Using PURPOSE-T in clinical practice: A realist evaluation.

AIM: To explain how the clinical and organisational context influenced the way the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE-T) is used by nursing staff to support their clinical judgement and decision making about care planning and delivery. METHODS: A realist process evaluation was undertaken in a large acute hospital trust using mixed methods incorporating organisational policy review, staff semi-structured, ethnographic observation of clinical care and patient record review. Approximately 75 h of ethnographic field work involving 72 patients, 15 patient record reviews and 16 staff interviews were undertaken on 4 wards. FINDINGS: Findings suggest PURPOSE-T assisted nurses differently depending on their level of experience. Those with less experience use it as an educational guide, while those with more experience made an initial clinical judgement and used PURPOSE-T as a safety net to ensure they hadn't missed anything. Nurses were concerned about demonstrating good documentation of assessment, care planning and delivery in order to underpin consistent communication about care and because they had an underlying fear of being blamed if things went wrong. There is an array of other contextual features that impact the planning and delivery of pressure area care that go beyond the use of PURPOSE-T alone, including systematic equipment provision, competing patient safety initiatives and rehabilitation requirements. CONCLUSION: The findings reinforce the assertion that PU-RAIs are complex interventions and could inform the development of a more integrated system of care which takes into account the contextual features associated with PU prevention in modern hospitals.

Exploring the psychosocial burden of foot complications in diabetes: A cross-sectional survey and qualitative interview study in a United Kingdom coastal community.

BACKGROUND: Foot complications in diabetes are common and destructive, resulting in substantial healthcare costs and high rates of morbidity. Coastal areas have a significantly higher burden of disease. People with diabetes experience disproportionately high rates of psychological health issues, including anxiety, depression and diabetes distress. These can affect self-management and concordance with preventive measures and treatments of foot complications, negatively impacting on outcomes. Access to psychological health services is variable across the United Kingdom and there is a paucity of high-quality evidence for the effectiveness of treatments for diabetes distress. This study aimed to explore experiences of psychosocial burden and perceptions and experiences of psychosocial support, among patients with diabetes and foot complications living in a coastal area. METHODS: Patients were eligible to participate if they had experienced diabetes-related foot complications (amputation, ulceration and/or Charcot neuroarthropathy) within the last 5 years and scored positive for diabetes distress on a validated screening tool (DDS2). Eligible patients completed cross-sectional questionnaires describing symptoms of diabetes distress (DDS17), anxiety (GAD-7) and depression (PHQ-9) and to take part in a face-to-face, semi-structured interview. Questionnaires were analysed using frequencies and interviews were analysed using reflexive thematic analysis. RESULTS: A total of 183 patients completed the DDS2 screening questionnaire. Of these, 56 (30.6%) screened positive for diabetes distress. Twenty-seven patients completed DDS17, GAD-7 and PHQ-9 questionnaires. Eleven (40.7%) participants indicated high levels of diabetes distress and four (14.8%) indicated moderate distress. Seventeen participants (age range 52-81 years; 12 men) took part in an interview. Four key themes were identified: impact of living with foot problems; emotional consequences of foot problems; experiences and perceptions of psychological support; and strategies to cope with the emotional impact of foot problems. CONCLUSION: Diabetes distress was prevalent among patients with diabetes-related foot complications. Foot problems impacted on participants' daily activities, social lives and ability to work. Despite expressing feelings of ongoing fear, worry and depression relating to their foot problems, only one participant had accessed formal psychological support. Many participants relied on talking to podiatrists at routine appointments and described developing various strategies to cope. The psychosocial burden of living with foot complications in diabetes must not be overlooked by health professionals. Findings from this study can inform the design of future services and interventions.

A cross sectional pilot study utilising STrain Analysis and Mapping of the Plantar Surface (STAMPS) to measure plantar load characteristics within a healthy population.

BACKGROUND: No in-shoe systems, measuring both components of plantar load (plantar pressure and shear stress) are available for use in patients with diabetes. The STAMPS (STrain Analysis and Mapping of the Plantar Surface) system utilises digital image correlation (DIC) to determine the strain sustained by a deformable insole, providing a more complete understanding of plantar shear load at the foot-surface interface. RESEARCH QUESTIONS: What is the normal range and pattern of strain at the foot-surface interface within a healthy population as measured by the STAMPS system? Is STAMPS a valid tool to measure the effects of plantar load? METHODS: A cross-sectional study of healthy participants was undertaken. Healthy adults without foot pathology or diabetes were included. Participants walked 20 steps with the STAMPS insole in a standardised shoe. Participants also walked 10 m with the Novel Pedar® plantar pressure measurement insole within the standardised shoe. Both measurements were repeated three times. Outcomes of interest were global and regional values for peak resultant strain (SMAG) and peak plantar pressure (PPP). RESULTS: In 18 participants, median peak SMAG and PPP were 35.01 % and 410.6kPa respectively. The regions of the hallux and heel sustained the highest SMAG (29.31 % (IQR 24.56-31.39) and 20.50 % (IQR 15.59-24.12) respectively) and PPP (344.8kPa (IQR 268.3 - 452.5) and 279.3kPa (IQR 231.3-302.1) respectively). SMAG was moderately correlated with PPP (r= 0.65, p < 0.001). Peak SMAG was located at the hallux in 55.6 % of participants, at the 1st metatarsal head (MTH) in 16.7 %, the heel in 16.7 %, toes 3-5 in 11.1 % and the MTH2 in 5.6 %. SIGNIFICANCE: The results demonstrate the STAMPS system is a valid tool to measure plantar strain. Further studies are required to investigate the effects of elevated strain and the relationship with diabetic foot ulcer formation.

Clinical perspectives on sampling and processing approaches for the management of infection in diabetic foot ulceration: A qualitative study.

Diabetic foot ulcers (DFUs) often become infected and are treated with antimicrobials, with samples collected to inform care. Swab samples are easier than tissue sampling but report fewer organisms. Compared with culture and sensitivity (C&S) methods, molecular microbiology identifies more organisms. Clinician perspectives on sampling and processing are unknown. We explored clinician perspectives on DFU sampling-tissue samples/wound swabs-and on processing techniques, culture and sensitivity or molecular techniques. The latter provides information on organisms which have not survived transport to the laboratory for culture. We solicited feedback on molecular microbiology reports. Qualitative study using semi-structured interview, with analysis using a Framework approach. CODIFI2 clinicians from UK DFU clinics. Seven consultants agreed to take part. They reported, overall, a preference for tissue samples over swabbing. Clinicians were not confident replacing C&S with molecular microbiology as the approach to reporting was unfamiliar. The study was small and did not recruit any podiatrists or nurses, who may have discipline-specific attitudes or perspectives on DFU care. Both sampling approaches appear to be used by clinicians. Molecular microbiology reports would not be, at present, suitable for replacement of traditional culture and sensitivity.

A realist evaluation of devices used for the prevention of heel pressure ulcers: An ethnographic study of clinical practice.

BACKGROUND: It is known that heel offloading devices are widely used in clinical practice for the prevention of heel pressure ulcers, even though there is a lack of robust, good quality evidence to inform their use. OBJECTIVE: To explore how and why heel offloading devices are used (or not used) and reasoning behind their use in population at high risk of developing heel pressure ulcers. METHODS: An ethnographic study was conducted as part of a realist evaluation in three orthopaedic wards in a large English hospital. Twelve observations took place, with 49 h and 35 min of patient care observed. A total of 32 patients were observed and 19 members of the nursing team were interviewed and in-depth interviews with the three ward managers were conducted. RESULTS: Although the focus of the study was on offloading devices, constant low pressure heel specific devices were also observed in use for pressure ulcer prevention, whilst offloading devices were perceived to be for higher risk patients or those already with a heel pressure ulcer. Nursing staff viewed leadership from the ward manager and the influence of the Tissue Viability Nurse Specialists as key mechanisms for the proactive use of devices. CONCLUSIONS: This study informs trial design as it has identified that a controlled clinical trial of both types of heel specific devices is required to inform evidence-based practice. Involving the ward managers and Tissue Viability Nurse Specialists during set up phase for clinical equipoise could improve recruitment. Tweetable abstract How, for whom, and in what circumstances do devices work to prevent heel pressure ulcers? Observations of clinical practice.

