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.

Active debridement of venous leg ulcers: a literature review to inform clinical practice.

Community nurses often care for patients with sloughy venous leg ulcers. Slough is viewed as a potential infection source and an impediment to healing, but it is unclear if active debridement of slough promotes healing. Using a clinical scenario as a contextual basis, this literature review sought research evidence to answer this clinical question. A strategy based on the '4S' approach was used to identify research evidence. The retrieved evidence included one systematic review, three clinical guidelines and six qualitative and quantitative studies. The analysis suggested that there is no robust evidence to support the routine practice of active debridement of venous leg ulcers to promote healing, and that debridement is associated with increased pain. Since autolytic debridement can be achieved through the application of graduated compression therapy, active debridement may offer no additional benefit.

The Epidemiology of Amputation Inequality Extends Beyond Diabetes in England.

The excess risk of amputation in the diabetic population is well documented. However, approximately half of all amputations in England are in people that do not have diabetes - the remainder being mainly peripheral arterial disease. Whilst the prevalence of foot ulcers in the population without diabetes is significantly lower than their diabetic counterparts, the actual number of people with ulcers, and, therefore, the burden on services, is, the same. In addition to this inequality, the prevalence of amputation is greater in men than women and in the North of England compared with the South. We suggest that whilst diabetes is an important inequality to continue addressing, it is not the only one.

Survey of registered nurses' selection of compression systems for the treatment of venous leg ulcers in the UK.

BACKGROUND: Venous leg ulceration is common in older adults in the United Kingdom. The gold-standard treatment is compression therapy. There are several compression bandage and hosiery systems that can be prescribed or purchased, but it was unclear what types of compression systems are currently being used to treat venous leg ulceration within the UK. This online scoping survey of registered nurses sought to (1) to identify what compression systems are available across the UK, (2) how frequently these are in use and (3) if there are any restrictions on their use. RESULTS: The results showed that registered nurses who treat patients with venous leg ulceration use a wide range of compression systems. The most frequently used systems are the 'less bulky' two-layer elastic and inelastic compression bandaging systems whilst two-layer hosiery was used less frequently and four-layer bandaging used infrequently. Nurses report that certain compression systems are less accessible through the usual procurement routes but this appears to be related to concerns about competency in application techniques. CONCLUSIONS: The data in this survey provides some important insights into the issues around the use of compression therapy for venous leg ulceration in the UK. Limiting access to certain types of compression may promote patient safety but limit patient choice. There may be underuse of the types of compression that promote patient independence, such as hosiery, and over-use of potentially sub-therapeutic therapy such as 'reduced compression'. Overall, this study suggests that further consideration is needed about the provision of compression therapy to UK patients with venous leg ulceration to optimise care and patient choice.

Development of a generic wound care assessment minimum data set.

BACKGROUND: At present there is no established national minimum data set (MDS) for generic wound assessment in England, which has led to a lack of standardisation and variable assessment criteria being used across the country. This hampers the quality and monitoring of wound healing progress and treatment. AIM: To establish a generic wound assessment MDS to underpin clinical practice. METHOD: The project comprised 1) a literature review to provide an overview of wound assessment best practice and identify potential assessment criteria for inclusion in the MDS and 2) a structured consensus study using an adapted Research and Development/University of California at Los Angeles Appropriateness method. This incorporated experts in the wound care field considering the evidence of a literature review and their experience to agree the assessment criteria to be included in the MDS. RESULTS: The literature review identified 24 papers that contained criteria which might be considered as part of generic wound assessment. From these papers 68 potential assessment items were identified and the expert group agreed that 37 (relating to general health information, baseline wound information, wound assessment parameters, wound symptoms and specialists) should be included in the MDS. DISCUSSION: Using a structured approach we have developed a generic wound assessment MDS to underpin wound assessment documentation and practice. It is anticipated that the MDS will facilitate a more consistent approach to generic wound assessment practice and support providers and commissioners of care to develop and re-focus services that promote improvements in wound care.

Confidence and clinical judgement in community nurses managing venous leg ulceration - A judgement analysis.

