E Andrea Nelson

Impact of Pressure Ulcers on Quality of Life in Older Patients: A Systematic Review

OBJECTIVES: To identify the impact of pressure ulcers (PUs) and PU interventions on health‐related quality of life (HRQL).

Patient risk factors for pressure ulcer development: Systematic review

OBJECTIVE To identify risk factors independently predictive of pressure ulcer development in adult patient populations? DESIGN A systematic review of primary research was undertaken, based upon methods recommended for effectiveness questions but adapted to identify observational risk factor studies. DATA SOURCES Fourteen electronic databases were searched, each from inception until March 2010, with hand searching of specialist journals and conference proceedings; contact with experts and a citation search. There was no language restriction. REVIEW METHODS Abstracts were screened, reviewed against the eligibility criteria, data extracted and quality appraised by at least one reviewer and checked by a second. Where necessary, statistical review was undertaken. We developed an assessment framework and quality classification based upon guidelines for assessing quality and methodological considerations in the analysis, meta-analysis and publication of observational studies. Studies were classified as high, moderate, low and very low quality. Risk factors were categorised into risk factor domains and sub-domains. Evidence tables were generated and a summary narrative synthesis by sub-domain and domain was undertaken. RESULTS Of 5462 abstracts retrieved, 365 were identified as potentially eligible and 54 fulfilled the eligibility criteria. The 54 studies included 34,449 patients and acute and community patient populations. Seventeen studies were classified as high or moderate quality, whilst 37 studies (68.5%) had inadequate numbers of pressure ulcers and other methodological limitations. Risk factors emerging most frequently as independent predictors of pressure ulcer development included three primary domains of mobility/activity, perfusion (including diabetes) and skin/pressure ulcer status. Skin moisture, age, haematological measures, nutrition and general health status are also important, but did not emerge as frequently as the three main domains. Body temperature and immunity may be important but require further confirmatory research. There is limited evidence that either race or gender is important. CONCLUSIONS Overall there is no single factor which can explain pressure ulcer risk, rather a complex interplay of factors which increase the probability of pressure ulcer development. The review highlights the limitations of over-interpretation of results from individual studies and the benefits of reviewing results from a number of studies to develop a more reliable overall assessment of factors which are important in affecting patient susceptibility.

Larval therapy for leg ulcers (VenUS II): randomised controlled trial

Objective To compare the clinical effectiveness of larval therapy with a standard debridement technique (hydrogel) for sloughy or necrotic leg ulcers. Design Pragmatic, three armed randomised controlled trial. Setting Community nurse led services, hospital wards, and hospital outpatient leg ulcer clinics in urban and rural settings, United Kingdom. Participants 267 patients with at least one venous or mixed venous and arterial ulcer with at least 25% coverage of slough or necrotic tissue, and an ankle brachial pressure index of 0.6 or more. Interventions Loose larvae, bagged larvae, and hydrogel. Main outcome measures The primary outcome was time to healing of the largest eligible ulcer. Secondary outcomes were time to debridement, health related quality of life (SF-12), bacterial load, presence of meticillin resistant Staphylococcus aureus, adverse events, and ulcer related pain (visual analogue scale, from 0 mm for no pain to 150 mm for worst pain imaginable). Results Time to healing was not significantly different between the loose or bagged larvae group and the hydrogel group (hazard ratio for healing using larvae v hydrogel 1.13, 95% confidence interval 0.76 to 1.68; P=0.54). Larval therapy significantly reduced the time to debridement (2.31, 1.65 to 3.2; P<0.001). Health related quality of life and change in bacterial load over time were not significantly different between the groups. 6.7% of participants had MRSA at baseline. No difference was found between larval therapy and hydrogel in their ability to eradicate MRSA by the end of the debridement phase (75% (9/12) v 50% (3/6); P=0.34), although this comparison was underpowered. Mean ulcer related pain scores were higher in either larvae group compared with hydrogel (mean difference in pain score: loose larvae v hydrogel 46.74 (95% confidence interval 32.44 to 61.04), P<0.001; bagged larvae v hydrogel 38.58 (23.46 to 53.70), P<0.001). Conclusions Larval therapy did not improve the rate of healing of sloughy or necrotic leg ulcers or reduce bacterial load compared with hydrogel but did significantly reduce the time to debridement and increase ulcer pain. Trial registration Current Controlled Trials ISRCTN55114812 and National Research Register N0484123692.

Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial

Abstract 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

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.

Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis

Abstract Objective To assess the 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 per patient on average, 95% confidence interval - £377.59 to £976.79) 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 an 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.

Cost effectiveness analysis of larval therapy for leg ulcers

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 (€109.61;

The prevalence of pressure ulcers in community settings: an observational study.

140.57) more per participant per year (95% confidence interval −£491.9 to £685.8) 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 per QALY gained and £40 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.

Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomised controlled trial

BACKGROUND Changes in healthcare and ageing populations have led to an increasing emphasis on the provision of healthcare in the community. Quality initiatives in healthcare have led to a focus upon pressure ulcer rates. However, published data on pressure ulcer prevalence in a community setting is currently very limited. OBJECTIVE The objective of this cross-sectional observational study was to determine the prevalence of patients with pressure ulcers in a community setting in the United Kingdom. DESIGN A cross-sectional observational study. SETTING Two community settings in the North of England. PARTICIPANTS Patients in the community who were aged 18 years or older at the time of the pressure ulcer prevalence audit were included. There were no exclusion criteria and consent was not a requirement. METHODS Each site used a different method to collect the data as per their usual method of prevalence data collection. Site 1 assessed all patients on the community nursing caseload: patients in residential homes, rehabilitation units, specialist palliative care units and all nursing homes in the locality, whether they were known to have a pressure ulcer or not. Site 2 assessed only those on the community nursing caseload who were known to have a pressure ulcer. Site 1 collected data between 8th February and 2nd April 2010 and site 2 between 12th April and 7th May 2010. RESULTS In site 1, 185 patients were assessed as having a pressure ulcer Grade ≥ 1, a prevalence rate of 0.77 per 1000 adults. In Site 2 102 patients were assessed as having a Grade ≥ 1 pressure ulcer, a prevalence rate of 0.40 per 1000 adults. Removing patients in nursing homes from the calculation gives a prevalence of 0.38 per 1000 adults for site 1 and 0.39 per 1000 adults for site 2. CONCLUSIONS This study provides prevalence data in a community setting which can be used to assess resource allocation and staff training. This study has highlighted that differences in methodology can affect prevalence results, and this should be taken into account in future research.

The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies.

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 registration ISRCTN21175670 and National Research Register N0484162339