What is different for people with MS who have pressure ulcers: A reflective study of the impact upon people's quality of life?

BACKGROUND: Multiple Sclerosis (MS) is a progressive, degenerative disease of the central nervous system. People with advanced disease who have compromised mobility, activity, sensory and/or cognitive abilities are at risk of pressure ulcers. Having a pressure ulcer has a substantial impact on a person's quality of life; a generic pressure ulcer Health Related Quality of Life (HRQL) framework has been used in this study. AIM: To explore the views and opinions of patients with MS who have a pressure ulcer using a thematic framework and compare these to the general pressure ulcer population. METHODS: Data for six MS patients was obtained through secondary analysis of transcripts from semi-structured interviews conducted during two studies which were part of a programme of HRQL Research. FINDINGS: Patients with MS reported that their pressure ulcer affected their lives physically, psychologically and socially. All were confined to bed (as part of their pressure ulcer treatment) and therefore unable to participate in activities. Difficulties with movement and activity were partially attributed to the MS. Patients with MS did not report feeling ill with their pressure ulcer and expressed positive emotions and optimism. Pain or discomfort was a feature of the pressure ulcer for most patients. CONCLUSIONS: Pressure ulcers have a major impact on QOL for all patients. Problems with mobility and activity associated with the pressure ulcer were confounded by the MS.

Patient-reported outcome measures for chronic wounds with particular reference to pressure ulcer research: a systematic review.

OBJECTIVES: Pressure ulcers are a major health problem, affect patient psychological, physical and social functioning, and cause significant treatment burden. For comprehensive assessment of the benefits of an intervention, patient-reported evidence of the impact of an intervention on important patient outcomes should be made. We systematically reviewed the quality of life literature on chronic wounds to determine the suitability of generic and chronic wound-specific outcome measures for use in evaluating patient outcomes in pressure ulcer research. DESIGN: A systematic review of the literature. DATA SOURCES: Searches of eight electronic databases from inception until May 2012 were undertaken. REVIEW METHODS: Quality of life domains, item content and content relevance were determined for identified outcome measures. The content validity of identified measures was assessed against an empirically derived pressure ulcer-specific conceptual framework. RESULTS: Three generic and 14 chronic wound measures were identified but no pressure ulcer-specific measures. None of the existing measures cover all quality of life domains important in pressure ulcers. One condition-specific measure, the Venous Leg Ulcer Measure, matched most closely conceptually, but failed to represent three important domains and contained items not specific to pressure ulcers. CONCLUSIONS: Currently, outcomes important in pressure ulcers are inadequately covered by generic and chronic wound-specific instruments despite similar conceptual models. Highlighted is the need for clear conceptualisation of content as well as determining appropriateness when selecting outcome measures in the future.

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

BACKGROUND: Patient-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. METHODS: We 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. RESULTS: The 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). CONCLUSIONS: The 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.

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.

Experiences of healthcare provision for foot ulceration occurring in people with rheumatoid arthritis.

BACKGROUND: Participants with rheumatoid arthritis (RA) report that foot ulceration has an impact on their health-related quality of life (HRQL) across physical, social and psychological domains. What is not known is how experiences of healthcare provision influence HRQL. The present study set out to map the patent journey while integrating the impact on HRQL. METHODS: A purposive sample of RA patients with open foot ulceration was recruited from podiatry clinics in West Yorkshire (UK) between May 2008 and June 2009. Patients with diabetes were excluded (the impact of foot ulceration in this group is well established). In-depth interviews were taped and transcribed. A framework approach to data management was used to facilitate a case- and theme-based analysis. RESULTS: Twenty-three RA patients (18 female, five male; aged 45-88 years) participated. Two themes and five sub-themes were identified. The patient journey theme comprised the following sub-themes: access to care; knowledge acquisition; care pathways and continuity of care. Patient-professional relationships comprised the sub-themes: therapeutic patient-professional relationships and task-orientated care. The journey took a highly variable course that was influenced by patient-specific factors (past experience of ulceration; symptomology; knowledge and self-efficacy); service-specific factors (access to care and care pathways) and professional-specific factors (knowing and trusting someone; holism). CONCLUSIONS: The present study highlights the need for clearer care pathways for patients affected by foot ulceration improved patient education and better coordination of care.

