To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

A single NHS hospital in the UK.

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

Tourette syndrome is a common, disabling childhood-onset condition. Exposure and response prevention (ERP) is an effective treatment for tics, yet access remains limited due to a shortage of trained therapists and uneven geographical distribution of services. The ORBIT trial demonstrated that internet-delivered ERP is both clinically and cost-effective, but was developed on a university research platform, not suitable for widescale roll-out. To enable adoption by the National Health Service (NHS) in England, ORBIT has been redeveloped on an NHS compliant platform. This study will evaluate the usability, acceptability and preliminary outcomes of ORBIT on the new platform within an NHS tic disorder service.

This single-cohort usability study will recruit 20 children and young people (aged 9–17) with tics and their chosen supporters (parents/carers). Participants will receive a 10-week online ERP intervention supported by trained coaches. Outcomes include uptake, adherence, system usability, satisfaction and clinical measures such as the Yale Global Tic Severity Scale, Parent Tic Questionnaire and Goal-Based Outcomes. Qualitative feedback will be collected via semi-structured exit interviews. Usability metrics and adverse events will be monitored throughout.

The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref: 25/NW/0107). The findings from the study will inform future NHS adoption. The results will be submitted for publication in peer-reviewed journals.

ISRCTN82718960. Registered 10 July 2025. https://doi.org/10.1186/ISRCTN82718960

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

Cross-sectional analysis

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

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

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

Hospitalised patients nearing the end of life (EOL) often face complex treatment decisions, leading to potential conflicts among care teams, patients and families. Palliative care consultations may enhance decision-making processes, improve satisfaction and reduce unnecessary interventions. This systematic review will assess the impact of palliative care consultations on treatment decisions, family and patient satisfaction, and psychological outcomes in hospitalised adults.

We will include randomised controlled trials comparing palliative care consultations to standard care in hospitalised adults. The primary outcomes will include decisions to withhold or withdraw treatments, patient and family satisfaction with EOL decision-making, and psychological outcomes such as anxiety, depression and post-traumatic stress disorder. Secondary outcomes will include intensive care unit (ICU) and hospital length of stay, utilisation of potentially non-beneficial treatments, and the use of institutional policies or legal actions. Databases including MEDLINE, Embase, CINAHL, Cochrane CENTRAL and PsycINFO will be systematically searched from inception to September 2025. Two independent reviewers will screen studies and extract data using Covidence. Meta-analyses will use random-effects models to generate pooled estimates for primary and secondary outcomes. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool, and evidence certainty will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. Subgroup analyses will explore variations by ICU versus non-ICU settings, cancer versus non-cancer diagnoses and default versus clinician-initiated consultations.

Ethical approval is not required for this review. Findings will be disseminated through peer-reviewed publications and conference presentations.

CRD420250624190.

To evaluate the impact of public–private mix (PPM) models for tuberculosis (TB) on health, process and system outcomes, adopting the WHO’s definition of PPM, which is a strategic partnership between national TB programmes and healthcare providers, both public and private, to deliver high-quality TB diagnosis and treatment.

Systematic review without meta-analysis using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.

EMBASE, MEDLINE, Health Management Information Consortium, Social Sciences Citation Index, Science Citation Index, Emerging Sources Citation Index, CENTRAL, Database of Disability and Inclusion Information Resources, WHO Library Database and 3ie.

We included all primary studies examining PPM models delivering TB services in urban health sectors in least-developed, low-income and lower–middle-income countries and territories.

17 reviewers were involved in data extraction in COVIDENCE using a prepiloted template. All extractions were completed by a single reviewer and checked by a second reviewer. Quality appraisal was carried out using the mixed-methods appraisal tool, covering mixed-methods, qualitative and quantitative study designs. Narrative synthesis was carried out by tabulating and summarising studies according to PPM models and reported in line with the synthesis without meta-analysis guidelines.

