title: The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials.
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 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.
authors.affiliation: Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum, Berlin D-13353, Germany Department of Cardiology, University Medical Center, Gottingen, Germany s.anker@cachexia.de.
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.affiliation: Department of Cardiology, Oslo University Hospital, Ullevål and Institute of Clinical Medicine, University of Oslo, Norway.
authors.forename: Stefan
authors.initials: S
authors.lastname: Agewall
authors.affiliation: University Medical Center Mannheim, Mannheim, Germany DZHK (German Centre for Cardiovascular Research) Partner Site, Mannheim, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Borggrefe
authors.affiliation: School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Calvert
authors.affiliation: Faculty of Medicine, McGill University, Montreal, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Jaime Caro
authors.affiliation: National Heart and Lung Institute, Imperial College London, London, UK.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Cowie
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.affiliation: invivodata, Inc., Pittsburgh, PA, USA.
authors.forename: Jean A
authors.initials: JA
authors.lastname: Paty
authors.affiliation: Department of Education, Royal Brompton and Harefield NHS Foundation Trust, London, UK.
authors.forename: Jillian P
authors.initials: JP
authors.lastname: Riley
authors.affiliation: Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden National Heart and Lung Institute, Imperial College, London, UK.
authors.forename: Karl
authors.initials: K
authors.lastname: Swedberg
authors.affiliation: Maria Cecilia Hospital, GVM Care and Research-E.S. Health Science Foundation, Cotignola, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Tavazzi
authors.affiliation: United BioSource Corporation, London, UK.
authors.forename: Ingela
authors.initials: I
authors.lastname: Wiklund
authors.affiliation: Centre for Cardiovascular Sciences, School of Clinical and Experimental Medicine, Sandwell and West Birmingham Hospitals National Health Service Trust, Birmingham, UK.
authors.forename: Paulus
authors.initials: P
authors.lastname: Kirchhof
mesh_terms: D002309:Cardiology; D002318:Cardiovascular Diseases / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection; D003627:Data Interpretation, Statistical; D005060:Europe; D006801:Humans; D033181:Information Dissemination; D007349:Insurance, Health, Reimbursement; D016134:Organizational Policy; D063868:Patient Outcome Assessment; D011788:Quality of Life; D012955:Societies, Medical; D009626:Terminology as Topic
keywords: Cardiovascular clinical trials; Health-related quality of life; Patient-reported outcomes