This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.

This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.

Tertiary centre within a population suffering from a diabetic epidemic.

All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.

A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.

DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.

This study aimed to determine the association between diabetes mellitus (DM) medication use and glycaemic control.

This was a retrospective diabetes registry-based cohort study.

Singapore.

Patients aged 18 and above with incident DM in the SingHealth Diabetes Registry from 2013 to 2020 were included. The entire study period included a 1 year baseline period, a 1 year observation period and a 3 month outcome period.

Drug use was measured using the proportion of days covered (PDC), and the changes in glycated haemoglobin (HbA1c) between the outcome and baseline periods were assessed. The associations between baseline HbA1c and PDC ≥0.80 and between PDC and change in HbA1c were analysed using logistic regression and the Kruskal–Wallis test, respectively.

Of 184 646 unique patients in the registry from 2013 to 2020, 36 314 met the inclusion and exclusion criteria and were included in the analysis. The median PDC for any DM drug, oral DM drugs and insulin during the observation period was 20.3%, 16.8% and 0%, respectively. Those who had good glycaemic control at baseline were less likely to receive DM drugs and those with poor baseline glycaemic control or missing baseline HbA1c were more likely to be consistent users (PDC >80%) (px 10^-16).

The relationship between DM drug use and glycaemic control is complex and non-monotonic. Higher PDC for any DM drug and oral DM drugs during the observation period was significantly associated with clinically relevant HbA1c improvements.

To explore multiprofessional views about system-wide factors influencing (impeding or facilitating) the delivery of stroke mechanical thrombectomy (MT) services and/or improvements to this pathway in England.

A pragmatic exploratory qualitative study using online focus groups and semi-structured interviews with National Health Service (NHS) professionals and those working in a stroke strategic/policy lead role. We thematically analysed the data using the Framework Approach to understand participants’ views on the challenges to improving current and future MT implementation.

NHS trusts and other key stroke strategic/policy organisations covering 10 geographical regions in England and a national perspective.

A total of 29 professionals, working in an NHS clinical and managerial position and/or a stroke strategic national/regional clinical/policy lead role, participated in five focus groups and six individual semi-structured interviews between April and June 2024.

We identified five themes relating to MT implementation progress and challenges (1) workforce, (2) clinical care pathways, (3) service/system, (4) cross-cutting theme: communications and (5) cross-cutting theme: culture. Our analysis emphasised the increasing complexity and inter-related factors shaping the emergency stroke pathway for MT provision and a need to acknowledge key people-related, organisational and sociocultural factors during service planning.

Despite the challenges and complexity, professionals were optimistic that further progress would be made with MT delivery in England. However, ongoing improvement strategies are required, which also acknowledge wider cultural factors and system-wide relationships and are not just focused on care pathways and resources.

Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.

Measure development and psychometric evaluation.

A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.

An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.

Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).

The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.

The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

NCT06849245.

To estimate the association between socioeconomic background (derived from household main earner occupation when the survey respondent was aged 14 years old) and likelihood of working as a doctor in adulthood in the UK, and estimate how associations varied over time for respondents who turned 18 years old in different decades.

Observational study of 10 years of pooled data from a nationally representative government survey.

The United Kingdom (UK).

358 934 respondents to the UK Office for National Statistics Labour Force Survey between July 2014 and September 2023. Respondents aged 22 years old or below or retired respondents aged 65 years old and above were excluded.

Whether the respondent was currently working as a medical practitioner (doctor).

2772 respondents were currently working as doctors (0.8% of respondents). 13% of doctors were from working-class backgrounds (National Statistics Socio-economic Classification 5–8), compared with 43% of non-doctor respondents, while 69% of doctors came from professional backgrounds (vs 32% of non-doctors) (unadjusted proportions). From multivariable Poisson regression models adjusting for year of survey, the year the respondent turned 18, sex, country of birth and ethnic group, the likelihood of being a doctor varied largely according to socioeconomic background, with those from professional backgrounds 3 times and 6 times more likely to become doctors than those from intermediate backgrounds and working class backgrounds, respectively (average predicted probability: 1.6% vs 0.5% vs 0.3%). Respondents growing up in households where the main earner was a doctor were by far the most likely to themselves report working as a doctor (average predicted probability: 10.1%), 15-fold more likely than all respondents with non-doctor backgrounds (risk ratio=15.0, 95% CIs 13.4 to 16.7), and between 3 times and 100 times more likely when compared with other specific occupation groups. Stratified analyses suggested socioeconomic inequalities were highly stable over time among respondents who turned 18 between the 1960s and the 2000s, and then weak evidence of decreasing diversity from 2010 to 2018.

There are large, persistent and potentially widening inequalities in the socioeconomic background of doctors working in the UK between 2014 and 2023, leading to doctors being highly socioeconomically unrepresentative of the general UK population. New data collections on the socioeconomic background of working doctors are needed to monitor this inequality and understand its effects on patient care. Increased and/or alternative efforts may be needed to address this entrenched inequality and improve social mobility into medicine.

Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.

We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.

The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).

NCT06731751.

To identify the factors influencing professionals’ implementation of the National Institute for Health and Care Excellence (NICE) guidelines on self-harm.

A rapid review evidence synthesis

Five electronic databases (ASSIA, CINAHL, EMBASE, MEDLINE, PsycINFO) and five indexing databases (Science Citation Index Expanded (SCIE), Social Sciences Citation Index (SSCI), Arts and Humanities Citation Index (AHCI), Emerging Sources Citation Index (ESCI) and Conference Proceedings Citation Index (CPCI)), using the Web of Science platform, were searched in December 2023 and repeated in July 2024.

We included quantitative and qualitative studies that investigated professionals’ knowledge and implementation of NICE guidelines on self-harm, that were in English language and published between 2004 and July 2024.

One reviewer used standardised methods to search, screen, select, quality assess and synthesise the included studies, to accelerate the review. Quality assessment was conducted using the Mixed Methods Appraisal Tool. Data were extracted and synthesised thematically using NICE guidance implementation priorities.

The review included 10 studies. Six were conducted in accident and emergency (A&E) settings, two in general practice, one in a burns and plastic surgery hospital department and one involved cross-sectoral health professionals. Key findings indicate that awareness and implementation of self-harm guidelines is low among health professionals. Systemic barriers include lack of staff training, negative staff attitudes towards people who self-harm and lack of resources.

There is a need to develop and implement regular training on self-harm, incorporating NICE guidance and measures, to integrate knowledge and mobilise practice changes. Further research into the implementation of NICE guidelines in children who self-harm is needed, and in a wider variety of health and social care settings. The absence of studies from the social care sector into professionals’ awareness and implementation of NICE guidelines on self-harm is a key limitation.

Post-intensive care syndrome (PICS) describes a cluster of ongoing symptoms experienced by a large proportion of patients previously admitted to critical care. Despite a large rise in survival following critical care, interventions to support recovery and combat PICS are lacking. It has been suggested that the use of digital tools such as virtual reality (VR) may play a useful role in the development of recovery-supporting interventions. We engaged with people with lived experience of critical care admission to coproduce a VR intervention (ViRtual REality to AiD recoverY post ICU (VR READY)). Here, we present a protocol for the initial feasibility and acceptability testing of this intervention.

This is a single-arm, single-site, non-randomised feasibility trial of VR READY. Up to 25 participants recently admitted to critical care will be recruited to use the VR READY intervention for at least 5 min per day for a period of 14 days. Participants must have capacity to consent and be free from ongoing delirium in order to participate. Outcomes relating to sleep and well-being will be measured at baseline and at day 14 after intervention delivery. The primary outcome is feasibility, which will be assessed according to prespecified criteria. Participants will complete a qualitative interview to assess acceptability of the intervention, trial design and outcomes approximately 1 month after completing the intervention period. No formal statistical analysis of outcomes will be conducted, but these will be summarised descriptively. Interviews will be subjected to reflexive thematic analysis.

This study received a favourable ethical opinion by North-East York Research Ethics Committee (Ref 23/NE/0113) in June 2024. Study results will be disseminated through the peer review literature, ISRCTN registry and directly to participants, which will be facilitated by the study public and patient involvement steering group.

ISRCTN88854487.

Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.

With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.

A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.

This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.

NCT06591195.

Vaccine hesitancy remains a critical public health challenge, especially in high-income countries. Gender differences in vaccine hesitancy can significantly affect vaccination rates and public health outcomes. The aim of this research is performing an umbrella review and meta-analysis to systematically investigate gender disparities in vaccine hesitancy for COVID-19 in high-income countries, as well as the quality, potential biases and dependability of epidemiological evidence.

The study will systematically search, extract and analyse data from reported systematic reviews and meta-analyses that focus specifically on gender differences in vaccine hesitancy. The search will include CINAHL, Cochrane Library, PubMed/MEDLINE, EMBASE and Epistemonikos for studies published from 2019 onward. The inclusion criteria will encompass systematic reviews and meta-analyses of non-interventional studies conducted in high-income countries. The identified factors contributing to vaccine hesitancy will be categorised based on demographic, psychological, social and economic dimensions. The methodological quality of the included meta-analyses will be assessed using the "Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses" tool.

Ethical approval is not required for this umbrella review. These results will be published in a peer-reviewed journal.

CRD42024572978.

Loneliness is a universal, subjective experience that arises from a perceived lack of meaningful social relationships or connectedness with those around us.1 2 It is characterised by feelings of isolation, emptiness and a sense of disconnectedness from others.1 While feelings of loneliness can be transient, chronic loneliness...

Sarcopenia and frailty have been identified as negative predictors of health outcomes. Patients with stroke, traumatic brain injury (TBI), knee osteoarthritis (OA) and breast cancer commonly experience low physical activity levels in the chronic phase of recovery. This prospective study aims to explore the feasibility of multimodal screening and longitudinal tracking of various biomarkers from the acute to chronic phase of disease to determine the relationship with frailty outcomes.

A prospective longitudinal observational cohort study involving Asian populations is planned over 3 years. Enrolled participants with index conditions of acute stroke, TBI, knee OA and breast cancer will be recruited from rehabilitation hospitals and clinics and followed longitudinally. Reference thresholds from the Asian Working Group on Sarcopenia will be used. Variables include self-reported questionnaires, disease and comorbidity characteristics, anthropometric measurements, appetite questionnaires, muscle ultrasound (MUS), muscle/bone mass, blood biomarkers and markerless gait motion systems. In particular, physical performance (short physical performance battery and hand grip strength), sarcopenia (SARC-F questionnaire) and frailty assessment (FRAIL score, clinical frailty scale), four-region MUS, body composition analysis, dual X-ray absorptiometry, bone mineral densitometry, physical activity levels (International Physical Activity Questionnaire for the elderly [IPAQ-E], fitness trackers) and health-related quality of life assessment (EuroQoL-5D questionnaire five level [EQ5D-5L]) will be used. Blood biomarkers measuring metabolic health (eg, glycated haemoglobin, cholesterol, fasting glucose and 25-OH vitamin D) and inflammation (eg, Tumor Necrosis Factor-alpha [TNF-α] and Monocyte Chemoattractant Protein-1 [MCP-1]) will be measured at baseline. Data collection will take place at postrecruitment baseline (hospital admission), 1, 6 months, 12 months and 2 years postrecruitment (inpatient) and at postrecruitment baseline, 6 months, 12 months and 2 years postrecruitment (outpatient).

Ethical approval has been obtained from the National Healthcare Group Domain Specific Review Board (2023/00105). Findings will be disseminated through conference presentations and publication in scientific journals.

NCT06073106.

Faecal immunochemical testing (FIT) is now commonplace in the UK to prioritise symptomatic patients for urgent gastrointestinal investigation. The test requires a stool sample to be collected at home by the patient and returned for analysis. In this qualitative study, we sought to understand the feasibility and acceptability of FIT-based triage for patients.

A cross-sectional, qualitative, experiential interview study.

Recruitment was through three participating UK NHS sites (Yorkshire, Midlands, North-East). Health professionals were also identified through membership of the BSG/ACPGBI Symptomatic FIT Guideline Development Group and snowball sampling.

We interviewed 21 patients who had completed FIT and been referred for colonoscopy and 30 primary and secondary care health professionals involved in symptomatic FIT delivery.

Completion of FIT was unproblematic from the perspective of patients who returned the test. However, health professionals expressed concern over non-return. Among patients, understanding of the purpose of FIT and the meaning of results varied. Health professionals acknowledged that ensuring patient understanding of these can be challenging. Patients believed colonoscopy was less likely to miss cancer than FIT. Patients with a family or personal history of cancer were particularly anxious and wanted the reassurance of colonoscopy, even with a negative FIT result.

We found no major barriers to the use of FIT in prioritising symptomatic patients for urgent investigation. Improving communication might increase compliance and, possibly, acceptability of non-referral for colonoscopy in the case of a negative test result.

Sodium-glucose co-transporter inhibitors have potential glycaemic and non-glycaemic benefits in people with type 1 diabetes (T1D). However, the increased risk of diabetic ketoacidosis (DKA) limits their widespread use. We hypothesise that dapagliflozin 10 mg daily, combined with the use of continuous ketone monitoring (CKM) and education strategies to mitigate progression to DKA, will demonstrate improved glycaemic control without increasing DKA events.

PARTNER is a multisite 6-month randomised crossover double-masked study involving Australian adults with T1D who have a Haemoglobin A1c (HbA1c)

The study has received ethical approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC reference 302/23). The results will be published in peer-reviewed journals and presented at national and international diabetes conferences.

ACTRN12624000448549.

