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Hoy — Octubre 2nd 2025Tus fuentes RSS

MINMON-J: a hybrid implementation pilot study evaluating a low-barrier hepatitis C treatment model in a jail setting

Por: Berk · J. · Fu · E. S. · Murphy · M. · Akiyama · M. J. · Sulkowski · M. · Rich · J. D. · Frank · H. E.
Introduction

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

Methods and analysis

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

Ethics and dissemination

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

Trial registration number

NCT06953479.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

ClinicalTrials.gov ID NCT05596175.

The adaptive physical activity programme in stroke (TAPAS): protocol for a process evaluation in a sequential multiple assignment randomised trial

Por: Rocliffe · P. · Whiston · A. · O Mahony · A. · OReilly · S. M. · OConnor · M. · Cunningham · N. · Glynn · L. · Walsh · J. C. · Walsh · C. · Hennessy · E. · Murphy · E. · Hunter · A. · Butler · M. · Paul · L. · Fitzsimons · C. F. · Richardson · I. · Bradley · J. G. · Salsberg · J. · Hayes
Introduction

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Methods and analysis

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethics and dissemination

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Initiatives to support nursing workforce sustainability: a rapid umbrella review protocol

Por: Murphy · G. T. · Sampalli · T. · Elliott-Rose · A. · Martin-Misener · R. · Sim · M. · Indar · A. · Murdoch · J. · Hancock · K. · MacKenzie · A. · Chamberland-Rowe · C. · MacInnis · M. · Murphy-Boyle · K. · Lownie · C. · Salmaniw · S.
Introduction

The COVID-19 pandemic has made long-standing nursing workforce challenges apparent on an international scale. Decision-makers must develop multi-pronged approaches to foster the development and maintenance of a strong nursing workforce to support health systems. These approaches require attendance to recruitment and retention initiatives that show promise for stabilising the nursing workforce now and into the future.

Methods and analysis

Searches were conducted across MEDLINE, Embase, CINAHL and Scopus from January 2014 up to 11 March 2024. This rapid umbrella review protocol is guided by the Joanna Briggs Institute scoping review methodology and adheres to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The research question guiding this review is: what structures have healthcare systems put in place to stabilise, support and sustain the nursing workforce? This review will include existing reviews of nursing workforce initiatives with outcomes that impact nursing recruitment and retention. Results will support local health transformation including the development of a jurisdictional nursing workforce stabilisation strategy. Findings from this review will be relevant for the design, refinement and implementation of nursing workforce sustainability strategies in countries around the globe and may apply to strategies for other healthcare workers.

Ethics and dissemination

Institutional research ethics board exemption was received. The research team is supported by an advisory group that includes provider and patient partners. The results from this study will inform the Nursing Workforce Strategy for the province of Nova Scotia as part of a larger Canadian Institutes of Health Research-funded project. They will also inform broader planning and strategy in Canada through integration with other evidence-generation activities such as comparative policy analyses and workforce planning exercises. Finally, the results will be published in a peer-reviewed journal.

Review registration number

Registered through Open Science Framework: https://doi.org/10.17605/OSF.IO/CUJYK

Lives Transformed—The Experiences of Significant Others Supporting Patients With Severe Burn Injury: A Narrative Inquiry

ABSTRACT

Aim

To explore the experiences of significant others of patients with severe burn injury in the intensive care unit. Specifically, how severe burn injury impacted the significant other and their role within their loved one's life.

Design

This qualitative study employed a Narrative Inquiry approach.

Methods

Interviews were undertaken during 2021–2022 with 17 participants who were the significant others of a patient with severe burn injury in the Intensive Care Unit. Recruitment occurred in New South Wales, Australia, from two tertiary hospitals providing care for people with major burns. A narrative inquiry approach was utilised, capturing stories through semi-structured interviews.

Results

Significant others experienced necessary changes in their life in response to the catastrophe. These included advocating, being present and ensuring their loved one's needs were met, while often neglecting themselves. Significant others contemplated their future as a carer to their loved one with severe burn injury, and adjusting their own career, finances and lifestyle, often as a long-term measure. The shifting of their role to carer ultimately transformed and redefined their relationships and lives.

Conclusion

Significant others endure immense trauma when a loved one sustains a severe burn injury. They require support but prioritise the patient by virtue of their critical illness. The life of the significant other is changed as they take on the role of carer and provide support. It is, therefore, imperative that the support needs of significant others are recognised, understood and addressed to ensure their well-being while processing the trauma.

