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Feasibility and acceptability of a personalised self-care support programme for primary care patients with diabetic foot ulcers delivered by wound care nurses: the HEALing study protocol

Por: Zhu · X. · Lee · E. S. · Chan · F. H. F. · Yin · R. · Lim · P. X. H. · Koh · R. W. S. · Judith · C. · Wei · L. · Li · S. · Phrommarad · P. · Chin · G. H. Y. · Lim · V. H. · Low · R. S. Y. · Chen · Y. C. · Griva · K.
Introduction

Diabetic foot ulcers (DFUs) are highly prevalent and recurrent complications of diabetes mellitus that have significant health and cost implications. Self-care is critical for preventing or delaying DFU and promoting healing, yet adherence to self-care recommendations is low. Interventions using motivational interviewing (MI) have been effective in supporting behaviour change and emotional adjustment, but evidence for DFU is scarce. This study will assess the acceptability, feasibility and preliminary efficacy of an MI-guided programme, Healing DFU through Empowerment and Active Listening (HEALing), and its integration in usual wound care practice.

Methods and analysis

This single-arm pilot study adopts a mixed-methods approach to assess the feasibility and acceptability of the HEALing intervention. HEALing is a practical, low-intensity, clinic-integrated personalised self-care support intervention, comprising three 30 min face-to-face sessions delivered over 6 weeks by trained wound care nurses, aiming to enhance self-care behaviours and support emotional adjustment in patients with DFU. Data will be collected from a battery of questionnaire-based surveys with patients (n=30), and in-depth individual interviews with both patients (n=30) and wound care nurse facilitators (n=10) from nurse-led wound clinics in a large primary care sector in Singapore.

The primary feasibility outcomes will include enrolment, retention (≥80%), data completion (≥80% of surveys) and participant satisfaction. Secondary outcomes will include self-report measures of illness perceptions, foot care confidence, diabetes distress, foot self-care behaviour, DFU knowledge, autonomy support and health-related quality of life, taken at baseline and post-intervention. Post-intervention interviews with patients and wound care nurse facilitators will be conducted to collect feedback on the programme and its implementation feasibility.

Ethics and dissemination

The study protocol has been approved by the local ethics committee, and written informed consent will be obtained from all participants. Findings will be disseminated through the first author’s PhD thesis, peer-reviewed journals, national and international conferences and public events.

Trial registration number

NCT06540170; Pre-results.

Mental healthcare and peer support may improve the experience of diabetes self-management during pregnancy

Por: Kozlowska · O. · Moore · C.

Commentary on: Sushko K, Strachan P, Butt M, Nerenberg K, Sherifali D. Supporting self-management in women with pre-existing diabetes in pregnancy: a mixed-methods sequential comparative case study. BMC nursing. 2024 Jan 2;23(1):1.

Implications for practice and research

  • Policies are required to support self-management of diabetes during labour and delivery in practice.

  • Future research should focus on developing and implementing interventions to support self-management of diabetes during labour and delivery.

  • Context

    Sushko et al1 highlight the increasing prevalence of pre-existing diabetes in pregnancy, which represents a risk to maternal and child health. Diabetes in pregnancy is associated with an increased risk of adverse perinatal and postnatal outcomes for pregnant people and infants. Thus, maintaining optimal glycaemic control during preconception and pregnancy is associated with a lower risk of complications. Many interventions and activities aim to improve glycaemic control in pregnancy, which are...

    Association of type 2 diabetes with reoperation, adverse events and mortality after hip and knee replacement: a Swedish register-based study including 109 938 hip and 80 897 knee replacements

    Por: Vinblad · J. · Bülow · E. · Nyberg · F. · Eeg-Olofsson · K. · W-Dahl · A. · Limbäck · G. · Englund · M. · Abbott · A. · DellIsola · A. · Rolfson · O.
    Objective

    Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.

    Design

    Observational study based on prospectively collected registry data analysed retrospectively.

    Setting and participants

    Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.

    Outcome measures

    The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.

    Results

    Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).

    Conclusion

    The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.

    Beyond AIC: An Interpretive Descriptive Qualitative Study of Youth Experiences and Perceptions of Living With Type 2 Diabetes

    ABSTRACT

    Objective

    To generate an in-depth understanding of the perceptions and experiences of individuals with youth-onset type 2 diabetes (T2D) to inform knowledge translation initiatives and clinical care.

