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AnteayerBMJ Open

Clean pulp versus sterile plastic for mid-stream urine collection: a paired equivalence study comparing the microbiological performance of a novel low carbon collection device with the standard of care

Por: John · J. B. · Holdsworth · B. · Clarke · N. · Vere · A. · Lynda · K. · Walker · A. · Yusuf · S. · Yick · V. · Doolan · T. · Harvey · P. · Ball · C. · Butler · C. · Lowe · N. · Welsh · V. · Mayne · A. · Swann · S. · Porter · R. · Burns-Cox · N.
Objectives

To determine whether a novel urine collection device (the ‘Pee-in-Pot (PiP)’) produces the same rates of reportable urine culture results as standard of care (SOC) urine collection. To determine whether the PiP produces comparable microscopy results to SOC urine collection. To estimate the carbon footprint of the PiP compared to SOC urine collection.

Design

A prospectively designed, single-centre, paired comparison study.

Setting

A district general hospital in Southwest England, including antenatal clinical, accident and emergency, medical and surgical ward environments.

Participants

Adults aged 18 or over.

Interventions

Urine passed through the PiP device before being decanted into a 10 mL boric acid tube for microscopy and culture, compared with the same urine contained only in a sterile plastic vessel before being decanted into a boric acid tube for microscopy and culture.

Primary outcome measure

The proportion of positive urine culture results.

Secondary outcome measures

The proportion of heavy mixed growth culture results. Comparison of particle counts: all small particles, bacteria, red blood cells and white blood cells.

Results

Microscopy was performed for 1353 paired samples, of which 808 paired samples both underwent culture. Overall, urine cultures were positive in 9.3% (75/808) and 10.0% (81/808) of PiP and control cases, respectively. Overall matching between PiP and control arms for reportable positive culture results was 98.5% (796/808), with a Cohen’s Kappa test coefficient () of 0.9149 (almost perfect agreement). There was no significant difference in the rate of positive urine culture results between testing arms for any organisms (margin of non-inferiority prospectively defined as ±2.5% for Escherichia coli positive cultures). For microscopy, there was agreement in meeting culture thresholds for 1308 of 1353 paired samples with a difference in culturing rates of 0.00517 (95% CI –0.0045 to 0.015, ie, high level of agreement). The estimated base case carbon footprint of PiP testing was 95g CO2e compared to 270g CO2e for SOC testing.

Conclusions

This study found the PiP to be non-inferior for routine urine microscopy and culture testing and to have a lower carbon footprint compared with SOC urine testing.

Non-randomised trial of a hepatitis C same-day test and treat model using antibody test only for people who inject drugs in Armenia, Georgia and Tanzania: a CUTTS HepC study protocol

Por: Draper · B. L. · Flynn · M. · Schroeder · S. · Wisse · E. · Aikaeli · F. · Han · Z. M. · Ayako · M. · Bajis · S. · Butsashvili · M. · Davtyan · K. · Kordzadze · T. · Lamand · P. · Luhmann · N. · Sargsyan · K. · Senkoro · M. · Scott · N. · Stone · J. · Vickerman · P. · Voloshin · A. · Walker
Introduction

Despite the availability of curative treatments, hepatitis C diagnosis and treatment coverage is suboptimal globally with few countries on track to achieve the WHO’s 2030 elimination targets. In 2022, an estimated 50 million people were living with hepatitis C, with 1 million new infections annually. Most people living with hepatitis C reside in low- and middle-income countries, and people who inject drugs are disproportionately affected by hepatitis C.

Continuing simplification of diagnostic pathways and treatment care models is required to improve linkage to care and reduce costs associated with hepatitis C treatment and cure.

Methods and analysis

This study is a multi-country non-randomised, quasi-experimental, prospective comparative two-arm trial. It aims to assess the feasibility of implementation, retention in hepatitis C care and achievement of cure and cost-effectiveness outcomes, comparing two simplified hepatitis C testing and treatment pathways.

Arm 1 is a standard simplified test and treat model of care following global guidance, and arm 2 is an innovative rapid, same-day treatment initiation model of care using a presumptive treatment approach based on shortened read-time of the point-of-care OraQuick hepatitis C antibody test result. Secondary outcomes include assessing the accuracy of the OraQuick hepatitis C antibody test in predicting viraemia and the acceptability of each pathway.

This study will be implemented in Armenia, Georgia and Tanzania. Treatment-naïve people who inject drugs aged over 18 years in each country will be eligible for enrolment.

Recruitment commenced in October 2024 in Armenia, June 2025 in Georgia and August 2025 in Tanzania and is anticipated to close by December 2026.

Ethics and dissemination

This trial has been reviewed by WHO Ethics Review Committee (ERC), Alfred Hospital Ethics Committee (Australia) and local country ERCs. Alongside journal publications and conferences, the results from this study will be disseminated through summary reports and workshops with key stakeholders and with communities of people affected by HCV through relevant organisations/networks, including the global Community Advisory Board (CAB). The study results will inform national scale-up of simplified care models and inform potential pathways for further simplification of care models, including the potential for one-step diagnostic pathways and same-day treatment in particular scenarios for the three study countries, and other low- and middle-income countries globally.

Trial registration number

NCT06159504.

Azithromycin use in labour to prevent sepsis among pregnant women undergoing vaginal delivery in Nigeria (AZIN-V): a study protocol for a hybrid type 2 effectiveness-implementation trial

Por: Afolabi · B. B. · Makwe · C. C. · Oluwole · E. O. · Obi-Jeff · C. · Mitchell · E. J. · Banke-Thomas · A. · Adeyemo · T. A. · Abioye · A. I. · Eboreime · E. A. · Saidu · A. D. · Okoro · U. A. · Akintan · P. · Osuagwu · C. S. · Chieme · C. F. · Lawanson · T. · Hossain · A. · Walker · K.
Introduction

Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.

Methods and analysis

This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).

For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.

Ethics and dissemination

This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.

Trial registration number

ISRCTN16415327.

Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE)--protocol for a multiphase study

Por: Cubillo (Larrakia/Wadjigan) · B. J. · Browne · J. · Sherriff · S. · Walker (Yorta Yorta) · T. · Hill · K. · Crocetti · A. · Mitchell · F. · Backholer · K. · Maddox · R. · Brown · A. · Allender · S. · Wright · C. J. C. · Lacy-Nichols · J. · Chamberlain · C. · Ropitini (Ngati Kahungu
Introduction

The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.

Methods and analysis

ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.

Ethics and dissemination

Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.

Optimal timing of induction of labour to improve maternal and perinatal outcomes: protocol for an individual participant data and network meta-analysis

Por: Meacham · H. · Ona-Igbru · A. · McNeill · R. · Ajayi · R. · Pickering · E. · Grobman · W. A. · Black · M. · Khalil · A. · Mccourt · C. · Miranda · A. · Mol · B. W. · Walker · K. · Wilson · A. · Zamora · J. · Thangaratinam · S. · Allotey · J.
Introduction

Despite advances in maternity care, stillbirth remains a major burden. It disproportionately affects black and Asian mothers, those with obesity and women over the age of 35 years. Induction of labour may benefit these women, but there is no clear evidence to guide recommendations on optimal timing of induction because of variations in the intervention and insufficient power in primary trials for rare outcomes such as stillbirth and perinatal mortality, or to assess whether effects differ by maternal characteristics. We will conduct an individual participant data (IPD) meta-analysis of randomised trials to assess the overall and differential effect of induction of labour, according to timing of induction and maternal characteristics, on adverse perinatal and maternal outcomes. We will also rank induction of labour timing strategies by their effectiveness to inform clinical and policy decision-making.

Methods and analysis

We will identify randomised trials on induction of labour by searching MEDLINE, CINAHL, EMBASE, BIOSIS, LILACS, Pascal, SCI, CDSR, ClinicalTrials.gov, ICTRP, ISRCTN registry, CENTRAL, DARE and Health Technology Assessment Database, without language restrictions, from inception to June 2025. Primary researchers of identified trials will be invited to join the OPTIMAL Collaboration and share the original trial data. Data integrity and trustworthiness assessment will be performed on all eligible trials. We will check each study’s IPD for consistency with the original authors before standardising and harmonising the data. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool. We will perform a series of one-and-two-stage random-effects meta-analyses to obtain the summary intervention effect on composite adverse perinatal outcome (stillbirth, neonatal death or severe morbidity requiring admission to neonatal unit) with 95% CIs and summary treatment–covariate interactions (maternal age, ethnicity, parity, socioeconomic status, body mass index and method of conception). Heterogeneity will be summarised using tau2, I2 and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Small study effects (potential publication bias) will be investigated using funnel plots.