Implications for Practice

With increased understanding of the significant others' experiences, healthcare providers can adopt a consultative approach, where roles and boundaries can be clearly identified. Through this process, healthcare providers can strengthen rapport and provide targeted support for significant others, as they navigate this traumatic life-altering event.

Patient or Public Contribution

No patient or public contribution.

Does online information about hormone replacement therapy (or menopause hormone therapy) reflect indications from the British National Formulary and guidance from the National Institute for Health and Care Excellence: a cross-sectional study of UK media

Por: McCartney · M. · Morgan-Young · R. · Sullivan · F. · Murphy · D. J. · Albulushi · J. · Larkin · J.
Objectives

To describe: (1) the most visible information (from individuals or organisations) on UK social media regarding hormone replacement therapy (HRT)/menopause hormone treatment for menopause; (2) claims made by these sources for HRT and testosterone outwith the indications specified by the British National Formulary (BNF) and the National Institute of Health and Care Excellence (NICE) (ie, vasomotor instability, vaginal dryness, low mood associated with the menopause and, for testosterone, low libido after treatment with HRT) and for use for the prevention of future ill health and (3) conflicts of interest of commentators.

Design

Cross-sectional study.

Setting

Online references to HRT, for use in menopause, in UK online media, comprising Facebook, Google, Instagram, TikTok and YouTube, 30 top ranked hits between 1 January 2022 and 1 June 2023 and Twitter (X) up to 1 May 2024.

Methods

Identification of the most visible information was performed via online searching with the term ‘HRT’ using incognito searches within each modality. Statements making claims were identified and analysed as to whether they were congruent with BNF and NICE advice on indications for use. Declarations of interest were extracted from the source or searched for if not apparent using a standardised search strategy. Data were entered into an Excel spreadsheet. Summary and descriptive statistics were used to summarise the results, including description of origin and types of claims, percentage of claims in agreement with NICE/BNF indications, relationship to financial interests and readership data, where available.

Results

180 recommendations and/or claims for HRT were examined (30 from each of six platforms), made by professional individuals (53.4%), laypeople (41.7%) and patient, media and professional organisations (4.9%) completing the total. Overall, 67.2% of claims were outside of BNF/NICE recommendations. 139 (77.2%) were associated with a conflict of interest. In 117 cases, this was a conflict either directly or indirectly related to menopause, through provision of private practice, pharmaceutical industry funding or retail products marketed at the menopause.

Conclusions

Social media commonly contains claims for HRT outside BNF/NICE guidance. Conflicts of interest by commentators are also common, directly or indirectly related to menopause. Less than a quarter of media contained no commercial conflict. Policymakers should consider means to ensure that non-conflicted, evidence-based information is visible to professionals, patients and the public.

Trial registration number

Open Science Framework (https://osf.io/r7e5c/).

Behaviour change interventions addressing patient antibiotic treatment-seeking behaviour for respiratory tract infections in primary and community care settings: a scoping review

Por: Maher · A. · Roche · K. · Morrissey · E. · Murphy · A. · Sheaf · G. · Ryan · C. · Molloy · G. J.
Objectives

This scoping review aimed to map studies on behaviour change interventions that address antibiotic treatment-seeking behaviour for respiratory tract infections in primary and community care settings.

Design

This review is based on the Joanna Briggs Institute guidelines for scoping reviews, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Data sources

A literature search in January 2024 and May 2024 was performed across Medline, Embase, CINAHL, PsycINFO, Web of Science Core Collection, Scopus, EThOS and Google Scholar was performed.

Eligibility criteria

Eligible studies described behaviour change interventions in primary and community care settings, published from 2000 onward across all countries.

Data extraction and synthesis

Descriptive data relating to study details and intervention functions were gathered and organised according to the Capability, Opportunity, Motivation and Behaviour change framework in a predeveloped data extraction sheet. Dual data extraction occurred, and inter-rater reliability results are reported (K=0.83).

Results

The scoping review identified 38 eligible studies, which consisted of randomised controlled trials (7/38), cluster randomised controlled trials (6/38), randomised experiments (5/38), cross-sectional studies (5/38), qualitative investigations (5/38) and quasi-experimental designs (4/38). Most interventions focused on educational resources (15/38), digital tools (7/38) and community campaigns (6/38), with fewer targeting decision-making processes (4/38) or psychological drivers of antibiotic-seeking behaviour (3/38). Only one study was conducted in low-income and middle-income countries, and only one separately assessed behaviour change as a measured outcome.

Conclusions

This scoping review highlights a wide range of research methodologies within the topic area. There was some limited evidence of intervention efficacy for antibiotic prescription rates, particularly interventions focused on enhancing knowledge and access to resources. However, more emphasis is needed on standardising outcome measures and evaluating long-term outcomes.

Effectiveness and cost-effectiveness of community-based TB screening algorithms using computer-aided detection (CAD) technology alone compared with CAD combined with point-of-care C reactive protein testing in Lesotho and South Africa: protocol for a pair

Por: Signorell · A. · van Heerden · A. · Ayakaka · I. · Jacobs · B. K. · Antillon · M. · Tediosi · F. · Verjans · A. · Brugger · C. · Harkare · H. V. · Labhardt · N. D. · Bosman · S. · Kamele · M. · Keitseng · M. · Madonsela · T. · Kurscheid · J. · Muhairwe · J. · Keter · A. K. · Murphy · K.
Introduction

Tuberculosis (TB) remains a significant public health challenge in many African communities, where underreporting and underdiagnosis are prevalent due to barriers in accessing care and inadequate diagnostic tools. This is particularly concerning in hard-to-reach areas with a high burden of TB/HIV co-infection, where missed or delayed diagnoses exacerbate disease transmission, increase mortality and lead to severe economic and health consequences. To address these challenges, it is crucial to evaluate innovative, cost-effective, community-based screening strategies that can improve early detection and linkage to care.

Methods and analysis

We conduct a prospective, community-based, diagnostic, pragmatic trial in communities of the Butha Buthe District in Lesotho and the Greater Edendale area of Msunduzi Municipality, KwaZulu-Natal in South Africa to compare two strategies for population-based TB screening: computer-aided detection (CAD) technology alone (CAD4TBv7 approach) versus CAD combined with point-of-care C reactive protein (CRP) testing (CAD4TBv7-CRP approach). Following a chest X-ray, CAD produces an abnormality score, which indicates the likelihood of TB. Score thresholds informing the screening logic for both approaches were determined based on the WHO’s target product profile for a TB screening test. CAD scores above a threshold prespecified for the CAD4TBv7 approach indicate confirmatory testing for TB (Xpert MTB/RIF Ultra). For the CAD4TBv7-CRP approach, a CAD score within a predefined window requires the conduct of the second screening test, CRP, while a score above the respective upper threshold is followed by Xpert MTB/RIF Ultra. A CRP result above the selected cut-off also requires a confirmatory TB test. Participants with CAD scores below the (lower) threshold and those with CRP levels below the cut-off are considered screen-negative. The trial aims to compare the yield of detected TB cases and cost-effectiveness between two screening approaches by applying a paired screen-positive design. 20 000 adult participants will be enrolled and will receive a posterior anterior digital chest X-ray which is analysed by CAD software.

Ethics and dissemination

The protocol was approved by National Health Research Ethics Committee in Lesotho (NH-REC, ID52-2022), the Human Sciences Research Council Research Ethics Committee (HSRC REC, REC 2/23/09/20) and the Provincial Health Research Committee of the Department of Health of KwaZulu-Natal (KZ_202209_022) in South Africa and from the Swiss Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2022–00044). This manuscript is based on protocol V.4.0, 19 January 2024. Trial findings will be disseminated through peer-reviewed publications, conference presentations and through communication offices of the consortium partners and the project’s website (https://tbtriage.com/).

Trial registration

ClinicalTrials.gov (NCT05526885), South African National Clinical Trials Register (SANCTR; DOH-27-092022-8096).

Role and responsibilities of a forensic mental health nurse: a scoping review protocol

Por: Tulloch · L. · Harkess-Murphy · E. · Walker · H. · Cheyne · J. · McCaig · M. · Ion · R.
Introduction

Forensic mental health nursing (FMHN) is a subspeciality of psychiatric nursing. An area of mental health nursing care that is situated at the intersection of health, social and criminal justice systems. Over the past two decades, FMHN has evolved beyond custodial and containment practice. Contemporary FMHN has an emphasis on therapeutic interventions, identifying patients as partners in care and nursed through a trauma-informed, recovery-orientated lens. Numerous scholars have examined the role of the FMHN and its inherent complexities. However, much of the existing literature is outdated and is limited in scope, describing the role and responsibilities of an FMHN relevant to contemporary practice. This paper maps the literature over the last 20 years to establish what explicitly defines the modern FMHN, specifically examining factors that have shaped the role and influenced patient outcomes and care delivery; including areas of good practice.

