Simon Palfreyman

Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial)

Antimicrobial silver dressings are used beneath graduated compression in the treatment of venous ulceration. There is little information on whether their use is effective. This was a prospective randomized trial and cost‐effectiveness analysis of silver‐donating versus non‐silver low‐adherence dressings in the treatment of venous leg ulcers.

Randomized clinical trial comparing surgery with conservative treatment for uncomplicated varicose veins.

Surgical treatment of medically uncomplicated varicose veins is common, but its clinical effectiveness remains uncertain.

A systematic review of compression hosiery for uncomplicated varicose veins

Objective Compression hosiery is widely used in the prevention and management of symptoms related to varicose veins. However, there are still gaps and questions in relation to its benefit. This review seeks to examine the current evidence regarding the effectiveness of compression hosiery in the treatment of varicose veins. Method Prospective, randomized controlled trials (RCTs) evaluating compression hosiery in the treatment of varicose veins were sought. Where RCTs were unavailable other evidence was included. Studies were included if they evaluated the application of compression to patients with a diagnosis of varicose veins. Twelve electronic bibliographic databases and 18 internet-based research resources were searched. Inclusion or exclusion of trials was decided by two reviewers acting independently. Results The search strategy identified 25 studies. Eleven were RCTs or systematic reviews, 12 non-randomized studies and two guidelines. No consensus was found regarding the class of compression needed for the effective management of varicose veins. Wearing compression improved symptom management, but could be confounded by the exclusion of high number of non-compliant patients within the trials. Wearing compression to slow the progression, or prevent the reoccurrence of varicose veins could not be supported by the current published evidence. Conclusion The evidence for the benefit of compression hosiery for varicose veins was equivocal. The published literature was often contradictory and had methodological flaws.

A prospective randomised controlled trial and economic modelling of antimicrobial silver dressings versus non-adherent control dressings for venous leg ulcers: the VULCAN trial.

OBJECTIVE To examine the effectiveness and cost-effectiveness of antimicrobial silver-donating dressings for venous leg ulcers compared with simple non-adherent (also known as low-adherent) dressings. DESIGN A pragmatic, prospective randomised controlled trial (RCT) and cost-effectiveness analysis of silver-donating versus low-adherent dressings in the treatment of venous leg ulcers. A non-randomised observational group was also recruited. SETTING Primary and secondary care services in the north and south of England (Sheffield and Exeter). PARTICIPANTS Consenting patients with active ulceration of the lower leg that had been present for a period of greater than 6 weeks. INTERVENTIONS Patients were randomised to receive either a silver-donating or non-silver low-adherent dressing applied beneath compression bandages or hosiery. The choice of dressing within these groups was left to clinician preference. Evaluation was by clinical assessment, supplemented by evaluation of quality of life and cost-effectiveness. MAIN OUTCOME MEASURES The primary outcome measure was complete ulcer healing at 12 weeks in the index limb. Secondary measures were costs and quality-adjusted life-years (QALYs), cost-effectiveness, time to healing, and recurrence rate at 6 months and 1 year. RESULTS In total, 304 participants were recruited to the clinical trial: 213 to the RCT and 91 to the observational arm. Within the RCT 107 were randomised to antimicrobial dressings and 106 to the control dressings. There were no significant differences (p > 0.05) between the two groups for the primary outcome measure of proportion of ulcers healed at 12 weeks (59.6% for silver and 56.7% for control dressings). The overall median time to healing was also not significantly different between the two groups (p = 0.408). A total of 24 patients had recurrent ulcers within 1 year; the recurrence rates of 11.6% (n = 11) for the antimicrobial and 14.4% (n = 13) for the control dressings were not significant. Mean utility valuations for both the EuroQol 5 dimensions (EQ-5D) quality of life questionnaire and Short Form 6 dimensions (SF-6D) utility index showed no differences for either group at 1, 3, 6 or 12 months. Compared with the control group, the antimicrobial group had an incremental cost of 97.85 pounds and an incremental QALY gain of 0.0002, giving an incremental cost-effectiveness ratio for the antimicrobial dressings of 489,250 pounds. Cost-effectiveness modelling of the results of the RCT showed that antimicrobial dressings were not cost-effective. CONCLUSIONS No significant differences in either primary or secondary end points were found between the use of antimicrobial silver-donating dressings and the control group of low-adherent dressings. Modelling showed that antimicrobial silver dressings were not cost-effective. TRIAL REGISTRATION Current Controlled Trials ISRCTN72485131.

