Adding the patient perspective: the necessity of patient reported outcomes in cardiac surgery clinical trials.

Abstract

Purpose of review: This review highlights the growing importance of patient reported outcomes (PROs) in cardiac surgery trials. Cardiac surgery trials have traditionally focused on cardiovascular events such as survival, stroke or myocardial infarction. However, as surgical outcomes have continued to improve, incorporating the patient's perspective through PROs has become increasingly critical. Incorporating PROs as key study outcomes provides essential patient data, while also overcoming the methodological limitations of classic composite endpoints.

Recent findings: Continued advancements in cardiac surgery have significantly reduced classic endpoint differentials, making it challenging to evaluate interventions with their use alone. PROs offer more granular details on the effects of surgical interventions compared to classic clinical events and are widely used in other medical fields. More recently, cardiac surgery trials have begun successfully implementing PROs, though there is need for greater utilization across the discipline.

Summary: The integration of PROs into cardiac surgery trials allows for better understanding of the impact of surgical interventions on patients' daily lives. While barriers exist, efforts to develop and standardize PRO measures promise to enhance the relevance of cardiac surgery clinical trials and ultimately improve patient care.