Can the introduction of a 12-lead ECG help reduce mortality in those presenting with foot ulceration to multidisciplinary diabetic foot clinics? An observational evaluation of a real-world implementation pilot in England.

AIMS/HYPOTHESIS: The risk of dying within 2 years of presentation with diabetic foot ulceration is over six times the risk of amputation, with CVD the major contributor. Using an observational evaluation of a real-world implementation pilot, we aimed to assess whether for those presenting with diabetic foot ulceration in England, introducing a 12-lead ECG into routine care followed by appropriate clinical action was associated with reduced mortality. METHODS: Between July 2014 and December 2017, ten multidisciplinary diabetic foot services in England participated in a pilot project introducing 12-lead ECGs for new attendees with foot ulceration. Inception coincided with launch of the National Diabetes Footcare Audit (NDFA), whereby all diabetic footcare services in England were invited to enter data on new attendees with foot ulceration. Poisson regression models assessed the mortality RR at 2 and 5 years following first assessment of those receiving care in a participating pilot unit vs those receiving care in any other unit in England, adjusting for age, sex, ethnicity, deprivation, type and duration of diabetes, ulcer severity, and morbidity in the year prior to first assessment. RESULTS: Of the 3110 people recorded in the NDFA at a participating unit during the pilot, 33% (1015) were recorded as having received an ECG. A further 25,195 people recorded in the NDFA had attended another English footcare service. Unadjusted mortality in the pilot units was 16.3% (165) at 2 years and 37.4% (380) at 5 years for those who received an ECG, and 20.5% (430) and 45.2% (950), respectively, for those who did not receive an ECG. For people included in the NDFA at other units, unadjusted mortality was 20.1% (5075) and 42.6% (10,745), respectively. In the fully adjusted model, mortality was not significantly lower for those attending participating units at 2 (RR 0.93 [95% CI 0.85, 1.01]) or 5 years (RR 0.95 [95% CI 0.90, 1.01]). At participating units, mortality in those who received an ECG vs those who did not was lower at 5 years (RR 0.86 [95% CI 0.76, 0.97]), but not at 2 years (RR 0.87 [95% CI 0.72, 1.04]). Comparing just those that received an ECG with attendees at all other centres in England, mortality was lower at 5 years (RR 0.87 [95% CI 0.78, 0.96]), but not at 2 years (RR 0.86 [95% CI 0.74, 1.01]). CONCLUSIONS/INTERPRETATION: The evaluation confirms the high mortality seen in those presenting with diabetic foot ulceration. Overall mortality at the participating units was not significantly reduced at 2 or 5 years, with confidence intervals just crossing parity. Implementation of the 12-lead ECG into the routine care pathway proved challenging for clinical teams-overall a third of attendees had one, although some units delivered the intervention to over 60% of attendees-and the evaluation was therefore underpowered. Nonetheless, the signals of potential mortality benefit among those who had an ECG suggest that units in a position to operationalise implementation may wish to consider this. DATA AVAILABILITY: Data from the National Diabetes Audit can be requested through the National Health Service Digital Data Access Request Service process at: https://digital.nhs.uk/services/data-access-request-service-dars/dars-products-and-services/data-set-catalogue/national-diabetes-audit-nda.

Goal setting as part of a holistic intervention to promote independence in older people with mild frailty: a process evaluation alongside a randomised controlled trial.

