Surgical site infections (SSI) in vascular surgery have a huge impact on patients’ morbidity and mortality and healthcare systems worldwide. Dialkylcarbamoylchoride (DACC) is a synthetically produced material that can irreversibly bind and inactivate bacteria that exhibit cell-surface hydrophobicity (CSH). The DACC in the Reduction of Surgical Site Infection (DRESSINg) trial is a multicentre randomised controlled trial which aims to assess the effectiveness of DACC-coated post-operative dressings in the prevention of SSI in vascular surgery. Seven hundred and eighteen participants undergoing clean or clean-contaminated lower limb vascular surgery will be randomised in a 1:1 ratio to either DACC-coated dressings or standard dressings for their postoperative wounds. The primary outcome is the incidence of SSI defined by the Centers for Disease Control and Prevention (CDC) criteria or total ASEPSIS score of 21 or more within 30 days of surgery. The secondary outcomes include satisfactory wound healing with a total ASEPSIS score of 10 or less, quality of life pre and post surgery, Bluebelle wound healing scores, resource use and financial (£), and environmental (KgCO2e) cost analyses. This multicentre randomised controlled trial will provide level 1 evidence on the effectiveness of preventing SSI in lower limb vascular surgery.
Shared decision-making is widely advocated in policy and practice, but how it is to be applied in a high-stakes clinical decision such as major lower limb amputation due to chronic limb-threatening ischaemia or diabetic foot is unclear. The aim of this study was to explore the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.
A qualitative study (done as part of a broader mixed-methods study) using semi-structured interviews. Interview transcriptions were analysed using thematic analysis.
Vascular centres in three large National Health Service hospitals in Wales and England, UK, between 1 October 2020 and 30 September 2022.
A purposive sample of 18 patients for whom major lower limb amputation was considered as a treatment option/carried out, with interviews conducted before or within 4 months of amputation and 4–6 months after amputation. A further purposive sample of 20 healthcare professionals (including eight surgeons) involved in supporting or conducting major lower limb amputation decision-making.
Five major categories were identified that highlighted the challenges of ensuring shared decision-making associated with major lower limb amputation: (i) patients’ limited understanding, (ii) variable patient attitudes to decision-making, (iii) healthcare professionals’ perceived challenges to sharing decision-making, (iv) surgeons’ paternalism and (v) patients’ and healthcare professionals’ decisional regret/possible consequences of challenges.
Amputation is a life-changing decision for both patients and healthcare professionals, with huge consequences. Despite being considered the gold standard, our findings highlight several challenges to effective shared decision-making for major lower limb amputation. Shared decision-making training for healthcare professionals is paramount if these limitations are to be addressed and patients are to feel confident in being adequately informed about the treatment decisions that they make.
Endometriosis is a common, benign, chronic inflammatory disease with multiple consequences, from chronic pain to systemic comorbidities and poor quality of life. As it usually affects people of reproductive age, one of the most distressing consequences is infertility, which can be only partly overcome by medically assisted reproduction. Poor outcomes are, in fact, frequent adverse events. As no definitive therapy exists for endometriosis-related infertility, affected women often tend to try either complementary and alternative medicine or self-management strategies to improve their quality of life, with the hope of also enhancing their fertility. Among available options, dietary interventions are commonly explored, even if no robust evidence is available on the optimal type of diet and its effects on reproductive outcomes. This trial will investigate whether an anti-inflammatory dietary intervention can improve fertility outcomes in women affected by endometriosis undergoing in vitro fertilisation (IVF).
The DietAry interveNtion in ameliorating fertiliTy parameters in women with Endometriosis undergoing IVF (DANTE) study is a single-centre, randomised, controlled, non-pharmacological interventional trial in patients living with endometriosis who are infertile and require IVF. Participants will be allocated to either a 12-week intervention based on an anti-inflammatory diet or no diet before the beginning of controlled ovarian stimulation. Following baseline assessment, 438 participants aged
The study has received ethics approval from Comitato Etico Territoriale Lombardia 3 (#5587_18.12.2024). Results will be presented in peer-reviewed journals and at international conferences.
Infection prevention and control (IPC) interventions are multifactorial and are used to prevent healthcare-associated infections in healthcare facilities. However, patient views and enabling patient and public involvement (PPI) in their development has been minimal.
This systematic review aims to identify peer-reviewed publications reporting patient satisfaction outcomes in the context of IPC interventions, to document the methods used to assess patient satisfaction and to conduct a meta-analysis on reported satisfaction outcomes.
Systematic review and meta-analysis following the Joanna Briggs Institute (JBI) methodology and the PRISMA statement, with oversight from a steering group including PPI partners. Studies in peer-reviewed journals were included based on eligibility criteria.
MEDLINE, Scopus, Web of Science, EMBASE, Cochrane Library, CINAHL and PsycINFO were searched in June 2024.
Included studies investigated satisfaction among hospitalised patients in acute care settings following IPC measures, including isolation, cohorting, screening, hand hygiene, antimicrobial stewardship, patient flagging, education, personal protective equipment use, visiting restrictions and treatment delays
Titles and abstracts were screened independently by two reviewers; disagreements were resolved by a third. Study quality was assessed using the JBI manual for evidence synthesis. A meta-analysis was conducted where four or more studies used comparable designs and methods within the same areas of IPC, with heterogeneity evaluated using Cochran’s Q statistic and I2 and pooled estimates calculated with 95% CIs using the Wilson (score) method.
Twenty-nine studies were identified. Among IPC measures, isolation precautions were the most commonly reported intervention (11 studies, 38%). The Likert scale was the predominant assessment method (13 studies, 45%). Patient satisfaction with IPC interventions ranged from 58.3% to 97.2%. Meta-analysis of four studies using the Hospital Consumer Assessment of Healthcare Providers and Systems survey showed substantial heterogeneity (I2, 55%, p=0.08) and a pooled patient satisfaction level of 69% (95% CI 63.6% to 74.4%) for isolation precautions.
Sixty-nine percent of isolated patients reported satisfaction with their care. Patient satisfaction with IPC interventions varies widely, highlighting limitations in current measurement approaches. Strengthening PPI in the design and evaluation of satisfaction measures is essential to capture meaningful data and improvements in IPC programmes.
IS 2024 CRD42024558385.
Many people with long-term conditions such as pain and arthritis struggle with their health and well-being. To support better self-management, a new peer-delivered coaching intervention (Health Connect Coaching) was set up at a National Health Service integrated care organisation in Southwest England. Based on principles of personalised care and supported goal setting, the one-to-one coaching programme, targeting patients with low activation, delivered coaching sessions in a step-down approach over 6 months. A randomised controlled feasibility trial (fRCT) of Health Connect Coaching was conducted to inform the design of a definitive randomised controlled trial. This article reports the embedded qualitative component of the fRCT, describing the experiences of coaches, peers and staff of implementing and participating in the intervention and trial that ultimately struggled to recruit sufficient peers.
Semi-structured online interviews were conducted with coaches (n=16) and peers (n=6), and informal discussions held with staff (n=7). Interviews were recorded and transcribed verbatim, and summaries of informal discussions were made. Data were analysed using thematic framework analysis.
Four themes were identified from the interview and discussion data: (1) motivation for participation, (2) balance, (3) flexibility and (4) connection and building relationships.
One-to-one peer coaching demonstrates potential as an intervention to enable people to better manage their chronic health condition. However, in people with low activation, programmes and effectiveness studies need to pay close attention in their design to the motivation of peers, flexible delivery models that enable connection but can accommodate fluctuating needs and facilitating links between coaching services and clinical teams.
