The development and validation of a patient-reported outcome measure of health-related quality of life for patients with pressure ulcers: PUQOL Project

This thesis aimed to establish the impact of pressure ulcers (PUs) on health-related quality of life (HRQL) and determine the need for a PU-specific patient-reported outcome (PRO) instrument. The thesis comprises literature reviews, development of a conceptual framework and development and evaluation of a PU-specific PRO (PU-QOLI) for future research and clinical practice. Methodological developments were woven into the research. This thesis demonstrates that PUs impact HRQL and there is need for standardised methods for assessing health outcomes important in PUs. The PU-QOLI was developed using qualitative and quantitative psychometric methods and meets international standards for rigorous measurement. Individual scales can be selected from 10 outcomes of PU-symptoms, physical functioning, psychological well-being, and social participation, intended for interview-administration. It is appropriate for use in adults with any type of PU and suitable for all UK healthcare settings. This research makes important contributions to the PU and wider health measurement fields. The findings demonstrate that mixed methods, including Rasch measurement, were suitable for developing a PRO instrument, the PU-QOLI provides a means for the comprehensive assessment of PU impact and for quantifying the benefits of PU interventions from the patient‟s perspective, thus far lacking in the area, and the use of PROs will provide evidence-based information to allow health authorities to select the most effective healthcare for patients and to audit and monitor the quality of care given in the PU field. This work was the first step towards establishing measurement precision. Further research is needed to improve some of the measurement properties of PU-QOLI scales, assess responsiveness, confirm study findings in an independent sample, investigate feasibility of use in specific subgroups and economic evaluation, and develop proxy measures and language translations. Long-term goals include developing the PU-QOLI as a clinical tool intended for individual-patient decision making.