    Design

    Interpretive descriptive qualitative study.

    Methods

    Individuals were eligible to participate if they received a T2D diagnosis on or before 18 years of age, resided in Manitoba, and were between 10 and 25 years of age at the time of data collection. Twenty-two individuals (13 females, 7 males, 2 prefer not to indicate gender; mean age = 19.3 years) participated in 22 semi-structured interviews (mean length: 29:01 min) remotely using Zoom video conferencing software or by telephone. Data were analysed using inductive thematic analysis.

    Results

    Four themes were generated: (1) Low public knowledge, misconceptions, and stigma impact youth experiences including those of diagnosis, disclosure, treatment, and supports; (2) shared familial experiences impacts perception of the future; (3) mental and emotional wellness is critically important but requires more attention; and (4) T2D carries unanticipated positive and negative impacts for youth.

    Conclusions

    Findings illustrate the complex interrelationships between public and personal conceptions of T2D, stigma, and T2D navigation, emphasising the centrality of emotional and mental well-being to participants' T2D experiences and management. This representation of experiences and perceptions of youth onset T2D offers direction for holistic and youth-centred research and care and highlights areas where further mental health and educational resources would be beneficial.

    Patient and Public Contribution

    The knowledge translation resource being developed from this study involves input from patient and public partners.

    Human papillomavirus, sexually transmitted infections, and antimicrobial resistance in West Africa: Estimating population burden and understanding exposures to accelerate vaccine impact and drive new interventions: The PHASE survey protocol

    by Adedapo Olufemi Bashorun, Larry Kotei, Abdoulie F. Jallow, Ousubie Jawla, Emmanuel U. Richard-Ugwuadu, Muhammed Jagana, Lamin Bah, Amadou Tijan Bah, Karamo Conteh, Mamadou S.K. Jallow, Mehrab Karim, Bai Lamin Dondeh, Anne Segonds-Pichon, Gary M. Clifford, Iacopo Baussano, Bruno Pichon, David Jeffries, Ed Clarke

    Human papillomavirus (HPV) infection is a primary cause of preventable deaths from cervical cancer, a condition of profound inequality with approximately 90% of deaths occurring in low- and middle-income countries, particularly in sub-Saharan Africa. In May 2018, the WHO Director-General declared a Joint Global Commitment to Cervical Cancer Elimination, highlighting the critical role of HPV vaccines in achieving this goal. However, there is a lack of systemically collected data on HPV prevalence in The Gambia, and impact data from high-income countries may not be reliably extrapolated to West African settings due to geographical variation in HPV types and distinct behavioural, biological, and sociodemographic exposures. The Gambia introduced a two-dose HPV vaccination schedule in 2019, but coverage has been very low, interrupted mainly by the COVID-19 pandemic. This presents a key opportunity to generate vital baseline data on HPV prevalence in the population before potential scale-up of vaccination efforts. The PHASE survey, a multi-stage cluster survey, aims to establish the baseline, population prevalence estimates of high-risk and low-risk, vaccine-type and non-vaccine-type HPV infection in 15- to 49-year-old females in The Gambia by measuring urinary HPV-DNA. The survey will also quantify the effects of various exposures on HPV prevalence, including sexual behaviour, the presence of other sexually-transmitted infections (STIs) - Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), syphilis, as well as blood borne viruses, human immunodeficiency virus (HIV), hepatitis B and hepatitis C; obstetric history, socio-demographic characteristics, and cervical cancer screening and/or treatment. Additionally, the study will provide important antimicrobial resistance (AMR) data for NG and MG in sub-Saharan Africa, a region poorly represented in global surveillance programs. This data is needed to guide regional treatment guidelines and advocate for new solutions, including gonococcal vaccines. The AMR data are expected to immediately influence recommendations regarding the appropriate choice of antibiotics for syndromic STI management in West Africa and hence to address an important driver of AMR in the sub-region. Leveraging on the Medical Research Council Unit The Gambia funded Health Demographic Surveillance system (HDSS) as its sampling frame, the survey will utilize validated diagnostic assays and culturally sensitive data collection methods, to ensure both scientific rigor and local relevance. Tools such as Audio Computer-Assisted Self-Interviewing (ACASI) technology, developed in consultation with local community advisory boards, are included to reduce social desirability bias in reporting sexual behaviour. This approach aims to maximize both the reliability and cultural appropriateness of the findings. This study directly addresses the critical need for baseline epidemiological data on HPV in a West African setting to accelerate vaccine impact and drive new interventions towards cervical cancer elimination. By understanding other factors that influence HPV (like other STIs, sexual behaviour, etc.), the study aims to ensure that, when the vaccine’s impact is measured later, changes in other confounding factors that may impact on HPV prevalence can be accounted for. The study will also establish the population prevalence of the measured STIs and their relationship to common symptoms and other adverse health outcomes related to STIs.

    Health economic impact of early versus delayed treatment of herpes simplex virus encephalitis in the UK

    Por: Defres · S. · Navvuga · P. · Moore · S. · Hardwick · H. · Easton · A. · Michael · B. D. · Kneen · R. · Griffiths · M. · ENCEPHUK Study Group · Medina-Lara · A. · Solomon · T. · Barlow · Beeching · Blanchard · Body · Boyd · Cebria-Prejan · Chadwick · Cooke · Crawford · Davies · Davies
    Objective

    Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

    Design and setting

    A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

    Study participants

    Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

    Primary and secondary outcome measures

    Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

    Results

    A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

    Conclusions

    This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

    Picture perfect: study protocol for assessing the accuracy, feasibility and acceptability of intraoral photographs captured by parents for remote dental screening in children - an observational mixed-methods study

    Por: Al-Yaseen · W. · Haghi Ashtiani · G. · Pattinson · R. · Pritchard · M. F. · Pickles · T. · Galloway · J. · Innes · N.
    Background

    Children with limited access to dental care can be negatively impacted by reduced frequency of oral health monitoring, delays in diagnosis of dental disease and increased waits for dental care, resulting in them experiencing more disease (extent and amount). Smartphone-based intraoral photography has been cited as having the potential to improve oral health monitoring for children through screening; however, it has not been well evaluated, and its limitations are unclear. The picture-perfect study aims to assess diagnostic accuracy, feasibility and acceptability to determine whether remote photographic monitoring can be effectively integrated into pathways of dental care for children aged 6-16 years.

    Methods

    Observational, cross-sectional, mixed-methods study with three workflows: Workflow 1: development of user-friendly, comprehensive guidance to help parent/carers (parents) take high-quality intraoral photographs of their children’s mouths. The guidance will be codesigned with parents and healthcare professionals. Workflow 2: diagnostic accuracy using intraoral photographs taken by a parent of their children will be evaluated by comparing clinicians' diagnoses from the photographs to gold-standard clinical visual-tactile examinations. Parent–child dyads (n=110) will be recruited to capture intraoral photographs using positioning aids, guidance and smartphones provided by the research team. The diagnoses will focus on plaque accumulation, gingival health, restoration status and dental caries. Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value, negative predictive value and area under the curve. Workflow 3: assessment of feasibility and acceptability will be through task completion rates, photograph quality and participant feedback. Qualitative interviews and an online survey will capture parents’ and children’s experiences. Observational data will provide insights into practical challenges.

    Ethics and dissemination

    This study, approved by the National Health Service (NHS) Research Ethics Committee (Integrated Research Application System [IRAS]: 24/EE0137), will be conducted in adherence to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participating parents, with age-appropriate assent from children prior to enrolment. Participants have the right to withdraw at any time without explanation, and their data will be anonymised to ensure privacy and confidentiality. Study findings will be disseminated through peer-reviewed journals, conference presentations and reports to relevant stakeholders.

    Trial registration

    The study protocol has been registered on the Open Science Framework: https://doi.org/10.17605/OSF.IO/WX29D.

    How can cities accelerate, support and evaluate actions for active movement for health: protocol for CITY-MOVE, a multicase implementation research study in six cities in three continents

    Por: van Olmen · J. · Thornton · L. · Ndejjo · R. · Lowry · R. · Wouters · E. · Correa Senior · J. C. · Negrin Marques · T. H. · Walker · J. · Oldenhof · L. · Bastiaens · H. · Klemenc Ketis · Z. · De Witte · C. · Exel · J. v. · on behalf of CITY-MOVE Consortium · Garzon · Manyahuillca
    Introduction

    Non-communicable diseases (NCDs) are a leading cause of global mortality, disproportionately affecting low and middle-income countries (LMICs). Physical inactivity, a key contributor to NCDs, is prevalent worldwide despite evidence supporting the health benefits of physical activity (PA). Cities, while often associated with barriers to PA, also present unique opportunities to enhance PA through systemic, context-sensitive interventions or so-called actions. However, evidence on effective city-level PA strategies, particularly in LMICs, remains limited. The CITY based interventions to stimulate active MOVEment for health (CITY-MOVE) project aims to accelerate, support and evaluate the implementation of PA actions at the city level by adapting the WHO Global Action Plan on Physical Activity into locally relevant strategies across six cities worldwide, accompanied by a cross-contextual evaluation framework to ensure transferability and scalability.

    Methods and analysis

    This multicase study examines 13 PA actions in six cities (Bogotá, Lima, Kampala, Antwerp, Rotterdam and Ljubljana) across three continents, addressing both early (design and implementation) and late (evaluation) action stages. Early-stage actions employ action research in Living Labs to codesign and implement PA initiatives with local stakeholders, while late-stage interventions focus on retrospective evaluations of implementation outcomes. The framework integrates the Medical Research Council guidance on complex interventions with the Context and Implementation of Complex Interventions. Mixed methods are employed, including document review, interviews, participatory workshops and quantitative analysis of PA and NCD indicators. A cross-contextual Multi-Criteria Decision Analysis (MCDA) framework will synthesise findings to inform scalability and transferability of actions.

    Ethics and dissemination

    Ethics approvals were obtained from local review boards in the participating cities.

    Dissemination will occur at three levels: local, regional and global. Locally, findings will be shared with city authorities, non-governmental organisations (NGOs) and healthcare providers through Living Labs and policy dialogues. At the regional level, knowledge will be spread across cities in Europe, Latin America and East Africa through Communities of Practice and the use of tools like the MCDA framework. Globally, the project will contribute to the scientific community and international organisations such as the WHO and UN-Habitat, by sharing results through open access publications, conferences and global networks to ensure widespread dissemination and sustainability of the project’s impacts.

    Registration details

    This study and its outcomes are publicly accessible on OSF (https://osf.io/mn8zd/) and ZENODO (https://zenodo.org/communities/citymove/).

    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

    Nurse‐Led Innovations for Optimising the Quality and Safety of Care for the Older Person in Residential Aged Care: A Warrant for Action

    ABSTRACT

    Aim

    To canvas the contemporary contextual forces within the Australian residential aged care sector and argue for new research and innovation. There is a pressing need to provide systematised, high-quality and person-centred care to our ageing populations, especially for those who rely on residential care. This paper advances a warrant for establishing a new systematic framework for assessment and management that serves as a foundation for effective person-centred care delivery.

    Design

    Position paper.

    Methods

    This paper promulgates the current dialogue among key stakeholders of quality residential aged care in Australia, including clinicians, regulatory agencies, researchers and consumers. A desktop review gathered relevant literature spanning research, standards and guidelines regarding current and future challenges in aged care in Australia.

    Results

    This position paper explores the issues of improving the quality and safety of residential aged care in Australia, including the lingering impact of COVID-19 and incoming reforms. It calls for nurse-led research and innovation to deliver tools to address these challenges.

    Conclusion

    The paper proposes an appropriate holistic, evidence-based nursing framework to optimise the quality and safety of residential aged care in Australia.

    Patient or Public Contribution

    This study did not include patient or public involvement in its design, conduct, or reporting.

    Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study: a protocol for a multicentre phase 1 safety trial of melatonin to augment therapeutic hypothermia for moderate/severe hypoxic ischaemic encephalopathy

    Por: Pang · R. · Macneil · A. · Wadke · A. · Jaami · Y. · Marlow · N. · Standing · J. F. · Dehbi · H.-M. · Tranter · P. · Robertson · N. J. · on behalf of the ACUMEN Consortium · Allegaert · Becher · Boardman · Boylan · Cowan · Dehbi · Foran · Hunt · Jaami · Kendall · MacNeil · Mahaveer
    Introduction

    Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).

    Methods and analysis

    The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of

    Ethics and dissemination

    Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.

    Trial registration number

    ISRCTN61218504. EU CT: 2025-520538-49-00.

