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A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

ABSTRACT

A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.

Quantitative retinal morphology and mortality in individuals with proliferative diabetic retinopathy: a retrospective cohort study in a large real-world population

Por: Khan · A. Z. · Ribeiro Reis · A. P. · Olvera-Barrios · A. · Zhou · Y. · Williamson · D. J. · Struyyen · R. R. · Khalid · H. · Egan · C. · Denniston · A. K. · Keane · P. A. · Wagner · S. K.
Objectives

To investigate whether quantitative retinal markers, derived from multimodal retinal imaging, are associated with increased risk of mortality among individuals with proliferative diabetic retinopathy (PDR), the most severe form of diabetic retinopathy.

Design

Longitudinal retrospective cohort analysis.

Setting

This study was nested within the AlzEye cohort, which links longitudinal multimodal retinal imaging data routinely collected from a large tertiary ophthalmic institution in London, UK, with nationally held hospital admissions data across England.

Participants

A total of 675 individuals (1129 eyes) with PDR were included from the AlzEye cohort. Participants were aged ≥40 years (mean age 57.3 years, SD 10.3), and 410 (60.7%) were male.

Outcome measures

The primary outcome was all-cause mortality. Quantitative retinal markers were derived from fundus photographs and optical coherence tomography using AutoMorph and Topcon Advanced Boundary Segmentation, respectively. We used unadjusted and adjusted Cox-proportional hazards models to estimate hazard ratios (HR) for the association between retinal features and time to death.

Results

After adjusting for sociodemographic factors, each 1-SD decrease in arterial fractal dimension (HR: 1.54, 95% CI: 1.18 to 2.04), arterial vessel density (HR: 1.59, 95% CI: 1.15 to 2.17), arterial average width (HR: 1.35, 95% CI: 1.02 to 1.79), central retinal arteriolar equivalent (HR: 1.39, 95% CI: 1.05 to 1.82) and ganglion cell-inner plexiform layer (GC-IPL) thickness (HR: 1.61, 95% CI: 1.03 to 2.50) was associated with increased mortality risk. When also adjusting for hypertension, arterial fractal dimension (HR: 1.45, 95% CI: 1.08 to 1.92), arterial vessel density (HR: 1.47, 95% CI: 1.05 to 2.08) and GC-IPL thickness (HR: 1.56, 95% CI: 1.03 to 2.38) remained significantly associated with mortality.

Conclusions

Several quantitative retinal markers, relating to both microvascular morphology and retinal neural thickness, are associated with increased mortality among individuals with PDR. The role of retinal imaging in identifying those individuals with PDR most at risk of imminent life-threatening sequelae warrants further investigation.

Experiences of using a physical activity and exercise digital intervention to reduce respiratory tract infections: a qualitative process evaluation

Por: Dennis · A. · Joseph · J. · Greenwell · K. · Miller · S. · Vennik · J. · Dennison · L. · Holt · S. · Bradbury · K. · Ainsworth · B. · Yardley · L. · Little · P. · Geraghty · A. W. A.
Objectives

Increasing physical activity and effectively managing stress can positively impact immunity and may reduce the duration of respiratory tract infections (RTIs). As part of a larger trial, participants accessed a digital behavioural change intervention that encouraged physical activity and stress management to reduce RTIs. We aimed to understand the barriers and facilitators to engaging in physical activity and stress reduction.

Design

A qualitative process analysis from semistructured interviews of the behavioural intervention in a randomised control trial.

Setting

Primary care in the UK.

Participants

34 participants (aged 18–82 years) in the behavioural intervention arm.

Interventions

The larger trial involved four interventions: a gel-based antiviral nasal spray; a saline water-based nasal spray; a behavioural intervention; usual care. In this study, we focused on participants allocated to the behavioural intervention. The behavioural intervention included two components: one to increase physical activity (getting active) and another for stress management techniques (healthy paths) to reduce RTIs.