Of the 57 included studies, covering quantitative (n=41), qualitative (n=6) and mixed-method (n=10) designs, the majority were from Southeast Asia (n=37). PPM models had overall positive results on TB treatment outcomes, access and coverage and value for money. They are linked with improved TB health workers’ skills and service delivery. Most outcomes tended to favour interface models, although with considerable heterogeneity. Inconsistent implementation of national TB guidelines, uncoordinated referrals and lack of trust among partners were identified as areas of improvement. Evidence was lacking on the involvement of informal providers within PPM models.

PPM models can be effective and cost-effective for TB care in urban low- and middle-income countries contexts, particularly when levels of mistrust between public and private sectors are addressed through principles of equal partnership. The evidence indicates that this may be more achievable when an interface organisation manages the partnership.

CRD42021289509.

To investigate vaccination coverage for influenza and COVID-19 in the SARS-CoV-2 immunity and reinfection evaluation (SIREN) study cohort of healthcare workers (HCWs) between 2020 and 2023 and explore vaccination enablers and barriers.

A mixed-methods study nested within SIREN, a multicentre prospective cohort study of HCWs across the UK. Quantitative and qualitative methods were used sequentially, using an expansion/explanation function, enabling emergent themes observed from the quantitative stage to be explored in the qualitative stage.

SIREN sites include secondary care centres and community mental health trusts in the UK.

Quantitative analysis was conducted on data from 6048 participants. Participants were representative of the HCW workforce, with the majority being women (83%) and of white ethnicity (88%). Nurses made up the largest occupational group (33%). Qualitative analysis of data from 24 participants including five focus groups (n=21) and three semistructured interviews (n=3); 82% women, 26% minority ethnic, all working age from across the UK.

Quantitative: vaccine coverage for COVID-19 and influenza vaccines by demographic with multivariable logistical regression used to assess differences. Qualitative: thematic analysis to explore reasons behind the results seen in the quantitative stage.

COVID-19 vaccination was initially high; 97% received two doses and 94% a first booster. However, coverage was reduced to 77%, for the second booster. Influenza vaccination coverage was lowest in 2020–2021 (46%), increasing to 73% in 2021–2022 and to 79% in 2022–2023. In 2022–2023, vaccination coverage was higher for influenza than for COVID-19. High vaccine coverage for both COVID-19 and influenza was observed in doctors, pharmacists and therapists. Porters, healthcare assistants and staff from minority ethnic groups had lower vaccine coverage for both COVID-19 and influenza. Four themes were identified: (1) attitudes towards vaccination changed throughout the COVID-19 pandemic; (2) HCWs used data to inform vaccination decisions; (3) poor communication in healthcare settings contributed to a reduction in vaccination; (4) there were both positive and negative impacts of the COVID-19 vaccine on influenza vaccine uptake and other vaccination programmes.

Between 2020 and 2023 in our cohort, COVID-19 vaccination coverage decreased, whereas influenza increased. Our study found attitudes to both vaccines have shifted, becoming more favourable to influenza and less to COVID-19 boosters. Barriers to COVID-19 boosters, including concerns about side effects and vaccine effectiveness, need to be addressed with improved communication on the benefits and adverse events. Future vaccination strategies should address the differences we have identified in vaccine coverage across demographics and occupational groups, including continued efforts to improve vaccine equity.

ISRCTN11041050.

Coronary revascularisation practices have evolved over the last three decades. This study sought to examine the variations in percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) rates, alongside mortality from acute myocardial infarction (AMI) across a group of 16 high-income countries between 2006 and 2020.

Retrospective observational analysis using data from the Organisation for Economic Co-operation and Development (OECD) database between 2006 and 2020. Estimated annual percent change in revascularisation was analysed using Joinpoint regression model, and mortality rates were evaluated using the locally weighted scatterplot smoothing model.

Publicly available data on PCI and CABG procedure rates alongside AMI mortality rate from 2006 to 2020.

16 countries from the OECD database.

Not applicable.

Standardised PCI and CABG procedure rates and AMI age-standardised mortality rate (ASMR) from 2006 to 2020.

Over the 15 year period, 14.0 million PCI and 2.8 million CABG procedures were collectively recorded across 16 countries. PCI rates varied among nations, but from 2006 to 2020 increased in 11 of the 16 nations overall, led by Finland (+36.0%), Ireland (+34.5%) and France (+31.5%). Meanwhile, CABG rates declined in 14 out of the 16 countries, with Luxembourg (–71.3%), the UK (–62.6%) and Finland (–60.6%) experiencing the most substantial decreases. Throughout the study period, the PCI-to-CABG ratio increased, while AMI ASMR decreased consistently across all countries.

Despite evidence supporting CABG over PCI in specific scenarios, CABG rates have declined, and PCI rates have increased. Possible factors for this trend may include patient preference and advancement in interventional techniques. The varied use of PCI among these nations, alongside a sustained decline in AMI mortality rates, may be expected given the importance of optimal medical therapy in the management of ischaemic heart disease. The results further suggest the significance of factors beyond revascularisation in driving improved outcomes.

There are little available data on the prevalence, economic and quality of life impacts of musculoskeletal disorders in sub-Saharan Africa. This lack of evidence is wholly disproportionate to the significant disability burden of musculoskeletal disorders as reported in high-income countries. Our research aimed to undertake an adequately powered study to identify, measure and value the health impact of musculoskeletal conditions in the Kilimanjaro region, Tanzania.

A community-based cross-sectional survey was undertaken between January 2021 and September 2021. A two-stage cluster sampling with replacement and probability proportional to size was used to select a representative sample of the population.

The survey was conducted in 15 villages in the Hai District, Kilimanjaro region, Tanzania.

Economic and health-related quality of life (HRQOL) questionnaires were administered to a sample of residents (aged over 5 years old) in selected households (N=1050). There were a total of 594 respondents, of whom 153 had a confirmed musculoskeletal disorder and 441 matched controls. Almost three-quarters of those identified as having a musculoskeletal disorder were female and had an average age of 66 years.

Questions on healthcare resource use, expenditure and quality of life were administered to all participants, with additional more detailed economic and quality of life questions administered to those who screened positive, indicating probable arthritis.

There is a statistically significant reduction in HRQOL, on average 25% from a utility score of 0.862 (0.837, 0.886) to 0.636 (0.580, 0.692) for those identified as having a musculoskeletal disorder compared with those without. The attributes ‘pain’ and ‘discomfort’ were the major contributors to this reduction in HRQOL.

This research has revealed a significant impact of musculoskeletal conditions on HRQOL in the Hai district in Tanzania. The evidence will be used to guide clinical health practices, interventions design, service provisions and health promotion and awareness activities at institutional, regional and national levels.

Low back pain (LBP) is the leading contributor to disability globally. It has a substantial impact on the lives of those who experience it, and places considerable economic burden on healthcare systems. Despite these impacts, and the consistency of guideline recommendations, many individuals do not receive recommended LBP management. Structural barriers to accessing timely, evidence-based care, as well as public uncertainty about where to seek appropriate management, can influence the care individuals receive. Telephone and digitally based helplines assist to overcome many traditional barriers to accessing care and offer a scalable platform to improve the delivery of guideline recommended management for LBP. However, uptake of such services can be limited without targeted promotion and patient-centred design. This project aims to codesign, implement and evaluate an upgraded component of an existing Australian helpline service, tailored for people with back pain and supported by a media awareness campaign. This protocol outlines the codesign process, implementation and planned evaluation of the helpline.

This protocol uses three complementary frameworks—an iterative codesign process, the Practical Robust Implementation Sustainability Model, and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework—to guide the codesign and development, implementation and evaluation of an upgraded helpline for people with LBP. The codesign process involves key stakeholders, including consumers and clinicians, to inform the development and implementation of both the upgraded helpline service and the media campaign to raise awareness and uptake of the helpline. Data sources will include a pre–post cohort of helpline service users, routinely collected service data (eg, monthly call rate) and health system data to evaluate the broader population level impact (eg, rates of emergency department presentations for LBP in the Australian region targeted by the media campaign). Implementation evaluation will include Reach, Effectiveness, Adoption, Implementation and Maintenance as well as internal and external environmental factors that influence the success of these outcome measures.

The project was approved by the University of Sydney’s Human Research Ethics Committee (HE001081). This project involves collaboration with consumers, clinicians and other stakeholders to interpret, translate and disseminate research findings to relevant audiences.

