Search

BackgroundCOVID-19 spread rapidly in UK care homes for older people in the early pandemic. National infection control recommendations included remote resident assessment. A region in North-West England introduced a digital COVID-19 symptom tracker for homes to identify early signs of resident deterioration to facilitate care responses. We examined the implementation, uptake and use of the tracker in care homes across four geographical case study localities in the first year of the pandemic.MethodsThis was a rapid, mixed-methods, multi-locality case study. Tracker uptake was calculated using the number of care homes taking up the tracker as a proportion of the total number of care homes in a locality. Mean tracker use was summarised at locality level and compared. Semi-structured interviews were conducted with professionals involved in tracker implementation and used to explore implementation factors across localities. Template Analysis with the Consolidated Framework for Implementation Research (CFIR) guided the interpretation of qualitative data.ResultsUptake varied across the four case study localities ranging between 13.8 and 77.8%.Tracker use decreased in all localities over time at different rates, with average use ranging between 18 and 58%. The implementation context differed between localities and the process of implementation deviated over time from the initially planned strategy, for stakeholder engagement and care homes’ training. Four interpretative themes reflected the most influential factors appearing to affect tracker uptake and use: (1) the process of implementation, (2) implementation readiness, (3) clarity of purpose/perceived value and (4) relative priority in the context of wider system pressures.ConclusionsOur study findings resonate with the digital solutions evidence base prior to the COVID-19 pandemic, suggesting three key factors that can inform future development and implementation of rapid digital responses in care home settings even in times of crisis: an incremental approach to implementation with testing of organisational readiness and attention to implementation climate, particularly the innovation’s fit with local contexts (i.e. systems, infrastructure, work processes and practices); involvement of end-users in innovation design and development; and enabling users’ easy access to sustained, high-quality, appropriate training and support to enable staff to adapt to digital solutions.

BackgroundIn the United Kingdom, the use of the terms ‘complex’ and ‘complexity’ alongside dementia is reflected in a number of policy and practice documents. However, there is a lack of evidence that explores how complexity is perceived, constructed and experienced by people with dementia, family carers and practitioners working in the NHS dementia inpatient assessment wards [dementia assessment wards].ObjectiveTo explore the meaning and concept of complexity in dementia from within the setting of a dementia assessment ward and develop a practice model.MethodsThe study was conducted over three phases: 1) an online electronic survey of UK national dementia leaders; 2) individual interviews and a focus group with dementia practitioners in two dementia assessment wards; 3) case studies of four patients with dementia resident on a dementia assessment ward which included their identified family carer/consultee, the named clinician on the ward involved in that person’s care and a care records review.ResultsThe findings highlighted that complexity is constructed through a number of interconnected and interrelated domains that vary in acuity. These findings have been developed into the ‘3 Fs Model of Complexity’ and the 3‘Fs’ stand for Fixed, Flexible and Fluctuating. The Fixed domain consists of six components which are always present in complexity. The Flexible domain consists of 14 components and a person with dementia may experience any number of Flexible domain components at any one time. The Fluctuating domain highlights that all components have the ability to vary in their acuity.ConclusionThe ‘3 Fs Model of Complexity’ may facilitate a more holistic view of a person with dementia than when ‘symptoms’ are viewed in isolation. Going forward, and subject to further refinement and testing, the ‘3 Fs Model of Complexity’ could help guide the selection of tailored, personalised interventions for people with dementia, including formulation approaches.

AIMS AND OBJECTIVES: To explore surgeons' and nurses' perspectives of managing surgical wounds healing by secondary intention.BACKGROUND: Every year, more than 10 million surgical operations are performed in the NHS in the UK. Most surgical wounds heal by primary intention, where the edges of the wound are brought together with staples, sutures, adhesive glue or clips. Sometimes wounds are deliberately left open to heal, from the base up, known as "healing by secondary intention." These wounds are often slow to heal, prone to infection and complex to manage.DESIGN: A qualitative, descriptive approach, using semi-structured interviews.METHODS: Interviews with five (general, vascular and plastic) surgeons and 7 nurses (3 tissue viability nurses, 2 district and 1 community nurse, and 1 hospital nurse) working in hospital and community care settings in two locations in the north of England. Data analysis followed the recommended sequential steps of "Framework" approach. Consolidated criteria for reporting qualitative research guided the study report.RESULTS: Participants reported that the main types of wounds healing by secondary intention that they manage are extensive abdominal cavity wounds; open wounds relating to treatment for pilonidal sinus; large open wounds on the feet of patients with diabetes; and axilla and groin wounds, associated with removal of lymph nodes for cancer. Infection and prolonged time to healing were the main challenges. Negative pressure wound therapy was the most favoured treatment option.CONCLUSIONS: Negative pressure wound therapy was advocated by professionals despite a lack of research evidence indicating clinical or cost-effectiveness. Our findings underscore the need for rigorous evaluation of negative pressure wound therapy, and other wound care treatments, through studies that include economic evaluation.RELEVANCE FOR CLINICAL PRACTICE: Clinical decision-making in wound care could be optimised through further robust studies to inform practitioners about the cost-effectiveness of available treatments.

