Conectar
Cognitive impairment is associated with people with diabetes-related foot ulcers (DFU). However, it is unclear if cognitive impairment is associated with the ulcer itself or other co-existing diabetes-related complications such as peripheral neuropathy. We aimed to investigate cognition in people with diabetes-related peripheral neuropathy and compare those with DFUs to those without DFUs. In this age- and sex-matched, multicentre, case-control, observational study of 89 participants with Type 2 diabetes and peripheral neuropathy, we compared 49 participants with DFUs (cases) to 40 without DFUs (controls). Global cognition scores were assessed using the Montreal Cognitive Assessment tool. Participants with DFUs had similar characteristics to those without DFUs (all, p > 0.05), except for lower body mass index (p = 0.028). Participants with active DFUs had significantly lower global cognition scores compared to those without DFUs (median [IQR] 24.0 [21.0–25.0], 26.0 [24.0–28.0]; p < 0.001). After adjusting for other diabetes-related complications, lower global cognition was independently associated with a DFU, peripheral artery disease, lower physical activity and no family history of diabetes (all, p ≤ 0.019). People with DFUs had lower cognitive scores than those without DFUs, suggesting that the DFU itself is independently associated with cognitive impairment. Future studies should explore causal pathways and targeted management strategies.
by Hemant Mahajan, Poppy Alice Carson Mallinson, Judith Lieber, Santhi Bhogadi, Santosh Kumar Banjara, Anoop Shah, Vipin Gupta, Gagandeep Kaur Walia, Bharati Kulkarni, Sanjay Kinra
Background and AimCardiovascular diseases (CVDs) represent a growing public-health challenge in India, where nearly one in four deaths is CVD-related. Accurate risk stratification underpins targeted prevention, yet laboratory-dependent tools are often impractical in resource-limited settings. The World Health Organization (WHO) and GLOBORISK initiatives both offer non-laboratory-based 10-year CVD risk algorithms alongside their laboratory-based counterparts. We aimed to compare laboratory- and non-laboratory-based WHO and GLOBORISK CVD risk scores, assess their concordance, and examine relationships with sub-clinical atherosclerosis in a rural Indian cohort.
Materials and MethodsWe conducted a cross-sectional analysis of 2,465 adults (1,184 men, 1,281 women) aged 40−74 years from the third wave (2010−12) of the Andhra Pradesh Children and Parents Study (APCAPS). Participants with prior CVD were excluded. Ten-year CVD risk was calculated using sex-specific WHO (South Asia) and India-calibrated GLOBORISK models, both laboratory-based (age, sex, smoking, systolic blood pressure, diabetes, total cholesterol) and non-laboratory-based (age, sex, smoking, systolic blood pressure, BMI) algorithms. Categorical agreement was quantified via percentage agreement and quadratic weighted kappa (κ); continuous agreement by Bland-Altman analysis. We also evaluated linear associations between each risk score (categorical and continuous) and three sub-clinical atherosclerosis markers: carotid intima-media thickness (CIMT), pulse-wave velocity (PWV), and augmentation index (AIx), through sex-stratified multi-level linear regression with random intercept at the household level, adjusting for multiple testing (p Results
Median WHO-CVD-risk was 6.0% (IQR 4% − 9%) in men and 3.0% (2% − 4%) in women for both lab and non-lab models; median GLOBORISK-CVD-risk was 12.0% (9% − 16%) for lab-model vs. 15.0% (10% − 16%) for non-lab-model in men and 5.0% (3% − 9%) for lab-model vs. 5.0% (3% − 9%) for non-lab-model in women. Categorical agreement was substantial to almost perfect: WHO κ = 0.82 (overall), GLOBORISK κ = 0.72. Bland-Altman analyses demonstrated mean differences Conclusion
Non-laboratory-based WHO and GLOBORISK CVD risk scores exhibit high overall agreement with laboratory-based models and correlate strongly with subclinical atherosclerosis in rural India. However, modest underestimation in high-risk subgroups (diabetics, hypercholesterolemia) warrants cautious interpretation. These findings support the feasibility of non-lab risk assessment in resource-constrained settings, while underscoring the need for prospective validation against hard cardiovascular outcomes prior to large-scale implementation.
Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender and sex differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, comorbidities, treatment approaches and survival outcomes. This study aims to explore gender/sex-specific variations in clinical management and their impact on mortality, complications and survival rates in gastric carcinoma patients in Germany. The findings may inform revisions to clinical guidelines and support the development of more personalised treatment strategies. This study aims to improve the quality of care for gastric cancer patients and promote more individualised, sex-sensitive medical practices.