Protocol for the Development of the Fourth Edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline Using GRADE Methods.

ABSTRACT: The National Pressure Injury Advisory Panel, European Pressure Ulcer Advisory Panel, and the Pan Pacific Pressure Injury Alliance are commencing a new (fourth) edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline . The fourth edition of the International Pressure Injury (PI) Guideline will be developed using GRADE methods to ensure a rigorous process consistent with evolving international standards. Clinical questions will address prevention and treatment of PIs, identification of individuals at risk of PIs, assessment of skin and tissues, and PI assessment. Implementation considerations supporting application of the guidance in clinical practice will be developed. The guideline development process will be overseen by a guideline governance group and methodologist; the guideline development team will include health professionals, educators, researchers, individuals with or at risk of PIs, and informal carers.This article presents the project structure and processes to be used to undertake a systematic literature search, appraise risk of bias of the evidence, and aggregate research findings. The methods detail how certainty of evidence will be evaluated; presentation of relative benefits, risks, feasibility, acceptability, and resource requirements; and how recommendations will be made and graded. The methods outline transparent processes of development that combine scientific research with best clinical practice. Strong involvement from health professionals, educators, individuals with PIs, and informal carers will enhance the guideline's relevance and facilitate uptake. This update builds on previous editions to ensure consistency and comparability, with methodology changes improving the guideline's quality and clarity.

STrain Analysis and Mapping of the Plantar Surface (STAMPS): A novel technique of plantar load analysis during gait.

Diabetic foot ulceration is driven by peripheral neuropathy, resulting in abnormal foot biomechanics and elevated plantar load. Plantar load comprises normal pressure and tangential shear stress. Currently, there are no in-shoe devices measuring both components of plantar load. The STAMPS (STrain Analysis and Mapping of the Plantar Surface) system was developed to address this and utilises digital image correlation (DIC) to determine the strain sustained by a plastically deformable insole, providing an assessment of plantar load at the foot-surface interface during gait. STAMPS was developed as a multi-layered insole, comprising a deformable mid-layer, onto which a stochastic speckle pattern film is applied. A custom-built imaging platform is used to obtain high resolution pre- and post-walking images. Images are imported into commercially available DIC software (GOM Correlate, 2020) to obtain pointwise strain data. The strain and displacement data are exported and post-processed with custom analysis routines (MATLAB, Mathworks Inc.), to obtain the resultant global and regional peak strain (SMAG), antero-posterior strain (SAP) and medio-lateral strain (SML). To validate the core technique an experimental test process used a Universal Mechanical Tester (UMT) system (UMT TriboLab, Bruker) to apply controlled vertical and tangential load regimes to the proposed multi-layer insole. A pilot study was then conducted to assess the efficacy of using the STAMPS system to measure in-shoe plantar strain in three healthy participants. Each participant walked 10 steps on the STAMPS insole using a standardised shoe. They also walked 10 m in the same shoe using a plantar pressure measurement insole (Novel Pedar®) to record peak plantar pressure (PPP) as a gold-standard comparator. The results of the experimental validation tests show that with increased normal force, at a constant shear distance, SMAG increased in a linear fashion. Furthermore, they showed that with increased shear distance, at a constant force, SMAG increased. The results of the pilot study found participant 1 demonstrated greatest SMAG in the region toes 3-5 (15.31%). The highest mean SMAG for participant 2 was at the hallux (29.31%). Participant 3 exhibited highest strain in the regions of the first and second metatarsal heads (58.85% and 41.62% respectively). Increased PPP was strongly associated with increased SMAG with a Spearman's correlation coefficient 0.673 (p < 0.0001). This study has demonstrated the efficacy of a novel method to assess plantar load across the plantar surface of the foot. Experimental testing validated the sensitivity of the method to both normal pressure and tangential shear stress. This technique was successfully incorporated into the STAMPS insole to reliably measure and quantify the cumulative degree of strain sustained by a plastically deformable insole during a period of gait, which can be used to infer plantar loading patterns. Future work will explore how these measures relate to different pathologies, such as regions at risk of diabetic foot ulceration.

