TY - JOUR
T1 - The importance of patient-reported outcomes
T2 - A call for their comprehensive integration in cardiovascular clinical trials
AU - Anker, Stefan D.
AU - Agewall, Stefan
AU - Borggrefe, Martin
AU - Calvert, Melanie
AU - Caro, J. Jaime
AU - Cowie, Martin R.
AU - Ford, Ian
AU - Paty, Jean A.
AU - Riley, Jillian P.
AU - Swedberg, Karl
AU - Tavazzi, Luigi
AU - Wiklund, Ingela
AU - Kirchhof, Paulus
PY - 2014/8/7
Y1 - 2014/8/7
N2 - 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.
AB - 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.
KW - Cardiovascular clinical trials
KW - Health-related quality of life
KW - Patient-reported outcomes
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U2 - 10.1093/eurheartj/ehu205
DO - 10.1093/eurheartj/ehu205
M3 - Article
C2 - 24904027
AN - SCOPUS:84906654366
VL - 35
SP - 2001
EP - 2009
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 30
ER -