Development and validation of a new patient-reported outcome measure for patients with pressure ulcers: the PU-QOL instr
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RESEARCH
Open Access
Development and validation of a new patient-reported outcome measure for patients with pressure ulcers: the PU-QOL instrument Claudia Gorecki1*, Julia M Brown1, Stefan Cano2, Donna L Lamping3, Michelle Briggs4, Susanne Coleman1, Carol Dealey5, Elizabeth McGinnis6, Andrea E Nelson4, Nikki Stubbs7, Lyn Wilson1 and Jane Nixon1
Abstract 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 80%)
● % of item-level missing data (50% completed items) [31] ● Items in scales rated ‘not relevant’
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