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

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

Development of a core outcome set for use in research evaluations of interventions for venous leg ulceration: International eDelphi consensus.

INTRODUCTION: Venous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual's health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU. AIM: To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment. METHOD: Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry). RESULTS: Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting. RECOMMENDATIONS: We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).

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

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

Identifying outcomes reported in trials of interventions in venous leg ulceration for a core outcome set development: A scoping review.

BACKGROUND: Venous leg ulceration is a chronic, recurring, condition causing significant patient morbidity. Randomised controlled trials evaluating treatments for venous leg ulceration provide evidence for clinical decision-making. For trial findings to be useful, outcomes measured need to be clinically meaningful, and consistently and fully reported across trials. A core outcome set is an agreed and standardised set of outcomes which should be, as a minimum, reported in all trials for a given indication. AIM: To identify the outcome domains and outcomes reported in trials of interventions for venous leg ulceration. METHODS: A scoping review of the literature was carried out. Randomised controlled trials within Cochrane systematic reviews looking at venous leg ulceration interventions and qualitative studies exploring venous leg ulceration were included. RESULTS: The review identified 807 outcomes from randomised controlled trials and 15 outcomes from qualitative studies, and these were grouped into 11 outcome domains: healing, patient reported symptoms, clinician reported symptoms, carer reported symptoms, life impacts, clinical signs, clinical measurement, performance of the intervention, resource use (supplies and clinician time) and adverse events. The outcome domain 'healing' included 111 outcomes, 'symptoms' 109, 'life impacts' 30, 'clinical signs' 88, 'clinical measurement' 184, 'performance of the intervention' 58, 'resource use' 52 and 'adverse events' 190. CONCLUSION: The scoping review identified a large number of outcomes (n = 822) across 11 related outcome domains, supporting the need for a core outcome set.

An evidence-based self-management package for urinary incontinence in older women: a mixed methods feasibility study.

BACKGROUND: Urinary incontinence (UI) is a distressing condition that limits women's quality of life and places a heavy burden on health care services. Behavioural treatments are recommended as a first-line treatment. An evidence-based self-management package was developed following the Medical Research Council (MRC) framework for complex interventions. This study aimed to evaluate the feasibility and acceptability of the intervention. METHODS: A mixed-methods approach was undertaken, namely a randomised controlled feasibility study with nested qualitative study. Fifty women aged 55 or over living with UI, recruited from community centres were randomly assigned to either a 3-month course with the package with a support session or a control group to receive the same package only 3 months later. Principal outcome measures were: self-reported quality of life, UI severity, self-efficacy and psychological status. Analysis of covariance was undertaken to estimate within- and between- group changes for all outcomes. Acceptability was explored using individual interviews at follow-up. RESULTS: Fifty women were randomised (24 to intervention, 26 to control); mean age of 69.7 (±9.1) years and mean UI frequency 2.2 (±2.2) episodes/day at baseline. Overall, 49 women (98%) completed 3-month follow-up (24 in the intervention, 25 in the control). A positive trend was detected in the impact of UI on their personal relationships (- 3.89, p = 0.088), symptom severity (- 1.77, p = 0.025), UI symptoms scale (- 1.87, p = 0.031) and anxiety status (- 2.31, p = 0.001), respectively. Changes in quality of life and self-efficacy did not differ significantly between groups. Majority of women (71%) in the intervention group reported subjective improvement after 3 months. Spearman correlation coefficient was 0.43 (p < 0.05) between their subjective perception of change and self-efficacy. Women perceived the package being acceptable and described that the package had the potential to increase their knowledge and confidence to manage symptoms and improve quality of life. CONCLUSIONS: The study demonstrated that the self-management package is feasible and acceptable for older women with UI. Further studies are needed with a large sample size in clinical settings to evaluate the effectiveness of this package. TRIAL REGISTRATION: ISRCTN17194896. Registered on 11th September 2019 (retrospectively registered).

Clinical evaluation of a new pressure ulcer risk assessment instrument, the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE T).

AIM: To test the psychometric properties and clinical usability of a new Pressure Ulcer Risk Assessment Instrument including inter-rater and test-retest reliability, convergent validity and data completeness. BACKGROUND: Methodological and practical limitations associated with traditional Pressure Ulcer Risk Assessment Instruments, prompted a programme to work to develop a new instrument, as part of the National Institute for Health Research funded, Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056). DESIGN: Observational field test. METHOD: For this clinical evaluation 230 patients were purposefully sampled across four broad levels of pressure ulcer risk with representation from four secondary care and four community NHS Trusts in England. Blinded and simultaneous paired (ward/community nurse and expert nurse) PURPOSE-T assessments were undertaken. Follow-up retest was undertaken by the expert nurse. Field notes of PURPOSE-T use were collected. Data were collected October 2012-January 2013. RESULTS: The clinical evaluation demonstrated "very good" (kappa) inter-rater and test-retest agreement for PURPOSE-T assessment decision overall. The percentage agreement for "problem/no problem" was over 75% for the main risk factors. Convergent validity demonstrated moderate to high associations with other measures of similar constructs. CONCLUSION: The PURPOSE-T evaluation facilitated the initial validation and clinical usability of the instrument and demonstrated that PURPOSE-T is suitable of use in clinical practice. Further study is needed to evaluate the impact of using the instrument on care processes and outcomes.

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.

Dance movement therapy for depression.

BACKGROUND: Depression is a debilitating condition affecting more than 350 million people worldwide (WHO 2012) with a limited number of evidence-based treatments. Drug treatments may be inappropriate due to side effects and cost, and not everyone can use talking therapies.There is a need for evidence-based treatments that can be applied across cultures and with people who find it difficult to verbally articulate thoughts and feelings. Dance movement therapy (DMT) is used with people from a range of cultural and intellectual backgrounds, but effectiveness remains unclear. OBJECTIVES: To examine the effects of DMT for depression with or without standard care, compared to no treatment or standard care alone, psychological therapies, drug treatment, or other physical interventions. Also, to compare the effectiveness of different DMT approaches. SEARCH METHODS: The Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR-Studies and CCDANCTR-References) and CINAHL were searched (to 2 Oct 2014) together with the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. The review authors also searched the Allied and Complementary Medicine Database (AMED), the Education Resources Information Center (ERIC) and Dissertation Abstracts (to August 2013), handsearched bibliographies, contacted professional associations, educational programmes and dance therapy experts worldwide. SELECTION CRITERIA: Inclusion criteria were: randomised controlled trials (RCTs) studying outcomes for people of any age with depression as defined by the trialist, with at least one group being DMT. DMT was defined as: participatory dance movement with clear psychotherapeutic intent, facilitated by an individual with a level of training that could be reasonably expected within the country in which the trial was conducted. For example, in the USA this would either be a trainee, or qualified and credentialed by the American Dance Therapy Association (ADTA). In the UK, the therapist would either be in training with, or accredited by, the Association for Dance Movement Psychotherapy (ADMP, UK). Similar professional bodies exist in Europe, but in some countries (e.g. China) where the profession is in development, a lower level of qualification would mirror the situation some decades previously in the USA or UK. Hence, the review authors accepted a relevant professional qualification (e.g. nursing or psychodynamic therapies) plus a clear description of the treatment that would indicate its adherence to published guidelines including Levy 1992, ADMP UK 2015, Meekums 2002, and Karkou 2006. DATA COLLECTION AND ANALYSIS: Study methodological quality was evaluated and data were extracted independently by the first two review authors using a data extraction form, the third author acting as an arbitrator. MAIN RESULTS: Three studies totalling 147 participants (107 adults and 40 adolescents) met the inclusion criteria. Seventy-four participants took part in DMT treatment, while 73 comprised the control groups. Two studies included male and female adults with depression. One of these studies included outpatient participants; the other study was conducted with inpatients at an urban hospital. The third study reported findings with female adolescents in a middle-school setting. All included studies collected continuous data using two different depression measures: the clinician-completed Hamilton Depression Rating Scale (HAM-D); and the Symptom Checklist-90-R (SCL-90-R) (self-rating scale).Statistical heterogeneity was identified between the three studies. There was no reliable effect of DMT on depression (SMD -0.67 95% CI -1.40 to 0.05; very low quality evidence). A planned subgroup analysis indicated a positive effect in adults, across two studies, 107 participants, but this failed to meet clinical significance (SMD -7.33 95% CI -9.92 to -4.73).One adult study reported drop-out rates, found to be non-significant with an odds ratio of 1.82 [95% CI 0.35 to 9.45]; low quality evidence. One study measured social functioning, demonstrating a large positive effect (MD -6.80 95 % CI -11.44 to -2.16; very low quality evidence), but this result was imprecise. One study showed no effect in either direction for quality of life (0.30 95% CI -0.60 to 1.20; low quality evidence) or self esteem (1.70 95% CI -2.36 to 5.76; low quality evidence). AUTHORS' CONCLUSIONS: The low-quality evidence from three small trials with 147 participants does not allow any firm conclusions to be drawn regarding the effectiveness of DMT for depression. Larger trials of high methodological quality are needed to assess DMT for depression, with economic analyses and acceptability measures and for all age groups.

A prospective cohort study of prognostic factors for the healing of heel pressure ulcers.

BACKGROUND: pressure ulcers, 25-30% of which are on the heels are a major burden to patients and healthcare systems. A better understanding of factors associated with healing is required to inform treatment and research priorities. OBJECTIVES: to identify patient and pressure ulcer characteristics associated with the healing of heel pressure ulcers. STUDY DESIGN AND SETTING: patients with heel pressure ulcers were recruited to a prospective cohort study in a large teaching hospital in the UK, with a maximum 18-month follow-up. Cox proportional hazards model regression analysis was used to identify prognostic factors for healing. RESULTS: one hundred and forty of 148 patients recruited were analysed. They had 183 pressure ulcers: 77 ulcers healed, 5 were on limbs amputated prior to ulcer healing, 88 were on patients who died prior to healing, 11 were present at the end of the study and 2 were lost to follow-up. The median time to healing was 121 (range 8-440) days. Of 12 variables associated with healing (P ≤ 0.2), multi-variable analysis identified two factors which were independently predictive of healing including the presence of a severe (versus superficial) ulcer (hazard ratio = 0.48, P < 0.1) and the presence of peripheral arterial disease (hazard ratio = 0.40, P < 0.1). CONCLUSIONS: increased ulcer severity and the presence of peripheral arterial disease significantly reduced the probability of healing. Treatments for heel pressure ulcers should consider the severity of the ulcer and the presence of peripheral arterial disease.

Compression for preventing recurrence of venous ulcers.

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. The majority of leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or weakness of the valves in the veins of the leg. Prevention and treatment of venous ulcers is aimed at reducing the pressure either by removing/repairing the veins, or by applying compression bandages/stockings to reduce the pressure in the veins.The majority of venous ulcers heal with compression bandages, however ulcers frequently recur. Clinical guidelines therefore recommend that people continue to wear compression, usually in the form of hosiery (tights, stockings, socks) after their ulcer heals, to prevent recurrence. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) in preventing the recurrence of venous ulcers. If compression does prevent ulceration compared with no compression, then to identify whether there is evidence to recommend particular levels of compression (high, medium or low, for example), types of compression, or brands of compression to prevent ulcer recurrence after healing. SEARCH METHODS: For this second update we searched The Cochrane Wounds Group Specialised Register (searched 4 September 2014) which includes the results of regular searches of MEDLINE, EMBASE and CINAHL; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 8). SELECTION CRITERIA: Randomised controlled trials (RCTs)evaluating compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: Two review authors undertook data extraction and risk of bias assessment independently. MAIN RESULTS: Four trials (979 participants) were eligible for inclusion in this review. One trial in patients with recently healed venous ulcers (n = 153) compared recurrence rates with and without compression and found that compression significantly reduced ulcer recurrence at six months (Risk ratio (RR) 0.46, 95% CI 0.27 to 0.76).Two trials compared high-compression hosiery (equivalent to UK class 3) with moderate-compression hosiery (equivalent to UK class 2). The first study (n=300) found no significant reduction in recurrence at five years follow up with high-compression hosiery compared with moderate-compression (RR 0.82, 95% CI 0.61 to 1.12). The second study (n = 338) assessed ulcer recurrence at three years follow up and found that high-compression hosiery reduced recurrence compared with moderate-compression (RR 0.57, 95% CI 0.39 to 0.81). Statistically significant heterogeneity precluded meta-analysis of the results from these studies. Patient-reported compliance rates were reported in both trials;,there was significantly higher compliance with medium-compression than with high-compression hosiery in one and no significant difference in the second.A fourth trial (166 patients) found no statistically significant difference in recurrence between two types of medium (UK class 2) compression hosiery (Medi versus Scholl: RR 0.74, 95% CI 0.45 to 1.2).No trials of compression bandages for preventing ulcer recurrence were identified. AUTHORS' CONCLUSIONS: There is evidence from one trial that compression hosiery reduces rates of reulceration of venous ulcers compared with no compression. Results from one trial suggest that recurrence is lower in high-compression hosiery than in medium-compression hosiery at three years whilst another trial found no difference at 5 years. Rates of patient intolerance of compression hosiery were high. There is insufficient evidence to aid selection of different types, brands, or lengths of compression hosiery.

