The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials.
Identifieur interne : 000D20 ( Main/Exploration ); précédent : 000D19; suivant : 000D21The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials.
Auteurs : Stefan D. Anker [Allemagne] ; Stefan Agewall [Norvège] ; Martin Borggrefe [Allemagne] ; Melanie Calvert [Royaume-Uni] ; J. Jaime Caro [Canada] ; Martin R. Cowie [Royaume-Uni] ; Ian Ford [Royaume-Uni] ; Jean A. Paty [États-Unis] ; Jillian P. Riley [Royaume-Uni] ; Karl Swedberg [Royaume-Uni] ; Luigi Tavazzi [Italie] ; Ingela Wiklund [Royaume-Uni] ; Paulus Kirchhof [Royaume-Uni]Source :
- European heart journal [ 1522-9645 ] ; 2014.
Descripteurs français
- KwdFr :
- Cardiologie, Collecte de données, Diffusion de l'information, Essais cliniques comme sujet (), Europe, Humains, Interprétation statistique de données, Maladies cardiovasculaires (), Politique organisationnelle, Qualité de vie, Remboursement par l'assurance maladie, Sociétés médicales, Terminologie comme sujet, Évaluation des résultats des patients.
- MESH :
- Cardiologie, Collecte de données, Diffusion de l'information, Essais cliniques comme sujet, Europe, Humains, Interprétation statistique de données, Maladies cardiovasculaires, Politique organisationnelle, Qualité de vie, Remboursement par l'assurance maladie, Sociétés médicales, Terminologie comme sujet, Évaluation des résultats des patients.
English descriptors
- KwdEn :
- Cardiology, Cardiovascular Diseases (therapy), Clinical Trials as Topic (methods), Data Collection, Data Interpretation, Statistical, Europe, Humans, Information Dissemination, Insurance, Health, Reimbursement, Organizational Policy, Patient Outcome Assessment, Quality of Life, Societies, Medical, Terminology as Topic.
- MESH :
- geographic : Europe.
- methods : Clinical Trials as Topic.
- therapy : Cardiovascular Diseases.
- Cardiology, Data Collection, Data Interpretation, Statistical, Humans, Information Dissemination, Insurance, Health, Reimbursement, Organizational Policy, Patient Outcome Assessment, Quality of Life, Societies, Medical, Terminology as Topic.
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.
DOI: 10.1093/eurheartj/ehu205
PubMed: 24904027
Affiliations:
- Allemagne, Canada, Italie, Norvège, Royaume-Uni, États-Unis
- Angleterre, Bade-Wurtemberg, District de Karlsruhe, Grand Londres, Midlands de l'Ouest, Pennsylvanie, Québec, Écosse
- Birmingham, Glasgow, Londres, Mannheim, Montréal
- Université McGill, Université de Birmingham, Université de Glasgow
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Le document en format XML
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Anker</name><affiliation wicri:level="1"><nlm: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.</nlm:affiliation><country wicri:rule="url">Allemagne</country><wicri:regionArea>Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum, Berlin D-13353, Germany Department of Cardiology, University Medical Center, Gottingen</wicri:regionArea><wicri:noRegion>Gottingen</wicri:noRegion><wicri:noRegion>Gottingen</wicri:noRegion><wicri:noRegion>Gottingen</wicri:noRegion></affiliation></author><author><name sortKey="Agewall, Stefan" sort="Agewall, Stefan" uniqKey="Agewall S" first="Stefan" last="Agewall">Stefan Agewall</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Oslo University Hospital, Ullevål and Institute of Clinical Medicine, University of Oslo, Norway.</nlm:affiliation><country xml:lang="fr">Norvège</country><wicri:regionArea>Department of Cardiology, Oslo University Hospital, Ullevål and Institute of Clinical Medicine, University of Oslo</wicri:regionArea><wicri:noRegion>University of Oslo</wicri:noRegion></affiliation></author><author><name sortKey="Borggrefe, Martin" sort="Borggrefe, Martin" uniqKey="Borggrefe M" first="Martin" last="Borggrefe">Martin Borggrefe</name><affiliation wicri:level="3"><nlm:affiliation>University Medical Center Mannheim, Mannheim, Germany DZHK (German Centre for Cardiovascular Research) Partner Site, Mannheim, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>University Medical Center Mannheim, Mannheim, Germany DZHK (German Centre for Cardiovascular Research) Partner Site, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Calvert, Melanie" sort="Calvert, Melanie" uniqKey="Calvert M" first="Melanie" last="Calvert">Melanie Calvert</name><affiliation wicri:level="4"><nlm:affiliation>School of Health and Population Sciences, University of Birmingham, Birmingham, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Health and Population Sciences, University of Birmingham, Birmingham</wicri:regionArea><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region><settlement type="city">Birmingham</settlement></placeName><orgName type="university">Université de Birmingham</orgName></affiliation></author><author><name sortKey="Jaime Caro, J" sort="Jaime Caro, J" uniqKey="Jaime Caro J" first="J" last="Jaime Caro">J. Jaime Caro</name><affiliation wicri:level="4"><nlm:affiliation>Faculty of Medicine, McGill University, Montreal, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Faculty of Medicine, McGill University, Montreal</wicri:regionArea><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region><settlement type="city">Montréal</settlement></placeName><orgName type="university">Université McGill</orgName></affiliation></author><author><name sortKey="Cowie, Martin R" sort="Cowie, Martin R" uniqKey="Cowie M" first="Martin R" last="Cowie">Martin R. Cowie</name><affiliation wicri:level="3"><nlm:affiliation>National Heart and Lung Institute, Imperial College London, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>National Heart and Lung Institute, Imperial College London, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name><affiliation wicri:level="4"><nlm:affiliation>Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Robertson Centre for Biostatistics, University of Glasgow, Glasgow</wicri:regionArea><orgName type="university">Université de Glasgow</orgName><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Paty, Jean A" sort="Paty, Jean A" uniqKey="Paty J" first="Jean A" last="Paty">Jean A. Paty</name><affiliation wicri:level="2"><nlm:affiliation>invivodata, Inc., Pittsburgh, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>invivodata, Inc., Pittsburgh, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Riley, Jillian P" sort="Riley, Jillian P" uniqKey="Riley J" first="Jillian P" last="Riley">Jillian P. Riley</name><affiliation wicri:level="3"><nlm:affiliation>Department of Education, Royal Brompton and Harefield NHS Foundation Trust, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Education, Royal Brompton and Harefield NHS Foundation Trust, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Swedberg, Karl" sort="Swedberg, Karl" uniqKey="Swedberg K" first="Karl" last="Swedberg">Karl Swedberg</name><affiliation wicri:level="3"><nlm:affiliation>Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden National Heart and Lung Institute, Imperial College, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden National Heart and Lung Institute, Imperial College, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name><affiliation wicri:level="1"><nlm:affiliation>Maria Cecilia Hospital, GVM Care and Research-E.S. Health Science Foundation, Cotignola, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Maria Cecilia Hospital, GVM Care and Research-E.S. Health Science Foundation, Cotignola</wicri:regionArea><wicri:noRegion>Cotignola</wicri:noRegion></affiliation></author><author><name sortKey="Wiklund, Ingela" sort="Wiklund, Ingela" uniqKey="Wiklund I" first="Ingela" last="Wiklund">Ingela Wiklund</name><affiliation wicri:level="3"><nlm:affiliation>United BioSource Corporation, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>United BioSource Corporation, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Kirchhof, Paulus" sort="Kirchhof, Paulus" uniqKey="Kirchhof P" first="Paulus" last="Kirchhof">Paulus Kirchhof</name><affiliation wicri:level="3"><nlm:affiliation>Centre for Cardiovascular Sciences, School of Clinical and Experimental Medicine, Sandwell and West Birmingham Hospitals National Health Service Trust, Birmingham, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Cardiovascular Sciences, School of Clinical and Experimental Medicine, Sandwell and West Birmingham Hospitals National Health Service Trust, Birmingham</wicri:regionArea><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region></placeName></affiliation></author></analytic><series><title level="j">European heart journal</title><idno type="eISSN">1522-9645</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cardiology</term><term>Cardiovascular Diseases (therapy)</term><term>Clinical Trials as Topic (methods)</term><term>Data Collection</term><term>Data Interpretation, Statistical</term><term>Europe</term><term>Humans</term><term>Information Dissemination</term><term>Insurance, Health, Reimbursement</term><term>Organizational Policy</term><term>Patient Outcome Assessment</term><term>Quality of Life</term><term>Societies, Medical</term><term>Terminology as Topic</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Cardiologie</term><term>Collecte de données</term><term>Diffusion de l'information</term><term>Essais cliniques comme sujet ()</term><term>Europe</term><term>Humains</term><term>Interprétation statistique de données</term><term>Maladies cardiovasculaires ()</term><term>Politique organisationnelle</term><term>Qualité de vie</term><term>Remboursement par l'assurance maladie</term><term>Sociétés médicales</term><term>Terminologie comme sujet</term><term>Évaluation des résultats des patients</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Europe</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Cardiovascular Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Cardiology</term><term>Data Collection</term><term>Data Interpretation, Statistical</term><term>Humans</term><term>Information Dissemination</term><term>Insurance, Health, Reimbursement</term><term>Organizational Policy</term><term>Patient Outcome Assessment</term><term>Quality of Life</term><term>Societies, Medical</term><term>Terminology as Topic</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Cardiologie</term><term>Collecte de données</term><term>Diffusion de l'information</term><term>Essais cliniques comme sujet</term><term>Europe</term><term>Humains</term><term>Interprétation statistique de données</term><term>Maladies cardiovasculaires</term><term>Politique organisationnelle</term><term>Qualité de vie</term><term>Remboursement par l'assurance maladie</term><term>Sociétés médicales</term><term>Terminologie comme sujet</term><term>Évaluation des résultats des patients</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Canada</li><li>Italie</li><li>Norvège</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Bade-Wurtemberg</li><li>District de Karlsruhe</li><li>Grand Londres</li><li>Midlands de l'Ouest</li><li>Pennsylvanie</li><li>Québec</li><li>Écosse</li></region><settlement><li>Birmingham</li><li>Glasgow</li><li>Londres</li><li>Mannheim</li><li>Montréal</li></settlement><orgName><li>Université McGill</li><li>Université de Birmingham</li><li>Université de Glasgow</li></orgName></list><tree><country name="Allemagne"><noRegion><name sortKey="Anker, Stefan D" sort="Anker, Stefan D" uniqKey="Anker S" first="Stefan D" last="Anker">Stefan D. Anker</name></noRegion><name sortKey="Borggrefe, Martin" sort="Borggrefe, Martin" uniqKey="Borggrefe M" first="Martin" last="Borggrefe">Martin Borggrefe</name></country><country name="Norvège"><noRegion><name sortKey="Agewall, Stefan" sort="Agewall, Stefan" uniqKey="Agewall S" first="Stefan" last="Agewall">Stefan Agewall</name></noRegion></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Calvert, Melanie" sort="Calvert, Melanie" uniqKey="Calvert M" first="Melanie" last="Calvert">Melanie Calvert</name></region><name sortKey="Cowie, Martin R" sort="Cowie, Martin R" uniqKey="Cowie M" first="Martin R" last="Cowie">Martin R. Cowie</name><name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name><name sortKey="Kirchhof, Paulus" sort="Kirchhof, Paulus" uniqKey="Kirchhof P" first="Paulus" last="Kirchhof">Paulus Kirchhof</name><name sortKey="Riley, Jillian P" sort="Riley, Jillian P" uniqKey="Riley J" first="Jillian P" last="Riley">Jillian P. Riley</name><name sortKey="Swedberg, Karl" sort="Swedberg, Karl" uniqKey="Swedberg K" first="Karl" last="Swedberg">Karl Swedberg</name><name sortKey="Wiklund, Ingela" sort="Wiklund, Ingela" uniqKey="Wiklund I" first="Ingela" last="Wiklund">Ingela Wiklund</name></country><country name="Canada"><region name="Québec"><name sortKey="Jaime Caro, J" sort="Jaime Caro, J" uniqKey="Jaime Caro J" first="J" last="Jaime Caro">J. Jaime Caro</name></region></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Paty, Jean A" sort="Paty, Jean A" uniqKey="Paty J" first="Jean A" last="Paty">Jean A. Paty</name></region></country><country name="Italie"><noRegion><name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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