    Protocol version

    Publication based on the UK protocol V.3.0, 08 May 2025

    Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility (JAKPPPOT) trial protocol

    Por: Gleeson · D. · Chapman · S. · McAteer · H. · Qin · A. · Gregory · J. · Pizzato · J. · Powell · K. · Sagoo · M. K. · Ye · W. · Naylor · A. · Moorhead · L. · Pink · A. E. · Woolf · R. · Barker · J. · Galloway · J. B. · Cro · S. · K Mahil · S. · Smith · C. H.
    Background

    Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.

    Methods and analysis

    The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.

    Ethics and dissemination

    This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.

    Trial registration number

    ISRCTN61751241.

    Core outcome set and measures of chest health in children and young people with cerebral palsy in the community setting: the CHESTI study protocol

    Por: Knight Lozano · R. · Morris · C. · Shannon · H. · Bell · K. · Malyon · H. · Melluish · J. · Latour · J. · CHESTI-study steering group · Andrews · Crombie · Gibson · Grace · Goddard · Kolawole · Lowndes · McNamara · Pilbury · Rapson · Scivier · Sellers · Weighton · Winston
    Introduction

    Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.

    Methods and analysis

    A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.

    Ethics and dissemination

    Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.

    Study registration

    COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)

    PROSPERO registration number

    CRD42024562735.

    Immunosuppression variably impacts outcomes for patients hospitalized with COVID-19: A retrospective cohort study

    by Vijeeth Guggilla, Jennifer A. Pacheco, Alexandre M. Carvalho, Grant R. Whitmer, Anna E. Pawlowski, Jodi L. Johnson, Catherine A. Gao, Chad J. Achenbach, Theresa L. Walunas

    Background

    Adults with immunosuppression are more likely to develop severe COVID-19 than adults without immunosuppression. Less is known about differences in outcomes for adults with immunosuppression who are hospitalized with COVID-19.

    Methods

    A retrospective cohort study of adults hospitalized with COVID-19 at Northwestern Medicine hospitals between 03/01/2020 and 05/31/2022 was performed. Regression analyses were performed comparing in-hospital mortality, intensive care unit (ICU) admission, oxygenation requirements, and hospital/ICU length of stay among patients without immunosuppression (n = 9079) and patients with immunosuppression (n = 873).

    Results

    Patients with immunosuppression had significantly higher mortality than patients without immunosuppression (OR: 1.33, 95% CI: 1.11–1.60). This effect was even stronger when controlling for age at admission, diabetes, obesity, SARS-CoV-2 variant era, and COVID-19 medication use (adjusted OR: 1.78, 95% CI: 1.46–2.16). ICU admission (adjusted OR: 1.64, 95% CI: 1.41–1.90) and invasive ventilation (adjusted OR: 1.68, 95% CI: 1.36–2.06) were also significantly higher in patients with immunosuppression. Hospitalization length (median: 7 days) and ICU length of stay (median: 2.5 days) were longer in patients with immunosuppression compared to patients without immunosuppression (median: 5 days, adjusted p  Conclusions

    Patients with immunosuppression had worse outcomes than patients without immunosuppression. Subgroup analyses showed that patients with solid organ transplant had the worst outcomes overall. Patients with HIV had similar outcomes as patients without immunosuppression unless CD4 cell count was low.

    Socioeconomic and demographic predictors of extracurricular achievements among UK medical students (FAST study)

    Por: Ferreira · T. · Collins · A. M. · Handscomb · A. · French · B. · Bolton · E. · Fortescue · A. · Plumb · E. · Feng · O. · The FAST Collaborative · Fallows · Valnarov-Boulter · Kuo · Sagdeo · McDermott · Luo · Wong · Fitzsimons-West · Ho · Hemayet · Sreekumar · Burley · Stavrinou · Lew
    Objective

    To investigate the relationship between demographic characteristics and extracurricular achievements among UK medical students.

    Design

    National, cross-sectional survey.

    Setting

    All 44 UK medical schools recognised by the General Medical Council.

    Participants

    8,395 medical students.

    Outcomes

    Binary indicators of extracurricular engagement, including PubMed-indexed authorship, academic presentations, quality improvement projects, leadership roles and academic prizes. Logistic regression models were used to explore associations with demographic and extracurricular achievement predictors.