Offloading devices for the prevention of heel pressure ulcers: A realist evaluation.

BACKGROUND: Heel pressure ulcers can cause pain, reduce mobility, lead to longer hospital stays and in severe cases can lead to sepsis, amputation, and death. Offloading boots are marketed as heel pressure ulcer prevention devices, working by removing pressure to the heel, yet there is little good quality evidence about their clinical effectiveness. Given that evidence is not guiding use of these devices, this study aims to explore, how, when, and why these devices are used in hospital settings. OBJECTIVE: To explore how offloading devices are used to prevent heel pressure ulcers, for whom and in what circumstances. METHODS: A realist evaluation was undertaken to explore the contexts, mechanisms, and outcomes that might influence how offloading devices are implemented and used in clinical practice for the prevention of heel pressure ulcers in hospitals. Eight Tissue Viability Nurse Specialists from across the UK (England, Wales, and Northern Ireland) were interviewed. Questions sought to elicit whether, and in what ways, initial theories about the use of heel pressure ulcers fitted with interviewee's experiences. RESULTS: Thirteen initial theories were refined into three programme theories about how offloading devices are used by nurses 'proactively' to prevent heel pressure ulcers, 'reactively' to treat and minimise deterioration of early-stage pressure ulcers, and patient factors that influence how these devices are used. CONCLUSIONS: Offloading devices were used in clinical practice by all the interviewees. It was viewed that they were not suitable to be used by every patient, at every point in their inpatient journey, nor was it financially viable. However, the interviewees thought that identifying suitable 'at risk' patient groups that can maintain use of the devices could lead to proactive and cost-effective use of the devices. This understanding of the contexts and mechanisms that influence the effective use of offloading devices has implications for clinical practice and design of clinical trials of offloading devices. TWEETABLE ABSTRACT: How, for whom, and in what circumstances do offloading devices work to prevent heel pressure ulcers? Tissue viability nurses' perspectives.

Using consensus methods to prioritize modifiable risk factors for development of manifestations of frailty in hospitalized older adults.

AIM: The aim of the study was to reach consensus on modifiable risk factors for a novel system of care to address Manifestations of Frailty in hospitalized older adults. DESIGN: Consensus study. METHOD: A modified nominal group technique, incorporating expert group face-to-face interaction, review of existing evidence and pre/post-meeting questionnaire completion was undertaken November 2019-February 2020. RESULTS: Seventy-one risk factors, within seven risk factor domains (pain, medication, fluid and nutrition intake, mobility, elimination, infection, additional patient factors) were considered. It was agreed that 44 risk factors incorporating patient, organizational and environmental risk factors were modifiable and should be included in a novel system of care.

Comparative effectiveness of heel-specific medical devices for the prevention of heel pressure ulcers: A systematic review.

BACKGROUND: Pressure ulcers (PUs) impact on patient's quality of life and are costly for healthcare providers. Heels are a particular concern due to specific risk factors. Relative effectiveness of medical devices, e.g., dressings, off-loading devices, heel cushioning devices, to reduce PU development is unknown. METHODS: Systematic review of the effectiveness of heel-specific medical devices for the prevention of heel PU (HPU)s. Database searches were performed from inception to June 2021 for RCTs. The primary outcome was incidence of new HPUs. Trials were assessed for risk of bias and data analysed with risk ratios, mean difference or hazard ratios as appropriate. RESULTS: Fifteen RCTs (4724 participants) were identified. Dressings, as constant low pressure (CLP) devices vs standard care: eight trials (very low quality) showed no-significant difference in effectiveness (RR 0.31, 95%CI 0.10 to 1.01). Off-loading devices vs standard care: three trials (low quality), showed significant reduction in development of Category≥1 HPUs (RR 0.20, 95%CI 0.05 to 0.80) two trials (medium quality), showed significant reduction in development of Category≥2 HPUs (RR 0.08, 95%CI 0.01 to 0.67). Comparisons between off-loading devices: two trials (low quality) showed no clear difference in HPU incidence. In a paediatric post-surgical population, one trial of off-loading device and one of a dressing (CLP device), both versus standard care, showed no clear difference in HPU incidence (RR 0.19 95%CI 0.02 to 1.55 and RR 0.89 95%CI 0.56 to 1.42 respectively). CONCLUSIONS: Off-loading devices may reduce HPU incidence, from low-quality evidence. There is insufficient evidence to suggest that dressings reduce HPU incidence.

The Use of Point-of-Care Bacterial Autofluorescence Imaging in the Management of Diabetic Foot Ulcers: A Pilot Randomized Controlled Trial.

OBJECTIVE: To estimate comparative healing rates and decision-making associated with the use of bacterial autofluorescence imaging in the management of diabetic foot ulcers (DFUs). RESEARCH DESIGN AND METHODS: This is a single-center (multidisciplinary outpatient clinic), prospective pilot, randomized controlled trial (RCT) in patients with an active DFU and no suspected clinical infection. Consenting patients were randomly assigned 1:1 to either treatment as usual informed by autofluorescence imaging (intervention), or treatment as usual alone (control). The primary outcome was the proportion of ulcers healed at 12 weeks by blinded assessment. Secondary outcomes included wound area reduction at 4 and 12 weeks, patient quality of life, and change in management decisions after autofluorescence imaging. RESULTS: Between November 2017 and November 2019, 56 patients were randomly assigned to the control or intervention group. The proportion of ulcers healed at 12 weeks in the autofluorescence arm was 45% (n = 13 of 29) vs. 22% (n = 6 of 27) in the control arm. Wound area reduction was 40.4% (autofluorescence) vs. 38.6% (control) at 4 weeks and 91.3% (autofluorescence) vs. 72.8% (control) at 12 weeks. Wound debridement was the most common intervention in wounds with positive autofluorescence imaging. There was a stepwise trend in healing favoring those with negative autofluorescence imaging, followed by those with positive autofluorescence who had intervention, and finally those with positive autofluorescence with no intervention. CONCLUSIONS: In the first RCT, to our knowledge, assessing the use of autofluorescence imaging in DFU management, our results suggest that a powered RCT is feasible and justified. Autofluorescence may be valuable in addition to standard care in the management of DFU.

Core outcomes for pressure ulcer prevention trials: results of an international consensus study: Classification: Outcomes and qualitative research.