BACKGROUND: Frailty is a condition resulting from a decline in physiological reserves caused by an accumulation of several deficits, which progressively impairs the ability to recover from health adverse events. Following a promising feasibility study, the HomeHealth trial assessed a holistic tailored intervention for older adults with mild frailty to promote independence in their own homes, compared with usual care. We aimed to understand how goal setting worked among older people with mild frailty. METHODS: This study was a process evaluation alongside the HomeHealth randomised trial in older adults with mild frailty. The intervention was delivered at participants' homes, either in person or by telephone or videoconferencing. We carried out semi-structured interviews with older participants who had received the intervention (between three and six appointments), on average 233 days (range 68-465) after their last appointment, purposively sampled according to age, gender, number of sessions attended, adverse events, ethnicity, Index of Multiple Deprivation, Montreal Cognitive Assessment (MoCA) and Barthel scores, research site, and HomeHealth worker. We also conducted interviews with HomeHealth workers who delivered the intervention (n=7). Interviews explored the experience and process of goal setting, benefits and challenges, perceived progress, and behaviour change maintenance after the service had finished. Ethics approval was obtained, and all participants gave informed consent. Interviews were thematically analysed. HomeHealth workers kept formal records of goals set and assessed progress towards goals (0-2 rating scale) during six monthly-sessions, which were descriptively summarised. FINDINGS: 56 interviews were completed between July 15, 2022, and May 18, 2023. Study participants (n=49) had a mean age of 80 years (range 66-94), including 32 (65%) women and 17 (35%) men. Participants self-identified as White (n=42), Asian (n=3), Black (n=2), Mixed (n=1), and other ethnic (n=1) backgrounds. Findings suggested goal setting could be both a challenge and a motivator for older participants with mild frailty. Goal setting worked well when the older person could identify a clear need and set realistic goals linked to functioning, which led to a positive sense of achievement. Challenges occurred when older people were already accessing multiple resources and health services, or where the terminology of "goals" was off-putting due to work or school connotations. Average progress towards goals was 1·15/2. Most participants set goals around improving mobility (or a combination of mobility and another goal type such as socialising), and there was evidence of participants sustaining these behaviour changes after the intervention. INTERPRETATION: Older people with mild frailty can engage well with goal setting to promote independence. The lapse between receiving the intervention and being interviewed limited recall for some participants. However, the acceptability and adherence to the intervention for older people with mild frailty, and their moderate progress towards goals, should encourage further tailored and person-centred practices to promote their independence. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment.

Participants' experiences of attending a structured education course (DAFNEplus) informed by behavioural science.

AIMS: As part of a broader process evaluation, we explored participants' experiences of, and engagement with, the DAFNEplus programme's group-based structured education course. This course, which was informed by behavioural science, provided participants with education and instruction to use flexible intensive insulin therapy (FIIT) together with techniques to identify and address unhelpful cognitive and emotional influences on their type 1 diabetes self-management. METHODS: We interviewed n = 28 DAFNEplus participants. Data were analysed thematically and took account of previous work exploring individuals' experiences of standard DAFNE courses. RESULTS: As well as benefitting from the DAFNEplus course's skills-based training and educational curriculum, participants' accounts suggested they had experienced cognitive and emotional changes that had positively influenced their confidence and motivation to adopt and sustain the use of FIIT. These benefits were most keenly felt by those who reported negative emotional states and mind-sets pre-course which had made their diabetes self-management challenging. Participants' cognitive and emotional changes were enabled through techniques used during the course to normalise setbacks and imperfect diabetes self-management, capitalise upon group synergies and encourage the use of social support, including from healthcare professionals. Participants also highlighted motivational gains arising from being reassured that diabetes complications are not common or inevitable if a FIIT regimen is followed. CONCLUSIONS: Our findings suggest that offering training in FIIT, in conjunction with behaviour change techniques that target unhelpful mindsets and emotional resilience, may be more effective in promoting diabetes self-management than offering education and skills training alone.

Sustaining the benefits of structured education: Participants' experiences of receiving structured individual support during a programme (DAFNEplus) informed by behavioural science.

AIMS: The DAFNEplus programme seeks to promote sustained improvements in glycaemic management by incorporating techniques from behavioural science. It includes five sessions of structured individual support delivered over 12 months following group education. As part of a broader evaluation, and to inform decision-making about roll-out in routine care, we explored participants' experiences of, and engagement with, that individual support. METHODS: We interviewed DAFNEplus participants (n = 28) about their experiences of receiving individual support and the impact they perceived it as having on their self management practices. We analysed data thematically. RESULTS: Participants described several important ways individual support had helped strengthen their self management, including: consolidating and expanding their understandings of flexible intensive insulin therapy; promoting ongoing review and refinement of behaviour; encouraging continued and effective use of data; and facilitating access to help from healthcare professionals to pre-empt or resolve emergent difficulties. Participants characterised themselves as moving towards independence in self management over the time they received individual support, with their accounts suggesting three key stages in that journey: 'Working with healthcare professionals'; 'Growing sense of responsibility'; and, 'Taking control'. Whilst all portrayed themselves as changed, participants' progress through those stages varied; a few continued to depend heavily on DAFNEplus facilitators for advice and/or direction at 12 months. CONCLUSIONS: While all participants benefited from individual support, our findings suggest that some may need, or gain further benefit from, longer-term, tailored support. This has important implications for decision-making about roll-out of DAFNEplus post-trial and for the development of future programmes seeking to bring about sustainable changes in self management practices.

Unique combination of hyaluronic acid and amino acids in the management of patients with a wide range of moderate-to-severe chronic wounds: Evidence from international clinical practice.

The availability of new products and strategies to manage wounds has taken a quantum leap in recent years. Healthcare professionals now have an extensive range of products to choose from, but while positive this also raises dilemmas in real-world clinical practice to decide on the most appropriate treatment for a given patient. Clinical trials confirm the effectiveness of the unique combination of hyaluronic acid and amino acids (Vulnamin®) in a range of wounds, but are these results replicated in real-world clinical practice? International experts presented their clinical experience with the use of the combination in difficult-to-treat wounds. The objective was to reach a consensus on how and when to use the unique combination products to provide a cost-effective, convenient option, in all healthcare settings that improves QoL for patients and their carers.

Self-caught methodologies for measuring mind wandering with meta-awareness: A systematic review.

Mind wandering, also known as task-unrelated thought, refers to the drift of attention from a focal task or train of thought. Because self-caught measures of mind wandering require participants to spontaneously indicate when they notice their attention drift, self-caught methodologies provide a way to measure mind wandering with meta-awareness. Given the proposed role of meta-awareness in mental health and psychological interventions, an overview of existing self-caught methodologies would help clinicians and researchers make informed decisions when choosing or adapting a mind wandering or meta-awareness measure. This systematic review included 39 studies after 790 studies were assessed for eligibility. All studies operationalised mind wandering as instances of attention drift from a primary task. Three types of primary task were identified: (1) tasks adapted from computerised continuous performance tests (CPT) of sustained attention, (2) tasks involving focusing on the breath or a stream of aural beats, akin to in-vivo mindfulness meditation, (3) tasks involving an everyday life activity such as reading. Although data on mind wandering without meta-awareness (e.g., measured with probe-caught measures) was also obtained in many studies, such data was not always used in conjunction with self-caught mind wandering data to determine level of mind wandering meta-awareness. Few studies reported both reliability and validity of the measures used. This review shows that considerable methodological heterogeneity exists in the literature. Methodological variants of self-caught mind wandering methodologies are documented and examined, and suggestions for future research and clinical work are suggested.

The role of emotion regulation in the relationship between mindfulness and risk factors for disordered eating: A longitudinal mediation analysis.

OBJECTIVE: Evidence suggests mindfulness may reduce risk factors for disordered eating. However, mechanisms of change in this relationship are unclear. This longitudinal study tested whether emotion regulation mediates the prospective associations between mindfulness and two proximal risk factors for disordered eating: weight and shape concerns, and negative affect. METHOD: This study is a secondary analysis of data collected within an eating disorder prevention trial. Adolescent girls (N = 374, Mage  = 15.70, SD = 0.77) completed self-report measures of mindfulness, emotion regulation, weight and shape concerns, and negative affect at baseline, 2 months following baseline, and 7 months following baseline. Path analyses were computed to test hypothesized indirect effects using confidence intervals based on 5000 bootstrap samples. RESULTS: Higher baseline mindfulness predicted lower weight and shape concerns and negative affect at 7 months via a mediator of better emotion regulation at 2 months. This effect remained while controlling for earlier measurements of the mediator and outcome in the model of negative affect but not weight and shape concerns. DISCUSSION: Emotion regulation may be an important mechanism explaining how mindfulness influences negative affect. Efforts should be made to intervene on mindfulness and emotion regulation in prevention and early intervention programmes for eating disorders and other psychiatric conditions. PUBLIC SIGNIFICANCE: Research has shown that mindfulness can help to reduce some of the risk of developing an eating disorder. This study explored whether mindfulness reduces some of this risk by helping people to better manage their emotions. Understanding this process can help us to develop better mindfulness-based strategies to support people who are at risk of developing an eating disorder.

Attendance, Weight Loss, and Participation in a Behavioural Diabetes Prevention Programme.

