Inter-rater reliability of the EPUAP pressure ulcer classification system using photographs

Background. Many classification systems for grading pressure ulcers are discussed in the literature. Correct identification and classification of a pressure ulcer is important for accurate reporting of the magnitude of the problem, and for timely prevention. The reliability of pressure ulcer classification systems has rarely been tested. Aims and objectives. The purpose of this paper is to examine the inter-rater reliability of classifying pressure ulcers according to the European Pressure Ulcer Advisory Panel classification system when using pressure ulcer photographs.Design. Survey was among pressure ulcer experts.Methods. Fifty-six photographs were presented to 44 pressure ulcer experts. The experts classified the lesions as normal skin, blanchable erythema, pressure ulcer (four grades) or incontinence lesion. Inter-rater reliability was calculated.Results. The multirater-Kappa for the entire group of experts was 0.80 (P < 0.001).Various groups of experts obtained comparable results. Differences in classifications are mainly limited to 1 degree of difference. Incontinence lesions are most often confused with grade 2 (blisters) and grade 3 pressure ulcers (superficial pressure ulcers).Conclusions. The inter-rater reliability of the European Pressure Ulcer Advisory Panel classification appears to be good for the assessment of photographs by experts. The difference between an incontinence lesion and a blister or a superficial pressure ulcer does not always seem clear.Relevance to clinical practice. The ability to determine correctly whether a lesion is a pressure ulcer lesion is important to assess the effectiveness of preventive measures. In addition, the ability to make a correct distinction between pressure ulcers and incontinence lesions is important as they require different preventive measures. A faulty classification leads to mistaken measures and negative results. Photographs can be used as a practice instrument to learn to discern pressure ulcers from incontinence lesions and to get to know the different grades of pressure ulcers. The Pressure Ulcer Classification software package has been developed to facilitate learning

Prophylactic dressing to minimize sacral pressure injuries in high-risk hospitalized patients: A pilot study

Aim: In this paper, we describe a trial protocol used to assess feasibility related to: study administration (recruitment, randomization, retention, compliance, eligibility criteria, suitability of protocol instructions and data collection questionnaires); resource and data management (suitability of site, time and budget allocation, management of personnel and data); intervention fidelity (treatment dose, violations); and effect size. Background: Pressure injury can lead to increases in hospital length of stay and cost. The sacrum is identified as one of the most common anatomical pressure injury sites for hospitalized patients. Silicone foam border dressings have been proposed as one strategy to reduce pressure injury incidence; however, rigorous testing of benefit in a general medical-surgical population is required. Design: Randomized controlled trial. Methods: Eighty patients will be recruited after assessment of high risk of pressure injury in a large tertiary hospital in south-east Queensland, Australia. Eligible, consenting participants will be randomly allocated to either a control group (routine care) or an intervention group (routine care and a sacral prophylactic dressing). The primary outcomes comprise feasibility criteria as identified above. The secondary measure is the presence and severity of sacral pressure injury via blind assessment of digital photographs. Research ethics approval was received in October 2013. Discussion: Prophylactic dressings applied to the sacrum may be an effective method for reducing pressure injury in high-risk general medical-surgical patients. However, more rigorous studies to confirm benefit are required. This pilot study will determine the feasibility and effect size to inform a larger randomized controlled trial

Developing the tissue viability seating guidelines

Background: Costs for the prevention and management of pressure ulcers have increased significantly with limited published advice from health and social care organisations on seating and preventing pressure ulcers. At the request of the UK Tissue Viability Society the aim of the publication was to develop a practical guide for people, carers and health and social care professionals on how the research and evidence base on pressure ulcer prevention and management can be applied to those who remain seated for extended periods of time. Methods and findings: The evidence base informing the guidelines was obtained by applying a triangulation of methods: a literature review, listening event and stakeholder group consultation. The purpose was to engage users and carers, academics, clinicians, inspectorate and charities, with an interest in seating, positioning and pressure management to: gather views, feedback, stories, and evidence of the current practices in the field to create a greater awareness of the issue. Conclusion: The new guidelines are inclusive of all people with short and long-term mobility issues to include all population groups. The document includes evidence on where pressure ulcers develop when seated, risk factors, best possible seated position and what seat adjustments are required, the ideal seating assessment, interventions, self-help suggestions and key seating outcomes. The updated TVS CPGs have been informed by the best available evidence, the insights and wisdom of experts, stakeholders and people who spend extended periods of time sitting

The impact of hoist sling materials on interface pressure whilst sitting in healthy volunteers and wheelchair users : a comparative study

Aim of the study To evaluate the effect of three sling fabrics on gluteal interface pressure whilst sitting in a population of wheelchair users and to compare these to data previously collected in a pilot study with a healthy population. Materials and methods A repeated measures experimental design was used with 32 adult wheelchair users (15 women, 17 men). Healthy population pilot study consisted of 61 participants (51 women, 10 men) recruited from staff and students at The University of Salford. Methods Gluteal pressures at six pressure zones were recorded using the X-sensor PX100 pressure sensor at 30 second intervals for 10 minutes. Data were collected in 4 conditions with participants seated in a standardised chair, followed by the chair with slings made of three different fabrics. Results The spacer fabric reduced the mean gluteal pressure more effectively than slipfit and polyester (p=0.014 and p=0.01 respectively, 95%CI) and reduced peak pressure at the left ischial tuberosity and coccyx when compared to the slipfit (p=0.003 and p=0.005) with the wheelchair users. When comparing data with the pilot study, the mean gluteal pressure and peak pressures at the ischial tuberosities and coccyx were significantly higher in the wheelchair user group (p<0.005). Conclusion The fabric identified as the most effective in reducing mean and peak pressures in both groups was the spacer fabric, suggesting that a spacer fabric sling is more likely to reduce the risk of pressure ulcer development. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors

Foam dressings for treating pressure ulcers

Background: Pressure ulcers, also known as pressure injuries and bed sores, are localised areas of injury to the skin or underlying tissues, or both. Dressings made from a variety of materials, including foam, are used to treat pressure ulcers. An evidence-based overview of dressings for pressure ulcers is needed to enable informed decision-making on dressing use. This review is part of a suite of Cochrane Reviews investigating the use of dressings in the treatment of pressure ulcers. Each review will focus on a particular dressing type. Objectives: To assess the clinical and cost effectiveness of foam wound dressings for healing pressure ulcers in people with an existing pressure ulcer in any care setting. Search methods: In February 2017 we searched: the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase; EBSCO CINAHL Plus and the NHS Economic Evaluation Database (NHS EED). We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria: Published or unpublished randomised controlled trials (RCTs) and cluster-RCTs, that compared the clinical and cost effectiveness of foam wound dressings for healing pressure ulcers (Category/Stage II or above). Data collection and analysis: Two review authors independently performed study selection, risk of bias and data extraction. A third reviewer resolved discrepancies between the review authors. Main results: We included nine trials with a total of 483 participants, all of whom were adults (59 years or older) with an existing pressure ulcer Category/Stage II or above. All trials had two arms, which compared foam dressings with other dressings for treating pressure ulcers. The certainty of evidence ranged from low to very low due to various combinations of selection, performance, attrition, detection and reporting bias, and imprecision due to small sample sizes and wide confidence intervals. We had very little confidence in the estimate of effect of included studies. Where a foam dressing was compared with another foam dressing, we established that the true effect was likely to be substantially less than the study's estimated effect. We present data for four comparisons. One trial compared a silicone foam dressing with another (hydropolymer) foam dressing (38 participants), with an eight-week (short-term) follow-up. It was uncertain whether alternate types of foam dressing affected the incidence of healed pressure ulcers (RR 0.89, 95% CI 0.45 to 1.75) or adverse events (RR 0.37, 95% CI 0.04 to 3.25), as the certainty of evidence was very low, downgraded for serious limitations in study design and very serious imprecision. Four trials with a median sample size of 20 participants (230 participants), compared foam dressings with hydrocolloid dressings for eight weeks or less (short-term). It was uncertain whether foam dressings affected the probability of healing in comparison to hydrocolloid dressings over a short follow-up period in three trials (RR 0.85, 95% CI 0.54 to 1.34), very low-certainty evidence, downgraded for very serious study limitations and serious imprecision. It was uncertain if there was a difference in risk of adverse events between groups (RR 0.88, 95% CI 0.37 to 2.11), very low-certainty evidence, downgraded for serious study limitations and very serious imprecision. Reduction in ulcer size, patient satisfaction/acceptability, pain and cost effectiveness data were also reported but we assessed the evidence as being of very low certainty. One trial (34 participants), compared foam and hydrogel dressings over an eight-week (short-term) follow-up. It was uncertain if the foam dressing affected the probability of healing (RR 1.00, 95% CI 0.78 to 1.28), time to complete healing (MD 5.67 days 95% CI -4.03 to 15.37), adverse events (RR 0.33, 95% CI 0.01 to 7.65) or reduction in ulcer size (MD 0.30 cm2 per day, 95% CI -0.15 to 0.75), as the certainty of the evidence was very low, downgraded for serious study limitations and very serious imprecision. The remaining three trials (181 participants) compared foam with basic wound contact dressings. Follow-up times ranged from short-term (8 weeks or less) to medium-term (8 to 24 weeks). It was uncertain whether foam dressings affected the probability of healing compared with basic wound contact dressings, in the short term (RR 1.33, 95% CI 0.62 to 2.88) or medium term (RR 1.17, 95% CI 0.79 to 1.72), or affected time to complete healing in the medium term (MD -35.80 days, 95% CI -56.77 to -14.83), or adverse events in the medium term (RR 0.58, 95% CI 0.33 to 1.05). This was due to the very low-certainty evidence, downgraded for serious to very serious study limitations and imprecision. Reduction in ulcer size, patient satisfaction/acceptability, pain and cost effectiveness data were also reported but again, we assessed the evidence as being of very low certainty. None of the included trials reported quality of life or pressure ulcer recurrence. Authors' conclusions: It is uncertain whether foam dressings are more clinically effective, more acceptable to users, or more cost effective compared to alternative dressings in treating pressure ulcers. It was difficult to make accurate comparisons between foam dressings and other dressings due to the lack of data on reduction of wound size, complete wound healing, treatment costs, or insufficient time-frames. Quality of life and patient (or carer) acceptability/satisfaction associated with foam dressings were not systematically measured in any of the included studies. We assessed the certainty of the evidence in the included trials as low to very low. Clinicians need to carefully consider the lack of robust evidence in relation to the clinical and cost-effectiveness of foam dressings for treating pressure ulcers when making treatment decisions, particularly when considering the wound management properties that may be offered by each dressing type and the care context.The NHMRC has provided funding for this review from its Centre of Research Excellence Scheme, which funds one or more of the authors. Griffith University, Australia. The National Institute for Health Research (NIHR), UK

An investigation of pressure ulcer risk, comfort and pain in medical imaging

In this study, we investigated the interface pressure of healthy volunteers on medical imaging (MI) table surfaces to determine the risks of developing pressure ulcers (PU). We also investigated volunteers’ perception of pain and comfort while lying on the MI table surfaces. Evidence from this study will enhance the understanding of factors contributing to PU formation and help improve service delivery to patients undergoing MI procedures

Using Cognitive Pre-Testing Methods in the Development of a New Evidenced-Based Pressure Ulcer Risk Assessment Instrument

