Psychometric validation of the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU®) patient-reported outcome instrument.

ABSTRACT: BACKGROUND:We aimed to develop a patient-reported outcome measure, in accordance with the US Food and Drug Administration guidance, to capture the impact of systemic sclerosis-related digital ulcers (SSc-DUs) on hand function. Psychometric analyses were conducted to evaluate and document the measurement properties of the resulting instrument-the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU®). METHODS:The HDISS-DU was developed through a series of confirmatory, qualitative concept-elicitation interviews (N = 36) to provide supportive evidence that the instrument captures all relevant issues and functional limitations relating to SSc-DUs in this patient population. Psychometric analyses used blinded data from two randomised, controlled, phase 3 trials in patients with SSc-D

SUBMITTER: Mouthon L 

PROVIDER: S-EPMC6945532 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature