The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials

Patient-reported outcomes (PROs), such as symptoms, health-related quality of life (HRQOL), or patient perceived health status, are reported directly by the patient and are powerful tools to inform patients, clinicians, and policy-makers about morbidity and 'patient suffering', especially...

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Bibliographic Details
Published in:European heart journal 2014-08, Vol.35 (30), p.2001-2009
Main Authors: Anker, Stefan D, Agewall, Stefan, Borggrefe, Martin, Calvert, Melanie, Jaime Caro, J, Cowie, Martin R, Ford, Ian, Paty, Jean A, Riley, Jillian P, Swedberg, Karl, Tavazzi, Luigi, Wiklund, Ingela, Kirchhof, Paulus
Format: Article
Language:English
Subjects:
Cardiology
Cardiovascular Diseases - therapy
Clinical Medicine
Clinical Trials as Topic - methods
Data Collection
Data Interpretation, Statistical
Europe
Humans
Information Dissemination
Insurance, Health, Reimbursement
Klinisk medicin
Medicin och hälsovetenskap
Organizational Policy
Patient Outcome Assessment
Quality of Life
Societies, Medical
Terminology as Topic
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Summary:Patient-reported outcomes (PROs), such as symptoms, health-related quality of life (HRQOL), or patient perceived health status, are reported directly by the patient and are powerful tools to inform patients, clinicians, and policy-makers about morbidity and 'patient suffering', especially in chronic diseases. Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention. Patient-reported outcomes can improve the quality of patient care by creating a holistic approach to clinical decision-making; however, PROs are not routinely used as key outcome measures in major cardiovascular clinical trials. Thus, limited information is available on the impact of cardiovascular therapeutics on PROs to guide patient-level clinical decision-making or policy-level decision-making. Cardiovascular clinical research should shift its focus to include PROs when evaluating the efficacy of therapeutic interventions, and PRO assessments should be scientifically rigorous. The European Society of Cardiology and other professional societies can take action to influence the uptake of PRO data in the research and clinical communities. This process of integrating PRO data into comprehensive efficacy evaluations will ultimately improve the quality of care for patients across the spectrum of cardiovascular disease.
ISSN:0195-668X
1522-9645
1522-9645
DOI:10.1093/eurheartj/ehu205