A qualitative study to explore the impact of foot ulceration on health-related quality of life in patients with rheumatoid arthritis.

BACKGROUND: The overall prevalence of foot ulceration occurring in patients with rheumatoid arthritis is estimated at 10-13% in the UK, with a high rate of recurrence. In contrast with diabetes, there has been a lack of research in this area and the impact of the problem from a patient perspective is poorly understood. OBJECTIVE: To explore the added impact of foot ulceration on health-related quality of life in non-diabetic patients with rheumatoid arthritis. DESIGN: Qualitative research design to elicit patient experiences. SETTINGS: Participants were recruited from hospital and community podiatry clinics in West Yorkshire (UK) between May 2008 and June 2009. PARTICIPANTS: A purposive sample of 23 adults with RA and open foot ulceration; patients with diabetes were excluded. METHODS: In-depth interviews were conducted with 23 participants using a topic guide. Framework analysis was employed to facilitate a case and theme based approach to identifying descriptive and explanatory accounts of the impact of foot ulceration on health-related quality of life. RESULTS: Participants indicated that foot ulceration impacted on their health-related quality of life across physical, social and psychological domains. Pain attributed to the ulcer was linked to new walking disability, affecting participants' lives in every domain. Pain and walking disability added to existing limitations in undertaking household tasks and personal care independently. Keeping the ulcer dry was a major problem for many in relation to personal hygiene. Participants described new restrictions in leisure activities which reduced social participation. Increased footwear/clothing restrictions affected self esteem and altered body image. An economic cost was attached to wound care and footwear alterations. Low mood, anxiety, frustration were attributed to the added impact of foot ulceration on their lives. Perceptions of impact fluctuated over time in relation to physical symptoms experienced by participants and the additional social limitations posed by the ulcer. CONCLUSION: Foot ulceration has an additional impact on health-related quality of life over and above the impact of rheumatoid arthritis in every domain. Whilst prevention is the ultimate goal, high rates of recurrence mean that clinicians need to consider ways to improve quality of life for affected patients throughout the patient journey.

Patient-reported pressure ulcer pain: a mixed-methods systematic review.

CONTEXT: Pressure ulcers (PUs) can cause patients considerable pain and discomfort; however, little is known about how PU pain affects patients' everyday lives. To improve outcomes for patients and to help clinicians manage PU pain, the existing qualitative and quantitative research bases were systematically reviewed. OBJECTIVES: The aims were to identify and synthesize all research that obtained verbal patient reports of PU-associated pain, including descriptions of the pain experience, intensity, quality, and impact to interpret the complexities of the pain experienced from PUs; describe specific characteristics of PU pain; and determine how it affects patients' lives. METHODS: We searched eight electronic databases (from inception to January 2010), hand searched and cross-referenced. Research studies that addressed the experience of PU-associated pain by direct patient reports were included. Two reviewers independently applied inclusion criteria and extracted findings, allocating findings to defined categories. Synthesis of findings and categories were reviewed by three reviewers until reaching consensus. RESULTS: Ten studies were included: six qualitative and four quantitative. These included 108 adults with PUs. The PU pain experience was mapped, producing a conceptual framework of five domains: communicating the pain, feeling the pain, impact of pain, self-management, and professional management, and represented by 23 subdomains and five mediating factors (four psychological well-being plus comorbidity). CONCLUSION: A biopsychosocial model of pain experienced from PUs is presented. Improved communication of pain experienced between the individual and health care professionals is needed to promote more effective PU pain management in the future.

