Use of patient‐reported outcomes in heart failure: from clinical trials to routine practice

Author:

Savarese Gianluigi1ORCID,Lindenfeld Joann2,Stolfo Davide13,Adams Kirkwood4,Ahmad Tariq5,Desai Nihar R.5,Ammirati Enrico6,Gottlieb Stephen S.7,Psotka Mitchell A.8,Rosano Giuseppe M.C.9,Allen Larry A.10

Affiliation:

1. Division of Cardiology, Department of Medicine Karolinska Institutet Stockholm Sweden

2. Vanderbilt Heart and Vascular Institute Vanderbilt University Medical Center Nashville TN USA

3. Cardiothoracovascular Department Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy

4. Division of Cardiology, Department of Medicine University of North Carolina at Chapel Hill Chapel Hill NC USA

5. Yale School of Medicine Section of Cardiovascular Medicine New Haven CT USA

6. De Gasperis Cardio Center ASST Grande Ospedale Metropolitano Niguarda Milan Italy

7. Division of Cardiovascular Medicine University of Maryland School of Medicine and Baltimore Veterans Administration Medical Center Baltimore MD USA

8. Inova Heart and Vascular Institute Falls Church VA USA

9. Centre for Clinical & Basic Research IRCCS San Raffaele Pisana Rome Italy

10. Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO USA

Abstract

AbstractHeart failure (HF) is a complex syndrome that affects mortality/morbidity and acts at different levels in the patient's life, resulting in a drastic impairment in multiple aspects of daily activities (e.g. physical, mental/emotional, and social) and leading to a reduction in quality of life. The definition of disease status and symptom severity has been traditionally based on the physician assessment, while the patient's experience of disease has been long overlooked. The active participation of patients in their own care is necessary to better understand the perception of disease and the multiple aspects of life affected, and to improve adherence to treatments. Patient‐reported outcomes (PROs) aim to switch traditional care to a more patient‐centred approach. Although PROs demonstrated precision in the evaluation of disease status and have a good association with prognosis in several randomized controlled trials, their implementation into clinical practice is limited. This review discusses the modalities of use of PROs in HF, summarizes the most largely adopted PROs in HF care, and provides an overview on the application of PROs in trials and the potential for their transition to clinical practice. By discussing the advantages and the disadvantages of their use, the reasons limiting their application in daily clinical routine, and the strategies that may promote their implementation, this review aims to foster the systematic integration of the patient's standpoint in HF care.

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine

Reference106 articles.

1. Global burden of heart failure: a comprehensive and updated review of epidemiology

2. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure

3. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary

4. Cardiovascular Health: The Importance of Measuring Patient-Reported Health Status

5. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health.Guidance for Industry – Patient‐Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.https://www.fda.gov/media/77832/download(last accessed 10 January 2023).

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