be obtained from all participants. The findings will be disseminated through a peer-reviewed publication, scientific events and stakeholder networks, including residential care facilities, to inform future practice and policy in dementia care.

Analytical validation of a homologous recombination deficiency signature (HRDsig) in pan-tumor tissue samples

by Wenshu Li, Jeffrey A. Leibowitz, Shuoguo Wang, Louisa Walker, Chang Xu, Kuei-Ting Chen, Alexa B. Schrock, Jason Hughes, Nimesh Patel, Julia A. Elvin, Lauren L. Ritterhouse, Ethan Sokol, Garrett Frampton, Lucas Dennis, Bahar Yilmazel, Brennan Decker

Homologous recombination repair (HRR) is a cellular pathway for high-fidelity double strand DNA break repair that uses the sister chromatid as a guide to ensure chromosomal integrity and cell viability. Deficiency in the HRR pathway (HRD) can sensitize tumors to poly (ADP-ribose) polymerase inhibitors (PARPi) and platinum-based chemotherapy, offering an avenue to identify patients who may benefit from targeted therapies. HRD signature (HRDsig) is a pan-solid-tumor biomarker on the FoundationOne®CDx (F1CDx®) assay that employs a DNA scar-based approach to calculate a score based on copy number features (e.g., segment size, oscillation patterns, and breakpoints per chromosome arm) and does not rely on HRR gene alterations, enabling detection of genomic and epigenetic mechanisms of HRD. After finalizing the HRDsig algorithm, analytical validation was conducted in a CAP-accredited, CLIA-certified laboratory on 278 solid tumor and normal tissue specimens. HRDsig results were compared with an independent HRD biomarker, defined by the presence of a reversion mutation restoring HRR gene function. In this evaluation, 100 HRD-positive and 126 HRD-negative samples showed a positive percent agreement of 90.00% and a negative percent agreement of 94.44%. The limit of detection (LoD) was estimated at 23.04% tumor purity, with the limit of blank (LoB) confirmed as zero in 60 normal tissue replicates. Reproducibility testing on 11 positive and 11 negative samples across multiple labs, reagent lots, and sequencers yielded agreement in 99.49% of positive and 99.73% of negative replicates. HRDsig status remained consistent in the presence of interfering substances, demonstrating 100% concordance in spiked samples. These validation results underscore the high analytical concordance, low false-positive rate, and overall robustness of HRDsig for reliable assessment of homologous recombination deficiency.

Feasibility and acceptability of a preoperative checklist health promotion in elective surgery in the UK: a mixed-methods study protocol

Por: Kathir Kamarajah · S. · Dhesi · J. · Khunti · K. · Nirantharakumar · K. · Hughes · C. · Yeung · J. · Ahuja · S. · Morton · D. · Bhangu · A.
Introduction

Multimorbidity or the presence of two or more long-term conditions is now common in people undergoing surgery. However, current care pathways often miss these healthcare encounters to support long-term health promotion. Therefore, there is a need for practical, scalable approaches that can be integrated into routine surgical care, for which limited solutions exist at present. We have co-designed a structured preoperative checklist to help identify and manage long-term conditions in patients listed for elective surgery. This study aims to evaluate the feasibility and acceptability of this preoperative checklist in patients undergoing elective surgery.

Methods and analysis

This is a mixed-methods feasibility study in one National Health Service trust in the UK. We will recruit up to 50 adults scheduled for elective surgery and use the checklist during initial surgical clinic appointments. Quantitative data will include recruitment and retention rates, completion of the checklist and baseline clinical characteristics, analysed using descriptive statistics. Qualitative data will be collected through semistructured interviews with up to 16 patients and clinicians. These interviews will be analysed thematically, guided by the Consolidated Framework for Implementation Research. Triangulation of quantitative and qualitative data will allow us to explore fidelity, acceptability, barriers and facilitators to implementation and refine the intervention ahead of a future pilot cluster randomised trial.

Ethics and dissemination

This study has received approval from the Yorkshire & The Humber - Sheffield Research Ethics Committee (approval number: 25/YH/0045). All participants will give written informed consent. Results will be published in peer-reviewed journals and shared with participants, the public and policy stakeholders.

Realist review of informal carer involvement in the transition of medicines-related care for patients moving from hospital to home

Por: Richardson · C. L. · Cooper · M. · Atkinson · O. · Black · D. · Lindsey · L. · Cooper · C. · Nazar · H. · Wong · G. · Hughes · C.
Objective

The aim of this work was to understand carer involvement in transitions of care from hospital to home in relation to medicines management. Specifically, via a realist review, to describe how carers provide support, to what extent do they support patients and under what circumstances are carers able to provide support towards patient care in relation to medicines management.