Ethics and dissemination

The study is registered on PROSPERO (CRD420251066346) and ethics approval is not required. We will disseminate findings widely to women, healthcare professionals and policymakers through academic, professional bodies and social media channels, and in peer-reviewed journals to achieve impact.

PROSPERO registration number

CRD420251066346.

Can vocational advice be delivered in primary care? The Work And Vocational advicE (WAVE) mixed method single arm feasibility study

Por: Wynne-Jones · G. · Sowden · G. · Madan · I. · Walker-Bone · K. · Chew-Graham · C. · Saunders · B. · Lewis · M. · Bromley · K. · Jowett · S. · Parsons · V. · Mansell · G. · Cooke · K. · Lawton · S. A. · Linaker · C. · Pemberton · J. · Cooper · C. · Foster · N. E.
Objectives

Most patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return to work and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The Work And Vocational advicE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA.

Design

A mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study.

Setting

Primary care.

Methods

The study included participant follow-up by fortnightly Short Message Service text and 6-week questionnaire. Stop/go criteria focus on recruitment and intervention engagement. The semistructured interviews explored participants’ experiences of recruitment and receipt and engagement with the intervention.

Results

19 participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with ≥50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a vocational support worker. Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable.

Conclusion

This study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement.

Trial registration number

NCT04543097.

Qualitative evidence of service user experiences and perspectives on long-acting injectable buprenorphine for opioid treatment: protocol for a scoping review

Por: Henderson · C. · Walker · S. · Lloyd · Z. · Gibbs · D. · Romero · L. · Stoove · M. A.
Introduction

There is substantial literature on opioid pharmacotherapies from a service user perspective, mostly focused on methadone and buprenorphine. However, as a relatively new formulation, much less is known about user experiences and views of Long-Acting Injectable Buprenorphine (LAIB). To date, no published reviews have qualitatively described LAIB service user experience. The objective of this scoping review is to identify and describe the peer-reviewed qualitative studies examining the service user experience of LAIB.

Methods and analysis

This scoping review will follow the methodology described by Arksey and O’Malley, further adapted by Levac et al and others. The search strategy will be developed in collaboration with an expert librarian and will include searches of Medline, Embase, PsycINFO, CINAHL, Scopus and Web of Science as well as citation chaining. The search dates will range from 2016, when LAIB was first approved, to the date of the final search. Included studies will investigate the perspectives and experiences of LAIB treatment participants with opioid dependence, within an Opioid Treatment Programme (OTP). For service users, the pharmacological formulation of LAIB significantly reshapes both the clinical practice and the social dynamics within OTPs. To effectively capture the depth and nuance of service users’ experiences, this review will be limited to qualitative, mixed-method, case series or case study designs, with a further restriction to peer-reviewed articles published in English. Identified references, with duplicates removed, will be imported into Covidence for title/abstract screening, full-text review and data extraction by two independent reviewers. All decisions on data inclusion or exclusion will be by consensus agreement, using a third reviewer if necessary. A living experience researcher will lead analysis of manuscript content in NVivo using inductive coding to produce a descriptive thematic analysis. The narrative summary will present key study characteristics, quality appraisal and synthesised findings that describe service user experiences and perspectives of LAIB, guided by the Systematic Reviews and Meta-Analysis for Scoping Reviews checklist.

Ethics and dissemination

This scoping review undertakes secondary analysis of data in the public domains only and thus does not require ethics approval given no participants are directly involved. The results of the review will be published in a peer-reviewed journal, presented at relevant academic and community conferences, and discussed and disseminated to/with community organisations, service users and policy-makers.

Data statement

Prepublication history and additional supplemental material for this paper are available online. To view these files, visit: Open Science Framework https://doi.org/10.17605/OSF.IO/XMHKN.

Safety and potential efficacy of DM199, a tissue kallikrein-1 analogue, for treating pre-eclampsia and fetal growth restriction: study protocol for a South African, hospital-based phase I/II open-label trial

Por: Cluver · C. A. · Thake · J. · Hassim · T. · van Greunen · A. · Budhram · S. · Knipe · K. · Decloedt · E. · Brink · L. · Langenegger · E. · Bergman · L. · Imberg · H. · Bekker · A. · Walker · S. P. · Tong · S.
Introduction

Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.

Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.

DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fetal growth restriction.

