Heart failure & cardiomyopathies
Patient-Reported Outcome Measures and Patient Engagement in Heart Failure Clinical Trials: Multi-Stakeholder Perspectives
Recommendations
As issued by the authors
PRO measures (PROMs) must be developed with involvement of patients, family members and caregivers from diverse demographic groups and communities
PRO data collection should become more routine in clinical trials and in clinical practice, possibly facilitated by digital tools and interdisciplinary patient advocacy
Standardization is needed of PROM instruments and of procedures for analysis, interpretation and reporting of PRO data
Further research is needed on the minimal clinically important difference: thresholds for different PROMs, consistency across trial populations, and standards for improvement warranting regulatory and reimbursement approvals
Original publication
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