ObjectiveThe COVID-19 pandemic increased the demand for rapid evaluation of innovation in health and social care. Assessment of rapid methodologies is lacking although challenges in ensuring rigour and effective use of resources are known. We mapped reports of rapid evaluations of health and social care innovations, categorised different approaches to rapid evaluation, explored comparative benefits of rapid evaluation, and identified knowledge gaps.DesignScoping review.Data sourcesMEDLINE, EMBASE and Health Management Information Consortium (HMIC) databases were searched through 13 September 2022.Eligibility criteria for selecting studiesWe included publications reporting primary research or methods for rapid evaluation of interventions or services in health and social care in high-income countries.Data extraction and synthesisTwo reviewers developed and piloted a data extraction form. One reviewer extracted data, a second reviewer checked 10% of the studies; disagreements and uncertainty were resolved through consensus. We used narrative synthesis to map different approaches to conducting rapid evaluation.ResultsWe identified 16 759 records and included 162 which met inclusion criteria.We identified four main approaches for rapid evaluation: (1) Using methodology designed specifically for rapid evaluation; (2) Increasing rapidity by doing less or using less time-intensive methodology; (3) Using alternative technologies and/or data to increase speed of existing evaluation method; (4) Adapting part of non-rapid evaluation.The COVID-19 pandemic resulted in an increase in publications and some limited changes in identified methods. We found little research comparing rapid and non-rapid evaluation.ConclusionsWe found a lack of clarity about what ‘rapid evaluation’ means but identified some useful preliminary categories. There is a need for clarity and consistency about what constitutes rapid evaluation; consistent terminology in reporting evaluations as rapid; development of specific methodologies for making evaluation more rapid; and assessment of advantages and disadvantages of rapid methodology in terms of rigour, cost and impact.

ObjectivesTo investigate factors that promote and prevent the use of compression therapy in people with venous leg ulcers.DesignQualitative interview study with nurses using the Theoretical Domains Framework (TDF).SettingThree National Health Service Trusts in England.ParticipantsPurposive sample of 15 nurses delivering wound care.ResultsNurses described factors which made provision of compression therapy challenging. Organisational barriers (TDF domains environmental context and resources/knowledge, skills/behavioural regulation) included heavy/increasing caseloads; lack of knowledge/skills and the provision of training; and prescribing issues (variations in bandaging systems/whether nurses could prescribe). Absence of specialist leg ulcer services to refer patients into was perceived as a barrier to providing optimal care by some community-based nurses. Compression use was perceived to be facilitated by clinics for timely initial assessment; continuity of staff and good liaison between vascular/leg ulcer clinics and community teams; clear local policies and care pathways; and opportunities for training such as ‘shadowing’ in vascular/leg ulcer clinics. Patient engagement barriers (TDF domains goals/beliefs about consequences) focused on getting patients ‘on board’ with compression, and supporting them in using it. Clear explanations were seen as key in promoting compression use.ConclusionsRising workload pressures present significant challenges to enhancing leg ulcer services. There may be opportunities to develop facilitated approaches to enable community nursing teams to make changes to practice, enhancing quality of patient care. The majority of venous leg ulcers could be managed in the community without referral to specialist community services if issues relating to workloads/skills/training are addressed. Barriers to promoting compression use could also be targeted, for example, through the development of clear patient information leaflets. While the patient engagement barriers may be easier/quicker to address than organisational barriers, unless organisational barriers are addressed it seems unlikely that all people who would benefit from compression therapy will receive it.

This work was supported by the National Institute for Health Research (NIHR), Health Technology Assessment Programme, project number 17/147/47. The HTA Programme is funded by the NIHR, with contributions from the Chief Scientist Office in Scotland and National Institute for Social Care and Health Research in Wales and the Health and Social Care R&D Division, Public Health Agency in Northern Ireland. Sponsor: Imperial College London., Introduction Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT. Methods and analysis Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23-32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective. Ethics and dissemination UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences., National Institute for Health Research (NIHR) 17/147/47, National Institute for Health Research (NIHR), Chief Scientist Office in Scotland, National Institute for Social Care and Health Research in Wales, Health and Social Care R&D Division, Public Health Agency in Northern Ireland, Imperial College London

This study is supported by the J P Moulton Charitable Foundation (grant number: N/A). The DCD allograft is provided free of charge by NHSBT., The authors wish to thank the principal investigators, research nurses and their teams at the recruiting sites. The authors also wish to thank the NHS Blood and Transplant (NHSBT) for providing the DCD allograft free of charge and for their support in training clinical staff, and the NIHR Clinical Research Networks (CRNs) for their support in identifying sites. Finally, the authors wish to thank all individuals who participated in the PPI focus groups and extend a special thank you to PPI representative Emanuel Ezeife, whose useful feedback helped to inform the design of the study., Introduction Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. Methods and analysis This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. Ethics and dissemination Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences., J P Moulton Charitable Foundation