Methods and analysis

This phase IB/IIA open-label trial at Tygerberg Hospital, Western Cape Province, South Africa, will determine the safety and effective dose of DM199 for pre-eclampsia and/or fetal growth restriction. The trial consists of two parts. Part 1 will be an ascending dose finding study, treating women with pre-eclampsia and severe hypertension who are for planned birth within 72 hours. This will search for doses that safely lower blood pressure (n=3/dose, recruiting up to 42 participants). Part 2 is a safety and efficacy study of three cohorts of pregnant women (n=30/cohort): (1) with pre-eclampsia and severe hypertension requiring delivery within 72 hours, (2) with preterm pre-eclampsia (

Ethics and dissemination

The trial has ethical approval (Health Research Ethics Committee, Stellenbosch University, Protocol number M24/04/009) and is registered (Pan African Clinical Trial Registry, PACTR202404895013782) and approved by the South African Health Products Regulatory Authority (20240801). Data will be presented at international conferences and published in peer-reviewed journals.

How do musculoskeletal disorders impact on quality of life in Tanzania? Results from a community-based survey

Por: Grieve · E. · Deidda · M. · Krauth · S. J. · Biswaro · S. M. · Halliday · J. E. B. · Hsieh · P.-H. · Kelly · C. · Kilonzo · K. · Kiula · K. P. · Kolimba · R. · Msoka · E. F. · Siebert · S. · Walker · R. · Yongolo · N. M. · Mmbaga · B. · McIntosh · E. · NIHR Global Health Group · Biswaro
Objectives

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.

Design

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.

Setting

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

Participants

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.

Primary and secondary outcome measures

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.

Results

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.

Conclusions

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.

Airway clearance techniques for adults receiving extracorporeal membrane oxygenation for severe acute respiratory failure: a scoping review protocol

Por: Lunn · T. · Swingwood · E. · Cochrane · H. · Walker · S. · Cramp · F.
Introduction

Patients receiving extracorporeal membrane oxygenation (ECMO) for severe acute respiratory failure (SARF) often experience significant challenges with airway clearance due to disease severity, ultra-protective ventilation strategies and suppression of mucociliary and cough mechanisms. Extremely low tidal volumes and minimal flow rates further hinder secretion mobilisation. Despite increasing global use of ECMO, there is currently no synthesis of evidence describing airway clearance practices, their physiological rationale or outcomes in this population.

This scoping review aims to explore the extent and nature of evidence on airway clearance interventions in invasively ventilated adult patients receiving ECMO for SARF. Specific objectives include mapping the types of interventions described and specific parameters, their intended physiological effects, reported outcomes and safety considerations.

Methods and analysis

This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive search will be undertaken across Embase, Ovid Emcare, Ovid Medline, CINAHL and grey literature sources including TRIP and Google Scholar. Eligible studies will include original data on airway clearance interventions in adult patients (≥16 years) receiving ECMO for SARF. Studies focused on paediatric populations, extracorporeal carbon dioxide removal, or solely cardiac ECMO will be excluded.

Two independent reviewers will screen titles, abstracts and full texts, extract data using a piloted tool and summarise findings using descriptive statistics and narrative synthesis. Basic qualitative content analysis will support mapping of interventions including parameters, their physiological and clinical rationale, and reported outcomes including adverse effects.

Ethics and dissemination

As this study involves a review of existing literature and does not include collection of primary data, ethical approval is not required. Findings will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic and professional meetings. The results are expected to highlight variations in practice and provide a foundation for future research aimed at optimising respiratory care and improving outcomes for patients receiving ECMO for SARF.

Registration

osf.io/ptfr7.

Equity of digital self-management tools in adults with multiple long-term conditions: a scoping review protocol

Por: Walker · H. · Robbins · T. · El-Osta · A. · Stirland · L. · Taylor · D. · Jones · A. · McBride · E. · Aslam · A.
Introduction

Adults living with multiple long-term conditions (MLTC)—defined as the presence of two or more physical or mental health conditions—often face fragmented and complex care. Digital tools offer scalable self-management solutions but may exacerbate inequities due to the digital divide and other factors. The aim of this scoping review is to map and summarise the existing literature on digital self-management tools used in MLTC, with a particular focus on how equity of access is considered in their development, implementation and evaluation.

