Table 3.

Prioritized patient-reported outcome measures by conceptual framework domain and future directions

Domain and Prioritized PROMs	Gaps and Future Directions
Fatigue and energy
Domain in general	• Concept elicitation to evaluate relative importance of energy and vitality
Chalder Fatigue Scale	• Developed for chronic fatigue so may not capture fatigue as relevant to kidney failure
	• Weak responsiveness testing relevant to KRT
	• No identified Spanish language version
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	• Lack of validation testing in the dialysis population
	• Lack of responsiveness testing relevant to KRT
	• Scoring not intuitive (i.e., not normalized and a higher score represents lesser fatigue)
Intrusion on family/social life
Domain in general	• Concept elicitation to prioritize most important aspects of family/social life to evaluate, including defining “family”
PROMIS Item Bank v2.0 Ability to Participate in Social Roles and Activities	• Lack of validation testing in the dialysis population
	• Lack of responsiveness testing relevant to KRT
Ability to be active
Domain in general	• Concept elicitation to prioritize most important aspects of activity to evaluate
	• Identification or development of measures assessing ability to work or go to school
PROMIS Physical Function Item Bank	• Lack of validation testing in the dialysis population
	• Full item bank (165 items) too burdensome and role of CAT in regulatory-focused clinical trials unclear; unclear if short form versions capture most important aspects of concept
	• Limited questions related to ability to work/go to school
Freedom domain of the CHOICE Health Experience Questionnaire (CHEQ)	• Validation testing among a more contemporary dialysis population
	• Lack of responsiveness testing relevant to KRT
Symptoms
Domain(s) in general	• Evaluation of symptom clusters as they relate to potential device physiologic targets (e.g., uremia-related symptoms, fluid-related symptoms)
	• Identification of optimal, symptom-specific PROMs
	• Known gaps in existing PROMs for the symptoms of cramping and swelling
PROMIS	• Lack of validation testing in the dialysis population
	• Lack of responsiveness testing relevant to KRT
Disease-specific symptom instruments	• Exploration of the potential overlap of function related to symptoms and function itself (as captured in the core domains)
	• Identification of symptom clusters relevant to physiologic targets

PROM, patient-reported outcome measure; PROMIS, Patient-Reported-Outcome Measures Information System; CAT, computerized adaptive testing.