Intermittent pneumatic compression for treating venous leg ulcers.

BACKGROUND: Intermittent pneumatic compression (IPC) is a mechanical method of delivering compression to swollen limbs that can be used to treat venous leg ulcers and limb swelling due to lymphoedema. OBJECTIVES: To determine whether IPC increases the healing of venous leg ulcers. To determine the effects of IPC on health related quality of life of venous leg ulcer patients. SEARCH METHODS: In April 2014, for this third update, we searched the Cochrane Wounds Group Specialised Register; 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: We included randomised controlled trials (RCTs) that compared the effects of IPC with control (sham IPC or no IPC) or made comparisons between IPC treatment regimens, in venous ulcer management. DATA COLLECTION AND ANALYSIS: Two review authors reviewed titles and abstracts and agreed on full studies to be retrieved. One review author extracted data and assessed studies for risk of bias and this was checked by a second review author. MAIN RESULTS: We identified nine randomised controlled trials (including 489 people in total). Only one trial was at low risk of bias overall having reported adequate randomisation, allocation concealment and blinded outcome assessment. In one trial (80 people) more ulcers healed with IPC than with dressings (62% vs 28%; p=0.002). Five trials compared IPC plus compression with compression alone. Two of these (97 people) found increased ulcer healing with IPC plus compression than with compression alone. The remaining three trials (122 people) found no evidence of a benefit for IPC plus compression compared with compression alone.Two trials (86 people) found no difference between IPC (without additional compression) and compression bandages alone.One trial (104 people) compared different ways of delivering IPC and found that rapid IPC healed more ulcers than slow IPC (86% vs 61%). AUTHORS' CONCLUSIONS: IPC may increase healing compared with no compression. It is unclear whether it can be used instead of compression bandages. There is some limited evidence that IPC may improve healing when added to compression bandages. Rapid IPC was better than slow IPC in one trial. Further trials are required to determine the reliability of current evidence, which patients may benefit from IPC in addition to compression bandages, and the optimum treatment regimen.

A new pressure ulcer conceptual framework.

AIM: This paper discusses the critical determinants of pressure ulcer development and proposes a new pressure ulcer conceptual framework. BACKGROUND: Recent work to develop and validate a new evidence-based pressure ulcer risk assessment framework was undertaken. This formed part of a Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research. The foundation for the risk assessment component incorporated a systematic review and a consensus study that highlighted the need to propose a new conceptual framework. DESIGN: Discussion Paper. DATA SOURCES: The new conceptual framework links evidence from biomechanical, physiological and epidemiological evidence, through use of data from a systematic review (search conducted March 2010), a consensus study (conducted December 2010-2011) and an international expert group meeting (conducted December 2011). IMPLICATIONS FOR NURSING: A new pressure ulcer conceptual framework incorporating key physiological and biomechanical components and their impact on internal strains, stresses and damage thresholds is proposed. Direct and key indirect causal factors suggested in a theoretical causal pathway are mapped to the physiological and biomechanical components of the framework. The new proposed conceptual framework provides the basis for understanding the critical determinants of pressure ulcer development and has the potential to influence risk assessment guidance and practice. It could also be used to underpin future research to explore the role of individual risk factors conceptually and operationally. CONCLUSION: By integrating existing knowledge from epidemiological, physiological and biomechanical evidence, a theoretical causal pathway and new conceptual framework are proposed with potential implications for practice and research.

Developing a pressure ulcer risk factor minimum data set and risk assessment framework.

AIM: To agree a draft pressure ulcer risk factor Minimum Data Set to underpin the development of a new evidenced-based Risk Assessment Framework. BACKGROUND: A recent systematic review identified the need for a pressure ulcer risk factor Minimum Data Set and development and validation of an evidenced-based pressure ulcer Risk Assessment Framework. This was undertaken through the Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research and incorporates five phases. This article reports phase two, a consensus study. DESIGN: Consensus study. METHOD: A modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. This incorporated an expert group, review of the evidence and the views of a Patient and Public Involvement service user group. Data were collected December 2010-December 2011. FINDINGS: The risk factors and assessment items of the Minimum Data Set (including immobility, pressure ulcer and skin status, perfusion, diabetes, skin moisture, sensory perception and nutrition) were agreed. In addition, a draft Risk Assessment Framework incorporating all Minimum Data Set items was developed, comprising a two stage assessment process (screening and detailed full assessment) and decision pathways. CONCLUSION: The draft Risk Assessment Framework will undergo further design and pre-testing with clinical nurses to assess and improve its usability. It will then be evaluated in clinical practice to assess its validity and reliability. The Minimum Data Set could be used in future for large scale risk factor studies informing refinement of the Risk Assessment Framework.

Different context, different results: venous ulcer healing and the use of two high-compression technologies.

AIMS AND OBJECTIVES: To update the evidence for the relative effectiveness of the four-layer and short-stretch compression technologies used for the treatment of venous ulcers. BACKGROUND: Compression bandages are the most effective method for venous ulcer healing. Both four-layer and short-stretch compression are effective but the relative benefit of one over the other is not fully understood. DESIGN: Meta-analysis of data from randomised trials of short-stretch and four-layer compression bandages. METHODS: We conducted a hazards ratio meta-analysis that combined the results from the existing review evidence with the latest randomised trial. RESULTS: Prior to inclusion of the Canadian Bandaging Trial, the meta-analysis of the available evidence from four trials indicated that short-stretch bandaging was associated with a lower chance of healing than four-layer bandaging. Adding this trial to the meta-analysis however, the relative benefit for the four-layer bandaging did not persist. CONCLUSIONS: Addition of the largest trial of compression technologies attenuated the apparent relative benefit for four-layer bandaging over short-stretch seen in the previous systematic reviews. This may be because the latest trial was large and found no difference in healing rates, attributed to the fact that both technologies were in common use in the trial centres, rather than being a trial of a new bandaging technology over an existing technology. RELEVANCE TO CLINICAL PRACTICE: This analysis indicates that the choice of a compression system can be safely made with equal regard to clinician choice, patient preference and economic considerations as these technologies appear comparable in terms of healing rates.

Pressure ulcer related pain in community populations: a prevalence survey.

BACKGROUND: Pressure ulcers are costly to the healthcare provider and can have a major impact on patient's quality of life. One of the most distressing symptoms reported is pain. There is very little published data on the prevalence and details of pain experienced by patients with pressure ulcers, particularly in community populations. The study was conducted in two community NHS sites in the North of England. METHODS: The aim was to estimate the prevalence of pressure area related pain within a community population. We also explored the type and severity of the pain and its association with pressure ulcer classification. A cross-sectional survey was performed of community nurses caseloads to identify adult patients with pressure ulcers and associated pain. Consenting patients then had a full pain assessment and verification of pressure ulcer grade. RESULTS: A total of 287 patients were identified with pressure ulcers (0.51 per 1000 adult population). Of the 176 patients who were asked, 133 (75.6%) reported pain. 37 patients consented to a detailed pain assessment. Painful pressure ulcers of all grades and on nearly all body sites were identified. Pain intensity was not related to number or severity of pressure ulcer. Both inflammatory and neuropathic pain were reported at all body sites however the proportion of neuropathic pain was greater in pressure ulcers on lower limbs. CONCLUSIONS: This study has identified the extent and type of pain suffered by community patients with pressure ulcers and indicates the need for systematic and regular pain assessment and treatment.

Skin grafting for venous leg ulcers.