Effects of intramuscular fat infiltration, scarring, and spasticity on the risk for sitting-acquired deep tissue injury in spinal cord injury patients.

Sitting-acquired deep tissue injury (DTI) is a severe form of pressure ulcer (PU) often affecting patients with spinal cord injury (SCI) who also tend to suffer from intramuscular fat infiltration, soft tissue scarring (due to previous PU), and/or muscle spasticity in their buttocks. We previously used finite element (FE) modeling to evaluate whether abnormal bodyweight is a risk factor for sitting-acquired DTI. Here we hypothesize that fat infiltration, scarring, or spasms increase internal loads in the gluteus muscles in the vicinity of the ischial tuberosities during sitting, which consequently put SCI patients with these conditions at a higher risk for DTI. Our objective was to determine changes in gluteal strains and stresses and tissue volumes exposed to elevated strains/stresses associated with these factors. Thirty-five FE models of coronal slices through the seated buttocks, simulating these conditions at different severities, were developed. We calculated peak strains and stresses in glutei and percentage volumes of muscle tissue exposed to above-critical strains/stresses (compression strain≥50%, compression/von Mises stress≥2 kPa, and strain energy density≥0.5 kPa). Progressive intramuscular fat infiltration increased all the aforementioned outcome measures. Increase in size of scar patterns that were contained in both muscle and fat tissues similarly elevated the outcome measures. Spasms increased muscle stresses and volumetric exposures to stress, but tissue volumes at risk were ∼1-2% and increases due to spasticity were slight. We conclude that the above potential risk factors can be listed according to the following order of importance: (i) fat infiltration, (ii) scars contained in both muscle and fat tissues, and (iii) spasms. This information should be considered when prioritizing prevention means and resources for patients with SCI.

Development of a conceptual framework of health-related quality of life in pressure ulcers: a patient-focused approach.

BACKGROUND: Evaluating outcomes such as health-related quality of life is particularly important and relevant in skin conditions such as pressure ulcers where the condition and associated interventions pose substantial burden to patients. Measures to evaluate such outcomes need to be developed by utilising patient-perspective to ensure that content and conceptualisation is relevant to patients. OBJECTIVES: Our aim was to develop a conceptual framework of health-related quality of life in pressure ulcers, based on patients' views about the impact of pressure ulcers and interventions on health-related quality of life to inform the development of a new patient-reported outcome measure. SETTING, PARTICIPANTS AND METHODS: We developed a working conceptual framework based on a previous review of the literature, then used semi-structured qualitative interviews with 30 adults with pressure ulcers (22-94 years) purposively sampled from hospital, community and rehabilitation care settings in England and Northern Ireland to obtain patients' views, and thematic content analysis and review by a multidisciplinary expert group to develop the final conceptual framework. FINDINGS: Our conceptual model includes four health-related quality of life domains (symptoms, physical functioning, psychological well-being, social functioning), divided into 13 sub-domains and defined by specific descriptive components. CONCLUSIONS: We have identified health-related quality of life outcomes that are important to people with pressure ulcers and developed a conceptual framework using robust and systematic methods, which provides the basis for the development of a new pressure ulcer-specific measure of health-related quality of life.

Evaluation of five search strategies in retrieving qualitative patient-reported electronic data on the impact of pressure ulcers on quality of life.

