Patient-reported outcomes in randomized controlled trials of heart failure: from inclusion to quality of reporting

Abstract

Patient-reported outcomes (PROs) produce meaningful information about patient-perceived health status reported directly by patients. Routine collection of PROs data is particularly important in chronic conditions, such as heart failure (HF). Major cardiovascular societies and regulatory agencies encouraged PRO inclusion in randomized controlled trials (RCTs), but PROs remain underutilized as a key outcome in these studies.

In this systematic review, we aimed to evaluate temporal trends and explore trial characteristics associated with PRO inclusion in HF RCTs published in high-impact medical journals. We also assessed the quality of PRO reporting against the Consolidated Standards of Reporting Trials PRO extension.

We found that over half of HF RCTs included a PRO. The proportion of RCTs with PROs increased significantly since 2000. A number of RCT characteristics such as multicentre; medium-sized (n = 51-250 participants); trials coordinated in Central and South America; and that tested health services, devices or surgery, exercise and rehabilitation interventions were independently associated with higher odds of PRO inclusion. The quality of PRO reporting was modest, with better reporting in RCTs with PROs a primary or co-primary endpoint.

Consistent PRO inclusion and high-quality reporting are necessary to increase the utility of these findings by patients, clinicians, and health care policy makers.