A landscape review to identify what matters to patients with thrombotic cardiovascular diseases and patient-reported outcome instruments which can be used to capture the patient experience.

ABSTRACT:

Purpose

Thrombotic cardiovascular diseases profoundly impact patients' health-related quality of life (HRQoL). However, patient-reported outcome (PRO) instruments that are disease-specific or antithrombotic-treatment focused, developed according to US Food and Drug Administration (FDA) guidance on PROs, and can be used in clinical trials, are lacking. The aim of this study was to understand concepts important to patients diagnosed with coronary artery disease (CAD) or acute coronary syndrome (ACS), atrial fibrillation (AF), or stroke who require antithrombotic treatment for reducing risk of future thrombotic events (indications being evaluated for an investigational new drug), identify PROs that measure relevant symptoms and impacts, and determine acceptability of PROs from a healt

SUBMITTER: Barsdorf AI 

PROVIDER: S-EPMC11802703 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature