Figure 1.

The proposed conceptual framework for a HRQOL PROM for transformative KRT devices includes three common domains and unlimited, device-specific symptom domains. The patient-reported outcome conceptual framework depicts the hypothesis that transformative KRT devices could affect HRQOL either directly, through changes in physiologic effects (e.g., improvement in fluid balance, reduction in intradialytic hypotension, etc.), and/or indirectly, through changes in patients’ experiences with the treatment (e.g., more dialysis-free time, fewer dietary restrictions, etc.). The framework consists of three core HRQOL-related domains posited as common to all devices (fatigue and energy, intrusion on family/social life, and ability to be active), and an unlimited number of flexible symptom domains that are device-specific. Relevant symptom domains would be selected on the basis of device characteristics and physiologic targets (e.g., clearance, ultrafiltration). A domain is the specific feeling, function, or perception being measured. HRQOL, health-related quality of life; PROM, patient-reported outcome measure.