Elizabeth McGinnis

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.

The influence of foot posture, support stiffness, heel pad loading and tissue mechanical properties on biomechanical factors associated with a risk of heel ulceration

Heel ulcers (HU) are the second most common type of pressure ulcers. In this work, we developed the first anatomically-realistic three-dimensional finite element model of the posterior heel for studying the risk for HU in bedridden patients. We specifically simulated a heel that is resting on supports with different stiffnesses at upright and inclined foot postures. Our objective was to examine the effects of foot posture and stiffness of the support on strains and stresses within the fat pad of the resting heel. We found that strains and stresses in the fat pad of the heel are considerably reduced when the foot is positioned so that its lateral aspect is at 90° with respect to the horizon compared to an abducted (60°) foot posture. The study therefore indicates that theoretically, an inclined foot posture puts a bedridden patient at a higher risk for HU with respect to an upright foot posture, which may be explained by the anatomy of the heel that faces a lower curvature and better cushioned region against the support when the foot is upright.

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

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

BackgroundPatients 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.MethodsWe 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).ResultsA 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).ConclusionOne 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.

Pressure ulcer related pain in community populations: a prevalence survey

BackgroundPressure 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.MethodsThe 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.ResultsA 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.ConclusionsThis 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.

Methods to assess cost-effectiveness and value of further research when data are sparse: Negative-pressure wound therapy for severe pressure ulcers

Health care resources are scarce, and decisions have to be made about how to allocate funds. Often, these decisions are based on sparse or imperfect evidence. One such example is negative-pressure wound therapy (NPWT), which is a widely used treatment for severe pressure ulcers; however, there is currently no robust evidence that it is effective or cost-effective. This work considers the decision to adopt NPWT given a range of alternative treatments, using a decision analytic modeling approach. Literature searches were conducted to identify existing evidence on model parameters. Given the limited evidence base, a second source of evidence, beliefs elicited from experts, was used. Judgments from experts on relevant (uncertain) quantities were obtained through a formal elicitation exercise. Additionally, data derived from a pilot trial were also used to inform the model. The 3 sources of evidence were collated, and the impact of each on cost-effectiveness was evaluated. An analysis of the value of further information indicated that a randomized controlled trial may be worthwhile in reducing decision uncertainty, where from a set of alternative designs, a 3-arm trial with longer follow-up was estimated to be the most efficient. The analyses presented demonstrate how allocation decisions about medical technologies can be explicitly informed when data are sparse and how this kind of analyses can be used to guide future research prioritization, not only indicating whether further research is worthwhile but what type of research is needed and how it should be designed.

Development and validation of a new patient-reported outcome measure for patients with pressure ulcers: the PU-QOL instrument.

BackgroundPatient-reported outcome (PRO) data are integral to patient care, policy decision making and healthcare delivery. PRO assessment in pressure ulcers is in its infancy, with few studies including PROs as study outcomes. Further, there are no pressure ulcer PRO instruments available.MethodsWe used gold-standard methods to develop and evaluate a new PRO instrument for people with pressure ulcers (the PU-QOL instrument). Firstly a conceptual framework was developed forming the basis of PU-QOL scales. Next an exhaustive item pool was used to produce a draft instrument that was pretested using mixed methods (cognitive interviews and Rasch Measurement Theory). Finally, we undertook psychometric evaluation in two parts. This first part was item reduction, using PU-QOL data from 227 patients. The second part was reliability and validity evaluation of the item-reduced version using both Traditional and Rasch methods, on PU-QOL data from 229 patients.ResultsThe final PU-QOL contains 10 scales for measuring symptoms, physical functioning, psychological well-being and social participation specific to pressure ulcers. It is intended for administration and patients rate the amount of “bother” attributed during the past week on a 3-point response scale. Scale scores are generated by summing items, with lower scores indicating better outcome. The PU-QOL instrument was found to be acceptable, reliable (Cronbach’s alpha values ranging 0.89 - 0.97) and valid (hypothesised correlations between PU-QOL and SF-12 scores (r >0.30) and PU-QOL scales and sociodemographic variables (r <0.30) were consistent with predictions).ConclusionsThe PU-QOL instrument provides a standardised method for assessing PROs, reflecting the domains in a pressure ulcer-specific conceptual framework. It is intended for evaluating patient orientated differences between interventions and in particular the impact from the perspective of patients.

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.

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034].

BackgroundNegative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial.MethodsThis was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up.ResultsThree hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months.ConclusionsThis pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial.Trial registrationCurrent Controlled Trials ISRCTN69032034.

Why do patients develop severe pressure ulcers? a retrospective case study.

Objectives This study focuses on the ways in which the organisational context can influence the development of severe pressure ulcers. Severe pressure ulcers are important indicators of failures in the organisation and delivery of treatment and care. We have a good understanding of patients’ risk factors, but a poor understanding of the role played by the organisational context in their development. Setting The study was undertaken in six sites in Yorkshire, England. The settings were sampled in order to maximise diversity, and included patients’ own homes, acute hospital medical and surgical wards, a community hospital and a nursing home during a period of respite care. Participants Data were collected about eight individuals who developed severe pressure ulcers, using a retrospective case study design. The data sources included interviews with individuals with severe pressure ulcers, and with staff who had treated and cared for them, and clinical notes. Results 4 accounts indicated that specific actions by clinicians contributed to the development of severe pressure ulcers. Seven of the 8 accounts indicated that they developed in organisational contexts where (1) clinicians failed to listen and respond to the patients’ or carers’ observations about their risks or the quality of their treatment and care, (2) clinicians failed to recognise and respond to clear signs that a patient had a pressure ulcer or was at risk of developing one and (3) services were not effectively coordinated. Conclusions Patient accounts could only be partially explained in terms of specific events or sequences of events. The findings support the conclusion that there was general acceptance of suboptimal clinical practices in 7 of the 8 contexts where patients developed severe pressure ulcers.