Results

We analysed the interviews using thematic analysis with a critical realist perspective (focusing on). We developed five themes: digital intervention engagement, views on intervention allocation, the role of getting active, the role of healthy paths and benefits reinforcing behaviour. Participants’ views on the relevance and benefit of the behavioural intervention shaped their engagement with the intervention website and behaviour. Facilitators of intervention engagement included awareness of inactivity, goal setting, increasing immunity, positive outcome expectations and benefits from changing behaviour. Barriers to engagement included negative outcome expectations, such as around efficacy of the behaviours.

Conclusions

Overall, the results highlighted the importance of positive expectations for a digital intervention promoting physical activity and stress management for RTI reduction. Future interventions should consider how to clearly communicate a broad range of perceived benefits to users.

Trial registrations

The trial was prospectively registered with International Standard Randomized Controlled Trial Number (ISRCTN) registry (17936080).

Chatbot‐Delivered Interventions for Improving Mental Health Among Young People: A Systematic Review and Meta‐Analysis

ABSTRACT

Background

The characteristics, application, and effectiveness of chatbots in improving the mental health of young people have yet to be confirmed through systematic review and meta-analysis.

Aim

This systematic review aims to evaluate the effectiveness of chatbot-delivered interventions for improving mental health among young people, identify factors influencing effectiveness, and examine feasibility and acceptability.

Methods

To identify eligible interventional studies, we systematically searched 11 databases and search engines covering a publication period of January 2014 to September 2024. Meta-analyses and subgroup analyses were performed on randomized controlled trials to investigate the effectiveness of chatbot-delivered interventions and potential influencing factors. Narrative syntheses were conducted to summarize the feasibility and acceptability of these interventions in all the included studies.

Results

We identified 29 eligible interventional studies, 13 of which were randomized controlled trials. The meta-analysis indicated that chatbot-delivered interventions significantly reduced distress (Hedge's g = −0.28, 95% CI [−0.46, −0.10]), but did not have a significant effect on psychological well-being (Hedge's g = 0.13, 95% CI [−0.16, 0.41]). The observed treatment effects were influenced by factors including sample type, delivery platform, interaction mode, and response generation approach. Overall, this review demonstrates that chatbot-delivered interventions were feasible and acceptable.

Linking Evidence to Action

This review demonstrated that chatbot-delivered interventions had positive effects on psychological distress among young people. Chatbot-delivered interventions have the potential to supplement existing mental health services provided by multidisciplinary healthcare professionals. Future recommendations include using instant messenger platforms for delivery, enhancing chatbots with multiple communication methods to improve interaction quality, and refining language processing, accuracy, privacy, and security measures.

Effectiveness of methadone versus buprenorphine in the treatment of opioid use disorder: secondary analyses of prospective cohort study data

Por: Naji · L. · Rosic · T. · Dennis · B. · Worster · A. · Paul · J. · Thabane · L. · Samaan · Z.
Objectives

To compare the effectiveness of buprenorphine-naloxone (bup/nal) and methadone maintenance therapy (MMT) in the treatment of patients with opioid use disorder (OUD) during the fentanyl era.

Design

Secondary analysis of prospective cohort study data.

Setting

Data for the study were collected from 54 clinical sites across Ontario, Canada, between May 2018 and January 2023.

Participants

To be included in the present study, participants had to be at least 16 years of age, have provided written informed consent and be receiving either MMT or bup/nal therapy for OUD. This study includes data from 2601 participants, of whom 2068 were receiving MMT and 533 were receiving bup/nal for OUD. The mean age of participants was 39.4 years (SD: 10.9), and 45% were female.

Interventions

MMT or bup/nal treatment for OUD.

Outcome measures

We employed a propensity score matched analysis to compare treatment outcomes among patients receiving MMT compared with bup/nal. We used ongoing illicit opioid use as an indicator of treatment outcome. We considered participants with >50% of urine drug screens in the past 12 months positive for non-prescribed opioids to be ‘non-responders’. We conducted subgroup analyses to identify whether treatment type was associated with ongoing non-prescribed opioid use among patients with and without a history of intravenous drug use (IVDU), and whether treatment type was associated with retention in treatment.

