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Scalability evaluation of a complex community-based falls prevention intervention in Australian stroke rehabilitation

Por: Lin · I. · Day · S. · Dean · C. M. · Clemson · L. M. · Glinsky · J. V. · Cusick · A. · Lannin · N. A. · Scrivener · K.
Objectives

To investigate the scalability of the multi-component Falls After Stroke Trial (FAST) intervention tailored to community-dwelling adults with stroke to enable post-trial implementation.

Design

A mixed-methods formative evaluation of FAST data guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.

Setting

Community settings across three states in Australia.

Participants

Stroke participants were a subset of FAST trial participants (n=50) who were community-dwelling adults who had experienced a stroke up to 5 years prior and were at risk of falling. Therapists who delivered the intervention in the trial (interventionists) were physiotherapists and occupational therapists, trained in the FAST intervention.

Interventions

The FAST intervention is an individually tailored home safety and functional exercise programme designed to reduce falls and improve community mobility. It is offered over a 6-month period using 10 home visits, two telephone calls and programme resources, for example, manual and worksheets.

Primary and secondary outcome measures

Trial data, including interventionist training records and delivery data, resources and stroke participants’ adherence data were used to assess the Adoption, Implementation and Maintenance dimensions of the RE-AIM framework.

Results

The FAST intervention was delivered by 22 interventionists. High implementation fidelity was shown with 90% of the stroke participants receiving FAST dose and content. Effective strategies supporting implementation included standardised programme resources, comprehensive pre-programme training, regular interventionist feedback and interventionist mentoring from experts. Online training and peer support networks will be required for scale up.

Conclusions

This study identifies how a complex intervention to prevent falls after stroke was successfully delivered. The AIM dimensions provided insights to FAST features essential for scale-up. Interventionist training, resources and mentoring/feedback were essential for adoption within the trial. Training and resources should be accessible in an online format for scale up (maintenance).

Trial registration number

ACTRN12619001114134.

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/).

Delivering public health advice to sign language users: a qualitative study with key stakeholders

Por: Rowland · R. · Bailey · J. · Thomson · C. · Woodside · J. V.
Objectives

There are more than 10 million deaf or hard of hearing people in the UK. While the deaf and hard of hearing population is heterogeneous, many of those with profound hearing loss are part of deaf communities (UK estimate around 120 000) which are defined minority communities. Many members of deaf communities are sign language users. Studies have shown that health behaviour and knowledge and health-related attitudes and beliefs are suboptimal among deaf and hard of hearing individuals, with reasons not well understood. This qualitative study aimed to explore the effectiveness of delivery of public health messages to sign language users and the potential methods of delivering public health messages beyond direct translation.

Design

Qualitative study, using a phenomenological research approach and using interviews and focus groups. Interviews and focus groups were conducted initially between January and March 2019 and again between September and October 2022. Groups were held where logistically possible. The sessions followed a topic guide developed following review of the literature and discussion with the research team and with patient and public involvement input and pilot testing, but allowed for deviation for discussion depending on the responses given. Interviews took place in either British Sign Language (BSL) or English, depending on the language preference of the participants. Transcripts were analysed using thematic analysis.

Setting

Deaf community and associated stakeholders in Northern Ireland.

Participants

Participants were recruited from members of the deaf community and associated stakeholders across Northern Ireland and sampled purposively to ensure variation in age, sex, language, profession, educational level and region.

Results

There were 16 one-to-one interviews and 5 focus groups held, in total involving 28 participants; 23 females and 5 males. 13 participants used BSL and 15 used English. Ages ranged from 23 to 77 years old. Participants included deaf community members (all BSL users and four English users) and key stakeholders involved in sign language and Healthcare. Interview duration ranged from 21 to 82 min. A number of themes were identified from the transcript analysis. These were broadly categorised into (1) current levels of awareness of public health messages, (2) barriers to accessing public health messages and (3) suggestions for facilitating improvement.

Conclusions

Participants reflected that, as with any heterogeneous population, levels of awareness of public health messages vary widely across Deaf communities. Overall levels of awareness were felt to be generally low and certainly much lower when compared with the hearing population. Particular difficulties were noted with regard to mental health, more abstract health-related concepts and preventative health measures. Participants identified not only communication barriers but also systemic, cultural and attitudinal barriers as contributing to this. Suggested next steps involve implementing legislative reforms to address systemic barriers, conducting awareness training to tackle attitudinal barriers, and launching culturally appropriate public health campaigns, all of which should be deaf-led to ensure the expertise and lived experiences of Deaf people guide the process.

Role of Adjunctive corticoSTEROIDs on clinical outcomes in severe Scrub typhus pneumonitis: ASTEROIDS study protocol - a randomised controlled trial

Por: Peter · J. V. · Venkatesh · B. · Premkumar · P. S. · Chacko · B. · Gunasekaran · K. · Krishna · B. · Chaudhry · D. · Saravu · K. · Wyawahare · M. · Ray · S. · Chandiraseharan · V. K. · Carey · R. · Rathinam · J. · Varghese · G. M.
Introduction

Recent studies have demonstrated a beneficial role of steroids in severe community-acquired pneumonia, severe COVID-19 infection and acute respiratory distress syndrome (ARDS) of diverse aetiology. This multicentre randomised controlled trial in severe scrub typhus pneumonitis and ARDS will compare the effects of 6 mg of dexamethasone once per day with placebo, in addition to standard treatment, on ventilator-free days (VFD), mortality and ventilatory requirement.

Methods and analysis

The study, involving six sites, will recruit 440 patients with severe scrub typhus pneumonitis or ARDS to concealed, block-randomised, site-specific assignment of dexamethasone or placebo for 4–7 days. The primary outcome will be VFD, defined as days alive and free of ventilation at 28 days. Secondary outcomes will include 28-day mortality, need and duration of ventilation, and treatment failure, defined as death, or escalation of respiratory support from simple devices (nasal cannula, mask) to non-invasive or invasive ventilation, or the use of open-labelled steroids for worsening shock. The study will also ascertain if antinuclear antibody (ANA) expression during the acute phase of illness will predict steroid responsiveness. Subgroup analyses will be conducted a priori on ANA expression and the need for ventilation. All analyses will be conducted on an intention-to-treat basis. The trial, which commenced in April 2025, would clarify the role of corticosteroids in scrub typhus pneumonitis.

Ethics and dissemination

The Institutional Review Board and Ethics Committee of the lead site, Christian Medical College, Vellore, India, has approved the study (IRB Min No 15920 (INTERVE) dated 22 November 2023). The remaining five sites have obtained approval from their respective ethics committees. Study results will be published in an international peer-reviewed journal.

Trial registration number

CTRI/2024/12/077709. Registered 5 December 2024.

Evaluation of optical sensor technology for the early detection of peripheral intravenous infiltration in neonates: a retrospective cohort study

Por: van Rens · M. F. P. T. · Hugill · K. · van der Lee · R. · Francia · A. L. V. · van Loon · F. H. J. v. · Bayoumi · M. A. A.
Objective

This study aimed to evaluate the utility of optical sensor-based technology in mitigating the frequency and severity of peripheral intravenous infiltration and/or extravasation (PIVIE) in neonates.

Design

Single-centre, retrospective, observational cohort study.

Setting

Tertiary-level neonatal intensive care unit (NICU) (112 cots) at the Women’s Wellness and Research Centre (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar, January 2019–December 2022.

Participants

All neonates admitted to the NICU requiring intravenous therapy via a neonatal short peripheral intravenous catheter (n-SPC) were included. Participants were excluded if the insertion was unsuccessful, if they had incomplete data, or if they received intravenous therapy exclusively through alternative vascular access devices.

Interventions

The study analysed two cohorts representing different clinical practices over two distinct periods. In the conventional cohort (Phase 1, 2019–2020), PIVIE detection relied solely on periodic ‘Touch Look Compare (TLC)’ assessments. In the ivWatch cohort (Phase 2, 2021–2022), continuous optical sensor-based monitoring using the ivWatch system was implemented alongside TLC assessments. This sequential design allowed for a comparison of outcomes between the two phases.

Outcome measurements

The primary outcomes were the occurrence and severity of PIVIE. Secondary outcomes included the influence of patient demographics, vascular access characteristics, and management details on PIVIE incidence and severity.

Results

Over the 4-year data collection period, 32 713 peripheral intravenous catheters were analysed across two cohorts. PIVIE was the most common reason for unplanned device removal. In the conventional cohort (Phase 1, 2019–2020), 4941 infiltration events were reported (29.9%), compared with 4872 events (30.1%) in the ivWatch cohort (Phase 2, 2021–2022). However, severity measures using the Intravenous Extravasation Grading Scale (IEGS) revealed a marked reduction in severe PIVIE cases, with severe events decreasing from 243 (4.9%) in the conventional cohort to 54 (1.1%) in the ivWatch cohort (p

Conclusions

PIVIE remains a frequent complication in neonatal vascular access. Continuous site monitoring with optical sensor technology was associated with earlier detection of PIVIE events and reduced IEGS severity scores. These findings highlight the potential of integrating sensor-based monitoring with traditional observational methods to improve patient outcomes in neonatal care.

Epidemiology and excess mortality of antimicrobial resistance in bacteraemias among cancer patients: a cohort study using routinely collected health data from regional hospital trusts in Oxford and Oslo, 2008-2018

Por: Danielsen · A. S. · Lim · C. · Yoon · C. H. · Gran · J. M. · Kacelnik · O. · Eyre · D. W. · Bjornholt · J. V.
Objectives

We investigated the epidemiology and impact on mortality of antimicrobial resistance (AMR) in cancer patients with bacteraemia at Oxford University Hospitals (OxUH), UK, and Oslo University Hospital (OsUH), Norway, during 2008–2018.

Design

Historical cohort study.

Setting

Regional hospital trusts with multiple sites in OxUH and OsUH.

Methods

Patients with cancer and blood cultures positive for one of six pathogen groups during a hospital stay within 3 years following their first cancer diagnosis were followed for 30 days after their first bacteraemia episode. We determined the number of cases and the proportion of infections with an AMR phenotype. Excess mortality and the population-attributable fraction (PAF) due to AMR were estimated by contrasting observed mortality at the end of follow-up with an estimated counterfactual scenario where AMR was absent from all bacteraemias, using inverse probability weighting.

Main outcome measure

30-day all-cause mortality following the first bacteraemia episode.

Main exposure measure

A resistant phenotype of the causative pathogen.

Results

The study included 1929 patients at OxUH and 1640 patients at OsUH. The highest resistance proportions were found for vancomycin resistance in enterococci (85/314, 27.1%) and carbapenem-resistance in Pseudomonas aeruginosa (63/260, 24.2%) at OxUH, and third-generation cephalosporin resistance in Escherichia coli (62/743, 8.3%) and Klebsiella pneumoniae (14/223, 6.3%) at OsUH. Observed mortality for all infections was 26.4% at OxUH, with an estimated counterfactual mortality without AMR of 24.7%, yielding an excess mortality of 1.7% (95% CI: 0.8 to 2.5%). The PAF was 6.3% (95% CI: 2.9 to 9.6%), meaning an estimated 32 of 509 deaths could be attributed to AMR. Limited events at OsUH precluded a similar estimate.

Conclusions

Despite estimating modest excess mortality, the mortality attributable to resistance in these two high-income, low-prevalence settings highlights the potential for escalation if global resistance trends continue to worsen.

What matters to patients with multiple sclerosis? Identifying patient-relevant attributes using a ranking exercise with open-ended answers from an online survey in Italy

Por: Bywall · K. S. · Kihlbom · U. · Johansson · J. V. · Pasquini · G. · Gerli · F. · Niccolai · C. · Della Bella · S. · Portaccio · E. · Betti · M. · Amato · M. P. · Martin · S.
Objectives

This study aimed to explore what intervention specificities or attributes newly diagnosed individuals with multiple sclerosis (MS) find important and to explore possible reasons behind their evaluations.

Design

A stepwise approach began with a systematic literature review to identify significant attributes. Patients with MS then assessed these attributes through an online survey, which included a ranking exercise and open-ended questions. Finally, the results were evaluated by the clinical team to select the most relevant factors for personalised care.

Setting and participants

From June 2023 to December 2023, all consecutive patients referred to the MS Center of Careggi University Hospital were screened for inclusion. Following recruitment, cognitive and physical assessments were administered at the Don Gnocchi Centre. All participants were interviewed by an experienced neuropsychologist.

Procedures

Participants were enrolled in the RELIABLE clinical trial, which included a ranking exercise and open-ended question. In the ranking exercise, patients prioritised levels of treatment attributes: treatment effects, methods of intervention, type of monitoring, monitoring, mode and mental support. The open-ended questions addressed the reasons behind the level rankings.

Results

Participants’ rankings revealed the most important levels of each attribute. The highest-ranked method of intervention was disease-modifying treatment, which received 164 points. For mental support, individual psychotherapy was deemed most important with 149 points. Preservation of cognitive function, a key treatment effect, received 144 points. Clinical check-ups were the top type of monitoring with 129 points. Lastly, the hybrid mode of monitoring (half remote/half in-person) was ranked with 77 points. Open-ended responses provided insights into the reasons behind these preferences, emphasising the importance of maintaining mobility, cognitive function and emotional well-being. The clinical team evaluated these findings, confirming that the selected attributes were both clinically relevant and aligned with patient priorities. This evaluation process ensured that the treatment specificities chosen for individualised care were comprehensive and reflective of patient needs.

Conclusions

By identifying and prioritising key treatment attributes, this research highlights the multifaceted nature of MS management and emphasises the importance of aligning treatment options with patient preferences. Addressing these factors through further quantitative preference assessments is essential for preventative MS care, improving patient outcomes and promoting a more patient-centred approach to treatment.

What ethical challenges arise in global health programmes? A qualitative case study of global health programme leaders experiences

Por: Grek · M. · Graham · A. · Addiss · D. · Lavery · J. V.
Objectives

The study aimed to describe the ethical challenges global health programme (GHP) leaders encounter in their day-to-day work and to understand how they address these ethical challenges, as an important first step toward improving the relevance and precision of ethical guidance for GHPs.

Design

We employed a qualitative case study approach using grounded theory data collection and analysis methods.

Setting

GHPs based at a major GHP hub in Decatur, Georgia, USA, providing a wide range of health services to more than 150 countries globally

Participants

Leaders of all 15 GHPs in the programme hub were invited to participate and 9 were available and consented to participate. Two senior leaders of the programme hub also participated in the study.

Results

We identified 10 categories of ethical challenges encountered by GHP leaders: (1) ethical misalignment between funders and implementing partners; (2) budgets functioning as constraints on ethical decision-making; (3) the limited impact of programmes on improving host country capacity; (4) concerns about missed opportunities to benefit host country communities; (5) shortcomings in current ethics guidance (6) issues in data governance, stewardship and management; (7) navigating complex sociocultural contexts; (8) photography in the context of GHPs; (9) trustworthiness and reputational risks and (10) accountability for unintended consequences. The challenges often result in divided or conflicting loyalties for GHP leaders and uncertainty about what to do. We have characterised this form of uncertainty as ‘moral ambiguity,’ which we define as the inability to discern the best ethical way forward when there is tension or conflict among multiple stakeholder interests.

