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Eur Heart J. 2014 Aug 7;35(30):2001-9. doi: 10.1093/eurheartj/ehu205. Epub 2014 Jun 5.

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

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Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum, Berlin D-13353, Germany Department of Cardiology, University Medical Center, Gottingen, Germany
Department of Cardiology, Oslo University Hospital, Ullevål and Institute of Clinical Medicine, University of Oslo, Norway.
University Medical Center Mannheim, Mannheim, Germany DZHK (German Centre for Cardiovascular Research) Partner Site, Mannheim, Germany.
School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
Faculty of Medicine, McGill University, Montreal, Canada.
National Heart and Lung Institute, Imperial College London, London, UK.
Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
invivodata, Inc., Pittsburgh, PA, USA.
Department of Education, Royal Brompton and Harefield NHS Foundation Trust, London, UK.
Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden National Heart and Lung Institute, Imperial College, London, UK.
Maria Cecilia Hospital, GVM Care and Research-E.S. Health Science Foundation, Cotignola, Italy.
United BioSource Corporation, London, UK.
Centre for Cardiovascular Sciences, School of Clinical and Experimental Medicine, Sandwell and West Birmingham Hospitals National Health Service Trust, Birmingham, UK.


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.


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

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