BACKGROUND: Venous leg ulceration is a recurrent, chronic, disabling condition. It affects up to one in 100 people at some time in their lives. Standard treatments are simple dressings and compression bandages or stockings. Sometimes, despite treatment, ulcers remain open for months or years. Sometimes skin grafts are used to stimulate healing. These may be taken, or grown into a dressing, from the patient's own uninjured skin (autografts), or applied as a sheet of bioengineered skin grown from donor cells (allograft). Preserved skin from other animals, such as pigs, has also been used (xenografts). OBJECTIVES: To assess the effect of skin grafts for treating venous leg ulcers. SEARCH METHODS: For this update we modified the search strategies and conducted searches of The Cochrane Wounds Group Specialised Register (searched 27 July 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7); Ovid MEDLINE (2008 to July Week 3 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, July 26, 2012); Ovid EMBASE (2008 to 2012 Week 29); and EBSCO CINAHL (2008 to 26 July 2012). We did not apply date or language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) of skin grafts in the treatment of venous leg ulcers. DATA COLLECTION AND ANALYSIS: Two review authors independently undertook data extraction and assessment of study quality. MAIN RESULTS: For this update of the review, we identified one new trial, bringing the total to 17 trials (1034 participants) - all of which were generally at moderate or high risk of bias. In 12 trials participants also received compression bandaging.Eleven trials compared a graft with standard care in which no graft was used. Two of these trials (102 participants) compared a dressing with an autograft; three trials (80 participants) compared frozen allografts with dressings, and two trials (45 participants) compared fresh allografts with dressings. Two trials (345 participants) compared tissue-engineered skin (bilayer artificial skin) with a dressing. In two trials (97 participants) a single-layer dermal replacement was compared with standard care.Six trials compared alternative skin grafting techniques. The first trial (92 participants) compared autografts with frozen allograft, a second (51 participants) compared a pinch graft (autograft) with porcine dermis (xenograft), the third (110 participants) compared growth-arrested human keratinocytes and fibroblasts with placebo, the fourth (10 participants) compared an autograft delivered on porcine pads with an autograft delivered on porcine gelatin microbeads, the fifth trial (92 participants) compared a meshed graft with a cultured keratinocyte autograft, and the sixth trial (50 participants) compared a frozen keratinocyte allograft with a lyophilised (freeze-dried) keratinocyte allografts.Significantly more ulcers healed when treated with bilayer artificial skin than with dressings. There was insufficient evidence from the other trials to determine whether other types of skin grafting increased the healing of venous ulcers. AUTHORS' CONCLUSIONS: Bilayer artificial skin, used in conjunction with compression bandaging, increases venous ulcer healing compared with a simple dressing plus compression. Further research is needed to assess whether other forms of skin grafts increase ulcer healing.

Homeopathy for treatment of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to decreased health-related quality of life and work productivity. Evidence-based treatment guidelines have not been able to give guidance on the effects of homeopathic treatment for IBS because no systematic reviews have been carried out to assess the effectiveness of homeopathic treatment for IBS. Two types of homeopathic treatment were evaluated in this systematic review. In clinical homeopathy a specific remedy is prescribed for a specific condition. This differs from individualised homeopathic treatment, where a homeopathic remedy based on a person's individual symptoms is prescribed after a detailed consultation. OBJECTIVES: To assess the effectiveness and safety of homeopathic treatment for treating IBS. SEARCH METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), Cochrane IBD/FBD Group Specialised Register, Cochrane Complementary Medicine Field Specialised Register and the database of the Homeopathic Library (Hom-inform) from inception to February 2013. SELECTION CRITERIA: Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS. The overall quality of the evidence supporting this outcome was assessed using the GRADE criteria. We calculated the mean difference (MD) and 95% confidence interval (CI) for continuous outcomes and the risk ratio (RR) and 95% CI for dichotomous outcomes. MAIN RESULTS: Three RCTs (213 participants) were included. No cohort or case-control studies were identified. Two studies published in 1976 and 1979 compared clinical homeopathy (homeopathic remedy) to placebo for constipation-predominant IBS. One study published in 1990 compared individualised homeopathic treatment (consultation plus remedy) to usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets asking the patient to take a high fibre diet) for the treatment of IBS in female patients. Due to the low quality of reporting in the included studies the risk of bias in all three studies was unclear on most criteria and high for some criteria. A meta-analysis of two small studies (129 participants with constipation-predominant IBS) found a statistically significant difference in global improvement between the homeopathic remedy asafoetida and placebo at a short-term follow-up of two weeks. Seventy-three per cent of patients in the homeopathy group improved compared to 45% of placebo patients (RR 1.61, 95% CI 1.18 to 2.18). There was no statistically significant difference in global improvement between the homeopathic remedies asafoetida plus nux vomica and placebo. Sixty-eight per cent of patients in the homeopathy group improved compared to 52% of placebo patients (1 study, N = 42, RR 1.31, 95% CI 0.80 to 2.15). GRADE analyses rated the overall quality of the evidence for the outcome global improvement as very low due to high or unknown risk of bias, short-term follow-up and sparse data. There was no statistically significant difference found between individualised homeopathic treatment and usual care (1 RCT, N = 20) for the outcome "feeling unwell", where the participant scored how "unwell" they felt before, and after treatment (MD 0.03; 95% CI -3.16 to 3.22). None of the included studies reported on adverse events. AUTHORS' CONCLUSIONS: A pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.

The prevalence of pain at pressure areas and pressure ulcers in hospitalised patients.

BACKGROUND: Patients with pressure ulcers (PUs) report that pain is their most distressing symptom, but there are few PU pain prevalence studies. We sought to estimate the prevalence of unattributed pressure area related pain (UPAR pain) which was defined as pain, soreness or discomfort reported by patients, on an "at risk" or PU skin site, reported at a patient level. METHODS: We undertook pain prevalence surveys in 2 large UK teaching hospital NHS Trusts (6 hospitals) and a district general hospital NHS Trust (3 hospitals) during their routine annual PU prevalence audits. The hospitals provide secondary and tertiary care beds in acute and elective surgery, trauma and orthopaedics, burns, medicine, elderly medicine, oncology and rehabilitation. Anonymised individual patient data were recorded by the ward nurse and PU prevalence team. The analysis of this prevalence survey included data summaries; no inferential statistical testing was planned or undertaken. Percentages were calculated using the total number of patients from the relevant population as the denominator (i.e. including all patients with missing data for that variable). RESULTS: A total of 3,397 patients in 9 acute hospitals were included in routine PU prevalence audits and, of these, 2010 (59.2%) patients participated in the pain prevalence study. UPAR pain prevalence was 16.3% (327/2010). 1769 patients had no PUs and of these 223 patients reported UPAR pain, a prevalence of 12.6%. Of the 241 people with pressure ulcers, 104 patients reported pain, a UPAR pain prevalence of 43.2% (104/241). CONCLUSION: One in six people in acute hospitals experience UPAR pain on 'at risk' or PU skin sites; one in every 8 people without PUs and, more than 2 out of every five people with PUs. The results provide a clear indication that all patients should be asked if they have pain at pressure areas even when they do not have a PU.

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

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

Topical agents or dressings for pain in venous leg ulcers.

BACKGROUND: Venous leg ulcers affect up to 1% of people at some time in their lives and are often painful. The main treatments are compression bandages and dressings. Topical treatments to reduce pain during and between dressing changes are sometimes used. OBJECTIVES: To determine the effects of topical agents or dressings for pain in venous leg ulcers. SEARCH METHODS: For this third update the following databases were searched: Cochrane Wounds Group Specialised Register (searched 9 May 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 4); Ovid MEDLINE (2009 to April Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations May 08, 2012); Ovid EMBASE (2009 to 2012 Week 18); and EBSCO CINAHL (2009 to May 2 2012). No date or language restrictions were applied. SELECTION CRITERIA: Published or unpublished randomised controlled trials (RCTs) that evaluated the effects of topical agents or dressing for the treatment of pain in venous ulcers were included. DATA COLLECTION AND ANALYSIS: Two review authors independently performed trial selection, data extraction and risk of bias assessment. MAIN RESULTS: Six trials (343 participants) evaluated Eutectic Mixture of Local Anaesthetics (EMLA): lidocaine-prilocaine cream for the pain associated with ulcer debridement. The between-group difference in pain measured on a 100 mm scale was statistically significant in favour of EMLA (MD -20.65, 95% CI -12.19 to -29.11). No significant between-group differences in burning or itching were observed.Two trials (470 participants with venous leg ulcers) evaluated ibuprofen slow-release foam dressings for persistent venous leg ulcer pain. Compared with local best practice, significantly more participants in the ibuprofen dressing group achieved the outcome of >50% of the total maximum pain relief score between day 1 and day 5 than participants in the local best practice group (RR 1.63, 95% CI 1.24 to 2.15). The number needed to treat was 6 (95% CI 4 to 12). In the second trial, compared with an identical non-ibuprofen foam dressing, there was no statistically significant difference in the proportion of participants experiencing slight to complete pain relief on the first evening of treatment.Limited data were available to assess healing rates or adverse events. AUTHORS' CONCLUSIONS: There is some evidence to suggest that ibuprofen dressings may offer pain relief to people with painful venous leg ulcers. EMLA (5%) appears to provide effective pain relief during the debridement of venous leg ulcers. Further research should consider standardised pain assessment methods and assess both the effect on ulcer healing and the impact of long term use of these treatments.