Conclusions

Our findings suggest that moral ambiguity is a common experience for GHP leaders and that current approaches to global health ethics fail to guide and support GHP leaders to recognise and address moral ambiguity and limit the distress it can cause. The experiences of GHP leaders offer important diagnostic insights for improving the way GHPs are imagined, financed, delivered and evaluated.

Frameworks, models and theories for prevention of child maltreatment: protocol for a scoping review from a population health perspective

Por: Rasch · L. · Alayli · A. · Ballmeyer · C. · Franco · J. V. A. · De Bock · F.
Introduction

Child maltreatment (CM) is a major public health issue with lifelong consequences on mental health, quality of life, educational and economic prospects of children who experienced CM. Early identification of maltreated children is important to prevent further CM and ensure that children’s basic needs are met, as well as to address and avoid further consequences. However, above and beyond early identification, it is crucial to avoid the occurrence of CM. This may include the reduction of risk factors at the family and community level as well as creating supportive environments for growing up safely. Therefore, we need to understand the prevention of CM conceptually and view it not only from a medical perspective, but also from a population health perspective. The aim of this scoping review is to identify and describe theories, models or frameworks on the prevention of CM from a broad population health perspective, considering primary, secondary and tertiary prevention strategies.

Methods and analysis

A broad search in four databases (PubMed (NIH NLM), PsycInfo (Ovid), CINAHL Plus (EBSCOhost) and Web of Science (Clarivate)) will be conducted from 2009 to current. Additionally, the grey literature on websites from key public health organisations will be considered. Results will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews: Checklist and Explanation (2018). The review will include articles describing a theory, model or framework on prevention strategies for CM. Studies focussing on single interventions that do not describe prevention strategies conceptually, will be excluded. General characteristics of the frameworks, theories and models and information on types of prevention strategies they describe will be extracted. Findings will be presented in a structured table format as well as narratively.

Ethics and dissemination

As we will not collect any personal, confidential or sensitive data, ethical approval is not required. We will publish our results in a scientific journal, present them at conferences and use them for further knowledge translation activities. The scoping review is registered with the Open Science framework: https://osf.io/49g7z/.

del Nido versus St. Thomas blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery

Por: Drury · N. E. · Handley · K. · Jarrett · H. · Griffin · T. · Sun · Y. · Bilkhoo · I. · Robertson · A. · Tooke · C. · Scholefield · B. R. · Dunn · W. B. · Kostolny · M. · Stoica · S. · van Doorn · C. · Pappachan · J. V. · Jones · T. J. · Caputo · M.
Introduction

Myocardial protection against ischaemia–reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, myocardial injury still occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. del Nido cardioplegia was designed to protect the immature myocardium and is widely used in the USA but has not previously been available in the UK, where St. Thomas’ blood cardioplegia is most common. The del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial will evaluate whether one solution is better than the other at improving myocardial protection by reducing myocardial injury, shortening ischaemic time and improving clinical outcomes.

Methods and analysis

The DESTINY trial is a multicentre, patient-blinded and assessor-blinded, parallel-group, individually randomised controlled trial recruiting up to 220 children undergoing surgery for congenital heart disease. Participants will be randomised in a 1:1 ratio to either del Nido cardioplegia or St. Thomas’ blood cardioplegia, with follow-up until 30 days following surgery. The primary outcome is area under the time–concentration curve for plasma high-sensitivity troponin I in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include the incidence of low cardiac output syndrome and Vasoactive-Inotropic Score in the first 48 hours, total aortic cross-clamp time, duration of mechanical ventilation and lengths of stay in the paediatric intensive care unit and the hospital.

Ethics and dissemination

The trial was approved by the West Midlands—Coventry and Warwickshire National Health Service Research Ethics Committee (21/WM/0149) on 30 June 2021. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a national charity.

Trial registration number

ISRCTN13638147; Pre-results.

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