Routine Assessment of Patient-Reported Health Status in Academic Clinics Did Not Improve Patient-Reported Health-Status: The PRO-HF Trial

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By Dami Aladesanmi on

Key Points:

  • The latest AHA/ACC Heart Failure (HF) guidelines recommend routine assessment of patient-reported health status, but no randomized trials have analyzed its possible impact on routine HF care.
  • This study compared routine health status assessment with the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) with usual care among HF clinic patients.
  • Primary outcome was patient-reported health status at 1 year while secondary outcomes included therapy patterns, testing, and care utilization. 
  • The study did not show significant differences in patient-reported health status between the KCCQ-12 arm and the usual care arm, nor differences in therapy patterns, testing, and care utilization.

The 2022 ACC/AHA HF guidelines note that routine assessment of patient-reported health status using a validated questionnaire can help provide longitudinal information with respect to functional status, symptom burden, and prognosis. In addition, although New York Heart Association (NYHA) class criteria is standard of care for physician assessment, studies have shown this is often discordant with patient-reported health status. In fact, some studies have also suggested that patient-reported health status may be more prognostic than NYHA class. Nevertheless, to date, there are no randomized trials investigating monitoring of patient-reported health status in routine HF care.

The PRO-HF trial sought to determine the impact of assessment from the well-validated Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) on HF clinic patients with primary outcome of patient-reported health status at one year. Secondary outcomes included therapy patterns, testing, and care utilization. Within a Stanford HF clinic, 1249 participants were randomized to either a “PRO” (patient-reported outcomes) arm with the KCCQ-12 questionnaire to be completed at each visit, or a usual HF care arm. After adjusting for baseline KCCQ-12 (of note, range 0-100 with 0 as worst health status and 100 as best health status), a final KCCQ-12 score was obtained at 1 year from participants in both arms.

Both arms were well-balanced, with median age 64 years old, 39% female patients, and baseline KCCQ-12 score similar (82; IQR 58-95). Overall, 87.2% of participants across clinic visits completed KCCQ-12 questionnaires, and 86.5% (1041/1204) of participants were alive to complete a final KCCQ-12 at trial completion. Ultimately, the study did not find a significant between-group difference (0.2; 95% CI: -1.7 to 2.0). This lack of difference persisted among age, gender, ejection fraction, and prior HF diagnosis. Furthermore, the study found no significant difference between both arms with respect to secondary outcomes of therapy patterns, testing, or care utilization. 

The authors note some possible limitations with the study. For example, their cohort had an overall very high KCCQ-12 score, consistent with already strong perceived health status. In addition, the study was limited to a single center academic HF clinic. Although the study found no significant change in patient-reported health outcome with regular monitoring of patient reported health status, the authors do remark on the value of such assessments for improving the accuracy of clinical health status assessment as well as the patient experience.