Methods and analysis

In line with the Joanna Briggs Institute (JBI) guidance on scoping reviews, including Arksey and O’Malley’s (2005) five-step framework, we will conduct a search within MEDLINE (EBSCO), CINAHL (EBSCO), PsycINFO (Ovid) and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials in the Cochrane Library. The first author conducted a preliminary search in October 2024 to identify literature in this area and a review of keywords to develop the foundation search strategy. The search strategy was constructed in the MEDLINE (EBSCO) database May 2025 by the lead author and an information specialist/librarian. Eligibility criteria of publications written in English, with a date range of 2004–2024, including the first quarter of 2025, forensic mental health nurse population and secure inpatient settings. All extracted literature will be exported into EndNote V.21 in order to support the removal of duplicates and assist in the screening and selection process. A two-step data selection process will include stage one, where two authors independently conduct a preliminary title and abstract screen of all extracted data using a data extraction instrument developed per JBI scoping review guidance. Each paper will be categorised as ‘yes’, ‘no’ or ‘maybe’. Step two: All documents categorised as ‘yes’ or ‘maybe’ will undergo a full-text screening. Narrative summaries and tables will present the results in full.

Ethics and dissemination

This scoping review will analyse existing published data; therefore, ethical approval is not required. The findings of this review will be presented at local and international conferences and published in peer-reviewed journals. The formal search will commence in June 2025, with an aim to submit in full for peer-review publication by October 2025.

Participative research for individualised care in cardiovascular diseases (PRIC-CVD): study protocol for a non-interventional, multicentre mixed-methods study as part of iCARE4CVD

Por: Steiner · B. · Verket · M. · Baldewijns · K. · Murphy · M. · McNulty · A. · Schwertfeger · M. · Friedl · S. · Barrett · M. · Hill · L. · Brandts · J. · Romero · I. · Helms · T. M. · Brunner-La Rocca · H.-P. · Zippel-Schultz · B. · on behalf of the iCARE4CVD Consortium
Introduction

Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Methods and analysis

Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

Ethics and dissemination

This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

DRKS00034899.

Protocol version

V2.1, 6 June 2024.

Cross-sectional study of the rates of military sexual trauma (MST) and associations with adverse mental health outcomes among UK female ex-service personnel: a study protocol

Por: Obradovic · T. · Murphy · D. · Fear · N. T. · Sharp · M.-L.
Introduction

This study investigates the rates of military sexual trauma (MST) and its associations with adverse mental health among a sample of UK female ex-service personnel who served during the Iraq/Afghanistan eras.

Methods and analysis

Female ex-service personnel, who participated in the fourth phase (Phase 4) of the King’s Centre for Military Health Research (KCMHR) Health and Well-being Cohort Study (2022–2023) and consented to be recontacted for follow-up studies (n=295), are being invited to participate in an online questionnaire between July 2024 and February 2025. The questionnaire contains surveys and questions related to experiences of sexual harassment and sexual assault during and outside of military service, disordered eating and broader female health issues. While the questionnaire relates to several female health topics, this study focuses on the surveys related to experiences of sexual trauma and eating disorders. Sociodemographic variables and some health variables, including post-traumatic stress disorder (PTSD), complex PTSD, common mental disorders, alcohol misuse, physical somatisation and social support, will be extracted from participants’ pre-existing data collected in Phase 4 of the KCMHR Cohort Study. Analyses will assess rates of MST, and hierarchical multiple logistic regressions will investigate associated health impacts. Rates and ORs, employing 95% CIs, will be reported.

Ethics and dissemination

This study has been granted full ethical approval by the King’s College London Research Ethics Committee (Ref: HR/DP-23/24–39040). Participants provide informed consent before participating and have access to a signposting booklet containing contact details for a range of support services. A risk protocol is in place, which outlines the procedure to be undertaken if a participant contacts the research team in distress. Findings will form part of a PhD thesis and will be further disseminated through peer-reviewed publication and dissemination with veteran mental health services and charities, and relevant government departments.

Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice

Por: Tahsin · F. · Doody · P. · Clyne · B. · Kiely · B. · Moriarty · F. · Gillespie · P. · Kenny · E. · Boland · F. · Byrne · M. · OConnor · L. · Murphy · A. W. · Smith · S. M.
Background

There is increasing awareness of the impact of living with multiple long-term conditions (referred to as multimorbidity) on patients and health systems. Managing multimorbidity remains a challenge for primary care providers; necessitating tailored interventions that are both clinically and cost effective. In the Irish health system, two pilot trials have demonstrated promising results for patients living with multimorbidity. The first, MultimorbiditY COllaborative Medication Review And DEcision making (MyComrade), involved pharmacists supporting the management of polypharmacy, and the second, Link MultiMorbidity (LinkMM), involved link workers delivering social prescribing. This definitive trial aims to evaluate the clinical and cost effectiveness of both these interventions, as well as conduct a process evaluation.

