Abstract
ObjectivesTo develop and undertake initial validation of a patient-reported outcome measure to assess health-related quality of life in patients with breast cancer–related upper limb lymphedema (ULL). Study Design and SettingWe developed and validated the Upper Limb Lymphedema Quality of Life (ULLQoL) scale in two stages: devising the items and pretesting with patients and clinicians; longitudinal validation to test its psychometric properties-underlying dimensions, internal consistency, test-retest reliability, construct validity, and responsiveness. Patients with ULL were recruited from two outpatient clinics. ResultsWe derived the ULLQoL scale from a pool of 98 items generated by patients. After further consultation, we produced the draft ULLQoL scale. For validation, 103 patients with ULL completed the draft scale and two generic health measures: SF-36 and ED-5D-3L. Psychometric analysis identified two components, physical and emotional well-being, with good internal consistency and test-retest reliability. Significant correlations with SF-36, EQ-5D-3L, and percentage excess limb volume confirmed construct validity. The ULLQoL scale showed good responsiveness to change reported by lymphedema patients and moderate to large effect sizes. ConclusionThe 14-item ULLQoL scale is a robust ULL-specific measure that is feasible and valid to use in both the clinical and research settings.
Accepted Version (
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Published Version
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