Results

Eight per cent of patients on bup/nal were considered non-responders, compared with 11.9% of patients on MMT. We did not find a statistically significant association between treatment type and treatment response. However, we did find that patients on MMT were more likely to stay in treatment for 12 months (OR 1.79, 95% CI 1.45 to 2.22, p

Conclusions

Among a cohort of patients with OUD receiving treatment during the fentanyl era, we find that there is no statistically significant difference in ongoing non-prescribed opioid use between patients receiving MMT compared with bup/nal. Future studies should aim to further compare treatment effectiveness using patient-centred outcomes and pragmatic trial designs.

Protocol: what are the ethnic inequities in care outcomes related to haematological malignancies, treated with transplant/cellular therapies, in the UK? A systematic review

Por: Cusworth · S. · Deplano · Z. · Denniston · A. K. · Burns · D. · Nirantharakumar · K. · Adderley · N. · Chandan · J. S.
Introduction

Haematological cancers are common in the UK, with a variety of morphologies. Stem cell transplants and chimeric antigen receptor (CAR) T-cell therapies provide significant options for hard to treat haematological cancers, although with difficult to predict outcomes. Research into the determinates of treatment efficacy, and access to treatments, is key to ensuring equal benefit across patients and patient safety. With this, there are concerns about the small representation of minority groups in related research. We aim to report on the current knowledge to guide future research.

Methods and analysis

A variety of databases will be searched for literature on UK minority ethnic populations receiving haematopoietic stem cell transplant or CAR T-cell therapy. Searches will be restricted to the year 2011 or later. Many outcomes will be analysed, covering the patient care pathway for those of the target population, although with a focus on follow-up after therapy. Plans have been made to conduct narrative synthesis, with meta-analysis where applicable.

Ethics and dissemination

Ethical approval is not required for this study. Outputs will be published in an appropriate journal and discussed with the wider National Institute for Health and Care Research Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics (BTRU) group. Discussions will also be undertaken with the BTRU patient partners group.

Evaluation of Nurse‐Led and Student‐Led Community‐Based Clinics: A Scoping Review

ABSTRACT

Aim

To synthesize approaches used to evaluate nurse-led clinics (NLCs) and student-led clinics (SLCs) delivering community-based primary healthcare.

Design

A scoping review based on Joanna Briggs Institute (JBI) guidelines.

Methods

This review included articles evaluating the impact of NLCs and SLCs, published between 2013 and 2023. The Quadruple Aim Framework for health systems quality improvement was a reference point for thematic analysis.

Data Sources

CINAHL Complete, ProQuest Nursing & Allied Health, PubMed, Scopus, Health Systems Evidence, Ovid Emcare and grey literature repositories were searched in March–June 2023.

Results

Our search yielded a total of 891 articles and 43 articles were included in this scoping review. Diverse quantitative and qualitative methods and concepts of interest were evident in the evaluations of NLCs (n = 15), medical SLCs (n = 15) and interprofessional SLCs (n = 13). Extracted data spoke to the evaluation of either client experience, health of communities, systems of care delivery or provider experience, with systems of care delivery being the most consistently evaluated domain across all clinic types.

Conclusion

Traditional and non-traditional evaluation measures spanning the Quadruple Aim Framework were used to study community-based NLCs and SLCs. Opportunities remain for broadening the range of indicators and methods used to capture clinic impact on health equity.

Implications for the Profession and/or Patient Care

Numerous transferable research approaches are available to students and clinical professionals for supporting the design and iterative improvement of innovative primary healthcare clinics.

Impact

The results highlight ways in which NLCs and SLCs may be evaluated for their concurrent impact on healthcare service delivery and clinical education systems.

Reporting Method

PRISMA-ScR.

Patient or Public Contribution

Feedback amassed during presentations to nursing audiences informed the enclosed discussion points.

Trial Registration

Review protocol was published with the Open Science Framework under ID 10.17605/OSF.IO/FP6S4

The Personal and Collective Resources of Nurses and the Relationship to Job Commitment and Work Engagement

ABSTRACT

Background

Identifying personal, social and emotional resources relevant to nurses' wellbeing and job engagement is important for addressing workforce shortages and nurse burnout, and turnover.