Background: Variation in development methods of Pressure Ulcer Risk Assessment Instruments has led to inconsistent inclusion of risk factors and concerns about content validity. A new evidenced-based Risk Assessment Instrument, the Pressure Ulcer Risk Primary Or Secondary Evaluation Tool - PURPOSE-T was developed as part of a National Institute for Health Research (NIHR) funded Pressure Ulcer Research Programme (PURPOSE: RP-PG-0407-10056). This paper reports the pre-test phase to assess and improve PURPOSE-T acceptability, usability and confirm content validity. Methods: A descriptive study incorporating cognitive pre-testing methods and integration of service user views was undertaken over 3 cycles comprising PURPOSE-T training, a focus group and one-to-one think-aloud interviews. Clinical nurses from 2 acute and 2 community NHS Trusts, were grouped according to job role. Focus group participants used 3 vignettes to complete PURPOSE-T assessments and then participated in the focus group. Think-aloud participants were interviewed during their completion of PURPOSE-T. After each pre-test cycle analysis was undertaken and adjustment/improvements made to PURPOSE-T in an iterative process. This incorporated the use of descriptive statistics for data completeness and decision rule compliance and directed content analysis for interview and focus group data. Data were collected April 2012-June 2012. Results: Thirty-four nurses participated in 3 pre-test cycles. Data from 3 focus groups, 12 think-aloud interviews incorporating 101 PURPOSE-T assessments led to changes to improve instrument content and design, flow and format, decision support and item-specific wording. Acceptability and usability were demonstrated by improved data completion and appropriate risk pathway allocation. The pre-test also confirmed content validity with clinical nurses. Conclusions: The pre-test was an important step in the development of the preliminary PURPOSE-T and the methods used may have wider instrument development application. PURPOSE-T proposes a new approach to pressure ulcer risk assessment, incorporating a screening stage, the inclusion of skin status to distinguish between those who require primary prevention and those who require secondary prevention/treatment and the use of colour to support pathway allocation and decision making. Further clinical evaluation is planned to assess the reliability and validity of PURPOSE-T and it’s impact on care processes and patient outcomes

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial

Background Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual’s functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers. Methods/Design PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 ‘high-risk’ patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee. Discussion The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for demonstrating either superiority, inferiority of mattresses or futility of the trial. The trial optimises the potential for producing robust clinical evidence on the effectiveness of two commonly used mattresses in clinical practice earlier than in a conventional design

Pressure UlceR Programme Of reSEarch (PURPOSE): using mixed methods (systematic reviews, prospective cohort, case study, consensus and psychometrics) to identify patient and organisational risk, develop a risk assessment tool and patient-reported outcome Quality of Life and Health Utility measures

Background: The Pressure UlceR Programme Of reSEarch (PURPOSE) consisted of two themes. Theme 1 focused on improving our understanding of individuals’ and organisational risk factors and on improving the quality of risk assessments (work packages 1–3) and theme 2 focused on developing patient-reported outcome measures (work packages 4 and 5). Methods: The programme comprised 21 individual pieces of work. Pain: (1) multicentre pain prevalence study in acute hospitals, (2) multicentre pain prevalence study in community localities incorporating (3) a comparison of case-finding methods, and (4) multicentre, prospective cohort study. Severe pressure ulcers: (5) retrospective case study, (6) patient involvement workshop with the Pressure Ulcer Research Service User Network for the UK (PURSUN UK) and (7) development of root cause analysis methodology. Risk assessment: (8) systematic review, (9) consensus study, (10) conceptual framework development and theoretical causal pathway, (11) design and pretesting of draft Risk Assessment Framework and (12) field test to assess reliability, validity, data completeness and clinical usability. Quality of life: (13) conceptual framework development (systematic review, patient interviews), (14 and 15) provisional instrument development, with items generated from patient interviews [from (1) above] two systematic reviews and experts, (16) pretesting of the provisional Pressure Ulcer Quality of Life (PU-QOL) instrument using mixed methods, (17) field test 1 including (18) optimal mode of administration substudy and item reduction with testing of scale formation, acceptability, scaling assumptions, reliability and validity, and (19) field test 2 – final psychometric evaluation to test scale targeting, item response categories, item fit, response bias, acceptability, scaling assumptions, reliability and validity. Cost–utility: (20) time trade-off task valuations of health states derived from selected PU-QOL items, and (21) validation of the items selected and psychometric properties of the new Pressure Ulcer Quality of Life Utility Index (PUQOL-UI). Key findings:Pain: prevalence studies – hospital and community patients experience both pressure area-related and pressure ulcer pain; pain cohort study – indicates that pain is independently predictive of category 2 (and above) pressure ulcer development. Severe pressure ulcers: these were more likely to develop in contexts in which clinicians failed to listen to patients/carers or recognise/respond to high risk or the presence of an existing pressure ulcer and services were not effectively co-ordinated; service users found the interactive workshop format valuable; including novel components (interviews with patients and carers) in root cause analysis improves the quality of the insights captured. Risk assessment: we developed a Pressure Ulcer Risk Assessment Framework, the PURPOSE-T, incorporating the Minimum Data Set, a screening stage, a full assessment stage, use of colour to support decision-making, and decision pathways that make a clear distinction between patients with an existing pressure ulcer(s) (or scarring from previous ulcers) who require secondary prevention and treatment and those at risk who require primary prevention (http://medhealth.leeds.ac.uk/accesspurposet). Quality of life: the final PU-QOL instrument consists of 10 scales to measure pain, exudate, odour, sleep, vitality, mobility/movement, daily activities, emotional well-being, self-consciousness and appearance, and participation (http://medhealth.leeds.ac.uk/puqol-ques). Cost–utility: seven items were selected from the PU-QOL instrument for inclusion in the PUQOL-UI (http://medhealth.leeds.ac.uk/puqol-ui); secondary study analysis indicated that item selection for the PUQOL-UI was appropriate and that the index was acceptable to patients and had adequate levels of validity. Conclusions: The PURPOSE programme has provided important insights for pressure ulcer prevention and treatment and involvement of service users in research and development, with implications for patient and public involvement, clinical practice, quality/safety/health service management and research including replication of the pain risk factor study, work exploring ‘best practice’ settings, the impact of including skin status as an indicator for escalation of preventative interventions, further psychometric evaluation of PU-QOL and PUQOL-UI the measurement of ‘disease attribution.’ Funding: The National Institute for Health Research Programme Grants for Applied Research programme

TEAM-UP for quality: a cluster randomized controlled trial protocol focused on preventing pressure ulcers through repositioning frequency and precipitating factors

Background: Pressure ulcers/injuries (PrUs), a critical concern for nursing homes (NH), are responsible for chronic wounds, amputations, septic infections, and premature deaths. PrUs occur most commonly in older adults and NH residence is a risk factor for their development, with at least one of every nine U.S. NH residents experiencing a PrU and many NHs having high incidence and prevalence rates, in some instances well over 20%. PrU direct treatment costs are greater than prevention costs, making prevention-focused protocols critical. Current PrU prevention protocols recommend repositioning residents at moderate, high, and severe risk every 2 h. The advent of visco- elastic (VE) high-density foam support-surfaces over the past decade may now make it possible to extend the repositioning interval to every 3 or 4 h without increasing PrU development. The TEAM-UP (Turn Everyone And Move for Ulcer Prevention) study aims to determine: 1) whether repositioning interval can be extended for NH residents without compromising PrU incidence and 2) how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. Methods: In this proposed cluster randomized study, 9 NHs will be randomly assigned to one of three repositioning intervals (2, 3, or 4 h) for a 4-week period. Each enrolled site will use a single NH-wide repositioning interval as the standard of care for residents at low, moderate, and high risk of PrU development (N = 951) meeting the following criteria: minimum 3-day stay, without PrUs, no adhesive allergy, and using VE support surfaces (mattresses). An FDA-cleared patient monitoring system that records position/movement of these residents via individual wireless sensors will be used to visually cue staff when residents need repositioning and document compliance with repositioning protocols. Discussion: This study will advance knowledge about repositioning frequency and clinically assessed PrU risk level in relation to PrU incidence and medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines. Trial registration: Clinical Trial Registration: NCT02996331