Methods

This is a pragmatic, multi-arm, definitive, cluster randomised controlled trial in Irish general practices. The trial will include three arms: (1) MyComrade; (2) LinkMM and (3) usual care, acting as an efficient shared control arm for both interventions. For this trial, 672 patients will be recruited from 48 general practices. The eligibility criteria for the patients will be: (1) over 18 years of age; (2) has two or more chronic conditions; (3) taking 10 or more regular medicines and (4) attending their general practice team for chronic disease management. Outcome data will be collected for all participants, across all trial arms at baseline and 6 months. Primary outcomes include the number of medicines (reflecting the MyComrade intervention) and patient capability (reflecting the LinkMM intervention). Secondary outcomes include proportions and types of potentially inappropriate medications, patient experience of care, patient activation, self-rated health, health-related quality of life, mortality and healthcare utilisation. Quantitative and qualitative data will be collected to inform the process evaluation. Additionally, an economic evaluation will be conducted to evaluate the cost-effectiveness of both interventions compared with the control arm.

Ethics and dissemination

The trial protocol was approved by the Irish College of General Practice (ICGP) Ethical Review Board (ref: ICGP_Rec_2023_016). A formal knowledge dissemination plan has been developed for the trial, which includes peer-reviewed publications, conference presentations and reports to healthcare professionals, commissioners and policymakers.

Trial registration number

ISRCTN11585238.

Cohort profile: Mother and Infant Metabolome and Microbiome (MIMM) study, a prospective cohort study of mothers and infants in Boston, Massachusetts

Por: Andrews · C. · Vodapally · S. · Foster · L. P. · Lawandy · I. · Murphy · M. · Castellanos · M. · Moncada · D. · Mourao · M. L. · Bhushan · B. · Berger · P. K. · Fichorova · R. · Monthe-Dreze · C. · Freedman · S. D. · Angelidou · A. · Martin · C. R. · Sen · S.
Purpose

Breastfeeding is beneficial to the health of both the mother and infant. Despite recommendations to breastfeed by organisations including the WHO and the American Academy of Pediatrics, rates of breastfeeding remain below public health goals. The Mother and Infant Metabolome and Microbiome (MIMM) study is a prospective cohort study of healthy mother-term infant dyads designed to comprehensively assess the perinatal, maternal, neonatal and infant factors that are associated with breastfeeding outcomes and human milk composition.

Participants

MIMM participants were recruited from two medical centres in Boston, Massachusetts, from 2019 to 2023 and are followed for 2 years. Dyads were included if the mother delivered a singleton infant at ≥37 weeks’ gestation, was discharged home 2 and infant gestational age was 39.3 weeks. Approximately 43% of infants were born via caesarean delivery, and 45.5% were female.

Findings to date

MIMM study procedures include longitudinal (1) collections of maternal blood, vaginal swab, stool and milk and infant blood and stool samples and (2) assessments of breastfeeding status, child neurodevelopment and growth and maternal health at birth, 6 weeks and 6, 12, 18 and 24 months. Data collection through 18 months is complete. The overall objective of the MIMM study is to identify potential targets to improve breastfeeding outcomes, human milk composition and ultimately, maternal and child health. Preliminary analyses, reported in conference presentations (with ongoing analyses and results manuscripts pending), have found that (1) mothers with higher levels of stress were less likely to be exclusively breastfeeding their infants at 6 weeks; (2) higher breastfeeding intensity was associated with greater postpartum weight loss at 6 weeks; (3) feeding type was a more relevant predictor of feeding frequency and volume compared with feeding mode; (4) infants who received exclusive human milk had higher food enjoyment compared with those who received any formula; and (5) infants of mothers with obesity had higher average feeding volume per feed.

Future plans

Data collection for the final 24-month visit is expected to be completed by August 2025. We expect that all sample assays will be completed by December 2025. Findings will continue to be submitted for presentation at scientific conferences, and we expect to publish the first findings from this cohort in manuscript format in 2025.

Predictors of sickness absence and intention to leave the profession among NHS staff in England during the COVID-19 pandemic: a prospective cohort study

Por: Scott · L. J. · Lamb · D. · Penfold · C. · Redaniel · M. T. · Trompeter · N. · Moran · P. · Bhundia · R. · Greenberg · N. · Raine · R. · Wessely · S. · Madan · I. · Aitken · P. · Rafferty · A. M. · Dorrington · S. · Morriss · R. · Murphy · D. · Stevelink · S. A. M.
Objectives

This study aims to determine key workforce variables (demographic, health and occupational) that predicted National Health Service (NHS) staff’s absence due to illness and expressed intention to leave their current profession.