BACKGROUND: There is substantial heterogeneity between trial outcomes in pressure ulcer prevention research. The development of core outcome sets is one strategy to improve comparability between trial results and thus increase the quality of evidence. OBJECTIVES: To identify core outcomes for pressure ulcer prevention trials. METHODS: A workshop was held with service users to discuss their views and understanding of the outcomes identified by a scoping review and to identify any missing outcomes. In a next step, a Delphi survey comprising three rounds was conducted to evaluate a compiled list of outcomes by their importance. Afterwards the preselection from the Delphi survey was discussed in a virtual consensus meeting with the aim of agreeing on a final set of core outcomes. Individuals who had completed all three rounds of the Delphi survey were eligible to participate in this meeting. Participants included practitioners, service users, researchers and industry representatives. The OUTPUTs project is registered in the COMET database and is part of the Cochrane Skin Core Outcome Set Initiative. RESULTS: The workshop did not reveal any missing outcomes, but highlighted the need for further efforts to make lay people understand what an outcome is in a study setting. The Delphi survey took place between December 2020 and June 2021. After the three rounds, 18 out of 37 presented outcomes were rated to be critically important. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set for pressure ulcer prevention trials: (i) pressure ulcer occurrence; (ii) pressure ulcer precursor signs and symptoms; (iii) mobility; (iv) acceptability and comfort of intervention; (v) adherence/compliance; and (vi) adverse events/safety. CONCLUSIONS: Based on a comprehensive list of outcomes in pressure ulcer prevention research, there was clear agreement on the six identified core outcomes in three international Delphi rounds and in the consensus meeting. Although outcome measurement instruments need to be identified next, the six identified core outcomes should already be considered in future trials, as service users, practitioners, researchers and industry representatives have agreed that they are critically important. What is already known about this topic? There are numerous trials on pressure ulcer prevention, but evidence on the effectiveness of preventive measures is limited due to heterogeneity between trial outcomes. The development of a core outcome set is one strategy to improve comparability between trial results. What does this study add? A service user workshop, a three-round Delphi survey and an online consensus meeting with practitioners, service users, researchers and industry representatives were conducted to identify core outcomes for pressure ulcer prevention trials. Six core outcomes were defined: (i) pressure ulcer occurrence, (ii) pressure ulcer precursor signs and symptoms, (iii) mobility, (iv) acceptability and comfort of intervention, (v) adherence/compliance and (vi) adverse events/safety. What are the clinical implications of this work? Better evidence of interventions for pressure ulcer prevention will help health professionals and service users to decide which interventions are most appropriate and effective. Better evidence may contribute to better pressure ulcer prevention.

Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS) cohort study. Part 1: a multicentre prospective observational cohort study in patients without planned compression.

BACKGROUND: There is no agreed treatment pathway following excision of keratinocyte cancer (KC). Compression therapy is considered beneficial for secondary intention healing on the lower leg; however, there is a lack of supportive evidence. To plan a randomized controlled trial (RCT), suitable data are needed. We report a multicentre prospective observational cohort study in this patient population with the intention of informing a future trial design. AIM: To estimate the time to healing in wounds healing by secondary intention without planned postoperative compression, following excision of KC on the lower leg; to characterize the patient population, including factors affecting healing; and to assess the incidence of complications. METHODS: This was a multicentre prospective observational cohort study. Inclusion criteria were age ≥ 18 years with planned excision of KC on the lower leg and healing by secondary intention, an ankle-brachial pressure index (ABPI) of ≥ 0.8; and written informed consent. Exclusion criteria included planned excision with primary closure, skin graft or flap; compression therapy for another indication; planned compression; inability of patient to receive, comply with or tolerate high compression; or a suspected diagnosis other than KC. RESULTS: This study recruited 58 patients from 9 secondary care dermatology clinics. In the analysis population (n = 53), mean age was 81 years (range 25-97 years), median time to healing was 81 days (95% CI 73-92) and 45 patients (84.9%) had healing of the wound at the 6-month follow-up. The healing prognostic factors were wound parameters and ABPI. Wound infections occurred in 16 participants (30.2%). Four patients (7.5%) were admitted to hospital; three because of an infection and one because of a fall. CONCLUSIONS: The collected data have informed the RCT preparation. A relatively high proportion (7.5-15%) of unhealed wounds, infection and hospital admissions demonstrate the need for clearly establishing potentially effective treatments to improve outcomes for this population.

Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS) cohort study. Part 2: feasibility data from a multicentre prospective observational cohort study to inform a future randomized controlled trial.