BACKGROUND: Weight loss in diabetes prevention programmes has been shown to be associated with participants' age, socio-economic status, and ethnicity. However, little is known about how these differences relate to attendance and whether such differences can be mediated by other potentially modifiable factors. Differential effectiveness across these factors may exacerbate health inequalities. METHOD: Prospective analysis of participant data collected by one provider of the standardised national NHS diabetes prevention programme in England. Mediation analysis was performed via a structural equation model to examine whether the number of attended sessions mediated the associations of age, socio-economic status, and ethnicity with follow-up weight. The group-level factor of number of attended sessions was examined using multiple linear regression as a benchmark; multilevel linear regression using three levels (venue, coach, and group); and fixed effects regression to account for venue-specific and coach-specific characteristics. RESULTS: The associations of age, socio-economic status, and ethnicity with follow-up weight were all mediated by the number of attended sessions. Group size was associated with attendance in an inverted 'U' shape, and the number of days between referral and group start was negatively associated with attendance. Time of day, day of the week, and the number of past groups led by the coach were not associated with attendance. CONCLUSION: Most of the differences in weight loss initially attributed to socio-demographic factors are mediated by the attendance of the diabetes prevention programme. Therefore, targeted efforts to improve uptake and adherence to such programmes may help alleviate inequalities.

Dispositional forgiveness buffers paranoia following interpersonal transgression.

OBJECTIVE: To test a novel proposition that dispositional forgiveness has the unrecognized benefit of buffering feelings of paranoia following negative interpersonal experiences and interpersonal transgressions. METHODS: In Study 1 (N = 128), we used an experimental paradigm, the Prisoner's Dilemma Game (PDG), to test the premise that an interpersonal transgression increases state paranoia. Study 2 (N = 180) used a longitudinal design to test the central proposition that dispositional forgiveness buffers state paranoia following naturally occurring difficult (vs pleasant) interpersonal events. Study 3 (N = 102) used a novel experimental paradigm to determine the causal effect of manipulating forgiveness on paranoia. RESULTS: In Study 1, interpersonal transgressions in the PDG increased paranoia. In Study 2, paranoia was higher following difficult (rather than pleasant) events, and higher levels of dispositional forgiveness moderated the negative effect of difficult events on paranoia. In Study 3, there was a causal effect of forgiveness on (reduced) paranoia. CONCLUSIONS: This is the first evidence that (1) interpersonal transgressions increase paranoia, (2) high dispositional forgiveness moderates the deleterious effect of interpersonal transgression on paranoia, and (3) dispositional forgiveness is causally related to less paranoia.

Experimental and clinical evidence for DACC-coated dressings: an update.

OBJECTIVE: To update the evidence in relation to the use of dialkylcarbamoyl chloride (DACC)-coated wound dressings in the prevention, treatment and management of wounds. METHOD: PubMed and PubMed Central databases were searched to identify articles published since 2020 describing the experimental and clinical evidence for DACC-coated dressings, and their antimicrobial effect, as well as their impact on the prevention and treatment of infected wounds. The identified articles were then narratively reviewed. RESULTS: The search yielded 113 articles (plus references from ad hoc sources), of which nine met the inclusion criteria. Of the nine included studies, five related to clinical aspects and four were laboratory studies. CONCLUSION: A number of new studies have provided further evidence for the mode of action of the antimicrobial effect of DACC-coated dressings and its wide spectrum effect (including World Health Organization-prioritised microorganisms). Additional clinical studies have provided evidence of new applications, such as in treating wounds in paediatric patients, and extended the evidence relating to their use in treating surgical site infections. Evidence also shows that DACC-coated wound dressings can aid in the binding of biofilms, and how this technology can align and support antimicrobial stewardship in the prevention of antimicrobial resistance.

A new algorithm for the management of diabetic foot ulcer: recommendations from Central and Eastern Europe.

There is wide regional variation in clinical practice and access to treatment for patients with diabetic foot ulcer (DFU) from countries in Central and Eastern Europe (CEE). A treatment algorithm that reflects current treatment practices while providing a common framework may facilitate best practice in DFU management and improve outcomes across the CEE region. Following a series of regional advisory board meetings with experts from Poland, the Czech Republic, Hungary and Croatia, we present consensus recommendations for the management of DFU and outline the key features of a unified algorithm for dissemination and use as a quick tool in clinical practice in CEE. The algorithm should be accessible to specialists as well as non-specialist clinicians and should incorporate: patient screening; checkpoints for assessment and referral; triggers of treatment change; and strategies for infection control, wound bed preparation and offloading. Among adjunctive treatments in DFU, there is a clear role for topical oxygen therapy, which can be used concomitantly with most existing treatment regimens in hard-to-heal wounds following standard of care. Countries from CEE face a number of challenges in the management of DFU. It is hoped that such an algorithm will help standardise the approach to DFU management and overcome some of these challenges. Ultimately, a regionwide treatment algorithm in CEE has the potential to improve clinical outcomes and save limbs.

Influences of decisions to attend a national diabetes prevention programme from people living in a socioeconomically deprived area.

AIMS: To explore key influences of decisions in participants from a socioeconomically deprived area to attend the Healthier You: NHS Diabetes Prevention Programme (NHSDPP). The NHSDPP is a lifestyle behaviour change programme for adults with prediabetes living in England. METHODS: Semi-structured interviews were conducted with 35 participants who had attended the initial assessment, but not yet started the NHSDPP; 23 were classified as "attenders," 12 as "non-attenders" after they were interviewed based on whether they had attended the first NHSDPP session or not. Transcribed interviews were analysed using inductive thematic analysis. RESULTS: Seven themes were derived from the data. The results demonstrate how understanding type 2 diabetes, making lifestyle changes, comparing themselves with others, having support and certain self-perceptions can all affect individuals' motivation to attend a diabetes prevention programme. Accessibility and practicalities also influenced both motivation and attendance. CONCLUSIONS: This study identified a range of different influences on decisions to attend a diabetes prevention programme, which programme organisers and healthcare professionals should consider to maximise attendance. Initial communication from general practitioners (GPs) and initial assessments are key points where people's beliefs and understanding could be explored.

Recommendations for monitoring and reporting harm in mindfulness for psychosis research.

There is increasing interest in potential harmful effects of mindfulness-based interventions. In relation to psychosis, inconsistency and shortcomings in how harm is monitored and reported are holding back our understanding. We offer eight recommendations to help build a firmer evidence base on potential harm in mindfulness for psychosis.

Need for care, adversity exposure and perceived stress in clinical and healthy voice-hearers.

OBJECTIVES: Psychosis, and in particular auditory verbal hallucinations (AVHs), are associated with adversity exposure. However, AVHs also occur in populations with no need for care or distress. AIMS: This study investigated whether adversity exposure would differentiate clinical and healthy voice-hearers within the context of a 'three-hit' model of vulnerability and stress exposure. METHODS: Samples of 57 clinical and 45 healthy voice-hearers were compared on the three 'hits': familial risk; adversity exposure in childhood and in adolescence/adulthood. RESULTS: Clinical voice-hearers showed greater familial risk than healthy voice-hearers, with more family members with a history of psychosis, but not with other mental disorders. The two groups did not differ in their exposure to adversity in childhood [sexual and non-sexual, victimisation; discrimination and socio-economic status (SES)]. Contrary to expectations, clinical voice-hearers did not differ from healthy voice-hearers in their exposure to victimisation (sexual/non-sexual) and discrimination in adolescence/adulthood, but reported more cannabis and substance misuse, and lower SES. CONCLUSIONS: The current study found no evidence that clinical and healthy voice-hearers differ in lifetime victimisation exposure, suggesting victimisation may be linked to the emergence of AVHs generally, rather than need-for-care. Familial risk, substance misuse and lower SES may be additional risk factors involved in the emergence of need-for-care and distress.

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel.

AIMS: Self-management programmes for type 1 diabetes, such as the UK's Dose Adjustment for Normal Eating (DAFNE), improve short-term clinical outcomes but difficulties maintaining behavioural changes attenuate long-term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change. METHODS: A four-step method was based on the BCW intervention development approach: (1) Identifying self-management behaviours and barriers/enablers to maintain them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation-Behaviour (COM-B) model. (2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). (3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. (4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co-designed by stakeholders (diabetologists, psychologists, specialist nurses and dieticians). RESULTS: In all, 34 barriers and 5 enablers to sustaining self-management post-DAFNE were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. In all, 27 BCTs were added, including 'Habit formation', 'Credible source' and 'Conserving mental resources'. In total, 15 stakeholder-agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co-designed components: (1) face-to-face group learning course, (2) individual structured follow-up sessions and (3) technological support, including blood glucose data management. CONCLUSIONS: This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self-management behaviours.

Making Legs Matter: A Case for System Change and Transformation in Lower-Limb Management.

This consensus document is endorsed by The Queen's Nursing Institute (QNI) and The Queen's Nursing Institute Scotland (QNIS).

Mindfulness-based crisis interventions (MBCI) for psychosis within acute inpatient psychiatric settings; a feasibility randomised controlled trial.

BACKGROUND: Inpatient psychiatric care is a scarce and expensive resource in the National Health Service (NHS), with chronic bed shortages being partly driven by high re-admission rates. Brief inpatient talking therapies for psychosis could help reduce re-admission rates. The primary aim was to assess feasibility and acceptability of a novel, brief, mindfulness-based intervention for inpatients with psychosis. The secondary aim was to collect pilot outcome data on readmission rate, at 6 and 12 months (m) post discharge, and self-report symptom measures at 6 m. METHODS: The amBITION study (BrIef Talking therapIes ON wards) was a parallel group, feasibility randomised controlled trial (RCT). In addition to treatment as usual (TAU), eligible inpatients with psychotic symptoms were randomly allocated to receive either (Mindfulness-Based Crisis Intervention; MBCI) or a control intervention (Social Activity Therapy; SAT), for 1-5 sessions. RESULTS: Fifty participants were recruited (26 MBCI; 24 SAT); all received at least 1 therapy session (mean = 3). Follow-up rates were 98% at 6 m and 96% at 12 m for service use data extracted from clinical notes, and 86% for self-report measures. At 6 m follow-up, re-admission rates were similar across groups (MBCI = 6, SAT = 5; odds ratio = 1.20, 95% CI: 0.312-4.61). At 12 m follow-up, re-admissions were lower in the MBCI group (MBCI = 7, SAT = 11; odds ratio = 0.46, 95% CI: 0.14-1.51). Three participants experienced adverse events; none was related to trial participation. CONCLUSIONS: Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission. These promising findings warrant progression to a larger clinical effectiveness trial. TRIAL REGISTRATION: ISRCTN37625384.

Evaluation of a superabsorbent wound dressing, patient and clinician perspective: a case series.

OBJECTIVE: The primary objective of this study was to evaluate the fluid management capabilities of a superabsorbent wound dressing (Zetuvit Plus Silicone), with secondary objectives related to parameters that support whether the dressing enables undisturbed healing. METHOD: This study was an open labelled non-comparative study. Patients included in the study were selected by the clinical investigator(s) according to whether the patient required a dressing for the management of moderately to highly exuding wounds. RESULTS: A total of 50 patients were included in the study. Results related to the primary objective demonstrated that the superabsorbent wound dressing was able to absorb all levels of exudate across the range (low to high). At each assessment time point these results show that in 98% of assessments the superabsorbent dressing was rated as 'very good' (91%) or 'good' (7%) at exudate management. Secondary objectives relating to wound bed preparation, healing and management of pain were also positive. Additionally, at the end of each patient treatment, the dressing's fluid management capabilities were rated overall as 'excellent' (100% of cases). There was little pain associated with the wound or at dressing change throughout the study and its flexibility/conformability allowed for comfort and patient satisfaction aligned with increased quality of life. Additionally, inclusion of a silicone adhesive layer allowed painless and atraumatic removal of the dressing, increasing patient comfort, both during wear and at dressing removal, and supported the description of enabling undisturbed wound healing. CONCLUSION: The superabsorbent wound dressing achieved the primary objective relating to wound exudate management in all the assessments undertaken in this study. In addition, the silicone interface allowed for undisturbed healing as evidenced by little or no adherence of the dressing to underlying tissue, preventing damage to periwound skin. Overall, the superabsorbent wound dressing with the addition of the silicone interface could offer advantages over other superabsorbent polymer dressings (that might adhere to the wound surface) or silicone wound dressings (that might not have the absorbent properties of this type of dressing).

Cost-effectiveness of superabsorbent wound dressing versus standard of care in patients with moderate-to-highly exuding leg ulcers.

OBJECTIVE: To determine the cost-effectiveness/utility of a superabsorbent wound dressing (Zetuvit Plus Silicone) versus the current standard of care (SoC) dressings, from the NHS perspective in England, in patients with moderate-to-high exudating leg ulcers. METHOD: A model-based economic evaluation was conducted to analyse the cost-effectiveness/utility of a new intervention. We used a microsimulation state-transition model with a time horizon of six months and a cycle length of one week. The model uses a combination of incidence base and risk prediction approach to inform transition probabilities. All clinical efficiency, health-related quality of life (HRQoL), cost and resource use inputs were informed by conducting a systematic review of UK specific literature. RESULTS: Treatment with the superabsorbent dressing leads to a total expected cost per patient for a six month period of £2887, associated with 15.933 expected quality adjusted life weeks and 10.9% healing rate. When treated with SoC, the total expected cost per patient for a six month period is £3109, 15.852 expected quality adjusted life weeks and 8% healing rate. Therefore, the superabsorbent dressing leads to an increase in quality-adjusted life weeks, an increase in healing rate by 2.9% and a cost-saving of £222 per single average patient over six months. Results of several scenario analyses, one-way deterministic sensitivity analysis, and probabilistic sensitivity analysis confirmed the robustness of base-case results. The probabilistic analysis confirmed that, in any combination of variable values, the superabsorbent dressing leads to cost saving results. CONCLUSION: According to the model prediction, the superabsorbent dressing leads to an increase in health benefits and a decrease in associated costs of treatment.

Adjunctive rifampicin for Staphylococcus aureus bacteraemia (ARREST): a multicentre, randomised, double-blind, placebo-controlled trial.

BACKGROUND: Staphylococcus aureus bacteraemia is a common cause of severe community-acquired and hospital-acquired infection worldwide. We tested the hypothesis that adjunctive rifampicin would reduce bacteriologically confirmed treatment failure or disease recurrence, or death, by enhancing early S aureus killing, sterilising infected foci and blood faster, and reducing risks of dissemination and metastatic infection. METHODS: In this multicentre, randomised, double-blind, placebo-controlled trial, adults (≥18 years) with S aureus bacteraemia who had received ≤96 h of active antibiotic therapy were recruited from 29 UK hospitals. Patients were randomly assigned (1:1) via a computer-generated sequential randomisation list to receive 2 weeks of adjunctive rifampicin (600 mg or 900 mg per day according to weight, oral or intravenous) versus identical placebo, together with standard antibiotic therapy. Randomisation was stratified by centre. Patients, investigators, and those caring for the patients were masked to group allocation. The primary outcome was time to bacteriologically confirmed treatment failure or disease recurrence, or death (all-cause), from randomisation to 12 weeks, adjudicated by an independent review committee masked to the treatment. Analysis was intention to treat. This trial was registered, number ISRCTN37666216, and is closed to new participants. FINDINGS: Between Dec 10, 2012, and Oct 25, 2016, 758 eligible participants were randomly assigned: 370 to rifampicin and 388 to placebo. 485 (64%) participants had community-acquired S aureus infections, and 132 (17%) had nosocomial S aureus infections. 47 (6%) had meticillin-resistant infections. 301 (40%) participants had an initial deep infection focus. Standard antibiotics were given for 29 (IQR 18-45) days; 619 (82%) participants received flucloxacillin. By week 12, 62 (17%) of participants who received rifampicin versus 71 (18%) who received placebo experienced treatment failure or disease recurrence, or died (absolute risk difference -1·4%, 95% CI -7·0 to 4·3; hazard ratio 0·96, 0·68-1·35, p=0·81). From randomisation to 12 weeks, no evidence of differences in serious (p=0·17) or grade 3-4 (p=0·36) adverse events were observed; however, 63 (17%) participants in the rifampicin group versus 39 (10%) in the placebo group had antibiotic or trial drug-modifying adverse events (p=0·004), and 24 (6%) versus six (2%) had drug interactions (p=0·0005). INTERPRETATION: Adjunctive rifampicin provided no overall benefit over standard antibiotic therapy in adults with S aureus bacteraemia. FUNDING: UK National Institute for Health Research Health Technology Assessment.