Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update).

AIMS: Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes-related foot ulcer. However, the rising incidence and costs of diabetes-related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes-related foot ulcers are supported by high-quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold-standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline. MATERIALS AND METHODS: We followed the GRADE approach by devising clinical questions and important outcomes in the Patient-Intervention-Control-Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders. RESULTS: From the results of the systematic review and evidence-to-decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post-operative wounds, the use of placental-derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions. CONCLUSIONS: These wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review.

BACKGROUND: It is critical that interventions used to enhance the healing of chronic foot ulcers in diabetes are backed by high-quality evidence and cost-effectiveness. In previous years, the systematic review accompanying guidelines published by the International Working Group of the Diabetic Foot performed 4-yearly updates of previous searches, including trials of prospective, cross-sectional and case-control design. AIMS: Due to a need to re-evaluate older studies against newer standards of reporting and assessment of risk of bias, we performed a whole new search from conception, but limiting studies to randomised control trials only. MATERIALS AND METHODS: For this systematic review, we searched PubMed, Scopus and Web of Science databases for published studies on randomised control trials of interventions to enhance healing of diabetes-related foot ulcers. We only included trials comparing interventions to standard of care. Two independent reviewers selected articles for inclusion and assessed relevant outcomes as well as methodological quality. RESULTS: The literature search identified 22,250 articles, of which 262 were selected for full text review across 10 categories of interventions. Overall, the certainty of evidence for a majority of wound healing interventions was low or very low, with moderate evidence existing for two interventions (sucrose-octasulfate and leucocyte, platelet and fibrin patch) and low quality evidence for a further four (hyperbaric oxygen, topical oxygen, placental derived products and negative pressure wound therapy). The majority of interventions had insufficient evidence. CONCLUSION: Overall, the evidence to support any other intervention to enhance wound healing is lacking and further high-quality randomised control trials are encouraged.

The impact of COVID-19 on the care of diabetic foot ulcers: A scoping review.

AIM: The aims and objectives of this scoping review were to conduct a systematic search of the literature to identify the nature and extent of the research evidence to which the COVID-19 pandemic impacted and disrupted the care of Diabetic Foot Ulcers (DFU) and the subsequent impact on patient outcomes. Secondly, to identify transformation in models of care and service delivery, adoption of innovative technologies and new models of service innovations, including modalities such as telehealth that were adopted during the pandemic. METHODS: This systematic scoping review was conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping reviews (PRISMA-ScR). RESULTS: Nineteen papers were included. These studies explored aspects of care for DFUs during the COVID-19 pandemic. The focus of these studies ranged from exploring new modalities of care such as telehealth, reporting of clinical outcomes, development of triage systems and patient behaviors during COVID-19. CONCLUSION: Ten of twelve studies reported on DFU outcomes and reported a worsening of outcomes compared to pre-pandemic times. Reduced DFU presentations, alongside an increase in urgent hospitalisations and amputation, were key themes that emerged from this review. More high-quality evidence is needed to establish any longer-lasting effects of the Covid-19 pandemic on people living with DFU. Further, there is a lack of evidence relating to the feasibility and success of telemedicine and limited data on changes to service delivery, including triage systems in this patient cohort.

Patients 'acceptance' of chronic wound-associated pain - A qualitative descriptive study.

Chronic wound-associated pain negatively impacts the quality of life of individuals and their families. To date, little research exists that has explored collectively how individuals describe wound pain, strategies they use to manage pain, and the perceived effectiveness of such strategies. Therefore, qualitative, semi-structured interviews were carried out between June and August 2021 with 13 individuals to gain a deeper understand of the experience and impact of chronic wound-associated pain in this population. Data were analyzed following Braun and Clarke's approach for reflexive thematic analysis using MAXQdA®. Two themes and subthemes were identified. Theme 1 reflects participants' characterization of pain and how wound-associated pain affected their daily life and how they learned to accept it. Participants felt functionally impaired. In theme 2, participants described how they accepted to live with such a pain even though they received support to manage their chronic wound-associated pain, especially during the dressing-changes. Patients depended on their health care professionals and family support networks to cope with the pain. Coping with pain is exhausting contributing to poorer quality of life. Health care professionals should be aware of wound-associated pain during dressing changes. Patients recommended the need for further research on dressings and not drugs to manage pain.

Psychological interventions for treating foot ulcers, and preventing their recurrence, in people with diabetes.

BACKGROUND: Diabetic foot ulceration (DFU) can be defined as a full-thickness wound below the ankle and is a major complication of diabetes mellitus. Despite best practice, many wounds fail to heal, and when they do, the risk of recurrence of DFU remains high. Beliefs about personal control, or influence, on ulceration are associated with better engagement with self-care in DFU. Psychological interventions aim to reduce levels of psychological distress and empower people to engage in self-care, and there is some evidence to suggest that they can impact positively on the rate of wound healing. OBJECTIVES: To evaluate the effects of psychological interventions on healing and recurrence of DFU. SEARCH METHODS: In September 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, Ovid PsycINFO and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and reviewed reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that evaluated psychological interventions compared with standard care, education or another psychological intervention. Our primary outcomes were the proportion of wounds completely healed; time to complete wound healing; time to recurrence and number of recurrences. DATA COLLECTION AND ANALYSIS: Four review authors independently screened titles and abstracts of the studies identified by the search strategy for eligibility. Three authors independently screened all potentially relevant studies using the inclusion criteria and carried out data extraction, assessment of risk of bias and GRADE assessment of the certainty of the evidence. MAIN RESULTS: We identified seven trials that met the inclusion criteria with a total of 290 participants: six RCTs and one quasi-RCT. The studies were conducted in Australia, the USA, the UK, Indonesia, Norway and South Africa. Three trials used a counselling-style intervention and one assessed an intervention designed to enhance an understanding of well-being. One RCT used a biofeedback relaxation training intervention and one used a psychosocial intervention based on cognitive behavioural therapy. A quasi-RCT assessed motivation and tailored the intervention accordingly. Due to the heterogeneity of the trials identified, pooling of data was judged inappropriate, and we therefore present a narrative synthesis. Comparisons were (1) psychological intervention compared with standard care and (2) psychological intervention compared with another psychological intervention. We are uncertain whether there is a difference between psychological intervention and standard care for people with diabetic foot ulceration in the proportion of wounds completely healed (two trials, data not pooled, first trial RR 6.25, 95% CI 0.35 to 112.5; 16 participants, second trial RR 0.59, 95% CI 0.26 to 1.39; 60 participants), in foot ulcer recurrence after one year (two trials, data not pooled, first trial RR 0.67, 95% CI 0.32 to 1.41; 41 participants, second trial RR 0.63, 95% CI 0.05 to 7.90; 13 participants) or in health-related quality of life (one trial, MD 5.52, 95% CI -5.80 to 16.84; 56 participants). This is based on very low-certainty evidence which we downgraded for very serious study limitations, risk of bias and imprecision. We are uncertain whether there is a difference in the proportion of wounds completely healed in people with diabetic foot ulceration depending on whether they receive a psychological intervention compared with another psychological intervention (one trial, RR 2.33, 95% CI 0.92 to 5.93; 16 participants). This is based on very low-certainty evidence from one study which we downgraded for very serious study limitations, risk of bias and imprecision. Time to complete wound healing was reported in two studies but not in a way that was suitable for inclusion in this review. One trial reported self-efficacy and two trials reported quality of life, but only one reported quality of life in a manner that enabled us to extract data for this review. No studies explored the other primary outcome (time to recurrence) or secondary outcomes (amputations (major or distal) or cost). AUTHORS' CONCLUSIONS: We are unable to determine whether psychological interventions are of any benefit to people with an active diabetic foot ulcer or a history of diabetic foot ulcers to achieve complete wound healing or prevent recurrence. This is because there are few trials of psychological interventions in this area. Of the trials we included, few measured all of our outcomes of interest and, where they did so, we judged the evidence, using GRADE criteria, to be of very low certainty.

Public & patient involvement to guide research in wound care in an Irish context. A round table report.

