Development of a conceptual framework of health-related quality of life in pressure ulcers: A patient-focused approach
Introduction
An important consideration when developing patient-reported outcome measures (PROM) is conceptualisation and content of the measure. Developers of quality of life measures have often utilised ‘top–down’ approaches (i.e., review of the literature and of content from existing measures) for conceptualisation and content development. A risk of this methodology for developing disease-specific measures is that they may not reflect those aspects of health-related quality of life (HRQL) that are most important to patients with the underlying condition. Not utilising patients’ perspective in the development of new measures may pose a threat to the content validity and responsiveness to change as outcomes relevant to patients may not be included (Guyatt and Cook, 1994).
Evaluating outcomes such as HRQL is particularly important and relevant in pressure ulcers (PU) where the condition and associated interventions pose substantial burden to patients. PUs are wounds that occur as localised damage to the skin and underlying tissue caused by pressure, friction, skin shear or a combination of these. They range in severity from non-blanchable skin erythema (grade 1) and superficial skin loss (grade 2) to large wounds involving fat, muscle and bone (grade 3/4) (European Pressure Ulcer Advisory Panel (EPUAP), 2006).
With widespread prevalence and incidence in all health settings (Kaltenthaler et al., 2001) and occurring at home (Margolis et al., 2002), PUs are a major health problem associated with increased morbidity (Thomas et al., 1996) and mortality (Allman et al., 1995), high healthcare costs and longer hospitalisation (Bennett et al., 2004) and have a substantial impact on patients’ HRQL (Gorecki et al., 2009). Intensive interventions for preventing and treating PUs, such as devices to manage tissue loads or distribute weight, wound cleaning and debridement, dressings, bacterial and infection management, and in some instances, adjunctive therapies (i.e., electrotherapy) (European Pressure Ulcer Advisory Panel (EPUAP), 2006), pose significant patient burden and thus also affect HRQL (Gorecki et al., 2009, Spilsbury et al., 2007).
HRQL is an essential component in evaluating healthcare. It is a multi-dimensional construct including psychological, physical, and social functioning, in addition to other dimensions that are affected by a health condition (Bowling, 2005, Ware, 1995, Ware et al., 1994, Wilson and Cleary, 1995). A recent systematic review of the literature found relatively few studies relating to HRQL in individuals with PUs (Gorecki et al., 2009). Previous research identified common concerns reported by patients about the experience of living with a PU and the burden of PU interventions on their lives (Fox, 2002, Franks et al., 2002, Gorecki et al., 2009, Gunes, 2008, Hopkins et al., 2006, Langemo et al., 2000, Quirino et al., 2003, Rastinehad, 2006, Roth et al., 2004, Spilsbury et al., 2007, Szor and Bourguignon, 1999). The major concerns identified relate to severe and persistent pain, early warning signs for skin damage (i.e., pain) do not prompt action, treatments increase pain and discomfort, and patients’ views and concerns relating to physical, social and psychological aspects are not being met. Evidence from qualitative research methods relates to patients’ experience of living with a PU (Fox, 2002, Hopkins et al., 2006, Langemo et al., 2000, Spilsbury et al., 2007) and not about how PUs impact HRQL. Lived experience studies give meaning to what it is like to experience having a PU, however, patient reports are broader than HRQL issues including experience of care reports and other factors that might be consequences of having PUs but that are not specifically HRQL; the distinction between concepts is not made. We were interested in the impact of PUs with a focus on identifying specific HRQL dimensions that PUs affect. For example, pain is reported by patients with PUs. Studies of lived experience identify the problem pain, describing it in terms of intensity and duration and suggest that PU-associated pain affects patient's lives. However, we were interested in specifically how PU-pain impacts HRQL dimensions (e.g., PU-pain prevents movement, causes difficulty walking and low mood). Albeit, the lived experience findings provided the basis for developing a working conceptual framework of HRQL consisting of broad physical, social, psychological, general health and symptom impact domains (Gorecki et al., 2009). However, the specific components in each HRQL domain impacted by PUs needed to be investigated and importance of HRQL domains determined with patients with PUs.
Quantitative data collection methods (i.e., use of generic PROMs to evaluate HRQL in PUs) have had inconsistent results; some findings indicate reductions in HRQL for patients with PUs compared to those without (Lyons and Sorenson, 2007) while others found no differences in HRQL between people with PUs and controls (Essex et al., 2009, Franks et al., 2002). There is no PU-specific measure to evaluate HRQL and no previous research has examined systematically the HRQL domains that are important to patients with PUs. The aim of this study was to refine and further develop the working conceptual framework, with input from patients pertaining to the specific HRQL domains and dimensions impacted by PUs. This was proposed in order to develop a final conceptual framework of HRQL in PUs, from the perspective of patients with PUs, to inform the development of a PU-specific PROM; a methodologically important step in the development of new PROMs.
Section snippets
Methods
Top–down (review of the literature) and bottom–up (qualitative data) approaches were combined to develop the conceptual framework. The top–down approach involved developing a working conceptual framework and topic guide of HRQL in PUs, based on the systematic review of the PU-specific qualitative and quantitative literature which focused predominantly on the lived experience of patients with PUs (Gorecki et al., 2009). The working framework consisted of broad provisional patient-reported
Results
The 30 participants ranged in age from 22 to 94 years (mean age 62.2 years), of which 18 (56%) were male and 19 had other chronic conditions (e.g., 8 with spinal cord injury (SCI); 3 with multiple sclerosis (MS)). Patients represented different settings (17 hospital or rehabilitation, 13 community), PU severity (12 superficial, 15 severe, 3 mixed severity, and 13 with more than one PU) and duration (a few days up to 4 years) and PU site (15 sacrum, 14 heel, and others on the lower back,
Discussion
We developed a conceptual framework of HRQL in PUs that includes four domains: PU-specific symptoms, physical functioning, psychological well-being and social functioning. These HRQL domains are similar to those in generic models (Bowling, 2005, Ware, 1995, Wilson and Cleary, 1995), however, also incorporated are components specific to PUs. For example, ‘social isolation’ is not often included in the social domain in generic models, but is important to people with PUs. In addition, ‘appearance
Conclusion
This study provides qualitative evidence about the components of HRQL that are important from the perspective of patients with PUs, an essential step in the development of new patient-reported outcome measures. We developed a conceptual framework of HRQL in PUs, including physical, social, psychological and symptom domains, which provides the basis for the development of a new PU-specific measure of HRQL.
Acknowledgements
Financial support was provided by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-0407-10056). The views and opinions expressed within this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The authors would like to thank: Professor E Andrea Nelson who undertook quality assessment of the first few transcripts; the clinical experts who reviewed final framework
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