BACKGROUND: The variation in the management of venous leg ulceration in the UK is partly attributable to an uncertain clinical environment but the quality of judgements is influenced by the how well nurses' confidence and accuracy are aligned. OBJECTIVES: To assess UK community nurses' confidence in the accuracy of their diagnostic judgements and treatment choices when managing venous leg ulceration. DESIGN: Judgement Analysis. SETTING: UK community and primary care nursing services. PARTICIPANTS: 18 community non-specialist nurses working in district (home) nursing teams and general practitioner services and 18 community tissue viability specialist nurses. METHODS: Using judgement analysis methods, 18 community non-specialist nurses and 18 community tissue viability specialist nurses made diagnoses and treatment judgements about compression therapy for 110 clinical scenarios and indicated their confidence for each judgement. An expert panel made consensus judgements for the same scenarios and these judgements were used as a standard against which to compare the participants. Confidence analysis was used to assess the nurses' confidence about their diagnostic judgements and treatment choices. RESULTS: Despite being very experienced, both non-specialist nurses' and specialist tissue viability nurses' levels of confidence were not well calibrated with their levels of accuracy. CONCLUSION: The results of this study are important as errors resulting from both over and under-confidence at the diagnostic phase of management may influence treatment choices, and thus increase the chances of treatment error.

A qualitative study of factors impacting upon the recruitment of participants to research studies in wound care - The community nurses' perspective.

OBJECTIVE: The focus of this study was to identify the factors that impact upon the recruitment of participants to research studies in wound care from the community nurses' perspective. METHOD: A qualitative approach utilising classic grounded theory methodology was used. Semi structured interviews were used to generate data and data analysis was facilitated by using QSR International's NVivo10 qualitative data analysis software (2012). RESULTS: Eight participants consisting of community registered nursing staff of differing levels of seniority took part in the study. Four main themes emerged from the data: CONCLUSIONS: There are a number of factors in addition to the eligibility criteria that influence community nurses when identifying potential participants for wound care trials. These factors limit the recruitment pool so may affect the transferability and generalisability of research findings to the intended population. The design of future recruitment strategies and the planning of study initiation training should take these factors into account.

Venous leg ulcers.

INTRODUCTION: Leg ulcers usually occur secondary to venous reflux or obstruction, but 20% of people with leg ulcers have arterial disease, with or without venous disorders. Between 1.5 and 3.0 in 1000 people have active leg ulcers. Prevalence increases with age to about 20 in 1000 people aged over 80 years. METHODS AND OUTCOMES: We conducted a systematic overview, aiming to answer the following clinical questions: What are the effects of treatments for venous leg ulcers? What are the effects of organisational interventions for venous leg ulcers? What are the effects of advice about self-help interventions in people receiving usual care for venous leg ulcers? What are the effects of interventions to prevent recurrence of venous leg ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2014 (Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview). RESULTS: At this update, searching of electronic databases retrieved 116 studies. After deduplication and removal of conference abstracts, 63 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 43 studies and the further review of 20 full publications. Of the 20 full articles evaluated, four systematic reviews were updated and four RCTs were added at this update. We performed a GRADE evaluation for 23 PICO combinations. CONCLUSIONS: In this systematic overview, we categorised the efficacy for 13 interventions based on information about the effectiveness and safety of advice to elevate leg, advice to keep leg active, compression stockings for prevention of recurrence, compression bandages and stockings to treat venous leg ulcers, laser treatment (low level), leg ulcer clinics, pentoxifylline, skin grafting, superficial vein surgery for prevention of recurrence, superficial vein surgery to treat venous leg ulcers, therapeutic ultrasound, and topical negative pressure.

A comparison of the management of venous leg ulceration by specialist and generalist community nurses: A judgement analysis.

BACKGROUND: Venous leg ulcer management in the UK varies significantly. Judgements made by nurses contribute to this variability and it is often assumed that specialist nurses make better judgements than non-specialist nurses. This paper compares the judgements of community tissue viability specialist nurses and community generalist nurses; specifically, the ways they use clinical information and their levels of accuracy. OBJECTIVES: To compare specialist and non-specialist UK community nurses' clinical information use when managing venous leg ulceration and their levels of accuracy when making diagnoses and judging the need for treatment. DESIGN: Judgement analysis. SETTING: UK community and primary care nursing services. PARTICIPANTS: 18 community generalist nurses working in district (home) nursing teams and general practitioner services and 18 community tissue viability specialist nurses. METHODS: Data were collected in 2011 and 2012. 18 community generalist nurses and 18 community tissue viability specialist nurses made diagnostic and treatment judgements on 110 clinical scenarios and indicated their confidence in each of their judgements. Scenarios were generated from real patient cases and presented online using text and photographs. An expert panel made judgements, and reached consensus on the same scenarios. These judgements were used as a standard against which to compare the participants. Logistic regression models and correlational statistics were used to generate various indices of judgement "performance": accuracy, consistency, confidence calibration and information use. Differences between groups of nurses with different levels of characteristics linked to expertise were explored using analysis of variance. RESULTS: Specialist nurses had similar cue usage to the generalist nurses but were more accurate when making diagnostic and treatment judgements. CONCLUSION: It is not obvious why the tissue viability specialist nurses were more accurate. One possible reason might be the greater opportunities for 'deliberate practice' afforded to specialists. However, restricting aspects of practice only to specialist nurses is likely to hinder the judgement performance of generalists.

Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial.

BACKGROUND: VEINES-QOL/Sym is a disease-specific quality of life instrument for use in venous diseases of the leg. Its relative scoring system precludes comparisons between studies. There were very few venous leg ulcer patients in the validation samples. We report a validation study for venous leg ulcers and develop a scoring system which enables comparison between studies. METHODS: Four hundred fifty-one participants in the VenUS IV trial of the management of venous leg ulcers were asked to complete a VEINES-QOL questionnaire at recruitment, along with SF-12, pain, and other aspects of quality of life. VEINES-QOL was repeated after two weeks and after 4 months. Healing of ulcers was confirmed by blind assessment of digital photographs. Three scoring systems for VEINES-QOL were compared. RESULTS: No floor or ceiling effects were observed for VEINES-QOL items, item-item correlations were weak to moderate, item-score correlations were moderate. Internal reliability was good. The VEINES-Sym subscale was confirmed by factor analysis. Test-retest reliability was satisfactory for the scale scores; individual items showed moderate to good agreement. Relationships with SF-12, pain, and the quality items confirmed construct validity. Participants whose ulcers had healed showed greater mean increase in scores than did those yet to heal, though they continued to report leg problems. An intrinsic scoring method appeared superior to the original relative method. CONCLUSIONS: VEINES-QOL was suitable for use in the study of venous leg ulcers. The intrinsic scoring method should be adopted, to facilitate comparisons between studies. TRIAL REGISTRATION: VenUS IV is registered with the ISRCTN register, number ISRCTN49373072 .

Alginate dressings for venous leg ulcers.

BACKGROUND: Venous leg ulcers are a common and recurring type of chronic, complex wound associated with considerable cost to patients and healthcare providers. To aid healing, primary wound contact dressings are usually applied to ulcers beneath compression devices. Alginate dressings are used frequently and there is a variety of alginate products on the market, however, the evidence base to guide dressing choice is sparse.  OBJECTIVES: To determine the effects of alginate dressings compared with alternative dressings, non-dressing treatments or no dressing, with or without concurrent compression therapy, on the healing of venous leg ulcers. SEARCH METHODS: For this first update, in March 2015, we searched the following databases: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions based on language or date of publication. SELECTION CRITERIA: Published or unpublished randomised controlled trials (RCTs) that evaluated the effects of any type of alginate dressing in the treatment of venous ulcers were included. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, data extraction and risk of bias assessment. Meta-analysis was undertaken when deemed feasible and appropriate. MAIN RESULTS: Five RCTs (295 participants) were included in this review. All were identified during the original review. The overall risk of bias was high for two RCTs and unclear for three. One RCT compared different proprietary alginate dressings (20 participants), three compared alginate and hydrocolloid dressings (215 participants), and one compared alginate and plain non-adherent dressings (60 participants). Follow-up periods were six weeks in three RCTs and 12 weeks in two. No statistically significant between-group differences were detected for any comparison, for any healing outcome. Meta-analysis was feasible for one comparison (alginate and hydrocolloid dressings), with data from two RCTs (84 participants) pooled for complete healing at six weeks: risk ratio 0.42 (95% confidence interval 0.14 to 1.21). Adverse event profiles were generally similar between groups (not assessed for alginate versus plain non-adherent dressings). AUTHORS' CONCLUSIONS: The current evidence base does not suggest that alginate dressings are more or less effective in the healing of venous leg ulcers than hydrocolloid or plain non-adherent dressings, and there is no evidence to indicate a difference between different proprietary alginate dressings. However, the RCTs in this area are considered to be of low or unclear methodological quality. Further, good quality evidence is required from well designed and rigorously conducted RCTs that employ - and clearly report on - methods to minimise bias, prior to any definitive conclusions being made regarding the efficacy of alginate dressings in the management of venous leg ulcers.

Diagnostic and treatment decision making in community nurses faced with a patient with possible venous leg ulceration: a signal detection analysis.