Design

A realist review was conducted in line with a published protocol and as registered via PROSPERO (CRD42021262827). An initial programme theory (PT) was developed before searches of three databases, PubMed, CINHAL and EMBASE, were conducted in accordance with eligibility criteria. Data were extracted from eligible studies and synthesised into realist causal explanations in the form of Context-Mechanism-Outcome-Configurations (CMOCs) and the PT was refined. Throughout the review, a patient and PPIE group (n≥5) was involved, meeting five times, to inform the research focus and develop CMOCs and the PT by providing feedback and ensuring they capture the carer experience.

Results

Following title and abstract screening of 4835 papers, the final number of included articles was 208. The evidence synthesis identified 31 CMOCs which were categorised into three themes: (1) continuum of support; (2) understanding the carers’ priorities, role and responsibilities through shared decision-making (SDM) and (3) access to appropriate materials, resources and support information. These themes were formed into an updated PT with accompanying narrative that explained the transition from hospital to home involving carers in medicines management and identified possible areas for future intervention development.

Conclusion

This review provides insights and recommendations on how carers can be better supported when managing medicines when patients are discharged from hospital. Carers need a continuum of support throughout and following the transition. Healthcare professionals can support this by understanding the carer’s priorities, role and responsibilities through SDM during the hospital stay. Consequently, carers can then be offered access to appropriate materials, resources and support information which allows them to provide better care relating to medicines in the long term.

Prevention and Early Delirium Identification Carer Toolkit (PREDICT): A Study Protocol for a Stepped‐Wedge, Cluster Randomised Controlled Trial

ABSTRACT

Background

Delirium, a common, serious and often preventable complication in older hospitalised adults, contributes to significant health and social care costs. Carers are uniquely positioned to identify early signs and support delirium prevention. The Prevention & Early Delirium Identification Carer Toolkit (PREDICT), a novel model of care designed to educate carers about delirium management and prevention strategies, enables them to actively participate in the care and recovery of their person. Developed through a comprehensive literature review, a co-designed eDelphi and pilot study, PREDICT demonstrated acceptability and feasibility.

Aims

To evaluate the effectiveness, implementation and cost-benefit of a PREDICT in hospital settings.

Method

A stepped-wedge cluster randomised controlled trial (SW-cRCT), consisting of a cohort study, healthcare service evaluation, and process evaluation. The study will assess carer and staff knowledge of delirium, carer care giving stress, health service outcomes (e.g., incidence, length of stay, readmissions) and cost-benefit.

Discussion

PREDICT is a scalable, person-centred approach that supports both patients and carers, with the potential to embed best-practice delirium management into routine healthcare.

Public and Patient Involvement

This study was developed in consultation with older adults, carers and healthcare staff. Two consumer representatives joined the project steering committee and contributed to shaping the research question, refining the study protocol and selecting outcome measures relevant to families and healthcare staff. Carers were involved in reviewing participant information sheets and the PREDICT website, providing feedback to ensure clarity and accessibility. Results will be shared with participants and the wider community through plain-language summaries and public presentations.

Trial Registration

Australian and New Zealand Clinical trial: ACTRN12625000705482 registered on the 3rd of July 2025

Understanding internet-supported self-management for low back pain in primary care: a qualitative process evaluation of the SupportBack 2 randomised controlled trial

Por: Geraghty · A. W. A. · Hughes · S. · Roberts · L. · Hill · J. C. · Foster · N. E. · Hay · E. · Mansell · G. · White · M. · Davies · F. · Steele · M. · Little · P. · Yardley · L.
Objective

The SupportBack 2 randomised controlled trial (RCT) compared the clinical and cost-effectiveness of an internet intervention supporting self-management versus usual primary care in reducing low back pain (LBP)-related disability. In this study, we aimed to identify and understand key processes and potential mechanisms underlying the impact of the intervention.

Design

This was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results).

Setting

Primary care in the UK (England).

Participants

46 trial participants experiencing LBP without indicators of serious spinal pathologies (eg, fractures, infection) took part in telephone interviews at either 3 (n=15), 6 (n=14) or 12 months (n=17) post randomisation. Five physiotherapists who provided telephone support for the internet intervention also took part in telephone interviews.

