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

Stefan D. Anker, Stefan Agewall, Martin Borggrefe, Melanie Calvert, J. Jaime Caro, Martin R. Cowie, Ian Ford, Jean A. Paty, Jillian P. Riley, Karl Swedberg, Luigi Tavazzi, Ingela Wiklund, Paulus Kirchhof

Research output: Contribution to journalArticlepeer-review

Abstract

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 ofPROdata 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.

Original languageEnglish
Pages (from-to)2001-2009
Number of pages9
JournalEuropean Heart Journal
Volume35
Issue number30
DOIs
Publication statusPublished - Aug 7 2014

Keywords

  • Cardiovascular clinical trials
  • Health-related quality of life
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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