Nosebleeds in hereditary hemorrhagic telangiectasia: Development of a patient-completed daily eDiary.

ABSTRACT:

Objective

A prospective, qualitative study was conducted to develop a patient-reported outcome measure (PROM) for daily administration via electronic diary (eDiary) to assess the severity of nosebleeds in patients with hereditary hemorrhagic telangiectasia (HHT), in accordance with Food and Drug Administration (FDA) PROM guidance criteria.

Methods

Three expert clinicians who treat patients with HHT provided input during instrument development, which comprised: 1) Peer-reviewed literature and instrument review; 2) Development of draft Nosebleed Diary items; 3a) Three rounds of qualitative interviews (two with a paper-based diary, one with an eDiary) with patients with documented severe epistaxis related to HHT, for concept elicitation and cognitive debriefing; 3b) Face validi

SUBMITTER: Clark M 

PROVIDER: S-EPMC6302722 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature