The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials
Open accessAbstract
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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The trial evaluates both efficacy and cost-effectiveness, adherent to recommendations by the American Heart Association and the European Society of Cardiology.
“The trial evaluates both the efficacy and the cost-effectiveness of the intervention, which is adherent to the recommendations by the American Heart Association [43] and the European Society of Cardiology [44].”
Study endpoints include not only clinical outcomes and cost-effectiveness but also patient-reported outcomes, as advocated both by the American Heart Association and the European Society of Cardiology, when evaluating the effects of clinical trials.
“In addition, study endpoints include not only clinical outcomes and cost-effectiveness but also patient-reported outcomes, as advocated both by the American Heart Association [53] and the European Society of Cardiology [54], when evaluating the effects of clinical trials.”
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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
- 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
- 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 · 2013: 1 · 2012: 1
- 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
- Social Sciences › Education › 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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