    Results

    Logistic regression analysis showed that students from private schools (OR 1.35, CI 1.20 to 1.53, p

    Conclusions

    Significant disparities in extracurricular achievement exist among UK medical students, principally associated with gender, private schooling and familial links to medicine. Apparent ethnic differences were largely attenuated after adjustment for other variables, indicating socioeconomic factors as stronger predictors of engagement. Given the role of these achievements in postgraduate selection, targeted interventions by medical schools and professional bodies to widen access to funding, mentorship and structured guidance for all students, regardless of perceived advantage, may support equitable opportunity without undermining merit-based standards.

    Specialty choices among UK medical students: certainty, confidence and key influences--a national survey (FAST Study)

    Por: Ferreira · T. · Collins · A. M. · Handscomb · A. · French · B. · Bolton · E. · Fortescue · A. · Plumb · E. · Feng · O. · the FAST Collaborative · Fallows · Valnarov-Boulter · Kuo · Sagdeo · McDermott · Luo · Wong · Fitzsimons-West · Ho · Hemayet · Sreekumar · Burley · Stavrinou · Lew
    Objective

    To explore factors influencing UK medical students’ specialty choices and examine variations in these influences across demographic groups and stages of training.

    Design

    National, cross-sectional online survey.

    Setting

    All 44 UK medical schools recognised by the General Medical Council.

    Participants

    8,395 medical students.

    Primary and secondary outcomes

    The primary outcome was the specialty preferences of UK medical students. The secondary outcomes were factors behind these preferences and how these factors vary across demographic groups and different stages of training.

    Results

    General Practice (15.3%), Paediatrics (10.6%) and Anaesthetics (9.9%) were the most preferred specialties among final-year students. Work-life balance (84.1%), compatibility with family life (78.2%), positive training experiences (85.2%) and future specialty outlook (74.9%) were key factors influencing specialty choice. Only 23.1% of students felt confident about securing a specialty training post, with confidence higher among males (OR 1.36, 95% CI 1.21 to 1.52, p

    Conclusions

    This study highlights disparities in specialty preferences and influencing factors among UK medical students. A focus on improving career guidance, exposure to various specialties and supporting equitable access to training opportunities is essential for fostering a motivated and sustainable medical workforce.

    Early supplementation for cows milk allergy prevention in breastfed infants in Poland (ESCAPE-PL): a protocol for randomised controlled trial

    Por: Horvath · A. · Wesolowska · A. · Strozyk · A. · Bzikowska-Jura · A. · Ambrozej · D. · Dumycz · K. · Feleszko · W. · Szajewska · H.
    Introduction

    Current recommendations for early introduction of cow’s milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. We aim to assess whether early supplementation with various nutritional interventions, including cow’s milk formula (CMF), amino acid formula (AAF), donor human milk (DHM) or high-pressure processed ‘pascalised’ DHM (DHM-P) is effective for the primary prevention of cow’s milk allergy (CMA) in breastfed neonates.

    Methods and analysis

    We will perform an open-label randomised, controlled, head-to-head trial with four parallel arms in three Polish study centres (Warsaw). 1000 healthy full-term newborns of mothers eager to exclusively breastfeed will be allocated to receive early supplementation with one of four nutritional interventions: CMF, AAF, DHM or DHM-P. All children will receive 10 mL of each intervention per day for the first 3 days of life; exclusive breastfeeding will be recommended. However, if any supplementation in addition to the breastfeeding is needed, the assigned nutritional intervention will be provided until 4 months of age. The primary outcome is a cumulative incidence of CMA confirmed by open oral food challenge at 4–6 months and 12 months of age. Secondary outcomes include an incidence of sensitisation to cow’s milk protein; a total score in the Cow’s Milk Related Symptom Score; the percentage of children with acquired tolerance to cow’s milk, feeding difficulties and exclusively and predominantly breastfed; an incidence of atopic dermatitis, allergic rhinitis and wheezing; growth; compliance and adverse events. The level of immunomodulatory factors in maternal milk and its nutritional component analysis will also be performed.

    Ethics and dissemination

    The ethics committee of the Medical University of Warsaw, Poland, approved this protocol (KB/61/2023). The results of this study will be submitted to a peer-reviewed journal no later than 1 year after data collection. The abstract will be presented at relevant national and international conferences.

    Trial registration number

    NCT06652698.