A systematic review of compression therapy for venous leg ulcers

The aim of the study was to determine the relative effectiveness of compression therapies used in the treatment of venous leg ulcers. Randomized controlled trials (RCT) were sought using a search strategy that aimed to identify relevant RCT by searching eight electronic databases (including Medline, Embase and CINHAL), conference proceedings and hand searching key journals. In addition, citations within papers were scrutinized to identify any relevant studies. Suitability for inclusion in this review was determined by a critical appraisal of key determinants of the quality of the trials. Trials that included patients of mixed ulcer aetiology were excluded unless the results of patients with venous disease were reported separately. Data was extracted independently by two reviewers and synthesized quantitatively and qualitatively. Losses to follow-up/withdrawals were assumed to be failures of treatment. A total of 132 articles were identified, and of these eight fulfilled the inclusion criteria. The remaining 126 trials were excluded due to trial design flaws, the inclusion of mixed/arterial aetiology ulcers or because they were non-RCT. Meta-analysis using a random-effects model showed the benefits of multi-layer and elastic compression bandages. It was concluded that more high-quality trials are required and that more emphasis should be placed on economic and quality of life data to try to ascertain the cost-effectiveness and utility of the treatment options available.

Cost-effectiveness analysis of surgery versus conservative treatment for uncomplicated varicose veins in a randomized clinical trial

Despite being a common procedure, the cost effectiveness of surgery for varicose veins has not been established.

A systematic review of health-related quality of life instruments used for people with venous ulcers: an assessment of their suitability and psychometric properties

AIMS AND OBJECTIVES To review the quality of life questionnaires used to measure the impact of venous ulceration and to evaluate their psychometric properties. BACKGROUND Venous leg ulcers have a negative impact on quality of life. Health-related quality of life can be measured using structured questionnaires. Nurses are the primary care providers for patients with venous ulceration and are ideally placed to assess and develop these types of questionnaires. There may also be an opportunity to use such quality of life instruments to measure the impact of nursing interventions in other areas where nurses are the key care providers. DESIGN Systematic review. METHOD Studies were sought that used quality of life instruments to evaluate the impact of venous ulceration. Fourteen electronic bibliographical databases and 11 Internet-based health services research related resources were searched. In addition, grey literature was sought and the reference lists of relevant articles checked. Data were extracted regarding the type of instrument used, sample, number of items and domains and psychometric performance of the instrument. RESULTS The initial search identified a total of 338 potential citations. After review, a total of 31 studies were included: 17 used generic and 14 used disease-specific instruments. Five different types of generic and seven disease-specific instruments were identified. There was significant heterogeneity between the studies in terms of study design, aetiology of ulceration and times of assessment. The disease-specific instruments showed limitations in relation to their applicability to venous ulcer patients because of flaws in design or validation. CONCLUSIONS The literature on quality of life related to venous ulceration failed to sufficiently distinguish between those with different causes of leg ulceration. There appeared to be problems with the ability of current quality of life instruments to detect changes in quality of life related to ulcer healing. Relevance to clinical practice.  There appears to be an opportunity for nurses to develop a health-related quality of life health-related quality of life instruments to evaluate their impact on patient outcomes. Such instruments could potentially allow nursing interventions to be assessed more effectively than the recently proposed nursing metrics.