Design, setting and participants

Staff from 18 NHS Trusts were surveyed between April 2020 and January 2021, and again approximately 12 months later.

Outcome measures

Logistic and linear regression were used to explore relationships between baseline exposures and four 12-month outcomes: absence due to COVID-19, absence due to non-COVID-19 illness, actively seeking employment outside current profession and regularly thinking about leaving current profession.

Results

22 555 participants (out of a possible 152 286 employees; 15%) completed the baseline questionnaire. 10 831 participants completed the short follow-up questionnaire at 12 months and 5868 also completed the long questionnaire; these participants were included in the analyses of sickness absence and intention to leave, respectively. 20% of participants took 5+ days of work absence for non-COVID-19 sickness in the 12 months between baseline and 12-month questionnaire; 14% took 5+ days of COVID-19-related sickness absence. At 12 months, 20% agreed or strongly agreed they were actively seeking employment outside their current profession; 24% thought about leaving their profession at least several times per week. Sickness absence (COVID-19 and non-COVID-19 related) and intention to leave the profession (actively seeking another role and thinking about leaving) were all more common among NHS staff who were younger, in a COVID-19 risk group, had a probable mental health disorder, and who did not feel supported by colleagues and managers.

Conclusions

Several factors affected both workforce retention and sickness absence. Of particular interest are the impact of colleague and manager support because they are modifiable. The NHS workforce is likely to benefit from training managers to speak with and support staff, especially those experiencing mental health difficulties. Further, staff should be given sufficient opportunities to form and foster social connections. Selection bias may have affected the presented results.

Preconception cardiometabolic health in patients seeking fertility services: protocol for a single-site, prospective cohort study

Por: Manning · H. · Murphy · H. M. · Cullen · J. · McGowan · E. L. · Healey · S. · Murphy · D. · Murphy · S. · Gao · Z. · Randell · E. W. · Basset · F. A. · Twells · L. · Wadden · K.
Introduction

Weight loss is often recommended as the primary intervention for infertility in individuals with high body mass index. However, focusing on body mass index might overlook other important factors like cardiometabolic health. This study aims to examine cardiometabolic health in patients seeking fertility treatment and its impact on reproductive outcomes.

Methods and analysis

A cross-sectional analysis of 800 systematically selected participants (400 couples) will be completed on a single visit to the study site. This session will involve taking blood samples to examine metabolic biomarkers, the completion of questionnaires assessing preconception health factors and an exercise ‘step test’ to assess cardiorespiratory fitness. Metabolic panels will be compared with target values and, where available, normative population data. Fitness data will be transformed into normative percentile values based on the participant’s age and sex. Patients will be followed for 2 years to allow yearly data collection related to conception, gestation and parturition. Associations between cardiometabolic health during the preconception phase and reproductive outcomes will be examined.

Ethics and dissemination

The Newfoundland and Labrador Health Research Ethics Board has provided ethical approval for this study (HREB #20230825). Each patient will be required to give written consent prior to any data collection. We will share study findings at conferences and submit manuscripts to peer-reviewed journals. Additionally, we will create knowledge translation presentations for Newfoundland and Labrador Fertility Services and Family Practice Clinics.

Identifying Barriers and Enablers for Nurse‐Initiated Care for Designing Implementation at Scale in Australian Emergency Departments: A Mixed Methods Study

ABSTRACT

Aim

The aim of this study was to (i) identify barriers and enablers and (ii) inform mitigating or strengthening strategies for implementing nurse-initiated care protocols at scale in emergency departments (EDs).

Design

Embedded mixed methods.

Methods

The study included four clusters with a total 29 EDs in NSW, Australia. Concurrent quantitative and qualitative data were collected via electronic nursing and medical staff surveys and analysed. Barriers and enablers to implementation were identified and mapped to the domains of the Theoretical Domains Framework (TDF). Selection of intervention functions and behaviour change techniques (BCTs) enabled development of implementation strategies.

Results

In total, 847 responses from nursing and medical staff (43%) reported four enablers for use and implementation: (i) knowing or being able to learn to use simple nurse-initiated care; (ii) protocols help staff remember care; (iii) carefully considered education programme with protected time to attend training; and (iv) benefits of nurse-initiated care. Nine barriers were identified: (i) lack of knowledge; (ii) lack of skills to initiate complex care (paediatric patients, high-risk medications and imaging); (iii) risk for inappropriate care from influence of cognitive bias on decision-making; (iv) punitive re-enforcement; (v) protocols that are too limited, complex or lack clarity; (vi) perceived lack of support from medical or management; (vii) perception that tasks are outside nursing role; (viii) concern nurse-initiated care may increase the already high workload of medical and nursing staff; and (ix) context. The barriers and enablers were mapped to nine TDF domains, five intervention functions and 18 BCTs informing implementation using strategies, including an education programme, pre-existing videos, audit and feedback, clinical champions and an implementation plan.

