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.

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.

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.

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.

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.

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.

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial.

BACKGROUND: Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. METHODS: We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. FINDINGS: We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. INTERPRETATION: Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. FUNDING: NIHR Health Technology Assessment programme (07/60/26).

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.

Topical agents and dressings for fungating wounds.

BACKGROUND: Fungating wounds arise from primary, secondary or recurrent malignant disease and are associated with advanced cancer. A small proportion of patients may achieve healing following surgical excision, but treatment is usually palliative. Fungating wound management usually aims to slow disease progression and optimise quality of life by alleviating physical symptoms, such as copious exudate, malodour, pain and the risk of haemorrhage, through selection of appropriate dressings and topical agents. OBJECTIVES: To review the evidence of the effects of dressings and topical agents on quality of life, and symptoms that impact on quality of life, in people with fungating malignant wounds. SEARCH METHODS: For this third update we searched the Wounds Group Specialised Register in August 2013; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. SELECTION CRITERIA: Eligible studies comprised randomised controlled trials (RCTs) or, in their absence, controlled clinical trials (CCTs) with a concurrent control group. DATA COLLECTION AND ANALYSIS: Data extraction and risk of bias assessment was undertaken by one review author and checked for accuracy by a second. MAIN RESULTS: Four trials involving 164 people were included. One RCT in women with superficial breast lesions compared 6% miltefosine solution with placebo and found that miltefosine delayed tumour progression. The study reported that the time to treatment failure was significantly longer in the miltefosine group (median 56 days) than in the placebo group (median 21 days) (p value 0.007, log-rank test). A second trial compared topical metronidazole with placebo but the results up to the point of cross-over were not statistically significant. A third trial compared the effect of foam dressings containing silver to foam dressings without silver and found that more patients experienced decreased malodour in the foam with silver group than in the foam alone group (p value=0.049). The fourth trial compared the effect of manuka honey-coated dressings with nanocrystalline silver-coated dressings and found no statistically significant difference with regard to exudate, malodour and wound pain. All trials, however, had methodological limitations. AUTHORS' CONCLUSIONS: There is weak evidence from one small trial that 6% miltefosine solution applied topically to people with superficial fungating breast lesions (smaller than 1cm) who have received either previous radiotherapy, surgery, hormonal therapy or chemotherapy for their breast cancer, may slow disease progression. There is also weak evidence to suggest that foam dressings containing silver may be effective in reducing malodour. There is insufficient evidence in this review to give a clear direction for practice with regard to improving quality of life or managing wound symptoms associated with fungating wounds. More research is needed.

Stockings or bandages for leg-ulcer compression?

BACKGROUND: Four-layer bandaging is the standard treatment for venous leg ulcers but is bulky and can restrict mobility. Two-layer compression stockings have recently been marketed but their clinical and cost effectiveness were unknown. AIM: To compare the clinical and cost effectiveness of four-layer bandaging with two-layer compression stockings. METHOD: In a pragmatic, open, randomised controlled trial 454 participants were randomly allocated two-layer compression stockings or four-layer bandages and followed for up to 12 months after healing. RESULTS: The median time to ulcer healing was almost identical (stockings group: 99 days, bandaging group: 98 days). More patients allocated stockings changed treatment but ulcer recurrence rates were higher in the bandaging group. Stockings cost 302 sterling pounds less per participant per year and had more than 95% probability of being the most cost-effective treatment. CONCLUSION: Two-layer compression stockings are a viable, cost-effective alternative to four-layer bandaging but may not be suitable for all patients.

Managing wound exudate and promoting healing.

Exudate is a product of the normal wound healing process. It is usually clear or amber coloured but variations in the colour, consistency, odour and amount can indicate disruption to the normal healing process. Certain types of chronic wound commonly seen in the community can be associated with the production of excessive exudate. Copious exudate can be distressing for patients and expensive for community health-care providers. Effective management depends on the accurate diagnosis and treatment of the underlying condition and skill in selecting the most appropriate dressing regime.

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.

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.

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.