BACKGROUND: Compression therapy is considered beneficial for postsurgical lower leg wound healing by secondary intention; however, there is a lack of supportive evidence. To plan a randomized controlled trial (RCT), suitable data are needed. AIM: To determine the feasibility of recruitment and estimate recruitment rate; to understand the standard postoperative wound management pathway; to determine uptake of optional additional clinic visits for healing confirmation; and to explore patient acceptability of compression bandaging and plan a future RCT. METHODS: Participant recruitment was performed from secondary care dermatology clinics, during a period of 22 months. Inclusion criteria were age ≥ 18 years, planned excision of keratinocyte cancer on the lower leg with healing by secondary intention and an ankle-brachial pressure index of ≥ 0.8. Exclusion criteria were planned primary closure/graft or flap; inability to receive, comply with or tolerate high compression; planned compression; or suspected melanoma. Patients were followed up weekly (maximum 6 months) in secondary care clinics and/or by telephone. Information was collected on healthcare resource use, unplanned compression, wound healing and an optional clinic visit to confirm healing. RESULTS: This study recruited 58 patients from 9 secondary care dermatology clinics over 22 months. Mean recruitment/centre/month was 0.8 (range 0.1-2.3). Four centres had dedicated Research Nurse support. The analysis population (n = 53) had weekly follow-up assessments. Standard care clinical contacts were: general practitioner (7 visits; 1.2%), community nurse (169; 28.5%), practice nurse visits (189; 31.8%) and dermatology clinic visits (138; 23.2%). Participants whose wounds healed (34 of 45; 75.6%) attended an optional clinic visit. CONCLUSION: Data were obtained to inform a future RCT. Recruitment rates were found to be higher in centres with dedicated research support. People would be willing to take part in a trial and attend a confirmation of healing visit.

Comparison of ALitretinoin with PUVA as the first-line treatment in patients with severe chronic HAnd eczema (ALPHA): study protocol for a randomised controlled trial.

INTRODUCTION: Hand eczema (HE) is one of the most common skin disorders and an important cause for morbidity and occupational disability. The 1-year prevalence of HE is estimated to be up to 10% and it is estimated that 5%-7% of those develop severe chronic HE. However, current clinical evidence is not compelling enough to guide clinical practice. In a survey among 194 UK dermatologists the most frequent first choice approaches were psoralen combined with ultraviolet A (UVA) treatment (PUVA), oral steroids and alitretinoin (AL). When asked which strategy was most efficient for long-term outcome 20% of clinicians indicated they did not know; 43% of clinicians reported AL and 30% reported PUVA. METHODS AND ANALYSIS: ALPHA is a multicentre, open, prospective, two-arm parallel group, randomised controlled trial comparing PUVA and AL with a planned sample size re-estimation. Between 500 and 780 participants will be randomised on a 1:1 basis. The physician's global assessment (PGA) will direct treatment after randomisation, non-responders will be treated according to usual clinical practice; providing valuable pilot data on second line therapeutic approaches to inform future trials.Assessments will be conducted up to 52 weeks post randomisation. The primary outcome measure is the Hand Eczema Severity Index at 12 weeks. Secondary outcome measures include modified Total Lesion Symptom Score, PGA, time to relapse, patient reported outcome measures and DNA extraction and assessment of genetic variants. A substudy on molecular inflammatory mediators will provide information on subgroup specific treatment responses. Photographs will be taken and HE severity assessed by a central review panel. ETHICS AND DISSEMINATION: Ethics approval was obtained from Leeds West Research Ethics Committee (14/YH/1259).Trial results will be disseminated at relevant clinical conferences and societies, published in peer-reviewed journals and through relevant patient groups. TRIAL REGISTRATION NUMBER: ISRCTN80206075.

Plantar shear stress in the diabetic foot: A systematic review and meta-analysis.

