Heart failure & cardiomyopathiesRandomised controlled trial
Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial
- Randomised controlled trial
- open-label
- parallel
- patient-level
- single academic heart failure (HF) clinic
Authors' conclusion
Routine PRO assessment in HF clinic visits did not impact patient-reported quality of life or other clinical outcomes.
Study context
- Population
- Patients with HF at an academic HF clinic, 2021–202217 clinicians
- Participants
- 1,248 patients
- Comparison
- Routine patient-reported outcome (PRO) assessment vs usual care
- PRO assessmentn = 624
- Usual caren = 624reference
- Primary endpoint
- KCCQ-12 overall summary score (OSS)
- Follow-up
- 12–15 months after randomization
Primary result
KCCQ-12 OSS
Baseline-adjusted mean difference
0.2
95% CI −1.7 to 2.0
P = 0.85
By group
PRO assessment
87.5
median · IQR 68.8–96.9
Usual care
87.6
median · IQR 69.7–96.9
PRO assessment vs Usual care
baseline-adjusted mean difference 0.2 (95% CI −1.7 to 2.0); P = 0.85
As reported in the abstract
Secondary outcomes
KCCQ-12 overall summary score (OSS) by baseline OSS (post hoc)
- Significant interaction with greater benefit at baseline OSS 60 to 80, not in less or more symptomatic participants
- post hoc analysis
1-year mortality, hospitalizations, ED visits, medication therapy, clinic follow-up, testing rates
- No significant differences between arms
Original publication
Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial. Circulation. Published 7 April 2024. doi:10.1161/circulationaha.124.069624
Summarised from the published abstract; every number is checked against it