Intervention

An internet intervention ‘SupportBack’ supporting self-management of LBP primarily through physical activity and exercise delivered in addition to usual care, with and without physiotherapist telephone support.

Analysis

Data were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations.

Results

Four explanatory themes were developed, with five context-mechanism-outcome configurations. Where benefit was reported, SupportBack appeared to work by facilitating a central associative process where participants linked increases in physical activity or exercise with improvements in LBP, then continued to use physical activity or exercise as key regulatory strategies. Participants who reported little or no benefit from the intervention appeared to experience several barriers to this associative process, including negative expectations, prohibitive beliefs about the cause of LBP or functional limitations preventing engagement. Physiotherapists appeared to provide accountability and validation for some; however, the remote telephone support that lacked physical assessment was viewed as limiting its potential value.

Conclusions

Digital interventions targeting physical activity and exercise to support LBP self-management may rely on mechanisms that are easily inhibited in complex, heterogeneous populations. Future research should focus on identifying and removing barriers that may limit the effectiveness of digital self-management support for LBP.

Emergency clinicians' use of adult and paediatric sepsis pathways: An implementation redesign using the behaviour change wheel

Abstract

Aims

To identify facilitators and barriers and tailor implementation strategies to optimize emergency clinician's use of adult and paediatric sepsis pathways.

Design

A qualitative descriptive study using focus group methodology.

Methods

Twenty-two emergency nurses and ten emergency medical officers from four Australian EDs participated in eight virtual focus groups. Participants were asked about their experiences using the New South Wales Clinical Excellence Commission adult and paediatric sepsis pathways using a semi-structured interview template. Facilitators and barriers to use of the sepsis pathways were categorized using the Theoretical Domains Framework. Tailored interventions were selected to address facilitators and barriers, and a re-implementation plan was devised guided by the Behaviour Change Wheel.

Results

Thirty-two facilitators and 58 barriers were identified corresponding to 11 Theoretical Domains Framework domains. Tailored strategies were selected to optimize emergency clinicians' use of the sepsis pathways including refinement of existing education and training programmes, modifications to the electronic medical record system, introduction of an audit and feedback system, staffing strategies and additional resources.

Conclusion

The implementation of sepsis pathways in the Emergency Department setting is complex, impacted by a multitude of factors requiring tailored strategies to address facilitators and barriers and optimize uptake.

Implications for Patient Care

This study presents a theory-informed systematic approach to successfully implement and embed adult and paediatric sepsis pathways into clinical practice in the Emergency Department.

Impact

Optimizing uptake of sepsis pathways has the potential to improve sepsis recognition and management, subsequently improving the outcome of patients with sepsis.

Reporting Method

The Consolidated Criteria for REporting Qualitative research guided the preparation of this report.

Patient or Public Contribution

Nil.

Scoping Review of Sexual and Gender Minority Health Research in Ireland

ABSTRACT

Aim

To map existing sexual and gender minority (SGM) health research in Ireland, identify gaps in literature and outline priorities for future research and healthcare. SGM is an umbrella term that includes people who identify as lesbian, gay, bisexual, transgender, queer or intersex and is sometimes abbreviated as LGBTQI+.

Design

A scoping review of peer-reviewed studies published between 2014 and 2024.

Methods

The review followed Joanna Briggs Institute (JBI) guidelines and PRISMA-ScR framework for scoping reviews. Articles were identified through systematic database searches and screened independently by reviewers.

Data Sources

PubMed, PsycINFO, CINAHL and Embase were searched for articles published between January 2014 and April 2024. Sixty studies met inclusion criteria.

Results

The review highlighted a disproportionate focus on gay, bisexual and other men who have sex with men (gbMSM), particularly regarding HIV and sexual health. Mental health research revealed high levels of anxiety, depression and suicidality, largely attributed to minority stress and systemic discrimination. Transgender health studies documented barriers to accessing gender-affirming care and mental health services. Few studies explored experiences of sexual minority women, older SGM individuals or intersex people. Intersectional perspectives on race, disability and socio-economic status were notably absent.

Conclusion

SGM health research in Ireland reflects significant progress in documenting disparities in mental and sexual health. However, there is a lack of representation for some groups. There is also limited attention to intersectionality. Systematic gaps in sexual orientation and gender identity (SOGI) data impede targeted policymaking and service delivery.

Implications for the Profession and/or Patient Care

Findings underscore the need for inclusive, culturally competent healthcare services, better integration of SGM health topics into nursing education, and community-centred interventions. Addressing structural barriers and improving provider competence can enhance equitable healthcare access for SGM populations.