Conclusion

A rigorous, systematic process generated a multifaceted implementation strategy for optimising nurse-initiated care in rural, regional and metropolitan EDs.

Implications

Staff wanted safe interventions that did not lead to increased workload. Staff also wanted support from management and medical teams. Common barriers included a lack of knowledge and skill in advanced practice. Clinicians and policymakers can consider these barriers and enablers globally when implementing in the ED and other high-acuity areas. Successful strategies targeting barriers to advanced practice by emergency nurses can be addressed at the local, state and national levels.

Impact

Implementation of new clinical practices in the ED is complex and presents challenges. Key barriers and enablers, including those related to initiating care and workloads in the ED were identified in this study. This research broadly impacts ED staff and policymakers globally.

Reporting Method

Mixed Methods Reporting in Rehabilitation & Health Sciences (MMR-RHS).

Patient or Public Contribution

Site senior nurse researchers for each cluster worked closely with site stakeholders, including local consumer groups. Consumer councils were engaged at all the sites. Site visits by the research nurses have been an important strategy for discussing the study with key stakeholders.

Trial Registration

Australian and New Zealand Clinical Trial: ACTRN12622001480774p

Real-world treatment patterns and outcomes among unresectable stage III non-small cell lung cancer

by Ashwini Arunachalam, Sneha Sura, John Murphy, Paul Conkling, Jerome Goldschmidt

Background

In 2018, the treatment options for unresectable stage III non-small cell lung cancer (NSCLC) changed with durvalumab, an immune checkpoint inhibitor (ICI), which was approved for consolidation therapy following concurrent chemoradiotherapy (cCRT) without disease progression. Despite durvalumab’s clinical benefit, many patients receiving this therapy developed progression. This study evaluated treatment patterns and clinical outcomes in real-world community oncology practices for patients with unresectable stage III NSCLC who received cCRT.

Methods

This study used The US Oncology Network’s (iKnowMed) electronic health record database supplemented by chart review and included adults diagnosed with unresectable stage III NSCLC initiating cCRT between 11/01/2017 and 10/31/2019, with follow-up through 04/30/2022. cCRT included concurrent treatment with platinum-based chemotherapy and radiation therapy (+/-14 days). Real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) were estimated from cCRT initiation using the Kaplan–Meier method.

Results

Among 426 patients, 61.5% received durvalumab post-cCRT (cCRT+durvalumab) and 38.5% did not (cCRT alone). Death (28.3%) and disease progression (22.2%) were the most common reasons for not initiating durvalumab. The median age for the cCRT+durvalumab and cCRT alone cohorts were 70 and 71 years, and 71.8% and 61.6% had Eastern Cooperative Oncology Group performance status of 0–1, respectively. 51.5% of cCRT+durvalumab discontinued durvalumab, primarily due to adverse events (35.8%) and disease progression (28.4%). Median rwOS was 50.2 (95% confidence interval [CI]:41.4, not reached) and 11.6 (95% CI:6.5,15.9) months for cCRT+durvalumab and cCRT alone, respectively. Median rwPFS was 28.5 (95% CI:23.3,36.4) months for cCRT+durvalumab and 6.3 (95% CI:4.3,9.3) months for cCRT alone, respectively. 23.7% (cCRT+durvalumab) and 26.2% (cCRT alone) received subsequent treatment, of which, 59.7% (cCRT+durvalumab) and 46.5% (cCRT alone) received ICI.

Conclusion

Four out of ten patients did not receive consolidation durvalumab mainly due to disease progression. Even among patients who initiated durvalumab, many patients relapsed and were retreated with ICIs. These findings underscore the need to refine treatment strategies for better outcomes in stage III unresectable NSCLC.

The establishment and value of peer group clinical supervision: A qualitative study of stakeholders' perspectives

Abstract

Aims

Explore perspectives of steering group members and external clinical supervision facilitators of developing and establishing peer group clinical supervision.

Background

The climate of healthcare is complex which can lead to staff burnout and challenges to practice. Clinical supervision is suggested as an approach to managing and leadership of such complexities.

Design

Qualitative descriptive.

Methods

Focus group interviews with 19 members of the peer group clinical supervision steering groups and individual interviews with five external clinical supervision facilitators from the Western region of Ireland were conducted. Data analysis followed Elo and Kyngäs' content analysis method, involving preparation, organising and reporting, to extract meaning and identify patterns from the qualitative data collected.