This nationwide, retrospective cohort study will analyse data from the German Diagnosis-Related Groups statistic and regional clinical cancer registries from 2017 to 2021. The study will evaluate both datasets separately, providing a comprehensive view of sex differences in gastric cancer care. Primary outcomes include hospital mortality and survival rates, while secondary endpoints include surgical complications, treatment modalities and postoperative outcomes. The analysis will investigate whether sex influences tumour characteristics, access to treatment and therapy effectiveness. Statistical methods such as descriptive analysis, regression models and survival analysis will be applied to identify sex-related variations in diagnosis, treatment and outcomes.
This study uses anonymised secondary data; thus, ethics approval is not necessary. Findings will be submitted to a peer-reviewed journal, reported to the Innovation Fund of the Federal Joint Committee of Germany, and a patient leaflet for the involved self-help groups will be made.
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). No therapy currently halts disease progression. The strong gut–liver axis implicated in PSC pathogenesis supports the investigation of microbiome-targeted treatments. Oral vancomycin (OV), an antibiotic with potential immunomodulatory properties, has shown encouraging results in improving clinical symptoms and liver biochemistry in PSC. However, prospective data on its safety and efficacy remain limited.
Oral Vancomycin for primary sclerosing Cholangitis in ITaly (VanC-IT) is a phase II, dose-finding, randomised, placebo-controlled, trial designed to evaluate the efficacy and safety of OV in patients with PSC, with or without underlying IBD. Adults and adolescents aged 15–75 years will be enrolled following a 10-week screening and run-in period and randomised in a 1:1:1 ratio to receive either placebo, OV 750 mg/day or OV 1500 mg/day for 24 weeks. Randomisation will be stratified by baseline liver stiffness (
The protocol has been approved by the Ethics Committee CE Brianza on 10 February 2023, number 4017. Trial registration number NCT05876182. Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.
To report how person-centred care principles are applied to care planning and to explore the contextual factors affecting their implementation in older adult care homes in England.
A combined framework analysis and quantitative content analysis study.
Using a semi-structured questionnaire, we interviewed 22 care home managers in England, exploring topics around care planning processes. Audio recordings were transcribed verbatim. Transcripts were analysed through a combined framework approach and content analysis.
Most care home managers discussed person-centred care planning in terms of understanding residents' values and preferences and their engagement in decision-making. Factors facilitating person-centred planning implementation included accessible planning tools, supportive care home leadership, effective communication and collaborative partnerships. Inhibiting factors included regulatory and care practice misalignment, time constraints and adverse staffing conditions.
Differences between care home practitioners' understanding and practice of person-centred care planning require further examination to improve understanding of the sector's complexity and to develop suitable care planning instruments.
Findings demonstrate a need for improved staff access to specialised person-centred care training and an opportunity for care home nursing practitioners to lead the co-development of digital person-centred care planning tools that reflect the reality of long-term care settings.
Identifying factors influencing the implementation of holistic approaches to care planning makes clear the need for modernising long-term care policy and practice to adapt to the contemporary challenges of the care home sector.
Study reporting was guided by the Standards for Reporting Qualitative Research.
Two public involvement advisors with lived experience of caring for a relative living in a care home contributed to the development of the interview guide, advised on care home engagement, guided the interpretation of the findings and commented on the drafted manuscript.
To explore the experiences of qualified nurses who have lived experience of self-harm (with or without suicidal intent) during nursing training or practice. Specifically, to examine characteristics and contributing factors and ideas for tailored suicide prevention interventions.
Exploratory qualitative study.
Individual semi-structured interviews were conducted with eight qualified female nurses who had self-harmed during nursing training or practice. Participants were recruited from three NHS hospital Trusts. Data were collected between June and September 2023 and analysed using reflexive thematic analysis.
Four themes were generated: (1) ‘I don't think work triggered it, but I don't think it helped’: characteristics and contributors to self-harm, (2) ‘You're a nurse now you can't talk about that’: nursing culture and barriers to workplace support seeking, (3) ‘Are you a nurse or are you a lived experience practitioner – can you be both?’: navigating a dual identity as a nurse with lived experience and (4) ‘We need the permission that it's ok to put us first’: workplace support and suggestions for suicide prevention.
Participants described their experiences of self-harm, including citing a range of contributory factors, with occupational issues being particularly salient. Cultural expectations and stigma prevented help-seeking and unique challenges regarding being both a clinician and an individual who has self-harmed were described. Reflections and perspectives on workplace and independent mental health support for nurses were shared.
Potential avenues for suicide prevention interventions tailored for the nursing profession may include challenging nursing culture and promoting help-seeking, peer support opportunities and implementation of education surrounding mental health and well-being in nursing curricula.
Reporting complied with the COREQ.
The topic guide and participant information sheet were developed in consultation with a group of qualified and student nurses with lived experience of suicidal thoughts and behaviours.
(1) Explore the role of core abdominal exercise in people living with a stoma in Australia; (2) determine whether the presence of a parastomal hernia influenced participant symptoms and complications, health status, experiences with different types of exercise, recall advice given by healthcare professionals; (3) determine whether there is an appetite for supervised/supported exercise programs.
A cross-sectional, anonymous survey.
Between August and September 2022. The survey included Likert scales and a single free text response. Logistic regression and Cramer's V were used to explore relationships between variables.
Approximately half (45.5%) of 105 participants reported a parastomal hernia. Those with a parastomal hernia were less likely to recall having received advice (15.20%) or demonstration (9.40%) pertaining to exercise. Less than a quarter of all participants completed strengthening (23.80%) or vigorous (22.90%) exercise. Fear of vigorous exercise, abdominal exercise and heavy lifting were high in both groups. Relationships between healthcare advice, exercise-related fears and avoidance of heavy lifting were observed.
Many Australians living with a stoma are not achieving physical activity recommendations. While exercise behaviours did not differ between people with and without a parastomal hernia, recall of healthcare advice around exercise did. Fear-avoidance relationships were observed.
Most people living with a stoma do not recall advice about core abdominal exercises. Healthcare practitioners need to be aware of fear-avoidance related to lifting among people living with a stoma. This was the first study in Australia, exploring perspectives and experiences regarding exercise; providing foundations for future research particularly exercise programs.
This study adhered to relevant EQUATOR guidelines and the reporting of survey studies (CROSS).
This study did not include patient or public involvement in its design, conduct, or reporting.
To evaluate the clinical effectiveness of a Nurse Practitioner led procedural support service for children with procedural anxiety, and identify facilitators and barriers to its sustained implementation and optimisation.
An effectiveness–implementation hybrid type 3 study used a prospective mixed methods evaluation approach.
From December 2022 to May 2023, data were collected from children, parents and clinicians using a nurse practitioner-led service at a quaternary paediatric hospital in Brisbane, Australia. A prospective audit assessed clinical outcomes, while qualitative interviews explored implementation barriers and facilitators.
The clinical audit (n = 40) confirmed the service was effective and safe, ensuring procedural completion with minimal distress. Descriptive statistics indicated low pain and anxiety scores. There was a moderate negative relationship between pain scores and the use of distraction techniques. Interviews with thirty-three participants showed the service improved access to procedural care, reduced the need for physical restraint and general anaesthesia, and enhanced clinical workflow through preadmission assessments.
Utilising a Nurse Practitioner support service represents a safe and effective strategy to enhance access for paediatric patients with procedural anxiety.
This study underscores the significance of specialised nursing roles in managing paediatric procedural anxiety, offering a replicable model to enhance procedural outcomes and mitigate medical trauma across healthcare settings.
Minimising pain and distress is important in all clinical encounters with children to reduce the risk of medical-related trauma and the future avoidance of healthcare.
The report of study outcomes was guided by the Standards for Reporting Implementation Studies (StaRI) initiative.
Patients or the public were not included in the design, conduct or reporting of the study.
by Samantha Jeffcoat, Adrian Aragon, Andrian Kuch, Shawn Farrokhi, Andrew Hooyman, Russell Johnson, Natalia Sanchez
Studies of locomotor adaptation have shown that adaptation can occur in short bouts and can continue for long bouts or across days. Information about task duration might influence the adaptation of gait features, given that task duration influences the time available to explore and adapt the aspects of gait that reduce energy cost. We hypothesized that information about task duration and frequency of updates influences adaptation to split-belt walking based on two competing mechanisms: individuals anticipating a prolonged adaptation period may either (1) extend exploration of energetically suboptimal gait patterns, or (2) adapt toward a more energy-efficient pattern earlier to maintain an energetic reserve. We tested three groups: N = 19 participants received minute-by-minute updates during a 10-minute adaptation duration (True group), N = 19 participants received no updates during a 10-minute adaptation duration and were misled to expect a prolonged 30-minute adaptation duration (False group), and N = 14 participants received one update halfway through a 10-minute adaptation duration (Control group). We measured step length asymmetry, leg work, and metabolic cost. Our results partially supported our hypothesis but did not confirm the underlying mechanisms. While step length asymmetry did not differ significantly between groups during adaptation, the True group generated a more effortful gait pattern with a greater increase in metabolic cost and higher work with the slow leg. Additionally, the True group showed no association between the different adapted gait variables such as step length asymmetry and metabolic cost, contrary to the Control and False groups. Finally, we observed that the False group showed greater retention of the split-belt aftereffects than the Control and False groups. Thus, adapted locomotor and energetic patterns are influenced by information about task duration, indicating that Information about task duration should be controlled for, or can be manipulated to elicit different efforts during adaptation.Peripheral arterial disease (PAD) commonly coexists with chronic kidney disease (CKD). Patients with symptomatic PAD often require endovascular revascularisation to relieve pain or salvage limbs. However, the iodinated intra-arterial contrast routinely used in these procedures is nephrotoxic, placing patients with CKD at increased risk of acute kidney injury (AKI) and long-term renal decline. Carbon dioxide (CO2) delivered via automated injection is a potential alternative imaging contrast medium. This trial will evaluate whether using CO2 instead of iodinated contrast reduces the risk of AKI and short-term renal function decline in this high-risk group.
This is a multicentre, open-label, prospective randomised controlled trial across six secondary-care National Health Service (NHS) vascular surgery centres. A total of 174 patients with PAD and CKD undergoing endovascular intervention will be randomised 1:1 to receive iodinated contrast (standard of care) or CO2 via automated injector (Angiodroid). All perioperative care will follow local NHS protocols.
The primary outcome is log serum creatinine at 2, 30 and 90 days postprocedure. Key secondary outcomes include: incidence and severity of AKI within 48 hours postprocedure, major adverse kidney events (death, dialysis or >25% estimated glomerular filtration rate decline) by 90 days, inpatient length of stay, procedural pain, quality of life, procedural success, reinterventions, acceptability and feasibility (patient/practitioner questionnaires) of using CO2, and cost-effectiveness (healthcare resource use analysis). A mixed-methods process evaluation will be undertaken with patients and clinicians.
The trial has been approved by an NHS ethical review committee (24/WA/0332) and patients have been involved in trial design. Findings will be disseminated to participants, clinicians and the wider public through patient groups, lay summaries, social media, conferences, peer-reviewed journals and NHS policy channels.
To establish, through patient and public involvement (PPI) events, the exercise barriers, facilitators and preferences of people with heart failure with preserved ejection fraction (HFpEF).
Qualitative ‘best fit’ framework analysis was used to analyse field notes and transcripts collected during three patient and public involvement meetings and three workshops. The best fit framework was based on the COM-B model of behaviour change, which has identified that Capability, Opportunity and Motivation components are essential for Behaviour change. The Consolidated criteria for Reporting Qualitative research checklist was used to structure the report.
Setting and participants: Community dwelling older adults with HFpEF.
24 people with HFpEF (n=16 female, 66%), 2 spouses and 2 people with chronic conditions participated in the PPI meetings and workshops. Multiple exercise-related capability (negative symptoms, functional ability, resilience and self-efficacy and knowledge and skill); opportunity (appealing components, optimal conditions, adequate support); and motivation factors (well-being, physical gains, goal achievement, sense of enjoyment) were identified as essential to facilitating change in exercise behaviours in people with HFpEF.
This study provides insight into capability, opportunity and motivation conditions that people with HFpEF feel are necessary to enable them to engage in exercise-related behaviour change. This work extends previous post hoc work by moving beyond identification of broad influencers that may enable or impede exercise intervention engagement, to identify intervention conditions necessary to affect change.
Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role.
Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The ‘caring-recruiting’ dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction.
This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The ‘caring-recruiting’ dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research.
The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as ‘hard to reach’ was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues.
This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role.
To evaluate the impact of a participatory, action-oriented implementation study, guided by the integrated Promoting Action on Research Implementation in Health Services framework, for optimising pain care processes in a tertiary paediatric emergency department.
Hybrid type 3 implementation effectiveness.
A collaborative appraisal of the context and culture of pain care informed two interdependent action cycles: Enabling nurse-initiated analgesia and involving families in pain care. The Kids Pain Collaborative, an authentic clinical–academic partnership, was central to facilitating successful implementation. Summative evaluation explored the impact of implementation on processes of pain care using an interrupted time series analysis and emotional touchpoint interviews with families.
Staff achieved clinically important and sustained improvements in the rate of nurse-initiated analgesia and pain assessment. Family involvement in pain care shifted from task-orientated practices towards more person-centred ways of working and decision-making. As capacity for collective leadership developed, frontline staff found ways to integrate the KPC approach into ED systems to lead pain care innovation beyond the life of the research project.
The Kids Pain Collaborative, as the overarching implementation strategy, created a practitioner-led coalition for change. Successful implementation was facilitated by working with four interdependent principles: Collaborative and authentic engagement; enabling context for cultural transformation; creating safe spaces for critical reflection and workplace learning; and embedding sustainable practice change.
A multi-level model of internal–external facilitation enabled sustained improvement in pain care practice. An embedded researcher was pivotal in this process.
Authentic engagement of clinicians and families was pivotal in transforming systems of pain care and enabling a culture where "it is not ok for children to wait in pain"
The principles underpinning the Kids Pain Collaborative are transferable to other emergency department and acute care contexts.
Standards for Reporting Implementation Studies checklist.
To implement strategies to improve the care of patients with acute pain in the emergency department (ED).
Pre–post implementation study using a Type 2 hybrid effectiveness–implementation design.
Implementation strategies were introduced and monitored through the Ottawa Model of Research Uses' assessment, monitoring and evaluation cycles, supported by focused and sustained facilitation.
Improvements in time-to-analgesia within 30 min (21%–27%), administration of nurse-initiated analgesia (NIA) (17%–27%) and measurement of pain (65%–75%) were achieved post-implementation. NIA was the strongest predictor of receiving analgesia within 30 min. Adoption of pain interventions into practice was not immediate yet responded to sustained facilitation of implementation strategies.
Collaboration with local clinicians to introduce simple interventions that did not disrupt workflow or substantially add to workload were effective in improving analgesia administration rates, and the proportion of patients receiving analgesia within 30 min. The assessment, monitoring and evaluation cycles enabled agile and responsive facilitation of implementation activities within the dynamic ED environment. Improvements took time to embed into practice, trending upward over the course of the implementation period, supporting the sustained facilitation approach throughout the study.
Sustained adoption of evidence-based pain interventions into the care of people presenting to the ED with acute pain can be achieved through sustained facilitation of implementation. NIA should be at the centre of acute pain management in the ED.
This study addressed the lingering gap between evidence and practice for patients with acute pain in the ED. Implementation of locally relevant/informed implementation strategies supported by focused and sustained facilitation improved the care of patients with acute pain in the ED. This research will have an impact on people presenting to EDs with acute pain, and on clinicians treating people with acute pain in the ED. Relevant equator guidelines were followed and the StaRI reporting method used.
No Patient or Public Contribution in this study.
To explore the implementation contexts and strategies that influence the uptake and selection of alternative peripherally inserted central catheter (PICC) materials and design.
Qualitative evaluation of end user perspectives within a randomized control trial of different PICC materials and design.
Semi-structured interviews with key stakeholders were undertaken via an adapted, rapid-analytic approach using the Consolidated Framework for Implementation Research. Outcomes were mapped against the Expert Recommendations for Implementing Change (ERIC) tool for strategies to guide innovation in PICC practice.
Participants (n = 23) represented a combination of users and inserters/purchasers, from adult and paediatric settings. Dominant themes included intervention characteristics (intervention source), inner setting (structural characteristics) and individuals involved (self-efficacy). Strategies emerging to support a change from ERIC mapping (n = 16) included promotion of intervention adaptability, inclusion of staff and consumer perspectives and sufficient funding. Implementation contexts such as inner setting and individuals involved equally impacted PICC success and implementation effectiveness and enabled a greater understanding of barriers and facilitators to intervention implementation in this trial.
Trial evidence is important, but healthcare decision-making requires consideration of local contexts especially resourcing. Implementation contexts for Australian healthcare settings include a practical, strategic toolkit for the implementation of alternative PICC materials and designs.
This study adhered to COREQ guidelines.
No patient or public contribution.
Paediatric patients with complex or acute conditions may require a central venous access device, however, almost one-third of these devices have associated complications (e.g. infections). Implementation of evidence-based practices regarding central venous access devices can reduce and potentially prevent complications.
This scoping review aimed to explore recent interventional research in CVAD management through an implementation lens.
This scoping review used the Arksey and O'Malley framework. Studies were included if they were written in English, published in 2012 to July 2023, involved children and were relevant to the study aims. Risk of bias was appraised by the Mixed Methods Appraisal Tool.
Searches were undertaken in EMBASE, CINAHL (Ebsco), PubMed, Web of Science and Cochrane Library (CENTRAL).
Of the 1769 studies identified in a systematic search, 46 studies were included. Studies mostly focused on health professionals and central venous access device maintenance and had quantitative pre-post study designs. Adherence to implementation frameworks was lacking, with many studies employing quality improvement approaches. Implementation strategies were typically multipronged, using health-professional education, bundles and working groups. Bundle compliance and reductions in central line-associated bloodstream infections were the most featured outcomes, with most studies primarily focusing on effectiveness outcomes.
Translation of evidence-based practices to the clinical setting is difficult and current adoption of implementation frameworks (apart from ‘quality improvement’) is limited. Implementation strategies are diverse and dependent on the local context, and study outcomes typically focus on the effectiveness of the physical intervention, rather than measuring the implementation effort itself.
Future intervention research requires a more uniform and deliberate application of implementation frameworks and strategies.
Greater exploration of relationships between frameworks and strategies and implementation and service outcomes is required to increase understanding of their role in maximizing resources to improve health care.
Adhered to best reporting guidelines as per PRISMA-ScR (Tricco et al., 2018).
No patient or public contribution.
Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.
The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.
The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.
To identify research gaps by mapping what is known about the barriers and enablers to pre-registration nursing students identifying signs of suicidal distress in healthcare consumers and providing clear pathways of support.
Scoping review.
This scoping review was conducted using Arksey and O'Malley's (2005) five stage framework and the Levec et al. (2010) extensions of this framework.
The Cumulative Index of Nursing and Allied Health Literature (CINAHL) Complete and Ovid MEDLINE databases were searched to identify relevant articles, keywords and search terms to inform the full search strategy for CINAHL. This search strategy was then adapted for Scopus, PsychInfo, Emcare, Medline and ERIC, searched in November 2024.
Studies eligible for inclusion (N = 28) represented research from 14 countries; most (53.5%, n = 15) used a quantitative design, 11 (39.3%) were qualitative and two (7.1%) used a mixed-methods design. Barriers found from the scoping review included a low level of knowledge of suicidality, stigma preventing students from assessing and acting on suicidal ideation, and a lack of confidence in providing care to healthcare consumers expressing suicidality. Enablers included lived experience, exposure to individuals expressing suicidal ideation and education, simulation and role play. This review also contributes to the existing literature about the relationship of nursing to existing suicide prevention frameworks and suggests revision of these frameworks to address staff attitudes and beliefs, as well as lived and living experience.
Nurses are ideally placed to assess and respond to suicidality among healthcare consumers, and preparation should begin during pre-registration studies. Our scoping review indicates that further research work is needed to address the barriers to working with healthcare consumers expressing suicidality and to enhance the enablers to provide safe care.
Addressing the barriers and enablers to pre-registration nursing students providing safe care for healthcare consumers expressing suicidality is essential. Further research is required to address the barriers and enhance the enablers identified in this scoping review.
What problem did the study address? This scoping review summarised the literature on pre-registration student ability to work with healthcare consumers expressing suicidality, identifying barriers and enablers. What were the main findings? Barriers include poor knowledge of suicidality, stigma, fear and a lack of confidence in working with healthcare consumers expressing suicidality. Enablers include lived experience, exposure to clinical settings where healthcare consumers express suicidality and simulation and education. Where and on whom will the research have an impact? The research will have an impact on providers of pre-registration nursing degrees, where the inclusion of content addressing suicidality and exposure to settings where individuals express suicidal ideation is shown to improve attitudes and knowledge of suicidality assessment.
PRISMA checklist for scoping reviews.
This study did not include patient or public involvement in its design, conduct or reporting.
This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.
A cross-sectional mixed methods online survey.
Primary care in England.
120 clinical pharmacists with experience in conducting SMRs in primary care.
Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.
These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.
In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.
An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.
The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.
FreshRSS 