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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., Competing Interests: Declaration of Competing interest The authors of this paper “The Impact of COVID-19 on the care of diabetic foot ulcers: a scoping review” declare no conflicts of interests. The first author, SF, is a PhD Candidate in the Discipline of Podiatric Medicine at the University of Galway, Ireland. SF is in receipt of a University of Galway Hardiman Scholarship that covers PhD fees and stipend. There are no other funding sources to declare., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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., (© 2024 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

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., (© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

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., Competing Interests: Declaration of competing interest We declare no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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., Competing Interests: The authors have no conflict of interest to declare.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Pallin JA et al.)

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., Competing Interests: Declarations of competing interest None'., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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.

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., (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

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 cm 2 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., (© 2019 by the Wound Healing Society.)

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.

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.

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.

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., Competing Interests: The authors have declared that no competing interests exist.

Loss of tactile sensory function is common with aging and can lead to numbness and difficulty with balance and gait. In previous work we found that subsensory electrical noise stimulation (SENS) applied to the tibial nerve improved tactile perception in the soles of the feet of healthy adults. In this work we aimed to determine if SENS remained effective in an older adult population with significant levels of sensory loss. Older adult subjects (N=8, female = 4, aged 65-80) had SENS applied via surface electrodes placed proximally to the medial and lateral malleoli. Vibration perception thresholds (VPTs) were assessed in six conditions, two control conditions (no SENS) and four SENS conditions (zero mean ±15µA, 30µA, 45µA and 60µA SD). VPT was assessed at three sites on the plantar aspect of the foot. Vibration perception was significantly improved in the presence of ±30µA SENS and by 16.2±2.4% (mean ± s.e.m.) when optimised for each subject. The improvement in perception was similar across all VPT test sites., (Copyright © 2016 IPEM. All rights reserved.)

Background: Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial., Methods: We undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen's kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial., Results: Digital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site., Conclusions: Despite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori., Trial Registration: ISRCTN Registry ISRCTN18994246.

Introduction: Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting., Methods and Analysis: This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists., Ethics and Dissemination: The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations., Trial Registration Number: Current Controlled Trials ISRCTN68240461 assigned 01/07/2011., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

The ability to improve peripheral neural transmission would have significant therapeutic potential in medicine. A technology of this kind could be used to restore and/or enhance sensory function in individuals with depressed sensory function, such as older adults or patients with peripheral neuropathies. The goal of this study was to investigate if a new paradigm of subsensory electrical noise stimulation enhances somatosensory function. Vibration (50Hz) was applied with a Neurothesiometer to the plantar aspect of the foot in the presence or absence of subsensory electrical noise (1/f type). The noise was applied at a proximal site, on a defined region of the tibial nerve path above the ankle. Vibration perception thresholds (VPT) of younger adults were measured in control and experimental conditions, in the absence or presence of noise respectively. An improvement of ∼16% in VPT was found in the presence of noise. These are the first data to demonstrate that modulation of axonal transmission with externally applied electrical noise improves perception of tactile stimuli in humans., (Copyright © 2014 IPEM. All rights reserved.)

In this article we highlight the ways in which young children draw on their family contexts in their meaning making about the causes of illness. Studies of young children's understanding of illness causality have largely focused on the nature of children's knowledge rather than the ways in which children acquire their knowledge. Seeking to advance a socio-constructivist understanding of young children's conceptualization of illness causality, we interviewed five four-year-old children and their family members. Analysis of participants' narrative accounts suggests that young children's illness causality constructions are significantly influenced by the particular illness experiences, illness prevention messages and behavioural rules within families. By identifying and acknowledging young children's meaning making within the socio-cultural context of the family, health practitioners may be better placed to develop effective health education programmes and provide enhanced psychosocial support for young children and their families.

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.

Background: Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. One such bias is the effect of patient's preference on outcome measures. The aims of this study were to examine whether patients' treatment preference affected clearance of plantar warts and explore whether there were any associations between patients' treatment preference and baseline variables in the EverT trial., Methods: Two hundred and forty patients were recruited from University podiatry schools, NHS podiatry clinics and primary care. Patients were aged 12 years and over and had at least one plantar wart which was suitable for treatment with salicylic acid and cryotherapy. Patients were asked their treatment preference prior to randomisation. The Kruskal-Wallis test was performed to test the association between preference group and continuous baseline variables. The Fisher's exact test was performed to test the association between preference group and categorical baseline variables. A logistic regression analysis was undertaken with verruca clearance (yes or no) as the dependent variable and treatment, age, type of verruca, previous treatment, treatment preference as independent variables. Two analyses were undertaken, one using the health professional reported outcome and one using the patient's self reported outcomes. Data on whether the patient found it necessary to stop the treatment to which they had been allocated and whether they started another treatment were summarised by treatment group., Results: Pre-randomisation preferences were: 10% for salicylic acid; 42% for cryotherapy and 48% no treatment preference. There was no evidence of an association between treatment preference group and either patient (p=0.95) or healthcare professional (p=0.46) reported verruca clearance rates. There was no evidence of an association between preference group and any of the baseline variables except gender, with more females expressing a preference for salicylic acid (p=0.004). There was no evidence that the number of times salicylic acid was applied was different between the preference groups at one week (p=0.89) or at three weeks (p=0.24). Similarly, for the number of clinic visits for cryotherapy (p=0.71) CONCLUSIONS: This secondary analysis showed no evidence to suggest that patients' baseline preferences affected verruca clearance rates or adherence with the treatment., Trial Registration: Current Controlled Trials ISRCTN18994246 and National Research Register N0484189151.

Background: Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts., Methods: A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis., Results: Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid., Conclusions: Cryotherapy is more costly and no more effective than salicylic acid., Trial Registration: Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.

Objective: To compare the clinical effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts., Design: A multicentre, open, two arm randomised controlled trial., Setting: University podiatry school clinics, NHS podiatry clinics, and primary care in England, Scotland, and Ireland., Participants: 240 patients aged 12 years and over, with a plantar wart that in the opinion of the healthcare professional was suitable for treatment with both cryotherapy and salicylic acid., Interventions: Cryotherapy with liquid nitrogen delivered by a healthcare professional, up to four treatments two to three weeks apart. Patient self treatment with 50% salicylic acid (Verrugon) daily up to a maximum of eight weeks., Main Outcome Measures: Complete clearance of all plantar warts at 12 weeks. Secondary outcomes were (a) complete clearance of all plantar warts at 12 weeks controlling for age, whether the wart had been treated previously, and type of wart, (b) patient self reported clearance of plantar warts at six months, (c) time to clearance of plantar wart, (d) number of plantar warts at 12 weeks, and (e) patient satisfaction with the treatment., Results: There was no evidence of a difference between the salicylic acid and cryotherapy groups in the proportions of participants with complete clearance of all plantar warts at 12 weeks (17/119 (14%) v 15/110 (14%), difference 0.65% (95% CI -8.33 to 9.63), P=0.89). The results did not change when the analysis was repeated but with adjustment for age, whether the wart had been treated previously, and type of plantar wart or for patients' preferences at baseline. There was no evidence of a difference between the salicylic acid and cryotherapy groups in self reported clearance of plantar warts at six months (29/95 (31%) v 33/98 (34%), difference -3.15% (-16.31 to 10.02), P=0.64) or in time to clearance (hazard ratio 0.80 (95% CI 0.51 to 1.25), P=0.33). There was also no evidence of a difference in the number of plantar warts at 12 weeks (incident rate ratio 1.08 (0.81 to 1.43), P=0.62)., Conclusions: Salicylic acid and the cryotherapy were equally effective for clearance of plantar warts., Trial Registration: Current Controlled Trials ISRCTN18994246, National Research Register N0484189151.

Diabetes mellitus is a global epidemic. Peripheral neuropathy and peripheral vascular disease are complications of diabetes mellitus and the primary causative factors for foot ulceration. Foot ulceration is the leading cause of hospitalization in people with diabetes mellitus. The burden of foot ulceration on health care systems and individual patients is immense. Despite conventional treatment, there persists a high incidence of amputation. A multidisciplinary approach is required to prevent ulcers. This review describes the etiology and risk factors for diabetic foot ulceration and a system for evaluating the diabetic foot. The assessment of neuropathy and the grading of foot ulcers are critically examined. This is important to allow for standardization in clinical trials. The management of diabetic foot syndrome is reviewed. The treatments to ensure vascular supply to the lower limb and control of infection as well as novel therapies, which are becoming available to treat nonhealing, "no-option" diabetic ulcers, are discussed.

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.

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.