Authors
- Giulia Paglione, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Roma, Italy; Clinical Research Service, IRCCS Policlinico San Donato, San Donato Milanese, Italy
- Rosario Caruso, Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
DOI
https://doi.org/10.65241/wh.8.1.7
Article type:
Review
Abstract:
Background:
Heart failure (HF) is a complex clinical syndrome marked by high heterogeneity in presentation, progression, and response to treatment. This variability, coupled with inconsistent outcome selection across clinical studies, complicates data synthesis and the development of generalizable evidence. Core Outcome Sets (COS) have been proposed to enhance outcome standardization, but their use in HF research and practice remains fragmented and underexamined. This paper presents two complementary components: (1) a discursive analysis of two exemplary COS, one developed for clinical trials (EuroHeart COS) and one for symptom monitoring in routine care (Lawson et al. COS), and (2) a methodological protocol for a future scoping review.
Methods:
The scoping review protocol follows Joanna Briggs Institute (JBI) and PRISMA-ScR guidelines and is designed to map existing COS in HF, identify development processes, outcome domains, and gaps. The discursive analysis explores stakeholder involvement, methodological rigor, patient-centeredness, and contextual adaptation.
Results:
The discursive analysis revealed epistemological contrasts between COS designed for research standardization versus those tailored to patient monitoring and decision support. EuroHeart emphasizes registry-based, clinically anchored endpoints, while Lawson et al. foregrounds patient-reported symptoms and usability in telemonitoring contexts. The forthcoming scoping review is anticipated to identify significant variability in the scope of COS, stakeholder engagement, and relevance across populations, with likely gaps in COS tailored to specific phenotypes, underrepresented groups, and real-world clinical practice.
Conclusions:
The development and implementation of COS in HF require a context-sensitive, inclusive, and methodologically transparent approach. This manuscript serves as both a critical reflection on COS logic and a practical guide to synthesizing available sets. Bridging theoretical discourse with systematic review methodology contributes to a more coordinated and patient-centered agenda for outcome standardization in research and care for patients with HF.
Keywords:
Core Outcome Sets; Heart Failure; Outcome Standardization; Scoping Review Protocol; Patient-Centered Outcomes.