BACKGROUND: To date, research into interventions to promote wound healing has been led by scientists, clinicians, industry and academics, each with their own particular area of interest. However, the real experts in this area are the people who live with wounds and their families and heretofore their voice has not influenced or shaped the research agenda. AIM: This event aimed to seek patient and carer involvement as experts due to their lived experience in wounds through a partnership approach to identify research priorities and address a lack of patient and carer involvement in wound care research. METHODS: A roundtable discussion format guided by the Scottish Health Council Participation Toolkit Supporting Patient Focus and Public Involvement in NHS Scotland was utilised. The Guidance for Reporting Involvement of Patients and the Public 2 - Short Form (GRIPP2-SF) guided the reporting process. RESULTS: Key areas for future research were identified and included; Patients and carers prioritised the establishment of support groups and the development of educational resources. Research priorities that emerged included understanding the impact of wounds, pain management, addressing educational needs and quantifying the financial burden on patients and carers of living with a wound. CONCLUSIONS: A key conclusion from this roundtable was that patients and their carers expressed a strong interest in further wound care related public and patient involvement events and identified areas for future research.

External validity of randomized controlled trials of interventions in venous leg ulceration: A systematic review.

We set out to evaluate quality of reporting of data related to external validity from randomized controlled trials (RCTs) assessing treatment interventions for active venous leg ulcers. Using a systematic review study design, we identified 144 full-text RCTs of treatment interventions, where the wound was assessed and published in English from 1998 to 2018. We found that the median study sample size was 75.5. Weighted mean wound size was 13.22 cm2 and weighted mean wound duration was 22.20 months. Forty-six (32%) reported numbers screened for eligibility and 27 (19%) reported the number who declined to participate; 19 (13%) reported on patient ethnicity; 60 (42%) reported comorbidities; and 5 (4%) reported current medication use. When reported, 60/102 (59%) excluded patients with an ankle-brachial pressure index <0.8; 68/135 (50%) were conducted in Europe, 6/135 (4%) in Asia, and 74/104 (71%) were conducted in outpatient facilities; 3 (2%) reported socioeconomic factors and 88 (61%) reported on adverse events. We concluded that there is inadequate reporting of data related to external validity in reports of RCTs assessing venous leg ulcers treatment interventions. Significant variability exists in the ankle-brachial pressure index cutoff point for inclusion or exclusion, making generalizability difficult to assess.

Estimating the health-care costs of wound care in Ireland.

OBJECTIVE: To estimate the cost of wound care to the Irish health-care system. METHODS: A bottom-up, prevalence-based analysis was undertaken using a decision analytic model to estimate costs. Health-care resource activity was identified from a recently published study from the UK and was valued using unit cost data for Ireland. RESULTS: The base case analysis estimated the total annual healthcare cost of wound care to be €629,064,198 (95% Confidence interval (CI): €452,673,358 to €844,087,124), accounting for 5% (95% CI: 3% to 6%) of total public health expenditure in Ireland in 2013. The average cost per patient was €3,941 (95% CI: €2,836 to €5,287). However, this study is subject to many limitations and plausible changes in the model's inputs showed that the total annual health-care cost of wound care could range from €281,438,970 to €844,316,912. CONCLUSION: Caring for wounds places a substantial burden on the Irish health-care system. In light of growing pressures to finance an already resource-constrained health-care system, these results provide useful information for those charged with future wound care service design and provision in Ireland and elsewhere.

"Remember the bubbles hurt you when you cook in the pan": young children's views of illness causality.

The present study examines four-year-old children's everyday understandings of illness causality. Research into young children's conceptualisation of illness has led to different expectations of children's comprehension and ongoing debate regarding the nature of children's knowledge. Awareness of preschoolers' spontaneous views of illness causality, rather than explanations restricted by predetermined response categories, is likely to assist practitioners to provide more appropriate interventions for young children. Adopting a socio-constructivist perspective of children's learning and development, and using a narrative methodology, we interviewed five preschoolers regarding their views of illness causality. As part of the interview process children were invited to construct their own storybooks about illness using photographs of children experiencing illness and a variety of art materials. Analysis of young children's narrative accounts revealed two major threads regarding children's illness causality constructions: (1) "behaviour-based explanations for illness", and (2) "illness prevention messages and behavioural rules". Findings suggest that four-year-olds' understanding may be more sophisticated than traditionally maintained, and that the illness prevention messages and behavioural rules within sociocultural contexts may significantly influence children's conceptualisation of illness causality.

Systematic review of topical interventions for the management of pain in chronic wounds.

Chronic wounds adversely affect quality of life. Pain is associated with chronic wounds, and its impact can vary according to wound aetiology, condition, and patient factors. This systematic review examined the effectiveness of topical interventions in the management chronic wound-related pain guided by PRISMA recommendations of randomised controlled trials (RCTs) where pain reduction is the primary outcome. Inclusion criteria were adults (older than 18 years) with chronic venous, arterial, diabetic, or pressure ulcers where pain has been managed through topical administration of pharmacological/nonpharmacological agents. Searches were conducted in Ovid Embase, Ovid MEDLINE, EBSCOhost, CINAHL, CENTRAL, PubMed, Web of Science, and Scopus. Studies were screened for eligibility; risk of bias and data were extracted by 2 independent assessors. Searches retrieved 10,327 titles and abstracts (7760 after deduplication). Nine full texts (1323 participants) examining ibuprofen (n = 4), morphine (n = 2), BWD + PHMB [polihexanide-containing biocellulose wound dressing] (n = 1), and EMLA (n = 2) were included. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Meta-analysis was not possible, but initial exploration suggests improved outcomes (reduced pain) for ibuprofen when compared with controls. Two studies involving morphine showed conflicting findings. Included studies often had small samples, and considering confounding factors (eg, comorbidities), the results should be interpreted with caution. Review of included studies suggests that topical interventions may provide pain relief in individuals with chronic wounds. Further adequately powered RCTs are recommended to assess the efficacy of topical interventions for the management of chronic wound-related pain.

Effects of Pilates on the risk of falls, gait, balance and functional mobility in healthy older adults: A randomised controlled trial.

OBJECTIVE: To investigate the effects of Pilates on falls risk, fear of falling, postural balance, functional mobility, spatiotemporal gait parameters, mobility and physical activity in older adults. DESIGN: Randomized Controlled Trial (RCT). METHODS: Sixty-one older adults, mean age 70.08 (SD = 5.51) were randomly allocated into a Pilates group (PG, n = 29) or control group (CG, n = 32). Intervention comprised a 12-week Pilates program, with exercises performed twice a week and supplementary exercises at home. The Montreal Cognitive Assessment (MOCA), was used to screen cognition. PRIMARY OUTCOMES: Fear of falling, postural balance (force platform), gait velocity (electronic walkway). SECONDARY OUTCOMES: Functional mobility, mobility, physical activity, and spatiotemporal parameters of gait. Statistical analysis was carried out using Generalized Estimating Equations (GEE). Covariates were adjusted. RESULTS: Positive effects were found for time effects: Time Up and Go (TUG), anteroposterior (AP) and mediolateral (ML) directions of balance, cadence, (stance, step and double support time). The step and double support time showed significant differences between the two groups (p < 0.05). Interaction between time and groups was found for FRT. Age was a significant factor in TUG, FRT, postural balance for AP under open eyes conditions. Health status was significant for ML in eyes open condition. Gait was significant for age, height and health status. CONCLUSION: Effects of 12 weeks of Pilates intervention on functional mobility, mobility, postural balance and spatiotemporal gait parameters were identified. Further trials of a longer duration are warranted to determine the effectiveness of Pilates on falls prevention.

Six weeks of Pilates improved functional mobility, postural balance and spatiotemporal parameters of gait to decrease the risk of falls in healthy older adults.

OBJECTIVE: To determine the effectiveness of Pilates exercises on falls risk factors. DESIGN: Prospective cohort, pre-test post-test study. Participants were selected using convenience and snowballing sampling. Pilates classes were held twice weekly for six weeks (1-h sessions) with a supplementary home programme. METHODS: A test of cognitive function, the Montreal Cognitive Assessment (MOCA), was employed to determine eligibility for inclusion. The following fall-predictor variable measures were employed: the 16 item Falls Efficacy Scale (FES), the short International Physical Activity Questionnaire (IPAQ), the Functional Reach Test (FRT), the Timed Up and Go (TUG), the GAITRite® system, Platform FOOTWORKpro. Multivariate analysis ANOVA with time as within subject factor was used to test for differences between pre and post-test scores adjusted for the factor Pilates. RESULTS: twenty-seven participants completed the study, mean age = 70.4 (SD = 4.5). After adjusting for the effect of the factor Pilates "previous experience or no previous experience of Pilates", statistically significant differences were identified in the following domains: The TUG (p < 0.001), FRT (p < 0.001), velocity, swing and stance time and the Mediolateral sway (p < 0.05). A significant difference was found between pre and post-test for anteroposterior sway in those with experience of Pilates (p < 0.05) and interaction between time and Pilates experience in Physical Activity (p < 0.05). CONCLUSION: Findings suggest that functional mobility, mobility, spatiotemporal parameters of gait, postural balance and physical activity improved in healthy older adults after 6 weeks of Pilates with a supplementary home programme.

A scoping review protocol to map the evidence on the risks and benefits of population based diabetic foot screening.

Background: Diabetic foot ulcers are one of the most common lower extremity complications of diabetes, with the lifetime risk of a person developing a DFU estimated to be as high as 34%. It is recommended that those with diabetes receive an annual review of their feet, by a trained healthcare professional, to identify risk factors for ulceration and allow for subsequent risk stratification, patient education and provision of appropriate care to prevent ulceration and amputation. Internationally, while many countries have a diabetic foot care pathway, it is not a structured population health screening programme unlike other areas of preventive care for people with diabetes such as retinopathy screening. A structured diabetic foot screening pathway could allow for earlier identification of the at-risk foot. However, the introduction of any population screening programme should meet the Wilson and Jungner principles of screening. This paper presents a protocol for a scoping review of existing evidence on screening for the at-risk-foot against the Wilson and Junger principles. Methods: The scoping review will be conducted in line with the six-stage methodological framework by Arksey & O'Mally and the Joanna Briggs Institute (JBI) scoping review methodology. Medline (EBSCO), Scopus, ScienceDirect and EMBASE databases will be searched. Studies relating to the burden of diabetic foot ulcers, their pathophysiology and screening tests for peripheral neuropathy and peripheral artery disease, and screening programmes will be included. A data extraction tool will be used to facilitate a chronological narrative synthesis of results. Results: These will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews (PRISMA-ScR). Conclusion: This scoping review will evaluate and map the evidence surrounding diabetic foot ulcers using the Wilson and Jungner principles of screening as a framework.

Pilates Reducing Falls Risk Factors in Healthy Older Adults: A Systematic Review and Meta-Analysis.

Background: The main theme of this systematic review and meta-analysis is to synthesize the evidence of randomized controlled trial of evidence of Pilates intervention, in comparison to control groups and other forms of exercise, for falls prevention in healthy older adults. Methods: The following electronic databases were searched up to October 2020; EMBASE, Scopus, Google Scholar, MEDLINE (Ovid), Science Direct, Cochrane, and CINAHL. The recommendations of the Preferred Reporting Items of Systematic Reviews and Meta-Analyses were followed. A PICOS approach was adopted as a framework to formulate the research question and set the inclusion and exclusion criteria. Participants were healthy older adults, defined as older adults who have maintained functional ability, including participants of both genders, those with a falls history, non-fallers, and individuals who were considered to be sedentary or active. Randomized controlled trials studies, written in the English language, from the decade, were included if they focused on specific outcome measures to decrease falls risk; functional mobility, mobility, fear of falling, gait, and postural stability. The PEDro scale was used to assess risk of bias. Results: There were included 12 studies. In total, 702 healthy older adults' participants were included. Pilates showed an effect in mediolateral directions in comparison to control groups (MD = -1.77, 95% CI, -2.84 to -0.70, p = 0.001, heterogeneity: I 2 = 3%), mobility (MD = 9.23, 95% CI, 5.74 to 12.73, p < 0.00001, heterogeneity: I 2 = 75%) and fear of falling (MD = -8.61, 95% CI, -10.16 to -7.07, p < 0.00001, heterogeneity: I 2 = 88%). In relation to other exercises group, Pilates showed positive effects in functional mobility (MD = -1.21, 95% CI, -2.30 to -0.11, p = 0.03, heterogeneity: I 2 = 80%), mobility (MD = 3.25, 95% CI, 1.46 to 5.04, p < 0.0004, heterogeneity: I 2 = 0%). No evidence of an improvement was found between the groups for dynamic gait index (MD = 2.26, 95% CI, -0.05 to 4.56, p = 0.06, heterogeneity: I 2 = 86%), anteroposterior directions of balance (MD = -1.58, 95% CI, -3.74 to -0.59, p = 0.15, heterogeneity: I 2 = 51%) and functional mobility when compared to control groups (no exercise) (MD = -1.24, 95% CI, -2.48 to -0.00, p = 0.05, heterogeneity: I 2 = 87%). Discussion: Pilates may be effective in decreasing the risk of falls in older adults. Pilates intervention was found to improve functional mobility, mobility, gait, fear of falling and postural stability and therefore there is some evidence to suggest that Pilates reduces certain risk factors for falls in healthy older adults. However, there is an absence of high-quality evidence in regards to the impact of Pilates on reducing falls and further robust RCTs are needed. Systematic Review Registration: [PROSPERO], identifier [CRD42021206134].

Screening for Atrial Fibrillation in Community and Primary CareSettings: A Scoping Review.

BACKGROUND: Atrial Fibrillation (AF) is the most common tachyarrhythmia and is associated with increased risk of stroke, morbidity and mortality. AF is responsible for up to a quarter of all strokes and is often asymptomatic until a stroke occurs.Screening for AF is a valuable approach to reduce the burden of stroke in the population. OBJECTIVES: The motivation for this review was to synthesise and appraise the evidence for screening for AF in the community. The aims of this scoping review are 1). To describe the prevalence of newly diagnosed AF in screening programmes 2). Identify which techniques/ tools are employed for AF screening 3). To describe the setting and personnel involved in screening for AF. ELIGIBILITY CRITERIA: All forms of AF screening in adults (≥18 years) in primary and community care settings. METHODS: This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping reviews (PRISMA-ScR). RESULTS: Fifty-nine papers were included; most were cross-sectional studies (n=41) and RCTs (n=7). Prevalence of AF ranged from 0-34.5%. Screening tools and techniquesincluded the 12-lead ECG (n=33), the 1-lead ECG smartphone based Alivecor® (n=14) and pulse palpation (n=12). Studies were undertaken in community settings (n=30) or in urban/rural primary care (n=28). Personnel collecting research data were in the main members of the research team (n=31), GPs (n=16), practice nurses (n=10), participants (n=8) and pharmacists (n=4). CONCLUSION: Prevalence of AF increased with advancing age. AF screening should target individuals at greatest risk of the condition including older adults≥65 years of age. Emerging novel technologies may increase the accessibility of AF screening in community and home settings. There is a need for high quality research to investigate AF prevalence and establish accuracy and validity for traditional versus novel screening tools used to screen for AF.

Understanding wound bed preparation and wound debridement.

Wound bed assessment and optimum local wound care are essential to facilitate the wound healing process. The presence of devitalized tissue, for instance necrotic tissue or slough, is common in hard-to-heal wounds and acts as a barrier to healing. There are several debridement options available to the practitioner with the choice of wound debridement technique being made following a holistic assessment of the patient and the wound. The method of debridement should be discussed with the patient and family where appropriate and consent to treatment obtained prior to the procedure being undertaken.

Topical antimicrobial agents for the treatment of chronic wounds.

Chronic wounds are commonly observed in acute and community settings. The management of chronic wounds represents a significant proportion of health-care resources and makes up a substantial amount of contact time with community-based nurses spending approximately 25% to 50% of their time treating wounds. Chronic wounds often exhibit increased bacterial burden that can negatively impact upon patients, reduce their quality of life and substantially increase treatment costs for health care providers. Antibiotic resistance has become a major medical and public health problem, and interest has been generated in the use of topical therapies to manage wound infection. This article presents an overview of the historical use of honey, silver and iodine for the treatment of infected wounds progressing through to modern day use and the current evidence base for the use of these antimicrobial agents in the management of infected wounds.

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

BACKGROUND: Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. METHODS: A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. RESULTS: Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). CONCLUSIONS: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).

BACKGROUND: Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. DESIGN: Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. RESULTS: In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. CONCLUSION: There was a small reduction in falls. The intervention may be cost-effective. TRIAL REGISTRATION: ISRCTN ISRCTN68240461.

Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial).

BACKGROUND: Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care. DESIGN: A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study. SETTING: Nine NHS trusts in the UK and one site in Ireland. PARTICIPANTS: In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote service. Blinding was not possible. INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises. MAIN OUTCOME MEASURES: The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness. RESULTS: The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05; p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00; p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI -£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants. LIMITATIONS: Owing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care. CONCLUSIONS: The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective. FUTURE WORK: Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68240461. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.