BACKGROUND: Judgements and decisions about venous leg ulcer management are characterised by uncertainty. Good judgements and reduced variations in practice require nurses to identify relevant "signals" in clinical encounters. Nurses, even experienced ones, vary in their ability to separate these signals from surrounding noise. OBJECTIVES: Examine specialist and generalist nurses' discrimination of clinical signals and noise when (i) diagnosing venous versus other causes leg ulceration, and (ii) starting multilayer compression therapy. DESIGN: A signal detection analysis within a cross sectional survey. SETTINGS: Four English NHS districts. PARTICIPANTS: Tissue viability specialist (n = 18) and generalist (district and practice nurses, n = 18) sampled from networks of nurses caring for people with leg ulcers. Mean age was 46 years, 78% had more than 10 years nursing experience. They worked on average 32.5 h per week, of which 10 h were spent caring for people with leg ulcers. METHODS: 110 clinical scenarios based on anonymous patient data from a large clinical trial of compression therapy for leg ulceration. The scenarios were classed as either signal (venous leg ulcer present and/or compression therapy warranted, n = 57) or no signal cases (other kind of ulcer and/or compression therapy contraindicated, n = 53) by four experts. Nurses made diagnostic and treatment judgements for each scenario. A signal detection analysis was undertaken for each nurse. Measures of signal detection (d prime or d') and judgement tendency or bias (C) were computed. Differences between specialist and generalist nurses were tested for using the Mann Whitney U test and graphically explored using Receiver Operating Curves (ROC). RESULTS: Specialists identified more true positive cases than the generalist nurses: 75% vs. 59% for the diagnostic judgement (p < 0.01) and 70% vs. 60% for the treatment judgement. They were significantly more sensitive to the signals present (d' 1.68 vs. 1.08 for the diagnostic judgement and 1.62 vs. 1.11 for the treatment judgement). Specialists exhibited a significantly higher bias towards initiating treatment (C = .81 vs. .56, p < 0.01) but this did not extend to their diagnostic judgements. Specialists also varied slightly less in their signal detection abilities. CONCLUSIONS: Nurse specialism was associated with better, but still variable, clinical diagnostic and treatment signal detection in simulated venous leg ulcer management.

Community nurses' judgement for the management of venous leg ulceration: a judgement analysis.

BACKGROUND: Nurses caring for the large numbers of people with leg ulceration play a key role in promoting quality in health via their diagnostic and treatment clinical judgements. In the UK, audit evidence suggests that the quality of these judgements is often sub optimal. Misdiagnosis and incorrect treatment choices are likely to affect healing rates, patients' quality of life, patient safety and healthcare costs. OBJECTIVES: To explore the diagnostic judgements and treatment choices of UK community nurses managing venous leg ulceration. DESIGN: A judgement analysis based on Brunswik's psychological Lens Model theory. SETTING: UK community and primary care nursing services. PARTICIPANTS: 18 community generalist nurses working in district (home) nursing teams and general practitioner services and 18 community tissue viability specialist nurses. METHODS: During 2011 and 2012, 36 nurses made diagnostic judgements and treatment choices in response to 110 clinical scenarios. Scenarios were generated from real patient cases and presented online using text and wound photographs. The consensus judgements of a panel of nurses with advanced knowledge of leg ulceration judged the same scenarios and provided a standard against which to compare the participants. Correlations and logistic regression models were constructed to generate various indices of judgement and decision "performance": accuracy (R(a)), consistency (R(s)) and information use (G) and uncertainty (R(e)). RESULTS: Taking uncertainty into account, nurses could theoretically have achieved a diagnostic level of accuracy of 0.63 but the nurses only achieved an accuracy of 0.48. For the treatment judgement (whether applying high compression was warranted) nurses could have achieved an accuracy of 0.88 but achieved only an accuracy of 0.49. This may have been due to the nurses giving insufficient weight to the diagnostic cues of medical history and appearance of the leg and ulcer and insufficient weight to the treatment cues of type of leg ulcer and pain. CONCLUSION: Clinical judgements and decisions made by nurses managing leg ulceration are complex and uncertain and some of the variability in judgements and choices can be explained by the ways in which nurses process the information and handle the uncertainties, present in clinical encounters.

VenUS IV (Venous leg Ulcer Study IV) - compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model.

BACKGROUND: Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB. OBJECTIVES: Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part III To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers. DESIGN: Part I A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part II MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part III A decision-analytic Markov model. SETTINGS: Part I Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland. PARTICIPANTS: Part I Patients aged ≥ 18 years with a venous leg ulcer, who were willing and able to tolerate high compression. INTERVENTIONS: Part I Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40 mmHg of compression at the ankle. Part II and III All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB). MAIN OUTCOME MEASURES: Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs. RESULTS: Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; p = 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HR = 0.56, 95% CI 0.33 to 0.94; p = 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a > 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part II The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part III Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers. CONCLUSIONS: Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49373072. 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. 18, No. 57. See the NIHR Journals Library website for further project information.