Cited by 362Health Systems, Economic Evaluations, Quality of LifeHealth Education and ValidationStatistical Methods in Clinical Trials

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

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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·2014·European Heart Journal

DOI 10.1093/eurheartj/ehu205

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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.

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Authors: Anker, S. D., Agewall, S., Borggrefe, M., Calvert, M., Jaime Caro, J., Cowie, M. R., Ford, I., Paty, J. A., Riley, J. P., Swedberg, K., Tavazzi, L., Wiklund, I., & Kirchhof, P.
Affiliations: Universitätsmedizin Göttingen (DE)
Oslo University Hospital (NO)
German Centre for Cardiovascular Research (DE)
University of Birmingham (GB)
University of Glasgow (GB)
Royal Brompton & Harefield NHS Foundation Trust (GB)
Imperial College London (GB)
Maria Cecilia Hospital (IT)
United BioSource Corporation (United Kingdom) (GB)
National Health Service (GB)
Corresponding author: Anker, Stefan D.
ORCID: Anker, Stefan D.
Agewall, Stefan
Borggrefe, Martin
Calvert, Melanie
Ford, Ian
Paty, Jean A.
Riley, Jillian P.
Swedberg, Karl
Tavazzi, Luigi
Wiklund, Ingela
Kirchhof, Paulus
Venue: European Heart Journal
Publisher: Oxford University Press (OUP)
Published: 2014-06-05
Volume: 35
Issue: 30
Pages: 2001-2009
ISSN: 0195-668X (ISSN-L)
1522-9645
DOI: 10.1093/eurheartj/ehu205
OpenAlex: W1981551890
Cited by: 362
References: 53
Citations by year: 2026: 15 · 2025: 24 · 2024: 24 · 2023: 31 · 2022: 36 · 2021: 38 · 2020: 50 · 2019: 35 · 2018: 21 · 2017: 23 · 2016: 28 · 2015: 29 · 2014: 5
FWCI: 8.29
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
Locations: European Heart Journal (publishedVersion, cc-by)
PubMed (publishedVersion)
ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
GRO (submittedVersion)
University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
Funders: Pfizer
Bayer HealthCare
European Society of Cardiology
Servier
Novartis Pharma
Medical Research Council (MR/K025643/1)
Topics: Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Health Sciences › Nursing › Research and Theory › Health Education and Validation
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: patient-reported outcomes, cardiovascular clinical trials, health-related quality of life, patient experience, outcome measures, cardiovascular therapeutics, clinical decision-making, chronic cardiovascular disease, European Society of Cardiology
MeSH terms: Cardiology, Cardiovascular Diseases, Clinical Trials as Topic, Data Collection, Data Interpretation, Statistical, Europe, Humans, Insurance, Health, Reimbursement, Terminology as Topic, Quality of Life, Societies, Medical, Organizational Policy, Information Dissemination, Patient Outcome Assessment

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

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