    Diverse diagnostic and management approaches for acute rheumatic fever in Australia and New Zealand: findings of a prospective clinical study

    Por: Peiris · R. · Webb · R. · Bennett · J. · Yan · J. · Francis · J. R. · Remenyi · B. · Chan Mow · F. · Burgess · R. · Wilson · N. J. · Stanley · A. · Francis · L. · Holloway · R. · Westbury · R. · Lawrence · S. · Hernandez-Gomez · Y. · Broadhurst · D. · Moreland · N. J. · McGregor · R. · Mot
    Objectives

    To describe diagnostic and management characteristics of acute rheumatic fever (ARF) among participants in the ‘Searching for a Technology-Driven Acute Rheumatic Fever Test’ study, in order to answer clinical questions and determine epidemiological and practice differences in different settings.

    Design

    Multisite, prospective cohort study.

    Setting

    One hospital in northern Australia and two hospitals in New Zealand, 2018–2021.

    Participants

    143 episodes of definite, probable or possible ARF among 141 participants (median age 10 years, range 5–23; 98% Indigenous).

    Primary and secondary outcome measures

    Participant characteristics, clinical, biochemical and echocardiographic data were explored using descriptive data. Associations with length of stay were determined using multivariable regression analysis.

    Results

    ARF presentations were heterogeneous with the most common ARF ‘phenotype’ in 19% of cases being carditis with joint manifestations (polyarthritis, monarthritis or polyarthralgia), fever and PR prolongation. The total proportion of children with carditis was 61%. Australian compared with New Zealand participants more commonly had ARF recurrence (22% vs 0%), underlying RHD (48% vs 0%), possible/probable ARF (23% vs 9%) and were underweight (64% vs 16%). Erythrocyte sedimentation rate (ESR) provided an incremental diagnostic yield of 21% compared with C reactive protein. No instances of RHD were diagnosed among participants in New Zealand. Positive throat Group A Streptococcus culture was more common in New Zealand than in Australian participants (69% vs 3%). Children often required prolonged hospitalisation, with median hospital length-of-stay being 7 days (range 2–66). Significant predictors for length of stay in a multivariable regression model were valve disease (adjusted OR (aOR) 1.56, 95% CI 1.23 to 1.98, p

    Conclusions

    This study provides new knowledge on ARF characteristics and management and highlights international variation in diagnostic and management practice. Differing approaches need to be aligned. Meanwhile, locally specific information can help guide patient expectations after ARF diagnosis.

    Immunomodulatory therapies in community-acquired pneumonia: a protocol for a systematic review and network meta-analysis

    Por: Flower · L. · Newman · J. · Couturier · D.-L. · Law · M. · Summers · C.
    Introduction

    Community-acquired pneumonia is the leading global cause of infection-related death. A subset of patients with pneumonia develops aberrant immune responses, resulting in harmful inflammation, tissue damage and significant mortality. Immunomodulatory therapies aim to blunt this dysregulated immune response and reduce resultant injury. No consensus exists on the use or impacts of immunomodulatory therapies in the management of community-acquired pneumonia. This protocol describes the methods we will use to undertake a systematic review and network meta-analysis of the effects of immunomodulatory therapies on the mortality of patients with community-acquired pneumonia.

    Methods

    We will undertake a systematic review and network meta-analysis investigating the use of immunomodulatory therapies in community-acquired pneumonia. Our protocol has been developed and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines and prospectively registered with PROSPERO (CRD42024565301). The primary objectives of this work are to compare the impact of immunomodulatory therapies on 28-day and 90-day mortality in adult patients admitted to hospital with a primary diagnosis of community-acquired pneumonia. The secondary objectives of this work are to identify any differences in the effectiveness of these immunomodulatory therapies in managing community-acquired pneumonia of differing aetiology and severity.

    We will conduct a literature search of Medline, Embase, Scopus, Web of Science and Global Health for all relevant articles until 30 June 2024. All observational, interventional and epidemiological studies published in English will be included, and each type of study design will be examined separately. All studies will have their titles and abstracts independently screened by two reviewers, followed by a full article eligibility review and data extraction. A third reviewer will adjudicate any disagreements. Data extracted will include, but not be limited to, the study design, country in which it was undertaken, patient characteristics (eg, age, sex, cause of CAP, severity of CAP), details regarding the immunomodulatory therapy and dosing used and the 28-day and 90-day mortality of each study arm.

    Analysis

    The risk of bias will be assessed using the Risk of Bias in Non-randomised Studies - of Exposure tool for non-randomised studies and the Cochrane Risk of Bias 2 tool for randomised control trials. The quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations for network meta-analysis framework. A quantitative synthesis of data is planned for 28-day and 90-day mortality rates.

    We will fit a random-effects network meta-analysis model that includes random effects for between-study heterogeneity and for inconsistency. This will be done using the metafor package for R. We will use a contrast-based approach, modelling estimated treatment effects using reference treatments. In the case of the primary objective, this will be the log odds ratio (OR) of mortality in one treatment compared with another.

    Each type of study design will be examined separately. Treatments using the same immunotherapy at different doses may be grouped if appropriate.

    Ethical approval and dissemination

    This will be a systematic review of published literature; therefore, ethical approval is not required. To ensure communication of our findings, we will publish our results in a peer-reviewed journal and present our findings at appropriate local, national and international meetings.

    PROSPERO registration number

    CRD42024565301.

    Men matter: a cross-sectional exploration of the forgotten fathers of children born to adolescent mothers in South Africa

    Por: Steventon Roberts · K. · Smith · C. · Cluver · L. D. · Toska · E. · Kelly · J. · Thomas · A. · Tolmay · J. · Marlow · M. · Sherr · L.
    Background

    Fathers are intricately bound to the experience of adolescent mothers and their children. Yet, fathers of children born to adolescent mothers, particularly within the context of HIV, remain neglected in the literature. These exploratory analyses provide insight into the characteristics of fathers of children born to adolescent mothers affected by HIV in South Africa.

    Setting

    Eastern Cape Province, South Africa.

    Design

    Cross-sectional data from a prospective cohort study.

    Participants

    Young mothers (10–24 years of age) and their children (0–68 months). All mothers completed detailed study questionnaires, including standardised and study-specific measures, relating to their self, their children and the fathers of their children. Summary statistics are presented based on maternal self-report of father characteristics. 2 tests and t-tests (Fisher’s exact/Kruskal-Wallis tests, where appropriate) were additionally used to explore sample characteristics (including father characteristics, maternal experience and child characteristics) according to paternal age and father involvement in childcare (defined by responses to four maternal self-report questions). Father characteristics were also explored according to maternal HIV status and maternal mental health status.

    Results

    40% of fathers were adolescents (10–19 years) at the birth of their children. Overall, father involvement was low (19.5%). Compared with noninvolved fathers, involved fathers were more likely to be older when their child was born (21 years vs 20 years, t=4.30, p=0.04), to be in a relationship with the mothers of their children (74.8% vs 47.2%, 2=40.8, p≤0.0001), to reside with their children and their mothers (14.7% vs 3.7%, 2=49.3, p≤0.0001) and to attend the first antenatal appointment (4.3% vs 1.5%, 2=5.21, p=0.02). A quarter (25.4%; 227/894) of the adolescent mothers in the sample were living with HIV. The prevalence of maternal HIV was found to be higher among adolescent mothers of children born to older fathers compared with adolescent fathers (31.7% vs 15.9%, 2=28.3, p≤0.001). Likewise, depressive symptoms were more prevalent among adolescent mothers of children born to older fathers compared with adolescent fathers (9.9% vs 5.3%, 2=6.08, p=0.01). Adolescent mothers reporting poor mental health were less likely to be in a relationship with the fathers of their children (41.8% vs 54.1%, 2=7.32, p=0.03) and more likely to experience domestic violence perpetrated by the fathers of their children (8.2% vs 3.3%, 2=6.07, p=0.01) and to engage in arguments about finances with the fathers of their children (30.0% vs 17.0%, 2=10.8, p=0.001). While some differences in individual subscales were identified, overall composite scores of child cognitive development did not differ according to father age or father involvement.

    Conclusions

    Analyses provide the first preliminary description of the fathers of children born to adolescent mothers affected by HIV in South Africa. Fathers are inherently tied to the experiences of adolescent mothers and their children. Father involvement with their children was low. Further research is required to explore the potential barriers to father involvement and pathways to overcome these. Efforts to bolster father engagement, such as the inclusion of fathers within maternal and child service provision, may have benefits for fathers, adolescent mothers and their children. There was a high prevalence of adolescent fatherhood in the study. Adolescent fathers may have specific needs requiring tailored intervention for adolescent parent families. The need for the inclusion of fathers within policy, programming and research remains.

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