Paediatric cervical spine injury (CSI) is uncommon but can have devastating consequences. Many children, however, present to emergency departments (EDs) for the assessment of possible CSI. While imaging can be used to determine the presence of injuries, these tests are not without risks and costs, including exposure to radiation and associated life-time cancer risks. Clinical decision rules (CDRs) to guide imaging decisions exist, although two of the existing rules, the National Emergency X-Radiography Low Risk Criteria and the Canadian C-Spine Rule (CCR), focus on adults and a newly developed paediatric rule from the Pediatric Emergency Care Applied Research Network (PECARN) is yet to be externally validated. This study aims to externally validate these three CDRs in children.

This is a multicentre prospective observational study of children younger than 16 years presenting with possible CSI following blunt trauma to 1 of 14 EDs across Australia, New Zealand and Singapore. Data will be collected on presenting features (history, injury mechanism, physical examination findings) and management (diagnostic imaging, admission, interventions, outcomes). The performance accuracy (sensitivity, specificity, negative and positive predictive values) of three existing CDRs in identifying children with study-defined CSIs and the specific CDR defined outcomes will be determined, along with multiple secondary outcomes including CSI epidemiology, investigations and management of possible CSI.

Ethics approval for the study was received from the Royal Children’s Hospital Melbourne Human Research Ethics Committee in Australia (HREC/69436/RCHM-2020) with additional approvals from the New Zealand Human and Disability Ethics Committee and the SingHealth Centralised Institutional Review Board. Findings will be disseminated through peer-reviewed publications and future management guidelines.

Registration with the Australian New Zealand Clinical Trials Registry prior to the commencement of participant recruitment (ACTRN12621001050842). 50% of expected patients have been enrolled to date.

Prospective, real-world clinical studies of the association between skin color and pulse oximeter (SpO2) accuracy in children are needed to address the limitations of previous research. Such studies are essential for generating evidence for clinicians, regulators and industry. This is the protocol for a multisite study funded by the National Heart, Lung, and Blood Institute (R01HL171313; 1 January 2024–31 December 2028).

In this pragmatic, observational study conducted in three large paediatric cardiac catheterisation centres in the USA, children undergoing cardiac catheterisation with directly measured arterial oxygen saturation will be prospectively enrolled. The outcome variable (SpO₂ bias) is the difference between contemporaneous paired measurements of pulse oximetry (SpO₂) and the standard reference comparator, arterial blood sample oxygen saturation (SaO₂), obtained during the catheterisation procedure. The independent variable is an objective measure of skin colour obtained via spectrophotometry. Our primary analysis is a multivariable regression model testing the relationship between skin colour and SpO₂ bias, after adjusting for covariates. We will also conduct a moderator analysis to identify factors that may affect the magnitude of the association. The target sample size is 584 participants.

This study was approved by the University of Pennsylvania Institutional Review Board (#854895) under expedited review. Study risks are minimal. Parental permission, and child assent when applicable, are obtained prior to enrolment. In accordance with the NIH Public Access Policy, publications associated with the study will be made publicly available through PubMed Central. The analytic dataset will be contributed to a repository for future use. In collaboration with a children’s hospital-based research family advisory council, interpretation and dissemination of the results for lay, clinical and scientific audiences will be considered.

Although not a clinical trial, this observational study is registered on ClinicalTrials.gov (identifier: NCT06529575) for public awareness.

The COVID-19 pandemic highlighted the significance of mathematical modelling in decision-making and the limited capacity in many low-income and middle-income countries (LMICs). Thus, we studied how modelling supported policy decision-making processes in LMICs during the pandemic (details in a separate paper).

We found that strong researcher–policymaker relationships and co-creation facilitated knowledge translation, while scepticism, political pressures and demand for quick outputs were barriers. We also noted that routine use of modelled evidence for decision-making requires sustained funding, capacity building for policy-facing modelling, robust data infrastructure and dedicated knowledge translation mechanisms.

These lessons helped us co-create a framework and policy roadmap for improving the routine use of modelling evidence in public health decision-making. This communication paper describes the framework components and provides an implementation approach and evidence for the recommendations. The components include (1) funding, (2) capacity building, (3) data infrastructure, (4) knowledge translation platforms and (5) a culture of evidence use.

Our framework integrates the supply (modellers) and demand (policymakers) sides and contextual factors that enable change. It is designed to be generic and disease-agnostic for any policy decision-making that modelling could support. It is not a decision-making tool but a guiding framework to help build capacity for evidence-based policy decision-making. The target audience is modellers and policymakers, but it could include other partners and implementers in public health decision-making.

The framework was created through engagements with policymakers and researchers and reflects their real-life experiences during the COVID-19 pandemic. Its purpose is to guide stakeholders, especially in lower-resourced settings, in building modelling capacity, prioritising efforts and creating an enabling environment for using models as part of the evidence base to inform public health decision-making. To validate its robustness and impact, further work is needed to implement and evaluate this framework in diverse settings.