Results

Developing peer group clinical supervision practice requires, clarity of purpose and function that address the pros and cons of clinical supervision. Organisational leadership is required to support and release staff for peer group clinical supervision and peer group clinical supervisors need to be credible and have a level of expertise in practice. When prepared and supported, the aspects of confidence, leadership, personal development and resilience develop.

Conclusion

Peer group clinical supervisors need training and ongoing continual professional development for their role, scope of practice and responsibilities. Sustainability rests on staff awareness and familiarity with the purpose and format of peer group clinical supervision and the regularity of sessions.

Implications for the profession and/or patient care

Peer group clinical supervision is a means of supporting improvement of patient care delivery while in parallel supporting personal and professional development of staff, building resilience in the workplace.

Impact

This study explored the implementation of peer group clinical supervision for staff across nursing and midwifery disciplines. It found that implementing peer group clinical supervision had a positive impact on staff well-being and morality and on patient care delivery. These findings influence healthcare service providers in implementing peer group clinical supervision in a sustainable way enabling nurses to continue working in complex healthcare environments delivering safe person-centred care.

Reporting method

The qualitative reporting guidelines Standards for Reporting Qualitative Research (SRQR) were followed.

Patient or public contribution

Patient/public involvement was addressed in this study by staff, managers, planners, directors, leaders and educationalists being involved at all stages of the study (concept, design, analysis and reporting).

Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double‐blind, placebo‐controlled trial

Abstract

This Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad-spectrum topical anti-infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double-blind, placebo-controlled, multicenter study consisted of 39 individuals undergoing pravibismane treatment and 13 individuals in the placebo group. Assessment of safety parameters included clinical observations of tolerability and pharmacokinetics from whole blood samples. Pravibismane was well-tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5 ng/mL) or in the low nanomolar range, which is orders of magnitude below the threshold of pharmacological relevance for pravibismane. Pravibismane treated subjects showed approximately 3-fold decrease in ulcer size compared to the placebo group (85% vs. 30%, p = 0.27). Furthermore, the incidence of ulcer-related lower limb amputations was approximately 6-fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (p = 0.15). There were no treatment emergent or serious adverse events related to study drug. The initial findings indicate that topical pravibismane was safe and potentially effective treatment for improving recovery from infected chronic ulcers by reducing ulcer size and facilitating wound healing in infected DFUs (ClinicalTrials.gov Identifier NCT02723539).

Youth, caregiver and healthcare professional perspectives on planning the implementation of a trauma‐informed care programme: A qualitative study

Abstract

Aims

To explore youth, caregiver and staff perspectives on their vision of trauma-informed care, and to identify and understand potential considerations for the implementation of a trauma-informed care programme in an inpatient mental health unit within a paediatric hospital.

Design and Methods

We applied the Interpretive Description approach, guided by complexity theory and the Implementation Roadmap, and used Applied Thematic Analysis methods.

Findings

Twenty-five individuals participated in individual or group interviews between March and June 2022, including 21 healthcare professionals, 3 youth and 1 caregiver. We identified two overarching themes. The first theme, ‘Understanding and addressing the underlying reasons for distress’, related to participants’ understanding and vision of TIC in the current setting comprising: (a) ‘Participants’ understanding of TIC’; (b) ‘Trauma screening and trauma processing within TIC’; (c) ‘Taking “a more individualized approach”’; (d) ‘Unit programming’; and (e) “Connecting to the community”. The second theme, ‘Factors that support or limit successful TIC implementation’ comprises: (a) ‘The need for a broad “cultural shift”’; (b) ‘The physical environment on the unit’; and (c) ‘Factors that may limit successful implementation’.

Conclusion

We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of engagement with youth, caregivers and staff in trauma-informed care delivery and implementation, (b) trauma-informed care core programme components, (c) factors that may support or limit success in implementing trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration (partnering with external organizations and sectors).

Impact

When implementing TIC, there is an ongoing need to increase clarity regarding TIC interventions and implementation initiatives. Youth, caregiver and healthcare professional participants shared considerations important for planning the delivery and implementation of trauma-informed care in their setting. We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of relational engagement, (b) trauma-informed care programme components, (c) factors that may support or limit successful implementation of trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration. Organizations wishing to implement trauma-informed care should consider ongoing engagement with all relevant knowledge user groups throughout the process.

Reporting Method

Standards for Reporting Qualitative Research (SRQR).

Patient or Public Contribution

The local hospital research institute's Patient and Family Advisory Committee reviewed the draft study methods and provided feedback.

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