ObjectivesTo investigate the period prevalence of complex wounds among the overall inpatients, and the impact of complex wounds on inpatient health expense and length of hospital stay (LOS).DesignAn observational study.Setting6056 healthcare institutions across Sichuan province in China.ParticipantsThis study included 4 033 763 people admitted to healthcare institutions during 1 September 2018 and 31 December 2018.ResultsThe point prevalence of complex wounds was 4.07 per 1000 among inpatients in Sichuan. The most common complex wounds were pressure ulcers (1.47 per 1000 among inpatients). Older, male, Han ethnic groups and retired people were most likely to suffer from complex wounds. The median LOS was longer for those with complex wounds as their main condition of treatment compared with all-cause admissions in Sichuan (12 days compared with 7 days; pConclusionsComplex wounds, especially pressure ulcers, are common in Sichuan province and their presence is associated with significantly longer lengths of hospital stay and higher medical costs. Additionally, this study only included admitted inpatients during the sampling time period, hence the prevalence of complex wounds may be underestimated. The high prevalence rate and heavy direct and indirect disease burden of complex wounds indicate that health policies for early detection and prevention of complex wounds in elders are urgently needed.

ObjectivesTo estimate and examine the direct healthcare costs of treating people with open venous leg ulcers in the UK.DesignCost-of-illness study.SettingA cross-sectional survey of nine National Health Service community locales over 2-week periods in 2015/2016.MethodsWe examined the resource use and prevalence of venous leg ulcer treatment in the community. Examination of variation in these obtained costs was performed by ordinary least squares regression. We used additional resource use information from a randomised control trial and extrapolated costs to the UK for an annual period.ResultsThe average 2-week per person cost of treating patients where a venous leg ulceration was the primary (most severe) wound was estimated at £166.39 (95% CI £157.78 to £175.00) with community staff time making up over half of this amount. Costs were higher where antimicrobial dressings were used and where wound care was delivered in the home. Among those with any recorded venous leg ulcer (primary and non-primary), we derived a point prevalence of 3.2 per 10 000 population and estimated that the annual prevalence could be no greater than 82.4 per 10 000 population. We estimated that the national cost of treating a venous leg ulcer was £102 million with a per person annual cost at £4787.70.ConclusionOur point prevalence figures are in line with the literature. However, our annual prevalence estimations and costs are far lower than those reported in recent literature which suggests that the costs of treating venous leg ulcers are lower than previously thought. Movement towards routinely collected and useable community care activity would help provide a transparent and deeper understanding of the scale and cost of wound care in the UK.

Background Surgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative‐pressure wound therapy (NPWT) despite a lack of high‐quality research evidence regarding its clinical and cost‐effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI. Methods Eligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1–2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed. Results A total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty‐four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0–72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study. Conclusion A full‐scale RCT to investigate the clinical and cost‐effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (www.iscrtn.com)

Study DesignNarrative review.ObjectivesPressure ulcers are a common complication in people with reduced sensation and limited mobility, occurring frequently in those who have sustained spinal cord injury. This narrative review summarises the evidence relating to interventions for the prevention and treatment of pressure ulcers, in particular from Cochrane systematic reviews. It also aims to highlight the degree to which people with spinal cord injury have been included as participants in randomised controlled trials included in Cochrane reviews of such interventions.SettingGlobal.MethodsThe Cochrane library (up to July 2017) was searched for systematic reviews of any type of intervention for the prevention or treatment of pressure ulcers. A search of PubMed (up to July 2017) was undertaken to identify other systematic reviews and additional published trial reports of interventions for pressure ulcer prevention and treatment.ResultsThe searches revealed 38 published systematic reviews (27 Cochrane and 11 others) and 6 additional published trial reports. An array of interventions is available for clinical use, but few have been evaluated adequately in people with SCI.ConclusionsThe effects of most interventions for preventing and treating pressure ulcers in people with spinal cord injury are highly uncertain. Existing evaluations of pressure ulcer interventions include very few participants with spinal cord injury. Subsequently, there is still a need for high-quality randomised trials of such interventions in this patient population.

Background Care bundles are a set of three to five evidence-informed practices performed collectively and reliably to improve the quality of care. Care bundles are used widely across healthcare settings with the aim of preventing and managing different health conditions. This is the first systematic review designed to determine the effects of care bundles on patient outcomes and the behaviour of healthcare workers in relation to fidelity with care bundles. Methods This systematic review is reported in line with the PRISMA statement for reporting systematic reviews and meta-analyses. A total of 5796 abstracts were retrieved through a systematic search for articles published between January 1, 2001, to February 4, 2017, in the Cochrane Central Register for Controlled Trials, MEDLINE, EMBASE, British Nursing Index, CINAHL, PsychInfo, British Library, Conference Proceeding Citation Index, OpenGrey trials (including cluster-randomised trials) and non-randomised studies (comprising controlled before-after studies, interrupted time series, cohort studies) of care bundles for any health condition and any healthcare settings were considered. Following the removal of duplicated studies, two reviewers independently screen 3134 records. Three authors performed data extraction independently. We compared the care bundles with usual care to evaluate the effects of care bundles on the risk of negative patient outcomes. Random-effect models were used to further explore the effects of subgroups. Results In total, 37 studies (6 randomised trials, 31 controlled before-after studies) were eligible for inclusion. The effect of care bundles on patient outcomes is uncertain. For randomised trial data, the pooled relative risk of negative effects between care bundle and control groups was 0.97 [95% CI 0.71 to 1.34; 2049 participants]. The relative risk of negative patient outcomes from controlled before-after studies favoured the care bundle treated groups (0.66 [95% CI 0.59 to 0.75; 119,178 participants]). However, using GRADE, we assessed the certainty of all of the evidence to be very low (downgraded for risk of bias, inconsistency, indirectness). Conclusions Very low quality evidence from controlled before-after studies suggests that care bundles may reduce the risk of negative outcomes when compared with usual care. By contrast, the better quality evidence from six randomised trials is more uncertain. Trial registration PROSPERO, CRD42016033175 Electronic supplementary material The online version of this article (10.1186/s13012-017-0670-0) contains supplementary material, which is available to authorized users.

ObjectivesIn healthcare systems, practices and products of unproven value and cost-effectiveness can decrease value and increase waste. Using the management of complex wounds, this study investigates temporal trends in the use of antimicrobials dressings, places this in the context of available evidence and discusses the potential impacts on the UK National Health Service (NHS).DesignSecondary descriptive and interrupted time series (ITS) analysis of NHS prescription data.SettingPrescribing Cost Analysis (PCA) details all NHS prescriptions dispensed in the community in England.InterventionsAn ITS design was used to compare annual changes in the expenditure and use of antimicrobial and non-antimicrobial dressings before and after the publication of the ‘intervention’ of key evidence-based Scottish Intercollegiate Guidelines Network (SIGN) guidance in 2010.Primary and secondary outcome measuresTrends in use and expenditure of antimicrobial dressings in relation to published clinical guidance.ResultsThere was a large increase in the prescribing of, and expenditure on, antimicrobial wound dressings between 1997 and 2016. In 1997, the total number of dressings prescribed was 5 792 700; increasing to 11 447 102 in 2009 with expenditure increasing from £1 960 386 to £32 841 263. During the year of the SIGN intervention (2010), there was a significant drop in the use of silver but there was no consistent ongoing reduction from 2011 to 2015.ConclusionsPrescribing data can be used to identify products of unproven benefit, which also impose a significant financial burden. This study quantifies the huge increase in the use of antimicrobial wound dressings over a 20-year period despite the lack of compelling evidence to support their routine use. There is some suggestion, however that the use and expenditure decreased after the publication of key guidance. Routine data can be used to as part of more systematic efforts to increase value and reduce waste in health systems.

Objectives Research has found unwarranted variation across community wound care services in the North of England, with underuse of evidence-based practice and overuse of interventions where there is little or no known patient benefit. This study explored the factors that influence care in community settings for people with complex wounds, to develop a deeper understanding of the current context of wound care and variation in practice.Design Qualitative focus group study using the Theoretical Domains Framework (TDF) to structure the questions, prompts and analyses.Setting Community healthcare settings in the North of England, UK.Participants Forty-six clinical professionals who cared for patients with complex wounds and eight non-clinical professionals who were responsible for procuring wound care products participated across six focus group interviews.Results We found the TDF domains: environmental context and resources, knowledge, skills, social influences and behaviour regulation to best explain the variation in wound care and the underuse of research evidence. Factors such as financial pressures were perceived as having a negative effect on the continuity of care, the availability of wound care services and workloads. We found practice to be mainly based on experiential knowledge and personal preference and highly influenced by colleagues, patients and the pharmaceutical industry, although not by research evidence.Conclusions Our study provides new insight into the role that experiential learning and social influences play in determining wound care and on the limited influence of research. Workforce pressures and limited resources are perceived to impede care by reducing patient access to services and the ability to provide holistic care. Participative collaboration between university and healthcare organisations may offer a supportive route to addressing issues, implementing sustainable changes to practice and service delivery and a resolute commitment to research use among clinical professionals.This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made.

ObjectiveTo develop, with nurse specialists and nursing home care staff, a theory and evidence-informedpressure injury preventioncare bundle for use in nursing home settings.DesignThe development of a care bundle.MethodsWe undertook a detailed, multistaged and theoretically driven development process. First, we identified evidence-informed pressure injury prevention practices: these formed an initial set of possible target behaviours to be considered for inclusion in the bundle. During a 4-hour workshop and supplemental email consultation with a total of 13 healthcare workers, we agreed the key target behaviours for the care bundle. We explored with staff the barriers and facilitators to prevention activity and defined intervention functions and behaviour change practices using the Behaviour Change Wheel.SettingNorth West England.ResultsThe target behaviours consisted of three elements: support surfaces, skin inspection and repositioning. We identified capability, opportunity and reflective motivation as influencing the pressure injury prevention behaviours of nursing home care staff. The intervention functions (education, training, modelling) and behaviour change techniques (information about social and environmental consequences, information on health consequences, feedback on behaviour, feedback on the outcome of behaviour, prompts/cues, instruction on how to perform the behaviour, demonstration of behaviour) were incorporated into the care bundle.ConclusionThis is the first description of a pressure injury prevention care bundle for nursing homes developed using the Behaviour Change Wheel. Key stakeholders identified and prioritised the appropriate target behaviours to aid pressure injury prevention in a nursing home setting.

AIMS AND OBJECTIVE: To investigate the amount, type and accuracy of citations use in support of product related claims from advertisements of wound care products. BACKGROUND: Although articles submitted to most medical journals are subjected to peer review, such scrutiny is often not required for the content of advertisements. DESIGN: A contents survey of advertisements from two wound care journals (Journal of Wound Care and Ostomy Wound Management) from 2002-2003 and the British Medical Journal, 2002-2003. METHODS: Data collected from advertisements included identification of product related claims made and any corresponding citations. Where journal articles were cited to support claims, the articles were obtained. Where data on file were cited, this material was requested. In each case the accuracy of claims in relation to the content of the supporting citation was assessed. RESULTS: The use of citations to support product related claims was infrequent in advertisements from wound care journals, where 35% of advertisements containing a product related claim also contained at least one citation, compared with 63% of advertisements from the British Medical Journal. Of citations that were supplied, journal articles were less common in the wound journals (40% vs. 73% in the British Medical Journal) and data on file more common (38% vs. 6% in the British Medical Journal). Where journal articles were obtained, 56% of claims in the wound care journals advertisements were not supported by the cited article, compared with 12% of claims in the British Medical Journal. CONCLUSION: The wound journals advertised predominantly medical devices. The use and accuracy of referencing in advertisements from wound care journals was poor. RELEVANCE TO CLINICAL PRACTICE: Nurses have increasing responsibilities for the prescribing of both drugs and devices, which must be accompanied by the ability to interpret marketing materials and research evidence critically. Nurse educators must ensure that nurse education generally and nurse prescriber training particularly, builds skills of information retrieval and critical appraisal.

Summary 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).

This paper describes the development of an evidence-linked clinical guideline for the management of uncomplicated venous leg ulcers. Guidelines are developed to provide recommendations for clinical practice which are based on summaries of good quality research evidence. The aim of the guideline discussed in this article is to direct primary health care practitioners to the most effective method of assessment and treatment of venous leg ulcers and to discourage practices that do not have convincing or sufficient evidence of effectiveness. The three most important steps to the development of a valid clinical guideline are: basing recommendations on the best available evidence; explicit linkage between guideline recommendations and quality of evidence; and the involvement of a multidisciplinary group. The steps are discussed in relation to the development of the guideline alongside an introductory presentation on the role guidelines can play in improving practice. Issues arising from guideline development such as valid ways of obtaining patient input and lack of evidence are also discussed.

Objective: To estimate the clinical and cost effectiveness of compression systems for treating venous leg ulcers. Methods: Systematic review of research. Search of 19 electronic databases including Medline, CINAHL, and Embase. Relevant journals and conference proceedings were hand searched and experts were consulted. Main outcome measures: Rate of healing and proportion of ulcers healed within a time period. Study selection: Randomised controlled trials, published or unpublished, with no restriction on date or language, that evaluated compression as a treatment for venous leg ulcers. Results: 24 randomised controlled trials were included in the review. The research evidence was quite weak: many trials had inadequate sample size and generally poor methodology. Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems. Conclusions: Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers. Insufficient reliable evidence exists to indicate which system is the most effective. More good quality randomised controlled trials in association with economic evaluations are needed, to ascertain the most cost effective system for treating venous leg ulcers. Key messages Compression treatment increases the healing of ulcers compared with no compression High compression is more effective than low compression but should only be used in the absence of significant arterial disease No clear differences in the effectiveness of different types of compression systems (multilayer and short stretch bandages and Unna9s boot) have been shown Intermittent pneumatic compression appears to be a useful adjunct to bandaging Rather than advocate one particular system, the increased use of any correctly applied high compression treatment should be promoted

INTRODUCTION: Obese women are more likely to develop a surgical site infection (SSI) following caesarean section (CS) than non-obese women. Negative pressure wound therapy (NPWT) is increasingly being used to reduce SSI with limited evidence for its effectiveness. OBJECTIVES: To determine the clinical and cost-effectiveness of using NPWT in obese women having elective and semiurgent CS. METHODS AND ANALYSIS: A multisite, superiority parallel pragmatic randomised controlled trial with an economic evaluation. Women with a body mass index (BMI) of ≥ 30, booked for elective and semiurgent CS at 4 Australian acute care hospitals will be targeted. A total of 2090 women will be enrolled. A centralised randomisation service will be used with participants block randomised to either NPWT or standard surgical dressings in a 1:1 ratio, stratified by hospital. The primary outcome is SSI; secondary outcomes include type of SSI, length of stay, readmission, wound complications and health-related quality of life. Economic outcomes include direct healthcare costs and cost-effectiveness, which will be evaluated using incremental cost per quality-adjusted life year gained. Data will be collected at baseline, and participants followed up on the second postoperative day and weekly from the day of surgery for 4 weeks. Outcome assessors will be masked to allocation. The primary statistical analysis will be based on intention-to-treat. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the ethics committees of the participating hospitals and universities. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12615000286549; Pre-results. Australian National Health & Medical Research Project Grant (APP1081026)

A questionnaire was completed by 146 community nurses which requested information on the types of leg ulcers they managed, along with details of their nursing assessment, monitoring and prevention strategies. Important differences in their reported clinical practice related to when they qualified as a community nurse. It is imperative that patients with chronic leg ulcers be given the benefit of a medical diagnosis, and an in-depth nursing assessment so that an appropriate and effective plan of management may be developed. Community nurses could benefit from further information on the aetiology and research-based management of patients with leg ulcers. A creative approach to the dissemination of research evidence for the management of leg ulcers, as part of continuing education initiatives, is required.

Objective: To compare the effectiveness of two types of compression treatment (four layer bandage and short stretch bandage) in people with venous leg ulceration.\ud \ud Design: Systematic review and meta-analysis of patient level data.\ud \ud Data: sources Electronic databases (the Cochrane Central Register of Controlled Trials, the Cochrane Wounds Group Specialised Register, Medline, Embase, CINAHL, and National Research Register) and reference lists of retrieved articles searched to identify relevant trials and primary investigators. Primary investigators of eligible trials were invited to contribute raw data for re-analysis.\ud \ud Review: methods Randomised controlled trials of four layer bandage compared with short stretch bandage in people with venous leg ulceration were eligible for inclusion. The primary outcome for the meta-analysis was time to healing. Cox proportional hazards models were run to compare the methods in terms of time to healing with adjustment for independent predictors of healing. Secondary outcomes included incidence and number of adverse events per patient.\ud \ud Results: Seven eligible trials were identified (887 patients), and patient level data were retrieved for five (797 patients, 90% of known randomised patients). The four layer bandage was associated with significantly shorter time to healing: hazard ratio (95% confidence interval) from multifactorial model based on five trials was 1.31 (1.09 to 1.58), P=0.005. Larger ulcer area at baseline, more chronic ulceration, and previous ulceration were all independent predictors of delayed healing. Data from two trials showed no evidence of a difference in adverse event profiles between the two bandage types.\ud \ud Conclusions: Venous leg ulcers in patients treated with four layer bandages heal faster, on average, than those of people treated with the short stretch bandage. Benefits were consistent across patients with differing prognostic profiles.

Objective: To assess the cost effectiveness of larval therapy compared with hydrogel in the management of leg ulcers. Design: Cost effectiveness and cost utility analyses carried out alongside a pragmatic multicentre, randomised, open trial with equal randomisation. Population: Intention to treat population comprising 267 patients with a venous or mixed venous and arterial ulcers with at least 25% coverage of slough or necrotic tissue. Interventions: Patients were randomly allocated to debridement with bagged larvae, loose larvae, or hydrogel. Main outcome measure: The time horizon was 12 months and costs were estimated from the UK National Health Service perspective. Cost effectiveness outcomes are expressed in terms of incremental costs per ulcer-free day (cost effectiveness analysis) and incremental costs per quality adjusted life years (cost utility analysis). Results: The larvae arms were pooled for the main analysis. Treatment with larval therapy cost, on average, 96.70 pound ((sic)109.61; $140.57) more per participant per year (95% confidence interval -491.9 pound to 685.8) pound than treatment with hydrogel. Participants treated with larval therapy healed, on average, 2.42 days before those in the hydrogel arm (95% confidence interval -0.95 to 31. 91 days) and had a slightly better health related quality of life, as the annual difference in QALYs was 0.011 (95% confidence interval -0.067 to 0.071). However, none of these differences was statistically significant. The incremental cost effectiveness ratio for the base case analysis was estimated at 8826 pound per QALY gained and 40 pound per ulcer-free day. Considerable uncertainty surrounds the outcome estimates. Conclusions: Debridement of sloughy or necrotic leg ulcers with larval therapy is likely to produce similar health benefits and have similar costs to treatment with hydrogel. Trial registration: Current Controlled Trials ISRCTN55114812 and National Research Register N0484123692.

Aims and objectives. This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Background. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Design. Qualitative focus group study. Methods. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. Findings. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. Conclusions. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal ‘participant observers.’ Such observations enhance understanding of the contexts being studied. Relevance to clinical practice. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Objective To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability. Design Pragmatic, open, multicentre, randomised controlled trial. Setting 11 hospitals in six NHS trusts. Participants 1972 people admitted to hospital as acute or elective patients. Interventions Participants were randomised to an alternating pressure mattress (n = 982) or an alternating pressure overlay (n = 990). Main outcome measures The proportion of participants developing a new pressure ulcer of grade 2 or worse; time to development of new pressure ulcers; proportions of participants developing a new ulcer within 30 days; healing of existing pressure ulcers; and patient acceptability. Results Intention to treat analysis found no difference in the proportions of participants developing a new pressure ulcer of grade 2 or worse (10.7% overlay patients, 10.3% mattress patients; difference 0.4%, 95% confidence interval - 2.3% to 3.1%, P = 0.75). More overlay patients requested change owing to dissatisfaction (23.3%) than mattress patients (18.9%, P = 0.02). Conclusion No difference was found between alternating pressure mattresses and alternating pressure overlays in the proportion of people who develop a pressure ulcer. Trial registration ISRCTN 78646179

Objective To assess tire cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital. Design Cost effectiveness analysis carried out alongside the pressure relieving support surfaces (PRESSURE) trial; a multicentre UK based pragmatic randomised controlled trial. Setting 11 hospitals in six UK NHS trusts. Participants Intention to treat population comprising 1971 participants. Main outcome measures Kaplan Meier estimates of restricted mean time to development of pressure ulcers and total costs for treatment in hospital. Results Alternating pressure mattresses were associated with lower overall costs (283.6 pound per patient on average, 95% confidence interval -377.59 pound to. 976.79) pound mainly due to reduced length of stay in hospital, and greater benefits (a delay in time to ulceration of 10.64 days on average, - 24.40 to 3.09). The differences in health benefits and total costs for hospital stay between alternating pressure mattresses and alternating pressure overlays were not statistically significant; however, a cost effectiveness acceptability curve indicated that on average alternating pressure mattresses compared with alternating pressure overlays were associated with air 80% probability of being cost saving. Conclusion Alternating pressure mattresses for the prevention of pressure ulcers are more likely to be cost effective and are more acceptable to patients than alternating pressure overlays.

Evidence-based practice means integrating the best available research evidence with information about patient preferences, clinician skill level, and available resources to make decisions about patient care. Barriers to the use of research-based evidence occur when time, access to journal articles, search skills, critical appraisal skills, and understanding of the language used in research are lacking. Resources are available to overcome these barriers and support an evidence-based nursing practice. This article highlights available resources and describes strategies that nurses can use to develop and sustain an evidence-based nursing practice.

The Art & Science section of Nursing Standard this week is devoted to encouraging nurses to use evidence in their practice. As well as publishing some of the papers from the recent Evidence-Based Nursing conference in London, this report is based on the editorial which appeared in the pilot issue of Evidence-Based Nursing, a new journal jointly published by the BMJ Publishing Group and the RCN Publishing Company. It highlights the importance of using evidence in practice and explores the role of the new journal, which will be launched in November 1997, in helping nurses to achieve this aim.

A descriptive survey of current reported practice by 146 community nurses for their nursing treatment of leg ulcers was undertaken. Sixty-four per cent of nurses reported they would apply compression bandages to only venous ulcers; in only 23% of cases could the products described achieve an adequate level of compression. A variety of modern wound dressings were used by the nurses; 89% of nurses reported using a combination of different products layered over the ulcer. There is no evidence that this has any beneficial effect and could therefore be a potential waste of money, as well as contributing to allergic skin reactions. It would be useful if primary-health-care teams and Family Health Service Authority information pharmacists formulated protocols based upon effective treatments for patients with chronic leg ulcers.

