Developing and testing a patient-reported outcome measure for post-stroke fatigue – a mixed-methods approach

Abstract

Post-stroke fatigue (PSF) is a highly prevalent condition which negatively impacts the lives of stroke survivors. Currently, there is a lack of evidence-based treatments for PSF, and a major barrier to further progress is the absence of a high-quality instrument to measure and diagnose PSF. The overarching aim of this thesis was to develop and evaluate a new patient-reported outcome measure (PROM) for fatigue in stroke patients. This thesis adhered to PROM development guidelines, combining qualitative and quantitative methods. We found that existing fatigue PROMs used in stroke populations have significant shortcomings and do not comply with the best practice guidelines and high standards set by regulators. As a result, we developed a new PROM specifically targeted for measuring PSF. We explored stroke survivors and health professionals’ experiences with fatigue, which further led to the formulation of a definition and a conceptual framework of PSF. These results guided the creation of items in our new PROM. The measurement properties of the instrument were then tested in additional studies with stroke patients. We found that our new PROM exhibited strong content validity, structural validity, and internal consistency.