Economic evaluations are essential for informing healthcare resource allocation. When conducted from a societal perspective, they may include productivity costs such as paid and unpaid productivity losses for patients and their caregivers. Although several methods exist to measure and value productivity costs, there is limited methodological consensus on which methods should be used. This scoping review aims to synthesise existing methods for measuring and valuing patient and caregiver productivity costs.
This review will follow the Arksey and O’Malley framework, enhanced by subsequent methodological guidance from Levac and the Joanna Briggs Institute. The six stages include identifying the research question; identifying relevant studies; selecting studies; charting the data; collating, summarising and reporting the results; and consultation. We will search MEDLINE, Embase and EconLit from 1996 to July 2025. Eligible sources will include peer-reviewed literature that reports methods for the measurement or valuation of productivity costs related to paid or unpaid work among patients or caregivers. Screening and data extraction will be conducted independently by two reviewers. Extracted data will include types of productivity costs, instruments used, valuation approaches, as well as recommendations on preferred measurement and valuation methods. Results will be synthesised thematically and reported using the Preferred Reporting Items for Systematic Review and Meta-Analysis for Scoping Reviews checklist.
Ethics approval is not required as this review will rely exclusively on publicly available literature and does not involve human participants or the use of primary data. The findings will first be shared with Canada’s Drug Agency as a report and then disseminated through peer-reviewed publication and academic presentations to inform future research and practice.
This protocol has been registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/FK9D4).
To assess the capability of a convolutional neural network trained by transfer learning on anterior segment optical coherence tomography (AS-OCT) images, Placido-disk corneal topography images and external photographs to predict age and biological sex.
Development of a deep learning model trained on retrospectively collected data using transfer learning.
A multicentre secondary care public health trust based in London.
We included 557,468 scans from 40,592 eyes of 20,542 patients. Data were extracted from all patients who underwent MS-39 imaging within our trust from October 2020 to March 2023.
Primary outcome measures for biological sex classification included accuracy, precision, recall, F1-score and area under the receiver operating curve (ROC-AUC). Primary outcome measures for age prediction were Pearson correlation coefficients (r), coefficients of determination (R²) and the mean absolute error (MAE) to evaluate the predictive performance. The secondary outcome was to visualise and interpret the model’s decision-making process through the construction of saliency maps.
For age prediction, the MAEs for the Placido, AS-OCT and external photograph models were 5.2, 5.1 and 6.2 years, respectively. For gender classification, the same models achieved ROC-AUCs of 0.88, 0.73 and 0.81, respectively. No difference in performance was found in the analysis of corneas with pathological topography. The saliency maps highlighted the peri-limbal cornea for age prediction and the central cornea for gender discrimination.
Our study demonstrates that deep learning models can extract age and gender information from anterior segment images. These findings support the concept that the anterior segment, like the retina, encodes important biological information. Future research should explore whether these models can predict specific systemic conditions.
Cystic fibrosis (CF) is an inherited condition, affecting approximately 150 000 people worldwide. Physical activity (PA) is an integral component in the management of CF. However, it is estimated that only a third of young people (with and without CF) achieve UK Chief Medical Officer guideline recommended levels of activity. The aim of this research was to use the person-based approach to develop an intervention supporting families with young people (aged 6–12 years) with CF to incorporate PA as a sustainable habit in their lives to increase the likelihood of sustained PA levels going into adolescence and adulthood.
Using the person-based approach, intervention content was created and iteratively adapted. This was initially guided by relevant literature; the guiding principles, logic model and preliminary content were developed via co-production with patient and public involvement (PPI) representatives (n=8) with lived experience of CF. The intervention was further refined/optimised using qualitative think-aloud and retrospective interviews, the results of the preliminary evaluation are reported. Think-aloud interviews were rapidly analysed using a table of changes analysis and used to inform adaptations to content. Retrospective interviews were analysed thematically.
Community settings in the UK.
Participants included six families with a child with CF aged between 6 years and 12 years old.
Intervention content consisted of nine sections and was delivered as a printable PDF file. Informed by the Capability, Opportunity, Motivation and Behaviour framework and self-determination theory, content focused on promotion of PA as a family activity that is fun, enjoyable, quick and achievable. It promoted ‘movement to make you feel good"’ and in short bursts of activity. Promotion of PA as medicine was avoided. The final intervention was considered to be engaging and acceptable.
Qualitative methods and PPI facilitated the development of a family-focused intervention supporting the integration of PA into daily life. This was viewed as acceptable and engaging among families of people with CF. Future research now needs to explore the effectiveness of the intervention for increasing PA behaviour.
To describe nurses' roles in transitional care planning during intensive care unit (ICU) family meetings for patients with prolonged mechanical ventilation (PMV).
A qualitative descriptive study.
Using secondary data from a trial of a decision aid about PMV, transcripts from 19 unstructured ICU family meetings were purposively sampled and analysed using directed content analysis.
Among 76 recorded ICU family meetings where nurses engaged and spoke at length beyond introduction, nurses spoke at length in 19 (25%) of them. These 19 family meetings were analysed in depth. Three themes were identified describing the roles nurses served: (1) Transitional care liaisons (e.g., introducing next levels of care, identifying/engaging family members, providing patient/family education, managing medications, planning for discharge, assessing patient/family needs, coordinating care, setting goals, providing care continuity, offering provider guidance and referring to resources); (2) information and communication facilitators (e.g., moderating family meetings, facilitating family understanding and serving as communication intermediaries) and (3) family support providers (e.g., providing emotional support, describing expectations and advocating for patients/families).
Although nurses play a central role in patient care, they engage in only a minority of ICU family meetings addressing transitional care planning. Increased nursing involvement in these discussions may enhance care coordination and better support families navigating complex care transitions.
Findings suggest that more consistent engagement of nurses in ICU family meetings has the potential to support transitional care planning and family-centred care for patients with PMV and their families.
This work adds to a growing body of knowledge about nurses' role in ICU transitional care planning. These findings provide valuable guidance for future research and development of transitional care standards to guide nurses in ICU transitional care planning.
The Consolidated Criteria for Reporting Qualitative Research Checklist (COREQ).
No patient or public contribution.
Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.
We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).
For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.
The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.
The tobacco and nicotine industry fuels tobacco-related addiction, disease and death. Indigenous peoples experience a disproportionate burden of commercial tobacco-related morbidity and mortality. Over the past two decades, significant progress has been made in reducing smoking prevalence among Indigenous peoples; however, smoking remains a leading contributor to the burden of death and disease. This review will summarise evidence on commercial tobacco resistance and/or eradication strategies, including policy reforms, in relation to Indigenous peoples across Oceania, the Pacific Islands and North America.
This review will follow guidelines from the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews and will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. This review will consider academic and grey literature published since 1 January 2000. The following electronic databases will be searched for relevant primary research articles and commentaries: PubMed, Scopus, Informit, Web of Science and PsycINFO. Additional searches will be conducted in ProQuest to identify relevant grey literature. Papers will be screened by two reviewers to determine eligibility, followed by full-text data extraction. Findings will be synthesised descriptively for each review question and by region. Studies included in the review will be assessed against criteria for Indigenous engagement in research.
This protocol was led by Indigenous interests, needs and rights of Indigenous peoples, consistent with the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), the WHO’s Framework Convention on Tobacco Control and ethical practice. This review was conceptualised with Indigenous leadership and through engagement, including but not limited to the Indigenous lived experience of the authors (MK, E-ST, HC, PNH, PH, SAM, AW, SW and RM). This review supports the global goal of eradicating commercial tobacco-related harms – reframing commercial tobacco use as a structurally imposed harm sustained by colonial and commercial forces rather than personal choice. Findings from this review will be shared with Indigenous partners and communities who requested this work and will be submitted for peer-reviewed publication.
Open Science Framework https://osf.io/wxqcb