Elevation devices for the prevention of heel pressure ulcers: a review

AIM The objective of this systematic literature review was to gain insight into the effectiveness of off-loading devices to prevent heel pressure ulcers within the acute hospital setting. BACKGROUND Heels have been identified as the second most common site for pressure ulcers. Devices which off-load pressure can include pillows, wedges and boots. It is unclear as to which method or device is best at preventing pressure ulcers. DESIGN AND METHODS A systematic review was carried out through the search of electronic databases and bibliographies of relevant publications. Randomised controlled trials (RCTs) and systematic reviews that compared devices which off-load heels to prevent pressure ulcers were identified. RESULTS A total of five studies were included in the review. The methodological quality of the studies was generally poor. The studies reported that heel-boot elevation devices appeared more beneficial. However, poor compliance with wearing the devices was identified, as well as a perceived increased risk of falls. There were little data on cost-effectiveness. CONCLUSIONS There is little high-quality trial evidence to support the routine use of heel devices to prevent pressure ulcers. However, they may have a role to play within a multifaceted programme of pressure-ulcer prevention.

A New Pragmatic Classification System for Varicose Veins

Objective: An anatomical classification system for varicose veins which has a direct and pragmatic bearing on treatment. Methods: A group of trial participants from the two vascular units involved met to design a system. A consensus on the form and content of the system was reached. This process included forming a set of ideal classification criteria, a literature review of existing classification systems and a pilot study of the proposed system. Results: The identified classification systems were felt to be unsatisfactory for a number of reasons including being difficult to understand and use, requiring special investigations and not linking through to clinical management options. The pilot study demonstrated consensus between clinicians when using our system. Conclusion: A system has been developed that is easy to learn, use and understand. It can be employed in a busy outpatient setting and produces an acceptable degree of agreement regarding the anatomical nature of varicose veins.

Patients at risk of pressure ulcers and moisture-related skin damage

T he problems associated with pressure ulcers and moisture-associated skin damage (MASD) are matters that clinicians are likely to have to deal with on a regular basis. Pressure ulcers and MASDs have different aetiologies, and their prevention and treatment can also differ. However, there are also some common issues that patients and clinicians will need to address. Pressure ulcers are a consequence of reduced mobility; the action of pressure causes damage to the skin and underlying tissues, resulting in superficial to deep full-thickness wounds (National Pressure Ulcer Advisory Panel (NPUAP) et al, 2014). MASD is related to the irritation and maceration of the skin and can result in partial thickness wounds that are caused by the exposure of the skin to faeces, urine, exudate or perspiration within skin folds (Gray et al, 2011). Prolonged contact with faeces and/or urine can lead to a particular form of MASD called incontinenceassociated dermatitis (IAD) (Voegeli, 2012). Both pressure ulcers and MASD can have a significant impact on the patient’s quality of life by causing pain, distress and loss of dignity (Benbow 2009; Bardsley, 2013). There are also differences between the two conditions in terms of trying to determine the number of people affected by pressure ulcers and MASD. In the UK, according to NHS Improving Quality (NHS IQ, 2016) based on the NHS Thermometer data, there are around a 180 000 new pressure ulcers per year. The overall costs to the NHS is hard to quantify but back in 2004 it was estimated to be between £1.4 billion and £2.1 billion annually (Bennett et al, 2004). More recently, costs were estimated at the individual patient level (Dealey et al, 2012) and ranged from £1214 (category 1) to £14 108 (category 4). The high costs associated with pressure ulcers may be one reason that pressure ulcer prevention has become ‘one of the biggest patient safety challenges facing the NHS’ (NHS IQ, 2016). In contrast, the number of people who are affected by MASD is less clear and precise, possibly due to a lack of adequate data collection, misreporting and poor assessment (Beeckman, 2016). However, it is thought to affect between 3% and 25% of patients (Idensohn, 2014). The estimation of the annual cost for MASD is also complicated by the lack of data, but it is likely that there is a significant financial impact on health professionals (Voegeli, 2016).