AIM: This paper is a report of a study conducted to compare the effectiveness of qualitative methodology search strategies with subject-specific (health-related quality of life) search strategies in the retrieval of qualitative patient-reported data of the impact of pressure ulcers on health-related quality of life. BACKGROUND: Methods to locate qualitative patient-reported health-related quality of life research data electronically have undergone little replication and validation. A major problem in searching for this type of data is that it is reported in accounts of both primary qualitative research as well as mixed methods research. DATA SOURCES: We combined five search strategies with terms for pressure ulcer and searched seven electronic databases from inception to October 2007. METHODS: The sensitivity, specificity, precision and accuracy for each search strategy were assessed. RESULTS: A subject-specific (health-related quality of life) search strategy, developed by us, had a high yield (100% sensitivity), but low specificity (<50%). The research methodology-based strategies had lower yields (sensitivity 72-83%) but high specificity (79-83%). Importantly, subject-specific search strategies identified all studies reporting qualitative patient-reported health-related quality of life data, whereas, research methodology-based strategies did not identify qualitative data reported in mixed method studies, making subject-based strategies more effective in retrieving qualitative patient-reported health-related quality of life research. CONCLUSION: An important consideration in the health-related quality of life field is that qualitative data are reported in both qualitative and mixed methodology research and searching for this type data involves trade-offs between yield, sensitivity and specificity. Accurate indexing of subject-specific outcomes and methodology used in electronic databases and publications is also needed.

Exposure to internal muscle tissue loads under the ischial tuberosities during sitting is elevated at abnormally high or low body mass indices.

Deep tissue injury (DTI) is a severe pressure ulcer characteristic of chairfast or bedfast individuals, such as those with impaired mobility or neurological disorders. A DTI differs from superficial pressure ulcers in that the onset of DTI occurs under intact skin, in skeletal muscle tissue overlying bony prominences, and progression of the wound continues subcutaneously until skin breakdown. Due to the nature of this silently progressing wound, it is highly important to screen potentially susceptible individuals for their risk of developing a DTI. Abnormally low and high values of the body mass index (BMI) have been proposed to be associated with pressure ulcers, but a clear mechanism is lacking. We hypothesize that during sitting, exposure to internal muscle tissue loads under the ischial tuberosities (IT) is elevated at abnormally high or low body mass indices. Our aims in this study were: (a) to develop biomechanical models of the IT region in the buttocks that represent an individual who is gaining or losing weight drastically. (b) To determine changes in internal tissue load measures: principal compression strain, strain energy density (SED), principal compression stress and von Mises stress versus the BMI. (c) To determine percentage volumes of muscle tissue exposed to critical levels of the above load measures, which were defined based on our previous animal and tissue engineered model experiments: strain>or=50%, stress>or=2 kPa, SED>or=0.5 kPa. A set of 21 finite element models, which represented the same individual, but with different BMI values within the normal range, above it and below it, was solved for the outcome measures listed above. The models had the same IT shape, size, distance between the IT, and (non-linear) mechanical properties for all soft tissues, but different thicknesses of gluteus muscles and fat tissue layers, corresponding to the BMI level. The resulted data indicated a trend of progressive increase in internal tissue loading, particularly in volumetric exposure to critical loading for BMI values outside the 17

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). DESIGN: Systematic review and metasynthesis of primary research reporting the impact of PU and PU interventions on HRQL according to direct patient reports. Quality assessment criteria were developed and applied. Data extraction identified findings in the form of direct quotes from patients or questionnaire items and domain results. Combined synthesis of qualitative and quantitative research was performed using content analysis to generate categories and themes from findings. Thirteen electronic databases were searched, and hand searching, cross-referencing, contact with experts, and an online search was undertaken. No language restrictions were applied. SETTING: Adults with PUs in acute, community, and long-term care settings across Europe, the United States, Asia, and Australia. PARTICIPANTS: Thirty-one studies including 2,463 participants with PUs were included in the review. Ages ranged from 17 to 96. RESULTS: The review included 10 qualitative and 21 quantitative studies; 293 findings, 46 categories, and 11 themes emerged. The 11 HRQL themes were physical impact, social impact, psychological effect, PU symptoms, general health, and other impacts of PUs: healthcare professional-client relationships, need for versus effect of interventions, impact on others, financial impact, perceived etiology, and need for knowledge. CONCLUSION: There is evidence that PUs and PU interventions have a significant impact on HRQL and cause substantial burden to patients.