Development of a conceptual model and patient-reported outcome measures for assessing symptoms and functioning in patients with heart failure.

ABSTRACT:

Purpose

Heart failure (HF) is a common condition that places considerable burden on patients. We aimed to develop a patient-reported outcome (PRO) measure to assess the symptoms and impacts of HF.

Methods

Phase 1: a targeted literature review, expert interviews, and concept elicitation (CE) interviews with patients with HF (n = 26) were used to develop a conceptual model of the core symptoms and impacts of HF. To capture these concepts, three new fit-for-purpose PRO questionnaires were constructed in accordance with US Food and Drug Administration PRO guidance. Phase 2: three 'waves' of cognitive interviews were conducted with patients with HF (n = 28) to validate and refine the questionnaires.

Results

Three key symptoms-shortness of breath, oedema, and fatigue-were i

SUBMITTER: Moshkovich O 

PROVIDER: S-EPMC7561560 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature