Abstract
Patient-reported outcomes (PROs) are reports of a person's health status that provide
a global perspective of patient well-being. PROs can be classified into 4 primary
domains: global, mental, physical, and social health. In this descriptive review,
we focus on how PROs can be used in cardiac clinical trials, with an emphasis on cardiac
surgical trials for patients with coronary heart disease and heart failure. We also
highlight ongoing challenges and provide specific suggestions and novel opportunities
to advance cardiac clinical trials. Current challenges include the long-term measurement
of PROs in clinical trials beyond 1 year, inconsistency in the choice of the outcome
measures among studies, and the lack of measurement of PROs across multiple domains.
Opportunities for advancement include measuring PROs using consumer health informatics
tools, including returning information back to participants in formats that they can
understand using visualization. Future opportunities include quantifying cohort-specific
minimal clinically important differences for PROs.
Résumé
Les résultats rapportés par les patients sont des rapports sur l’état de santé d'une
personne qui fournissent une vue d'ensemble du bien-être du patient. Ces résultats
peuvent être classés en quatre domaines principaux : santé générale, santé mentale,
santé physique et santé sociale. Dans cette revue descriptive, nous nous attardons
à la façon dont les résultats rapportés par les patients peuvent être utilisés dans
les essais cliniques sur les maladies, particulièrement dans les essais portant sur
les interventions chirurgicales chez des patients atteints de coronaropathie et cardiaque.
Nous soulignons également les défis constants qui doivent être relevés et fournissons
des suggestions précises et de nouvelles possibilités pour faire avancer les essais
cliniques sur les maladies cardiaques. Les défis actuels comprennent la mesure à long
terme des résultats rapportés par les patients dans le cadre d'essais cliniques qui
s’étendent au-delà de 1 an, l'hétérogénéité dans le choix des mesures des résultats
parmi les études, et l'absence de mesure des résultats rapportés par les patients
dans de nombreux domaines. Les possibilités d'avancement comprennent la mesure des
résultats rapportés par les patients à l'aide d'outils informatiques pour la santé
des consommateurs, qui prévoient notamment le renvoi de renseignements aux participants
dans des formats qu'ils peuvent comprendre faisant appel à des représentations visuelles.
Les possibilités futures comprennent la quantification des différences minimales cliniquement
importantes propres à une cohorte en ce qui a trait aux résultats rapportés par les
patients.
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Article info
Publication history
Published online: May 08, 2021
Accepted:
April 11,
2021
Received:
February 10,
2021
Footnotes
See page 1349 for disclosure information.
Identification
Copyright
© 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