Methods and analysis

Scoping review methodology will be based on the Joanna Briggs Institute guidance for scoping reviews and Arskey and O’Malley’s framework and will be reported in alignment with Preferred Reporting Items for Systematic Review and Meta-Analyses extension for Scoping Reviews. Comprehensive search terms based on ‘multimorbidity’, ‘digital tools’ and ‘self-management’ have been developed. Peer-reviewed publications will be identified using MEDLINE, Embase, Emcare, Scopus, CINAHL and PubMed. Two reviewers will independently screen titles and abstracts, with subsequent full text review also being performed in duplicate to ensure they meet the eligibility criteria. Discrepancies will be resolved by discussion with a third reviewer. Included studies will focus on digital tools for the self-management of MLTC in adults (≥18 years old) in any setting. Equity dimensions will include, but are not limited to, digital literacy, treatment burden, socioeconomic status, polypharmacy and access disparities.

Ethics and dissemination

Ethical approval is not required for this scoping review. The results of the scoping review will be published in an open access, peer-reviewed journal for wider dissemination. Additionally, findings will contribute to topic guides and mapping of a research networking event with key stakeholders (including patient and public involvement and engagement members, clinicians, researchers and industry) in MLTC, around the same subject area.

Integration of precision medicine into routine cancer care--protocol for the Precision Care Initiative: a research programme of effectiveness-implementation hybrid trials

Por: Liang · S. · McKay · S. · Lin · F. · Zaheed · M. · Morrow · A. · Douglas · B. · Chan · J. · Monaghan · H. · Chan · P. · Kennedy · E. · Tyedmers · E. · Walker · S. · Leaney · K. · Napier · C. E. · Middleton · S. · Butow · P. · Williams · R. · Parkinson · B. · Ballinger · M. L. · Tucker · K. · G
Introduction

Genomic diagnostics have accelerated therapeutic and preventative breakthroughs in oncology and cancer genetics. Despite increased access, the implementation of genomics-based care faces serious fragmentation and scalability issues due to a lack of system support. The Precision Care Initiative aims to develop a novel and scalable Precision Care Clinic (PCC). It is designed to coordinate precision medicine in oncology and streamline decision support for referring oncologists and geneticists. The PCC will enhance quality of care through multifaceted, patient-centred communication. It will also improve translational capacity by integrating team expertise in precision oncology, implementation science, clinical informatics, cancer genetics, health economics and patient-reported measures.

Methods and analysis

This programme uses a type I and type II hybrid effectiveness-implementation trial design sequentially. The complex clinical intervention is precision oncology—matching the targeted treatment or risk management strategy to the right patient, based on their genomic, cancer staging, environmental, lifestyle and biological characteristics, etc. The service intervention is the PCC, providing centralised multidisciplinary review to facilitate shared decision-making with clinicians for the provision of optimal precision oncology care for their patients. The implementation intervention is the co-designed implementation platform—applying evidence-based implementation approaches and Learning Health System principles to enhance feasibility and sustainability. All adult patients across Australia referred to the PCC (n=est. 100–150/year), and healthcare professional interest holders involved in the delivery of precision oncology services, are eligible to participate. Over the study course, phase I involves using a mixed-methods approach to inform iterative co-design and pilot testing of the first PCC with an accompanying implementation platform, and a suite of outcome measures to assess effectiveness; phase II (hybrid type I) includes the implementation of the PCC and evaluation of the outcome measures designed in phase I; phase III (hybrid type II) involves a co-design of local adaptations and testing the effectiveness of the PCC model nationally.

Ethics and dissemination

The study received ethical approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00373). Study results will be presented at relevant conferences and published in peer-reviewed journals.

Trial registration number

NCT06077110

Development of methods to identify digitally excluded older people, and tailoring of interventions to meet their digital needs: a protocol for a mixed-methods study (the INCLUDE study)

Por: Brundle · C. · Johansson · J. F. · Best · K. · Clegg · A. · Forster · A. · Atkinson · T. · Foster · M. · Humphrey · S. · Iliff · A. · Inglis · J. · Walker · C. · Graham · L.
Introduction

Digital inclusion (which includes skills, accessibility and connectivity to the internet and digital devices) is a ‘super social determinant of health’ because it affects many aspects of life that influence health. Older people are especially vulnerable to digital exclusion. Existing digital inclusion interventions are commonly offered opportunistically to people who come into contact with services, or in specific locations. The lack of systematic identification of need unintentionally excludes older people who may be most in need of support, and that support is not addressing their needs.

Methods and analysis

This multi-method project includes six workstreams: (1) A survey of people aged 65+ to ask about digital use and engagement. Survey data will be used to develop a model that predicts digital exclusion from data available in primary care records. (2) Testing, via a further survey, the external validity of the model to identify those who are digitally excluded. (3) Interviews with community service providers to identify, understand and define the components of existing digital inclusion services for older people. Concurrently, a rapid review of the literature will identify evidence for interventions aimed at supporting digitally excluded adults aged 65+. (4) Interviews with people aged 65+ representing a range of digital use will explore factors from the COM-B model that influence digital behaviours—their capability (C), opportunity (O) and motivation (M) relating to digital engagement. Analysis outputs will identify the intersectional nature of barriers or facilitators to digital inclusion. (5) Co-production workshops with older people and community service providers will identify key components of interventions that are required to address digital exclusion. Components will be mapped against existing interventions, and the ‘best fit’ intervention(s) refined. An implementation plan will be developed in parallel. (6) Feasibility testing of the refined intervention(s) to assess acceptability and obtain feedback on content and delivery mechanisms.

Ethics and dissemination

This study was approved by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee on 23 October 2023 (ref. 23/YH/0234). Findings will be disseminated in academic journals and shared at webinars, seminars, conferences and events arranged by organisations operating across the digital inclusion and older people fields.

Trial registration

https://www.isrctn.com/ISRCTN18306736

Development and psychometric evaluation of a new self-report measure to assess patient engagement behaviours and capacity in the USA: the Patient Engagement Capacity Survey

Por: Gregory · M. E. · Sieck · C. J. · Walker · D. M. · Di Tosto · G. · Edwards · M. C. · McAlearney · A. S. · Gebretsadik · S. · DeVos · T. V. · Hefner · J. L.
Objective

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.

Design

Measure development and psychometric evaluation.

Setting and participants

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.

Methods

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.

Primary and secondary outcome measures

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

Results

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.

Conclusions

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.

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/).

Investigating discrepancies in perceptions regarding the provision of hospital rest and relaxation spaces in Scotland during the COVID-19 pandemic and beyond: a qualitative study

Por: Walker · K. A. · Cunningham · K. B. · Ferguson · J. · Gibson Smith · K. · Scanlan · G. M. · Cecil · J. E. · Gordon · L. · Laidlaw · A. · Pope · L. M. · Johnston · P. · Aitken · G.
Objectives

To investigate discrepancies in perceptions regarding the accessibility and availability of rest and relaxation (R&R) spaces between hospital doctors in Scotland and NHS Scotland regional health boards (HBs), with the intention of informing best practices for organisational policy on the provision of R&R spaces both now and in the future.

Design

A qualitative study, through an inhabited institutionalism (II) lens, of semi-structured interviews of hospital doctors across the career continuum in Scotland and all NHS regional HBs in Scotland providing written information relating to R&R space provision.

Setting

NHS Scotland during the COVID-19 pandemic and beyond.

Participants

Hospital doctors (n=30) who had participated in a larger qualitative study and provided specific insights on R&R spaces. All NHS Scotland regional HBs (n=14).

Results

Although HBs reported the provision of R&R spaces, numerous doctors reported R&R spaces had been removed, relocated or were inaccessible. Furthermore, limited awareness of their availability attributed to inadequate communication, compounded the issue. This divergence between institutional reporting and front-line experience can be interpreted through the lens of II, which posits that institutional polices are often interpreted and implemented differently.

Conclusions

This study emphasises how crucial R&R spaces are to promoting doctors’ well-being especially during the time of high stress. HBs must not only guarantee the accessibility and physical availability of R&R spaces but also enhance their communication regarding the provision.

Midlife cognitive testing in Africa: validity of the Harmonised Cognitive Assessment Protocol in the Kenya Life Panel Survey

Por: Gross · A. L. · Duhon · M. · Ochieng · E. · Ikanga · J. N. · Dow · W. H. · Lee · J. · Walker · M. W. · Layvant · M. · Ngugi · A. · Ehrlich · J. R. · Miguel · E. A.
Objectives

Cohort studies of ageing and cognitive decline typically do not begin fielding comprehensive cognitive assessments until older adulthood. However, for identifying preventable dementia risk factors, there is strong value in beginning at earlier ages. The case is especially compelling in sub-Saharan Africa, where the number of older individuals is expected to triple in the next three decades, and where risk factors may operate more intensively at earlier ages. This study reports on the adaptation and validity of the Harmonised Cognitive Assessment Protocol (HCAP) approach in the Kenya Life Panel Survey (KLPS), collected among middle-aged respondents.

Design

To evaluate the validity of the HCAP approach in Kenya, this study assesses model fit statistics from confirmatory factor analyses (CFA) and tests measurement invariance by respondent characteristics.

Setting

Both rural and urban areas in Kenya.

Participants

A sample of n=5878 individuals from the KLPS, who have been surveyed regularly since they were schoolchildren in the 1990s. The HCAP assessment was administered in 2023 at an average age of 37 years (10–90 range 34 to 41).

Primary and secondary outcome measures

For each individual, the CFA generates a general cognitive performance score, and cognitive performance scores for five distinct domains, including memory, executive functioning, language, orientation to time and place, and visuospatial functioning.

Results

Fit of the models to the data was adequate for general cognitive performance (root mean squared error of approximation (RMSEA)=0.03; comparative fit index (CFI)=0.94; standardised root mean residual (SRMR)=0.05), language (RMSEA=0.02; CFI=0.95; SRMR=0.05) and good for memory (RMSEA=0.05; CFI=0.99; SRMR=0.02) and executive functioning (RMSEA=0.03; CFI=0.98; SRMR=0.03). The CFA indicate that the factor structure is consistent with findings from other countries and that reliability for the general cognitive performance score was high. Statistical models also suggest invariance at the scalar level for leading demographic (gender, age) and socioeconomic (education, occupational complexity) characteristics.

Conclusions

This study demonstrates that the cognitive functioning of mid-age Kenyans appears to be well captured by the adapted protocol. While there is a moderate decline in cognitive performance among older individuals, this relationship appears to be mediated by education, indicating that this KLPS HCAP provides a valuable baseline for studying future cognitive decline.

Cluster randomised controlled trial of a household-level, group preconception nutrition awareness and norm intervention (SUMADHUR) combined with multiple micronutrient supplements (MMS) for newly married households: a protocol

Por: Diamond-Smith · N. · Puri · M. C. · Borak · L. · Walker · D. · Charlebois · E. · Weiser · S. D. · McDonald · C. M.
Introduction

Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.

Methods and analysis

This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B12). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.

Ethics and dissemination

The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.

All data will be made publicly available (deidentified) after the publication of the main impact paper.

Trial registration number

NCT06810440.

Comparing thermal imaging and non-contact infrared thermometers for monitoring skin temperature in a prospective cohort with lower limb cellulitis

Por: Cross · E. L. A. · Llewelyn · M. J. · Walker · S. · Hayward · G.
Objective

Skin temperature assessment is essential for the diagnosis of cellulitis and monitoring treatment response, but is currently subjective and can contribute to overdiagnosis. We aimed to characterise skin temperature changes over time in cellulitis and compare two objective measurement approaches, a thermal imaging camera (TIC) and a non-contact infrared thermometer (NCIT).

Design

A device comparison study nested within a prospective cohort. We measured limb temperatures daily for 4 days using a TIC and two NCITs.

Setting

Two acute hospitals in the UK’s National Health Service.

Participants

202 adults (age ≥18 years) diagnosed with lower limb cellulitis who attended hospital for antibiotic treatment.

Outcome measures

We used linear mixed-effects models to quantify changes in temperature over time and intraclass correlation coefficients (ICC) to assess reliability. We compared temperature measurements between devices using Lin’s concordance coefficients and Bland-Altman plots with estimated 95% limits of agreement.

Results

202 patients were included: 95% white ethnicity. Baseline limb temperature differences varied between 2.4°C and 3.4°C, depending on the device. All devices showed significant reductions in affected limb temperature per day, with the largest decrease recorded by the TIC (–0.34°C per day, 95% CI –0.48°C to –0.19°C, p

Conclusions

Daily temperature changes may be too small for reliable monitoring at the individual patient level, but cumulative changes from day 0 to day 3 may be sufficient for clinical interpretation, despite limitations in the precision of device measurements. NCITs’ measurement capabilities differ widely, so these devices cannot be used interchangeably. Due to this and the potential benefits of advanced thermal image analysis, TICs should be prioritised for further study in cellulitis. Future research should confirm our findings in different skin tones and explore the clinical utility of thermal imaging in enabling earlier diagnosis or detecting signs of therapeutic failure.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

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