Objective To assess the clinical effectiveness of weekly delivery of low dose, high frequency therapeutic ultrasound in conjunction with standard care for hard to heal venous leg ulcers. Design Multicentre, pragmatic, two arm randomised controlled trial. Setting Community and district nurse led services, community leg ulcer clinics, and hospital outpatient leg ulcer clinics in 12 urban and rural settings (11 in the United Kingdom and one in the Republic of Ireland). Participants 337 patients with at least one venous leg ulcer of >6 months’ duration or >5 cm2 area and an ankle brachial pressure index of ≥0.8. Interventions Weekly administration of low dose, high frequency ultrasound therapy (0.5 W/cm2, 1 MHz, pulsed pattern of 1:4) for up to 12 weeks plus standard care compared with standard care alone. Main outcome measures Primary outcome was time to healing of the largest eligible leg ulcer. Secondary outcomes were proportion of patients healed by 12 months, percentage and absolute change in ulcer size, proportion of time participants were ulcer-free, health related quality of life, and adverse events. Results The two groups showed no significant difference in the time to healing of the reference leg ulcer (log rank test, P=0.61). After adjustment for baseline ulcer area, baseline ulcer duration, use of compression bandaging, and study centre, there was still no evidence of a difference in time to healing (hazard ratio 0.99 (95% confidence interval 0.70 to 1.40), P=0.97). The median time to healing of the reference leg ulcer was inestimable. There was no significant difference between groups in the proportion of participants with all ulcers healed by 12 months (72/168 in ultrasound group v 78/169 in standard care group, P=0.39 for Fisher’s exact test) nor in the change in ulcer size at four weeks by treatment group (model estimate 0.05 (95% CI –0.09 to 0.19)). There was no difference in time to complete healing of all ulcers (log rank test, P=0.61), with median time to healing of 328 days (95% CI 235 to inestimable) with standard care and 365 days (224 days to inestimable) with ultrasound. There was no evidence of a difference in rates of recurrence of healed ulcers (17/31 with ultrasound v 14/31 with standard care, P=0.68 for Fisher’s exact test). There was no difference between the two groups in health related quality of life, both for the physical component score (model estimate 0.69 (–1.79 to 3.08)) and the mental component score (model estimate –0.93 (–3.30 to 1.44)), but there were significantly more adverse events in the ultrasound group (model estimate 0.30 (0.01 to 0.60)). There was a significant relation between time to ulcer healing and baseline ulcer area (hazard ratio 0.64 (0.55 to 0.75)) and baseline ulcer duration (hazard ratio 0.59 (0.50 to 0.71)), with larger and older ulcers taking longer to heal. In addition, those centres with high recruitment rates had the highest healing rates. Conclusions Low dose, high frequency ultrasound administered weekly for 12 weeks during dressing changes in addition to standard care did not increase ulcer healing rates, affect quality of life, or reduce ulcer recurrence. Trial registrationISRCTN21175670 and National Research Register N0484162339

In the editorial accompanying our three papers on leg ulcers, Grey and colleagues make several points that deserve reply.1 2 3 4 They do not like our selection of time to healing as the primary outcome in the larval therapy study, but debridement is practised precisely because it is thought to aid healing. They claim that debridement “is more valuable to clinicians,” but is …

EDITOR—The statement by Thomas and Asaad, that vacuum assisted closure (VAC) and maggots should be considered as first line rather than alternative treatment in hard to heal, cavitating, intransigent ulcers with sloughy and unhealthy …

Objectives To assess the extent and pattern of implementation of guidance issued by the National Institute for Clinical Excellence (NICE). \ud \ud Design Interrupted time series analysis, review of case notes, survey, and interviews. \ud \ud Setting Acute and primary care trusts in England and Wales. \ud \ud Participants All primary care prescribing, hospital pharmacies; a random sample of 20 acute trusts, 17 mental health trusts, and 21 primary care trusts; and senior clinicians and managers from five acute trusts. \ud \ud Main outcome measures Rates of prescribing and use of procedures and medical devices relative to evidence based guidance. \ud \ud Results 6308 usable patient audit forms were returned. Implementation of NICE guidance varied by trust and by topic. Prescribing of some taxanes for cancer (P < 0.002) and orlistat for obesity (P < 0.001) significantly increased in line with guidance. Prescribing of drugs for Alzheimer's disease and prophylactic extraction of wisdom teeth showed trends consistent with, but not obviously a consequence of, the guidance. Prescribing practice often did not accord with the details of the guidance. No change was apparent in the use of hearing aids, hip prostheses, implantable cardioverter defibrillators, laparoscopic hernia repair, and laparoscopic colorectal cancer surgery after NICE guidance had been issued. \ud \ud Conclusions Implementation of NICE guidance has been variable. Guidance seems more likely to be adopted when there is strong professional support, a stable and convincing evidence base, and no increased or unfunded costs, in organisations that have established good systems for tracking guidance implementation and where the professionals involved are not isolated. Guidance needs to be clear and reflect the clinical context.

What's the difference between medical and nursing care? The answer is not straightforward, but shortages in the medical workforce mean that nurses are increasingly called on to undertake work that was previously done by doctors (such as undertaking surgery,1 prescribing drugs, performing triage in emergency departments), whereas shortages in the nursing workforce mean that healthcare assistants now do many tasks that nurses are trained to do. This fluidity in professional roles and competencies enables the health workforce to respond to need, but are outcomes for patients being improved? Do these benefits come at an additional cost, and if so, are they worth paying for?