Impact

This review addresses the fragmented state of SGM health research in Ireland, highlighting gaps in representation and systemic issues.

No Patient or Public Contribution

Authorship includes individuals from various sexual and gender minority communities.

Comparative relationships between physical and verbal abuse of children, life course mental well-being and trends in exposure: a multi-study secondary analysis of cross-sectional surveys in England and Wales

Por: Bellis · M. A. · Hughes · K. · Ford · K. · Quigg · Z. · Butler · N. · Wilson · C.
Objectives

To test associations between mental well-being across the life course and exposure to childhood physical and/or verbal abuse.

Design

Secondary analysis of combined data from seven cross-sectional general adult population surveys measuring childhood experience of physical and/or verbal abuse and current mental well-being.

Setting

Households across England and Wales.

Participants

20 687 residents in England and Wales aged 18 years or over.

Measures

Self-reported childhood physical and verbal abuse using questions from an Adverse Childhood Experiences tool. Individual and combined components of adult mental well-being measured using the short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS).

Results

Exposure to either childhood physical abuse or verbal abuse was associated independently with a similar significant increase in likelihood of low adult mental well-being, with exposure to both abuse types compounding increases (adjusted ORs 1.52, 1.64, 2.15 respectively, reference category: neither abuse type). Individual components of mental well-being showed similar associations, with adjusted prevalence of never or rarely having felt close to people in the last 2 weeks rising from 7.7% (neither abuse type) to 9.9% (physical abuse), 13.6% (verbal abuse) and 18.2% (both types of abuse). Within sample trends showed a significant drop in the prevalence of child physical abuse from around 20% in those born from 1950 to 1979 to 10% in those born in 2000 or after. However, verbal abuse rose from 11.9% in those born before 1950 to nearly 20% in those born in 2000 or after.

Conclusion

Exposure to childhood physical or verbal abuse have similar associations with lower mental well-being during adulthood. Interventions to reduce child abuse, including physical chastisement, should consider both physical and verbal abuse and their individual and combined consequences to life course health. The potential role of childhood verbal abuse in escalating levels of poor mental health among younger age groups needs greater consideration.

Exploring patient and professional perspectives on implementing pharmacogenomic testing in the UK primary care setting and estimating the cost-effectiveness: a mixed-methods study protocol

Por: Qureshi · S. · Latif · A. · Hughes · D. A. · Timmons · S. · Avery · A.
Introduction

Pharmacogenomic testing could potentially reduce the number of adverse drug reactions and improve treatment outcomes through tailoring treatment to an individual’s genetic makeup. Despite its benefits and the ambitions to integrate into routine care, the implementation of pharmacogenomic testing in primary care settings remains limited. This study aims to qualitatively explore the views of healthcare professionals (HCPs) and patients on implementing pharmacogenomic testing in the UK National Health Service (NHS) primary care setting and to estimate the cost-effectiveness of service-delivery implementation by comparing different HCPs’ models of care.

Method

This study consists of three workstreams (WS). WS1 is semi-structured interviews with General Practitioners, pharmacists, nurses and patients (24 participants) to explore implementation issues, including the perceived barriers and facilitators to delivering a pharmacogenomic service. WS2 consists of focus groups (between 24–36 participants) with genomic experts to develop practical pharmacogenomic-guided clinical pathways for primary care. WS3 will estimate the cost-effectiveness of implementing pharmacogenomic testing when led by different HCPs incorporating parameters from the literature, expert opinions, as well as data from WS1 and WS2.

Analysis

Thematic analysis will be used to analyse the qualitative data from WS1 and WS2, mapping findings onto the Consolidated Framework for Implementation Research domains, which will also be used as the theoretical framework. WS3 will be a decision-analytic model developed in Microsoft Excel to compare the cost-effectiveness of pharmacist-led, GP-led, nurse-led or multidisciplinary pathways.

Ethics and dissemination

This study has been approved by the NHS Health Research Authority and Health and Care Research Wales (24/PR/1088). Findings will be disseminated through peer-reviewed publications, conference presentations and engagement with NHS policymakers and Genomics England.

Patient-reported outcome measures for fatigue in patients with chronic kidney disease: a systematic review

Por: Hughes · A. · Ju · A. · Cazzolli · R. · Howell · M. · Guha · C. · Levin · A. · Manera · K. · Teixeira-Pinto · A. · Torrisi · L. G. · Wheeler · D. C. · Wong · G. · Wu · R. · Jaure · A.
Objective

Fatigue is a common and debilitating symptom that is associated with an increased risk of mortality, dialysis initiation and hospitalisation among patients with chronic kidney disease (CKD). The aim of this study was to identify the characteristics, content and psychometric properties of patient-reported outcome measures (PROMs) used to measure fatigue in patients with CKD not requiring kidney replacement therapy (KRT).

Design

Systematic review. The characteristics, dimensions of fatigue and psychometric properties of these measures were extracted and analysed.

Data sources

We searched MEDLINE, Embase, PsycINFO and CINAHL from database inception to February 2023.

Eligibility criteria for selecting studies

All studies that reported fatigue in patients with CKD stages 1–5 not receiving KRT.

Results

We identified 97 studies (20 (21%) randomised trials, 2 (2%) non-randomised trials and 75 (77%) observational studies). 27 different measures were used to assess fatigue, of which three were author-developed measures. The 36-Item Short Form Health Survey (SF-36) and Kidney Disease Quality of Life – Short Form (KDQOL-SF) were the most frequently used measures (41 (42%) and 24 (25%) studies, respectively). Six (22%) measures were specific to fatigue (Chalder Fatigue Questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue Scale, Functional Assessment of Cancer Therapy-Fatigue, Fatigue Severity Scale, and author developed Chen & Ku 1998, and Hao et al 2021) while 21 (78%) included a fatigue subscale or item within a broader construct for example, quality of life. Various content domains assessed included tiredness, ability to think clearly, level of energy, muscle weakness, ability to concentrate, verbal abilities, motivation, memory, negative emotions and life participation. Only two measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Kidney Symptom Questionnaire) were developed specifically for CKD, but they were not specific to fatigue. Six measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Functional Assessment of Cancer Therapy – Anemia, Revised Illness Perception Questionnaire, Kidney Symptom Questionnaire, Short Form 6 Dimension and 36-Item Short Form Health Survey) had been validated in patients with CKD not requiring KRT.

Conclusion

PROMs used to assess fatigue in patients with CKD vary in content and few were specific to fatigue in patients with CKD not requiring KRT. Data to support the psychometric robustness of PROMs for fatigue in CKD were sparse. A validated and content-relevant measure to assess fatigue in patients with CKD is needed.

Comparative analysis of HIV data completeness in Haitis iSante Plus Electronic Medical Record system across children, adolescents and adults: a cross-sectional evaluation of 2016-2022 data

Por: Odeny · B. · Honore · J. G. · Balan · J. G. · Hughes · J. P. · Wagenaar · B. · Gloyd · S. · Celestin · K. · Elisma · M. · Francois · K. · Puttkammer · N.
Objective

To evaluate and compare documentation completeness of HIV-related data by age group (children, adolescents and adults) in Haiti’s Electronic Medical Record (EMR) system.

Design

Cross-sectional evaluation.

Setting

EMR data for 36 965 enrolment visits, and 123 608 return visits from 58 facilities in Haiti (from 2016 to 2022).

Participants

Children, adolescents and adults accessing HIV care and treatment services in Haiti.

Main exposure measure

Health facility attendance for HIV-related healthcare.

Main outcome measure

Level of data completeness, as a measure of data quality. We developed Composite Completeness Scores (CCS scores) to measure data completeness. Lower scores meant lower completeness. Generalised linear models were used to investigate factors associated with completeness.

Results

At the enrolment visit, most patients were adults (81.6%) and female (56.7%). Most facilities were health centres (75.9%). The overall average enrolment visit CCS score was 54.0%. At enrolment, being a child (CCS score difference=–7.08, 95% CI: –11.31 to –2.86) and a more recent year of enrolment (–6.01, 95% CI: –11.69 to –0.33) were significantly associated with lower completeness scores than being an adult and having an earlier year of enrolment, respectively. The overall average return visit CCS score was 49.6%. At the return visit, children (–6.76, 95% CI: –10.07 to –3.45) had significantly lower average completeness scores than adults. For first viral load documentation, children had lower odds of completeness compared with adults (adjusted OR=0.21, 95% CI: 0.16 to 0.28). Sex, year of enrolment, facility ownership (public, private, mixed), total patient volume and duration of EMR use were not significantly associated with completeness of documentation at the enrolment and return visits.

Conclusions

We observed disparities in electronic data completeness by age group, which may be indicative of digital health disparities. Documentation was particularly poor among children and declined over time for enrolment visits. Further research is needed to understand and address these documentation gaps.

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