Aim

This study examined the relationships between New Zealand (NZ) nurses' personal resources (resilience, adaptability, self-efficacy, collective efficacy) and their occupational commitment and job engagement.

Sample

Participants were 270 New Zealand nurses.

Methods

Quantitative research design involving a confirmatory factor analysis was used to provide measurement support and to obtain latent correlations among factors. The final analysis was performed using structural equation modelling. The Job Demands-Resources (JD-R) model was adopted as the conceptual framework for this study.

Results

The personal resources for New Zealand nurses of self-efficacy, adaptability and resilience were generally positively associated with their occupational commitment and job engagement. In addition, New Zealand nurses' collective efficacy was seen as important for managing the demands of the job.

Conclusion

Taken together, findings offer an understanding about the salient personal and collective resources in relation to New Zealand nurses wellbeing and job engagement.

Implications for the Profession

Future research could explore how integrating cultural perspectives can improve job satisfaction and retention among nurses who identify as coming from collectivist cultures. The personal resources used in this study also need to be examined from a Māori perspective to ensure their relevance to the health and wellbeing of Māori nurses.

Impact

This study highlights the crucial role of collective support in enhancing job engagement among nurses. It underscores the importance of incorporating a cultural lens in workplace research, showing how collective efficacy can help individual nurses adapt to workplace challenges and reduce their intention to leave amid global nurse shortages.

Reporting Method

STROBE.

No patient/public contribution.

Struggles of Fatherhood: A Prospective Study on the Incidence of Paternal Postpartum Depression and Associated Factors

ABSTRACT

Aim

To investigate the incidence and the factors associated with paternal postpartum depression amongst new fathers in Singapore.

Design

A prospective repeated measures study was conducted from September 2023 to March 2024.

Methods

A total of 200 fathers aged 21 years and above who had a neonate born at full term and no serious health events for both mother and neonate were recruited from a local hospital via convenience sampling. Fathers completed questionnaires at the third trimester of pregnancy (baseline) and 1 month postpartum. Multiple regression analyses were used to identify significant factors associated with postpartum depression in fathers.

Results

The incidence of paternal postpartum depression was 5.26% at 1 month post-childbirth, using the Edinburgh Postpartum Depression Scale (EPDS). Using the Gotland Male Depression Scale (GMDS), 7% of the fathers were identified with high risk of depression and 14.3% of the fathers had moderate depressive symptoms. Paternal postpartum depression at 1 month post-childbirth could be predicted by paternal postpartum depression scores at baseline measured by EPDS and GMDS, as well as by baseline perceived social support and parental self-efficacy at 1 month post-childbirth.

Conclusion

This study found that a considerable number of fathers in Singapore are at risk of postpartum depression. There is an urgent need for the development of more comprehensive tools to measure postpartum depression in fathers that are culturally adapted to the local context.

Implications

Early screening during antenatal visits enables timely intervention and access to support, benefiting the entire family. Nurses could help fathers to be more involved by extending patient education and teaching infant care skills to both parents. When counselling patients, the involvement of extended family members and navigating new roles as caregivers of a new baby and breadwinners are important considerations for new parents.

Impact

This study is the first of its kind to measure the incidence of postpartum depression amongst new fathers in an urban multicultural Asian setting, like Singapore. The study found that the incidence of postpartum depression in fathers were 5.26% when measured using EPDS and 14.3% when measured using GMDS at 1 month postpartum. These findings could inform future family-centred and father-specific interventions to improve the mental health outcomes of new parents.

Reporting Method

This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.

Patient or Public Contribution

No patient or public contribution.

A purified reconstituted bilayer matrix shows improved outcomes in treatment of non‐healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi‐centre clinical trial

Abstract

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis

Abstract

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.

Development, psychometric assessment, and predictive validity of the comprehensive breastfeeding knowledge scale

To develop a breastfeeding knowledge scale that aligns with the Baby Friendly Hospital Initiative and psychometrically test it among expectant parents.
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