ReviewPatient-reported outcome measures for chronic wounds with particular reference to pressure ulcer research: A systematic review
Introduction
Pressure ulcers (PUs) are one of many chronic wound conditions that are a major health problem to patients, healthcare professionals and the healthcare system, affecting approximately 1 in 10 hospital and 1 in 20 community patients (Kaltenthaler et al., 2001, Vanderwee et al., 2007, James et al., 2010). They are wounds of the skin and deeper soft tissue that occur in areas of bony prominence due to pressure alone or pressure in combination with shearing forces (National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel, 2009). They range in severity from non-blanchable skin erythema (category 1) and superficial skin loss (category 2) to large wounds involving fat, muscle and bone (category 3/4). The impact of PUs on health-related quality of life (HRQL) is substantial, causing pain and discomfort and affecting sleep, rehabilitation, mobility, and psychological, physical and social aspects of patient's lives (Gorecki et al., 2009a, Gorecki et al., 2009b). In addition, the intensive treatment required for treating PUs is associated with significant treatment burden, which further impacts HRQL outcomes (Gorecki et al., 2009a, Gorecki et al., 2009b).
HRQL is a multidimensional construct that encompasses four primary domains (variables): psychological; physical; social and role functioning; and issues relating to well-being (Fallowfield, 1990, Ware, 1995). Assessment of HRQL is considered subjective in nature and therefore best measured by directly asking the person themselves through the use of patient-reported outcome measures (PROMs) or rating scales. The best PROMs are designed to probe people in a structured, formal way to give reproducible, meaningful, quantitative assessments of how people feel and how they function from their perspective (US FDA, 2009). PROMs may be generic; designed to measure concepts that are relevant across different diseases, outcomes, treatments and populations, or disease/condition-specific; used to assess the impact of a specific disease on patients’ HRQL, with the goal of detecting clinically important changes (Patrick and Deyo, 1989).
The application and use of PROMs in the evaluation of healthcare has become increasingly important in many disease areas (Fitzpatrick et al., 1998, Garratt et al., 2002), with an international consensus on the use of scientifically robust measures in healthcare evaluation (Fitzpatrick et al., 1998, Garratt et al., 2002, US FDA, 2009). There has been a growth of PROMs to evaluate HRQL in chronic skin conditions, with a number of condition-specific measures developed for different types of chronic wounds (e.g. leg ulcer). A recent review of the PU-specific HRQL literature found no condition-specific PROM for assessing HRQL outcomes in patients with PUs (Gorecki et al., 2009a, Gorecki et al., 2009b). Moreover, assessment of outcomes in clinical trials of PU intervention effectiveness has either been limited to conventional clinical outcomes or has used limited, inappropriate (i.e. not fit for purpose) or inadequately validated PROMs (Nixon et al., 2006).
Despite the impact on HRQL, no research has been undertaken to determine the availability of PROMs, either generic or condition-specific, and their suitability for use in PU research. We have recently developed a PU-specific HRQL conceptual framework derived from a systematic review of the international literature (Gorecki et al., 2009a, Gorecki et al., 2009b) and the views of patients with PUs (Gorecki et al., 2009a, Gorecki et al., 2009b). The conceptual framework includes four HRQL domains divided into 13 sub-domains (Box 1; see Gorecki et al., 2010a, Gorecki et al., 2010b for specific descriptive components). The conceptual framework provides a structured and formal framework against which the content of any available PROMs can be assessed.
Our aim was to identify generic, PU-specific and chronic skin wound-specific PROMs used to assess HRQL in patients with PUs or other chronic skin wounds and determine their suitability for use with patients with PUs.
Section snippets
Criteria for study inclusion/exclusion
Studies of any design were included if PROMs were used to assess HRQL or related concepts in adult (aged 18 or over) patient populations presenting with any grade PU or other chronic wounds, from hospital, rehabilitation or community health settings within Europe, North America or Australia. We considered that measures developed outside these regions might not be culturally appropriate for Western populations due to cross-cultural differences.
Studies were excluded if HRQL was: (i) assessed by
Search results
We retrieved 2665 papers, of which 257 were assessed as potentially relevant and 55 met inclusion criteria (Fig. 1). From these, 20 potential instruments were identified; however, three were excluded, two were still at development stage and therefore had yet to determine reliability and validity (Gorecki et al., 2012, Palfreyman et al., 2007) and the third provided no psychometric evidence (Naylor, 2002). A total of 17 PROMs fulfilled the inclusion criteria, including three generic and 14
Summary of evidence
We found that few studies have measured HRQL outcomes related to PU and treatment impact. Where HRQL outcomes have been assessed, generic or chronic-wound specific measures have been used. HRQL is a complex construct in terms of conceptualisation and measurement. Conceptualisation of HRQL specific to PUs has been mapped including four core HRQL assessment domains (Gorecki et al., 2010a, Gorecki et al., 2010b). This review identified that these domains are common in other generic and chronic
Conclusion
This comprehensive and systematic review of the international literature on PUs and other similar chronic wounds evaluated currently available PROMs based on content validity, item specificity and content relevance against an empirically derived PU-specific conceptual framework. It provides information necessary for the appropriate selection of PROMs when measuring the impact of PUs on HRQL. Currently, the HRQL domains important in PUs are inadequately covered by generic and chronic
Conflict of interest
The authors declare that they have no conflict of interest.
Funding
This paper presents independent research commissioned by the National Institute for Health Research (NIHR) under its programme Grants for Applied research funding scheme (RP-PG-0407-10056). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Acknowledgments
The authors would like to thank the Methodological Research Advisory Group for review of the search strategy: Stefan Cano; Sarah Smith; and Kritika Samsi, and Dr Sylvia Feyler (Leeds, UK) for translating the FLQA measure into English.
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