Global migration has steadily risen, with 16% of the UK population born abroad. Migrants (defined here as foreign-born individuals) face unique health risks, including potential higher rates and delays in diagnosis of infectious and non-communicable diseases, compounded by significant barriers to healthcare. UK Public Health guidelines recommend screening at-risk migrants, but primary care often faces significant challenges in achieving this, exacerbating health disparities. The Health Catch-UP! tool was developed as a novel digital, multidisease screening and catch-up vaccination solution to support primary care to identify at-risk adult migrants and offer individualised care. The tool has been shown to be acceptable and feasible and to increase migrant health screening in previous studies, but to facilitate use in routine care requires the development of an implementation package. This protocol describes the development and optimisation of an implementation package for Health Catch-UP! following the person-based approach (PBA), a participatory intervention development methodology, and evaluates our use of this methodological approach for migrant participants.

Through engagement with both migrants and primary healthcare professionals (approximately 80–100 participants) via participatory workshops, focus groups and think-aloud interviews, the study aims to cocreate a comprehensive Health Catch-UP! implementation package. This package will encompass healthcare professional support materials, patient resources and potential Health Catch-UP! care pathways (delivery models), developed through iterative refinement based on user feedback and behavioural theory. The study will involve three linked phases (1) planning: formation of an academic–community coalition and cocreation of guiding principles, logic model and intervention planning table, (2) intervention development: focus groups and participatory workshops to coproduce prototype implementation materials and (3) intervention optimisation: think-aloud interviews to iteratively refine the final implementation package. An embedded mixed-methods evaluation of how we used the PBA will allow shared learning from the use of this methodology within the migrant health context.

Ethics approval granted by the St George’s University Research Ethics Committee (REC reference: 2024.0191). A community celebration event will be held to recognise contributions and to demonstrate impact.

To evaluate the psychometric properties of the Hospital Survey on Patient Safety Culture (HSoPSC) version 2.0 in Ethiopian public hospitals.

A cross-sectional study.

Five public hospitals in Eastern Ethiopia.

Healthcare professionals (N=582).

An adapted and contextualised version of HSoPSC 2.0 was used to conduct structural validity using exploratory and confirmatory factor analyses (EFA and CFA). Convergent and discriminant validity were evaluated through item loadings and interfactor correlations, respectively. Reliability was measured using McDonald’s omega and Cronbach’s alpha.

CFA indicated a poor model fit for the original 10-factor, 32-item HSoPSC 2.0 across all statistical indices: relative chi-square (²/df=7.71), root mean square error of approximation (RMSEA=0.108), standardised root mean square residual (SRMR=0.088), comparative fit index (CFI=0.814) and Tucker-Lewis’s index (TLI=0.780). Consequently, a comprehensive EFA was conducted, which identified a revised model comprising 5-factor, 21-item. This model accounted for 62.8% of the total variance and demonstrated strong construct validity, with excellent fit indices (²/df=3.67, RMSEA=0.068, SRMR=0.034, CFI=0.969, TLI=0.945). Internal consistency, assessed via McDonald’s omega and Cronbach’s alpha, exceeded the acceptable threshold of 0.70 across all dimensions, except for Response to Error (0.66). The convergent and discriminant validity of the new model was confirmed, ensuring an accurate representation of the underlying constructs.

The original HSoPSC 2.0 with 10-factor, 32-item failed to demonstrate structural validity in the Ethiopian healthcare context. In contrast, a revised 5-factor, 21-item model showed strong validity and acceptable reliability. This adapted version provides a culturally and contextually relevant tool for assessing patient safety culture in Ethiopian healthcare settings.

The main objective of the Health Survey of São Paulo or Inquérito de Saúde de São Paulo (ISA) in Portuguese, is to generate health indicators to support research and policy planning. The ISA-Physical Activity and Environment Longitudinal Study has the primary objective of examining built and social environmental determinants of leisure-time physical activity and active transportation.

The baseline (2014–2015) study included 4042 participants aged 12 years and older, men and women, living across the five regions of São Paulo city. Data were collected through household interviews. The second wave (2020–2021) used telephone interviews and included 1434 participants aged 18 or older, 58.6% female and representing 35% of the baseline sample. The third wave (2023–2024) included 1583 participants through household or telephone interviews, 58.6% of female and represented 39% of the original cohort.

The study has collected extensive individual-level data, including physical activity behaviours, health status and related behaviours, self-report of diseases and sociodemographic characteristics; built environment features such as public open spaces, transport infrastructure, schools and healthcare facilities, walkability index, sidewalks, traffic control and social environment features, such as crime occurrence and socioeconomic index. Analyses have identified changes in the built environment and their associations with physical activity and obesity. Infrastructure improvements, such as the increase of bike paths and outdoor gyms, have been more frequent in wealthier areas, reinforcing spatial inequalities. Increased availability of public open spaces has been associated with increased leisure-time walking. Obesity has shown a growing trend, particularly among specific sociodemographic groups, while physical activity has demonstrated protective effects against obesity. Cycling for transportation has remained stable over time, with disparities by gender and physical activity status.

The plan is to conduct the fourth wave in 2026 and 2027 and the fifth wave in 2029 and 2030.

Obesity disproportionately affects ethnic minority populations due to structural inequalities, such as limited access to healthy food, inadequate healthcare and systemic racism. Universal weight management programmes often fail to meet the unique needs of ethnic minority populations. These universal interventions may lead to lower engagement and poorer health outcomes compared with those observed in non-minoritised ethnic groups. This systematic review will examine the impact of culturally tailored interventions to treat and manage obesity in adult ethnic minority populations on weight- and health-related outcomes (meta-analysis) and patient experience (qualitative evidence synthesis).

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. Interventions of interest will include standalone or multicomponent behavioural interventions with culturally tailored elements of design or delivery. These will be compared against standard weight management interventions or usual care in adults from ethnic minority populations living with obesity. The primary outcome is the mean percentage weight (kg) change between pre–post interventions. A search of databases (Ovid MEDLINE, Embase, APA PsycINFO, Scopus and Web of Science) was conducted in February 2025. Eligible studies include randomised controlled trials (RCTs), quasi-experimental (non-randomised trials, pre–post interventions) and qualitative research. Risk of bias will be assessed with the Cochrane Risk of Bias 2 tool and the Mixed Methods Appraisal Tool. Narrative synthesis will be performed according to the synthesis without meta-analysis guidelines. For eligible RCTs, a random-effects meta-analysis will calculate pooled effect sizes between pre–post intervention using standardised mean differences, with additional sensitivity and subgroup analyses. Qualitative evidence synthesis will be performed using semi-automated text analytics (unsupervised machine learning) and inductive thematic analysis.

Ethical approval is not required. Findings will be disseminated through peer-reviewed journal publications, conference presentations, professional organisations and patient and public networks.

CRD42025636750.

Artificial intelligence (AI)-based clinical decision support systems (CDSSs) are currently being developed to aid prescribing in primary care. There is a lack of research on how these systems will be perceived and used by healthcare professionals and subsequently on how to optimise the implementation process of AI-based CDSSs (AICDSSs).

To explore healthcare professionals’ perspectives on the use of an AICDSS for prescribing in co-existing multiple long-term conditions (MLTC), and the relevance to shared decision making (SDM).

Qualitative study using template analysis of semistructured interviews, based on a case vignette and a mock-up of an AICDSS.

Healthcare professionals prescribing for patients working in the English National Health Service (NHS) primary care in the West Midlands region.

A purposive sample of general practitioners/resident doctors (10), nurse prescribers (3) and prescribing pharmacists (2) working in the English NHS primary care.

The proposed tool generated interest among the participants. Findings included the perception of the tool as user friendly and as a valuable complement to existing clinical guidelines, particularly in a patient population with multiple long-term conditions and polypharmacy, where existing guidelines may be inadequate. Concerns were raised about integration into existing clinical documentation systems, medicolegal aspects, how to interpret findings that were inconsistent with clinical guidelines, and the impact on patient-prescriber relationships. Views differed on whether the tool would aid SDM.

AICDSSs such as the OPTIMAL tool hold potential for optimising pharmaceutical treatment in patients with MLTC. However, specific issues related to the tool need to be addressed and careful implementation into the existing clinical practice is necessary to realise the potential benefits.

People experiencing severe and multiple disadvantage (SMD: homelessness, substance use and criminal offending) have multiple intersecting unmet health and social care needs and high mortality rates, often due to street-drug overdose. Pilot randomised controlled trials (RCTs) suggest an integrated, holistic, collaborative outreach intervention (Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx)) involving generalist-trained pharmacists, nurses or General Practitioners accompanied by staff from third sector homeless organisations may improve outcomes, including reducing overdose.

Multicentre, parallel group, prospective RCT with parallel economic and process evaluation. Set in six areas of Scotland, UK, 378 adults with SMD will be recruited and randomised (stratified by setting and previous non-fatal overdoses) to PHOENIx intervention in addition to usual care (UC) or UC. Aiming to meet participants weekly for 9–15 months, PHOENIx teams assess and address health and social care needs while referring onwards as necessary, co-ordinating care with wider health and third sector teams. During a person-centred consultation, in the participants’ choice of venue, and taking account of the participant’s priorities, the NHS clinician may prescribe, de-prescribe and treat, for example, wound care, and refer to other health services as necessary. The third sector worker may help with welfare benefit applications, social prescribing or advocacy, for example, securing stable housing. Pairings of clinicians and third sector workers support the same participants. The primary outcome is time to first fatal/non-fatal street-drug overdose at nine months. Secondary endpoints include health-related quality of life, healthcare use and criminal justice encounters. A health economic evaluation will assess cost per quality adjusted life year of PHOENIx relative to standard care. A parallel qualitative process evaluation will explore the perceptions and experiences of PHOENIx, by participants, stakeholders and PHOENIx staff.

The primary and other time-to-event secondary outcomes will be analysed by Cox proportional hazards regression.

IRAS number 345246, approved 23/10/2024 by North of Scotland Research Ethics Service. Results will be shared with participants, third sector homelessness organisations, health and social care partnerships, then peer-reviewed journals and conferences worldwide, from the first quarter of 2027.

ISRCTN12234059 registered on 20/2/2025 (ISRCTN).

Dysregulated immunity may account for an increased risk of infection and other adverse outcomes among frail hospitalised persons. The primary objective of this study is to examine whether baseline frailty is associated with the risk of developing ventilator-associated pneumonia (VAP) or other intensive care unit (ICU)-acquired infections among invasively ventilated adults. Additional objectives are to examine the relationship between frailty and hospital length of stay, discharge to a long-term care facility and vital status. We hypothesise that persons with frailty compared with others would have an increased risk of VAP and other infections, a longer hospital stay, higher probability of discharge to a long-term care facility and higher mortality.

This is a preplanned secondary analysis of the PROSPECT trial (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) which enrolled patients across 44 ICUs in three countries. We will use Cox proportional hazards regression analysis to assess the association of frailty with the clinical outcomes of interest, adjusting for other baseline variables. Baseline demographic and descriptive outcome data will be reported using descriptive statistics. Regression results will be presented as adjusted HRs or ORs with 95% CIs for the associations of each independent variable with the primary, secondary and tertiary outcomes.

Participating hospital research ethics board approved the PROSPECT trial and data collection. The protocol for this study was approved by the Hamilton Integrated Research Ethics Board on 20 August 2015 (Project ID:19128). This study will identify whether frailty is associated with risk of VAP and other healthcare-associated infections in invasively ventilated patients, adjusted for other baseline factors. Results may be useful to patients, their caregivers, clinicians and the design of future research. Findings will be disseminated to investigators at a meeting of the Canadian Critical Care Trials Group. We will present study results at an international conference in the fields of critical care and infectious diseases, to coincide with or precede open-access peer-review publication. To aid knowledge dissemination, we will use a variety of formats. For example, for traditional and social media, we will create two different visual abstracts and infographics of our results suitable to share on clinician-facing and public-facing platforms.

NCT02462590.