AIMS: Diabetic foot ulceration (DFU) is a multifactorial process involving undetected, repetitive trauma resulting in inflammation and tissue breakdown. Shear stress forms a major part of plantar load, the aim of this review is to determine whether elevated shear stress results in ulceration. METHODS: A systematic review of the Ovid Medline, EMBASE, CINAHL and Cochrane library databases was performed. Studies involving patients with diabetes who underwent plantar shear stress assessment were included. The primary outcome was plantar shear stress in patients with diabetes who had a current/previous DFU compared with those with no prior ulceration. Meta-analysis was performed comparing shear stress between those with a current or previous DFU and those without, and those with diabetes and healthy controls. RESULTS: The search strategy identified 1461 potentially relevant articles, 16 studies met the inclusion criteria, involving a total of 597 patients. Comparing shear stress between the current/previous DFU group and those without: Standardised mean difference (SMD) 0.62 (95% CI -0.01 to 1.25), in favour of greater shear stress within the DFU group, p = 0.05. Comparing shear stress between people with diabetes and healthy controls: 0.36 (95% CI -0.31 to 1.03), in favour of greater shear stress within the diabetes group, p = 0.29. CONCLUSION: This review suggests that that patients with diabetes and a history of ulceration exhibit greater shear stress than their ulcer-free counterparts. This strengthens the premise that development of systems to measure shear stress may be helpful in DFU prediction and prevention.

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial.

BACKGROUND: Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children's centre and local authority stakeholders. METHODS: We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children's centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results. RESULTS: Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference - 1.2%; 95% CI - 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI - 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881). CONCLUSIONS: During a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme. TRIAL REGISTRATION: ClinicalTrials.gov NCT02675699 . Registered on 4 February 2016.

Pressure Relieving Support Surfaces: a Randomised Evaluation 2 (PRESSURE 2): using photography for blinded central endpoint review.

BACKGROUND: PRESSURE 2 is a randomised evaluation of the clinical and cost-effectiveness of two types of mattress for the prevention of pressure ulcers (PUs). The primary clinical endpoint was time to development of a category ≥2 PU. The current 'gold standard' for PU identification is expert clinical assessment. Due to the mattress appearance, a blinded assessment of the endpoint is not possible. This poses a risk to the internal validity of the study. A possible approach is to use photographs of skin sites, with central blinded review. However, there are practical and scientific concerns including patients' consent to photographs, burden of data collection, photograph quality, data completeness and comparison of photographs to the current 'gold standard'. This paper reports the findings of the PRESSURE 2 photographic validation sub-study. METHOD: Where consent was obtained, photographs were taken of all category ≥2 PUs on the first presentation to assess over-reporting, and for the assessment of under-reporting, a random sample of 10% patients had an assessment by an independent clinical assessor who also photographed two skin sites. The staff were trained in taking and transferring photographs using standardised procedures and equipment. A card included in the photograph recorded participant details and a 'greyscale' for correction of white balance during processing. Three blinded reviewers assessed the photographs and rated how confident they were in their assessment. RESULTS: The trial recruited 2029 patients; 85% consented to photography, and 532 photographs were received and used in the blinded central review. The level of confidence varied by skin classification with more confidence observed when the skin was assessed as being less severe than a category ≥2 PU. Overall, there was a very good reliability compared to the gold standard expert clinical assessment (87.8%, kappa 0.82). CONCLUSION: Study findings have usefully informed the scientific and practical issues of blinded assessment of PU status to reducing the risk of bias in medical device trials. The reliability of central blinded expert photography was found to be 'very good' (PABAK). Photographs have been found to be an acceptable method of data validation for participants. Methods to improve the quality of photographs would increase the confidence in the assessments. TRIAL REGISTRATION: ISRCTN Registry ISRCTN01151335 . Registered on 19 April 2013.

Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol).

BACKGROUND: A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. AIM: The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. METHODS: Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.